Processed Products Establishment Inspection Manual

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Table of Contents

Introduction

The primary purpose of this manual is to provide inspectors with a ready made reference of procedures to follow in their work. It will also be of assistance in training new personnel and in maintaining uniformity in our inspection work.

An attempt has been made to include guidelines for the inspection of all registered processed products establishments. This manual is meant to serve as guidance in the traditional method of food processing establishment inspection, but it cannot cover all peculiarities that may develop from time to time. When issues not covered by the manual arise, the Program Network Specialist should be consulted for assistance. The Processed Products Establishment Inspection Manual is not meant to serve as a Hazard Analysis Critical Control Point (HACCP) document, but the Manual could be used as a reference in the development of such quality management systems.

The Processed Products Establishment Inspection Manual has been incorporated into CFIA's new inspection database "Multi Commodity Activities Programme" (MCAP). Relevant information related to Registered Processed Product Food Establishments has been entered and stored in the database. Inspection worksheets and reports derived from inspections are generated from the MCAP database.

Note:

This manual has no precedence over any federal regulations. For legal requirements, consultation of the appropriate set of regulations is recommended.

Program Objective

To evaluate the establishment's control over equipment, premises, operations and environmental conditions in order to effect compliance with the Processed Prducts Regulations and to produce safe and wholesome products.

Some of the program goals include:

  • To confirm that processed fruit and vegetable products are processed under safe and sanitary conditions by identifying and requiring compliance to health and safety standards and other regulatory requirements.
  • To establish clear national standards procedures and for establishment inspection.

General Principles of Food Hygiene, Composition and Labelling; Code of Practice (GPFHCL)

The GPFHCL describes the Canadian requirements to ensure compliance with Good Manufacturing Practices (GMP) for foods and other food requirements under the Food and Drugs Act and Regulations. The principles and assessment criteria of this establishment manual were taken from the GPFHCL and were modified to reflect the requirements of the Processed Products Regulations and other applicable regulations, standards and policies.

Responsibilities

  1. Industry

    Industry is responsible for:

    • the safety and quality of food products offered for sale;
    • compliance with appropriate government regulations.

    Since the inspection program measures the attainment of these responsibilities, industry is encouraged to actively participate with the inspection team in the inspection of their establishment. As well, they are further encouraged to implement the same inspection program and self monitor their performance on an ongoing basis.

    • Establishment management is responsible to:
    • accompany the inspection team;
    • provide for the dismantling of equipment, when required;
    • assist in record and program reviews.

    This will facilitate an accurate and thorough evaluation of items.

  2. Canadian Food Inspection Agency

    The Canadian Food Inspection Agency (CFIA) is responsible for the delivery of the program as designed.

    The Government of Canada has consolidated all federally-mandated food inspection and quarantine services into a single federal food inspection agency. The consolidation into a single agency enhances food safety systems by integrating the delivery of inspection and quarantine services previously provided by Agriculture and Agri-Food Canada, Health Canada, and Fisheries and Oceans Canada. All inspection services related to food safety, economic fraud, trade-related requirements, and animal and plant health programs are provided by CFIA.

  3. Health Canada

    The responsibility for food safety policy, standard-setting, risk assessment, analytical testing research and audit will be reinforced and remain with Health Canada.

Chapter 1 - Registration of Establishment

1.1 Legal Requirements

1.1.1 Registration Requirements

Registration is required to enable an establishment preparing processed fruit and vegetable products regulated under the Processed Products Regulations (PPR):

  • export them (either under the establishment's own label or that of a buyer or first dealer),
  • trade them interprovincially (either under the establishment's own label or that of a buyer or first dealer),
  • apply a Canadian grade mark to the applicable products.

The following terms are defined in the Section 2.(1) of the Processed Products Regulations:

  • "Establishment" means any place in which fruits or vegetables, or any product thereof, are prepared for food;
  • "Registered Establishment" means an establishment that is registered pursuant to subsection 11(1) of the PPR
  • "First dealer" means any person operating as a wholesaler, retailer or distributor who buys and sells under his own private label any food product prepared for him in a registered establishment.
  • "Processed" means canned, cooked, frozen, dehydrated, concentrated, pickled or otherwise prepared for food to assure preservation of a food product in transport, distribution and storage but does not include the final cooking or preparation of a food product for use as a meal or part of a meal such as may be done by restaurants, hospitals, food centres, catering establishments, central kitchens or similar establishments where food is prepared for consumption rather than for extended preservation.

Sections 10 and 11 under Part II of the PPR outline the procedures for registering an establishment.

Sections 13 to 17 under Part II of the PPR outlines the conditions that an establishment must meet in order to become and remain registered.

Section 13 of the Canadian Agricultural Products Act (CAPA) outlines the conditions of Registration and operation of an establishment as a registered establishment under this Act, and states that the establishment and all agricultural products in it are subject to this Act and its Regulations. Products subject to the PPR and produced in a registered establishment must meet all of the requirements (grades, standards, etc.) of the PPR even if the products do not leave the province of origin.

Please note that all local and provincial ordinances and codes must also be observed.

1.1.2 Determining which establishments need to be registered

The following guidelines are applied in determining which establishments must be registered. These guidelines apply in addition to the conditions in section 1.1.1

  1. Activities such as picking, sorting and washing the raw materials (the fresh fruits and vegetables) that go into making processed products are excluded from the provisions of sections 56 and 59 of the PPR. These fresh raw products are dealt with under the Fresh Fruits and Vegetables Regulations. Establishments that pick, sort and wash the fresh fruits and vegetables, which are then sent to a processor, are not subject to registration under the PPR.
  2. Any establishment which processes fresh fruit and vegetables from their own farm into processed products is subject to registration because the actions they perform on the fruits and vegetables are considered both "preparation" according to the CAPA and "processed" according to the PPR.
  3. Sections 56 and 59 of the PPR are not restricted to food products processed but extend to products prepared in a registered establishment. Thus, establishment that undertakes any preparation action in respect to a processed product (after the agricultural products are processed) is also subject to registration for the purpose of sections 56 and 59. Establishments that prepare an already-processed food product are also subject to registration.

Processing means canning, cooking, freezing, concentrating, pickling, or otherwise preparing a food product to assure preservation of the food product in transport, distribution and storage.

Preparation includes processing, slaughtering, storing, inspecting, grading, packing, assembling, pricing, marketing and labelling an agricultural product.

Preservation can include freezing, thermal processing, acidifying, fermenting or aseptic processing.

Packing can include placing the food product in metal cans, retortable pouches, bottling, aseptic packaging, plastic bags or cardboard containers.

Examples which apply these guidelines:

Scenario 1: A Canadian farm picks, cleans and packs blueberries into cartons in the field. They are shipped to the USA to be frozen. The farm then imports the frozen fruit back into Canada for sale.

Interpretation: Registration is not required (1.1.2 guideline 1). The product was exported under the Fresh Fruit and Vegetable Regulations. The product would be imported under the Processed Products Regulations (e.g., must be accompanied by an import declaration, may require a Ministerial Exemption or LTL Label Approval Number).

Scenario 2: Fruit is picked in a particular province, then cleaned in a barn, roughly packed in large flats and shipped to another province, where it is inspected, sorted and cleaned, packaged and frozen. A Canada grade mark is applied to the packaging. The product is then sold in the province in which the freezing portion of the process had taken place.

Interpretation: The grower in the first province does not have to be registered, as the fruit is being shipped under the Fresh Fruits and Vegetables Regulations. The establishment preparing and freezing the product must be registered because they are applying a Canada grade. If a Canada grade was not applied and the product was sold in the province in which it was prepared, packaged and preserved, no registration would be required and the product would not be subject to the PPR. If the frozen product was shipped back to the original province, the establishment preparing, packaging and freezing would require registration and the product would be subject to the PPR and therefore must be graded accordingly.

Scenario 3: An entrepreneur prepares 5000 cases (12 jars/case) of dill pickles, packed in glass. Processing is conducted in a rented church kitchen. This activity takes place once per year, over a one month period, usually in the fall at harvest. The product is sold at farmer's market within the province.

Interpretation: Registration is not required when product is sold within the province and the product is subject solely to the Food and Drug Regulations and Consumer Packaging and Labelling Regulations.

Scenario 4: A company ferments pickles and ships them in bulk to a packer in the same town. The packer bottles, labels and sells the pickles within the province.

Interpretation: Neither establishment needs to be registered and the product is subject solely to the Food and Drug Regulations and Consumer Packaging and Labelling Regulations.

Scenario 5: A registered establishment prepares and preserves pickles and ships them to a packer in the same town. The packer bottles, labels and sells them outside the province.

Interpretation: The packer needs to be registered because the product is shipped outside the province.

Scenario 6: A company prepares, ferments, bottles and labels pickles for a first dealer who sells them outside the province of origin.

Interpretation: The company must be registered, because the product is being shipped outside the province. The first dealer does not need to be registered.

Scenario 7: Several entrepreneurs will share a common facility to product their products. They will each pack for a certain period of time under their own labels. The products will be sold outside the province.

Interpretation: The facility must be registered, but it can only have one establishment number. It will be registered to one operator (as selected by the applicants) and the other users will be named in the "Also Doing Business as" section of the Application for Registration. The operator will be responsible for ensuring that the conditions of registration are met and maintained. It will be the operator's responsibility to address deficiencies noted when the other users are processing and preparing in the facility.

1.1.3 Products Regulated under the Processed Products Regulations

All regulated products are indicated in PPR Schedules I, II and III. An establishment processing and shipping interprovincially or internationally, or applying a grade to any of these products must be registered. Depending on the schedule in which the product is included, different regulatory requirements apply:

Schedule I: Canned and Frozen Fruit and Vegetable Products

Graded Products: For these products, grades are required and substandard grades are not allowed unless the product is marked "substandard" (PPR, Section 38.(2)). The product must meet the compositional standard defined under each grade.

Optional Grades: For these products, grades are optional and substandard grades are allowed when no grade is declared. The product must meet the compositional standard defined under each grade.

Schedule II: Canned and Frozen Fruit and Vegetable Products

Standards of Identity: For these products, no grades exist. The use of the standard of identity name is permitted only if the product meets the compositional standard.

Schedule III: Canned and Frozen Fruit and Vegetable Products

Standard Containers: Contains all the products for which standard containers apply.

Note: for some products, only standard containers apply. Establishment preparing such product must be registered. For example, no grade or standard of identity exists for baby foods, but there are standard requirements. Therefore, establishments processing baby foods (excluding frozen) must be registered.

Please refer to your local CFIA inspection office or consult the PPR for more information on product standards.

1.1.4 Products Regulated Under Other Regulations

Registration with CFIA is required for any establishment producing fish products, maple products, honey, dairy products, meat and poultry products. Please refer to your local CFIA inspection office to obtain more information.

Products not covered under a standardized agricultural products legislation (e.g.: coated french fries, jams with alcohol, bakery products, peanut butter) fall under the Food and Drug Act and Regulations, the Consumer, Packaging and Labelling Act and Regulations, and other relevant legislation. At this time, there are no registration requirements for establishments producing these products; however, they are still subject to CFIA inspection.

1.2 Applicant's Steps for Registration

1.2.1 Applicant Forms

The following two forms must be submitted to the local CFIA inspection office:

Following are instructions on completing the forms.

1.2.1.1 Application for Registration of an Establishment

  1. Type of Application: Check the appropriate box.
    • New: For a new establishment or when the location of an establishment has moved;
    • Renewal: For the annual renewal of the registration Establishment registrations must be renewed every 12 months, counting date the date on which the registration was issued);
    • Revision: For any changes made to the legal name of the establishment or the address of the processing establishment (the location of the establishment has not moved).
  2. Preferred Language of Correspondence: Check the appropriate box.
  3. Existing Registration Number (if applicable): For renewal or revision, indicate the registration number assigned to the establishment.
  4. Legal Status of Business: Check the appropriate box.
    • Corporation or Limited Company: This consists of a legally registered or incorporated entity. The business name usually includes Ltd. or Inc. in the title. The business must be federally or provincially registered. Copies of official articles of incorporation or other registration documents are required. Example: National Preserves Inc.
    • Partnership: When two or more people operate a business, they may form a partnership. This partnership must be federally or provincially registered. Example: Mike Smith and Sons.
    • Individual: This consists of one person operating a business. This person can operate without a business registration or documentation as long as the person's first name and surname are used in the business name. Example: John White's Preserves. An individual can operate a business without using their own name in the business name but in that case the name should be registered.
    • Co-operative: This is a business such as a farmer co-operative that has been created under the Co-operative Act. This business must provide legal documents establishing the co-operative. Example: Frozen Blueberry Packers Co-operative.
  5. Legal Name of Business as Registered
    • Please ensure that the company name recorded on the form is exactly the same as the legal name on the articles of incorporation partnership documents on the documents establishing the co-operative. Under the "Also Doing Business as" heading the applicant should indicate each additional commercial or operating name which they use.
    • In the case of shared facilities, the legal name of each business or individual (other than the applicant) using the premises to process food products must be indicated in the "Also Doing Business as" section.
    • In cases where the company name is not registered or incorporated, or not partnership or co-operative exists, the complete name of the individual requesting registration must be in the "Legal Name of Business" section. The company or operating name used by the individual should be included under "Also Doing Business".
  6. Street Address or Legal Description of Location of Establishment:
    • Please note that there is a separate box to indicate the mailing address. When a postal box number is available it must be shown in the box assigned for the mailing address.
    • Urban Areas : The street number, street name, town and province are acceptable as the legal address to be indicated in this box.
    • Rural Areas : The street number, street name, town and province are acceptable as the legal address to be indicated in this box. However, where street numbers and names are available, the legal address in use in the province must be identified. The Ontario format is as follows: lot, concession, township and municipality or county. In the Atlantic provinces, some places are still only identified by a registered survey number.
  7. Mailing address (if different): Please indicate the complete mailing address including postal code. If the mailing address is different or the same as the physical address, "same as above" is an acceptable entry in the "Mailing Address" box. When a P.O. box number is available it must be shown in this box.
  8. Telephone and Facsimile: Provide the telephone and facsimile numbers of establishment or operator.
  9. Name and Address Including Postal Code of Applicant: In this box, please indicate the name, title and address of an individual who will be the contact for registration. This is the address to which all future registration correspondence will be sent. If the address of the applicant is exactly the same as in the above fields, indicate "same as above". For the smaller businesses, the address may be the address of the establishment or a personal address. For larger corporations, the address may be the establishment address or the address of the head office. This box may also be used to indicate the e-mail address of the contact, where available.
  10. Telephone and Facsimile: Provide the telephone and facsimile numbers of the applicant if different from the establishment's numbers
  11. Partnership/Individual Ownership: This box only needs to be completed for partnerships or individual ownerships. Provide the names, titles, and addresses of all parties involved in the business. If more room is required for this information another page can be attached.
  12. Signature: The person who signs the form must be a responsible person within the company (i.e., a director or shareholder) and must ensure that all information on the form is correct before signing. In addition to the signature, please print date of request, and identify the title or official capacity of the person who signs the form.
  13. Agency Use Only - this area is reserved for agency officials to sign, date, and make any necessary comments after reviewing the applications.
  14. Reverse Side of Application

    Please check the "Processed Products Regulations" box. This application form is only for PPR registration, so do not check other boxes even if the establishment is or wishes to be registered under other regulations. An entirely separate application form will need to be filled out to apply for registration under other regulations.

1.2.1.2 Descriptive Profile of Applicant Establishment for Processed Products

A Descriptive Profile should always accompany the "Application for Registration of any Establishment" form. It is important to complete the Descriptive Profile properly. The information provided on this profile is required to identify the type of the establishment and the type of products produced. This information is essential in planning the inspection schedule.

  1. Name of the establishment

    The name of the establishment must correspond with the name on the "Application for Registration of an Establishment" form. It is important to complete the Descriptive Profile properly. Also the address of the processing establishment must be provided.

  2. Type of Establishment Please check the box that applies to the appropriate type of establishment. For establishments registered under the PPR, the options are:
    • ALAFP/LAFP (Acidified Low-Acid and Low-Acid Food Products) or
    • OTLA (Other Than Low-Acid Food Products).
    • For information on establishment products and types see section 1.3.2. If an establishment wishes to be registered for more than one commodity group (i.e. OTLA - Other Than Low-Acid Food Products and MP - Maple Products Packing Plant) a separate set of application forms must be filled out for each commodity group.
  3. Commodities Packed - Indicate all products produced or packed.
  4. For Internal Use

    Comments: This area is reserved for Agency officials to make any comments regarding the registration.

    Registration Recommended: Once the application has been reviewed, an Agency official will check the appropriate box. The recommendation will then be signed and dated by the responsible Agency official.

  5. Reverse side of Descriptive Profile:
    • Direction (Map) to Location of Establishment: Please make a schematic drawing of the location, especially if the establishment may be difficult to find. A map is not necessary when renewing a registration as long as a map has been provided previously and/or the inspector knows how to find the plant.

1.2.2 Construction and Equipment Requirements

Buildings exterior, interior and surrounding areas must be designed, constructed and maintained in a manner to prevent conditions which may result in the contamination of food.

Materials used to construct buildings and equipment should be on the CFIA's Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products. It is an excellent reference when deciding on construction materials and equipment. All direct food contact surfaces must be listed in the Reference Listing.

The Processed Products Program does not register or approve blueprints or pieces of equipment.

More details on construction and equipment requirements can be obtained through your local CFIA inspection office or by referring to Chapter 4 of this manual.

1.2.3 Written Program Document

There are regulatory requirements (PPR, Sections 13 to 17) for establishments to have developed, documented and implemented programs to control factors not directly related to manufactured controls but essential in any food establishment. These are universal steps or procedures that control the operational conditions within a food establishment allowing for environmental conditions that are favourable to the production of safe food.

  1. Sanitation Program (required for the registration under PPR, sections 10(2) and 16(2)): This program must be reviewed and approved by the responsible inspectors prior to registration. The inspector may require some changes to the programs if it is incomplete or if some improvements are needed.
  2. Pest Control Program (PPR, section 16(8)): This program has to be developed and maintained by the establishment.
  3. Recall Plan (PPR, section 30.2(d)): This written program is to be developed by the establishment, when processing Low Acid Foods and Acidified Low Acid Foods
  4. Process Files (PPR, section 30.2(a)(i)): This written program is to be developed by the establishment, when processing Low Acid Foods and Acidified Low Acid Foods

The last three supplementary programs do not have to be reviewed and approved by the responsible inspectors prior to registration. However, all written programs must be based on the standards and regulations as stated in the CAPA and the PPR.

More details on these programs can be obtained through your local CFIA inspection office or by referring to Chapter 4 of this manual.

1.2.4 Suggested References

Acts and Regulations

The Regulations are available on the CFIA Website: (www.inspection.gc.ca/eng/1299846777345/1299847442232)

Reference Listing of Accepted Construction Materials, Packaging Materials and Non-food Chemical Products

  • This is a current list of materials and non food chemicals which have been found by Health Canada and CFIA to be acceptable for use in establishments operating under the authority of the CFIA. The primary purpose of this publication is to provide a ready made reference for both inspection personnel and representatives of the managerial staff of establishments, to indicate the acceptance status for products intended for use in establishments. The inclusion of the name of a product in this list is not to be construed as an endorsement of that product.
  • You can contact your local CFIA inspection office for information on how to obtain approval for the use of new materials or products in establishments.
  • Other useful information (e.g. Food Safety Enhancement Programme (FSEP) and (HACCP) can be found on the CFIA Website.

1.2.5 Internal Establishment Inspection

Prior to submitting an application to be registered, the establishment management is expected to carry out independent sanitation audits of their food processing facility, based on the CFIA program requirements, and to make appropriate corrections based on their findings.

1.2.6 Application Submission

A complete registration package must include the following:

  • Application for registration of an establishment (CFIA/ACIA 3043)
  • Descriptive Profile of applicant establishment for processed products (CFIA/ACIA 3382)
  • Sanitation Program (as required by PPR, Section 10(2).
    • An approval note from the inspector is acceptable for lengthy programs.
  • Corporate Papers (if applicable, photocopies are permitted;
  • Registration Fees (see section 1.3); and,
  • For establishments requesting reduced inspection fee, a Letter of production volume or estimated production volume for the coming year.

The required forms are available through the Forms Catalogue.

The application package should be forwarded to the local CFIA inspection office for new applications, arrangements must be made for a pre-registration establishment inspection.

1.3 Fees

1.3.1 Purpose of Inspection Fees

Fees are based on the Processed Products Fees Order that can be found on the CFIA Website. This order states that a fee is payable for the registration of an establishment, or the renewal of an existing registration, on a yearly basis. The purpose of the fees is to cover part of the costs associated with inspection activities.

1.3.2 Establishment Registration Fees

Registration Validity Period

  • All establishment registrations will be valid for one year, from the date of registration. The expiry date will be indicated on the Certificate of Registration.

Registration Fees by Type of Operation

  • The annual fees payable for the registration of a processed fruit and vegetable establishment are as follows:

* Plus applicable taxes

Table 1-1 Registration Fees
Level of Inspection Service Acidified and Low Acid Food Products Other than Low Acid Food Products
Full $2710* $850*
Reduced $625* $300*

1.3.2.1 Level of Inspection Service

The Processed Products Fees Order does not define the terms full inspection service and reduced inspection service but make reference to the definitions in this manual. These definitions are as follows:

  1. Full Inspection Service: The full inspection service status applies to all establishments not meeting the criteria for reduced inspection service status, as defined below.
  2. Reduced Inspection Service: Operators of establishments may apply for reduced inspection service status if the following criteria are met:
    1. The establishment's annual production of PPR-regulated foods is not greater than 250,000 kg. This volume does not include commodities covered by other legislation (Dairy, Meat, Honey, Fish, Eggs) or products subject solely to the Food and Drugs Act and Regulations. A statement of the production volume for the previous year must be provided with the application for registration. For new establishments, a statement of the estimated production volume for the first year of production is acceptable. In subsequent years, volume of production for the previous year must be submitted. An audited statement may be required.
    2. The Overall Establishment Rating is "Acceptable" when the application is made. Lower fees are justified by the fact that fewer resources are required for the inspection of smaller establishments, if they maintain a good record.

1.3.2.2 Type of Products

The following terms (except Other than Low-Acid Food Products) are defined in sub-section 2.(1) of the PPR:

  • Acidified Low-Acid Food Products (ALAF): A food that has been acidified or fermented so as to obtain an equilibrium pH of 4.6 or lower after heat processing.
  • Low-Acid Food Products (LAF): A food product any component of which has a pH value above 4.6 and a water activity (Aw) above 0.85 after thermal processing.
  • Other than Low-Acid Food Products (OTLA): Any food product not covered by the first two categories. Lower fees will be applied to establishments producing OTLA food products because of the lower risk associated with the production of these products.

1.3.3 Refunding Establishment Registration Fees

Refunds will be handled on a case by case basis using the following guidelines:

  1. A refund could be issued to an establishment that wishes to de-register; they must be in good standing and must apply to their local Regional Program Officer or Area Program Specialist in writing, who will forward the request to the Director of the Accounts Receivable Service Centre.
  2. A refund will not be issued for a de-registration (cancellation) due to non-compliance.
  3. A refund will not be issued for a change of ownership, since the Registration Certificate is non-transferable. The previous owner will forfeit any "unused" portion of their registration fees and the new owner will pay for a full year as a new applicant would.
  4. If granted, a refund will be based on the length of time remaining in the registration period, calculated to the nearest month.
  5. There is no fee for processing a refund.

1.3.4 Label Registration Fees

Pre-market registration of labels and recipes for certain meat and processed products no longer required

Regulations Amending the Processed Products Regulations

1.4 CFIA Responsibilties

1.4.1 Establishment Registration Package Review by the inspector

The registration package, as described in section 1.2.6, will be reviewed by the inspector and any missing information required will be requested from the establishment. Once the registration package has been reviewed and the registration fee has been paid, an inspection time will be arranged with the establishment managers.

1.4.2 Establishment Inspection

The establishment will receive an in-depth inspection (conducted using MCAP using the reserved registration #) in order to assess compliance with Sections 13 to 17 inclusive of the PPR. The Inspector will generate a MCAP worksheet so that all of the applicable tasks in Chapters 4 and 5 of this manual can be assessed for compliance before registration.

Inspectors will discuss results with establishment management. An Inspection Report (CFIA/ACIA 0992), noting all deficiencies, will be left with the applicant. The MCAP worksheet will be kept on file by CFIA. Prior to registration, the applicant must correct the deficiencies associated with sections 13 to 17, noted on the report and contact the inspector to verify that all regulatory requirements are met. An acceptable action plan must be submitted to address all remaining deficiencies.

In this case, registration can be recommended.

1.4.3 Recommendation to Register

When Operations has reviewed the required documents and the inspection report, and has determined that the applicant-establishment meets all the registration requirements, the Supervisor or Regional Program Officer will sign and date the Descriptive Profile (CFIA/ACIA 3382) and select "Yes" under "Registration Recommended". The package is then sent to the Area Program Network Specialist along with the proof of fee payments.

The Area Program Specialist will review the application package then sign the Application for Registration of an Establishment form (CFIA/ACIA 3043) in the "Agency use only" section and issue the Certificate of Registration. A copy of the Certificate of Registration, the Application for Registration and the Descriptive Profile) will be sent to Headquarters to officially enter the establishment in the National Registration List.

A reserved registration number may unofficially be provided to an applicant/establishment who wishes to prepare in advance labels and cartons for printing; however the applicant/establishment must be informed that no interprovincial and/or export trade is allowed prior to receiving their Certificate of Registration. A reserved number can be obtained from the Area Program Network Specialist, who will request it from the National Program Officer by providing the applicant's name, address and establishment type (ALAFP/LAFP or OTLA - see section 1.2.1.2).

1.4.4 Certificate of Registration

Formal acknowledgement of an establishment's registration is confirmed through the issuance of a Certificate of Registration. The Certificate of Registration is sent to the establishment and is accompanied by a letter explaining the meaning and conditions of registration. The "Date of Registration" shall be the date on which the Certificate is issued. The Certificates of Registration must be renewed annually with fee payment unless registration suspension or cancellation is invoked or registration is revoked.

1.5 Registered Establishment's Responsibilities

1.5.1 Responsibilities

After the processed products establishment becomes registered, its operator has several obligations and responsibilities:

  1. Establishment and Label Registration Fees: The establishment and label registration fees must be paid upon application and upon the renewal due date.
  2. Certificate of Registration:
    1. The Certificate of Registration must be posted in a conspicuous place in the establishment for the period during which it remains in force.
    2. The Certificate of Registration cannot be assigned or transferred to another establishment, location, owner, leaser or renter.
  3. Establishment Registration Number: The registration number assigned to the establishment must be marked on one panel of the shipping cartons for all food products subject to the PPR. The registration number can also be applied to products subject solely to the Food and Drug Regulations, which are prepared in a Registered Establishment.
  4. Label Registration Requirements: All labels of food products subject to the PPR must meet the marking requirements and must be registered by the CFIA, as stated in Part IV of those Regulations. The operator of a registered establishment shall keep in the establishment the Notice of Label Registration and a sample of every registered label used in the establishment.
  5. Assistance to Inspectors: During an inspection, investigation, or sampling activity, the registered operator must provide to the inspector reasonable assistance to enable them to carry out their duties and must also provide to the inspector the information required as stated in Part V, Section 48 of the PPR.
  6. Sampling: The operator must supply, free of charge, samples as requested by the inspector for grading and analysis as stated in Section 21(1)b of the CAPA and Section 23(1)a of the Food and Drugs Act (FDA).
  7. Maintenance and Operation: The establishment must be maintained and operated in accordance with the Regulations.
  8. Operational Changes:
    1. The operator must inform the local inspector prior to undertaking changes, such as:
      1. Structural expansion or renovation;
      2. Process alterations or additions (freezing, canning, retorting, process flow);
      3. company name.
    2. The local inspector will indicate to the operator if new documents or forms must be submitted and if a new certificate will be issued. An inspection of the new installation or the establishment may be required.
  9. Change of Ownership or Physical Location: The establishment should notify the inspector prior to a change in ownership or physical location. The establishment will be treated as a new applicant. They must apply for registration (see section 1.2) and will be subject to an inspection as per section 1.4.2
  10. Closure: The local inspector should be notified in advance if the establishment plans to cease operating and close. A Letter of Cancellation (Appendix 1-3) will be sent, and arrangements will be made to retrieve the Certificate of Registration from the establishment. The Registration Number will be held for two years in case of re-registration.

1.5.2 Renewal Procedure

CFIA Area Offices will issue a registration renewal notice before a registration expires (see Appendix 1-1). Establishments must submit the following renewal package:

  1. Completed Application for Registration of an Establishment (CFIA/ACIA 3043) and Descriptive Profile of Applicant Establishment for Processed Products, Maple and Honey (CFIA/ACIA 3382) forms
  2. Sanitation Program, if different from the previous year;
  3. Corporate Papers, if different from the previous year (e.g. change of principle officers);
  4. Registration fees; and,
  5. Statement of Production Volume for establishments paying reduced fees (see section 1.3.2).

The package must be forwarded to the Regional or Area contact named in the renewal notice.

The registration number will be reserved for two years. Should the establishment resume production of processed products, they must apply for a new registration.

Appendix 1-1: Notice of Pending Expiry

(CFIA office Address)

(Date)

(2820-1-Reg #(registration #)

(Establishment representative)

(Address of establishment)

Subject: Notice of Pending Expiry Of Processing Establishment Registration - (Date)

Please be advised that the registration for your federally registered establishment to operate under Processed Products Regulations (PPR) expires on (Date). Subsection 56(1) and 59(1) of the PPR state that establishments that prepare processed food products under PPR and trade these products internationally and/or interprovincially, or mark these products with a Canadian grade mark must be registered. Establishments that allow their registration to lapse will lose their registration and subsequent trade privileges.

A renewal package which includes the necessary application forms and the current fee structure is enclosed with this letter. Please indicate any changes to your business on these application forms. A change in the registered business name should be supported by copies of the necessary legal documents.

The completed application forms for renewal along with the fee payment (cheque, credit card or money order payable to the Receiver-General) must be returned to the following address of the Regional Office of the Canadian Food Inspection Agency (CFIA) before (Date):

(Regional Officer or Area Specialist)

(Address of Regional or Area Office)

Please note that any registration renewals for honey and maple products establishments should be completed on separate application forms because these products are regulated under different federal legislation.

Establishments no longer requiring federal registration should notify the Regional Office at this time.

If you have any questions, please contact the undersigned or your local CFIA representative.

Yours truly,

Processed Products Program Network Specialist

Enclosure

c.c.:

Appendix 1-2: Notice of Entry

(CFIA office Address)

(Date)

(2820-1-Reg #(registration #)

(Establishment representative)

(Address of establishment)

Subject: Notice of Expiry Of Processing Establishment Registration - (Date)

Please be advised that the registration for your federally registered establishment to operate under Processed Products Regulations (PPR) expired on (Date). Subsection 56(1) and 59(1) of the PPR state that establishments that prepare processed food products under PPR and trade these products internationally and/or interprovincially, or mark these products with a Canadian grade mark must be registered.

Establishments that allow their registration to lapse, will lose their registration and subsequent trade privileges.

If you wish to maintain your registration, please submit completed application forms for renewal along with the fee payment (cheque, credit card or money order payable to the Receiver-General) to the following address of the Regional Office of the Canadian Food Inspection Agency (CFIA) as soon as possible:

(Regional Officer or Area Specialist)

(Address of Regional or Area Office)

If you have any questions, please contact the undersigned or your local CFIA representative.

Yours truly,

Processed Products Program Network Specialist

Enclosure

c.c.:

Appendix 1-3: Cancellation of Expired Registration

(CFIA office Address)

(Date)

(2820-1-Reg #(registration #)

(Establishment representative)

(Address of establishment)

Subject: Cancellation of Expired Processing Establishment Registration

Please be advised that the registration for your establishment to operate under the Processed Products Regulations (PPR) expired on (Date). As we have not yet received your renewal application for FISCAL YEAR, we are interpreting this as your intention to let your establishment's federal registration lapse. The name and address of your establishment will be deleted from our list of registered processed establishments.

Subsection 56(1) and 59(1) of the PPR state that establishments that prepare processed food products under PPR and trade these products internationally and/or interprovincially, or mark these products with a Canadian grade mark must be registered.

Violating these regulations may cause Canadian Food Inspection Agency (CFIA) to take appropriate enforcement action.

If it is your intention to maintain your registration, please notify us immediately and send a completed application and payment to the above noted office.

If you require further information and/or application forms, please do not hesitate to contact the undersigned or your local CFIA representative.

Yours truly,

Processed Products Program Network Specialist

Enclosure

Chapter 2 - Establishment Inspection Methods and Procedures

2.1 Introduction

This Chapter describes the processes and procedures involved in the inspection of establishments registered under the Processed Products Regulations. As such, this Chapter begins with a general description of the set-up and content of Chapters 4 and 5, which contain the inspection criteria that will be applied during establishment inspections

2.1.1 Chapter 4: General Inspection Criteria

Chapter 4 sets out the general inspection criteria which apply to all establishments. The chapter is divided into seven major sections:

  • 4.1. Premises
  • 4.2. Transportation and Storage
  • 4.3. Equipment
  • 4.4. Personnel
  • 4.5. Sanitation and Pest Control
  • 4.6. Complaints and Recalls
  • 4.7. Records

2.1.2 Chapter 5: Manufacturing Controls

Chapter 5 sets out the inspection criteria for the major steps involved in controlling processed products manufacturing. The chapter is divided into fourteen major sections:

  • 5.1.1 Product Formulation
  • 5.1.2 Process Design
  • 5.1.3 Incoming Material Control
  • 5.1.4 In-Process Package Control
  • 5.1.5 Product Preparation/Blending
  • 5.1.6 Filling
  • 5.1.7 Container Closure Control
  • 5.1.8 Product Coding Control
  • 5.1.9 Pre-Process Control
  • 5.1.10 Process Control
  • 5.1.11 Post-Process Control
  • 5.1.12 Labelling Control
  • 5.1.13 Deviations and Corrective Actions
  • 5.1.14 Verification of Product Safety and Quality
Table 2-1: Annual In-Depth Inspection Frequencies
Section 4.1 Premises
Subsection 4.1.2 Building Interior
Task 4.1.2.3 Ventilation
MCAP Task and Revision Date Task 103 - April 2, 2001
Principle Statement Adequate ventilation is provided to prevent excessive heat, steam, condensation and dust, and to remove contaminated air.
Assessment Criteria Ventilation provides sufficient air exchange to prevent unacceptable accumulations of steam, condensation, dust, excessive heat or contaminated air.

Ventilation openings are equipped with close-fitting screens or filters as appropriate to prevent the intake of pests or contaminated air.

Filters are cleaned or repaired as necessary.

Rating Guide Examples
Rating I N/A
Rating II Inadequate ventilation and high risk of contamination, i.e. infestation, microorganisms, condensation, etc.

Condensation dripping on product which will have no further kill step

Rating III Inadequate ventilation, condensation/mould evident, contamination not likely

Screens, filters not tight fitting

Legal Authority PPR 14(1) (c) Protected against entry of pests, birds, etc.

(e) Adequate ventilation system

(h) (iii) Dressing rooms, lunch rooms and lavatories well ventilated

Section: Major divisions of Chapters 4 and 5, as described in sections 2.1.1 and 2.1.2 above.

Subsection: Subdivisions of the sections of Chapters 4 and 5.

Task: A specific element within the Subsection.

MCAP Task & Revision Date: Corresponding MCAP task number and the latest revision date.

Principle Statement: Principle statements are generic, broad, outcome based statements which are similar in style to CFIA Code of Practice - General Principles of Food Hygiene, Composition and Labelling, April 2006 (RDIMS 577408), the Codex Alimentarius Commission General Principles of Food Hygiene and the International Standards Organization (ISO) standards. Under each task number, principle statements express the intent of the applicable legal authority (see below) and are written to permit flexibility with respect to the type of process and the possible introduction of new technologies. Each principle statement can only be assessed once per inspection.

Assessment Criteria: The assessment criteria section lists the factors that will be evaluated by an inspector to determine if a manufacturer is in compliance with the principle statement of each task. Where appropriate, examples are used to clarify assessment criteria. Assessment criteria help provide transparency to the food industry with respect to the specific factors required and assessed by the CFIA. As new technologies and/or commodities become available, evaluation of additional criteria may become necessary. For this reason, assessment criteria given in this manual should not be regarded as exhaustive.

Rating Guide Examples: The rating guide examples are intended to be a source of guidance for inspectors when assessing the risk associated with a deficiency. Rating guide examples provide benchmarks to inspectors and promote uniformity and transparency in the assessment of conditions and operations in the processed products industry. The examples illustrate a range within which most deficiencies can be classified but do not cover all possible deficiencies or concerns. Unusual circumstances which are not addressed in the manual or circumstances where similar examples cannot be found in the rating guide can be addressed by the supervisor or the Area/Regional Program Specialist.

Legal Authority: A reference to the applicable sections of the regulations accompanies each task. The following abbreviations are used:

2.1.3 Compliance Ratings

For each task assessed, one of the following compliance ratings will be assigned. See section 2.3.6 for details on assigning a compliance rating.

  • Category I: Deficiencies entailing a risk with a high likelihood of occurrence and serious health consequences.
  • Category II: Deficiencies entailing a moderate health risk, a direct source of contamination or adulteration (e.g. sensitive ingredients, foreign materials), or repetitive regulatory infractions.
  • Category III: Deficiencies entailing regulatory violations, a low health risk or an indirect source of contamination or adulteration.
  • Satisfactory (S): No deficiencies, no health risks and no risks of contamination or adulteration were observed.
  • Not Applicable (N/A): The specific task is not applicable to the establishment. Tasks assessed N/A will have no impact on the overall establishment rating.
  • Not Inspected (N/I): The task cannot be assessed because the equipment is not available for inspection or because the task to be assessed is related to a part of the establishment that is not operational. Tasks assessed N/I will have no impact on the overall establishment rating.

2.2 Preparing for an Inspection

The importance of proper and adequate preparation can not be overemphasized. As with almost any task or project, good preparation will not only make the job easier and the inspector more confident but it will ensure better results.

2.2.1 Determining the Inspection Type

There are two types of inspections conducted:

  1. In-Depth Inspection
  2. Directed Inspection (formerly known as a "Follow-up" Inspection)

During an In-Depth Inspection all applicable generic inspection criteria from Chapter Four, as well as all criteria for the selected scope (process type) from Chapter Five are assessed. One scope (see section 2.2.3) and equipment system (e.g. retort type) and all associated processing lines feeding that equipment system should be inspected. In addition, all items on the Outstanding Tasks Report from MCAP must be reviewed. An In-Depth Inspection is also an excellent opportunity to collect product samples, if time permits.

Directed Inspections are performed as a follow-up to an In-Depth Inspection and/or to collect product samples. For details on Directed Inspections see section 2.5.3.

2.2.2 Establishing the Inspection Frequency

Table 2-2 outlines the minimum frequencies of In-Depth Inspections per Registered Establishment per year. The levels of inspection service and types of establishments are defined in Chapter 1, section 1.3.2 of this manual.

Table 2-2: Annual In-Depth Inspection Frequencies
Level of Inspection Service Low-Acid and Acidified
Low-Acid Food Products
Other than Low-Acid Food Products
Full 2 1
Reduced 1 1

2.2.3 Determining the Inspection Scope

The tasks in Chapter 4 apply to all establishments and should be assessed during each In-Depth Inspection, regardless of the scope selected for Chapter 5. Depending on the type of establishment and the products being produced, certain tasks in Chapter 4 may not apply.

Chapter 5 is divided into 6 scopes, based on processes and types of products:

  1. Low Acid Foods (LAF) in Hermetically Sealed Containers (HSC)
  2. Acidified Low Acid Foods (ALAF) Fresh Pack, Fermented Pack
  3. Acid Foods
  4. Frozen Foods
  5. Low Water Activity Foods (Low Aw)
  6. Low and High Acid Aseptic Foods (under development)

To assist in selecting the appropriate scope(s) for an establishment inspection, the following additional information is presented:

  1. Low Acid Foods (LAF) in Hermetically Sealed Containers (HSC)
    • Method of preservation: thermal treatment to achieve commercial sterility (12D process)
    • Products with a pH above 4.6 and a water activity (Aw) value above 0.85
    • Traditionally, the product is packaged hermetically, then processed for sterility.
    • Alternately, the product can be sterilized and then aseptically packed in hermetically sealed containers.
    • Examples: canned vegetables, vegetable broth in a Tetra-Brik™ or Combibloc™, retortable pouched entrées, most vegetable juices
  2. Acidified Low Acid Foods (ALAF)
    • Fresh Pack
      • Method of preservation: acidification + some heat treatment (to discourage spoilage)
      • Fresh vegetables are combined with brine (vinegar, salt, sugar, spices, seasonings, etc.) then heat-treated and left to reach an equilibrium pH of less than 4.6.
      • Final acidification occurs as the product sits in the finished package.
      • Examples: most relishes and chutneys, pickled cucumbers, pickled mushrooms, pickled beets, pickled onions
    • Fermented pack
      • Method of preservation: acidification + some heat treatment, preservatives and/or refrigeration (to discourage spoilage)
      • Low-acid products are left to acidify by natural fermentation in bulk (barrels, totes, silos, etc.).
      • The acidified vegetables are then packed in either the original brine or a new brine. Examples: "traditional" dill pickles, sauerkraut, olives (could include relishes and chutneys)
  3. Acid Foods
    • Method of preservation: inherent acidity + some heat treatment (to discourage spoilage)
    • Foods which naturally have a pH of less than 4.6 and 4.9 for tomato products naturally and a high water activity (above roughly 0.85)
    • Examples: canned fruits, canned tomato products, fruit juices and nectars
  4. Frozen Foods
    • Method of preservation: freezing and held below -18 °C
    • Fruits and vegetables that have been frozen, regardless of pH or Aw
    • Fresh produce is prepared (peeled, cut, blanched, etc.) and then subjected to sub-zero temperatures to solidify the water within.
    • Examples: frozen vegetables (peas, broccoli, etc.), frozen fruit (berries, apples, etc.) and frozen fruit juices (concentrated orange and apple)
  5. Low Water Activity Foods (Low Aw)
    • Method of preservation: a lack of available moisture + low pH (incidental)
    • By removing water and adding sweeteners (or other humectants), the water activity is reduced to below 0.85.
    • These products may also have some natural acidity, but this is not the main method of preservation.
    • Examples: fruit jams, jellies, marmalades, maraschino cherries, glace fruit
  6. Low and High Acid Aseptic Foods (under development)
    • Method of preservation: inherent acidity + heat treatment and proper packaging (to inhibit spoilage)
    • Examples: "Tetra pak™" or "Combibloc™" juices, bag in box juices

When determining the inspection scope, keep in mind that more than one scope could apply to a single establishment (e.g., an establishment could produce pickles, jams, and juices). During a registration inspection for a new establishment all available scopes (process types) must be inspected (see Chapter 1 for more details). For regular inspections, only one scope should be selected per In-Depth Inspection. For the first regular In-Depth Inspection (newly registered establishment), select the scope with the highest risk.

The order of relative risk, from highest to lowest is:

  1. Low Acid Foods in Hermetically Sealed Containers and Low Acid Aseptic Foods
  2. Acidified Low Acid Foods (fresh pack or fermented)
  3. Frozen Foods
  4. All others (Acid Foods, Low Water Activity Foods, High Acid Aseptic Foods)

A different scope should be selected for each subsequent In-Depth Inspection until all relevant scopes have been used, then the cycle begins again. In establishments with a low acid component, this scope must be inspected at least once per year. However, in order to inspect other scopes, establishments on a reduced level of inspection service (see Table 2-2) must have all available scopes assessed. Usually these establishments are seasonal and should have other scopes assessed at the same time as the inspection of the low acid component. Alternatively, even though they are on reduced schedule, these establishments could be visited more than once in a year to inspect an other-than-low-acid scope to ensure every scope in the establishment will be assessed over a number of years.

Once the appropriate scope has been identified it should be selected in MCAP. MCAP automatically generates the appropriate worksheet for printing. In general, inspectors should not modify the worksheet as generated by MCAP. If certain tasks do not apply, they must be rated N/A or N/I (see sections 2.1.3 and 2.3.6), not deleted from the MCAP worksheet because it is important to indicate why the task was not assessed. However, since only one scope can be selected in MCAP, when assessing more than one scope, inspectors may add any necessary tasks to the MCAP worksheet. See the Table of Contents in Chapters 4 and 5 to help identify which tasks apply to each scope.

2.2.4 Non-PPR Product Lines

When an establishment is registered under other programs (Meat, Fish, Dairy, Honey, Maple) in addition to Processed Products, management at the responsible CFIA office, through consultations with Programs, must decide how to apply the various establishment inspection programs.

If a Processed Products establishment also produces products that are covered solely under the Food and Drug Regulations (FDR), the Processed Products inspector is responsible for inspecting these production lines as well. Most tasks in Chapter 4 of this manual apply to lines that produce products solely under the FDR. Some of the common tasks from Chapter 5 apply as well, such as Product Formulae (5.1.1.1), Food Additives and Processing Aids (5.1.1.3) and Label Registration/Accuracy (5.1.1.5). It is up to the inspector to determine which tasks from the Chapter 5 apply to each of the non-PPR lines.

2.2.5 Creating the Inspection Team

The team concept is useful for the inspection of food processing operations. The size of the inspection team is a decision made by the management at the responsible CFIA office, and should be based on:

  • The complexity and risk of the manufacturing process(es), for example low acid processes
  • The size of the establishment
  • The type of inspection (In-Depth or Directed)
  • The time frame in which the inspection is to be conducted
  • The experience of inspector(s)

The team approach is used for the following reasons:

  • Inspectors may exchange places during the inspection in order to provide a fresh perspective on a particular activity.
  • Inspectors with different experience and backgrounds have a broader experience base.
  • It greatly improves inspection uniformity, as long as the same inspectors do not always work together. Each inspector learns something from the other inspector, making the Region more consistent when identifying and scoring of infractions.

Often, the inspection team may consist of only one inspector. In these cases, another inspector or the supervisor must be available (via phone, etc.) in case the responsible inspector requires assistance.

2.2.6 Notifying the Establishment

Under normal circumstances, the inspector should not notify the establishment's management of upcoming inspection date(s). However, if production is irregular the inspector may wish to verify that the establishment will be operating during the time of the planned inspection. Seasonal operations should communicate with the inspector regarding when they will be operating.

2.2.7 Reviewing the Establishment File and Other Documentation

In order to be properly prepared, the inspection team should review the Establishment File, the relevant legislation and manuals, and any other relevant documentation prior to the actual inspection.

2.2.7.1 Establishment File

For a list of the items that should be included in a complete establishment file, see section 2.6. The inspection team must take the time to read through the establishment file (at a minimum, the previous year's documents) in order to:

  • identify the establishment manager and key personnel by name;
  • review previous In-Depth Inspection reports;
  • review Directed Inspection and Product Inspection results;
  • identify outstanding deficiencies;
  • review any consumer complaints;
  • be aware of the size and complexity of the establishment;
  • note any unique features of establishment (e.g. equipment, technology, and product lines);
  • decide where the inspection will begin, identify when a major clean up will be observed and find out when a second shift (if applicable) can be observed; and,
  • familiarize themselves with the product(s) being processed (including ingredients, additives and processing aids) and the processes and equipment in use.

2.2.7.2 Legislation and Manuals

The inspection team must review the relevant sections of the:

This will ensure familiarity with:

  • grades and/or standards for the product(s) being processed, including permitted ingredients and additives;
  • general and product-specific labelling requirements and standard container sizes;
  • the process(es) being inspected, and;
  • inspection procedures.

2.2.8 Inspection Material and Equipment

Each inspector must have the following items and use or wear them in the appropriate situations:

  • Identification
    • inspector's identification card (must always be carried)
    • business cards
  • Attire
    • a clean, CSA-approved safety hat (white)
    • hair and (if applicable) beard covers without holes (not mesh/net types) in good condition
    • CSA-approved ear and eye protection
    • nuisance dust mask (if necessary)
    • a clean, white lab coat or coveralls with snap or Velcro fasteners, having no pockets above the waist (re-useable or disposable)
    • "freezer coat" and insulated gloves (if necessary)
    • safety reflector vest (if necessary)
    • sanitary gloves to cover plain, non-removable wedding bands (if necessary)
    • sanitized rubber safety boots (if necessary) or clean, CSA-approved safety footwear
  • Equipment
    • a case or bag
    • a pen without a cap
    • a clean, non-porous clipboard that can be easily sanitized
    • a flashlight in good working order
    • a calibrated light meter
    • a calibrated thermometer with steel shaft
    • sampling supplies (cups, sterilized bags, spoons, etc.)
    • coolers and ice packs for transporting temperature-sensitive samples
    • additional equipment as required during Directed Inspection
  • Forms and References
    • MCAP inspection worksheet (with appropriate scope, see section 2.2.3)
    • Inspection Report (CFIA/ACIA 0992)
    • Notice of Detention (CFIA/ACIA 3256) and Notice of Release (CFIA/ACIA 3257) forms
    • supplementary tags and CFIA seal tape
    • receipts:
      • Sample Portion (Official Sample) (CFIA/ACIA 0072)
      • Receipt for Sample(s) Taken (CFIA/ACIA 4168)
    • a copy of the applicable regulations and the inspection manuals

All forms are available to CFIA staff only and can be found in the internal forms catalogue or Desktop eForms

2.3 Conducting the Inspection

2.3.1 Professionalism

The inspector is an official representative of the Agency and must exhibit a professional image when dealing with establishment officials. All information discussed and obtained from a specific company must remain confidential. However, this does not preclude government inspection reports being made available under the provisions of the Access to Information Act.

The inspection team should park in a suitable area and ensure that their clothing (see section 2.2.8) and behaviour is appropriate (no jewellery, watch, gum chewing, etc.). Plain wedding bands and MedicAlert™ bracelets/necklaces are acceptable, as long as they are properly secured and covered (i.e., with a rubber glove or beneath the clothing). Establishment policies must be respected at all times.

2.3.2 Opening Meeting

Upon arrival at the establishment, the inspection team should conduct an opening meeting to:

  • introduce themselves to the establishment manager or person in charge;
  • present their identification or business cards;
  • explain the objective of the inspection
  • determine the establishment's work schedule and discuss the inspection plan/order (see section 2.3.3);
  • invite an establishment representative(s) to accompany the inspection team (see below);
  • ask about any special protective equipment requirements, safety measures or policies specific for that particular plant, and;
  • make arrangements for a Preliminary Closing Meeting (see section 2.3.8) and/or a Final Exit Meeting (see section 2.4.4 to discuss the inspection findings.

The establishment management should be encouraged to provide a knowledgeable representative (management, foreman, quality control) to accompany the inspection team throughout the inspection. This allows for questions to be asked on the spot and serious infractions to be addressed immediately. Any infraction that is identified during an inspection and corrected immediately must still be documented and rated appropriately on the inspection report (see section 2.4.3). Inspectors must be careful not to allow the accompanying plant personnel to rush the inspection or lead them away from infractions.

Establishment personnel are encouraged to carry out their own inspections along with the inspection team and/or independently as required by their establishment.

2.3.3 Scheduling and Inspection Order

During the opening meeting, the inspection team should have determined the establishment's working schedule, which will help when planning the inspection. Every effort should be made to assess equipment prior to start-up, in an operational condition and during disassembly, washing and sanitizing. If applicable, the inspection team should be present for shift changes (morning to afternoon, afternoon to evening, etc.) to observe the change-over routine (finishing and starting employee habits, traffic patterns, equipment cleaning, etc.) and note any deficiencies.

When possible, inspectors should be as efficient as possible in arranging the inspection order.

The inspection team should complete all tasks that require walking through the plant, observing the physical conditions of premises, personnel, equipment, etc., before proceeding with records and written programs.

The inspection should begin with the critical processing steps (e.g. retort room for low-acid establishments) and areas where major problems were revealed during previous inspections. In general, to reduce the risk of cross-contamination, the inspection team should work from the microbiologically cleanest areas to the least microbiologically clean areas (e.g., start in the packaging area and work towards raw receiving or establishment exterior).

2.3.4 Inspection Techniques

Every effort must be made by the inspection team to minimize cross-contamination. Utilize hand washing/sanitizing facilities as frequently as possible.

In general, inspectors should direct questions to management rather than to employees or non-plant personnel (e.g. truck drivers). However, questioning establishment employees can help determine if personnel are adequately trained and whether or not establishment procedures (regular production procedures, sanitation procedures, deviation procedures) are being followed properly.

In storage, mixing and blending areas, take note of ingredients, additives, and processing aids in use (especially those which you suspect could be non-permitted) so that they can be verified for compliance with the Processed Products Regulations and the Food and Drug Regulations.

In the labelling area(s), obtain a sample label of the product(s) currently being processed and packed. Briefly check the label for obvious infractions while in the establishment. Attach the label to a worksheet so it can be reviewed more closely back at the office.

In the boiler room, note the boiler additives being used, especially if steam is being used in any product or on any product contact surfaces in the establishment.

In other non-food chemical storage areas and the boiler room, note the chemical names, trade names and manufacturers of the sanitation and water/steam treatment products. Compare the list of products in use with the establishment's sanitation program and the CFIA's Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products (http://www.inspection.gc.ca/active/scripts/fssa/reference/reference.asp?lang=e). These chemicals should be stored away from the main traffic stream and away from ingredients and packaging materials. Other poisonous chemicals, such as pesticides, must be stored in a separate area (preferably restricted) away from all cleaning chemicals and food products.

2.3.5 Writing Inspection Observations

The observations made on the MCAP worksheet are a record of the conditions at the time of the In-Depth Inspection and the objective evidence used to determine category ratings. Great care must be taken to ensure that inspection observations are clear and concise, accurate, unbiased, relevant and sufficient to assign an accurate rating. Each team member should complete his/her own worksheet observations. Record which products are produced each day of the inspection. Table 2-3 outlines guidelines can be used to help write inspection observations.

Table 2-3: Observation Guidelines
Observation Criteria Example of poor description Example of high quality observations
Fully describe the non-conformity. Include the location of the infraction and details such as the severity of the problem (amount, proximity to product, how product is affected, etc.). Rust on equipment. Moderate rust on 3 of 4 pickle slicer frame legs on Line 1.
Fully describe the non-conformity. Include the location of the infraction and details such as the severity of the problem (amount, proximity to product, how product is affected, etc.). Build-up of weeds outside. Vegetation, approximately 2 feet high, growing close to wall on west side of building.
Do not draw conclusions Equipment stored in and unacceptable manner. Hand tools at filling station left on floor, not in their designated storage spot.
Do not make recommendations for correction. Kettles 1 and 2 need cleaning. Build-up of fruit residue on outside of kettles 1 and 2.
Do not make recommendations for correction. Housekeeping needs improvement. Hoses and aprons left on floor behind filler 3.
Avoid FSEP and other program requirements or terminology (References to Corrective Action Requests (CARs), Prerequisite Programs, verification frequencies, regulatory audits, etc.). Coving where walls meet floor is filthy (Meat requirement) Build-up of dirt where east-facing wall meets floor.
State only objective facts. Personal opinions, conjecture and speculation do not belong in the Observations. Pest control program out of date appears that the representative isn't doing his job. 2 rodent traps added in warehouse, changes not reflected on Trap Location Map.
State only objective facts. Personal opinions, conjecture and speculation do not belong in the Observations. The apple receiving area is disgusting. Build-up of dirt and filth in tote dumping area (apple reception).
Tasks rated N/I or N/A should either have a brief comment describing why that task is not applicable or not inspected. N/A This task does not apply because the equipment is not in use in the establishment.
Tasks rated N/I or N/A should either have a brief comment describing why that task is not applicable or not inspected. N/I This task was not inspected because the equipment is not in use at this time (no production)
Do not include names of individuals, instead, use positions or titles John Smith did not initial log. Retort operator (4-8pm shift) did not initial retort log at the 6pm retort process on May 15th.

Ensure that you review your comments, correct spelling mistakes and that the comments are with the correct task and that each non-satisfactory task has adequate comments.

2.3.6 Assessing Compliance and Assigning Compliance Ratings

Prior to discussing inspection results with the establishment, the inspection team should meet in private to discuss the inspection results among themselves to ensure agreement and consistency.

The inspection team must review all recorded observations and assign a compliance rating (see section 2.1.3) for each task.

Since only one compliance rating is possible for each task, when there are two or more non-compliances found for a task, the most serious category rating must be assigned to the task (see figure 2-2). However, within the task, the observations should be clearly grouped and each group may be assigned a different category rating even though the overall task is assigned only one rating (the most severe). The overall task rating is what counts towards calculation of the overall establishment compliance ratings. Grouping observations by category rating helps to make determining corrective action timeframes easier. This grouping does not necessarily have to be done on the worksheet used during the inspection, but should be done when entering observations into MCAP for the final report (see section 2.4.1).

Rating guide examples given for each inspection task in Chapters 4 and 5 provide benchmarks to inspectors. The examples illustrate a range within which most deficiencies can be classified, but do not cover all possible deficiencies or concerns. Unusual circumstances not addressed in the manual or circumstances where similar examples cannot be found in the rating guide can be addressed by the supervisor or Area/Regional Program Specialist.

2.3.7 Observations with Health and Safety Implications

When observations warrant Category I or Category II infractions and identify a direct source of contamination or adulteration, or multiple regulatory violations, the following guidelines are used to evaluate the potential food safety risk and identify necessary product action.

The inspection team must evaluate product safety, notify the establishment management and require the establishment to implement corrective action immediately or as soon as possible, depending on the circumstances. The inspectors must contact the appropriate CFIA supervisor as soon as possible to inform him/her of the situation. Any infraction that is identified during an inspection and corrected immediately by the establishment's staff must still be documented and rated appropriately on the inspection report (see section 2.4.3).

A full evaluation must be initiated while the inspection is still in progress, following the steps below:

  1. Determine the potential cause(s) of the infraction to evaluate product safety.
  2. Determine when the deficiency first occurred.
  3. Detain all potentially unsafe products and contact the Regional/Area Recall Coordinator if the products are on the retail market.
  4. If the cause of the deficiency cannot be determined immediately or if product safety cannot be evaluated, place all product under detention until satisfactory corrective action is implemented.
  5. Draw samples for evaluation (e.g. lab analysis), if necessary.
  6. Evaluate the establishment's proposed corrective action and ensure it is implemented immediately, if required.
  7. Copy documents, obtain records and make note that may later be required for compliance actions.
  8. Refer to Chapter 3 if the establishment is not cooperative.

If additional corrective action is not required immediately, ensure that the company submits an Action Plan in writing and implements corrective action within 24 hours.

Refer to section 2.5.2 for details on evaluating corrective action plans.

2.3.8 Preliminary Closing Meeting with Management

At the conclusion of the inspection activities, the inspection team may meet with the appropriate member(s) of the establishment management team to:

  • review the inspection findings;
  • highlight the key observations, and;
  • establish a date and time for the final exit meeting or arrange for delivery of the final report (see section 2.4.4).

If it is determined that the final report will be delivered in lieu of a Final Exit Meeting, the inspection team must be sure to fully explain the inspection findings during the Preliminary Closing Meeting. It is important that the establishment management understands the inspection findings and the reasons why certain items are unsatisfactory and require correction or improvement.

2.4 Final Report and Exit Meeting

2.4.1 Entering Observations into MCAP

Once back at the office, the inspection team must enter the inspection findings into the Multi-Commodity Activities Program (MCAP) database. Transfer all hand-written inspection observations into MCAP. In the "comments" section on the MCAP report, record which products are produced each day of the In-Depth Inspection (see figure 2-1 for the location of the comments section in the MCAP system).

Click on image for larger view
Figure 2-1: Multi Commodity Activities Program screen shot to show the location of the Comments section

Figure 2-1: MCAP screen shot to show the location of the "Comments" section

If more than one observation applies to a single task, be sure the comments are clear and well organized. Bullet points or numbering can help keep different observations separate. In cases where the observations show that more than one rating is possible for one task, the observations should be clearly grouped by category rating to make determining corrective action timeframes easier. Only one overall rating is assigned for each task (see section 2.3.6), as illustrated in figure 2-2, below.

Click on image for larger view
Figure 2-2: Multi Commodity Activities Program screen shot to show how to capture two or more ratings on a single task (Category II and Category III ratings on inspection task 101, 4.1.2.1)

Figure 2-2: MCAP screen shot to show how to capture two or more ratings on a single task (Category II and Category III ratings on inspection task 101, 4.1.2.1)

MCAP can generate the following documents:

  • The Inspection Worksheet: a complete list of all tasks rated during the inspection;
  • The Non-Compliance Report: a list of Category I, II, and III deficiencies;
  • The Category Rating: a list of overall compliance percentage rating per category. This may need to be verified by manual calculations;
  • The Outstanding Task Report: a list of all infractions that have not been closed in MCAP.

2.4.2 Minimum Compliance and Corrective Action Deadlines

The establishment must submit a Written Corrective Action Plan (see section 2.5.1 for more details) within the time frames outlined in Table 2-4. The time frames begin the day after the exit meeting or delivery of the final report (see section 2.4.4).

The Category Rating report from MCAP is used to state the overall compliance percentages for each category (these may have to be verified by manual calculations).

The Minimum Compliance percentages (see Table 2-4) are based on health risk and compliance with the applicable regulations. Since the deadlines in Table 2-4 are maximum time frames, the inspection team may request action plan submission and/or corrective action within a shorter time frame. When establishments are found to be below minimum compliance, the inspection team should work in consultation with the establishment's management to determine which infractions should be given priority for correction in order to achieve minimum compliance. These infractions should be given a completion date that is reasonably achievable, but helps the establishment to achieve minimum compliance quickly. The remainder of the outstanding infractions must be addressed within the time frames outlined in Table 2-4.

Table 2-4: Observation Guidelines
Category Minimum compliance Action Plan Submission Corrective Action
I 100% ImmediateTable Note * ImmediateTable Note *
II 75% less than 2 weeks less than 1 month
III 65% less than 1 month less than 1 year

Table Note

Table Note *

For all Category I infractions, corrective actions, even if they are just temporary measures, must be completed immediately (before the conclusion of the In-Depth Inspection). If the establishment requires extra time for long-term corrective actions or preventative measures, they must discuss this with the inspection team during the inspection and submit an action plan within 24 hours of the identification of the infraction.

Return to table note * referrer

2.4.3 Final Report and Cover Letter

A complete In-Depth Inspection Report package includes:

  • a Cover Letter (see Appendix 2-1) requesting the Written Corrective Action Plan(s) within the time frames outlined in Table 2-4;
  • the Category Rating report from MCAP;
  • the Non-Compliance Report from MCAP; and,
  • the printed MCAP Worksheet (if requested by the regulated party).

Once the In-Depth Inspection Report package is completed, the inspection team (and the supervisor, if required), should review it for accuracy:

  • Compare the total number of tasks required for the selected scope with the sum of the ratings (Satisfacatory + Non-Compliant + N/I + N/A) to ensure they match.
  • Compare the cover letter with the Category Rating report to ensure the category ratings match; and,
  • Proofread the reports and cover letter to eliminate spelling and grammatical errors.

2.4.4 Final Exit Meeting or Delivery of Final Report

The inspection team should conduct a Final Exit Meeting with the establishment's management at the time previously arranged during the Preliminary Closing Meeting (see section 2.3.8). During the Final Exit Meeting the inspection team will:

  • provide company management with the complete In-Depth Inspection Report package
  • begin with general remarks pointing out positive observations as appropriate
  • summarize the non-conformities by severity i.e. Category I, Category II and Category III
  • request that a Written Corrective Action Plan be submitted within appropriate timeframe (see Table 2-4).

In some situations, due to seasonality or travel time, the final report may be faxed or mailed to the company in place of an exit meeting. In such cases, the inspection team must ensure the establishment management understands the findings of the inspection and what is expected of them in regards to corrective action. This can be done either through the Preliminary Closing Meeting (see section 2.3.8) or by the inspectors making themselves available for questions or discussion over the phone or email.

2.4.5 Amending Inspection Results

If a deficiency was improperly categorized and the Inspection Report Package has already been delivered to the establishment, the inspector(s), supervisor and program officer/specialist should discuss the situation and decide if the inspection results should be amended. If an amendment is deemed appropriate the inspector should:

  • contact the establishment to inform them that an amended package will be sent and request that the first package is returned to the issuing office for disposition;
  • make the necessary changes to the MCAP Worksheet;
  • indicate "TASK(S) (numbers) AMENDED (date)" in the Comments section in MCAP (see Figure 2-1);
  • reprint the MCAP Worksheet, Non-Compliance Report, and Category Rating Report
  • hand-write "TASK(S) (numbers) AMENDED (date)" on both copies of the Non-Compliance and Category Rating Reports; and,
  • print a new Cover Letter, modified to indicate that the report was amended and to specify the changes.

2.5 Inspection Follow-Up

2.5.1 Written Corrective Action Plan

The establishment must submit a Written Corrective Action Plan within the time frames outlined in Table 2-4. The time frames begin the day after the exit meeting.

For each infraction in the Non-Compliance Report, the establishment must provide:

  • action to be taken;
  • time frame for corrective action to be completed;
  • person responsible for correcting the problem; and,
  • measures to prevent reoccurrence.

If more than one infraction is noted for a single task, each of the infractions must be addressed separately by the Corrective Action Plan. Once completed, the action plan must be signed and dated by an establishment official. To ensure all the necessary information is addressed in the Written Corrective Action Plan, the establishment may use the Corrective Action Plan Template included in Appendix 2-4 (also found in RDIMS 1568449).

If an Action Plan is not received by the due date, the responsible inspector will send a registered letter to the company requesting a Corrective Action Plan within 5 working days of receipt of the letter. If the action plan is not received after the 5 days, the inspector will complete an Inspector Non-Compliance Report (CFIA/ACIA 5393) and forward it to their supervisor. Further enforcement action may become necessary (see Chapter 3).

2.5.2 Evaluating the Corrective Action Plan

The Written Corrective Action Plan submitted by the company must be evaluated by the inspection team. To help with the evaluation of the corrective action plan, the inspectors may use the Corrective Action Plan Assessment Form found in Appendix 2-5 (also found in RDIMS 1568506).

The action plan will be rejected if:

  • any of the information listed in section 2.5.1 above is missing;
  • any infractions are not addressed;
  • the time frames for corrective action exceed those in Table 2-4, or those requested by the inspector;
  • the action to be taken will not correct the infraction.

In a timely manner, the inspector will notify the company in writing whether the action plan is accepted or rejected. See Appendix 2-2 for the template letter for action plan acceptance and Appendix 2-3 for the template letter for action plan rejection.

If the action plan is accepted, the inspector will plan the Directed Inspections according to the proposed dates of completion for the corrective actions (see Table 2-4).

If the action plan is rejected, the company will be requested to submit a revised action plan within 5 working days of receiving the Rejection Letter.

If a revised action plan is not received within the 5 days, or if the revised action plan is rejected, the inspector will complete an Inspector Non-Compliance Report (CFIA/ACIA 5393) and forward it to their supervisor. Further enforcement action may become necessary (see Chapter 3).

If only simple clarifications are needed on the action plan, the inspector may request these from the establishment via email. All email correspondence regarding action plans must be kept in the establishment's file.

2.5.3 Directed Inspections

A Directed Inspection is a partial inspection of an establishment. Directed Inspections are used for one or both of the following:

  1. To assess the corrective actions implemented by the establishment according to their Written Corrective Action Plan.
  2. To collect samples for product inspection or laboratory sample submission.

Frequencies for Directed Inspections conducted for the purpose of collecting samples should be determined in consultation with supervisors and based on Operational Workplans, the Processed Products Program - Product Inspection Frequencies and/or the Processed Products Program - Product Sampling Plans.

Frequencies for Directed Inspections conducted to assess corrective actions will vary according to the number and severity of non compliant inspection tasks. These Directed Inspections must be completed in a timely manner to ensure that the establishment has implemented their corrective actions as outlined in their Written Corrective Action Plan.

Category I Infractions

Due to the severity of these deficiencies, corrective action for most Category I infractions should have been implemented and assessed immediately (i.e., before the conclusion of In-Depth Inspection). In some cases, the establishment may have implemented corrective actions that are just temporary and submitted an action plan detailing long-term corrective actions. If so, a Directed Inspection must be completed within 24 hours of the proposed correction date. Enforcement action should be taken if the corrective actions are not implemented or are not effective (see Chapter 3).

Category II and III infractions

Assessment of Category II corrective actions should be a priority over Category III infractions. If there are multiple completion dates within a category, the inspector and supervisor must plan at least one inspection to verify all the corrective actions. Further inspections may be necessary and can be planned at the inspector's discretion, in consultation with their supervisor. In some cases, when only Category III infractions have been identified, a Directed Inspection may not be necessary and instead, assessment of the corrective actions can take place during the next In-Depth Inspection.

Establishments below minimum compliance

At the discretion of the inspection team, establishments that are found to be below minimum compliance may be given shorter time periods to submit action plans and implement corrective actions (see section 2.4.2 for more details). To ensure the establishment achieves minimum compliance as quickly as possible, a Directed Inspection should be planned immediately after the corrective action completion dates agreed upon by the establishment's management and the inspection team. During this Directed Inspection, the inspector must verify that the establishment has implemented effective corrective actions on at least enough of the outstanding infractions to bring the establishment into compliance. Further Directed Inspections may be planned to assess the remainder of the outstanding infractions.

Once the inspector verifies, through a Directed Inspection, that the corrective actions were implemented as per the accepted Action Plan, the Directed Inspection findings and the date of the Directed Inspection will be entered in the "Resolved Comments" and "Resolved Date" columns in MCAP, respectively. See the MCAP manual for more details. If the establishment requests a record of the Directed Inspection, the inspector can summarize the findings on an Inspection Report (CFIA/ACIA 0992) and distribute as necessary. This form is also provides a record of the Directed Inspection for the establishment file.

In general, Directed Inspections do not involve the identification of new infractions. However, sometimes during Directed Inspections the inspector may observe infractions that require attention. In such cases, the inspector should record these findings on an Inspection Report (CFIA/ACIA 0992) and request that corrective action be taken within a time frame that is appropriate for the type of infraction.

If a Directed Inspection reveals that a corrective action was not implemented within the timeframe given on the Corrective Action Plan, the inspector will complete an Inspector Non-Compliance Report (CFIA/ACIA 5393) and forward it to their supervisor. Further enforcement action may become necessary (see Chapter 3). If several Directed Inspections do not indicate satisfactory corrective action and it is felt that compliance will not be forthcoming, procedures to cancel or suspend registration should be initiated (refer to Chapter 3 for more details).

2.6 The Establishment File

A complete Establishment File should contain a minimum 3 years of all of the following items:

  1. A current Outstanding Tasks Report
    • Previous In-Depth Inspection Report packages (as presented to the establishment)
    • Cover letter (see Appendix 2-1)
    • Non-Compliance Report from MCAP
    • Category Rating from MCAP
    • Completed MCAP Worksheet (if requested by the establishment)
  2. Follow-up documentation resulting from each In-Depth Inspection:
    • Written Corrective Action Plan as submitted by the establishment
    • any correspondence requesting changes to the Action Plan and any modified Corrective Action Plans
    • Letters of Acceptance (see Appendix 2-2) and/or Rejection (see Appendix 2-3) of Written Corrective Action Plan
    • results of Directed Inspections
  3. Product-related reports:
    • Grading and Inspection Report (CFIA/ACIA 0989)
    • Inspection Reports (CFIA/ACIA 0992) for product inspections
    • Laboratory Reports of Analysis (LSTS)
    • IMS reports and consumer complaint documentation
  4. Other establishment documentation:
    • copy of the Certificate of Registration and renewal documentation
    • blueprints and product flowcharts (if available)
    • plant management contact list (names, phone numbers, email addresses)
    • product lists and lot code definitions
  5. Compliance and Enforcement documents:
    • warning letters
    • Notice of Detention (CFIA/ACIA 3256) and Notice of Release (CFIA/ACIA 3257) forms
    • Inspector Non-Compliance Reports (CFIA/ACIA 5393)
    • other enforcement correspondence and related records
    • General correspondence (email, etc.)

All documents listed above should be kept in an orderly manner and easily accessible for any inspector or supervisor who wishes to review the establishment file.

Appendix 2-1 Template Cover Letter

Canadian Food Inspection Agency
<Office address>
<Date>

<Establishment representative>
<Title>
<Establishment address>

Subject: In-Depth Establishment Inspection Results for Establishment <##>, <inspection date, product, processing system>

Dear <Establishment Representative>:

Please find enclosed the Establishment Inspection Report, generated from the In-Depth Inspection of <Establishment name and registration ##> on <Dates>. The Processed Products Establishment Inspection Manual was used to assess the establishment during this inspection. The inspection was completed by <Inspection team members>. During the exit meeting all deficiencies were discussed with you <or name of other representative(s)>.

The Risk Category Ratings below have resulted in an <Acceptable or Unacceptable> Overall Establishment Rating.

Risk Category/Compliance Level

I / __%
II / __%
III / __%

A complete list of infractions can be found in the attached Non-Compliance Report.

You are reminded that you may be in contravention of Sections 15 to 17 <and/or Sections 30.1 to 30.3 if the plant produces low acid food products packed in hermetically sealed containers> of the Processed Products Regulations under the Canada Agricultural Products Act.

Please forward your signed Written Corrective Action Plan(s), addressing all items in the Non-Compliance Report, to this office no later than:

Category I Infractions / <Date>
Category II Infractions / <Date>
Category III Infractions / <Date>

<We or I> would like to thank you and your staff for your cooperation during this inspection. Please do not hesitate to contact me at <telephone number> if you have any questions.

Yours truly,

<Name and title>

cc: <Regional or Area Program Officer, if necessary> <Inspection Supervisor>

Appendix 2-2 Template Action Plan Acceptance Letter

Canadian Food Inspection Agency
<Office address>
<Date>

<Establishment representative>
<Title>
Establishment address>

Subject: Acceptance of Action Plan from In-Depth Establishment Inspection Results for Establishment <##>, <inspection date, product, processing system>

Dear <Establishment Representative>:

Thank you for your Written Corrective Action Plan, received <Date>. The inspection team, consisting of <names of inspectors> has reviewed the action plan and accepted your proposed corrective actions. Shortly after your stated dates of completion, we will verify through Directed Inspection(s) that your corrective actions were implemented as written.

Please do not hesitate to contact me at <telephone number> if you have any questions.

Yours truly,

<Name and title>

cc: <Regional or Area Program Officer, if necessary> <Inspection Supervisor>

Appendix 2-3 Template Action Plan Rejection Letter

Canadian Food Inspection Agency
<Office address>
<Date>

<Establishment representative>
<Title>
Establishment address>

Subject: Rejection of Action Plan from In-Depth Establishment Inspection Results for Establishment <##>, <inspection date, product, processing system>

Dear <Establishment Representative>:

Thank you for your Written Corrective Action Plan, received <Date>. The inspection team, consisting of <names of inspectors>, has reviewed the action plan and must reject it for the following reasons:

<List reasons for the rejection - see section 2.5.2, do not make recommendations.>

Please submit a revised Written Corrective Action Plan by <Date>. Please do not hesitate to contact me at <telephone number> if you have any questions.

Yours truly,

<Name and title>

cc: <Regional or Area Program Officer, if necessary> <Inspection Supervisor>

Appendix 2-4 Corrective Action Plan Template

Contact your Area and Regional Office.

Appendix 2-5 Corrective Action Plan Assessment Form

Contact your Area and Regional Office.

Chapter 3 - Enforcement and Compliance Actions

3.0 Scope

This Compliance and Enforcement Strategy provides a framework that outlines the principles and actions that will be followed by Canadian Food Inspection Agency (CFIA) inspectors in verifying that registered establishments operate in compliance with the Canada Agricultural Products Act (CAP Act), Processed Products Regulations (PPR), and other applicable legislation. This program specific strategy is consistent with the CFIA's revised Enforcement and Compliance Policy developed and maintained by the Enforcement and Investigation Services (EIS) Division. The CFIA Enforcement and Compliance Policy provides the overarching policy for enforcement and compliance activities across all commodity programs.

Compliance is normally achieved through a co-operative approach between the regulated party and the CFIA in correcting non-conformities through the development of appropriate Corrective Action Plans or other methods. However, when this co-operative approach has ceased, or when the regulated party is incapable of correcting non-conformities, this Compliance and Enforcement Strategy provides CFIA staff with enforcement options that are to be used in responding to infractions of the Canada Agricultural Products Act (CAP Act), the Processed Products Regulations (PPR) and other relevant applicable legislation. This policy also defines discretionary parameters for inspectors and establishes principles for fair and consistent enforcement.

3.1 Authorities

3.2 Responsibility for enforcement actions

CFIA Area Executive Directors are accountable for enforcement actions taken in their respective Areas including refusal, suspension and revocation of certificates of registration. They are also responsible for the approval of all recommendations to prosecute. The Regional Director must also be consulted and informed when significant enforcement actions are being considered. The accountability process for enforcement action is outlined in Chapter 15 of the Enforcement and Compliance Policy.

3.3 General enforcement and compliance principles

The CFIA will encourage compliance with the CAP Act, PPR and other applicable legislation through consultation, education and enforcement. These activities are based on the following guiding principles:

  • Canada's processed fruit and vegetable products must comply with applicable legislation;
  • Application and enforcement of the CAP Act, PPR and other applicable legislation are to be carried out in a fair, consistent and uniform manner in accordance with this strategy and the CFIA's Enforcement and Compliance Policy;
  • CFIA inspectors, who are fully conversant with the CAP Act, PPR and other applicable legislation, will conduct inspections, audits, compliance and enforcement and other regulatory activities;
  • CFIA inspectors will consider the facts and circumstances of non-compliance incidents with objectivity and take appropriate corrective action;
  • CFIA inspectors will take an active role in promoting and monitoring compliance and responding to non-compliance;
  • Education measures used to promote compliance will include the publication of information and consultation with regulated parties. CFIA inspectors administering and enforcing legislation and the regulated parties who must comply with the legislation, need to understand why legislation exists, why compliance is necessary, and how enforcement will be carried out; and
  • CFIA inspectors will be available to explain the requirements of the legislation and maintain open lines of communication to regulated parties and communicate to CFIA management the comments and concerns raised by the regulated parties.

3.4 Inspection Powers and Authorities

The following identifies the appropriate legal authorities that are available to inspectors designated under the Canada Agricultural Products Act, the Food and Drugs Act, the Consumer Packaging and Labelling Act and their Regulations.

Canada Agricultural Products Act

Inspectors may:

  • enter and inspect any place in which the inspector believes on reasonable grounds there is any agricultural product or other thing in respect of which this Act or the Regulations apply;
  • stop any vehicle in which the inspector believes on reasonable grounds there is any agricultural product or other thing in respect of which this Act or the Regulations apply;
  • open any container that the inspector believes on reasonable grounds contains an agricultural product;
  • inspect any agricultural product or other thing and take samples of it free of charge;
  • require any person to produce for inspection or copying, in whole or in part, any record or other document that the inspector believes on reasonable grounds contains any information relevant to the administration of this Act or the Regulations; and
  • seize and detain any agricultural product or other thing which the inspector believes on reasonable grounds is in contravention of the Act or Regulations.

In exercising the above authorities, inspectors may:

  • use or cause to be used any data processing system at the place to examine any data contained in or available to the data processing system;
  • reproduce any record or cause it to be reproduced from the data in the form of a printout or other intelligible output and take the printout or other output for examination or copying; and
  • use or cause to be used any copying equipment at the place to make copies of any record or other document.

Food and Drugs Act and Regulations

Inspectors may:

  • enter any place where the inspector believes on reasonable grounds any food is manufactured, prepared, preserved, packaged or stored;
  • examine any food and take samples thereof, and examine anything that the inspector believes on reasonable grounds is used or capable of being used for that manufacture, preparation, preservation, packaging or storing;
  • enter any conveyance that the inspector believes on reasonable grounds is used to carry any food and examine any food found therein and take samples thereof;
  • open and examine any receptacle or package that the inspector believes on reasonable grounds contains any food;
  • examine and make copies of, or extracts from, any books, documents or other records found in any place referred to in this subsection that the inspector believes on reasonable grounds contain any information relevant to the enforcement of this Act with respect to food; and
  • seize and detain for such time as may be necessary any food by means of or in relation to which the inspector believes on reasonable grounds any provision of this Act or the Regulations has been contravened.

In exercising the above authorities, inspectors may also take photographs of::

  • any food;
  • any place where, on reasonable grounds, the inspector believes any food is manufactured, prepared, preserved, packaged or stored; and
  • anything that, on reasonable grounds, the inspector believes is used or capable of being used for the manufacture, preparation, preservation, packaging or storing of any food.

Consumer Packaging and Labelling Act and Regulations

Inspectors may:

  • enter any premises of a dealer or any other place in which the inspector believes on reasonable grounds there is any prepackaged product that is owned by a dealer;
  • examine any prepackaged product found therein;
  • open and examine any package found therein that he believes on reasonable grounds contains any prepackaged product;
  • examine any documents or papers, including books, reports, records, shipping bills and bills of lading, or any data entered or recorded by any system of mechanical or electronic data processing or by any other information storage device, that he believes on reasonable grounds contain any information relevant to the enforcement of this Act and make copies thereof or extracts therefrom;
  • at the request of the person from whom a product or other thing was seized, allow that person or any person authorized by that person to examine the product or other thing so seized and, where practicable, furnish a sample thereof to such person; and
  • seize and detain any product or any labelling, packaging or advertising material by means of or in relation to which the inspector believes on reasonable grounds the contravention was committed.

When exercising their powers and authorities, inspectors may be requested to produce their certificates of designation and shall produce them upon request. Inspectors may not enter a dwelling-place to conduct an inspection unless a search warrant has been issued or where legislative authority allows them to enter without a warrant under exigent circumstances. Use of the authority to enter under exigent circumstances will only be exercised where there is an immediate threat to the health and safety of the public or environment, or a serious threat or risk of disease to humans, establishments or animals.

3.4.1 Indirect Powers

All reasonable assistance will be provided to an inspector, or any person acting under the authority of the inspector, by the owner or person in charge of a place, including a conveyance, and every person found in the place that is entered by an inspector. In addition, they will also provide the inspector with any information relevant to the administration of any of the CFIA's Acts.

3.4.2 Direct Powers

During the course of an inspection, inspectors have the power and authority to respond to non compliance. They may:

  • recommend licence or registration withdrawal;
  • order the removal of imports from Canada;
  • restrict or prohibit the movement of products regulated by the CFIA;
  • seize and detain products or other things;
  • order the forfeiture of seized products not removed from country; and
  • order the disposal of products (to be exercised only in severe circumstances or upon receipt of a court order).

3.5 Responses to non-compliance

Where CFIA inspectors have reasonable grounds to believe there has been a contravention of the CAP Act, the PPR or other applicable legislation, they will conduct inspections to determine the facts of the alleged infraction(s). Inspectors and Inspection Managers may seek the advice, guidance and assistance of the Enforcement and Investigation Services, Regional Investigator, particularly in instances involving circumstances of a complex nature that require specialized investigational expertise. If there is sufficient evidence to proceed with enforcement action, the inspector should gather and preserve evidence. Once non-compliance has been verified, the inspector will complete an Inspector Non-Compliance Report and submit it to their Inspection Manager.

Instances of non-compliance will be re-evaluated by Enforcement and Investigation Services, prior to proceeding with enforcement action. The following factors, along with other applicable information, will be considered when deciding upon the most appropriate action:

  • the offender's history of compliance with the legislation;
  • a willingness to achieve compliance;
  • evidence of corrective action taken;
  • the intent of the non-compliant party (alleged violator); and
  • the seriousness of harm or potential harm.

3.5.1 Warning

A written warning letter may be used in instances where the non-compliance is unintentional, easily corrected, the accused demonstrates due diligence and the individual or company has made reasonable efforts to remedy or mitigate the consequences of the contravention and compliance has been achieved.

3.5.2 Prosecution Action

Prosecutions shall be considered for offences under the Acts and Regulations enforced by the CFIA except where, in accordance with the enforcement and compliance policy, it has been determined that:

  • warning under this policy is the most effective means of achieving compliance; or
  • licence or registration suspension or cancellation is the most effective means of achieving compliance.

Prosecution will always be pursued when the offence involves:

  • death of, or injury to, a person and the evidence indicates that the death or injury was directly attributed to failure to comply with any of the provisions of the Acts or Regulations administered and/or enforced by the CFIA;
  • serious harm or risk to the environment;
  • risk to the health and safety of humans, animals;
  • the prohibited sale of food;
  • the unsafe manufacturing of food;
  • economic fraud;
  • forging, altering or tampering with an inspection certificate;
  • knowingly providing false or misleading information, or making a false or misleading statement to an inspector;
  • obstructing or interfering with an inspector exercising his/her powers or carrying out his/her duties and functions;
  • removing, altering or interfering with any thing seized and detained or the movement of which is restricted or prohibited;
  • producing records, documents or electronic data that knowingly contains false or misleading information;
  • refusal to comply with the directions of an inspector, a detention order or a recall order; or
  • a conviction for a previous similar offence, a repeated offence or a continuing offence.

The Acts administered by the CFIA allow offences to be prosecuted by either summary conviction or as an indictable offence. It is determined by the Crown prosecutor whether to prosecute by way of summary conviction or indictment.

3.5.3 Product Detention

An inspector has the authority, under Section 23 of the CAP Act, to seize and detain non-compliant agricultural products. The detention of agricultural products or other things is generally appropriate when a violation is suspected and when:

  • the violation poses a health and safety risk;
  • the violation creates unfair competition to other compliant products; or
  • the person demonstrates an unwillingness to comply by failing to remove the product from the market or failing to take corrective action to bring the product into compliance.
  • the product has been illegally imported into Canada (Note: this type of infraction cannot be brought into compliance by means of a corrective action); or
  • the product is not in compliance with the CAP Act and/or PPR.

Detention of the products can be maintained until:

  • the product is brought into compliance or removed from Canada;
  • court proceedings have been instituted; or
  • the statutory time limitation expires (Subsection 27(1), CAP Act) allows for 180 days, unless legal proceedings have been initiated).

Detention of product is considered one of the most expeditious and effective tools to promote compliance.

3.5.4 Forfeiture

Forfeiture can occur in the following instances:

  • where imported non-compliant products are not removed from Canada as instructed by an inspector (Section 30, CAP Act);
  • when a person consents to forfeiture; or
  • when the Court makes such an order.

Forfeited products will be disposed of as provided for by the Court, or as directed by the Minister where provided for in the Acts. This will generally be at the expense of the person from whom the product was seized.

3.5.5 Disposal

The CAP Act allows for the disposal of perishable products, as well as the disposal of a seized product that has been forfeited.

3.6 Suspension or cancellation of registration

There are four circumstances where deregistration procedures will be considered:

  • establishment closure, for reasons such as fire, flood but not including labour management disputes;
  • non-operating status (12 consecutive months) or failure to pay fees;
  • critical problems of a public health significance; or
  • serious or continuous violations to the Act and/or Regulations

3.6.1 Establishment Closure

Where a registered establishment closes due to a decision of the operators and owners (e.g. bankruptcy), the Regional Director responsible for the Area and the Director, Food of Plant Origin Division, must be informed as soon as possible. It is the Inspection Manager's responsibility to verify that the registration certificate is removed from the establishment, and the establishment's management have been informed of what the cancellation of the registration means in a letter acknowledging the cancellation. The name and address of that establishment will then be removed from the central list of registered establishments. The registration number normally will be held (e.g. not reissued) for a period of two (2) years to avoid any possible confusion.

3.6.2 Non Operating Status or Failure to Pay Annual Registration Fees

Where a registered establishment has not operated for a period of twelve consecutive months or fails to pay fees to the CFIA related to maintaining registration status or product inspection.

C.M.S will be updated to indicate the inactive status of the establishment. The name and address of the establishment will be removed from the central list of registered establishments and the registration number will be held (not reissued) for a period of two (2) years.

3.6.3 Critical Deficiencies of Public Health Significance

Where an inspection of a registered establishment determines that the Act and/or Regulations are being violated to the extent that the health of the public is being jeopardized by the finished products being produced, and the operator fails, or is unable, to take immediate corrective actions, steps to suspend the registration will be taken immediately (see Section 3.7). Cancellation of registration procedures are also initiated (see Section 3.8).

3.6.4 Serious or Continuous Violations to the Regulations During Establishment Inspection

Where an in-depth inspection of a registered establishment results in an unsatisfactory rating, the documented results of the inspection will be utilized to possibly effect the cancellation of their registration or aide in prosecution. Where there are serious or continuous non-compliance issues that are not corrected quickly and cooperatively, the following procedures must be followed closely for any unsatisfactory rated establishment:

  • the Regional Director must keep the appropriate CFIA Regional, Area and Headquarters staff apprised of any developments;
  • each suspension or cancellation step must be followed and fully documented (see Section 3.7 or 3.8);
  • the necessary enforcement actions must be taken;
  • any product affected by the non-compliant conditions in the establishment must not present a potential health hazard.

3.7 Suspension of Registration

3.7.1 Regulatory Authority

Subsection 12 (2) (3) and (4) of the Processed Products Regulations states:

(2) The registration of an establishment may be suspended by the Director

  1. where
    1. the establishment does not comply with any provision of the Act or these Regulations,
    2. the operator of the establishment does not comply with any provision of the Act or these Regulations, or
    3. the Director believes, on reasonable grounds, that to allow the establishment to continue operating would constitute a risk to public health; and
  2. where the operator has failed or is unable to take immediate corrective action.

(3) No registration referred to in subsection (2) shall be suspended unless

  1. an inspector has prepared a written report setting out the reasons for the suspension and the corrective measures required and has forwarded a copy of that report to the operator; and
  2. a Notice of Suspension of Registration is delivered to the operator.

(4) A suspension of registration under subsection (2) shall remain in effect

  1. until the required corrective measures have been taken;
  2. where a cancellation procedure has been commenced under subsection (5), until the resolution of the cancellation issue; or
  3. where a cancellation procedure has not been commenced under subsection (5), until a period of 90 days has elapsed.

3.7.2 Steps for Suspension of Registration

For any unsatisfactory rated establishment where the evidence shows that allowing the establishment to continue operating would constitute a public health hazard, the following procedures must be followed:

  • The Inspection Manager is consulted by the operations staff before the suspension.
  • The inspector prepares a written report setting out the reasons for the suspension procedures being initiated. The inspector must ensure that the operator of the establishment receives a copy of the written report.
  • The Inspection Manager's responsibility to notify the appropriate CFIA Regional and Area personnel of the intent to proceed with suspension.
  • any product(s) affected by the non-compliance in the establishment is (are) immediately detained; and any product on the market is evaluated for recall in conjunction with OFSR.
  • (A decision is made by the Regional Director to proceed or not to proceed with suspension.
  • A Notice of Suspension of Registration (see Appendix 3-1) signed by the Regional Director is delivered to the operator of the establishment. The establishment can no longer ship regulated products outside of the province or apply a Canada grade.

In all instances of establishments not immediately correcting serious infraction(s), The Inspection Manager or his designate will inform the Area Program Network Specialist. The Area Program Network Director will then notify the Director, Food of Plant Origin Division of the intent to cancel the establishment's registration.

3.8 Cancellation of Registration

3.8.1 Regulatory Authority

Subsection 12(6) of the Processed Products Regulations states:

" No Certificate of Registration referred to subsection (5) shall be cancelled unless:

  1. an inspector has, at the time of his inspection, notified the operator of the failure to comply with any provision of the Act or these Regulations;
  2. a copy of the inspection report has been delivered to the operator
    1. identifying the provision of the Act or these Regulations that has not been complied with, and
    2. specifying the period of time for compliance with that provision of the Act and these Regulations in order to prevent the cancellation of the registration;
  3. the operator has failed to comply with or failed to bring the establishment into compliance with the provisions of the Act and these Regulations within the period of time specified in the inspection report or continues, after that period, to violate or fail to comply with any provision of the Act or these Regulations;
  4. the operator has been given an opportunity to be heard in respect of the cancellation; and
  5. a Notice of Cancellation of Registration according to Form 4 of Schedule VII is delivered to the operator.

3.8.2 Steps for Cancellation

  1. The directed inspection(s) reveal that the company has not brought about improved compliance or no action plan or a non satisfactory action plan is received from the establishment.
  2. The inspector informs the Inspection Manager that the plant has not improved their level of compliance or there is a lack of cooperation from the establishment (no action plan or a non satisfactory action plan received).
  3. A team is formed to conduct a full in-depth inspection. The team is comprised of a Regional Specialist or Area Program Network Specialist, a Responsible Inspector and a Senior Inspector.
  4. A second in-depth inspection is carried out to reassess the level of compliance and to discuss the appropriateness of the actions and target dates of the corrective action plan if received.
  5. If the second in-depth inspection results still do not meet any of the minimum compliance percentages in Table I or if no written action plan or a non satisfactory action plan from the first in-depth has been received from the establishment, the inspector in charge of the establishment will convene a meeting with senior managers of the establishment.
  6. At this meeting, outstanding Category I, II and III violations will be identified and a written commitment will be requested from the establishment's management within a mutually agreeable time frame. The meeting should be attended by the inspection team and any other food inspection authority involved with the establishment (e.g. provincial inspection officials, local health authorities). Minutes of the meeting will be recorded and distributed by the Inspector in charge of the establishment copies to the Inspection Team Members, Inspection Manager, and appropriate Regional and Area CFIA personnel.
  7. When the above steps have been taken and it is obvious that the operators can not or will not correct the infractions, a "Covering Letter" (Appendix 3-2) will be delivered to the establishment indicating that a cancellation is being considered and arrangements will be made for a Hearing prior to cancellation.
  8. The establishment's management is invited in writing to a Hearing (Appendix 3-3). If the establishment agrees to a Hearing it is confirmed in writing (Appendix 3-4) at a mutually agreed-to location, date and time and they are also informed that they have the right to bring legal representation or technical support. The CFIA will be represented at the hearing by the Director or a representative appointed by the Director, the Inspection Team and a CFIA legal advisor, if required.
  9. At the end of the hearing, a decision will be made to proceed with cancellation of the registration or to carry out a third in-depth inspection (Appendix 3-5).
  10. If the cancellation option is chosen, a Notice of Cancellation of Certificate of Registration (Appendix 3-6) will be signed by the Director, Food of Plant Origin Division and delivered to the establishment.
  11. If the in-depth inspection option is chosen and it is found during the inspection that the operator has taken corrective measures to bring the plant into compliance, a letter notifying the establishment of the decision not to cancel the registration will be sent by the Director.
  12. When the registration is cancelled, the establishment will not be allowed to market products regulated under the PPR outside the province or through an agent who may market them outside the province and to apply a Canada grade.
  13. When a cancellation occurs all Areas will be notified by copy of the Notice of Cancellation of Registration. If an inspector has reason to believe that the operator of the deregistered establishment is marketing agricultural products outside the province or applying a Canada grade, the appropriate Enforcement and Investigation Services office should be contacted.

Appendix 3-1: Notice of Suspension of Registration

(Address)

(Date)

2820-1- Reg. #

(Name and Address of establishment)

Subject: Notice of Suspension of Registration

Registered under the Canada Agricultural Products Act

This is to advise you that, in accordance with subsection 12(3) of the Processed Products Regulations, the registration for the above establishment is suspended, effective (date).

The Certificate of Registration issued pursuant to subsection 11(1) of the said Regulations is to be surrendered to an inspector upon receipt of this notice.

Date:

Regional Director

Appendix 3-2: - Covering Letter after Second In-depth (Serious Violations)

(Date)

Registered Mail

(Name of establishment)
(Complete address)

Attn: (Name of Establishment Manager and Title)

Subject: Establishment Inspection Results - Follow-up Inspection

(Salutation)

The following is a summary of the results of two recent inspections performed on your establishment by the Canadian Food Inspection Agency.

On (Dates) an inspection was carried out by Inspector(s) (Names of Inspectors). Several major infractions were identified at that time and discussed with you following the inspection. A letter, dated (Date of letter) was sent to you confirming these unsatisfactory conditions and you were requested to provide a written plan of corrective action. To date, your corrective action plan has not been received.

On (Dates) a follow-up inspection was carried out by the undersigned and Bill Jones to review the establishment conditions again and check the progress of your corrective actions. You will find a copy of that inspection report enclosed. While it was noted that some of the serious infractions had been brought into compliance, there still remains several infractions which require immediate attention:

(List major violations (serious infractions) in order of priority)

Upon completion of the inspection, we discussed the above infractions, as well as the fact that a written corrective action plan has not yet been received. We request your immediate attention to the correction of the infractions and to providing us with a written corrective action plan outlining these corrections within reasonable time frames.

As you are aware, these infractions contravene sections 13 to 17 inclusive of the Processed Products Regulations, as established under the Canada Agricultural Products Act. Processing establishments must be in compliance with both the Act and the Regulations to maintain their registration, allowing them to ship their agricultural food products outside the province.

If these infractions are not corrected immediately and a corrective action plan is not received within seven (7) days of your receipt of this letter, a hearing will be convened for the purpose of determining whether to cancel your establishment's registration.

If you have any questions on any of the matters covered by this letter, please do not hesitate to contact this office (123-4567).

Sincerely,

(Name of Inspection Manager)
Inspection Manager

c.c: (Name of President of establishment, Title, Name of establishment)

Appendix 3-3 :Hearing Convocation Letter

(Date)

Registered Mail

(Name of establishment)
(Complete address)

Attn: (Name of Establishment Manager and Title)

Subject: Establishment Inspection Results - Hearing Convocation

(Salutation)

Thank you for the corrective action plan submitted February 15, 2000 addressing a number of the infractions pointed out in my letter of February 10, 2000. Upon review, however, we note that four (4) critical infractions are not mentioned in your plan (see below) and time frames suggested for corrections of five infractions (see below) are not satisfactory.

(List of missing infractions)

(List of infractions for which unsatisfactory time frames were received)

In view of the above, we feel that it is necessary to convene a hearing to discuss your establishment's registration. This will provide you and your representatives with an opportunity to indicate what corrective action you have taken to achieve compliance with the Regulations.

Subsections 12(5) and 12(6) of the Processed Products Regulations state:

"(5) The registration of an establishment may be cancelled by the Director.

  1. where the establishment does not comply with any provision of the Act or these Regulations; or
  2. where the operator of the establishment fails to comply with any provision of the Act or these Regulations."

"(6) No registration referred to in subsection (5) shall be cancelled unless

  1. an inspector has, at the time of his inspection, notified the operator of the failure to comply with any provision of the Act or these Regulations;
  2. a copy of an inspection report has been delivered to the operator
    1. identifying the provision of the Act or these Regulations that has not been complied with, and
    2. specifying the period of time for compliance with that provision of the Act and these Regulations in order to prevent the cancellation of the registration;
  3. the operator has failed to comply with or failed to bring the establishment into compliance with the provision of the Act and these Regulations within the period of time specified in the inspection report or continues, after that period, to violate or fail to comply with any provision of the Act or these Regulations;
  4. the operator has been given an opportunity to be heard in respect of the cancellation; and
  5. a Notice of Cancellation of Registration in the form of Form 4 of Schedule VII is delivered to the operator."

If you wish to have a hearing, please contact the undersigned before (Date), so that a place, date and time may be scheduled. If we do not receive notification by (Date) it will be assumed that you do not wish to have a hearing, and a recommendation to cancel your registration will be forwarded to CFIA - Headquarters.

If you have questions about any of the matters covered by this letter, please do not hesitate to contact me (123-4567).

Sincerely,

c.c: (Name of President of establishment, Title, Name of establishment)

Appendix 3-4: Hearing Confirmation Letter

(Date)

Registered Mail

(Name of establishment)
(Complete address)

Attn: (Name of Establishment Manager and Title)

Subject: Hearing Confirmation

(Salutation)

Thank you for your letter requesting a hearing to discuss the registration of your establishment and the maintenance of your registration under the Processed Products Regulations. Please be advised that you have the right to bring legal representation and/or technical advisors to this meeting.

It has been agreed that the hearing will be held on (Date), at (Time) at:

(Complete address of office)

While waiting to speak with you again on this subject, please be assured that I sincerely wish you my best sentiments.

(Name of Inspection Manager)
Inspection Manager

Appendix 3-5: Hearing Follow-up Letter

Date

Registered Mail

(Name of establishment)
(Complete address)

Attn: (Name of Establishment Manager and Title)

Subject: Hearing Follow-up

(Salutation)

This will confirm our discussion on March 15, 2000, of your establishment and the actions you have taken, and will be taking, to bring your establishment into compliance with the Processed Products Regulations.

At the hearing you indicated that, to date, corrections have been made to all infractions outlined in the letter of February 10, 2000, from Mr. Functionnaire, except for the following four (4) items:

List outstanding major infractions

It is understood that item(s) (list item numbers) will be corrected by (Date), (list item numbers) will be corrected before (Date).

After (2nd date), another inspection will be performed at your establishment. If the corrections made are satisfactory and your establishment's infraction rating falls within an acceptable range, your registration will be maintained.

If your establishment's infraction rating does not fall within the acceptable range during this inspection, a recommendation to cancel your registration will be sent to CFIA - Headquarters. Cancellation of registration will result in a loss of privilege to sell your food products outside the province.

Sincerely,

(Name of Executive Director)
Executive Director - Operations (Area)

c.c.

(Name of President of establishment, Title, Name of establishment)

Appendix 3-6: Notice of Cancellation of Registration

Address

(Date)

2820-1- Reg. #

(Name and Address of establishment)

Subject: Notice of Cancellation of Registration

Registered under the Canada Agricultural Products Act

This is to advise you that, in accordance with subsection 12(6) of the Processed Products Regulations, the registration for the above establishment is suspended, effective (date).

The Certificate of Registration issued pursuant to subsection 11(1) of the said Regulations is to be surrendered to an inspector upon receipt of this notice.

Director
Food of Plant Origin Division

Chapter 4 - Generic Inspection Standard

4.1 Premises

4.1.1 Building Exterior
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
4.1.1.1 0001 Outside Property and Building X X X X X X
4.1.2 Building Interior
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
4.1.2.1 101 Design, Construction and Maintenance X X X X X X
4.1.2.2 102 Lighting X X X X X X
4.1.2.3 103 Ventilation X X X X X X
4.1.2.4 104 Waste Disposal X X X X X X
4.1.3 Sanitary Facilities
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
4.1.3.1 201 Employee Facilities X X X X X X
4.1.3.2 202 Equipment Cleaning and Sanitizing Facilities X X X X X X
4.1.4 Water/Ice/Steam Quality
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
4.1.4.1 301 Water and Ice X X X X X X
4.1.4.2 302 Steam X X X X X X
4.1.4.3 303 Water/Ice/Steam Quality Records X X X X X X

4.2 Transportation and Storage

4.2.1 Transportation
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
4.2.1.1 401 Food Carriers X X X X X X
4.2.1.2 402 Temperature Controls X X X X X X
4.2.2 Storage
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
4.2.2.1 501 Incoming Materials Storage X X X X X X
4.2.2.2 502 Non Food Chemicals - Receiving and Storage X X X X X X
4.2.2.3 503 Finished Product Storage X X X X X X
4.2.2.4 504 Finished Product Storage - Frozen         X  

4.3 Equipment

4.3.1 General Equipment
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
4.3.1.1 601 Design and Installation X X X X X X
4.3.1.2 602 Food Contact Surfaces X X X X X X
4.3.1.3 603 Equipment Maintenance and Calibration Program X X X X X X
4.3.1.4 604 Equipment Maintenance Records X X X X X X
4.3.1.5 605 Equipment Calibration Records X X X X X X
4.3.2 Pre-Process Equipment
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
4.3.2.1 701 Preparation/Blending Equipment and Instrumentation X X X X X X
4.3.2.2 702 Filling Equipment and Instrumentation X X X X X X
4.3.2.3 703 Container Closure Equipment X X X X X X
4.3.3 Retort Equipment
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
4.3.3.1 801 Design, Installation and Maintenance (Still Steam Retort) X          
4.3.3.2 802 Retort Instrumentation X          
4.3.4 Post-Process Equipment
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
4.3.4.1 901 Post-Process Cooling Canal and Handling Equipment X X X X   X
4.3.4.2 902 Low Vacuum Detection Equipment X X X X   X

4.4 Personnel

4.4.1 Training
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
4.4.1.1 1001 General Food Hygiene Training X X X X X X
4.4.1.2 1002 Technical Training X X X X X X
4.4.2 Hygiene and Health Requirements
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
4.4.2.1 1101 Cleanliness and Conduct X X X X X X
4.4.2.2 1102 Communicable Diseases/Injuries X X X X X X

4.5 Sanitation (and Pest Control)

4.5.1 Sanitation
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
4.5.1.1 1201 Written Sanitation Program and Effectiveness Evaluation X X X X X X
4.5.1.2 1202 Equipment Cleanliness X X X X X X
4.5.1.3 1203 Premises Cleanliness X X X X X X
4.5.1.4 1204 Sanitation Records X X X X X X
4.5.2 Pest Control
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
4.5.2.1 1301 Pest Control Program X X X X X X
4.5.2.2 1302 Pest Control Records X X X X X X

4.6 Complaints and Recalls

4.6.1 Complaint Handling
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
4.6.1.1 1401 Product Complaints X X X X X X
4.6.1.2 1402 Complaint Records X X X X X X
4.6.2 Recalls
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
4.6.2.1 1501 Recall Plan X X X X X X
4.6.2.2 1502 Product Code Identification X X X X X X
4.6.2.3 1503 Recall Capability X X X X X X
4.6.2.4 1504 Distribution Records X X X X X X

4.7 Records

4.7.1 General Records
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
4.7.1.1 1601 General Record Requirements X X X X X X
4.7.1.2 1602 General Regulatory Requirements X X X X X X

Total number of tasks for each product type (inspection scope)

45 - Low Acid Foods (LAF) in HSC
43 - Fresh Pack (ALAF)
43 - Fermented Pack (ALAF)
43 - Acid Foods (AF)
42 - Frozen Foods (FF)
43 - Low Water Activity (LAw)

Generic Inspection Standard
Task 0001
4.1 Premises
4.1.1 Building Exterior
4.1.1.1 Outside Property and Building
Task 0001 April 1, 2002
Principle Buildings and surrounding areas are designed, constructed and maintained in a manner to prevent conditions which may result in the contamination of food.
Assessment Criteria Grounds, Roadways and Drainage
  • The surrounding land is maintained to control sources of contamination such as debris and pest harbourage areas.
  • The building is not located in close proximity to any environmental contaminants.
  • Roadways are properly graded, compacted, dust proofed and drained.
  • The surrounding property is adequately drained.

Exterior Building Structure

  • The building exterior is designed, constructed and maintained to prevent entry of contaminants and pests, e.g., no unprotected openings, air intakes are appropriately located, and the roof, walls and foundation are maintained to prevent leakage.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Exterior of building in poor condition allowing entry of pests
  • Pest harbourage areas and evidence of pest infestation inside the building
  • Accumulation of stagnant/pooled water resulting in obnoxious odours, close to raw material
  • Accumulation of garbage/waste resulting in obnoxious odours, close to raw material
Rating III
  • Inadequate drainage and pooling of water around building - no obnoxious odours
  • Exterior of building in poor condition but no signs of pest entry
  • Roadways not properly graded, compacted, dust proofed or drained
  • Pest harbourage areas but no signs of pest entry
Legal Authorities PPR 13 (a) Free or debris or refuse
(b) Good drainage
(c) Not in proximity or source of pollution, pest harbourage
14(1) (a) Sound construction - good repair
(b) Acceptable materials
(c) Protected against the entrance of any vermin
Task 101
4.1 Premises
4.1.2 Building Interior
4.1.2.1 Design, Construction and Maintenance
Task 101 April 1, 2002
Principle Building interiors and structures are designed, constructed and maintained in a manner to prevent conditions which may result in the contamination of food.
Assessment Criteria Floors, Walls, Ceilings
  • Floors, walls, and ceilings are constructed of material that is durable, impervious, smooth, cleanable, and suitable for the production conditions in the area.
  • Where appropriate, wall, floor and ceiling joints are sealed and angles are coved to prevent contamination and facilitate cleaning.
  • Floors, walls and ceilings are composed of materials that will not result in the contamination of the environment or food.
  • Floors are sufficiently sloped to permit liquids to drain to trapped outlets.
  • Ceilings, overhead structures, stairs, and elevators are designed, constructed and maintained to prevent contamination.

Windows and Doors

  • Windows are sealed or equipped with close fitting screens.
  • Where there is a likelihood of breakage of glass windows that could result in the contamination of food, the windows are constructed of alternative materials or are adequately protected.
  • Doors have smooth, non-absorbent surfaces and are close fitting and self-closing where appropriate.

Process Flow Separation

  • Adequate separation of activities is provided by physical or other effective means where cross contamination may result.
  • Buildings and facilities are designed to facilitate hygienic operations by means of a regulated flow in the process from the arrival of the raw material at the premises to the finished product.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Windows and doors improperly sealed and evidence of major infestation and contamination in the establishment
  • Flaking paint or rust on overhead structures and wall that may result in contamination
  • Inadequate drainage causing stagnant/pooled water and obnoxious odours in close proximity to foods
  • Incompatible operations with potential of cross contamination of pathogens (salmonella, listeria etc.) in ready to eat frozen foods
Rating III
  • Floors not properly sloped, and pooling of water - no obnoxious odours
  • Windows and doors improperly sealed and pest entry possible, etc.
  • Cleaning and handling operation of raw material in close proximity to product in process.
Legal Authorities PPR 14(1)(a) Sound construction - good repair
(b) Acceptable materials
(c) Protected against entrance of birds, insects etc.
(1)(d) Floors , walls and ceilings -cleanable and impervious to moisture
(1)(g) Separation of incompatible operations
16(5) Acceptable materials used for repairs
Task 102
4.1 Premises
4.1.2 Building Interior
4.1.2.2 Lighting
Task 102 January 31, 2008
Principle Light is adequate for the activity being conducted. Where appropriate, light bulbs and fixtures are protected to prevent contamination of food.
Assessment Criteria Lighting is appropriate such that the intended production or inspection activity can be effectively conducted. The lighting does not alter food colour and is not be less than the following intensity:
  • 540 lux (50 foot candles) in inspection* and grading areas;
  • 220 lux (20 foot candles) in work areas;
  • 110 lux (10 foot candles) in other areas;

* Inspection areas are defined as any point where the food product or container is visually inspected or instruments are monitored (e.g., empty container evaluation, product sorting, inspection, grading and sampling).

Light bulbs and fixtures located in areas where there is exposed food are of a safety type or are protected to prevent contamination of food in case of breakage.

Rating Guide Examples
Rating I
  • remains of broken glass from lighting found on product or on food contact surface
Rating II
  • unprotected lighting over exposed food in processing
  • light intensity is not sufficient to conduct process control activities, e.g., reading critical instruments
Rating III
  • Light intensity is below minimum requirements and process safety not affected in adequate drainage and pooling of water around building - no obnoxious odours
Legal Authority PPR 14(1)(e) Adequate lighting
(f) Light bulbs and fixtures - safety type
16(6) 540 lux for product sorting and inspection
Task 103
4.1 Premises
4.1.1 Building Interior
4.1.2.3 Ventilation
Task 103 April 1, 2002
Principle Adequate ventilation is provided to prevent excessive heat, steam, condensation, and dust, and to remove contaminated air.
Assessment Criteria
  • Ventilation provides sufficient air exchange to prevent unacceptable accumulations of steam, condensation, dust, excessive heat or contaminated air.
  • Ventilation openings are equipped with close fitting screens or filters as appropriate to prevent the intake of pests or contaminated air. Filters are cleaned or replaced as necessary.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Inadequate ventilation and high risk of contamination, i.e., infestation, microorganisms, condensation, etc.
  • Condensation dripping on product which will have no further kill step
Rating III
  • Inadequate ventilation, condensation/mould evident, contamination not likely
  • Condensation dripping on product which will have no further kill step
Legal Authorities PPR 14(1)(c) Protected against entrance of insect, birds etc.
(e) Adequate ventilation system
(h)(iii) Dressing rooms, lunch rooms and lavatories well ventilated
Task 104
4.1 Premises
4.1.2 Building Interior
Task 4.1.2.4 Waste Disposal
Task 104 April 1, 2002
Principle Sewage, effluent and waste storage and disposal systems are designed, constructed and maintained to prevent contamination.
Assessment Criteria
  • Drainage and sewage systems are equipped with appropriate traps and vents. Drains are easily cleanable in processing area.
  • Establishments are designed and constructed so that there is no cross-connection between the sewage system and any other waste effluent system in the establishment.
  • Effluent or sewage lines do not pass directly over or through production areas unless they are controlled to prevent contamination.
  • Adequate facilities and equipment are provided and maintained for the storage of waste and inedible material prior to removal from the establishment. These facilities are designed to prevent contamination.
  • Containers used for waste are clearly identified, leak proof and where appropriate are covered.
  • Waste is removed and containers are cleaned and sanitized at an appropriate frequency to minimize contamination potentials.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Leaking waste lines over production areas
  • Accumulation of garbage/waste resulting in obnoxious odours and /or potential cross-contamination
  • Waste effluent backing up into food handling areas
Rating III
  • Cross connections identified between sewage and other waste effluent system(s)
  • Accumulation of raw product, garbage, waste; no obnoxious odours or potential for cross contamination
  • Waste containers not clearly identified
  • Inadequate cleaning of waste containers
  • Drains not easily cleanable
Legal Authority PPR 14(1)(e) Plumbing meets requirements of operation
(j) Adequate disposal
(k) Drainage and sewage facilities:
  1. Plumbing code
  2. Handle all wastes
  3. Traps and vents
  4. No cross-contamination of effluents
  5. Located to prevent product contamination
16 (7) Sinks and drains maintained to prevent odours and fumes
(11) Waste containers identified
Task 201
4.1 Premises
4.1.3 Sanitary Facilities
4.1.3.1 Employee Facilities
Task 201 April 1, 2002
Principle Employee facilities are designed, constructed and maintained to permit effective employee hygiene and to prevent contamination.
Assessment Criteria
  • Processing areas are provided with an adequate number of conveniently located handwashing stations with trapped waste pipes to drains.
  • Washrooms have hot and cold potable running water, soap dispensers, soap, sanitary hand drying equipment or supplies and a cleanable waste receptacle.
  • Lavatories are separate and do not lead directly into any room used for handling a food product.
  • Washrooms, lunchrooms and change rooms are maintained in a clean condition and are adequately ventilated.
  • Handwashing notices are posted in prominent places in the establishment. Instructing employees engaged in the preparation of a food product to clean their hands immediately after using toilet facilities.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • No soap for handwashing for employees manipulating food, post-blancher area (frozen foods)
Rating III
  • No soap, no hot water for handwashing
  • No handwash stations in production areas
  • No handwashing notices posted
  • Not adequately ventilated
  • Lavatories not separated from processing areas
  • Untidy and unclean - poor housekeeping
Legal Authority PPR 14(1)(h) Employees facilities: dressing rooms, lunchrooms and lavatories are:
  1. Kept clean and in a sanitary condition
  2. Adequate in size and equipment
  3. Well lighted and ventilated
  4. Lavatories are separated from food handling area

14(1)(i) Hot and cold potable water

16(4) Handwashing notices
(7) Maintained to prevent any odours or fumes pervading food handling rooms
Task 202
4.1 Premises
4.1.3 Sanitary Facilities
4.1.3.2 Equipment Cleaning and Sanitizing Facilities
Task 202 April 1, 2002
Principle Facilities for cleaning and sanitizing equipment are adequately designed, constructed and maintained to prevent contamination.
Assessment Criteria
  • Facilities are constructed of corrosion resistant materials capable of being easily cleaned and are provided with potable water at temperatures appropriate for the cleaning chemicals used.
  • Equipment cleaning and sanitizing facilities are adequately separated from food storage, processing and packaging areas to prevent contamination.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Inadequate separation from food areas with a high risk of contamination with hazardous materials
Rating III
  • Inadequate separation from food areas but a low risk of contamination
  • Facilities not properly constructed, i.e. not easily cleaned, surfaces cannot withstand cleaning chemicals which are being used
Legal Authorities PPR 14(1) (a) Sound construction good repair
(e) Adequate ventilation and plumbing
(g) Separation of incompatible operations
(i) Adequate quantity and pressure of hot and cold potable water
(n) Facilities for washing, cleaning and sanitizing equipment
Task 301
4.1 Premises
4.1.4 Water/Ice/Steam Quality
Task 4.1.4.1 Water and Ice
Task 301 January 31, 2008
Principle The potability of hot and cold water, and ice is controlled to prevent contamination.
Assessment Criteria Water that is used solely for fire protection, boilers or auxiliary services (e.g. cooling of compressor heads) does not have to meet the same criteria for potability. It must be contained in a closed system (see "Water system design" for further details)

Water testing

Water meets the requirements of Health Canada's "Guidelines for Canadian Drinking Water Quality".

  • Microbiological analysis
    • Satisfactory microbiological analysis results of the source water is provided by the operator prior to establishment registration and then at least once per year.
      • If the source of the water is a private well, the manufacturer undertakes analysis.
      • If the source of the water is municipal and the analysis is carried out be the municipality, the manufacturer can obtain the results. Otherwise, the manufacturer undertakes analysis.
    • In-plant water is analyzed by the manufacturer at a frequency adequate to confirm its potability (at least once per year). Such analyses will determine if the plant's water lines and filters are sanitary and effective. Suitable sites for sampling include water fountains, hand-washing stations, and points of use, such as hoses.
  • Chemical analysis
    • Satisfactory chemical analysis results of the source water are provided by the operator prior to establishment registration.
      • If the source of the water is a private well, the manufacturer undertakes analysis
      • If the source of the water is municipal and the analysis is carried out by the municipality, the manufacturer can obtain their results. Otherwise, the manufacturer undertakes analysis.
    • Subsequent testing, once an establishment is registered may be required if there is any change to the source of the water or piping system within the establishment.

Ice testing

Ice used as an ingredient or in direct contact with food is made from potable water and is protected from contamination

  • Microbiological analysis
    • Ice produced at the establishment is analyzed at a frequency adequate to confirm microbial quality (at least once per year).
    • Ice purchased by the manufacturer is treated as an incoming ingredient and is assessed under task 501 - Ingredients and Packaging Materials Storage.

Water treatment

Source water (municipal or well) is treated and monitored if it poses a contamination risk to the product.

In plant water is treated and monitored as appropriate to the intended purpose if it is:

  • Re-circulated (e.g., cooling water in a juice pasteurizer);
  • Reused (e.g., in cooling tunnels for jams, pickles, etc.)*;
  • Recovered from processing steps for further use (e.g. finished product rinse water used to flume raw or partially prepared products).

    *Note: See 5.1.11.2 for LACF cooling water control.

The treatment method (ozone, chlorine, UV, filtration etc.) and the factors relating to its efficacy (turbidity, pH, time, temperature, etc.) are monitored and controlled to prevent contamination.

  • In the case of chemical bactericides (e.g., chlorine), the residual levels are monitored at a frequency adequate (at least twice daily) to ensure that the established limits are met.

Water treatment chemicals, when used, are listed in the "Reference Listing of Accepted Construction Materials, Packaging Materials and Non Food Chemical Products", published by CFIA or the Manufacturer has a "letter of no objection" from Health Canada.

Water system design

There are no cross connections between potable and non potable water supplies.

Re-circulated water has a separate distribution system which is clearly identified.

All hoses, taps and other similar sources of possible contamination are designed to prevent back flow or back siphonage.

Where it is necessary to store water, storage facilities are adequately designed, constructed and maintained to prevent contamination (e.g., covered).

Adverse water events

The manufacturer has an action plan in the event of a boil water advisory/water safety alert. The action plan includes, but is not limited to disinfection or treatment of plant water, alternate water source, plant closure and an investigation into the safety of the product produced prior to the advisory.

Rating Guide Examples
Rating I
  • N/A
Rating II
  • Water or food contact ice does not meet the safety requirements of Health Canada's "Guidelines for Canadian Drinking Water Quality".
  • Water or ice is not tested.
  • Re-circulated or reused water is not treated and/or monitored.
  • Cross-contamination of potable and non-potable water.
  • Use of non-accepted chemicals for water treatment which may be hazardous.
Rating III
  • Water treatment chemicals not accepted but not hazardous.
  • Water or ice is not tested at an adequate frequency.
  • Re-circulated or reused water is not appropriately treated and/or monitored.
  • The treatment method and it's related factors are not monitored and/or controlled.
  • The manufacturer lacks or has an incomplete action plan for an adverse water event.
Legal Authorities PPR 14(1)(i) potable hot and cold water protected against contamination, adequate in quantity and pressure
(2) Non potable may be used for fire protection, boilers or auxiliary services if there is no connection between system of non potable water and system of potable water
16 (9) Chemical agents properly used
(12) Exposure to contamination
Task 302
4.1 Premises
4.1.4 Water/Ice/Steam Quality
Task 4.1.4.2 Steam
Task 302 April 1, 2002
Principle The potability of steam in direct contact with food or food contact surfaces is controlled to prevent product contamination.
Assessment Criteria
  • Boiler treatment chemicals used should be listed in the "Reference Listing of Accepted Construction Materials, Packaging Materials, and Non-Food Chemical Products" published by CFIA or the manufacturer has a "letter of no objection" from Health Canada.
  • Boiler feedwater is tested regularly and the chemical treatment is controlled to prevent contamination.
  • The steam supply where there is direct food contact or in contact with food contact surfaces is generated from potable water.
  • Traps are provided as necessary to ensure adequate condensate removal and elimination of foreign materials.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • Direct steam injection and no traps for condensate removal.
  • Possible carryover of chemicals with steam and direct contact with product.
  • Food contact steam made from non potable water.
Legal Authorities PPR 16(15) Steam generated from potable water when used in the processing of a food
(9) Chemical agents properly used
(12) Exposure to contamination
Task 303
4.1 Premises
4.1.4 Water/Ice/Steam Quality
Task 4.1.4.3 Water/Ice/Steam Quality Records
Task 303 January 31, 2008
Principle Written records that adequately reflect control of water, ice and steam quality and treatment are available upon request.
Assessment Criteria The manufacturer has records available to demonstrate the adequacy of the microbiological and/or chemical safety of the water, ice and steam supply as follows:

Water Potability Records

  • water source
  • sample site and date
  • analytical results
  • analyst
  • analysis date

Water Treatment Records

  • method of treatment
  • sample site and date
  • analytical results
  • analysis date
  • analyst

Boiler Feedwater Treatment Records

  • method of treatment
  • analytical results
  • date
  • analyst

Flume Water Treatment Records

  • method of treatment
  • analytical results
  • date
  • analyst

Chiller Water Treatment Records

  • method of treatment
  • analytical results
  • date
  • analyst

Ice Records

  • source
  • date
  • analytical results
  • analyst
  • analysis date

Adverse Water Event Records

  • Dates
  • action(s) taken
  • details of event
  • products affected and/or analytical results (if applicable, including prior to the event)
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • records are incomplete
Task 401
4.2 Transportation and Storage
4.2.1 Transportation
Task 4.2.1.1 Food Carriers
Task 401 April 1, 2002
Principle Carriers used by the manufacturer are designed, constructed, maintained, cleaned and utilized in a manner to prevent food contamination.
Assessment Criteria The manufacturer verifies that carriers are suitable for the transportation of food. For example:
  • Carriers are inspected by the manufacturer on receipt and prior to loading to ensure they are free from contamination and suitable for the transportation of food.
  • The manufacturer has a program in place to demonstrate the adequacy of cleaning and sanitizing, e.g., for bulk carriers a written cleaning and sanitizing procedure is available.
  • Where the same carriers are used for food and non-food loads (e.g. dual use), procedures are in place to restrict the type of non-food loads to those that do not pose a risk to subsequent food loads after an acceptable cleanout or to food loads in the same shipment. For example:
    • The manufacturer receives a cleaning certificate and a record of the previous material transported prior to loading or unloading dual use tankers.
    • The manufacturer has a program in place to verify the adequacy of cleaning, e.g., tanker inspections, sensory evaluation of ingredients and/or analysis as appropriate.
  • Carriers are loaded, arranged and unloaded in manner that prevents damage and contamination of the food.
  • Bulk tanks are designed and constructed to permit complete drainage and to prevent contamination.
  • Where appropriate, materials used in carrier construction are suitable for food contact.
Rating Guide Examples
Rating I
  • Tankers used for food and hazardous materials, without a cleaning certificate, no record of previous material transported and adequacy of cleaning not verified.
Rating II
  • Tankers or carriers are used for food and hazardous, non-food materials but a cleaning certificate and history of use is provided. The company has an inspection protocol for cleanliness and maintenance.
  • Tankers or carriers are inspected, but are not rejected for unacceptable conditions, e.g. smell of gas, pesticides, hazardous foreign material, etc.;
  • Use of dual tankers not adequately designed for complete drainage.
Rating III
  • No cleaning certificate provided with tanker used for food and non-hazardous, non-food materials
  • No program to verify adequacy of cleaning but cleaning certificate provided with tanker used for food and non-hazardous, non-food materials
  • Inadequate inspection of carriers for cleanliness and maintenance
  • No inspection of carriers of bulk raw product e.g., raw peas
Task 402
4.2 Transportation and Storage
4.2.1 Transportation
Task 4.2.1.2 Temperature Controls
Task 402 April 1, 2002
Principle Ingredients and finished product requiring temperature controls are transported in a manner to prevent temperature abuse that could result in deterioration affecting product wholesomeness and safety.
Assessment Criteria
  • Ingredients requiring refrigeration are transported at a temperature that assures food preservation and the temperature is appropriately monitored. Frozen ingredients are transported at temperatures that do not permit thawing.
  • Finished product is transported under conditions to minimize microbiological, physical and chemical deterioration, e.g., in the case of low acid canned foods thermophilic spoilage, rusting or corrosion.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Evidence of thawing of frozen vegetables being received in carriers with no safety evaluation
  • Transportation of temperature/time sensitive ingredients consistently above 4°C with no safety evaluation e.g. Pork for beans with pork
Rating III
  • Food is transported under elevated temperature conditions which result in minimal product spoilage
Task 501
4.2 Transportation and Storage
4.2.2 Storage
Task 4.2.2.1 Ingredients and Packaging Materials Storage
Task 501 April 1, 2002
Principle Storage and handling of ingredients (incoming and in-process) and packaging materials is controlled to prevent damage and contamination.
Assessment Criteria
  • Ingredients requiring refrigeration are stored at 4°C (39°F) or less and are appropriately monitored. Frozen ingredients are stored at temperatures that do not permit thawing and are appropriately monitored.
  • Ingredients and packaging materials are handled and stored in a manner to prevent damage and/or contamination.
  • Ingredient, and where appropriate, packaging material rotation, is controlled to prevent deterioration and spoilage.
  • Humidity sensitive ingredients and packaging materials are stored under appropriate conditions to prevent deterioration.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Open/damaged containers of ingredients not covered to prevent contamination
  • Storage of temperature/time sensitive ingredients consistently above 4°C
  • Improper storage or inadequate rotation of nutrients, e.g. vitamins, resulting in a loss of potency
Rating III
  • Storage at greater than 4°C and low risk of spoilage, e.g., short storage time
  • Inadequate rotation of ingredients or packaging materials resulting in possible deterioration or spoilage, e.g., dried out sealing compound on over age can ends
Legal Authorities PPR 14(1)(p) Maintaining temperature and humidity
16(12) Exposure to a source of contamination
(13) Temperature and humidity control
Task 502
4.2 Transportation and Storage
4.2.2 Storage
Task 4.2.2.2 Non Food Chemicals - Receiving and Storage
Task 502 April 1, 2002
Principle Non-food chemicals are received and stored in a manner to prevent contamination of food, packaging materials and food contact surfaces.
Assessment Criteria
  • Chemicals are received and stored in a dry, well ventilated area.
  • Non-food chemicals are stored in designated areas such that there is no possibility for cross-contamination of food or food contact surfaces.
  • Where required for on-going use in food handling areas these chemicals are stored in a manner that prevents contamination of food, food contact surfaces or packaging materials.
  • Chemicals are stored and mixed in clean, correctly labeled containers.
  • Chemicals are dispensed and handled only by authorized and properly trained personnel.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Hazardous non-food chemicals stored in an unlabelled food container in a processing area
Rating III
  • Chemicals stored in corroded containers
  • Storage conditions inadequate, e.g., damp or insufficient ventilation, not directly affecting finished product or equipment
  • Non food chemicals in unlabelled containers in the processing areas
Legal Authorities PPR 14(1)(g) Separation of incompatible operations
16(9) Chemical storage and labelling
(12) Exposure to a source of contamination
Task 503
4.2 Transportation and Storage
4.2.3 Storage
Task 4.2.2.3 Finished Product Storage
Task 503 January 31, 2008
Principle Finished products are stored and handled to prevent damage and contamination.
Assessment Criteria
  • Finished product is stored and handled under conditions to minimize deterioration, e.g., thermophilic spoilage, rusting or corrosion.
  • Finished products requiring refrigeration are stored at 4°C (39°F) or less and are appropriately monitored.
  • Finished product is stored and handled in a manner to minimize damage, e.g., control of stacking heights and forklift damage.
  • Stock rotation is controlled to minimize deterioration that could present a health hazard, e.g., rusting, corrosion resulting in leakage.
  • Returned defective or suspect product is clearly identified and isolated in a designated area for appropriate disposition.
Rating Guide Examples
Rating I
  • No evaluation of leaking and/or swollen LACF product, e.g., customer returns or product in the warehouse
Rating II
  • No evaluation of leaking product, e.g., customer returns or product in the warehouse
Rating III
  • Inadequacies in stock rotation system to ensure oldest product is shipped first and evidence of container deterioration
  • Inadequate control of finished product handling, e.g., damaged containers evident
Legal Authorities PPR 14(1)(p) Maintaining temperature and humidity
16(12) Exposure to a source of contamination
(14) Adversely affect colour or appearance
Task 504
4.2 Transportation and Storage
4.2.2 Storage
Task 4.2.2.4 Finished Product Storage - Frozen
Task 504 April 1, 2002
Principle Frozen products are stored and handled to prevent damage, contamination and thawing.
Assessment Criteria
  • Frozen product is stored in a freezer storage maintained at -18°C or lower. Temperature fluctuations are undesirable.
  • Freezer temperatures are monitored on a regular frequency.
  • Ice buildup is controlled.
  • Stock rotation is controlled to minimize deterioration that could present a quality problem e.g. freezer burn.
  • Finished product is stored and handled in a manner to minimize damage, e.g., control of stacking heights and forklift damage.
  • Returned defective or suspect product is clearly identified and isolated in a designated area for appropriate disposition.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Freezer temperatures are not monitored or maintained and thawing of product is found
Rating III
  • Freezer temperatures are not monitored or maintained
  • Inadequacies in stock rotation system to ensure oldest product is shipped first
  • Inadequate control of finished product handling, e.g., damaged containers evident
  • No segregation of returned product, e.g., customer returns or product in the warehouse
Legal Authorities PPR 14(1)(p) Maintaining temperature and humidity
16(12) Exposure to a source of contamination
(14) Adversely affect colour or appearance
Task 601
4.3 Equipment
4.3.1 General Equipment
Task 4.3.1.1 Design and Installation
Task 601 April 1, 2002
Principle All equipment and utensils are designed, constructed and installed to function as intended, to permit effective cleaning and sanitation and to prevent contamination.
Assessment Criteria
  • Equipment is designed, constructed and installed:
    • To ensure that it is capable of delivering the requirements of the process
    • To be accessible for cleaning, sanitizing, maintenance and inspection
    • To prevent contamination of the product during operations, e.g., location of lubricant reservoirs
  • Equipment and utensils used to handle contaminated materials shall be properly identified and shall be used for its intended purpose.
  • Where necessary, equipment is exhausted to the outside to prevent excessive condensation, e.g., filler bowls, blanchers, retorts.
  • Equipment is designed, constructed and installed to permit proper drainage and where appropriate, is connected directly to drains.
Rating Guide Examples
Rating I
  • Special equipment not functioning as intended and affecting process and product safety, e.g., dicers, slicers producing too large or too small a particle not meeting the requirements of the process (LACF)
Rating II
  • Consistent contamination due to poor design/installation, e.g., product residues of a putrid, filthy, rotten, disgusting nature
  • Potential contamination of a chemical nature due to poor design/installation, e.g., by dripping of lubricants from bearings, gears, motors, and other overhead equipment
Rating III
  • Design, construction and/or installation does not permit adequate cleaning (e.g., equipment installed too close from walls and ceilings)
  • Manually cleaned equipment not easily disassembled
  • Improper drainage or exhaust of equipment
  • Welded joints not even, continuous and smooth
  • Wooden utensils used in processing area
  • Utensils used to handle contaminated materials are not properly identified
  • Tanks improperly covered
Legal Authorities PPR 14(1) (l) Equipment
  1. Acceptable material
  2. Cleanable and accessible
  3. Effective
(p) Temperature and humidity of rooms
16(11) Utensils identification and use
Task 602
4.3 Equipment
4.3.1 General Equipment
Task 4.3.1.2 Food Contact Surfaces
Task 602 January 31, 2008
Principle Food contact surfaces are constructed of appropriate materials and are maintained in a manner to prevent contamination of food.
Assessment Criteria
  • Food contact surfaces of equipment and utensils are smooth, non-corrosive, non-absorbent, non-toxic, and free from pitting, cracks or crevices and can withstand repeated cleaning and sanitation.
  • Coatings, paints, chemicals, lubricants and other materials used for food contact surfaces or equipment where there is a possibility of contact with food should be listed in the "Reference Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents", published by CFIA or the manufacturer should have "a letter of no objection" from Health Canada.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Use of coatings, paints or materials not listed in the CFIA Reference listing or reviewed by Health Canada , which are potentially hazardous (e.g., a lubricant intended for automotive use).
Rating III
  • Surfaces are pitted, cracked, absorbent.
  • Welded joints not even, continuous and smooth.
  • Use of coatings, paints or materials not listed in the CFIA Reference listing or reviewed by Health Canada , known to be non-hazardous (e.g., a plastic pipe that is not on the Reference Listing).
  • Utensils/equipment not stored on clean, rust-resistant racks.
Legal Authorities PPR 14(1) m) Food contact surfaces are:
  1. non-toxic
  2. smooth
  3. free from pitting, crevices and loose scale
  4. non-absorbent
  5. cleanable
16(12) Exposure to contamination
Task 603
4.3 Equipment
4.3.1 General Equipment
Task 4.3.1.3 Equipment Maintenance and Calibration Program
Task 603 January 31, 2008
Principle An effective maintenance and calibration program is in place to ensure that equipment performs consistently as intended and prevents contamination of product.
Assessment Criteria Maintenance:
  • The manufacturer has an effective written preventative maintenance program to ensure that equipment that may impact on food safety functions as intended. This includes:
    • A list of equipment requiring regular maintenance
    • The maintenance procedures and frequencies, e.g., equipment inspection, adjustments and part replacements are based on the equipment manufacturer's manual or equivalent, or are based on operating conditions that could affect the condition of the equipment
  • The preventative maintenance program is adhered to.
  • Equipment is maintained to ensure that no physical or chemical hazard potentials result, e.g., inappropriate repairs, flaking paint and rust, excessive lubrication. Specific maintenance requirements are assessed under Tasks 4.3.2, 4.3.3 and 4.3.4.
Calibration:
  • Written protocols, including calibration methods and frequencies, are established by the manufacturer for equipment monitoring and/or controlling devices that may impact on food safety. Specific calibration requirements are assessed under Tasks 4.3.2, 4.3.3, and 4.3.4.
Maintenance & Calibration:
  • Maintenance and calibration of equipment is performed by appropriately trained personnel.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • No preventative maintenance or calibration program for critical equipment, e.g.., closing machines, retort equipment and instrumentation, pH meter for equilibrium pH (pickles).
  • The maintenance program for critical equipment is deficient, e.g.., frequency less than equipment manufacturer's recommendations.
  • Improper maintenance of non-critical equipment with a potential for harmful extraneous matter contamination (e.g., nails, sharp pieces of metal, glass).
Rating III
  • Incomplete equipment maintenance and calibration program e.g. missing frequencies for non-critical equipment.
  • No written equipment maintenance and calibration program.
  • No maintenance for non-critical equipment, e.g., sorting belts, ingredient containers, can transfer equipment.
  • Improper maintenance of non-critical equipment, e.g., washing or sorting equipment not functioning as intended.
  • Improper maintenance of non-critical equipment with a potential for non-harmful extraneous matter contamination (e.g., rust, grease, paint).
Legal Authorities PPR 30.2 c) Procedure for maintenance of thermal processing equipment
Task 604
4.3 Equipment
4.3.1 General Equipment
Task 4.3.1.4 Equipment Maintenance Records
Task 604 April 1, 2002
Principle Records are available to demonstrate adherence to the maintenance program for critical equipment.
Assessment Criteria The typical information expected in maintenance records for critical equipment:
  • identification of equipment
  • maintenance activity
  • date, person
  • reason for activity
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • Information in maintenance records not complete
  • No maintenance records for critical equipment
Legal Authorities PPR 30.2 f) (iv) Maintenance Records of Thermal Processing Equipment (LACF only)
Task 605
4.3 Equipment
4.3.1 General Equipment
Task 4.3.1.5 Equipment Calibration Records
Task 605 April 1, 2002
Principle Records are available to demonstrate adherence to the calibration/testing program of equipment/ instruments critical to food safety.
Assessment Criteria Records are available to demonstrate that all equipment and instruments critical to food safety are calibrated or tested according to accepted frequency and procedures or according to manufacturer's specifications.

Typical information expected in calibration records includes:

  • Identification of equipment to be calibrated
  • Identification of reference standard
  • Date of calibration
  • Person conducting calibration
  • Methodology/procedure used for calibration, e.g.: temperature, pressure
  • Calibration results
    • The difference, +/-, between the work instrument and reference instrument before calibration
    • The difference, +/-, between the work instrument and reference instrument after calibration
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • Records are incomplete, e.g., calibration results (variance) not recorded
  • Absence of calibration records
  • Calibration not done correctly
Legal Authorities PPR 30.2 f) (iv) Maintenance Records of Thermal Processing Equipment (LACF only)
Task 701
4.3 Equipment
4.3.2 Pre-Process Equipment
Task 4.3.2.1 Preparation/Blending Equipment and Instrumentation
Task 701 April 1, 2002
Principle Preparation and blending equipment is designed, constructed, installed and maintained such that the equipment is capable of delivering the required process to ensure product safety.
Assessment Criteria Equipment and instruments which control factors critical to product safety are designed, installed, constructed and calibrated as necessary to ensure that they function as intended. The following are some examples of instrumentation that may be required for preparation/blending equipment to control factors critical to the process:

Mercury in Glass (MIG) Thermometers, Temperature Recorders, Other Temperature Measuring Devices.

  • Refer to assessment criteria in sub item 4.3.3.2 - Retort Instrumentation.

Scales/Meters

  • Refer to assessment criteria in sub item 4.3.2.2 - Filling Equipment and Instrumentation.

Magnets

  • The strength and type of magnets is appropriate to the use.
  • Magnets are installed in manner to effectively remove ferrous metal prior to or after certain operations, e.g., dicing, slicing or filling.
  • The strength of magnets is confirmed as necessary.
  • Magnets are monitored as necessary to ensure effective operation and surface exposure.

Metal Detectors

  • Metal detection equipment, if installed and used, is designed, constructed, installed, calibrated and maintained in accordance to the equipment manufacturer's manual to ensure effective removal of metals. This may include: adjustment for product effect, selection of target metal and size, timing of the reject mechanism and suitability for operational conditions.

Other Instrumentation

  • Other specialized instrumentation necessary for the control of critical factors are in place and calibrated as necessary, e.g., pH meters, refractometer.
Rating Guide Examples
Rating I
  • No calibration of measuring equipment affecting the critical factors (e.g. size graders, dicers are not calibrated and exceed the limits of the thermal process) (LACF)
Rating II
  • pH meter not maintained or calibrated, in brine preparation or direct acidification (for ALACF)
Rating III
  • Metal detector, if installed, is functioning but not calibrated to achieve optimum sensitivity as per manufacturer's specifications
  • Measuring devices for non-critical ingredients are not calibrated at the required frequency
Legal Authorities PPR 30.2 c) Maintenance Records of Thermal Processing Equipment (LACF only)
Task 702
4.3 Equipment
4.3.2 Pre-Process Equipment
Task 4.3.2.2 Filling Equipment and Instrumentation
Task 702 April 1, 2002
Principle Filling equipment is designed, constructed, installed and maintained such that the equipment is capable of meeting the critical factors specified in the scheduled process.
Assessment Criteria Filling equipment is designed, constructed, installed and maintained as necessary to provide the required fill weight/volume, the minimum initial temperature and to meet headspace/vacuum requirements. The following are some Examples of equipment that may be required for control of critical filling factors:

MIG Thermometers, Temperature Recorders, Other Temperature Measuring Devices

  • Refer to assessment criteria in sub item 4.3.3.2, Retort Instrumentation.

Scales/Meters

  • The sensitivity is appropriate to the use.
  • Scales are designed to withstand the environmental conditions or are adequately protected.
  • Scales and meters are calibrated as necessary to ensure accuracy at all times.

Headspacers

  • Headspacers are designed, constructed, installed and maintained to provide the required headspace and to prevent can damage.
Rating Guide Examples
Rating I
  • Scales or meters not calibrated for critical factors, (e.g. fill weight, drained weight exceeds thermal process requirements)
Rating II
  • Headspacer not set up to deliver required headspace resulting in excessive buckling occurs
Rating III
  • Measuring devices for non-critical ingredients are not calibrated at the required frequency
Legal Authorities PPR 14 (1) l) Equipment
  1. Acceptable material
  2. Cleanable and accessible
  3. Effective
Task 703
4.3 Equipment
4.3.2 Pre-Process Equipment
Task 4.3.2.3 Container Closure Equipment
Task 703 April 1, 2002
Principle Container closure equipment is designed, constructed, installed and maintained such that the equipment is capable of hermetically sealing containers and, where necessary, providing the required vacuum.
Assessment Criteria
  • Container closure equipment is installed, set up and maintained according to the manufacturer's specifications.
  • Equipment is capable of consistently producing hermetic seals and the required vacuum where necessary.

Note: Anytime the equipment is delivering a defect included in the Metal Defect Manual it should be evaluated as either Minor or Serious.

Rating Guide Examples
Rating I
  • closing machine cannot deliver the required vacuum for vacuum packed products
Rating II
  • Closing equipment set-up is deficient, (e.g. changeover in can size resulting in a risk of leakage)
  • Container closure equipment is producing an unacceptable level of seam defects
Rating III
  • Excessive grease on closer
Legal Authorities PPR 14(1) l) Equipment
30.3 (c) LACF seamer maintenance
Task 801
4.3 Equipment
4.3.3 Retort Equipment
Task 4.3.3.1 Design, Installation and Maintenance (Still Steam Retort)
Task 801 January 31, 2008
Principle Retort equipment is designed, constructed, installed and maintained to be capable of delivering the requirements of the thermal process.
Assessment Criteria The retort system is designed, installed, constructed and maintained such that the equipment is capable of delivering the required process and controlling factors critical to thermal processing. Components of the system include:

Steam Supply

  • Steam supply is adequate to meet the minimum requirements for venting and processing under all operating conditions, e.g., the steam supply is adequate to meet the maximum demand for venting multiple retorts.

Steam Controller

  • The retort is equipped with a steam controller suitable to maintain a consistent retort temperature.

Steam Inlet

  • The steam inlet is large enough to provide sufficient steam and is located opposite to the vent.

Steam Spreaders

  • Horizontal retorts are equipped with perforated steam spreaders that extend throughout the length of the retort.
  • Crateless retorts with top steam entry are equipped with circular steam spreaders.
  • Vertical retorts do not require spreaders; however, where spreaders are used they conform to the type used in the temperature distribution studies.
  • The cross-sectional area of the spreader perforations is equal to 12 to 2 times the cross-sectional area of the smallest part of steam inlet line.
  • Spreaders are checked regularly to ensure they are not blocked or otherwise alter steam distribution.

Valves

  • Valves controlling air and water flow are designed to prevent leakage into the retort during processing, e.g., globe valves.
  • Valves controlling venting are fully open and are designed such that they do not impede the rapid discharge of air and steam from retort, e.g., gate valve, plug cock.

Vents

  • Vents have an atmospheric break if connected to a closed drain system.
  • The cross-sectional area of manifolds connecting vent pipes from a single retort or from several steam retorts should be equal to or greater than the combined cross- sectional areas of the vents for the maximum number of retorts to be vented at one time, as identified in the temperature distribution studies.
  • Manifolds connecting several retort lines are not equipped with valves.
  • The manufacturer has temperature distribution studies to verify the adequacy of the piping arrangement used for venting.
  • Manifold headers should be so designed to prevent accumulation of condensate.

Steam Traps

  • Steam traps are maintained at an appropriate frequency to ensure proper operation.

Bleeders

  • Bleeders are a minimum of 1/16" when used to bleed wells for thermometers or temperature recorder bulbs. All other bleeders are a minimum of 1/8" in diameter.
  • Bleeders in vertical retorts are located opposite to the steam entry. Top steam entry retorts have a condensate bleeder located at the bottom of the retort.
  • Crateless retorts with top steam entry shall have at least one 3/8" or larger condensate bleeders in the bottom door.
  • All bleeders, including condensate bleeders are arranged so that the operator can observe that they are functioning adequately.

Mufflers

  • Verification is required that mufflers do not impede air removal during the vent and process.

Water

  • Water supply piping to the retort is equipped with backflow prevention devices or vacuum breakers to prevent back siphoning.
  • Horizontal retorts with top water spreaders with upward facing holes are designed so that the header pipe extends past the location of the last basket. A single 1/4" hole is drilled in the bottom of the each end cap so that water will empty out of the spreader away from any baskets.
  • Water spreaders are designed to ensure that the water is uniformly distributed for proper cooling of the containers
  • For immersion cooling an overflow line is located above the top layer of containers to ensure that all containers are immersed in the cooling water.

Retort doors

  • Crateless retorts are equipped with perforated false bottoms to ensure adequate steam circulation to allow condensate to drain to the condensate bleeder, and to prevent possible contact between containers and condensate.

Retort Structure

  • Bottom crate supports are designed so as not to prevent adequate steam distribution.
  • Retorts and baskets are designed in a manner to ensure adequate spacing between baskets and retort walls to provide uniform steam distribution.
  • Baffle plates are not used in retorts.

Crates, Baskets, Divider Plates

  • All crates, baskets, and dividers are uniformly perforated and sized to ensure adequate steam distribution, e.g., 1" holes on 2" centers or equivalent.
  • All crates, baskets, and dividers are free from rough projections, weld beads, sharp corners, or edges that could damage the containers.

Preventative Maintenance Program

  • An annual retort equipment survey.
  • Inspection of pipes for evidence of internal scale buildup. Scale will reduce the internal diameter of the pipe reducing it's carrying capacity.
  • Replacement of parts, e.g. valves, pipes, etc with identical parts.
  • Inspection of all manual and automatic valves to ensure:
    • steam, vent and controller valves open fully
    • air and water valves do not leak into the retort
    • automatic valves
Rating Guide Examples
Rating I
  • Steam supply is inadequate and critical limits are affected, e.g., vent not achieved and possible under process
  • Absence of a condensate bleeder for vertical steam retorts with |top| steam entry
  • No false bottom doors for crateless retorts
  • Water valve leaking allowing water to accumulate in the retort
Rating II
  • Bleeder discharge not visible to the operator or not checked adequately
  • Dividers with different hole configurations used without process authority approval
Rating III
  • N/A
Legal Authorities PPR 14(1) l) Equipment
30.3 h) Maintenance of thermal processing equipment (LACF only)
Task 802
4.3 Equipment
4.3.3 Retort Equipment
Task 4.3.3.2 Retort Instrumentation
Task 802 January 31, 2008
Principle Retort instrumentation is designed, installed, calibrated and maintained such that the instrumentation is capable of measuring, controlling and/or recording the critical factors in the thermal process.
Assessment Criteria
  • Air operated control systems are equipped with adequate filter systems to supply clean dry air at sufficient pressure.
  • Each retort is equipped with at least one Mercury in Glass indicating thermometer, a temperature/time recording device and one pressure gauge.
  • The official temperature indicating device shall be Mercury in Glass thermometer.
  • The retort processing area is equipped with an official timing device.

Temperature Measuring Devices

  • Sensors or thermometer bulbs located in external wells or within the retort shell are installed to ensure a full steam flow past the entire length of the thermometer bulb or sensor.
  • The manufacturer uses one temperature scale consistently throughout the processing system, i.e., Celsius or Fahrenheit.

MIG Thermometers

  • Mercury in Glass thermometers are calibrated against a known standard just prior to installation, a minimum of once per year, or more frequently as necessary to ensure their accuracy. If there is a deviation of more than 0.5°C (1) from the standard thermometer, corrective action is taken. Thermometer scales are within the operating range, are easily readable to 0.5°C (1°F), and do not contain more than 4°C/cm (17°F/inch).

Temperature Recorders

  • The scale of the temperature recording chart is not more than 12°C/cm (55°F/inch) within the range of 10°C (18°F) of process temperature and the chart graduation does not exceed 1°C (2°F) within 6°C (11°F) of processing temperature. The accuracy of temperature recorders is verified upon installation, a minimum once per year or more frequently as necessary to ensure their accuracy.

Other Temperature Measuring Devices

  • Where used, other temperature measuring devices are installed calibrated and maintained as necessary to ensure accuracy, e.g., Resistance Temperature Detectors (RTD's), bimetal thermometers.

Timing Devices

  • Timing devices and recorders are verified to ensure accuracy upon installation, annually, or more frequently as necessary to ensure accuracy.
  • Where timing devices are not equipped with a power backup, controls are in place to verify that process time requirements are met.
  • Official timing device should be located so that it can be easily and accurately read by the operator.

Pressure Gauges

  • Each retort is equipped with an accurate pressure gauge,
    • With a range of 0 to 30 psi (0 to 206.8 kPa)
    • Graduated in divisions of 2 psi (14 kPa) or less
    • A minimum dial diameter of 32@ (8.9 cm)
    • Is connected to the retort shell or external shell by a short gooseneck tube the pressure gauge should not be more than 4" (10 cm) higher than the gooseneck
  • Each pressure gauge is calibrated at least annually or more frequently as necessary to ensure accuracy.

Electronic Devices

  • The capability of electronic devices is at least equivalent to that of traditional devices used for measuring and controlling critical parameters such as time, temperature and pressure (traditional devices include for example, temperature recorder controllers).
Rating Guide Examples
Rating I
  • Variance of automatic timers exceeds the limits specified in the process resulting in under processing

NOTE: "under processing" would be evaluated in chapter 5

Rating II
  • Calibration using a standard of unknown accuracy
  • Absence of annual calibration of measuring instruments critical to food safety (ie. Indicating thermometers)
Rating III
  • Pressure gauge is inaccurate
  • Absence of annual calibration of measuring instruments non-critical to food safety (ie. pressure gauges on still steam retorts)
Legal Authorities PPR 14(1) l) Equipment
30.3 (i) Monitoring devices of thermal processing equipment
(LACF only)
Task 901
4.3 Equipment
4.3.4 Post-Process Equipment
Task 4.3.4.1 Post-Process Cooling Canal and Handling Equipment
Task 901 April 1, 2002
Principle Post-process cooling canal and handling equipment is designed, constructed, installed and maintained to prevent contamination and damage to containers.
Assessment Criteria
  • Equipment is designed, constructed, installed and maintained to prevent impact damage of containers and minimize contamination.
  • Equipment is free from rough projections, sharp corners or edges that can damage containers.
  • Bactericide in feed is appropriately located to ensure adequate levels and mixing of bactericide in the cooling canal.
  • Cooling system is maintained to prevent the buildup of rust.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Equipment design, installation or maintenance is causing serious can damage, e.g., timing, speeds on conveyors/transfer points not synchronized, conveyors causing cable cuts
  • Bactericide in feed inappropriately located to ensure adequate residual in the cooling canal
Rating III
  • Minor can damage caused by inadequate equipment design, e.g., can unscramblers, busse unloaders, conveyors
Legal Authorities PPR 14(1)(l) Equipment
  1. Acceptable material
  2. Cleanable and accessible
  3. Effective
Task 902
4.3 Equipment
4.3.4 Post-Process Equipment
Task 4.3.4.1 Low Vacuum Detection Equipment
Task 902 April 1, 2002
Principle Low vacuum detection equipment is designed, installed, calibrated and maintained to eject containers with inadequate vacuum.
Assessment Criteria
  • Low vacuum detection equipment is installed at an appropriate location in the line to permit efficient inspection of vacuum in post process containers.
  • Units are installed, calibrated and maintained as appropriate.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Equipment not functioning as intended (e.g., units not adequately installed, maintained or calibrated; test cans passing through unit undetected)
Rating III
  • The frequency of calibration is less than that recommended by the equipment manufacturer
Legal Authorities PPR 14(1)(l) Equipment
  1. Acceptable material
  2. Cleanable and accessible
  3. Effective
30.3 (i) Monitoring devices of thermal processing equipment (LACF only)
Task 1001
4.4 Personnel
4.4.1 Training
Task 4.4.1.1 General Food Hygiene Training
Task 1001 April 1, 2002
Principle Every food handler is trained in personal hygiene and hygienic handling of food such that they understand the precautions necessary to prevent the contamination of food.
Assessment Criteria The manufacturer has a written training program for employees which is delivered as follows:
  • Appropriate training in personal hygiene and hygienic handling of food is provided to all food handlers at the beginning of their employment.
  • The original food hygiene training is reinforced and updated at appropriate intervals.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • No employee training
Rating III
  • Employees trained with no written program
Legal Authorities PPR 16(12) Exposure to a source of contamination
Task 1002
4.4 Personnel
4.4.1 Training
Task 4.4.2.2 Technical Training
Task 1002 April 1, 2002
Principle Personnel are trained such that they have adequate technical knowledge and understanding of the operation(s) or process(es) for which they are responsible to ensure food safety.
Assessment Criteria Training is appropriate to the complexity of the manufacturing process and the tasks assigned, e.g.:
  • Personnel are trained to understand the importance of the critical control points for which they are responsible; the critical limits, the procedures for monitoring, the action to be taken if the limits are not met, and the records to be kept.
  • Retort operators are trained to have current knowledge of equipment and process technology, e.g., apprenticeship training.
  • Retort operators have successfully completed, or are supervised by an individual who has successfully completed a thermal processing course from a recognized individual or institution.
  • Personnel responsible for conducting and supervising visual and destructive container examination are trained to have complete knowledge of container defects and evaluation.
  • Personnel responsible for conducting post-process container integrity evaluations are appropriately trained to ensure proper assessment of rejects for container defects, e.g., line operators may be trained in general container defect recognition and may perform assessments on obvious causes for rejection, however, non-obvious causes for rejection may be referred to container integrity experts such as quality assurance personnel or the container supplier.
  • Personnel responsible for maintenance of equipment impacting on food safety, have been appropriately trained to identify deficiencies that could affect product safety and to take the appropriate corrective action, e.g., in house repairs, contract repairs. Individuals performing maintenance on specific equipment are appropriately trained e.g., closing machines, recorders, double dud detector equipment etc.
  • Personnel and supervisors responsible for the sanitation program are appropriately trained to understand the principles and methods required for effective cleaning and sanitizing.
  • Additional training is provided as necessary to ensure current knowledge of equipment and process technology, e.g., specific technical training, apprenticeship programs, etc.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Personnel do not understand the critical control points for which they are responsible
  • Retort operators or their supervisors have not completed a thermal processing course
  • Maintenance staff responsible for critical equipment have not received appropriate training
Rating III
  • employee follows the method of sanitation but has not been trained in the principles for cleaning and sanitation
Legal Authorities PPR 30.3(e) Certificate of competence in thermal processing
Task 1101
4.4 Personnel
4.4.1 Hygiene and Health Requirements
Task 4.4.2.1 Cleanliness and Conduct
Task 1101 April 1, 2002
Principle All persons entering food handling areas maintain an appropriate degree of personal cleanliness and take the appropriate precautions to prevent the contamination of food.
Assessment Criteria
  • All persons wash their hands upon entering food handling areas, before starting work, after handling contaminated materials, after breaks and after using toilet facilities. Where necessary to minimize microbiological contamination, employees use disinfectant hand dips.
  • Protective clothing, hair covering, footwear and/or gloves, appropriate to the operation in which the employee is engaged, are worn and maintained in a sanitary manner, e.g., employees in production areas wear effective hair coverings.
  • Any behaviour which could result in contamination of food, such as eating, use of tobacco, chewing gum, or unhygienic practices such as spitting are prohibited in food handling areas.
  • All persons entering food handling areas remove jewellery and other objects which may fall into or otherwise contaminate food. Jewellery which cannot be removed, including wedding bands and medical alerts, is covered.
  • Personal effects and street clothing are not kept in food handling areas and are stored in a manner to prevent contamination.
  • Access of personnel and visitors is controlled to prevent contamination. The traffic pattern of employees prevents cross-contamination of the product.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Employees handling food not washing their hands nor using disinfectant hand dips which could contamination of product
Rating III
  • Personal effects at the work station
  • Personnel wearing jewellery, e.g., earrings
  • Uncontrolled visitor access
  • Unclean and improper clothing
  • Items in breast pockets
  • Employees eating, smoking, chewing gum
  • Poor hygienic practices
  • No or improperly worn hair covering
Legal Authorities PPR 16(4) Handwashing notices posted
17(2) Handwashing
(3) Sanitary clothing, hair covering, impermeable gloves
(4) Tobacco, chewing gum, food
(5) Object that may contaminate the food
Task 1102
4.4 Personnel
4.4.1 Hygiene and Health Requirements
Task 4.4.2.2 Communicable Diseases/Injuries
Task 1102 April 1, 2002
Principle No person while known to be infected with a disease likely to be transmitted through food, or with open cuts or wounds, is permitted to work in food handling areas where there is a likelihood of such a person directly or indirectly contaminating the food.
Assessment Criteria
  • The manufacturer has and enforces a policy to prevent personnel known to be suffering from, or known to be carriers of a disease transmissible through food, from working in food handling areas.
  • The manufacturer requires that employees advise management when they are suffering from a communicable disease likely to be transmitted through food.
  • Employees having open cuts or wounds do not handle food or food contact surfaces unless the injury is completely protected by a secure waterproof covering, e.g., rubber gloves.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Employees working with open cuts and wounds handling food
  • Employees working with uncovered bandages on hands handling food
Rating III
  • Manufacturer does not have a policy for food handlers suffering from diseases transmissible through food
Legal Authorities PPR 17(1) Communicable disease
Task 1201
4.5 Sanitation (and Pest Control)
4.5.1 Sanitation
Task 4.5.1.1 Written Sanitation Program and Effectiveness Evaluation
Task 1201 April 1, 2002
Principle An effective sanitation program for equipment and premises is in place to prevent contamination of food.
Assessment Criteria The manufacturer has a written cleaning and sanitation program for all equipment which includes:
  • The identification of responsible person
  • The frequency of the activity
  • Chemicals and concentration used
  • Temperature requirements

Procedures for cleaning and sanitizing as follows:

Cleaned Out of Place Equipment (C.O.P., e.g., hand-cleaned)

  • Identify equipment and utensils
  • Disassembly/reassembly instructions as required for cleaning and inspection
  • Areas on equipment requiring special attention are identified
  • Method of cleaning, sanitizing and rinsing

Cleaned in Place Equipment (C.I.P)

  • Identify lines and/or equipment
  • CIP setup instructions
  • Method of cleaning, sanitizing and rinsing
  • Disassembly/reassembly instructions as required for cleaning and inspection

The manufacturer has a written cleaning and sanitation program for premises (production and storage areas) which specifies areas to be cleaned, method of cleaning, person responsible and the frequency of the activity. Special sanitation and housekeeping procedures required during production are specified within the document, e.g., removal of product residues during breaks.

Chemicals are used in accordance with the manufacturer's instructions and should be listed in the "Reference Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents", published by CFIA or the manufacturer should have a "letter of no objection" from Health Canada.

Cleaning and sanitizing equipment is designed for its intended use and is properly maintained.

The sanitation program is carried out in a manner that does not contaminate food or packaging materials during or subsequent to cleaning and sanitizing, e.g., aerosols, chemical residues.

Effectiveness of the sanitation program is monitored and verified (e.g., by routine inspection of premises and equipment and/or microbiological testing) and where necessary, the program is adjusted accordingly.

Operations begin only after sanitation requirements have been met.

Rating Guide Examples
Rating I
  • N/A
Rating II
  • Incomplete sanitation program resulting in improper rinse of food contact surface and a contamination of product with concentrated cleaning material
Rating III
  • Incomplete sanitation program
  • Chemical used in sanitation program not listed in the "Reference Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents", published by CFIA.
  • Chemical used for cleaning food contact surface not listed in the "Reference Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents", published by CFIA
  • No written sanitation program
  • Effectiveness of the sanitation program is not monitored and verified
Legal Authorities PPR 10(2) Sanitation program
16(1) Maintain sanitary conditions
(2) Follow sanitation program
(9) Label/store/use chemicals for sanitation
(12) Exposure to contamination
(14) Food Contact Surfaces
Task 1202
4.5 Sanitation (and Pest Control)
4.5.1 Sanitation
Task 4.5.1.2 Equipment Cleanliness
Task 1202 April 1, 2002
Principle The sanitation program is being followed so that the equipment and utensils are maintained in a sanitary condition that prevents contamination of food.
Assessment Criteria The manufacturer maintains the equipment, utensils and other tools in a clean and sanitary manner:
  • Food contact surfaces are maintained in a sanitary manner, free from accumulations of food particles, dust, grease, grime
  • Sanitation program as written is followed - frequency; equipment is disassembled as required; correct chemicals and concentrations are used; etc.
  • Utensils and tools are stored on conveniently located rust-resistant rack
  • Sanitation is carried out in a manner that does not contaminate food or packaging materials (remove, cover or other adequate protection)
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Equipment was not completely clean after the final kill step e.g., post blanch equipment not clean on frozen product lines
  • Clean up not done as scheduled -some build up of food materials and/or foul odour
  • Incomplete rinsing after cleaning resulting in chemical contamination of product
  • Poor sanitation practices e.g. splashing of cleaning chemicals and wash up water onto operating lines or packaging material
Rating III
  • Utensils are sitting on the floor
  • Clean up not done as scheduled -light build up of food materials and no odour
  • Equipment was not completely clean for products with a final kill step
  • Pre blanch equipment was not completely clean after cleanup
Legal Authorities PPR 16(1) Maintenance of sanitary condition
(2) Sanitation Program Followed
(9) Handling and use of non food chemicals
(12) Exposure to contamination
(14) Food Contact Surfaces
Task 1203
4.5 Sanitation (and Pest Control)
4.5.1 Sanitation
Task 4.5.1.3 Premises Cleanliness
Task 1203 April 1, 2002
Principle The sanitation program is being followed so that the interior of the building and all other physical facilities are maintained in a sanitary and tidy condition that prevents contamination of food.
Assessment Criteria The manufacturer maintains the building and physical facilities in a clean and sanitary manner.
  • The premises are kept free of debris and refuse
  • Floor, wall and ceiling surfaces are maintained in a sanitary manner, free from accumulations of food particles, dust, grease, grime
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Poor sanitation practices e.g., splashing of cleaning chemicals and wash up water onto operating lines or packaging material
  • Heavy buildup of mould or old food materials on windows, doors, walls, ceilings etc mostly in post kill step areas where there is a high risk of food contamination
Rating III
  • Walls, ceilings, floors, doors, windows and/or unclean - light build up of mould or old food materials - pre kill step areas, storage, receiving
  • Dusty Overhead beams throughout plant
  • Poor housekeeping which may result in potential harbourage of pests
Legal Authorities PPR 16(1) Maintenance of sanitary condition
(2) Sanitation Program Followed
(9) Handling and use of non-food chemicals
(12) Exposure to contamination
Task 1204
4.5 Sanitation (and Pest Control)
4.5.1 Sanitation
Task 4.5.1.4 Sanitation Records
Task 1204 April 1, 2002
Principle Records are available to demonstrate the effectiveness of the sanitation program.
Assessment Criteria The records of sanitation activities include the date, person responsible, the findings, corrective action taken, and microbiological test results where appropriate.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • No sanitation records
  • Missing dates or initials on a daily sanitation record
  • Isolated instance of missing information on a daily sanitation record
Task 1301
4.5 Sanitation (and Pest Control)
4.5.1 Pest Control
Task 4.5.2.1 Pest Control Program
Task 1301 April 1, 2002
Principle Effective pest control programs are in place to prevent entry, detect and eliminate pests and to prevent the contamination of food.
Assessment Criteria There is an effective written pest control program for the premises and equipment that includes:
  • The identification of the person at the manufacturer assigned responsibility for pest control.
  • Where applicable, the name of the pest control company or the name of the person contracted for the pest control program.
  • The list of chemicals used, the concentration, the location where applied, method and frequency of application.
  • A map of trap locations.
  • The type and frequency of inspection to verify the effectiveness of the program.
  • Pesticides used are registered under the Pest Control Products Act and Regulations and are listed in the "Reference Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents", published by CFIA. Pesticides are used in accordance with the label instructions.
  • Treatment of equipment, premises or ingredients to control pests is conducted in a manner to ensure that the maximum residue limit of the Food and Drugs Act and Regulations is not exceeded, e.g., limiting the number of fumigation treatments per lot.
  • Birds and animals, other those intended for slaughter, are excluded from establishments.
  • Pallets and materials are stored at a sufficient distance from the wall to avoid potential harbourage of pests. Congested storage conditions are avoided.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Major infestation with a high risk of contamination
  • Pesticide used inappropriately and risk of direct contamination (spraying during operation)
Rating III
  • Pesticides not listed in the "Reference Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents", published by CFIA
  • No map of trap locations
  • No person designated for pest control
  • Low level infestation
  • No written pest control program
  • Materials stored too close to walls - possible harbourage
Legal Authorities PPR 16(8) Pest control Program
Task 1302
4.5 Sanitation (and Pest Control)
4.5.1 Pest Control
Task 4.5.2.2 Pest Control Records
Task 1302 April 1, 2002
Principle Records are available to demonstrate the effectiveness of the pest control program.
Assessment Criteria Minimum pest control records include:
  • Results of the inspection programs and the corrective action taken e.g., findings in traps, location of insect infestation.
  • Record of pest control activities, e.g., pesticide used, method and location of application, dates of fumigation, etc.
  • Date, person responsible.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • No pest control records
  • Missing dates or initials on pest control record
  • Isolate instance of missing information on pest control record
Task 1401
4.6 Complaints and Recalls
4.6.1 Complaint Handling
Task 4.6.1.1 Product Complaints
Task 1401 April 1, 2002
Principle The establishment has an effective system for handling and investigating complaints.
Assessment Criteria The manufacturer has a system to handle and investigate product complaints as follows:
  • The manufacturer has identified the person or persons responsible for receiving, evaluating, categorizing and/or investigating complaints.
  • Complaints are accurately categorized according to health and safety risks.
  • Potentially serious complaints are forwarded immediately to appropriate personnel for action.
  • Safety and contamination complaints are investigated by appropriately trained technical personnel.
  • Examination of the complainant's specimen, retail product or other product of the same code is conducted on complaints related to food safety.
  • The depth of the investigation is appropriate to the risk and similar complaint trends.
  • Appropriate corrective action is taken for deviations identified during the investigation.
Rating Guide Examples
Rating I
  • No investigation of complaints involving putrid swollen cans (LAF)
Rating II
  • Complaints affecting food safety (illness, glass, metal, swells, spoilage, leakage, etc.), are not referred to appropriate personnel for action
  • Complaints not investigated thoroughly, e.g., a complaint of a putrid, swollen can is only superficially investigated, process records not reviewed
  • Potentially serious complaints are not investigated promptly
Rating III
  • No investigation of complaints involving swollen high acid cans
Task 1402
4.6 Complaints and Recalls
4.6.1 Complaint Handling
Task 4.6.1.2 Complaint Records
Task 1402 April 1, 2002
Principle Records of product complaints, investigation findings and action taken are available upon request.
Assessment Criteria The establishment maintains or has access to detailed records of consumer complaints received, investigation, findings and corrective action taken. The minimum information required for complaint records related to Health and Safety Issues are as follows:

Consumer Information

  • Name, address, telephone number, date received
  • Details of complaint and/or illness
  • Product name, code, size
  • Retail outlet

Investigation

  • Name of person responsible for investigation
  • Date investigated
  • Findings of investigation
  • Corrective action taken
Rating Guide Examples
Rating I
  • N/A
Rating II
  • No records of health and safety complaints and investigations
Rating III
  • Records are incomplete but there is sufficient information to verify the adequacy of complaint investigation, e.g., consumer name, address, date, retail outlet, etc.
Task 1501
4.6 Complaints and Recalls
4.6.1 Recalls
Task 4.6.2.1 Recall Plan
Task 1501 April 1, 2002
Principle Every manufacturer of a food establishes a written recall plan to permit the complete, rapid recall of any lot of food from the market.
Assessment Criteria The written recall plan includes:
  • The person or persons responsible, e.g., recall coordinator(s) including after hours name and contact.
  • The roles and responsibilities for coordination and implementation of a recall.
  • Methods to identify, locate and control recalled product.
  • A requirement to investigate other products that may be affected by the hazard and that should be included in the recall.
  • Procedure for monitoring the effectiveness of the recall, e.g., effectiveness check to the appropriate level of distribution specified in the recall notice.
  • Appropriate CFIA local office coordinates.

Recall notification as follows:

  • Amount of product produced, in inventory and distributed
  • Name, size, code or lot numbers of food recalled
  • Area of distribution of product, e.g., local, national, international
  • Reason for the recall
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • Incomplete written recall plan
  • No written recall plan
Legal Authorities PPR 30.2 (d) written recall plan (LACF) only)
(g) Notify the inspector of a recall (LACF only)
30.3 (d) Voding requirements (LACF only)
Task 1502
4.6 Complaints and Recalls
4.6.1 Recalls
Task 4.6.2.2 Product Code Identification
Task 1502 April 1, 2002
Principle Where required, each container of prepackaged food is identified with code marks or lot numbers marks either on the label or container as applicable.
Assessment Criteria The coding requirements are different depending on the food types:

For low acid foods and acidified low acid foods:

  • The container shall be marked in a legible and permanent manner.
  • The code mark identifies the establishment, the product*, the day, month and year in which the food was rendered commercially sterile.
  • *The product identification is not mandatory when the product is packed in a transparent container through which the product can be seen and identified.
  • Code marks used and the exact meaning of the code are available.

For graded canned fruits:

  • On the label or on the container, a code mark indicating the establishment where the product was packed and the date of packing.

For products prepared in a registered establishment which are packed for a first dealer under his private label:

  • The registration number of the establishment or his identifying code mark shall appear on the label or be embossed or inkjetted on the container.

For other food products

  • Coding is suggested but not mandatory. However if the food product is not coded, it may trigger to recall all production, when a recall is necessary.
  • Where used, case codes are legible and represent the container code within.
  • All packages in which containers of food products are packed shall be marked on one panel with the registration number of the establishment in which the product was packed and the name and address of the operator or the first dealer.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • Case code does not coincide with can code
  • No code, illegible code (where code is mandatory)
Legal Authorities PPR 30.3 d) coding requirements (LACF)
31 aa) Coding requirements for canned graded fruit and vegetables
33 Establishment identification on the label or the container when product is packed for a first dealer
46 e) Registration number of the packer on the external packages
Task 1503
4.6 Complaints and Recalls
4.6.1 Recalls
Task 4.6.2.3 Recall Capability
Task 1503 April 1, 2002
Principle Recall plans are tested periodically to verify the capability to rapidly identify and remove product from the market.
Assessment Criteria The manufacturer is capable of producing accurate information on a timely basis to verify that all affected product can be rapidly identified and removed from the marketplace. This can be demonstrated by the manufacturer as follows:
  • Periodic testing (internal simulations) to verify the capability of the recall plan to rapidly identify and control a code lot of potentially affected product and reconcile the amount of product produced, in inventory and in distribution. Any deficiencies in the recall plan are identified and corrected.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Recall plans tested and found not to be effective. No corrective action taken
Rating III
  • Recall plans have never been tested
  • Identified deficiencies have never been corrected
Legal Authorities PPR 30.2 d) written recall plan (LACF only)
g) Notify the inspector of a recall (LACF only)
30.3 d) Coding requirements (LACF only)
Task 1504
4.6 Complaints and Recalls
4.6.1 Recalls
Task 4.6.2.4 Distribution Records
Task 1504 April 1, 2002
Principle Product distribution records are available to enable the manufacturer to recall any lot of food.
Assessment Criteria Distribution records contain sufficient information to permit traceability to a particular code or lot number. The following minimum information is required for distribution records:
  • Product identification and size
  • Lot number or code
  • Quantity
  • Customer names, addresses, and phone numbers to the initial level of product distribution
Rating Guide Examples
Rating I
  • N/A
Rating II
  • No distribution records
Rating III
  • Information on distribution records incomplete
Legal Authorities PPR 30.2(f) three year requirements for LACF
(i) Volume, identification and distribution
Task 1601
4.7 Records
4.7.1 General Records
Task 4.7.1.1 General Record Requirements
Task 1601 April 1, 2002
Principle Information is recorded in a manner to represent an accurate history of the product or process. Records are retained for the required period of time.
Assessment Criteria The following are requirements for all record keeping activities
  • Records are legible, permanent and accurately reflect the actual event, condition or activity.
  • Errors or changes are identified in a manner such that the original record is clear, e.g., strike out with a single stroke and initial the correction/change.
  • Each entry on a record is made by the responsible person at the time that the specific event occurred. The completed records are signed and dated by the responsible person.
  • Critical records are signed by a qualified individual designated by management prior to distribution of product, e.g., records related to the adequacy of the thermal process and the achievement of a hermetic seal. All other records are reviewed at an appropriate frequency to provide an early indication of potentially serious deficiencies.
  • Records are retained for at least one year after the expiry date on the label or container or if there is no expiry date, for at least two years after the date of sale. (for LAF, see task 5.1.10.7 - Thermal process records)
  • Records are maintained and are available upon request.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • Inadequate record keeping practices
Task 1602
4.7 Records
4.7.1 General Records
Task 4.7.1.1 General Regulatory Requirements
Task 1602 April 1, 2002
Principle Current Certificate of Registration is posted in a conspicuous place in the establishment for the period during which the certificate remains in force.
Assessment Criteria
  • Current registration certificate is posted.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • Current certificate of registration not posted
Legal Authorities PPR 11(2) Certificate of registration posted

Chapter 5 - Process Products

5.1 Manufacturing Controls

5.1.1 Product Formulation
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
5.1.1.1 5101 Product Formulae X X X X X X
5.1.1.2 5102 Product Formulation X N/A N/A N/A N/A N/A
5.1.1.3 5103 Food Additives and Processing Aids X X X X X X
5.1.1.4 5104 Nutritional Enrichment Requirements N/A N/A N/A X X N/A
5.1.1.5 5105 Label Accuracy / Registration X X X X X X
5.1.1.6 5106 Factors Critical to Acidification in Product Formulation - Fresh Pack N/A X N/A N/A N/A N/A
5.1.1.7 5107 Factors Critical to Fermentation in Product Formulation - Fermented N/A N/A X N/A N/A N/A
5.1.2 Process Design
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
5.1.2.1 5201 Validated Scheduled Process - Low Acid Foods X N/A N/A N/A N/A N/A
5.1.2.2 5202 Temperature Distribution - Low Acid Foods X N/A N/A N/A N/A N/A
5.1.2.3 5203 Thermal Process Records - Low Acid Foods X N/A N/A N/A N/A N/A
5.1.2.4 5204 Process Design - Acid Foods and Low Water (Aw) Activity Foods N/A N/A N/A X N/A X
5.1.2.5 5205 Process Design - Fresh Pack N/A X N/A N/A N/A N/A
5.1.2.6 5206 Process Design - Fermented N/A N/A X N/A N/A N/A
5.1.2.7 5207 Process Design - Blanching and Freezing N/A N/A N/A N/A X N/A
5.1.3 Incoming Material Control
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
5.1.3.1 5301 Ingredients, Additives and Processing Aids X X X X X X
5.1.3.2 5302 Packaging Materials - Cans X X X X N/A X
5.1.3.3 5303 Packaging Materials - Other than cans X X X X X X
5.1.3.4 5304 Incoming Material Control Records X X X X X X
5.1.4 In-Process Package Control
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
5.1.4.1 5401 Empty Container / Packaging Handling - Other than cans, glass X X X X X X
5.1.4.2 5402 Empty Container Handling - Cans X X X X N/A X
5.1.4.3 5403 Empty Container Handling - Glass X X X X N/A X
5.1.4.4 5404 Container Cleaning - New Containers X X X X X X
5.1.4.5 5405 Container Examination and Cleaning - Reusable Containers N/A X X X X X
5.1.4.6 5406 Empty Container Records X X X X X X
5.1.4.7 5407 Protection of Clean or Cleaned Containers X X X X X X
5.1.4.8 5408 Glass Breakage Procedure X X X X N/A X
5.1.4.9 5409 Glass Breakage Records X X X X N/A X
5.1.5 Product Preparation/Blending
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
5.1.5.1 5501 Critical Factor Control - General -All Products X X X X X X
5.1.5.2 5502 Critical Factor Control - Low Acid Foods X N/A N/A N/A N/A N/A
5.1.5.3 5503 Critical Factor Control - Fresh Pack/Fermented N/A N/A X X N/A N/A
5.1.5.4 5504 Product Preparation/Blending Records X X X X N/A X
5.1.5.5 5505 Cleaning/Sorting Contamination Control X X X X X X
5.1.5.6 5506 Quality Specifications Control X X X X X X
5.1.6 Filling
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
5.1.6.1 5601 Filling of Containers - Low Acid Foods X N/A N/A N/A N/A N/A
5.1.6.2 5602 Filling of All Container Types - Non Low Acid Foods N/A X X X X X
5.1.6.3 5603 Standard Containers Sizes and Net Quantity X X X X X X
5.1.6.4 5604 Filling of Cans X X X X X X
5.1.6.5 5605 Filling of Glass Containers X X X X N/A X
5.1.6.6 5606 Filling of Pouches X X X X X X
5.1.6.7 5607 Filling Records - Low Acid Foods X N/A N/A N/A N/A N/A
5.1.6.8 5608 Filled Unsealed Container Handling X X X X X X
5.1.6.9 5609 Metal Contamination Control X X X X X X
5.1.7 Container Closure Control
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
5.1.7.1 5701 Glass Capping X X X X N/A X
5.1.7.2 5702 Pouch Sealing X X X X N/A X
5.1.7.3 5703 Vacuum - Low Acid Foods X N/A N/A N/A N/A N/A
5.1.7.4 5704 Vacuum - Acid Foods and Low Water (Aw) Foods N/A N/A N/A X N/A X
5.1.7.5 5705 Visual Examination - Low Acid and Acidified Low Acid Foods X X X N/A N/A N/A
5.1.7.6 5706 Destructive Examination - Low Acid and Acidified Low Acid Foods X X X N/A N/A N/A
5.1.7.7 5707 Visual Examination - Acid and Low Aw Foods N/A N/A N/A X N/A X
5.1.7.8 5708 Destructive Examination - Acid and Low Aw Foods N/A N/A N/A X N/A X
5.1.7.9 5709 Pre-Thermal Process Sealed Container Handling X X X X N/A X
5.1.7.10 5710 Container Closure - Frozen Foods N/A N/A N/A N/A X N/A
5.1.7.11 5711 Container Closure Control Records - Low Acid and Acidified Low Acid Foods X X X N/A N/A N/A
5.1.7.12 5712 Container Coding Control - Mechanical Coding - Low Acid and Acidified Low Acid Foods X X X N/A N/A N/A
5.1.7.13 5713 Container Coding Control - Mechanical Coding - Acid and Low Aw Foods N/A N/A N/A X N/A X
5.1.8 Product Coding Control
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
5.1.8.1 5801 Coding Control X X X X X X
5.1.9 Pre-Process Control
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
5.1.9.1 5901 Maximum Time Lapse - Low Acid Foods in Hermetically Sealed Containers X N/A N/A N/A N/A N/A
5.1.9.2 5902 Retort Loading - Low Acid Foods in Hermetically Sealed Containers X N/A N/A N/A N/A N/A
5.1.9.3 5903 Traffic Control and Process Indicators - Low Acid Foods in Hermetically Sealed Containers X N/A N/A N/A N/A N/A
5.1.10 Process Control
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
5.1.10.1 6001 Initial Temperature (IT) - Low Acid Foods X N/A N/A N/A N/A N/A
5.1.10.2 6002 Venting and Process Schedule Accessibility - Low Acid Foods X N/A N/A N/A N/A N/A
5.1.10.3 6003 Retort operating Procedures - Low Acid Foods X N/A N/A N/A N/A N/A
5.1.10.4 6004 Vent Control - Low Acid Foods X N/A N/A N/A N/A N/A
5.1.10.5 6005 Process Time Control - Low Acid Foods X N/A N/A N/A N/A N/A
5.1.10.6 6006 Process Temperature Control - Low Acid Foods X N/A N/A N/A N/A N/A
5.1.10.7 6007 Thermal Process Control Records - Low Acid Foods X N/A N/A N/A N/A N/A
5.1.10.8 6008 Process Time/Temperature Control - Acid Foods and Low Aw Foods N/A N/A N/A X N/A X
5.1.10.9 6009 Control of Pasteurization - Fresh Pack/Fermented N/A X X N/A N/A N/A
5.1.10.10 6010 Process Control Records - Acid, Acidified Low Acid and Low Aw Foods N/A X X X N/A X
5.1.10.11 6011 Blanching and Freezing N/A N/A N/A N/A X N/A
5.1.11 Post-Process Control
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
5.1.11.1 6101 Cooling Controls - Low Acid Foods X N/A N/A N/A N/A N/A
5.1.11.2 6102 Cooling Water Control - Low Acid Foods X N/A N/A N/A N/A N/A
5.1.11.3 6103 Cooling Water Control Records X X X X N/A X
5.1.11.4 6104 Container Handling/Drying - Low Acid Foods X N/A N/A N/A N/A N/A
5.1.11.5 6105 Post-Process Container Integrity Verification - Low Acid Foods X N/A N/A N/A N/A N/A
5.1.11.6 6106 Container Handling - Frozen Foods N/A N/A N/A N/A X N/A
5.1.11.7 6107 Post-Process Critical Factors Verification - Fresh Pack/Fermented N/A N/A X X N/A N/A
5.1.11.8 6108 Post-Process Container Integrity and Vacuum - Glass/Pouches X X X X N/A X
5.1.11.9 6109 Post-Process Critical Factors Records -Acidified Low Acid Foods N/A X X N/A N/A N/A
5.1.11.10 6110 Post-Process Container Integrity Records - Glass and Pouches X X X X N/A X
5.1.12 Labelling Control
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
5.1.12.1 6201 Control of Labels/Labelling X X X X X X
5.1.13 Deviations and Corrective Action
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
5.1.13.1 6301 Deviation Control - Critical Factors and Food Safety - Low Acid Foods and Acidified Low Acid Foods X X X N/A N/A N/A
5.1.13.2 6302 Corrective Action - Critical Factors and Food Safety - Low Acid Foods and Acidified Low Acid Foods X X X N/A N/A N/A
5.1.13.3 6303 Deviations and Corrective Action Records - Critical Factors and Food Safety - Low Acid Foods and Acidified Low Acid Foods X X X N/A N/A N/A
5.1.14 Verification of Product Safety and Quality
Section Task Number Manufacturing Controls Low Acid Foods (LAF) in HSC Fresh Pack (ALAF) Fermented Pack (ALAF) Acid Foods Frozen Foods Low Water Activity
5.1.14.1 6401 Verification of Product Safety X X X X X X

Total number of tasks for each product type (inspection scope)

63 - Low Acid Foods (LAF) in HSC
49 - Fresh Pack (ALAF)
49 - Fermented Pack (ALAF)
43 - Acid Foods (AF)
28 - Frozen Foods (FF)
43 - Low Water Activity (LAw)

Manufacturing Controls
Task 5101
5.1 Manufacturing Controls
5.1.1 Product Formulation
5.1.1.1 Product Formulae
Task 5101 April 2, 2001
Principle Current written formulae are available for each product prepared by the establishment.
Assessment Criteria
  • Written master formulae are available.
  • The formulae contain all details of the formulation as follows:
    • identification of specific ingredients and additives (e.g., concentration, type)
    • amounts of additives and ingredients
  • The master formulae are current for the products being prepared by the establishment and meets all the requirements of the applicable regulations.
Rating I Examples
Rating I
  • N/A
Rating Guide II
  • Formula is absent, incomplete or not current resulting in inadequate control at preparation/blending.
  • Specifications and amounts of ingredients and additives are not identified in the formula or related documentation.
Rating Guide III
  • Formula is absent or not current but safety is not affected.
Legal Authorities
  • PPR, Schedule I, Table I and II + specific commodity requirements
  • PPR, Schedule I, Standard of Identity for each specific product
  • PPR, 2.1(1)(f) Requirements of Foods and Drug Regulations and also see specific commodity for standards
  • PPR, 30.2(a)(ii) Formulation of food product
Manufacturing Controls
Task 5102
5.1 Manufacturing Controls
5.1.1 Product Formulation
5.1.1.2 Factors Critical to Heat Processing in Product Formulation - Low Acid Foods
Task 5102 April 1, 2002
Principle Any factors in the product formulation that are critical to the achievement of commercial sterility are identified.
Assessment Criteria
  • Ingredients critical to product preservation are identified with their specifications and limits.

Note: Inadequate identification of critical ingredients and their specifications may indicate lack of awareness or control of critical factors that could result in product spoilage.

Rating Guide Examples
Rating I
  • Specifications and limits for critical factors are not identified in the formula or related documentation and there is no control elsewhere in the process, e.g., dice size or maximum tolerance of mushroom fines not specified in the formula, viscosity in canned cream corn (related to starch quantity and type).
Rating II
  • N/A
Rating III
  • Critical factors are not identified in the formula or related documentation but are controlled somewhere in the process and are within the limits of the process requirements and safety is not affected.
Legal Authorities
  • PPR, 30.2(a) Keep written description of schedule process
  • PPR, 30.2(e) Data on the development of schedule process
Manufacturing Controls
Task 5103
5.1 Manufacturing Controls
5.1.1 Product Formulation
5.1.1.3 Food Additives and Processing Aids
Task 5103 April 1, 2002
Principle Food additives and processing aids are controlled to meet the requirements of all applicable regulations.
Assessment Criteria
  • The manufacturer ensures that all food additives and processing aids used are permitted for use in the particular food and meet the requirements of all applicable regulations.
  • The manufacturer has specifications for all food additives and processing aids
  • The manufacturer controls allergenic additives and processing aids to ensure that they are properly identified in the formulation.
  • Where there are no requirements in the Food and Drugs Act and Regulations, the manufacturer requires that all food additives/processing aids be Food Chemical Codex (FCC) grade or equivalent, e.g., specification sheets, clear identification of the grade on the additive package, or blanket guarantees.
  • The manufacturer has verified and can demonstrate through calculations that food additives are used within the maximum level specified in the Food and Drug Regulations.
  • The manufacturer has a letter of no objection from Health Canada for non regulated processing aids.
  • Processing Aids are used as per manufacturers instructions.
Rating Guide Examples
Rating I
  • Use of processing aids that are allergenic and are not declared on the label of the food product
Rating II
  • Manufacturer is not using FCC grade or equivalent.
  • Level of additive/processing aids is violative and safety may be affected.
  • Processing aids are not used according to manufacturers instructions and safety may be affected.
Rating III
  • Level of additive/processing aids is violative but safety is not affected.
  • Additive/processing aids used is not permitted but safety is not affected.
Legal Authorities
  • PPR, 2.1(1)(f) Requirements of Foods and Drug Regulations
  • PPR, Schedule I, Tables I and II + specific commodity requirements
  • PPR, Schedule I, Standard of Identity for each specific product
Manufacturing Controls
Task 5104
5.1 Manufacturing Controls
5.1.1 Product Formulation
5.1.1.4 Nutrient Enrichment Requirements
Task 5104 April 1, 2002
Principle The addition of nutrients to food products is controlled to meet the requirements of the Food and Drugs Act and Regulations and Processed Products Regulations.
Assessment Criteria
  • Nutrients used are permitted in accordance with the Food and Drug Regulations.
  • The nutrient content of the product is accurately reflected on the label.
  • The manufacturer has specifications for nutrients.
  • The manufacturer has received certification from the supplier as follows:
    • a certificate of analysis accompanies each lot of nutrient
    • for nutrients used in foods that are the sole source of nutrition, each certificate is verified through analysis
  • The manufacturer has verified and can demonstrate through calculations that nutrients are used within the limits specified in the Food and Drug Regulations.
Rating Guide Examples
Rating I
  • Level of nutrient is violative and could result in permanent health consequences, e.g., inadequate fortification for foods that are a sole source of nutrition, toxic levels of fat soluble vitamins.
Rating II
  • Addition of incorrect amounts of nutrients.
  • Levels of addition were calculated incorrectly or not at all.
  • Nutrient is not permitted, or level of nutrient(s) is violative and could result in temporary health consequences.
  • No system in place to adjust formulas and variations in potency noted.
Rating III
  • Nutrient is not permitted and safety is not affected.
Legal Authorities
  • PPR 2.1(1)(f), Requirements of Food and Drug Regulations
  • PPR 31 (u) and (v) Vitaminized or vitamin C added declaration
Manufacturing Controls
Task 5105
5.1 Manufacturing Controls
5.1.1 Product Formulation
5.1.1.5 Label Accuracy / Registration
Task 5105 April 1, 2002
Principle The manufacturer ensures that the label information (product name and list of ingredients) accurately represents the composition of the product. The label, as required, is registered with CFIA.
Assessment Criteria Procedures are in place to ensure that labels accurately represent product formulation and composition especially where allergens and/or sensitive ingredients are used. The following are examples of such procedures:
  • new label review
  • labels are registered if required and the establishment has a label approval file
  • incoming label review for accuracy/correctness
  • formulation changes/substitutions
Rating Guide Examples
Rating I
  • Omission of allergens in list of ingredients with a known history of producing anaphylactic reaction in sensitive individuals (ref - List of allergens in Appendix IX) and are not declared on the label of the food.
Rating II
  • Inadequate or no control of label accuracy and the sensitive ingredients (e.g. lactose, monosodium glutamate) are used in the plant.
  • Omission of sensitive ingredients in list of ingredients (e.g. lactose, monosodium glutamate).
Rating III
  • Use of labels with inaccurate ingredient listings but no listed allergens used in the plant.
  • Inadequate control of label accuracy, e.g., no new label review but no listed allergens used in the plant .
  • Labels requiring registration are not registered.
  • No label registration file.
Legal Authorities
  • PPR, 2.1(1)(f) Requirements of Food and Drug Regulations
  • F&DR B.01.008(3) Ingredients in descending order
  • PPR 31(ee), List of ingredients and components
  • PPR, 42, Common name on main panel
  • PPR, 44(1) - Label must be registered
  • PPR, 44(6) Label file
Manufacturing Controls
Task 5106
5.1 Manufacturing Controls
5.1.1 Product Formulation
5.1.1.6 Factors Critical to Acidification in Product Formulation - Fresh Pack
Task 5106 April 1, 2002
Principle Any factors in the product formulation that are critical to the achievement of acidification are identified.
Critères d'évaluation Ingredients critical to process safety are identified with their specifications and limits:
  • identification of acid: type and concentration, e.g., percent of acid or grains vinegar (United States or Canada)
  • amounts of acid required to prepare the brine at the appropriate concentration (dilution)
  • acid concentration of the brine (pH measurement or titratable acidity)
  • solid-liquid ratio (brine volume in the container, drained weight, number of whole cucumbers, etc.)
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • Dilution method is not specified but the specifications of the brine are satisfactory.
  • No written formulation.
  • Acid concentration of the brine is not specified in the product formulation which may result in inadequate control of the brine concentration.
  • Specifications and amount of ingredients and preservatives are not identified in the formula or related documentation ex: solid/liquid ratio.
Legal Authorities
  • PPR 30.2(a)(ii), The operator must keep in the establishment, for every low-acid food product that is processed, the formulation of the food product
  • F&DR, N/A
Manufacturing Controls
Task 5107
5.1 Manufacturing Controls
5.1.1 Product Formulation
5.1.1.7 Factors Critical to Fermentation in Product Formulation - Fermented Pack
Task 5107 April 1, 2002
Principle Any factors in the product formulation that are critical to the achievement of acidification (fermentation) are identified.
Assessment Criteria Ingredients related to the achievement of acidification (fermentation) are identified with their specifications and limits:
  • Fermentation:
    • product/brine ratio
    • salt concentration
    • acidity and pH.
  • Cover liquid (new brine)
    • type and concentration of the acid solution (i.e. Percentage of acid or number of grains of vinegar (USA))
    • quantity of acid necessary for the preparation of the brine, the concentration required
    • concentration of the acid of the brine (pH or the titratable acidity)
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • Specifications and amounts of ingredients used in the preparation of the brine are not specified in a formula.
Legal Authorities
  • PPR, 30.2(a)(ii), The operator must keep in the establishment, for every low-acid food product that is processed, the formulation of the food product
Manufacturing Controls
Task 5201
5.1 Manufacturing Controls
5.1.2 Process Design
5.1.2.1 Validated Scheduled Process - Low Acid Foods
Task 5201 April 1, 2002
Principle
  • For every low acid food, container type and size, a written description of the scheduled process, together with the name of the Process Authority responsible for its development is available upon request.
  • All critical factors for each product, including the critical limits for each factor are identified, tested and evaluated in the development of the process and are included in the scheduled process.
  • The thermal process is established using accepted scientific methods. Details of actual experimental methods are available.
  • Any changes to the product formulation or the process are validated by the Process Authority.
Assessment Criteria The manufacturer has a written description of the validated process for each formulation, container type, size and format (can orientation, style of pack, etc.) produced.

Process Evaluation - Process from Bulletin 26-L

  • If an NFPA (National Food Processors Association) process from Bulletin 26L is used, the manufacturer verifies that the actual process including all critical factors matches all requirements of the NFPA process.
  • If the actual process including all critical factors is identical to the NFPA process, heat penetration data is not necessary.
  • The manufacturer ensures that the NFPA processes used are updated as new information becomes available. Updates may be available through membership in NFPA.
  • If the actual process is not identical to the NFPA process, the process is treated as a non-standardized process.

Process Evaluation - Non Standardized Process

If a non-standardized process has been developed (e.g. a non-NFPA process):

  • All processes are developed and evaluated by a process authority.
  • All critical factors are identified, tested and evaluated during the development of the process and are included in the scheduled process.

For example:

  • fill weight, e.g., vegetables, meat
  • drained weight, e.g., spinach, okra
  • pH, e.g., acidified foods
  • solid/liquid ratio, e.g., spinach
  • initial temperature
  • preservatives, e.g., nitrites
  • water activity, e.g., reduced moisture, cakes, puddings
  • viscosity, e.g., starch is added, conduction/convection heating - broken heating curves
  • moisture levels, e.g., kidney beans
  • vacuum, e.g., vacuum packed corn
  • headspace and agitation speed e.g., agitating retorts
  • overpressure, where applicable
  • cooling method, where applicable
  • percent of air in steam e.g., Lagarde
  • product/container orientation
  • container type, size and format

Documentation is available to demonstrate that the most extreme/worst case conditions are considered in the development of the process.

  • Process development takes into consideration the actual production capabilities, e.g., filler capability to deliver the weight range specified in the validated process.
  • The interaction of critical factors has been evaluated.

Corrective action procedures for process deviations are validated to ensure the achievement of commercial sterility, e.g., alternative processes are validated.

Process Authority

  • The process authority has sufficient knowledge, training and experience to complete thermal processing evaluations.
  • The process authority has access to adequate facilities for making such determinations, e.g., a laboratory having microbiological testing capability as well as a pilot plant, processing and sterilizing equipment.

Scientific Methods

The process authority demonstrates that adequate procedures for heat penetration testing have been followed through documentation, for example:

  • positioning of thermocouples in containers (cold spot)
  • calibration of thermocouples
  • number and location of test containers per trial
  • product orientation in the can and retort
  • method of calculation of Fo necessary to destroy spores of C. botulinum for each product
  • equipment used to perform the experiments
  • calibration of test instruments
  • a sufficient number of heat penetration trials has been completed to verify that the process is adequate for the critical limits of each factor

The procedures conform to the following References; "Procedures for Carrying Out a Heat Penetration Test and Analysis of the Resulting Data", Irving J. Pflug, Ph.D., University of Minnesota; "Designation: F 1168-88 Standard Guide for Use in the Establishment of Thermal Processes for Food Packaged in Flexible Containers"; American Society for Testing and Material (ASTM); Institute For Thermal Processing Specialists (IFTPS) or equivalent.

Process Verification

  • The manufacturer has written confirmation from the process authority that the heat penetration and calculated lethality of the process achieves commercial sterility.
  • If the calculated lethality is below the minimum generally recognized commercial sterility Fo, additional information may be required, e.g., inoculated pack studies, preservation system, incubation studies, etc., for the purpose of conducting a health hazard evaluation.

Change Control

Any changes to the parameters on which the scheduled process was based are validated by the process authority, for example, formulation, procedure or equipment changes.

  • Calibration of thermocouples:
    • number and location of test containers per trial
    • product orientation in the can and retort
    • method of calculation of F° necessary to destroy spores of C. botulinum for each product
    • equipment used to perform the experiments
    • calibration of test instruments
    • a sufficient number of heat penetration trials has been completed to verify that the process is adequate for the critical limits of each factor
  • The procedures conform to the following References; "Procedures for Carrying Out a Heat Penetration Test and Analysis of the Resulting Data", Irving J. Pflug, Ph.D., University of Minnesota; "Designation: F 1168-88 Standard Guide for Use in the Establishment of Thermal Processes for Food Packaged in Flexible Containers"; American Society for Testing and Material (ASTM); Institute For Thermal Processing Specialists (IFTPS) or equivalent
Rating Guide Examples
Rating I
  • Product formulation has been changed but not validated by a Process Authority.
  • The NFPA process being used is not current and safety is compromised.
Rating II
  • No process validation or process validation is incomplete, e.g., validation was conducted on a different formula.
  • Scientific methods are deficient (equipment or procedures).
  • The NFPA process being used is not current and safety may be compromised.
Rating III
  • The NFPA process being used is not current and safety is not compromised.
Legal Authorities
  • PPR, 30.2(a), Description of a schedule process
  • PPR, 30.2(e) Data for the development of a schedule process
Manufacturing Controls
Task 5202
5.1 Manufacturing Controls
5.1.2 Process Design
5.1.2.2 Temperature Distribution - Low Acid Foods
Task 5202 April 1, 2002
Principle
  • Temperature distribution tests are carried out upon installation and at a sufficient frequency to ensure the adequacy of the vent schedule.
  • Temperature distribution tests meet the requirements of the "Government of Canada Guidelines for Temperature Distribution Studies when Processing in Steam Still Retorts Excluding Crateless Retorts".
Assessment Criteria
  • Temperature distribution studies have been conducted on all retort systems. (A retort system could consist of a single retort or a group of identically equipped retorts).
  • Temperature Distribution studies comply with the protocol entitled, "Government of Canada Guidelines for Temperature Distribution Studies when Processing in Steam Still Retorts Excluding Crateless Retorts" or equivalent.
  • Frequency
    • Upon installation.
    • After making changes as follows:
      • Changes in steam demand which reduce the header pressure since the original tests, e.g., additional or larger retorts, use of blanchers, etc.
      • Changes in steam supply which reduce the header pressure since the original tests.
      • Can size used in the original tests is no longer the smallest can packed by the manufacturer.
      • Reduction in initial temperature of product.
      • Changes in piping since the original tests, e.g., length, diameter, number of turns or elbows, number and/or size of steam spreader holes, mufflers, etc. Ideally, all retorts should be identically piped. If not, each unique piping arrangement should be tested.
      • Changes in construction of the retort crates. Ideally, all crates should be identical. If not, those likely to impede steam flow the most should have been used in the original tests.
      • Changes in busse separator sheets, e.g., hole size, pattern.
      • Changes in loading the retort crates (e.g., changing from jumble pack to busse loaded, increasing the number of layers in a busse crate).
      • Changes in the interior retort structure.
      • Retort operator log sheets indicate an unusual increase in the time required to reach vent or process temperature.
      • Changes in valve type or size.
  • Temperature distribution studies are conducted every two years in the absence of an effective preventative maintenance program. The preventative maintenance program is described in sub item 4.3.3.1 and 4.3.3.2.
Rating Guide Examples
Rating I
  • Temperature distribution tests are inadequate or absent, e.g., no temperature distribution tests conducted upon installation; changes have occurred and temperature distribution tests have not been conducted.
Rating II
  • Temperature distribution tests are conducted but are incomplete e.g., temperature distribution is based on less than three repeatable runs, (References protocol).
Rating III
  • N/A
Legal Authorities
  • PPR 30.2(a), Description of a schedule process;
  • PPR 30.2(e), Data for the development of a schedule process
Manufacturing Controls
Task 5203
5.1 Manufacturing Controls
5.1.2 Process Design
5.1.2.3 Thermal Process Records
Task 5203 April 1, 2002
Principle Records are available to demonstrate the adequacy of heat penetration and temperature distribution studies.
Assessment Criteria Heat Penetration
  • Heat penetration records are available for each product formulation, container size and format, except for those products that are identical to those specified in a NFPA process.
  • Minimum record requirements include:
    • name of process authority
    • critical factors tested and evaluated and their limits
    • worst case conditions tested
    • records to demonstrate that the deviation procedures are based on heat penetration studies
    • records of all parameters of scientific test methods
    • records of all verification tests for each product
    • records of heat penetration studies demonstCote the safety of the process for any formulation or procedure changes

Temperature Distribution

  • Minimum record requirements include:
    • Retort Test Conditions
      • date, person responsible, reason for test and retort number
      • can size, can configuration in basket, number of layers, types and number of baskets used
      • initial temperature, placement of thermocouples and steam manifold/header pressure
      • calibration of thermocouples and data logger
      • description of the retort design, e.g., piping, baffles, spreaders and valves
  • Temperature Distribution Test Results
    • temperature controller and data logger charts
    • time, temperature and MIG (Mercury In Glass) temperature at which thermocouple equilibrium was achieved
    • time steam on and time vent closed
    • retort temperature when vent closed
    • time process temperature was achieved
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Records are absent, inaccurate or incomplete.
  • For temperature distribution - description of the retort test conditions not complete, e.g., type of dividers not specified but only one style of divider is in the plant and the type of divider used in the temperature distribution tests is not known.
  • For temperature distribution - no records; description of the retort test conditions is not complete, e.g., types of dividers used is not specified and several styles are available in the plant.
  • For heat penetration - records of the parameters in the heat penetration studies are deficient, e.g., type of thermocouple used not recorded.
  • For heat penetration - no records; formulation changes noted and no heat penetration study records to support safety.
Rating III
  • Deficiencies in records which do not affect verification of the adequacy of heat penetration or temperature distribution testing, e.g., date or signature of person conducting the test missing.
Legal Authorities
  • PPR 30.2(f) Records that set out product history
Manufacturing Controls
Task 5204
5.1 Manufacturing Controls
5.1.2 Process Design
5.1.2.4 Process Design - Acid Foods and Low Aw Foods
Task 5204 December 20, 2006
Principle The manufacturer demonstrates the process is designed in a manner to ensure the safety of the product.
Assessment Criteria
  • For every acid food and low water activity food, a written description of the process design is available upon request.
  • The process is established using accepted scientific methods.
  • All factors for each product are identified, tested and evaluated during the development of the process and are included in the process design.

For example:

  • pH
  • solid/liquid ratio
  • additives
  • water activity
  • viscosity
  • pressure (re flashing if required)
  • pasteurization time and temperature
  • fill temperature for hot filled products
  • container inversion for hot filled products
  • other factors

The process design includes:

  • the pressure requirements in the holding tube to prevent product flashing
  • the sterilization procedure for the processor, auxiliary equipment, aseptic holding tanks, aseptic product transfer lines, valves, and packaging equipment
  • the factors required to maintain product and equipment commercially sterility

Any changes to the parameters on which the process design was based are validated, for example, formulation, procedure or equipment changes.

Rating Guide Examples
Rating I
  • N/A
Rating II
  • The manufacturer does not have a written process design for acid foods where there may be a food safety risk.
  • The process design does not include the limits to sterilize the product, processing equipment, aseptic lines and tanks and packaging.
  • The process design does not include the limits to maintain the system commercially sterile.
Rating III
  • The manufacturer does not have a written process design, for acid foods with no food safety risks.
Legal Authorities
  • PPR Schedule I, Table I, Section 1 prepared by heat processing
  • PPR Schedule I, Standards of identity of specific products
Manufacturing Controls
Task 5205
5.1 Manufacturing Controls
5.1.2 Process Design
5.1.2.5 Process Design - Acidified Low Acid Foods - Fresh Pack Pickles
Task 5205 April 1, 2002
Principle The manufacturer demonstrates the process is designed in a manner to ensure the safety of the product.
Assessment Criteria
  • For every product a written description of the process, including procedures, is available upon request.
  • The process is established using accepted scientific methods and hygienic Principles. Details of actual experimental methods are available.

Acidification - Safety Concern

  • Direct addition of a predetermined amount of acid to individual containers during production is a satisfactory method for acidification. All acidified food shall have an equilibrium pH of 4.6 or below, which is generally achieved within 24 hours of heat treatment (often called "pasteurization").

Heat Treatment - Quality Concern (avoid spoilage of the product)

  • Every manufacturer should have standard pasteurization procedures developed by competent technical personnel. Pasteurization procedures should indicate the temperature of the food at the time it enters the pasteurizer and temperature to be achieved inside the container and holding time.
  • The widely accepted heat treatment procedures for pickles having an equilibrated pH less than 4.0 are heating to 74°C (165°F) at the center of jar and holding at that temperature for 15 minutes. Any other heat treatment procedure developed by competent technical personnel would be acceptable.
    • Mathematical method: pasteurization procedure is calculated based upon details of the heat resistance of the most heat resistant microorganism which might be present and cause spoilage, and details of the rate of heat penetration to the coldest point in slowest heating container under the actual pasteurization procedures;
    • Experimental packs: Containers are inoculated with a large number of cells of the most heat resistant organisms. After pasteurization, these containers are incubated at the optimum temperature for the growth of the organism.

Critical Factors

  • All critical factors for each product, including the critical limits for each factor are identified, tested and evaluated in the development of the process, for example:
    • pH of brine
    • solid/liquid ratio (brine volume, number of whole pickles, etc.)
    • equilibrium pH

Important Factors (Spoilage related)

  • All important factors for each product are identified, tested and evaluated in the development of the process:
    • heat treatment

Note: The degree of testing and evaluation required is relative to the risk of the operation. Any changes to the process are assessed to ensure there is no impact on the safety or composition of the product.

Rating Guide Examples
Rating I
  • The pickle is designed as a low acid food; pH greater than 4.6 and water activity greater than 0.85,without requiring commercial sterilization at retort temperatures and is marketed without refrigeration.
Rating II
  • No process validation or process validation is incomplete, e.g. heat treatment process or equilibrium pH methodology is inferior to those found in literature and there is no documentation available to demonstrate the efficacy of the process being used.
Rating III
  • N/A
Legal Authorities
  • PPR, 30.2(a) (i), the operator of a registered establishment in which a low-acid food product packed in a hermetically sealed container is thermally processed must keep a written description of scheduled process together with the name of the person responsible for the development of the scheduled process.
  • PPR, 30.2(e) If requested by an inspector, produce written statement of all relevant data used in the development of the scheduled process
Manufacturing Controls
Task 5206
5.1 Manufacturing Controls
5.1.2 Process Design
5.1.2.6 Process Design - Acidified Low Acid Foods - Fermented Pickles
Task 5206 April 1, 2002
Principle The manufacturer demonstrates the process is designed in a manner to ensure the safety of the product.
Assessment Criteria
  • For every product a written description of the process, including procedures, is available upon request.
  • The process is established using accepted scientific methods and must respect sanitation Principles. Details of actual experimental methods are available.
  • Any changes to the product formulation or the process are assessed to ensure there is no impact on the safety or composition of the product.

Fermentation - Safety Concern

  • The process should be developed in order to use pH, Aw, preservatives, salt, refrigeration, etc. to obtain a safe fermented product. For the fermentation process the following factors should be considered:
    • Acidity and pH
      • The fermentation of vegetables or fruits is done under conditions of salinity that will help to the development of lactic bacteria. In some process, acid may be added in the initial brine to have conditions that will favor the lactic fermentation. Appropriate fermentation will result in acidification of the product. Where the fermentation is not adequately started, balancing the salt content or addition of vinegar to acidify the media would be a corrective measure that will help to contribute to a proper fermentation that will bring the acidification of the product.
    • Product/brine ratios
      • For cucumber fermentation (in tank), the general method of salting is to use a 30° to 40° salometer brine in the bottom of the tank. Once the cucumbers are added, the brine should decrease to 25° salometer. The brine shall cover all product completely.
    • Salt concentration
      • For cucumber fermentation (in tank), usually the brine strength is gradually raised by adding enough dry salt on the cover to give a holding strength of 16 to 18 percent at the end of four to six weeks.
      • For cucumber fermentation (in tank), Low Salt Brining consists to maintain 5-8 % of salt during fermentation. The addition of calcium ions in the form of calcium chloride has been found to allow fermentation at lower salt concentration. 0.20 to 0.35% (based on the tank contents) of calcium chloride is added.
      • In specific product and fermentation procedures, the salt content can be lower (e.g. 2.25-2.50% of salt for sauerkraut fermentation). The levels of salt and calcium chloride, if any, are to be specified in the process design.
      • Fermented foods should have a pH value of 4.6 or lower. Higher pH value would require a retort treatment in order to obtain commercial sterility, unless the product is kept refrigerated (if refrigerated, "keep refrigerated" shall be declared on the label) or preservatives are used to ensure preservation.

Salt stock storage - Safety Concern

  • Process design should include the salt concentration, acidity and pH levels to be maintained during storing. Vegetables should be kept under the surface of the brine. When completely cured in a 60° salometer brine, pickles will keep satisfactory for a year or more.

Desalting of salt stock product - Quality Concern:

  • The 15 to 18 percent of salt in the salted stock is reduced to about 4 percent.

Packing - Quality Concern

  • Packing media is detailed:
    • pH of the packing brine.
    • Sweet pickles are packed with the proper quantity of sugar and are preserved adequately (pH of 4.6 or lower and use of preservatives).

Pasteurization and /or preservatives system - Quality Concern (avoid spoilage of the product)

  • The pasteurization for fermented product is optional. Use of preservatives can be sufficient for proper conservation of the product. e.g.: peppers and relish.

Critical Factors

  • All critical factors for each product, including the critical limits for each factor are identified, tested and evaluated in the development of the process; for example:
    • pH of the product or equilibrium pH when packed in new brine.

Important Factors

  • All important factors for each product are identified, tested and evaluated in development of the process:
    • integrity of containers and closures
    • vacuum (immediately after capper and after pasteurization)
    • pasteurization 145° F / 63°C at the cold point unless not applicable
    • preservative system for product packed in non hermetically sealed containers , e.g. pails

Note: The degree of testing and evaluation required is relative to the risk of the operation.

Rating Guide Examples
Rating I
  • N/A
Rating II
  • Fermentation process that does not specify the minimum salt content or that does not mention the necessity to have a good salt distribution.
Rating III
  • Process has been developed according to traditional procedures. The process is not documented in a way that all the critical parts are outlined (salt concentration, final pH, etc), but the product is safe.
Legal Authorities
  • PPR 30.2 (a) The operator of a registered establishment in which a low-acid food product packed in a hermetically sealed container is thermally processed must keep a written description of the scheduled process together with the name of the person responsible of the development of the scheduled process
  • PPR 30.2 (e) The operator of a registered establishment in which a low-acid food product packed in a hermetically sealed container is thermally processed must if requested by an inspector, produce written statement of all relevant data used in the development of the scheduled process
  • PPR 31(oo) The words "keep refrigerated" if the product is sauerkraut with preservative
  • F&DR B.01.007 Instructions for the proper storage
Manufacturing Controls
Task 5207
5.1 Manufacturing Controls
5.1.2 Process Design
5.1.2.7 Process Design Blanching and Freezing
Task 5207 April 1, 2002
Principle Vegetable products have a written description of the blanching/cooling/freezing process available, designed to ensure the quality of the product and reduce the microbial load.

Fruit Products have a written description of the freezing process available.

Assessment Criteria
  • The manufacturer has a written description of the time and temperature for the blanching of vegetables.
    • During the blanching process, the product should attain the time/temperature outlined in the process design. Factors affecting the exposure times are:
      • particle size - the larger the particle the longer exposure necessary to attain the desired temperature throughout
      • temperature of blancher
      • depth of food on belt or in flume - thicker layers require more time for penetration of heat
      • blanching medium - steam has a slower penetration rate into product than water so longer exposure times are required
  • Peroxidase testing should be done by the manufacturer to ensure vegetable products are properly blanched.
  • Some vegetables are not usually blanched e.g. onions, celery. The products may be treated by other means to reduce the microbial load e.g. chemical treatment, chlorine. Any chemical used shall be listed in the "References Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents" or a letter of no objection from Health Canada.
  • The manufacturer has a written description of the freezing process for both fruits and vegetables.
    • Freezing should occur quickly after blanching without delay. Freezing of fruits and vegetables should be carried out in a way that the range of maximum crystallization (-1 C to -5 C) is passed quickly. Freezing should not be considered complete until the product has reached -18 C at the thermal center after thermal stabilization.
    • The cooling and freezing media are controlled and free from pathogens and chemicals.
    • Bacteria count in frozen vegetables shall not exceed, 250,000 viable aerobic mesophiles per gram of product; and 100 aerobic thermophilic spores per gram of product if the frozen vegetable is intended for remanufacturing purposes.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • No written description exists but safety not compromised.
  • The manufacturer does not have a system in place to ensure that the process used is that as described in the process design.
Legal Authorities
  • PPR, Schedule I Table II
  • PPR, Schedule II Specified Standards of Identity
  • PPR, 2.1 (1) All components and ingredients of a food must be sound, wholesome and edible
  • PPR, 14.(1)(i)
  • PPR, 16(13) Product must be maintained at a correct temperature
Manufacturing Controls
Task 5301
5.1 Manufacturing Controls
5.1.3 Incoming Material Control
5.1.3.1 Ingredients/Additives and Processing Aids
Task 5301 April 1, 2002
Principle The manufacturer controls incoming ingredients, food additives and processing aids such that no biological, chemical or physical hazards (BCP) result in the food.
Assessment Criteria
  • The manufacturer controls incoming ingredients, food additives and processing aids through one of the following programs or equivalent.
  • The first three options apply to ingredients, food additives and processing aids that may be critical factors where further processing is not likely to eliminate a hazard.
  • The fourth option applies to ingredients, food additives and processing aids that are not likely to impact on the safety of the food.

Note: Specifications for food additives and nutrients are assessed under Sections 5.1.1.3 (task 5103) and 5.1.1.4. (task 5104)

Option 1 - Periodic Evaluation of Incoming Ingredients, food additives and processing aids

  • The manufacturer has written specifications for ingredients, food additives and processing aids.
  • Purchasing specifications include a provision for compliance with the Food and Drugs Act and Regulations and any other applicable regulations.
  • The manufacturer maintains a documented history of adherence to specifications for each supplier, e.g., analytical results.
  • The manufacturer obtains a certificate of analysis for each lot.
  • A representative sample is taken to verify the accuracy of the certificates of analysis at a scheduled frequency, e.g., monthly.
  • A new history of adherence to specifications is established when a firm changes suppliers, purchases ingredients, food additives and processing aids from a new supplier, purchases a new ingredient from an existing supplier or when spot checks do not agree with the certificate of analysis.

Option 2 - 100% Lots Inspected

  • The manufacturer has written specifications for ingredients, food additives and processing aids.
  • Each incoming lot is sampled according to a pre-determined sampling plan and analyzed for adherence to specifications.

Option 3 0 Vendor Certification

  • When the manufacturer relies on vendor certification the following minimum requirements are in place:
    • The manufacturer has written specifications for ingredients, food additives and processing aids.
    • The manufacturer has documentation to demonstrate adequate knowledge of the vendor's process. This may include, for example: process flow charts, on site evaluations, identification of critical control points, specifications, control limits, monitoring programs and frequencies, corrective action and verification procedures.
    • The manufacturer has data to demonstrate the capability of the vendor's process to consistently manufacture within specifications. This may include process capability studies. Statistical process control charts for each critical control point shall be available upon request from each supplier.
    • Prior to implementation of a periodic monitoring program, the firm analyses an appropriate number of consecutive lots, to establish a historical data base and confirm adherence to specifications.
    • The manufacturer conducts periodic monitoring to verify adherence to specifications, e.g., annually.
    • The manufacturer conducts vendor audits to validate the status of the vendor certification program.

Option 4 - Specification Requirements

  • Where incoming ingredients, food additives and processing aids are not likely to impact on the safety of the food:
    • The manufacturer has written specifications for these ingredients, food additives and processing aids.
    • Purchasing specifications include a provision for compliance with the Food and Drugs Act and Regulations.

Non-Conforming Ingredients, food additives and processing aids (applies to all options)

  • When ingredients, food additives and processing aids are found not to meet specifications the manufacturer investigates and identifies the root cause. If the ingredients, food additives and processing aids do not meet specifications but have not been used it is not considered a deviation. However, if it is possible that ingredients, food additives and processing aids not meeting specifications have been used, the manufacturer should initiate deviation/corrective action as per Section 5.1.13 (tasks 6301, 6302, and 6303), Deviations and Corrective Action.
  • Purchasing specifications include a provision for compliance with the Food and Drugs Act and Regulations or any other applicable regulations.
  • Ingredients, food additives or processing aids arriving in dirty packaging are either rejected or packaging material cleaned before use. See section 5.1.5.5 (task 5505)
Rating Guide Examples
Rating I
  • No ingredient specifications, certification or monitoring for critical ingredients, food additives and processing aids.
Rating II
  • The manufacturer has specifications for critical ingredients, food additives and processing aids but cannot demonstrate adherence, e.g., no certification or monitoring program.
  • Acceptance of non-conforming ingredients, food additives and processing aids contaminated with excessive amounts, non-hazardous avoidable material, e.g., insects.
  • Acceptance of non-conforming ingredients, food additives and processing aids contaminated with hazardous foreign material, e.g., glass.
Rating III
  • No specifications for non-critical ingredients, food additives and processing aids e.g. Sugar, salt, calcium chloride.
  • For critical ingredients, food additives and processing aids no certificates of analysis but the manufacturer has written specifications, maintains a documented history of adherence and verifies adherence to specifications.
  • Acceptance of non-conforming ingredients, food additives and processing aids contaminated with non hazardous foreign material, e.g., dust, dirt.
Legal Authorities
  • PPR 2.1(1) All ingredients, food additives and processing aids are not adulterated nor contaminated
  • PPR, 16(13) Food must be kept at the correct temperature and humidity
  • PPR, 16(16) Raw material are washed as needed to remove soil or contamination
  • PPR, 16(17) Raw materials are inspected, sorted and culled
Manufacturing Controls
Task 5302
5.1 Manufacturing Controls
5.1.3 Incoming Material Control
5.1.3.2 Packaging Materials - Cans
Task 5302 April 1, 2002
Principle The manufacturer controls incoming packaging materials such that no biological, chemical or physical hazards (BCP) result in the food.
Assessment Criteria
  • Packaging material should be approved as food grade and listed in the "References Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents" as published by the CFIA.
  • Purchasing specifications include a provision for compliance with the CAP Act and Processed Products Regulations including prescribed container sizes.
  • Packaging materials in use for foods shall comply with Division 23 - Food Packaging Materials of the Food and Drug Regulations.
  • Packaging materials are properly protected on arrival.
  • Packaging material evaluations are carried out under the control of a qualified person who has successfully completed a container evaluation course from a recognized institution.

Note: Qualifications are described under Section 4.4.1.2, Technical Training.

The manufacturer controls packaging materials through one of the following monitoring and/or certification programs or equivalent:

Option 1 - Periodic Evaluation of Incoming Packaging Material

  • The manufacturer has written specifications for containers and ends:
    • physical dimensions
    • double seam dimensions
    • material specifications
    • performance specifications
  • The manufacturer verifies the adherence to specifications by each supplier. A representative sample is taken to visually verify adherence to specifications at a scheduled frequency, e.g., monthly.
  • The manufacturer has a documented history of adherence to specifications for each supplier.
  • A new history of adherence to specifications is established when a manufacturer changes suppliers, packaging materials or when spot checks do not agree with specifications.

Option 2 - 100% Lot Inspection

  • The manufacturer has written specifications for containers and ends.
  • Each incoming lot is evaluated to ensure that specifications are met and containers are free from defects.
  • The minimum sample size for visual evaluation of incoming containers is 200 containers/ends selected randomly from each lot.

Option 3 - Vendor Certification

  • When the manufacturer relies on vendor certification the following minimum requirements are in place.
  • The manufacturer has documentation to demonstrate adequate knowledge of the vendor's process. This may include; process flow charts, on site evaluations, identification of critical control points, specifications, control limits, monitoring programs and frequencies, corrective action and verification procedures.
  • The manufacturer has data to demonstrate the capability of the vendor's process to consistently manufacture within specifications. This may include: statistical process control charts for each critical control point and process capability studies.
  • Prior to implementation of a spot check program the manufacturer analyzes an appropriate number of consecutive lots to establish a historical data base and confirms adherence to specifications, e.g., annually.
  • The manufacturer conducts periodic monitoring to verify adherence to specifications.
  • The manufacturer conducts vendor audits to validate the status of the vendor certification program.

Option 4 - Specification Requirements

  • Where packaging materials are not likely to impact on the safety of the food:
    • The manufacturer has written specifications for the packaging material.
    • Purchasing specifications include a provision for compliance with the CAP Act and Processed Products Regulations including prescribed container sizes.

Non-Conforming Packaging Material - (applies to options 1 to 3)

  • When packaging material is found not to meet specifications the manufacturer investigates and identifies the root cause. If the packaging material does not meet specifications but has not been used it is not considered a deviation. However, if it is possible that packaging material not meeting specifications has been used, the manufacturer should initiate deviation/corrective action as per Section 5.1.13 (tâches 6301, 6302, et 6303), Deviations and Corrective Action
Rating Guide Examples
Rating I
  • No inspection of empty containers where there is a contamination with hazardous extraneous material e.g. glass particles >2 mm and without any further inversion/cleaning and/or inspection steps before filling.
Rating II
  • Packaging material contains substances which may be injurious to consumers health and cannot be removed by subsequent steps of inspection or cleaning.
  • The packaging material does not comply with Division 23 of the Food and Drugs Regulations.
Rating III
  • Periodic evaluation - monitoring is not done as scheduled to visually verify adherence to specifications.
  • The manufacturer has specifications but cannot demonstrate adherence, e.g., no certification from the supplier or monitoring by the manufacturer is deficient.
  • The manufacturer has no control over incoming packaging materials, e.g., no specifications, certification or monitoring.
  • Containers not adequately protected. e.g. Protective coverings for packaging materials damaged/missing.
Legal Authorities
  • PPR, 16(12), Product cannot be exposed to a source of contamination
  • PPR, 30.3 (a), Container is suitable for use
  • PPR, Schedule III, Tables I, II, III Prescribed container sizes for specified products
  • Div 23, FDA&R No Package shall contaminate food
Manufacturing Controls
Task 5303
5.1 Manufacturing Controls
5.1.3 Incoming Material Control
5.1.3.3 Packaging Materials - General Other Than Cans
Task 5303 April 1, 2002
Principle The manufacturer controls incoming packaging materials such that no biological, chemical or physical hazards (BCP) result in the food.
Assessment Criteria
  • Packaging material should be:
    • Accepted Construction, Packaging Materials and Non-Food Chemical Agents" as published by the CFIA.
    • Purchasing specifications include a provision for compliance with the CAP Act and Processed Products Regulations including prescribed container sizes.
    • Packaging materials in use for foods shall comply with Division 23 - Food Packaging Materials of the Food and Drug Regulations.
    • Packaging materials are properly protected on arrival.
  • Packaging material evaluations are carried out under the control of a qualified person who has successfully completed a container evaluation course from a recognized institution (only needed for Low Acid Foods (LAF) in Hermetically Sealed Containers and Acidified Low Acid Foods (ALAF) (fresh pack or fermented).

    Note: Qualifications are described under Section 4.4.1.2, Technical Training.

  • The manufacturer controls packaging materials through one of the following monitoring and/or certification programs or equivalent.

Option 1 - Periodic Evaluation of Incoming Packaging Material

  • The manufacturer has written specifications for containers and lids:
    • physical dimensions
    • material specifications
    • performance specifications
  • The manufacturer verifies the adherence to specifications by each supplier. A representative sample is taken to visually verify adherence to specifications at a scheduled frequency, e.g., monthly.
  • The manufacturer has a documented history of adherence to specifications for each supplier.
  • A new history of adherence to specifications is established when a manufacturer changes suppliers, packaging materials or when spot checks do not agree with specifications.

Option 2 - 100% Lot Inspection

  • The manufacturer has written specifications for containers and lids.
  • Each incoming lot is evaluated to ensure that specifications are met and containers are free from defects.

Option 3 - Vendor Certification

  • When the manufacturer relies on vendor certification the following minimum requirements are in place:
    • The manufacturer has documentation to demonstrate adequate knowledge of the vendor's process. This may include; process flow charts, on site evaluations, identification of critical control points, specifications, control limits, monitoring programs and frequencies, corrective action and verification procedures.
    • The manufacturer has data to demonstrate the capability of the vendor's process to consistently manufacture within specifications. This may include: statistical process control charts for each critical control point and process capability studies.
    • Prior to implementation of a spot check program the manufacturer analyzes an appropriate number of consecutive lots to establish a historical data base and confirms adherence to specifications, e.g., annually.
    • The manufacturer conducts periodic monitoring to verify adherence to specifications.
    • The manufacturer conducts vendor audits to validate the status of the vendor certification program.

Option 4 - Specification Requirements

  • Where packaging materials are not likely to impact on the safety of the food:
    • The manufacturer has written specifications for the packaging materials and lids.
    • Purchasing specifications include a provision for compliance with the CAP Act and Processed Products Regulations.

Non-Conforming Packaging Material - (applies to options 1 to 3)

  • When packaging material is found not to meet specifications the manufacturer investigates and identifies the root cause. If the packaging material does not meet specifications but has not been used it is not considered a deviation. However, if it is possible that packaging material not meeting specifications has been used, the manufacturer should initiate deviation/corrective action as per Section 5.1.13(tasks 6301, 6302, and 6303), Deviations and Corrective Action.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Packaging material contains substances which may be injurious to consumers health. The packaging material does not comply with Division 23 of the Food and Drugs Regulations.
  • Protective covering absent and evidence of hazardous extraneous material contamination found.
Rating III
  • Periodic evaluation - a representative sample is not taken to visually verify adherence to specifications.
  • The manufacturer has specifications but cannot demonstrate adherence, e.g., no certification from the supplier or monitoring by the manufacturer is deficient.
  • The manufacturer has no control over incoming packaging materials, e.g., no specifications, certification or monitoring.
  • Containers not adequately protected. e.g. Protective coverings for packaging materials damaged/missing.
Legal Authorities
  • PPR, 16(12), Product cannot be exposed to a source of contamination
  • PPR, 30.3(a), Container is suitable for use
  • PPR, Schedule III, Tables I, II, III Prescribed container sizes
Manufacturing Controls
Task 5304
5.1 Manufacturing Controls
5.1.3 Incoming Material Control
5.1.3.4 Incoming Material Control Records
Task 5304 April 1, 2002
Principle The manufacturer has records available that demonstrate the adequacy of incoming material control.
Assessment Criteria The minimum record requirements for the following monitoring and/or certification options are:

Periodic Evaluations

  • History of adherence to specifications, i.e., analytical results.
  • Spot checks, i.e., analytical results.

100% Lot Inspection

  • Analytical results for each incoming lot.

Vendor Certification

  • Records which demonstrate knowledge of the vendor's process, e.g., process flow charts, critical control point identification, process specifications, critical limits, monitoring and verification reports, corrective action plans and reports, and on site evaluation reports.
  • Records which demonstrate the capability of vendor's process, e.g., capability studies. Statistical process control charts are available upon request.
  • Historical data base, e.g., analytical results on consecutive lots.
  • Periodic monitoring, e.g., analytical results.
  • Vendor audits, e.g., audit reports.

Specifications

  • Records of incoming materials specifications

Non-Conforming Incoming Materials

  • Identification of the material.
  • Identification of the deficiency.
  • Preventative and corrective action taken.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • Inaccurate, incomplete or absence of records which does not permit verification of incoming materials controls, e.g., the manufacturer relies on 100% inspection and analytical results of incoming lots are not kept for ingredients which could impact on the safety of the process.
Legal Authorities
  • none
Manufacturing Controls
Task 5401
5.1 Manufacturing Controls
5.1.4 In-Process Package Control
5.1.4.1 Empty Container/ Packaging Material Handling General Other Than Cans, Glass
Task 5401 April 1, 2002
Principle Empty container/packaging material handling is controlled to minimize damage and to prevent the use of damaged, defective or contaminated containers/packaging material.
Assessment Criteria The manufacturer has an effective system in place to minimize damage and/or contamination and to prevent the use of damaged or defective containers/packaging material:
  • The manufacturer has an effective system in place to prevent the use of:
    • contaminated, damaged or defective containers
    • contaminated, damaged or defective unformed packaging material e.g., roll stock
  • Packaging is handled and transferred in a manner that minimize damage and contamination, e.g. forklifts, conveyors, transfer points, synchronization of line speed etc.
  • Prior to use, packaging is examined for damage (cracks and fractures) and contamination (e.g., glass, rust, foreign material, old food particles etc).
  • Packaging is used for its intended purposes only.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • The manufacturer does not have an effective system in place to prevent the use of: contaminated, damaged or defective containers.
  • Inappropriate handling of packaging material in the establishment causing damage/contamination e.g. rough handling, in-plant storage without protection.
  • Dirty field containers used to hold frozen berries etc.
Legal Authorities
  • PPR, 30.3(a) Suitable for use
  • PPR, 16(12), Product cannot be exposed to a source of contamination
Manufacturing Controls
Task 5402
5.1 Manufacturing Controls
5.1.4 In-Process Package Control
5.1.4.2 Empty Container Handling - Cans
Task 5402 April 1, 2002
Principle Empty container handling is controlled to minimize damage and to prevent the use of damaged, defective or contaminated containers.
Assessment Criteria The manufacturer has an effective system in place to minimize damage and to prevent the use of damaged or defective containers. This can be accomplished either through:

Option 1 - Continuous Visual Monitoring

  • Prior to depalletizing, containers are examined for damage, e.g., exterior pallet examination of 4 sides.
  • Empty containers are visually examined to identify, remove and segregate defective containers during depalletizing or on-line.
  • Adequate lighting is provided at inspection stations and an adequate system or method is in place to inspect containers, e.g., overhead mirrors are suspended at the depalletizer, line speeds are appropriate.
  • Containers are handled and transferred in a manner that minimizes damage and contamination, e.g., conveyors, transfer points etc.
  • Type and number of defects are recorded (4.6.1.3).

Option 2 - Container Handling Damage Control

  • The manufacturer has controls in place to prevent container damage as follows:
    • Vendor Controls
      • The manufacturer verifies that the supplier has effective controls in place to minimize damage of containers. Verification may be accomplished through review of the supplier's internal audits and through vendor audits. Can handling controls include; careful handling, minimizing handling of pallets and optimizing pallet protection during loading, shipping and storage, e.g., size of pallet, condition of the pallet, condition of the slip sheets, shrouding, strapping pressure, corner protectors.
    • Manufacturer's Controls
      • The manufacturer has controls in place to minimize damage, and verifies the effectiveness of these controls through periodic audits:
        • receiving controls, e.g., driver handling, unloading, identification of damage problems and corrective action
        • storage controls, e.g., stacking restrictions, heights, spacing, protection from damage and contamination
        • depalletizing and conveying controls, e.g., careful loading, removal of damaged containers during de-shrouding, effectiveness of damage control, synchronization of line speeds, transfer points
        • identification of deficiencies in control and corrective action taken
      • Containers are used for their intended purpose only.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Cans with serious defects not removed from the line (LAF).
  • In process can handling causes serious damage to cans (LAF).
Rating III
  • Pallets of cans are not examined prior to depalletizing,, however, other subsequent visual inspection is satisfactory.
  • Can handling damage control - e.g., the manufacturer has controls in place but does not verify the supplier's controls (as outlined in Option 2).
  • Continuous visual monitoring of cans is deficient preventing adequate inspection, e.g., no mirrors, insufficient lighting, excessive line speed, etc.
  • In process can handling causes minor damage to cans.
  • Cans used for other than intended purpose.
Legal Authorities
  • PPR, 30.3(a), Suitable for use
  • PPR, 16(12), Product cannot be exposed to a source of contamination
Manufacturing Controls
Task 5403
5.1 Manufacturing Controls
5.1.4 In-Process Package Control
5.1.4.3 Empty Container Handling - Glass
Task 5403 April 1, 2002
Principle Empty glass container handling is controlled to minimize damage and to prevent the use of damaged, defective or contaminated containers.
Assessment Criteria The manufacturer has an effective system in place to minimize damage and contamination. This must be accomplished through appropriate in plant container handling:
  • Containers are handled and transferred in a manner that minimizes damage and contamination, e.g., conveyors, transfer points.
  • Temperature differential between warehouse storage and cleaner/filler is monitored to avoid thermal shock breakage, or
  • Tempering tunnel temperature is controlled to minimize thermal shock breakage.

The manufacturer must have an effective system in place to prevent the use of damaged, defective or contaminated containers. This can be accomplished either through:

Option 1 - Continuous Visual Monitoring

  • Prior to depalletizing, glass containers are examined for damage, e.g., exterior pallet examination of four sides.
  • Empty containers are visually or electronically examined to identify, remove and segregate defective, damaged or contaminated containers during depalletizing or on-line.
  • Type and number of defects are recorded (4.6.1.3).
  • Visual inspection system:
    • adequate lighting is provided at inspection stations and an adequate system or method is in place to inspect containers, e.g., overhead mirrors are suspended at the depalletizer, line speeds are appropriate
  • Electronic inspection system:
    • defect standards are used to set up the system which reflects the defects expected and found on line
    • the electronic system is tested at a pre-determined frequency using the defect standards to ensure proper operation
    • there is a back-up system in place in case the electronic inspection system fails

Option 2 - Handling Damage Control

  • The manufacturer has controls in place to prevent container damage as follows:
    • Vendor Controls
      • The manufacturer verifies that the supplier has effective controls in place to minimize damage of containers. Verification may be accomplished through review of the supplier's internal audits and through vendor audits. Container handling controls include; careful handling, minimizing handling of pallets and optimizing pallet protection during loading, shipping and storage, e.g., size of pallet, condition of the pallet, condition of the slip sheets, shrouding, strapping pressure, corner protectors.
    • Manufacturer's Controls
      • The manufacturer has controls in place to minimize damage, and verifies the effectiveness of these controls through periodic audits:
        • receiving controls, e.g., driver handling, unloading, identification of damage problems and corrective actions
        • storage controls, e.g., stacking restrictions, heights, spacing, protection from damage and contamination
        • depalletizing and conveying controls, e.g., careful loading, removal of damaged containers during de-shrouding, effectiveness of damage control synchronization of line speeds, transfer points
        • identification of deficiencies in control and corrective action taken
      • Containers are used for their intended purpose only.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Damaged and defective glass containers not removed.
Rating III
  • Pallets of bottles are not examined prior to depalletizing,, however, other subsequent visual inspection is satisfactory.
  • Glass container handling damage control - e.g., the manufacturer has controls in place but does not verify the supplier's controls (as outlined in Option 2).
  • The glass container handling damage control or visual monitoring program is absent or deficient such that defective containers may be used.
  • Continuous visual monitoring - deficiencies which prevent adequate inspection, e.g., no mirrors, insufficient lighting, excessive line speed.
  • Container handling damage control - e.g., deficiencies in the control program which may result in use of seriously damaged containers.
  • Containers used for purposes other than intended use.
  • Electronic inspection equipment is not functioning properly.
  • Excessive temperature differential causing glass cracking.
Legal Authorities
  • PPR, 30.3(a), Suitable for use
  • PPR, 16(12), Product cannot be exposed to a source of contamination
Manufacturing Controls
Task 5404
5.1 Manufacturing Controls
5.1.4 In-Process Package Control
5.1.4.4 Container Cleaning - New containers
Task 5404 April 1, 2002
Principle Where applicable new container cleaning is controlled prior to filling to remove extraneous material that may contaminate the product.
Assessment Criteria The manufacturer has a system in place to ensure that only clean containers are filled.
  • Containers that require cleaning are cleaned by:
    • Inversion in conjunction with pressured air, water, steam or suction to remove extraneous material. Where water or steam are used, the water or steam shall be potable. Where detergent or sanitizers are used , they are used in accordance with the manufacturer's instructions and should be listed in the "References Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents", published by CFIA or the manufacturer has a "letter of no objection" from Health Canada.
  • A container cleaning system that:
    • operates at all times that the line is in operation
    • is efficient to remove harmful extraneous material
    • is maintained, e.g., nozzles not plugged, free from accumulated debris
  • For small operations, manual inversion and examination of every container to ensure they are clean could be sufficient.
  • Containers that may not require cleaning:
    • new plastic containers received and stored in plastic bags and protected from further contamination
    • plastic pails received stacked and inverted to protect them from contamination
    • plastic film and unformed pouch material protected from contamination
Rating Guide Examples
Rating I
  • Hazardous extraneous material not removed e.g. glass > 2mm.
Rating II
  • Containers not inverted and evidence of contamination with harmful extraneous material.
  • No container cleaning system and evidence of major contamination with objectionable material.
Rating III
  • Container cleaning system not fully operational, e.g., nozzles partially plugged.
Legal Authorities
  • PPR, 14(o), Appropriate container cleaning equipment
  • PPR, 16(10) Free from foreign material
  • PPR, 16(9) Proper use of cleaners
  • References listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents
Manufacturing Controls
Task 5405
5.1 Manufacturing Controls
5.1.4 In-Process Package Control
5.1.4.5 Container Examination and Cleaning - Reusable Containers
Task 5405 September 17, 2002
Principle Reusable containers are examined and cleaned prior to filling to ensure the containers are fit for use. Remove any material that may contaminate the product.
Assessment Criteria The manufacturer has controls in place to examine and remove unacceptable reusable containers prior to use.
  • Only containers previously used to contain food products or reconditioned for use in the food industry are utilized. All suspect container are discarded.
  • Drums/lids that are rusty or flaking varnish/paint are diverted from the food container pile or reconditioned.
  • Severely dented drums are removed from food container pile
  • Broken totes are repaired or discarded.
  • Containers which may have held other than food products or packaging material are removed from the premises.

The manufacturer has a system in place to thoroughly clean bulk containers before use.

  • In place an effective cleaning system, e.g. High pressure washer, steam, etc.
  • Where water or steam are used, the water or steam is potable and the containers are inverted; where detergent or sanitizers are used , they are used in accordance with the manufacturer's instructions and should be listed in the "References Listing of Accepted Construction, Packaging Materials and Non-Food Chemical Agents", published by CFIA or the manufacturer has a "letter of no objection" from Health Canada.
  • The container cleaning system operates at all times that the line is in operation.
  • The cleaning system is maintained, e.g., nozzles not plugged, free from accumulated debris.
Rating Guide Examples
Rating I
  • Hazardous extraneous material not removed e.g. glass > 2mm.
  • Non reconditioned drums which had previously held container toxic chemicals are used to pack food.
Rating II
  • Containers not inverted/cleaned and evidence of contamination with harmful extraneous material (glass, wooden part, grease and oils).
  • No container cleaning system and evidence of major contamination with objectionable material (food residues, soil, insects).
  • No container inspection system and containers previously used to contain non food chemicals are used as food containers.
  • History of containers is unknown.
Rating III
  • Container cleaning system not fully operational, e.g., nozzles partially plugged.
  • No container inspection system and barrels with excess rust/flaking paint are used to pack food.
Legal Authorities
  • PPR, 14(o), Appropriate cleaning system
  • PPR, 16(10), Free from foreign material
  • PPR, 16(9), Proper use of cleaners
  • PPR, 16(12), Product cannot be exposed to a source of contamination
Manufacturing Controls
Task 5406
5.1 Manufacturing Controls
5.1.4 In-Process Packaging Controls
5.1.4.6 Empty Container Records (Cans, Bottles, Plastic, Brick Pak, Pouches, etc.)
Task 5406 April 1, 2002
Principle Records of empty container usage by lot are maintained and are available upon request.

Written records of control of can handling damage and/or visual monitoring of empty containers are maintained and are available on request.

Assessment Criteria Empty Container Usage
  • The manufacturer records the date and can lot number or retains the pallet tag to permit lot traceability.

Can Damage

  • Continuous Visual Monitoring.
  • Records are kept of the defects identified at the depalletizer or on-line inspection; and/or

Container Handling Damage Control

  • The manufacturer retains records of internal and vendor audit reports.
  • The manufacturer maintains records of major activities related to can handling damage. For example, investigation reports including identification and scope of problems and the corrective action taken to minimize the possibility of recurrence.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • Records are incomplete or absent, e.g., no lot traceability.
Legal Authorities
  • none
Manufacturing Controls
Task 5407
5.1 Manufacturing Controls
5.1.4 In-Process Package Control
5.1.4.7 Protection of Clean or Cleaned Containers
Task 5407 September 17, 2002
Principle Clean and/or cleaned containers are protected from contamination prior to filling.
Assessment Criteria The manufacturer has controls in place to prevent contamination of clean and/or cleaned containers, e.g.:
  • no containers are left on the line between the cleaner and the filler at breaks, during clean-up or extended downtime unless adequate measures are in place to prevent contamination
  • line stoppage procedures
  • clean up methods
  • disposal methods for removing damaged or contaminated containers
  • glass breakage procedure is followed see section 5408
  • minimum distance exists between filler and cleaner
Rating Guide Examples
Rating I
  • Containers left unprotected on the line during breaks, clean-up, downtime where there is a high risk of contamination to clean or cleaned contain with hazardous extraneous material e.g. glass particles >2 mm.
  • High risk of contamination to clean or cleaned containers with hazardous extraneous material e.g. glass particles >2 mm.
  • Hazardous extraneous material >2 mm found in cleaned containers.
Rating II
  • Containers left unprotected on the line during breaks, clean-up, downtime where there is a high risk of contamination e.g. wash up water, condensate.
  • High risk of contamination to clean or cleaned containers with hazardous extraneous material e.g. glass particles
  • Glass breakage procedure is not being followed.
Rating III
  • Containers left unprotected on the line at breaks and downtime where there is a low to moderate risk of contamination.
  • Distance between cleaner and filler is too great, cleaned containers are not protected and there is a low possibility of contamination.
Legal Authorities
  • PPR, 16(3), Strict sanitary control
  • PPR, 16(10), Free from foreign material
  • PPR, 16(12), Product cannot be exposed to a source of contamination
  • PPR, 16(14), Product cannot contact anything that may affect quality or color
Manufacturing Controls
Task 5408
5.1 Manufacturing Controls
5.1.4 In-Process Package Control
5.1.4.8 Glass Breakage Procedure
Task 5408 September 17, 2002
Principle The manufacturer has an effective glass breakage control procedure developed for their operations.
Assessment Criteria
  • The manufacturer has a written procedure developed for each line where glass is used (related to the speed of the line, the jar size).
  • The glass breakage procedure specifies:
    • who is responsible
    • the line where it applies
    • the immediate action to initiate when a glass breakage occur (e.g., stop the line);
    • the number of jars (or length of conveyor) to reject from the line (empty jars, filled jars, closed jars) depending of where the breakage occurs
    • the cleaning procedure of the piece of equipment or conveyor and surrounding area where the breakage occurred (e.g., cleaning material to use)
    • evaluation of the cause of breakage
    • disposal of the glass/jars and affected product
  • The glass breakage procedure has to be available to the production employees.
  • If product is recycled, any glass particle is effectively removed.
  • Any other glass breakage occurrences (e.g. from glass bulbs, thermometers, etc.) are to be covered by this procedure.

Note: The application of the glass breakage procedure is evaluated within the process step ( filling, closure etc.).

Rating Guide Examples
Rating I
  • N/A
Rating II
  • No written glass breakage procedure.
Rating III
  • Glass breakage procedure not available to production employees.
  • Incomplete glass breakage procedure.
Legal Authorities
  • PPR, 16(10), Free from foreign material
Manufacturing Controls
Task 5409
5.1 Manufacturing Controls
5.1.4 In-Process Package Control
5.1.4.9 Glass Breakage Records
Task 5409 April 1, 2002
Principle Glass breakage records are maintained and are available on request.
Assessment Criteria
  • Records are available and demonstrate control of broken glass and affected product.
  • Glass breakage records has to include:
    • the date/time, where it occurred, corrective action taken, responsible person initials or signature
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • Insufficient information on records. which do not permit confirmation of the adequacy of glass clean up.
Legal Authorities
  • none
Manufacturing Controls
Task 5501
5.1 Manufacturing Controls
5.1.5 Product Preparation/Blending
5.1.5.1 Critical Factor Control - General - All Products
Task 5501 April 1, 2002
Principle Critical factors specified in the formulation or hazards associated with the preparation are controlled during preparation and blending to minimize biological, chemical, nutritional or physical hazards (BCP).
Assessment Criteria The manufacturer has controls in place to prevent hazards associated with product preparation/blending. Critical areas include:

Allergens (See Appendix IX)

  • The manufacturer has controls in place to prevent the presence of undeclared allergens and other ingredients which may cause sensitivity reactions. Allergens are those ingredients that will elicit an allergic response in sensitive individuals.
  • Areas that may require control include:
    • misdirection of ingredients
    • use of rework
    • contamination by undeclared ingredients
    • ingredient carryover
    • ingredient substitutions
    • contamination due to residues from previous run, e.g., product changeovers

Food Additives (e.g., colors, preservatives, firming agents, antifoaming agents, processing aids).

  • The manufacturer has controls in place to ensure that food additives are permitted and are used within allowable levels. These include:
    • clear identification of additives
    • accurate measurement
    • adequate blending for homogeneity

Nutrient Enrichment

  • The manufacturer has controls in place to ensure that nutrient levels comply with regulatory and label requirements including:
    • clear identification of nutrient
    • proper storage and handling to maintain nutrient potency
    • accurate measurement
    • adequate blending for homogeneity
Rating Guide Examples
Rating I
  • Inadequate or no control of rework, substitutions and use of the allergens with a known history of producing anaphylactic reaction in sensitive individuals (see Appendix IX ).
  • Inadequate control and evidence of the above allergens in the food e.g. sulphiting agents in glazed fruit.
Rating II
  • Use of rework or ingredient substitutions is not adequately controlled and the sensitive ingredients (e.g., lactose, MSG) are used in the plant.
  • Amount of additives or nutrients being blended does not meet formula requirements and safety may be affected.
Rating III
  • Lack of control resulting in significant variation in the levels of food additives and nutrients outside formula requirements but not affecting food safety.
  • Ingredient substitutions and use of rework is not adequately controlled but no listed allergens used in the plant (See Appendix IX) (e.g., lactose, MSG).
Legal Authorities
  • PPR 2.1(1)(f) Meets the requirements of the Food and Drug Regulations
  • F&DR, B.01.008(3) Ingredients must be shown in descending order of proportion on the label
Manufacturing Controls
Task 5502
5.1 Manufacturing Controls
5.1.5 Product Preparation/Blending
5.1.5.2 Critical Factor Control - Low Acid Foods
Task 5502 April 1, 2002
Principle Critical factors specified in the scheduled process and formulation are controlled during preparation and blending to minimize biological chemical or physical hazards (BCP).
Assessment Criteria The manufacturer has controls in place to prevent hazards and quality issues associated with product preparation/blending. Critical areas include:

Thermal Processing

  • The manufacturer has controls for critical factors identified in the validated process. Examples of critical factors are:
    • size control, e.g., dicing, grinding, slicing
    • temperature treatment control, e.g., heating, blanching (textural changes), defrosting, cooling
    • moisture control, e.g., rehydration, concentration (viscosity, Brix)
    • proportioning control, e.g., weighing, volumetric control (metering)
    • pH/Acidity control, e.g., pH measurement, titratable acidity for pectinization
    • preservatives, e.g., as allowed by the Food and Drug Regulations and PPR
    • firming agents e.g. calcium chloride

Preparation/Blending Microbial Control

  • The manufacturer controls time and temperature during preparation, blending and holding of in-process materials to prevent conditions that could result in excessive microbial growth or in the production of enterotoxin by Staphylococcus aureus.
Rating Guide Examples
Rating I
  • Inadequate control of critical factors specified in the scheduled process, e.g., inaccurate preparation, blending or measurement of critical ingredients.
Rating II
  • Inadequate control of pre-process holding conditions that may result in the growth of Staphylococcus aureus.
Rating III
  • N/A
Legal Authorities
  • PPR 30.3(f), Thermal process meets or exceeds schedule process
  • PPR Schedules I and II
  • Food and Drug Regulations, B11
Manufacturing Controls
Task 5503
5.1 Manufacturing Controls
5.1.5 Product Preparation/Blending
5.1.5.3 Critical Factor Control - Fresh Pack/Fermented
Task 5503 April 1, 2002
Principle Critical factors specified in the formulation are controlled during preparation and blending to minimize biological, chemical, nutritional or physical hazards (BCP).
Assessment Criteria The manufacturer has controls in place to prevent hazards associated with product preparation/blending. Critical areas include control of acidification of the brine used to pack fresh pack or fermented pickles as well as the prevention of the introduction of harmful extraneous matters in food products. The manufacturer also monitors the pH and/Titratable acidity development of the fermentation process:

Acidification/Brine Preparation

  • The manufacturer has controls for critical factors identified in the process design which will contribute to obtain the equilibrium pH of less than 4.6, such as:
    • appropriate acid: type and concentration, e.g. percent of acid or grains vinegar (United States or Canada)
    • amounts of acid required
    • pH measurement and/or titratable acidity of the brine
  • Where a food has come into contact with a strong base such as lime (Olives) and there may actually be undissolved particles present, these particles can result in an occasional final container having a pH greater than 4.6.

Microbial Controls

  • The manufacturers monitors periodically the pH/titratable acidity of the product and brine during the fermentation process.
  • The fermentation conditions [e.g. time, % salt, (salt additions)] are controlled in order to obtain the acidification of the product and brine to prevent undesirable microbial growth or the production of metabolic byproducts of microbial growth.
  • Low-acid ingredients (i.e. cucumbers) destined to become acidified foods shall not be held for extended periods under conditions which allow the growth of pathogens.
Rating Guide Examples
Rating I
  • Inadequate control of critical factors specified in the process design, e.g. inaccurate preparation, blending or measurement of critical ingredients which may have an impact on the equilibrium pH of the finished product.
  • Lack of control of sulfite addition.
Rating II
  • Amount of additives being blended does not meet formula requirements and preservation of the product may be affected.
Rating III
  • N/A
Legal Authorities
  • PPR 30.3 (f), Thermal process meets or exceeds scheduled process
  • CFIA Pickle Manual
Manufacturing Controls
Task 5504
5.1 Manufacturing Controls
5.1.5 Product Preparation / Blending
5.1.5.4 Product Preparation/Blending Records
Task 5504 April 1, 2002
Principle Critical factor control records are maintained and are available on request.
Assessment Criteria Records are available to demonstrate control of product preparation/blending as follows:
  • Records to demonstrate adherence to critical limits specified in the formula
  • records for critical factors specified in the validated thermal process
  • for nutrients in foods that are a sole source of nutrition
  • records for critical factors specified in the acidification process:
    • pH or titratable acidity measurements of the brine
    • solid/liquid ratio (drained weight)
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Record entries for critical factors are not complete, e.g., results not recorded at time of activity, activity conducted but not consistently recorded.
  • Records absent, inaccurate or incomplete for critical factors.
Rating III
  • Deficiencies in record keeping which do not affect verification of the adequacy of critical factor controls.
Legal Authorities
  • PPR, 30.2(f) Records that set out the low acid food product history
Manufacturing Controls
Task 5505
5.1 Manufacturing Controls
5.1.5 Product Preparation/Blending
5.1.5.5 Cleaning/Sorting Contamination Control
Task 5505 September 17, 2002
Principle Raw materials, ingredients and ingredient containers are cleaned, sorted, and/or prepared in such a manner as to prevent contamination.
Assessment Criteria The manufacturer controls the following hazards where appropriate using the following means:

Biological hazards

  • Visual inspection controls, e.g., removal of decomposed product.
  • Washing using potable water e.g., reduction of the microbial load.
  • Washing using disinfection agent in water e.g. reduction of the microbial load.

Chemical hazards

  • Control by washing raw material to remove/reduce chemical/pesticides residue applied by the grower.
  • Control of natural toxins by sorting, e.g., color (glycoalkaloids in potatoes).
  • Disinfectant water is used as per manufacturer's instructions. Disinfectants are listed in the "Reference Listing of Accepted Consutruction Materials, Packaging Materials and Non-Food Chemical Products" published by CFIA or the manufacturer has a "letter of no objection" from Health Canada. The concentration of disinfectant is to be controlled and the product is rinsed with potable water when necessary.

Physical hazards

  • Metal contamination controls, e.g., magnets, metal detectors.
  • Other extraneous matter controls, e.g., sorting/cleaning by gravity, air or water, inspection.
  • Pit portion control e.g., peach or cherry.

The manufacturer removes the non hazardous extraneous materials and defective products e.g., vegetative material, insects, plastic, culls etc. by sorting/cleaning by gravity, air, water, or inspection.

Rating Guide Examples
Rating I
  • Inadequate cleaning, sorting, and/or preparation of raw material where there is a contamination with hazardous extraneous material e.g. glass particles > 2 mm and without any further control before filling.
Rating II
  • Inadequate control of pit material > 2 mm.
  • Deficiencies in the removal of hazardous contaminants - decayed apples not sufficiently removed to prevent patulin contamination.
  • Contamination concern - e.g., high risk of contamination with avoidable filth.
  • Health risk concern - e.g., absence of control in removal of hazardous contaminants such as glass, metal.
  • Disinfectant material not used as per manufacturers instructions.
  • Dirty ingredient containers not cleaned before ingredient is used.
Rating III
  • Inadequate control of pit material < 2 mm.
  • Deficiencies in the removal of non-hazardous contaminants, e.g., washing of raw materials is ineffective.
  • Product not rinsed after disinfectant.
Legal Authorities
  • PPR, 2.1(1), Is not contaminated
  • PPR, 2.1(d), Prepared in a sanitary manner
  • PPR, 16(13), Food must be kept at the correct temperature and humidity
  • PPR, 16(16), Raw material are washed as needed to remove soil or contamination
  • PPR, 16(17), Raw materials are inspected, sorted and culled
Manufacturing Controls
Task 5506
5.1 Manufacturing Controls
5.1.5 Product Preparation/Blending
5.1.5.6 Quality Specifications Control
Task 5506 September 17, 2002
Principle The manufacturer has controls in place to ensure product meets quality specifications and regulatory requirements (grades and standards of identity).
Assessment Criteria The manufacturer controls the preparation and blending activities to ensure all product meets quality specification.
  • Preparation, peeling, coring, de-stemming.
  • Size control, e.g., dicing, grinding, slicing.
  • Time/temperature control, e.g., heating, cooking, blanching, frying (textural changes), defrosting, cooling.
  • Moisture control, e.g., reconstitution, drying, rehydration, concentration, (viscosity, Brix).
  • Ingredient proportion control, e.g., sugar, salt, starch, weighing, volumetric control (metering).
  • Ingredient authenticity (Economic Fraud)
  • pH/Acidity control, pH measurement, titratable acidity (e.g., for pectinization).
  • blending/mixing e.g., concentrate and water.
  • Chemically preserved fruit/vegetables is thoroughly washed prior to processing to ensure it meets the requirements of B11 of the food and Drugs e.g., SO2 preserved fruit.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • Product not manufactured according to quality specifications/formulation.
  • Inadequate control of soluble solids could lead to growth of yeasts and molds.
  • Inadequate control of the slicing/dicing of fruits and vegetables.
  • Manufacturer is not meeting the time/temperature requirements as outlined in the process design with no safety impact.
  • Inadequate control of firming agents resulting in poor quality product.
Legal Authorities
  • PPR, 2.1 (1) (c) All components and ingredients of a food must be sound, wholesome and edible
  • PPR Section 6, Schedule II Standards for Fruit and Vegetable products are prescribed
  • PPR Section 31 (e) Product shall be labeled with the true and correct grade name
  • PPR Schedules I and II
  • PPR: Table XI, Part I, II, III and IV Grades and identity standards
  • PPR: 2.1.1 References to F&DR
Manufacturing Controls
Task 5601
5.1 Manufacturing Controls
5.1.6 Filling
5.1.6.1 Filling of Containers - Low Acid Foods
Task 5601 April 1, 2002
Principle Factors for container filling specified in the scheduled process are controlled.
Assessment Criteria The manufacturer controls all filling factors specified in the scheduled process, e.g.:
  • fill temperature
  • ingredient distribution, e.g., meat, gravy, vegetables
  • orientation of products in the containers and handling, e.g., wieners, asparagus
  • volume/weight control, e.g., proportion weights, fill weights, head space
  • correct container is being used e.g., can-enamel, coatings, tin plate, bottle, pouch, etc.
  • proper packing medium used
  • product is protected from contamination during filling

Please refer to relative sections for filling criteria for specific types of containers.

Rating Guide Examples
Rating I
  • Inadequate or absent control for critical filling factors specified in the scheduled process, e.g., drained weight exceeds process requirements, product orientation incorrect, incorrect can size.
Rating II
  • Inadequate control of filling factors, however; other controls reduce the likelihood of a health risk occurring, e.g., inadequate control of filling temperature but other controls, such as monitoring of IT at retorts, reduces the risk of under processing.
Rating III
  • Incorrect can type (enamel) is used.
Legal Authorities
  • PPR 30.3(b), Filling is in compliance with schedule process
  • PPR, 30.3(a), Containers suitable for use
  • PPR, 20 - 22, Prescribed container sizes are used to pack fruit & vegetable products
Manufacturing Controls
Task 5602
5.1 Manufacturing Controls
5.1.6 Filling
5.1.6.2 Filling of all Container Types - Non Low Acid Foods
Task 5602 April 1, 2002
Principle Factors for container filling specified in the process design are controlled.
Assessment Criteria The manufacturer controls all filling factors as specified in the process design , e.g.:
  • correct container type
  • drained weight
  • fill temperature, e.g., frozen product not allowed to thaw, minimum temperature for hot filled product
  • net quantity
  • liquid/solid ratio
  • head space
  • vacuum
  • proper packing medium used
  • product is protected from contamination during filling

Please refer to relative sections for filling criteria for specific types of containers.

Rating Guide Examples
Rating I
  • Inadequate or absent control for critical filling factors specified in the process design , e.g., liquid/solid ratio (fresh pack pickles only).
Rating II
  • Inadequate control of filling factors, however; other controls reduce the likelihood of a health risk occurring, e.g., inadequate control of filling temperature but other controls, such as monitoring of IT at pasteurizer, reduces the risk of under processing.
  • Inadequate control of hot fill temperature for juices - no other controls to reduce the likelihood of a health risk.
  • Incorrect container type is used (glass vs metal) where product is pasteurized in the container.
  • Inadequate brine used for filling of pickles (fresh pack or fermented), but Equilibrium pH and final pH are not at risk.
Rating III
  • Incorrect container type is used (container lining).
  • No vacuum in containers where specified in the process design.
  • Product temperature not maintained (frozen or refrigerated).
Legal Authorities
  • PPR, 2.1, All ingredients, food additives and processing aids are not adulterated, or contaminated and are prepared in a sanitary manner
  • PPR, 16(12), Product cannot be exposed to a source of contamination
  • PPR, 20 - 23, Prescribed container sizes are used to pack fruit & vegetable products
  • PPR, 26(3), Minimum fill for frozen product is 90% of container capacity
  • PPR, 30.3 (a) Container suitable for use (ALAF)
  • PPR, 30.3(b) Filling is in compliance with schedule process (ALAF)
  • PPR, Schedule I Table II Micro specifications for Frozen Vegetables
Manufacturing Controls
Task 5603
5.1 Manufacturing Controls
5.1.6 Filling
5.1.6.3 Standard Containers Sizes and Net Quantity
Task 5603 April 1, 2002
Principle Container sizes and fill are controlled to meet the requirements of the PPR and the Consumer Packaging Act and Regulations.
Assessment Criteria The manufacturer uses containers that:
  • Meet the prescribed container sizes and dimensions as outlined in the PPR if applicable (unless for export).
  • Are filled to meet volume/weight requirements of the PPR and the CPLR.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • Manufacturer uses containers not prescribed in the PPR
  • Fill weight is not controlled to meet the declared net quantity (fraud only).
Legal Authorities
  • PPR, 20 - 27 Containers must be prescribed sizes. Container sizes smaller than the smallest prescribed sizes (specified containers) must have registered labels. Fill weight must meet prescribed amount.
  • PPR, 57, Standard containers sizes and fill weights exempted for export
Manufacturing Controls
Task 5604
5.1 Manufacturing Controls
5.1.6 Filling
5.1.6.4 Filling of Cans
Task 5604 April 1, 2002
Principle Controls are in place to prevent damage or interference in the sealing area of cans prior to closing.
Assessment Criteria The manufacturer controls sealing area interference where appropriate by:
  • continuous monitoring of containers and/or caps to eliminate sealing area interference, e.g., visual or electronic examination
  • verification of the effectiveness of continuous monitoring, e.g., quality assurance checks prior to sealing
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Sealing area interference control is absent or ineffective resulting in serious double seam defects, e.g.., droops LAF and Acidified Foods.
Rating III
  • Sealing area interference control is absent or ineffective resulting in minor sealing defects.
  • Sealing area interference control is absent or ineffective resulting in serious double seam defects, e.g., droops Acid Foods in HSC, Frozen Foods.
Legal Authorities
  • PPR, 30.3(l) Containers handled to avoid damage
Manufacturing Controls
Task 5605
5.1 Manufacturing Controls
5.1.6 Filling
5.1.6.5 Filling of Glass Containers
Task 5605 April 1, 2002
Principle Controls are in place to prevent damage or breakage of glass containers during the filling process.
Assessment Criteria The manufacturer controls the glass breakage in the filling equipment area by:
  • Evaluating areas that may contaminate the product with glass.
  • Checking of alignment and timing.
  • Inspecting filling area regularly for broken glass.
  • Monitoring/gap detecting for a possible broken container. The gap detector will shut down a piece of equipment when a major container break occurs. The unit counts the number of containers entering and exiting the equipment. Any discrepancies in the counts indicates a container failure.
  • For products filled on a carbonated beverage filler i.e., juices, water, refer to inspectional method 302.2 (6) in the Food Inspection References Manual.
  • Removal of broken glass.
  • Tearing down of equipment to the extent necessary to remove the potential for glass contamination i.e., seal, rubbers, valve blow outs, valve dismantling.
  • Continuous monitoring of containers and/or caps to eliminate sealing area interference, e.g., visual or electronic examination.
  • Verification of the effectiveness of continuous monitoring, e.g., quality assurance checks prior to sealing.
Rating Guide Examples
Rating I
  • Broken glass found on food contact surfaces or in jars.
Rating II
  • Filling area not inspected regularly for broken glass.
  • Sealing area interference control is absent or ineffective resulting in serious sealing defects, (Low Acid Foods and Acidified Foods).
Rating III
  • Gap detector not tested.
  • Sealing area interference control is absent or ineffective resulting in minor sealing defects.
  • Sealing area interference control is absent or ineffective resulting in serious sealing defects, e.g., closure defects droops (Acid Foods in HSC, Frozen Foods).
Legal Authorities
  • PPR 2.1 (1) Is not contaminated, adulterated, etc.
Manufacturing Controls
Task 5606
5.1 Manufacturing Controls
5.1.6 Filling
5.1.6.6 Filling of Pouches
Task 5606 April 1, 2002
Principle Controls are in place to prevent damage or interference in the sealing area prior to closing for products containing any material known to interfere with the formation of the seam.
Assessment Criteria The pouch is filled without contaminating the seal area:
  • filler drip does not contaminate seal area of empty pouches
  • product or liquids not drawn onto seal area by high vacuum
  • product not overfilled onto the sealing area
  • seal not stressed by insufficient air evacuation or excess back flush
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Sealing area interference control is absent or ineffective resulting in serious sealing defects (LAF).
  • Seals stressed by improper air evacuation (LAF).
Rating III
  • Sealing area interference control is absent or ineffective resulting in minor sealing defects
  • Sealing area interference control is absent or ineffective resulting in serious seam defects, e.g., blister Acid Foods in HSC, Frozen Canned Foods.
Legal Authorities
  • PPR, 2.1 All ingredients, food additives and processing aids are not adulterated, or contaminated and are prepared in a sanitary manner
  • PPR, 30.3(c), Closing heads are evaluated to ensure container is properly sealed
  • PPR, 16(12), Product cannot be exposed to a source of contamination
  • Flexible Retort Pouch Defects, Identification and Classification Manual, (1998 Draft)
 
Manufacturing Controls
Task 5607
5.1 Manufacturing Controls
5.1.6 Filling
5.1.6.7 Filling Records - Low Acid Foods
Task 5607 April 1, 2002
Principle Records demonstCote control of critical factors in filling are maintained and are available on request.
Assessment Criteria The manufacturer has records to demonstrate adequate control of critical factors in filling specified in the scheduled process, e.g.;
  • Temperature control records, e.g., filler bowl temperature recorder charts and/or manual records.
  • Ingredient distribution control records, e.g., visual checks for product orientation.
  • Weight/volume control records, e.g., portion weights from multi-phase fillers, total weights, head space.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Absent or inadequate records for critical factors, e.g., temperature recorder controller, temperature recorder (where it is the only means of monitoring temperature), statistical process control charts used to control ingredient distribution or weight/volume.
Rating III
  • Deficiencies which do not affect verification of the adequacy of critical factors in filling, e.g., date missing, date missing for one time period, not signed by operator.
Legal Authorities
  • PPR 30.2(f) Records set out the low acid food product history
Manufacturing Controls
Task 5608
5.1 Manufacturing Controls
5.1.6 Filling
5.1.6.8 Filled Unsealed Container Handling
Task 5608 April 1, 2002
Principle The processor ensures filled containers are conveyed from the filler to the sealer/seamer in a manner to prevent biological, chemical or physical hazards (BCP) from being imparted to food through breakage, damage and/or contamination of the container, product and/or sealing/seaming area.
Assessment Criteria

Unsealed containers are conveyed from filler to sealer/seamer in a manner to prevent breakage/damage and hazardous contamination.

The processor has the following controls in place:

  • no containers are left on the line between the filler and the sealer/seamer at breaks, during clean-up or extended downtime e.g. line stoppage procedures,clean-up procedures
  • disposal methods for removing damaged or contaminated containers
  • equipment and surfaces contacting the container shall not result in damage or abrasion
  • pouch breakage procedure is followed
  • glass breakage procedure is followed
Rating Guide Examples
Rating I
  • Unprotected filled containers left on line, containing hazardous extraneous material >2mm.
Rating II
  • Filled containers left unprotected on the line during breaks, clean-up, downtime where there is a high risk of contamination e.g. wash up water, condensate, spoilage or conditions affecting the process.
  • Filled containers left unprotected on the line during breaks, clean-up, downtime where there is a high risk of contamination with hazardous extraneous material.
  • Clips to hold pouches, damage the sealing area causing serious seal defects (LAF Products).
Rating III
  • Filled containers left unprotected on the line at breaks and downtime where there is a low to moderate risk of contamination, spoilage or change in conditions affecting the process.
  • Clips to hold pouches, damage the sealing area causing minor seal defects (LAF Products).
  • Clips to hold pouches, damage the sealing area causing serious seal defects (Acid Foods in HSC).
Legal Authorities
  • PPR, 16(12), Product cannot be exposed to a source of contamination
Manufacturing Controls
Task 5609
5.1 Manufacturing Controls
5.1.6 Filling
5.1.6.9 Metal Contamination Control
Task 5609 April 1, 2002
Principle Controls, if in place, ensures the detection and removal of any extraneous metal.
Assessment Criteria
  • During operations, the manufacturer monitors equipment (metal detectors, magnets, etc) to ensure it detects and removes extraneous metal.
  • If a metal detector is used, shall be tested on a regular frequency to ensure it is operating in accordance with detector manufacturer specifications.
  • If equipment other than a metal detector is being used, it shall be shown that it is operating in accordance with specifications.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Metal detector in operation, but hazardous metal fragments found in product.
Rating III
  • Metal detector not operating in accordance with manufacturer=s specifications (if installed).
  • Insufficient exposed surface area on magnet.
Legal Authorities
  • PPR, 2.1 All ingredients, food additives and processing aids are not adulterated, or contaminated and are prepared in a sanitary manner
  • PPR, 16(12), Product cannot be exposed to a source of contamination
Manufacturing Controls
Task 5701
5.1 Manufacturing Controls
5.1.7 Container Closure Control
5.1.7.1 Glass Capping
Task 5701 April 1, 2002
Principle Controls are in place to prevent damage or breakage of glass container during the capping process and to ensure a hermetic seal.
Assessment Criteria The manufacturer controls the closing equipment to ensure the integrity of the container and the hermetic seal by:
  • protecting the cap/lid hopper from glass contamination
  • adjusting closing equipment to avoid chipping either the finish or glass edge and forming a hermetic seal
  • broken glass is removed from capping equipment and surroundings
  • closure heads are adjusted based on the results of the destructive examination to ensure hermetic seal
Rating Guide Examples
Rating I
  • Broken glass found in capper hopper or on capper machinery.
Rating II
  • Capper area not inspected regularly for broken glass.
  • Closure heads not adjusted to ensure hermetic seal.
Rating III
  • N/A
Legal Authorities
  • PPR, 2.1 All ingredients, food additives and processing aids are not adulterated
  • PPR, 16(12), Product cannot be exposed to a source of contamination
  • PPR, 30.3(c), Closing heads are evaluated to ensure container is properly sealed
Manufacturing Controls
Task 5702
5.1 Manufacturing Controls
5.1.7 Container Closure Control
5.1.7.2 Pouch Sealing
Task 5702 April 1, 2002
Principle The pouch is sealed under controlled conditions to ensure a hermetic seal.
Assessment Criteria The manufacturer controls the sealing equipment and conditions to ensure a hermetic seal. The critical parameters of pouch closure/hermetic seal are:
  • properly formed & undamaged pouches are used
  • the proper placement of the pouches within the jaws of the sealing machine - equipment & pouch alignment
  • sealing material compatibility
  • flat, smooth & parallel sealing surfaces
  • sealing pressure by the sealing tool holding the pieces together
  • sealing time of the sealing tool holding the pieces together
  • correct temperature of fusion
  • condition of the sealing surface
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Improper pouches are used, causing serious seal defects (LAF).
Rating III
  • Pouch not properly placed in the sealing jaws causing minor seal defects (LAF).
  • Pouch not properly placed in the sealing jaws causing minor or serious seal defects (Acid Foods in HSC).
Legal Authorities
  • PPR, 2.1, All ingredients, food additives and processing aids are not adulterated
  • PPR 2.4, Food product container is not defective
  • PPR, 16(12), Product cannot be exposed to a source of contamination
  • PPR, 30.3(c), Closing heads are evaluated to ensure container is properly sealed
  • Flexible Retort Pouch Defects, Identification and Classification Manual, (1998 Draft)
Manufacturing Controls
Task 5703
5.1 Manufacturing Controls
5.1.7 Container Closure Control
5.1.7.3 Vacuum - Low Acid Vacuum-packed Foods
Task 5703 December 20, 2006
Principle Container vacuum is controlled to meet the requirements of the scheduled process, to protect the hermetic seal, to prevent permanent distortion of container ends during processing and to maintain concave ends during distribution and storage.
Assessment Criteria This section ONLY applies to products that are vacuum-packed (e.g., corn or sweet potatoes).
  • The manufacturer has specifications and controls for container vacuum as follows:
    • all factors affecting vacuum are controlled, e.g., temperature, air exhaustion by steam or mechanical vacuum, fill weight/volume and head space to prevent permanent seam distortion during processing
    • where appropriate, container vacuum is monitored and controlled to ensure adherence to the requirements of the scheduled process
Rating Guide Examples
Rating I
  • Insufficient control of vacuum where vacuum is a critical factor in the scheduled process.
Rating II
  • Consistently packing product with no or low vacuum which does not permit verification of a hermetic seal (LAF).
  • Insufficient control of vacuum causing (LAF) permanent seam distortion.
Rating III
  • Deficiencies in vacuum control which occasionally results in no or low vacuum.
Legal Authorities
  • PPR, (LAF) 30.3(C), Operations at each closing head is evaluated
  • PPR 2.4, Food product container is not defective
Manufacturing Controls
Task 5704
5.1 Manufacturing Controls
5.1.7 Container Closure Control
5.1.7.4 Vacuum - Acid Foods and Low Water (Aw) Activity Foods
Task 5704 December 20, 2006
Principle Container vacuum is controlled to meet the requirements of the process design , to protect the hermetic seal, to prevent permanent distortion of container ends during processing and to maintain concave ends during distribution and storage.
Assessment Criteria The manufacturer has specifications and controls for container vacuum as follows:
  • all factors affecting vacuum are controlled, e.g., temperature, air exhaustion by steam or mechanical vacuum, fill weight/volume and head space to prevent permanent seam distortion during processing
  • where appropriate, container vacuum is monitored and controlled to ensure adherence to the requirements of the process design
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • Deficiencies in vacuum control which occasionally results in no or low vacuum.
  • Consistently packing product with no or low vacuum which does not permit verification of a hermetic seal.
  • Insufficient control of vacuum causing permanent seam distortion.
Legal Authorities
  • PPR, 2.1, All ingredients, food additives and processing aids are not adulterated, or contaminated and are prepared in a sanitary manner
  • PPR 2.4, Food product container is not defective
Manufacturing Controls
Task 5705
5.1 Manufacturing Controls
5.1.7 Container Closure Control
5.1.7.5 Visual Examination for Low Acid and Acidified Low Acid Foods
Task 5705 April 1, 2002
Principle Visual examinations of ends and sealed containers are conducted to identify and control defects that may compromise the hermetic seal.
Assessment Criteria Cans:
  • Visual examinations are in accordance with the Government of Canada "Metal Can Defect Identification and Classification Manual".
  • The manufacturer visually monitors ends for damage prior to use.
  • The manufacturer visually examines sealed containers for defects, as follows: a minimum of at least 1 can from each seaming head at intervals not exceeding 30 minutes.

Jars: External Inspections at Capper

  • The manufacturer visually monitors caps for damage prior to use
  • The manufacturer visually examines sealed containers for defects, as follows:
    • Straight line cappers a minimum of 6 consecutive jars every 30 minutes.
    • Rotary cappers - 1 jar from each head every 30 minutes.

Pouches:

All other types:

  • examinations are conducted at start-up, after major jams or after adjustments.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Less than 1 can/bottle/pouch per head examined.
  • Sealed containers are visually inspected at time intervals significantly exceeding 30 minutes on a consistent basis, e.g., two, three or four hour intervals.
  • Absence of visual examinations of sealed containers after startup, major jams, etc.
Rating III
  • Ends/caps are not visually checked prior to use.
  • Sealed containers are visually inspected at time intervals occasionally exceeding 30 minutes.
Legal Authorities
  • PPR 2.4, Food product container is not defective
  • PPR (LAF) 30.3(C), Operations at each closing head is evaluated
Manufacturing Controls
Task 5706
5.1 Manufacturing Controls
5.1.7 Container Closure Control
5.1.7.6 Destructive Examination for Low Acid and Acidified Low Acid Foods
Task 5706 April 1, 2002
Principle Destructive examinations of double seams, caps and pouch seams are conducted to identify and control defects that may compromise the hermetic seal.
Assessment Criteria Note: Qualifications are described under Section 4.4.1.2, Technical Training.

The manufacturer conducts destructive examinations to ensure conformance to specifications as follows:

Frequency

  • intervals do not exceed four hours
  • a minimum of one container from each seaming, sealing, turret feed or closure head is examined
  • tear downs are conducted at start-up, after severe jam-ups, after changeovers and after adjustments to the closing /sealing machine

Cans:

  • Destructive or tear down examinations are conducted in accordance with the "Government of Canada Metal Can Defect Identification and Classification Manual".
  • Seam Measurements
    • The manufacturer conducts double seam tear downs and internal and external measurements as follows:
      • external - thickness and height
      • internal - body hook, cover hook, optical overlap or equivalent
      • visual inspection - tightness Rating

Jars:

  • Container Closure Examination:(The manufacturer also verifies closure after cooling by physical measurements: see 5.1.1.8, task 6108).
  • Destructive exam: Different types of inspections are available for the closure control of jars, their applicability depends on the type of closure and the type of capper. These measurement should be taken by authorized personnel.
    • straight Line Machines 3 jars taken consecutively every 4 hours
    • rotary capper 1 jar per head every 4 hours
  • The usual controls are:
    • Security Value
    • Removal Torque (optional)
      • Measured with a Torque-meter
    • Gasket:
      • The gasket should have a uniform 360° impression in it, resulting from contact with the glass finish.

Pouches:

  • Destructive or tear down examinations are conducted in accordance with the Flexible Retort Pouch Defects, Identification and Classification Manual, Draft Version (April 1, 1998)
  • empty containers are tested for bond strength
  • Tests include:
    • burst test
    • in-process after pouch formation - Air Burst bottom and side seal
    • in-process-after closure seal - Air Burst Top Seal visual for defects
    • tensile test
    • seam examination for evidence of product in seal area and seal width
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Intervals significantly or consistently exceed four hours.
  • Absence of destructive examinations.
  • Teardowns not conducted at start-up, after severe jam-ups, after changeovers and after adjustments to the closing machine.
Rating III
  • Intervals occasionally exceed four hours.
Legal Authorities
  • PPR 2.4, Food product container is not defective
  • PPR (LAF) 30.3(C), Operations at each closing head is evaluated
Manufacturing Controls
Task 5707
5.1 Manufacturing Controls
5.1.7 Container Closure Control
5.1.7.7 Visual Examination Acid and Low Aw Foods
Task 5707 April 1, 2002
Principle Visual examinations of ends and sealed containers are conducted to identify and control defects that may compromise the hermetic seal.
Assessment Criteria
  • Visual examinations are in accordance with the Government of Canada "Metal Can Defect Identification and Classification Manual" and Flexible Retort Pouch Defects, Identification and Classification Manual, (1998 Draft).
  • The manufacturer visually monitors ends for damage prior to use.
  • The manufacturer visually examines sealed containers for defects. e.g., a minimum of one container from each seaming, sealing, turret feed or closure head is examined.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • Visual checks on ends/lids not conducted.
  • Visual checks on bottles, cans and pouches not conducted.
Legal Authorities
  • PPR 2.4, Food product container is not defective
  • PPR 2.1, All ingredients, food additives and processing aids are not adulterated, or contaminated and are prepared in a sanitary manner contaminated
Manufacturing Controls
Task 5708
5.1 Manufacturing Controls
5.1.7 Container Closure Control
5.1.7.8 Destructive Examination for Acid and Low Aw Foods
Task 5708 April 1, 2002
Principle Destructive examinations of double seams and caps are conducted to identify and control defects that may compromise the hermetic seal.
Assessment Criteria Note: Qualifications are described under Section 4.4.1.2, Technical Training.

The manufacturer conducts destructive examinations to ensure conformance to specifications as follows:

  • Destructive or tear down examinations are conducted in accordance with the "Government of Canada Metal Can Defect Identification and Classification Manual" and Flexible Retort Pouch Defects, Identification and Classification Manual, (1998 Draft)
  • Security value - This measurement should be taken at intervals during every production period. After processing and cooling, the gasket should have a uniform 360 degree impression resulting from contact with the glass finish.

Frequency

  • Tear downs are conducted at an appropriate frequency.
  • Tear downs are conducted at start-up, after severe jam-ups, after changeovers and after adjustments to the closing machine.
  • Inspection of closure of jars shall be made both at the closing machine and after cooling of the finished product.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • Destructive examinations not conducted at regular intervals.
  • Teardowns not conducted at start-up, after severe jam-ups, after changeovers and after adjustments to the closing machine.
Legal Authorities
  • PPR 2.4, Food product container is not defective
  • PPR 2.1, All ingredients, food additives and processing aids are not adulterated, or contaminated and are prepared in a sanitary manner contaminated
Manufacturing Controls
Task 5709
5.1 Manufacturing Controls
5.1.7 Container Closure Control
5.1.7.9 Pre-Thermal Process Sealed Container Handling
Task 5709 April 1, 2002
Principle Container handling systems are controlled to minimize damage which could compromise container integrity.

Container exteriors are effectively cleaned prior to processing, where necessary.

Assessment Criteria
  • The manufacturer has a program in place to identify and eliminate points where container damage could occur. Particular attention is given to container transfer points, areas where containers abruptly change speed or direction, controls to stop conveyors when containers are stationary and synchronization of container handling systems.
  • Where necessary, the manufacturer cleans containers and monitors the effectiveness of cleaning, e.g., removal of extraneous material from can exteriors.
  • Pouches are handled in a manner to prevent puncturing by sharp objects or abrasion from equipment.
  • Pouches are minimally handled.
  • Excessive flexing, folding, movement and vibration of pouches is avoided.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Cable cut where the outer layer of metal is torn or cut through (LAF).
  • Deficiencies in control resulting in severe damage of double seam (LAF).
  • Deficiencies in control resulting in serious container handling defects to pouches (LAF).
Rating III
  • Deficiencies in control resulting in minor abrasion of double seam.
  • Containers not effectively cleaned.
  • Deficiencies in control resulting in minor handling defects to pouches.
  • Deficiencies in control resulting in serious container handling defects to pouches (Acid Foods).
  • Deficiencies in control resulting in serious can handling defects (Acid Foods).
Legal Authorities
  • PPR, 2.1, All ingredients, food additives and processing aids are not adulterated, contaminated
  • PPR 2.4, Food product container is not defective
  • PPR, 16(12), Product cannot be exposed to a source of contamination
  • PPR, 16(14), Product cannot contact anything that may affect quality or color
Manufacturing Controls
Task 5710
5.1 Manufacturing Controls
5.1.7 Container Closure Control
5.1.7.10 Container Closure - Frozen
Task 5710 April 1, 2002
Principle Containers are closed/sealed in accordance with the manufacturers specifications.
Assessment Criteria The manufacturer properly closes/seals the package/container according to manufacturers specification. Net quantity is maintained

The manufacturer visually examines sealed packages for defects.

  • Heat Application - pure pac and plastic bags- Continuous seals.
  • Metal Ends are properly mechanically seamed to body of the cans.
  • Mechanical Press On Lids- pails and tubs or totes.
  • Klick Lock - seams heat sealed/glued as required.
  • Cardboard Box with poly liner - poly lined folded over, taped or tied, The boxes are glued, taped or stapled.
  • Totes with poly liner - liner properly folded over.
  • Barrels (open head) - metal and plastic - liner is tied and lid applied.
  • Barrels (closed head) - metal and plastic - no liner - bung is plugged.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • Visual checks on containers not conducted.
  • Packages are not properly closed.
Legal Authorities
  • PPR, 2.1, All ingredients, food additives and processing aids are not adulterated, contaminated
  • PPR 2.4, Food product container is not defective
  • PPR, 16(12), Product cannot be exposed to a source of contamination
  • PPR, 16(14), Product cannot contact anything that may affect quality or color
Manufacturing Controls
Task 5711
5.1 Manufacturing Controls
5.1.7 Container Closure Controls
5.1.7.11 Container Closure Control Records - Low Acid and Acidified Low Acid Foods
Task 5711 April 1, 2002
Principle Written records of all visual and destructive container integrity examinations are maintained and available upon request.
Assessment Criteria The manufacturer has records to demonstrate adequate control of the container closure operation. The minimum container closure records are as follows:

Visual Examination Records

  • code lot
  • date and time of evaluation
  • examination results
  • corrective actions taken

Destructive Examination Records

  • code lot
  • date and time of closure evaluation
  • container closure specifications (cans, jars, pouches, bricks etc)
  • container closure measurements
  • corrective actions taken
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Deficiencies which do not permit verification of the adequacy of container integrity examinations, e.g., no record of tightness, overlap, etc. (LAF).
  • Absence of records which are part of the control mechanism, e.g., destructive examination records.
Rating III
  • Deficiencies which do not affect verification of the adequacy of container integrity examinations, e.g., minor variations in frequency.
Legal Authorities
  • PPR, 30.2(f) Records set out the low acid food product history (LAF)
Manufacturing Controls
Task 5712
5.1 Manufacturing Controls
5.1.7 Container Closure Control
5.1.7.12 Container Coding Control - Mechanical Coding Low Acid and Acidified Low Acid Foods
Task 5712 April 1, 2002
Principle Mechanical coding is controlled to ensure that codes do not adversely affect container integrity.
Assessment Criteria
  • The manufacturer has a system of control in place to prevent damage by coding, e.g., letters and code blocks that are damaged or worn, misaligned or improperly matched letters and pressure applied, etc.
  • The manufacturer conducts visual monitoring for enamel damage, metal fracture or perforation at regular intervals and after adjustments or changes to the coder.
  • Mechanical coding equipment is maintained to prevent damage to containers.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Use of excessively worn letters or code blocks resulting in fractured enamel or metal in products subject to accelerated corrosion. No leakers identified but likelihood of leakage occurring within normal shelf life. Coding can compromise the integrity of containers.
  • Perforated metal and leakage identified.
  • Lack of maintenance of code blocks and letters resulting in fractured codes caused by worn code blocks and letters.
Rating III
  • Inadequate monitoring but controls are effective, i.e., no defective containers identified.
Legal Authorities
  • PPR 16(12), Product cannot be exposed to a source of contamination
  • PPR 30.3(c), Closing heads are evaluated to ensure container is properly sealed
  • F&DR B.27.003, No person must sell a low-acid food packaged in a hermetically sealed container where the container is swollen, is not properly sealed, or has any defect that may adversely affect its hermetic seal
Manufacturing Controls
Task 5713
5.1 Manufacturing Controls
5.1.7 Container Closure Control
5.1.7.13 Container Coding Control - Mechanical Coding Acid Foods
Task 5713 April 1, 2002
Principle Mechanical coding is controlled to ensure that codes do not adversely affect container integrity.
Assessment Criteria
  • The manufacturer has a system of control in place to prevent damage by coding, e.g., letters and code blocks that are damaged or worn, misaligned or improperly matched letters and pressure applied, etc.
  • The manufacturer conducts visual monitoring for enamel damage, metal fracture or perforation at regular intervals and after adjustments or changes to the coder.
  • Mechanical coding equipment is maintained to prevent damage to containers.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • Inadequate monitoring but controls are effective, i.e., no defective containers identified.
  • Use of excessively worn letters or code blocks resulting in fractured enamel or metal in products subject to accelerated corrosion. No leakers identified but likelihood of leakage occurring within normal shelf life.
  • Perforated metal and leakage identified.
  • Lack of maintenance of code blocks and letters resulting in fractured codes caused by worn code blocks and letters.
Legal Authorities
  • PPR, 16(12), Product cannot be exposed to a source of contamination
Manufacturing Controls
Task 5801
5.1 Manufacturing Controls
5.1.8 Product Coding Control
5.1.8.1 Coding Control
Task 5801 April 1, 2002
Principle Coding is controlled to ensure that codes are present as required and are legible.
Critères d'évaluation The following food products shall be coded: low acid foods, acidified low acid foods, graded fruits, and all products which are packed for a first dealer. ( See task 4.6.2.2.for specific coding requirements).
  • The manufacturer has a system of coding which ensures that each hermetically sealed container of:
    • low acid foods and acidified low acid foods has a legible and permanent code
    • graded fruits has a legible code
  • Code marks used and the exact meaning of the code are available to the inspector.
  • Where applicable, the code accurately reflects the "best before" date, expiration date, or shelf life of the food.
Rating Guide Examples  
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • No coding or illegible codes identified.
Legal Authorities
  • PPR 2.1, All ingredients, food additives and processing aids are not adulterated, or contaminated and are prepared in a sanitary manner
  • PPR 30.3(d), Container is marked in a legible and permanent manner to identify the establishment, the food product and the date on which the food product is thermally processed and, where any part of this information is coded, the meaning of the code used is made available to an inspector on request
  • PPR 31(aa), Code marks indicate establishment where product was packed and date of pack for graded canned fruits & vegetables
  • PPR 33, Product packed for first dealer shall have be coded with establishment registration number or establishment identification code
Manufacturing Controls
Task 5901
5.1 Manufacturing Controls
5.1.9 Pre-Process Control
5.1.9.1 Maximum Time Lapse - Low Acid Foods in Hermetically Sealed Containers
Task 5901 April 1, 2002
Principle The elapsed time between sealing of containers and the commencement of thermal processing is controlled to ensure adherence to factors critical to product safety.
Assessment Criteria Generally elapsed time does not exceed one hour, unless:
  • The manufacturer can demonstrate that the product is commercially sterile and is free from toxins under the most extreme time, temperature and product conditions.
  • Sealed product is held at temperatures that will not permit the growth of microorganisms that could impact on the safety of the process (less than 4°C [39°F] or greater than 65°C [149°F]).
  • The heat transfer characteristics of the product are not affected.
  • The manufacturer has control over the time lapse between sealing and retorting, e.g., reporting of line breakdowns or interruptions that may result in excessive lapse times.
  • If the time lapse exceeds that demonstrated by the manufacturer to be safe, the product is treated as a process deviation and is held for safety evaluation.
  • If there are line breakdowns or interruptions, the manufacturer processes product in partially filled retorts to ensure that the maximum lapse time is not exceeded.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • The time lapse exceeds that determined to be safe by the process authority.
Rating III
  • Lapse times occasionally slightly exceed one hour, e.g., time lapse 75 minutes, product temperature 62°C (144°F) and no assessment by a processing authority.
Legal Authorities
  • PPR 30.1(1), Product must be processed until it is commercially sterile
  • PPR, 30.3(f), Requirements of the schedule process shall be met
Manufacturing Controls
Task 5902
5.1 Manufacturing Controls
5.1.9 Pre-Process Control
5.1.9.2 Retort Loading - Low Acid Foods in Hermetically Sealed Containers
Task 5902 April 1, 2002
Principle Loading of baskets is controlled to ensure the safety of the thermal process and to prevent damage to the containers.
Assessment Criteria The manufacturer controls basket loading to meet the requirements of the scheduled process and to prevent container damage as follows:

Loading Procedures

  • The manufacturer adheres to the loading requirements specified in the temperature distribution studies and process schedule, e.g., layering of dividers, types of dividers, hole configuration of the dividers (e.g., size, pattern, area), product orientation, number of layers per basket, pouch placement, etc.
  • The manufacturer does not permit nesting of cans or touching of pouches unless it has been included in the temperature distribution studies and scheduled process.

Damage Control

  • The manufacturer has adequate controls in place to minimize impact damage during loading (e.g., use of damaged baskets, rough handling of full baskets) and inadequate cushioning of containers during scrambled/jumble loading is prevented.
  • Pouch racks are kept free of rust, scale etc that may cause pin holing.
Rating Guide Examples
Rating I
  • Baskets not loaded to meet requirements of the temperature distribution or heat penetration studies (use of double dividers, can orientation - asparagus) (LAF).
  • Pouches touching resulting in under processing.
Rating II
  • Inadequate control of basket loading practices such that damage affecting the hermetic seal could occur.
  • Container damage and leakage.
  • Rust or scale on pouch racks which could cause pinholing.
Rating III
  • Use of damaged baskets that may cause minor defects on cans.
Legal Authorities
Manufacturing Controls
Task 5903
5.1 Manufacturing Controls
5.1.9 Contrôle du procédé avant le traitement thermique
5.1.9.3 Contrôle du cheminement des produits et des indicateurs de traitement --Aliments peu acides
Task 5903 April 1, 2002
Principle Traffic of processed and unprocessed product is controlled to prevent unprocessed product from by-passing the retort, to prevent co-mingling of unprocessed containers with processed containers, and to ensure that each basket goes to the appropriate retort.
Assessment Criteria The manufacturer controls processed and unprocessed product as follows:
  • Control systems are in place to prevent co-mingling of processed and unprocessed products, e.g., physical separation between closing and retorting, mess guards around crateless retorts.
  • Containers of unknown process status are immediately destroyed, e.g., cans found lying under or beside retorts are punctured.
  • Where there are multiple retorts and products requiring different processes, there is a system of identification to verify that each basket has been directed to the correct retort, e.g., a tag system.
  • All baskets or containers are clearly marked with a heat sensitive indicator(s) that undergoes changes only after exposure to processing temperatures, e.g., thermotropic ink, tape, tags.
  • Indicators are stored and handled according to manufacturer's recommendations to ensure adequate performance.
  • After retorting, the manufacturer monitors the indicator to verify that each retort basket was subjected to a heat process (indicators do not verify that the correct temperature or time was achieved during the process).
Rating Guide Examples
Rating I
  • Incomplete control of unprocessed product, e.g., tags are not functioning as required due to improper storage and handling, the indicator on each basket is not checked after processing.
  • Absence of controls to prevent misdirected baskets; mixing of products requiring different processes; products by-passing the retort.
  • Containers of unknown status left in retort area and not destroyed.
Rating II
  • N/A
Rating III
  • N/A
Legal Authorities
  • PPR 30.3(j), Use of heat sensitive indicators
Manufacturing Controls
Task 6001
5.1 Manufacturing Controls
5.1.10 Process Control
5.1.10.1 Initial Temperature (IT) - Low Acid Foods
Task 6001 April 1, 2002
Principle The temperature of the contents of the coldest container at the start of the process is controlled to ensure that it is no lower than the minimum specified in the scheduled process.
Assessment Criteria The manufacturer has controls in place to ensure that the initial temperature requirements of the scheduled process are met, e.g.:
  • The manufacturer monitors the temperature to ensure that the product does not drop below the specified initial temperature, e.g., temperature of the coldest can for each retort load.
  • The manufacturer's procedure for determining the initial temperature reflects the procedure used to determine the minimum IT during the heat penetration studies, e.g., the product is stirred or shaken, the temperature is taken at the center or in several locations for multi-phase products.
Rating Guide Examples
Rating I
  • The initial temperature is below that required by the scheduled process.
Rating II
  • Procedures for determining initial temperature are not the same as those used in the heat penetration tests.
  • Monitoring frequency is not sufficient to verify that initial temperature requirements are met.
Rating III
  • N/A
Legal Authorities
  • PPR 30.3(f), Thermal process meets the schedule process
Manufacturing Controls
Task 6002
5.1 Manufacturing Controls
5.1.10 Process Control
5.1.10.2 Venting and Process Schedule Accessibility - Low Acid Foods
Task 6002 April 1, 2002
Principle Schedules for venting and processing for each product and container size are readily accessible to the retort operator.
Assessment Criteria
  • The manufacturer ensures that correct vent and process schedules for each product and container size being processed are accessible to the operator, i.e., posted at the retort or available at the retort operator's station.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • Process or vent schedules are not readily accessible or available to the operator.
Legal Authorities
  • PPR 30.3(g), Located near the unit of thermal processing
Manufacturing Controls
Task 6003
5.1 Manufacturing Controls
5.1.10 Process Control
5.1.10.3 Retort operating Procedures - Low Acid Foods
Task 6003 April 1, 2002
Principle The operating retort procedures are carried out by a qualified operator to meet the temperature distribution and scheduled process requirements.
Assessment Criteria Note: Qualifications are described under section 4.4.1.2, Technical Training.

The manufacturer controls retort operations as follows:

  • Written Retort operating Procedures
  • Retort operating procedures include venting, processing and cooling procedures and instructions for handling deviations, e.g., the operator has clear instructions to either extend the process, reprocess and/or isolate affected product for safety evaluation.
  • The procedures are based on critical factors identified in the temperature distribution studies and in the validated process, and provide clear instructions to the operator.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Written retort operating procedures are deficient resulting in a possible processing error.
Rating III
  • Written retort operating procedures are deficient but safety is not affected.
Legal Authorities
  • PPR 30.3(e), Certificate of competence for thermal processing
  • PPR 30.3(f), Thermal process meets schedule process
  • PPR 30.3(g), Location of schedule process
Manufacturing Controls
Task 6004
5.1 Manufacturing Controls
5.1.10 Process Control
5.1.10.4 Vent Control - Low Acid Foods
Task 6004 April 1, 2002
Principle Venting is controlled to ensure adherence to the conditions under which the temperature distribution studies were conducted.
Assessment Criteria The manufacturer controls venting as follows:
  • The vent schedule meets both the minimum time and temperature requirements established in the temperature distribution tests.
  • The vent procedure is carried out in adherence to specifications resulting from the temperature distribution studies, e.g., loading configuration, steam manifold pressure, number of retorts being vented at one time.
  • The manufacturer controls venting to ensure adherence to the procedures.
Rating Guide Examples
Rating I
  • Vent does not meet the minimum time or temperature requirements and the operating process is equal to the scheduled process.
  • No vent.
Rating II
  • Vent does not meet the minimum time or temperature requirements but the operating process is greater than the scheduled process, i.e., process has a safety margin.
Rating III
  • N/A
Legal Authorities
  • PPR 30.1(1), Product processed to meet commercial sterility
  • PPR 30.3(f), Thermal process meets schedule process
Manufacturing Controls
Task 6005
5.1 Manufacturing Controls
5.1.10 Process Control
5.1.10.5 Process Time Control for Low Acid Foods
Task 6005 April 1, 2002
Principle Process time is controlled to ensure that the minimum time requirements of the scheduled process are met.
Assessment Criteria The manufacturer controls process time as follows:
  • The process time meets the minimum requirements of the scheduled process.
  • The operator monitors and controls process time using an official timing device, e.g., clock.
  • Process time is verified by the operator with a written log and a recording chart.
  • The timing of the process does not begin until the retort has been properly vented and the scheduled process temperature has been achieved.
  • For systems using automatic time control, the accuracy of the timer is verified by the operator at an appropriate frequency, e.g., the operator compares the timer against the official timing device.
  • The retort processing time is confirmed by the operator using the official timing device and logged prior to termination of the thermal process.
  • When more than one official timing device is used they are synchronized.
  • The time on the recorder chart agrees with the actual time of day on the official timing device.
  • Process time is controlled to ensure that the full time specified in the scheduled process is achieved, e.g., where an official timing device does not indicate seconds a one minute safety factor is added to the vent and to the process.

Process deviation controls are to be evaluated under section 5.1.13.1 (task 6301).

Rating Guide Examples
Rating I
  • Actual process time is less than the scheduled process time and no deviation control is initiated.
Rating II
  • Official timing devices not synchronized and more than one clock can be used for the same retort.
Rating III
  • The actual process time is less than the operating process requirements, but still meets the scheduled process requirements.
  • The time on the recorder varies significantly with the actual time on the official timing device.
  • Official timing devices used are not synchronized, but only one clock can be used for each retort.
Legal Authorities
  • PPR 30.1(1), Product processed to meet commercial sterility
  • PPR 30.3(f), Thermal process meets schedule process
Manufacturing Controls
Task 6006
5.1 Manufacturing Controls
5.1.10 Process Control
5.1.10.6 Process Temperature Control for Low Acid Foods
Task 6006 April 1, 2002
Principle The process temperature is controlled to meet the minimum temperature requirements of the scheduled process.
Assessment Criteria The manufacturer controls process temperature as follows:
  • The minimum temperature requirements for the scheduled process are met.
  • The operator monitors the indicating thermometer temperature at the start of the process and at least once during the process to verify that the minimum temperature is achieved and maintained.
  • The operator compares the indicating thermometer temperature with the recorder temperature at least once during the process after temperature equilibrium has been achieved.
  • The recording thermometer does not vary by more than 0.5° C (1° F) from the indicating thermometer and at no time reads higher than the indicating thermometer.
  • The operator ensures that the recording chart produces a continuous record of the temperature. In the absence of the continuous record (ink skips), the operator adequately documents that the temperature was maintained.
  • The correct chart is used for the recorder, e.g., the numbers on the chart match those on the panel of the recorder specified by the instrument manufacturer.

Process deviation controls are to be evaluated under Task 5.1.13.1 (task 6301).

Rating Guide Examples
Rating I
  • The recorder reads higher than the indicating thermometer and the indicating temperature is less than the scheduled process and no deviation control is initiated.
  • Actual process temperature is less than the scheduled process temperature and no deviation control is initiated.
Rating II
  • Consistent ink skips and the manufacturer has not taken corrective action.
  • The recording thermometer varies by more than 0.5° C (1° F) from the indicating thermometer.
Rating III
  • The manufacturer uses both Fahrenheit and Celsius temperature scales.
  • Wrong chart used, but operator's log is complete.
  • The recorder reads higher than the indicating thermometer, but the indicating temperature is above the scheduled process temperature.
  • Occasional ink skips.
Legal Authorities
  • PPR 30.1(1), Product processed to meet commercial sterility
  • PPR 30.3(f), Thermal process meets schedule process
Manufacturing Controls
Task 6007
5.1 Manufacturing Controls
5.1.10 Process Control
5.1.10.7 Thermal Process Control Records - Low Acid Foods
Task 6007 April 1, 2002
Principle Written records that adequately reflect the control of the thermal process are available upon request.
Assessment Criteria The manufacturer maintains, for not less than 3 years after the date of processing, records to demonstrate the safety of the thermal process as follows:

Retort Operator's Log

The following minimum information is recorded on the retort operator's log:

  • process schedule requirements
  • product/style of pack
  • retort number
  • number of baskets in the retort
  • cook number
  • container size
  • container code
  • initial temperature
  • time steam on (vent open)
  • temperature prior to closing the vent
  • time vent closed
  • time temperature up (process starts)
  • time steam off (process ends)
  • indicating temperature near start of process
  • chart temperature near start of process
  • indicating thermometer temperature during processing
  • date

Note: Minimum information required on records may vary depending on the degree of system automation.

Recording Chart

The following minimum information is recorded on the recording chart:

  • retort number
  • date
  • product
  • container size
  • code
  • retort operator's initials

Deviations

  • Deviations are noted on the records by the operator.

Note: Qualifications are described under sub item 4.4.1.2, Technical Training.

Rating Guide Examples
Rating I
  • N/A
Rating II
  • Key information missing from the operator's log that is required to verify the process, e.g., vent time, temperature, product, size where multiple product sizes are processed in the same day.
  • No permanent record of process time or temperature.
  • Deviations not noted on the records and no process adjustment made.
Rating III
  • Records not kept for not less than 3 years after the date of processing.
  • Missing information on the recording chart.
  • Missing information on the operator's log, e.g., retort number, number of baskets, code, process schedule requirements, etc.
Legal Authorities
  • PPR 30.2(f), Records set out the low-acid food product history
Manufacturing Controls
Task 6008
5.1 Manufacturing Controls
5.1.10 Process Control
5.1.10.8 Process Time/Temperature Control for Acid and Low Aw Foods
Task 6008 April 1, 2002
Principle Process time and temperature are controlled to ensure that the minimum time/temperature requirements of the process design are met.
Assessment Criteria The manufacturer controls process time/temperature as follows:
  • The process time meets the minimum requirements of the process design.
  • The minimum temperature requirements of the process design are met.
    • The retort vent schedule should be met.
    • Heating tunnels i.e. water or steam, are heated prior to commencement of production.
    • Hot filled cans are inverted for the time prescribed in the process design to sterilize lids.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Actual process time is less than the process design time.
  • Actual process temperature is less than the process design temperature.
  • Hot filled cans are not inverted.
Rating III
  • The actual process time is less than the operating process requirements, but still meets the process design requirements.
  • The actual process temperature is less than the operating process requirements, but still meets the process design requirements.
Legal Authorities
  • PPR 16(12), Not exposed to a source of contamination
Manufacturing Controls
Task 6009
5.1 Manufacturing Controls
5.1.10 Process Control
5.1.10.9 Control of Pasteurization - Fresh Pack/Fermented
Task 6009 April 1, 2002
Principle Pasteurization is controlled to prevent the spoilage of fresh pack or fermented product as described in the process design.
Assessment Criteria The manufacturer ensures all important processing factors are addressed, and they are controlled within acceptable limits.
  • Pasteurization
    • Pasteurizer should be in good operating condition, food should be properly packed, sealed and at the correct temperature when entering the pasteurizer. The correct temperatures are achieved during the pasteurization process.
      • incoming steam line (pressure gauge functional, valves)
      • conveying belt speed
      • pasteurizer temperature in sections
      • jars evenly distributed across full width of pasteurizer
      • temperature of product at cold spot (center of a large pickle located just below the center of the container)
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Pasteurization parameters have not been fully followed but Equilibrium pH is satisfactory.
Rating III
  • An important factor not fully controlled which may result in a spoilage problem.
Legal Authorities
  • PPR 30.3(f), No low-acid food product packed in a hermetically sealed container must be thermally processed in a registered establishment unless the thermal process meets or exceeds the requirements of the scheduled process
  • F&DR B.27.002, Commercial sterility
  • FDR B.27.003, No person must sell a low-acid food packaged in a hermetically sealed container where the container is swollen, is not properly sealed, or has any defect that may adversely affect its hermetic seal
Manufacturing Controls
Task 6010
5.1 Contrôle de la fabrication
5.1.10 Process Control
5.1.10.10 Process Control Records - Acid, Acidified Low Acid or Low Aw Foods
Task 6010 April 1, 2002
Principle

Written records that adequately reflect the control of the acid or acidified low acid thermal process should be available upon request.

Assessment Criteria For acidified low acid product, the manufacturer shall have records available to demonstrate that the process was complete.

For acid product, the manufacturer should have records available to demonstrate that the process was complete.

Operator's Records

The following information should be recorded on the operator's records:

  • product/style of pack
  • process design requirements
  • container size
  • container code
  • initial temperature
  • chart temperature near start of process (when a chart is used)
  • process temperature e.g., retort, pasteurizer
  • indicating thermometer temperature during process
  • belt/reel speed (related to time of processing)
  • date of processing
  • time of processing (batch process)
  • fill temperature (hot filled product)
  • operator's initials

Note: Minimum information required on records may vary depending on the degree of system automation.

Recording Chart

The following minimum information should be recorded on the recording chart:

  • date
  • product
  • container size
  • code
  • operator's initials

Deviations

  • Deviations are noted on the records by the operator.

Note: Qualifications are described under sub item 4.4.1.2, Technical Training.

Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • Missing information on the recording chart.
  • Missing information on the operator's log, e.g., code, process schedule requirements, etc.
Legal Authorities
  • PPR 16(12), Not exposed to a source of contamination
  • PPR 30.2(f), Records set out the low acid food product history
Manufacturing Controls
Task 6011
5.1 Manufacturing Controls
5.1.10 Process Control
5.1.10.11 Blanching and Freezing
Task 6011 April 1, 2002
Principle

Manufacturer controls blanching and freezing conditions to meet the requirements of the process design.

Assessment Criteria The manufacturer controls are as follows:

Blanching:

  • The time and temperature is controlled to ensure enzyme deactivation and reduction of microbial load.
  • Blanched product is cooled and promptly conveyed to the freezer under sanitary conditions to prevent contamination and bacterial growth.

Freezing: (IQF)

  • Product is in a frozen state at the freezing tunnel exit. Product temperature or state is monitored as product leaves the freezing tunnel.

Prepackaged (bulk or consumer size):

  • Product temperature is quickly brought down through the range of maximum crystallization (-1 C to -5 C). Freezer temperature is monitored to ensure maximum freezing capacity. Freezing should not be considered complete until the product has reached -18 C at the thermal center.
  • Product is stacked to allow air flow and circulation.
Rating I
  • N/A
Rating II
  • Product held too long between blanching and freezing resulting in the growth of pathogens.
Rating III
  • Freezer capacity is inadequate to freeze product in specified time frames.
  • Freezing coils not defrosted frequently enough in freezing tunnel resulting in inadequately frozen material.
  • Freezer temperature not monitored.
  • Peroxidase test indicates inadequate blanching (Frozen Vegetables excluding Fried).
Legal Authorities
  • PPR, 2.1, All ingredients, food additives and processing aids are not adulterated, or contaminated and are prepared in a sanitary manner
  • PPR Schedule I and II
Manufacturing Controls
Task 6101
5.1 Manufacturing Controls
5.1.11 Post-Process Control
5.1.11.1 Cooling Controls - Low Acid Foods
Task 6101 April 1, 2002
Principle Cooling is controlled to minimize post-process contamination, thermophilic growth and container damage.
Assessment Criteria The manufacturer controls product cooling as follows:
  • The operator controls pressure in the retort to prevent excessive pressure differentials between the interior and exterior of the container that may result in paneling, buckling, seam distortion and bursting.
  • Where thermophilic bacterial growth is a concern (LAF and product with pH from 4.0 to 4.6 ), containers are cooled as rapidly as possible to prevent spoilage.
  • Can/jars cooling temperature is controlled to retain enough residual heat to rapidly evaporate water for corrosion prevention (105 - 110°F).
  • Cooling rate of glass jars is controlled to prevent thermal shock.
  • Pouches are cooled to an internal temperature of 110 - 140°F.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Improper cooling and storage conditions that maintain elevated product temperature, possibly resulting in thermophilic growth.
  • Paneled or buckled containers with possible leakage.
Rating III
  • Lack of control of container cooling, thermophilic growth not a concern, e.g., minor corrosion due to over cooling.
  • Minor container damage with a low likelihood of leakage.
Legal Authorities
  • PPR 30.3(f), Thermal process meets the schedule process
  • PPR 30.3(l), Containers are handled to avoid damage
Manufacturing Controls
Task 6102
5.1 Manufacturing Controls
5.1.11 Post-Process Control
5.1.11.2 Verification of Product Safety
Task 6102 December 20, 2006
Principle The cooling water conditions are controlled to minimize the potential of post-process bacterial contamination.
Assessment Criteria The manufacturer controls cooling water as follows:

Note: Treatment with a bactericide is not required when single use potable water is used for cooling processed containers in a retort/pasteurizer.

  • Recycled cooling water is treated with a bactericide prior to use.
  • Bactericide is applied in a manner to ensure that an effective residual level is maintained throughout the cooling system (e.g., 0.5 to 2.0 ppm for free available chlorine).
  • Bactericide levels are monitored at a frequency adequate to ensure that specified limits are consistently achieved.
  • Test reagents are suitable and effective.
  • Monitoring is conducted at the location(s) in the cooling system where the bactericide level is the lowest.
  • Cooling systems are maintained to prevent buildup of organic and inorganic materials which may reduce the effectiveness of the bactericide.

For the verification of the microbiological quality of the cooling water refer to 5.1.14.1 (task 6401) - Verification of product quality and safety

Rating Guide Examples
Rating I
  • N/A
Rating II
  • Recirculated water is not treated by the manufacturer.
  • Bactericide monitoring not conducted, taken at wrong location or tested at insufficient frequency.
  • Inadequate treatment, measurable residual not consistently maintained.
  • Untreated water from other than municipal source used for cooling.
Rating III
  • Excessive buildup of organic material which could affect the residual bactericide level.
Legal Authorities
  • none
Manufacturing Controls
Task 6103
5.1 Manufacturing Controls
5.1.11 Post-Process Control
5.1.11.3 Verification of Product Safety
Task 6103 April 1, 2002
Principle Written records that adequately reflect control of the cooling water quality and bactericide treatment are available upon request.
Assessment Criteria The manufacturer has records available to demonstrate the adequacy of cooling water quality treatment as follows:

Note: Records not required where single use potable water is used.

Water Treatment Records

  • date and time of analysis
  • concentration of residual bactericide and pH
  • method of analysis
  • code
  • product
  • analyst
  • retort system/sample site.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • Missing information on water treatment records.
  • No records of water treatment.
Legal Authorities
  • PPR 30.2(f), Records set out the low-acid canned food history
Manufacturing Controls
Task 6104
5.1 Manufacturing Controls
5.1.11 Post-Process Control
5.1.11.1 Verification of Product Safety
Task 6104 April 1, 2002
Principle Container handling and drying systems are controlled to minimize damage and/or post-process bacterial contamination.
Assessment Criteria The manufacturer controls container handling and drying systems as follows:

Cans and Glass:

  • Containers are tilted to remove excess water.
  • Until the container vacuum is achieved and the compound has established proper sealing integrity.
    • containers are handled in a manner to prevent contact with unsanitary surfaces, e.g., employee contact, water splash from floors, sprays, aerosols, condensation and unsanitary equipment
    • containers are handled in a manner to minimize impact damage and damage caused by equipment, e.g., cable burns/cuts, abrasion, dents, seam damage
    • Containers are dried as soon as possible after processing.

Pouches are:

  • Minimally handled.
  • Excess flexing, folding, movement and vibration are avoided.
  • Handled in a manner to prevent puncturing, etc.
  • Rigid packaging may be used to minimize container damage. If final protective packaging is done outside primary processing plant extreme care should taken to transport pouches to their packaging location.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Cable cut where the outer layer of metal is torn or cut resulting in a high risk of leakage (LAF).
  • Hot, distended containers in contact with unsanitary surfaces (LAF).
  • Deficiencies in control resulting in serious container handling defects (LAF).
Rating III
  • Wet containers with partial vacuum in contact with can handling equipment.
  • Dirty recycled cardboard used to separate slightly wet cans.
  • Deficiencies in control resulting in minor container handling defects.
Legal Authorities
  • PPR 30.3(1), Containers are handled to avoid damage
  • PPR 16.(12), Product cannot be exposed to a source of contamination
Manufacturing Controls
Task 6105
5.1 Manufacturing Controls
5.1.11 Post-Process Control
5.1.11.1 Verification of Product Safety
Task 6105 December 20, 2006
Principle The manufacturer has a system in place to monitor the integrity of processed containers.Critères d'évaluation
Assessment Criteria Note: Qualifications are described under Section 4.4.1.2, Technical Training.

The manufacturer monitors container integrity through at least one of the following options or equivalent:

Option 1 - Low Vacuum Detection Equipment (immediately or after 10 days)

Note: Option 1 pertains only to the operation of equipment including monitoring and verification testing. Functioning of low vacuum detection equipment is assessed at Section 4.3.4.2.

  • The manufacturer routinely monitors container integrity by passing product through low vacuum detection equipment.
  • Qualified personnel monitor the type and number of ejects.

Option 2 - Visual Inspection Program

  • Containers from each lot are examined by qualified personnel, using the Visual Inspection Protocol.
  • Qualified personnel monitor the type and number of defects.

Option 3 - Incubation Program

  • A representative sample of containers from each lot is incubated and examined by qualified personnel.
  • Qualified personnel monitor the type and number of defects.
  • Time/temperature conditions selected by the manufacturer are adequate to detect leakage and subsequent microbial growth.

When deficiencies in monitoring can integrity are identified in this sub item, the follow-up is assessed in Section 5.1.13.1, Deviation Control.

Rating Guide Examples
Rating I
  • N/A
Rating II
  • Ineffective or no monitoring of low vacuum detection equipment, e.g., no testing with defective containers to verify equipment is operating, swell or leaking cans in evidence.
  • Ejects are not evaluated.
Rating III
  • Effective low vacuum removal but inconsistent monitoring of ejects in regular production.
Legal Authorities
  • PPR 2.4, Food product container is not defective
  • PPR 30.2(f)(vi), Records of incubation results
Manufacturing Controls
Task 6106
5.1 Manufacturing Controls
5.1.11 Post-Process Control
5.1.11.5 Post-Process Container Integrity Verification - Low Acid Foods
Task 6106 April 1, 2002
Principle Container and bulk product handling are controlled to minimize damage and/or post-process biological, chemical or physical contamination.
Assessment Criteria Containers and bulk product are handled in a manner to minimize damage either physical or affecting quality.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • N/A
Rating III
  • Handling product such that containers are damaged e.g., forklift damage, sharp edges on equipment.
  • Delay between packaging and movement to freezer storage.
Legal Authorities
  • PPR, 16(3), Strict sanitary control
  • PPR, 16(12), Product cannot be exposed to a source of contamination
  • PPR, 2.1, All ingredients, food additives and processing aids are not adulterated, or contaminated and are prepared in a sanitary manner
Manufacturing Controls
Task 6107
5.1 Manufacturing Controls
5.1.11 Post-Process Control
5.1.11.7 Post-Process Critical Factors Verification Fresh Pack/Fermented
Task 6107 December 20, 2006
Principle Controls are in place to ensure the equilibrium pH is satisfactory.
Assessment Criteria The manufacturer ensures that all critical processing factors are addressed, and are controlled within acceptable limits, e.g.:

Equilibrium pH

  • Equilibrium pH shall be 4.6 or below. The pH shall be tested after the product has reached equilibrium, which is generally achieved within 24 hours after heat treatment.
  • The equilibrium pH can also be measured by blending the product and brine after processing to a uniform consistency and taking the pH of the puree.

Filled container (Fresh Pack)

  • Solid/liquid ratio is verified.
Rating Guide Examples
Rating I
  • pH of the product is greater than 4.6, the product is not heat processed at sterilization temperatures and the product will be marketed without refrigeration or preservative system.
Rating II
  • Equilibrium pH (critical factor) has not been checked prior to the shipping of the product.
  • Equilibrium pH of product close to but lower than 4.6 is not verified at a sufficient frequency to ensure product safety.
Rating III
  • N/A
Legal Authorities
  • PPR 2.1, All ingredients, food additives and processing aids are not adulterated, or contaminated and are prepared in a sanitary manner
  • PPR 2.4, Food product container is not defective
  • 30.3(b), Containers filled in compliance with scheduled process
  • 30.3(f), Thermal process meets or exceeds scheduled process
Manufacturing Controls
Task 6108
5.1 Manufacturing Controls
5.1.11 Post-Process Control
5.1.11.8 Post-Process Container Integrity and Vacuum - Glass/Pouches
Task 6108 April 1, 2002
Principle Controls are in place to ensure the hermetic seal and vacuum are maintained after cooling.
Assessment Criteria Container Closure Examination

Jars:

  • The manufacturer verifies closure after cooling by physical measurements (closure application measurements are also taken at capper: see sections 5.1.7.3 (task 5703) and 5.1.7.5(task 5705).
  • Visual exam
    • On a minimum of 6 random jars or as specified by the jar manufacturer, at intervals not exceeding 30 minutes.
  • Destructive exam
    • Different types of inspections are available for the closure control of jars, their applicability depends on the type of closure and the type of capper. Theses measurement should be taken by authorized personnel every 4 hours after cooling. The usual controls are:
    • Vacuum
      • Jars shall have measurable vacuum.
    • Security Value
      • Removal Torque (optional)
      • Measured with a Torque-meter.
    • Gasket
      • After processing and cooling, the gasket should have a uniform 360° impression in it resulting from contact with the glass finish.

Pouches:

  • Final Package after retorting Air Burst 13 random samples 6 burst randomly (6 bottom and side, 7 for top seal).
  • Tear downs are conducted after twenty-four hours or more storage period:
  • REF: Chapter 4, p.20 of the Flexible Retort Pouch Defects, Identification and Classification Manual, (1998 Draft)
    • Seal strength and width are evaluated on 4 pouches per retort load.
    • Residual Gas Test is conducted on one pouch per retort load.
  • The manufacturer must also visually examine all the samples for defaults
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Less than 6 bottles or 4 pouches per retort load are examined.
  • Time intervals significantly exceed 30 minutes on a consistent basis, e.g., two, three or four hour intervals.
  • Absence of visual examinations (jars).
Rating III
  • No control of hermeticity for fermented or non-fermented pickles.
Legal Authorities
  • PPR 2.1, All ingredients, food additives and processing aids are not adulterated, or contaminated and are prepared in a sanitary manner
  • PPR 2.4, Food product container is not defective
  • PPR - 30.3(b), Containers filled in compliance with scheduled process
Manufacturing Controls
Task 6109
5.1 Manufacturing Controls
5.1.11 Post-Process Control
5.1.11.9 Post-Process Critical Factors Records - Fresh Pack/Fermented
Task 6109 April 1, 2002
Principle Written records that adequately reflect the control of critical processing factors are available upon request.
Assessment Criteria The manufacturer has records that demonstrate control of the critical processing factors and product composition.
  • Equilibrium pH records for each lot of production (product, date and container size).
  • Solid/liquid ratio records (Fresh Pack).
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Incomplete records related to the Equilibrium pH (critical factor).
Rating III
  • N/A
Legal Authorities
  • PPR 30.2(f), Records that set out the low acid food product history
Manufacturing Controls
Task 6110
5.1 Manufacturing Controls
5.1.11 Post-Process Control
5.1.11.10 Post-Process Container Integrity Records - Glass and Pouches
Task 6110 April 1, 2002
Principle Written records of all post-process visual and destructive container integrity examinations are maintained and available upon request.
Assessment Criteria The manufacturer has records to demonstrate adequate control of the container closure operation. The minimum container closure records are as follows:

Visual Examination Records:

  • code lot
  • date and time of evaluation
  • examination results of complete inspection for visual defects
  • corrective actions taken

Destructive Examination Records:

  • code lot
  • date and time of closure evaluation
  • container closure specifications
  • closure measurements
  • corrective actions taken
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Deficiencies which do not permit verification of the adequacy of container integrity examinations, e.g., no record of pouch seal width or strength, cap removal (glass jars), etc., (LAF).
  • Absence of records, e.g., destructive examination (LAF).
Rating III
  • Record deficiencies which do not affect verification of the adequacy of container integrity examinations, e.g., minor variations in the frequency.
Legal Authorities
  • PPR 30.2(f), Records set out the low acid food product history (LAF)
Manufacturing Controls
Task 6201
5.1 Manufacturing Controls
5.1.12 Labelling Control
5.1.12.1 Control of Labels/Labelling
Task 6201 April 1, 2002
Principle The manufacturer has controls in place to prevent mislabelling. Case labelling is controlled.
Assessment Criteria The manufacturer has controls in place to prevent the mislabelling of products especially where allergens and/or sensitive ingredients are used.

Typical controls may include:

  • Effective separation of product types during changeovers, e.g., use of marked cans or visual inspection to ensure lines are empty.
  • At the labeller different product labels are effectively separated and the number of product label types is kept to a minimum.
  • Use of identifying marks and/or colors on labels to ensure correct labels are being loaded into the labeller.
  • Tops and bottoms of label bundles are visually checked for mixed labels prior to use.
  • Prevention of mixing of individual or bundles of labels during storage, e.g., storage in separate boxes, no loose labels, and ensuring that unused labels are returned to the correct boxes.
  • Controls are in place to ensure the product being supplied or added to the labelling operation correspond to the labels in use, e.g., product codes are checked before each basket, bright pallet or rework is added to line.
  • Where used, case codes are legible and represent the container code of the product within them.
  • Registration number of the manufacturer is on the shipping container.
Rating Guide Examples
Rating I
  • Use of incorrect labels or inadequate control of label application and use of allergens with a known history of producing anaphylactic reaction in sensitive individuals (see Appendix IX).
Rating II
  • Incorrect labels or inadequate control of label application and the sensitive ingredients (e.g., lactose, MSG) are used in the plant.
Rating III
  • Incorrect labels or inadequate control of label application but no listed allergens used in the plant.
  • Allergen is listed but label has other regulatory violations.
Legal Authorities
  • PPR 2.1(1), Adulterated and contaminated
  • PPR, 2.1(1)(f), Requirements of Food and Drug Regulations
  • PPR 31(ee), List of ingredients and components
  • PPR - 44(1), (6) 46(e) 47 (1) (2)
  • PPR, 42, Common name, grade name and net quantity on main panel
  • F&DR B.01.008(3), Ingredients in descending order
Manufacturing Controls
Task 6301
5.1 Manufacturing Controls
5.1.13 Deviations and Corrective Action
5.1.13.1 Deviation Control - Critical Factors and Food Safety (Low Acid and Acidified Low Acid Foods)
Task 6301 April 1, 2002
Principle Procedures are in place to identify, isolate and evaluate products when critical limits are not achieved, and when other defects occur which could affect product safety.
Assessment Criteria The manufacturer controls deviations as follows:

Identification of Deviation

  • The manufacturer has a system in place to identify deviations when they occur, e.g., when critical limits are not achieved or when other factors affecting product safety are not adequately controlled.

Isolation of Affected Product

  • The manufacturer has effective procedures in place to isolate, clearly mark and control all product manufactured during the deviation period.
  • All unsatisfactory product is isolated back to the point where the process was last in control, this could be beyond the last satisfactory record.
  • Isolated product is clearly marked, e.g., tags firmly attached with the following information; hold number, product, the amount, date held, the reason for the hold, the name of the person holding the product.
  • The manufacturer maintains control of the product from the hold date to the date of final disposition.

Evaluation of Affected Product

  • Product evaluation is conducted by a qualified person, e.g., thermal process deviations are evaluated by a competent process authority, manual sorting of suspect lots for leakage are conducted by adequately trained personnel.
  • Evaluation is adequate to detect potential health hazards, i.e., sampling is adequate to identify the extent of the problem, the tests are appropriate, the judgement is based on sound science and the product is not released until the evaluation has determined that no potential health hazard exists. For example, use of dud detection equipment to sort suspect lots.
Rating Guide Examples
Rating I
  • Affected product with a known health risk is not isolated back to the point of last control.
Rating II
  • Affected product, where safety is in question is not separated or identified.
  • Inadequate evaluation of affected product, e.g., not evaluated by competent person, sample/inspection not sufficient to provide basis for evaluation, etc.
  • No system in place to handle deviations affecting leakage of low acid product
  • Affected product where safety is in question is not isolated.
  • No system in place to handle deviations affecting safety, e.g., thermal processing, formulation, etc.
Rating III
  • Information missing on tags affixed to isolated product.
Legal Authorities
  • PPR 2.1, All ingredients, food additives and processing aids are not adulterated, or contaminated and are prepared in a sanitary manner
  • PPR, 30.2(f), Records that set out the low-acid food product history
Manufacturing Controls
Task 6302
5.1 Manufacturing Controls
5.1.13 Deviations and Corrective Action
5.1.13.2 Corrective Action - Critical Factors and Food Safety (Low Acid and Acidified Low Acid Foods)
Task 6302 April 1, 2002
Principle Corrective action taken following any deviation is effective to ensure the safety of the product and to prevent recurrence of the deviation.
Assessment Criteria The manufacturer's corrective action program includes the following:
  • Investigation is completed to determine the cause of the deviation.
  • Effective measures are taken to prevent recurrence of the deviation.
  • The manufacturer verifies the effectiveness of the corrective action taken.
Rating Guide Examples
Rating I
  • No corrective action and safety is affected, e.g., there is a risk of recurrence of the deviation and the probability exists that future defective product will not be detected.
Rating II
  • No corrective action and safety may be affected, e.g., there is a risk of recurrence of the deviation but detection and removal of defective product is probable.
Rating III
  • No corrective action taken, e.g., deviation from ingredient specifications not affecting safety.
Legal Authorities
  • PPR 2.1, All ingredients, food additives and processing aids are not adulterated, or contaminated and are prepared in a sanitary manner
  • PPR 30.2(f)(v), Corrective action taken for low acid canned foods
Manufacturing Controls
Task 6303
5.1 Manufacturing Controls
5.1.13 Deviations and Corrective Action
5.1.13.3 Deviations and Corrective Action Records - Critical Factors and Food Safety (Low Acid and Acidified Low Acid Foods)
Task 6303 April 1, 2002
Principle Records are available to demonstrate the control of deviations and the effectiveness of corrective actions taken.
Assessment Criteria The following minimum information is recorded in the deviation and corrective action records:

Deviation/Hold

  • product/code
  • date produced/held/released
  • reason for the hold
  • amount of product held, e.g., back to the point where the process was last in control
  • amount of product sorted
  • results of evaluation/sort, e.g., amount analyzed, analysis report of the number and nature of defects
  • signature of personnel responsible for hold and evaluation
  • disposition of held product, e.g., destroyed, employee sales, distress or salvage, reconditioning, retail sales
  • signed authorization for disposition

Corrective Action

  • cause of deviation identified
  • corrective action taken to correct deficiency
  • follow-up/assessment of effectiveness of corrective action
  • date
  • signature of person responsible
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Records are absent or deficient such that effectiveness of the deviation and corrective action cannot be verified, e.g., deviation identified but no record of control or disposition of affected product.
Rating III
  • Records not complete, e.g., no signed authorization, however; it is still possible to verify the effectiveness of the deviation/corrective action.
Legal Authorities
  • PPR 30.2(f), Records that set out the low-acid food product history
Manufacturing Controls
Task 6401
5.1 Manufacturing Controls
5.1.14 Verification of Product Safety and Quality
5.1.14.1 Verification of Product Safety
Task 6401 December 2, 2011
Principle The manufacturer should use supplementary methods of evaluation to verify the effectiveness of controls affecting product safety.
Assessment Criteria The manufacturer should verify the effectiveness of controls affecting product safety.

Note: Where appropriate, verification applies to all sections of the standard.

Examples of Verification Methods:

  • Sampling and analysis of in-process and finished product for the appropriate chemical (e.g. Arsenic in Fruit Juices), microbiological (e.g. Listeria) or physical hazards (BCP).
  • Sampling and analysis to verify that specific manufacturing controls are effective, e.g., microbiological checks of treated cooling water, microbiological checks of surfaces coming into contact with hot, wet cans.
  • Independent, external audits.
  • Internal audits.
  • Incubation testing to confirm commercial sterility/hermetic seal.
  • Screening, dud detection, verify weighing.
  • Analysis of consumer complaint trends.
  • Vendor audits.

Frequency of Verification:

  • The manufacturer should conduct verification at a sufficient frequency to validate the effectiveness of the manufacturing controls.

Responsibility for Verification:

  • Individuals or organizations responsible for verification are identified. These individuals or organizations are suitably qualified.
Rating Guide Examples
Rating I
  • N/A
Rating II
  • Records are absent or deficient such that effectiveness of the deviation and corrective action cannot be verified, e.g., deviation identified but no record of control or disposition of affected product.
Rating III
  • Records not complete, e.g., no signed authorization, however; it is still possible to verify the effectiveness of the deviation/corrective action.
Legal Authorities
  • none
Date modified: