General Principles of Food Hygiene, Composition and Labelling
1 - Control of Operation

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1.1 Product Formulation and Composition

1.1.1 Availability and Accuracy of the Product Formula

A current written formula is available for each product processed.

Rationale

A current written formula provides a basis for assessment of food additives, composition, labelling, nutritional requirements, food allergens and the scheduled process.

Assessment Criteria

  • A written formula is available for each product.
  • The formula contains all details of the formulation as follows:
    • identification of all ingredients (e.g. brand/supplier, concentration, type, common name, specific name of food colours) and components (ingredients of ingredients);
    • amounts of all ingredients, including food additives and added nutrients.
  • Products are formulated to comply with food standards, when they exist.
  • Products are formulated to ensure accurate nutrition declarations.
  • The formula is current for the products being processed.

1.1.2 Identification of Critical Processing Factors in Product Formulation

Any factors in the product formulation that are critical to a safe process and to the delivery of a product with a uniform composition are identified.

Rationale

Inadequate identification of either critical ingredients and their specifications, or critical preparation/process steps, could result in an inadequate process, which could affect product safety or lead to inaccurate nutrient composition.

Assessment Criteria

  • Ingredients critical to the product's composition and its nutritional profile, and to the safety of the process, are identified with their specifications and limits.
  • Ingredients susceptible to property changes and nutrient losses are identified.
  • Control factors that are critical to the safety and integrity of the product are identified (this includes microbiological, chemical or physical concerns, as well as concerns related to allergens, extraneous material, etc.).  Their specifications and limits are identified (e.g. thermal process, pH and water activity for ready-to-eat fermented meats, salt content for brined mushrooms, sulphur content on dried fruit, etc.).

1.1.3 Compositional Requirements

The nutrient content of the food is controlled to meet declared label values and applicable requirements found in the Food and Drugs Act and the Food and Drug Regulations.

The addition of vitamins, mineral nutrients and amino acids to food products is controlled to meet the requirements of the Food and Drugs Act and the Food and Drug Regulations.

Foods for which nutrient content claims and health claims are made meet the compositional requirements of the Food and Drug Regulations [Division 24, B.01.503, B.01.601].

Products comply with food standards when they exist.

Rationale

Formulation controls are necessary to prevent hazards that could result from excesses, inadequacies and omissions of nutrients. Examples include fortified foods and foods for which there are nutrition and/or health claims (e.g. calorie-reduced, low sodium).

Inaccurate nutrition information, nutrient content claims or health claims may pose a health risk to those under dietary management for chronic diseases (such as diabetes, heart disease, high blood pressure, cancer and osteoporosis) or for those who are making food choices based on the nutrient content of the food.

Inadequate control of food composition could also result in product misrepresentation and fraud. Consumers expect that the declared ingredients, compositional standards, nutrition information and claims accurately reflect the food's composition.

Assessment Criteria

  • The manufacturer has control over the formulation to ensure that all nutrient content declarations and regulatory requirements, including compositional requirements, are met.

Added nutrients

  • Vitamins and mineral nutrients are added to foods in accordance with the Food and Drug Regulations (e.g. nutrients are permitted in the specific foods and added at the appropriate levels).
  • The manufacturer has specifications for nutrients.
  • The manufacturer receives the following documentation:
    • nutrition information for each shipment of nutrient premix [B.01.404]; and
    • a Certificate of Analysis for 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 through testing and can demonstrate through calculations that nutrients are used within the limits specified in the Food and Drug Regulations.

Nutritional composition requirements

  • Foods for which there are nutritional composition requirements (e.g. meal replacements, nutritional supplements, flour) meet these requirements.
  • Final products meet the composition requirements for any nutrient content claim or health claim made on the label or in any advertisements.
  • The nutrient content of the product is accurately reflected on the label and in compliance with the Food and Drug Regulations (i.e. the list of ingredients and the Nutrition Facts table).
  • Label values have a high probability of being accurate and are rounded in compliance with the Food and Drug Regulations [Column 4 of the tables to section B.01.401 and B.01.402].
  • Individual lots have a high probability of meeting the CFIA's Nutrition Labelling Compliance Test throughout the period the label is in use.
  • The manufacturer verifies, as often as necessary, that the Nutrition Facts table is accurate and within tolerance.

Food standards

  • Product formulations are designed to ensure that standardized food products meet the regulated standards of identity and composition.
  • Controls are in place to ensure that the health, safety and fraud provisions of standards are consistently met.

NOTE: The following documents provide further guidance on composition and labelling. They are available on the CFIA website.

  1. The Evaluation Standard for Nutrition Labelling addresses, in detail, the requirements of the Nutrition Facts table and the factors involved in determining nutrient content and producing a product with a consistent nutrient profile. This document may be found within the Nutrition Labelling Toolkit.
  2. The Guide to Food Labelling and Advertising provides detailed guidance on the requirements for nutrient content and diet-related health claims.
  3. The Nutrition Labelling Compliance Test constitutes the CFIA methodology for assessing the accuracy of nutrition labelling and claims

1.1.4 Food Additives

Food additives are controlled to meet the requirements of the Food and Drugs Act and the Food and Drug Regulations.

Rationale

Inadequate control of food additives could result in chemical or biological hazards.

Assessment Criteria

  • The manufacturer ensures that all food additives that are used are permitted for use in the particular food and meet the requirements of the Food and Drug Regulations [Division 16] and other applicable regulations.
  • The manufacturer has specifications for all food additives.
  • Where there are no specifications in the Food and Drugs Act and the Food and Drug Regulations, the manufacturer requires that all food additives meet the United States Pharmacopeia Food Chemical Codex (FCC) specifications or equivalent (e.g. specification sheets or Letters of Guarantee).
  • 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.

1.2 Labelling and Net Quantity

1.2.1 Labelling

The manufacturer has controls in place to ensure that the labels are complete and accurate, and meet the requirements of the Food and Drugs Act, the Food and Drug Regulations and the Consumer Packaging and Labelling Act and Regulations.

Rationale

Mandatory information on food labels allows consumers to make informed choices by:

  • providing basic product information (e.g. the product's common name, its list of ingredients, its net quantity, its durable life date (if applicable) and country of origin, as well as the name and address of the manufacturer, dealer or importer); and
  • providing health, safety and nutrition information (e.g. instructions for safe storage and handling, nutrition information in the Nutrition Facts table and specific information on products for special dietary use).

Inaccurate labels may be considered false and misleading and in violation of section 5.1 of the Food and Drugs Act.

NOTE: Mandatory information is determined, in part, by the regulatory requirements specific to the commodity in question.

Assessment Criteria

  • The manufacturer has procedures in place to ensure that all mandatory information is properly declared on food labels in accordance with Canadian food labelling legislation, and that all label claims are accurate and not misleading. The following are examples of such procedures.
    • Personnel responsible for the label development, design and sign off, whether company employees or consultants, have a good understanding of Canadian food legislation and labelling requirements and are kept current with respect to regulatory changes.
    • Labels are reviewed both for compliance with Canadian legislation (e.g. presence of mandatory labelling), and for accuracy and correctness of information. This assessment includes mandatory information, quality claims (e.g. natural, fresh), compositional claims (e.g. no preservatives.), nutrition claims, method of production claims (e.g. organic, grain fed) and standards of identity.
    • New labels and changes to current labels (e.g. changes to artwork, text and layout) are reviewed for compliance with Canadian legislation.
    • Incoming labels from labelling and/or printing companies are reviewed against signed-off proofs.
    • Corrective labels applied to products to bring them into compliance are reviewed against signed-off proofs.
    • Changes in packaging are assessed for their impact on product labelling (e.g. changes in the size of the principal display surface, the available display surface or the location of the principal display panel).
    • All pamphlets, posters, handouts and other Canadian advertising materials developed and/or distributed by the manufacturer are reviewed and verified for accuracy and compliance with Canadian legislation (see Chapter 3 of the Guide to Food Labelling and Advertising).
    • Foods containing ingredients that are on Canada's list of priority allergens are labelled so that consumers are aware of their presence.

NOTE: The CFIA website provides extensive information and guidance to the food industry regarding food allergens, including additional information on each of Canada's priority allergens, guidance on the Labelling of Foods Causing Allergies and Sensitivities and A Tool for Managing Allergen Risk in Food Products.

1.2.2 Net Quantity

Controls are in place to ensure that net quantity declarations are accurate and comply with the Consumer Packaging and Labelling Act and Regulations and the Weights and Measures Act and Regulations, where applicable.

Rationale

Companies that do not declare accurate net quantities for their products have an unfair competitive advantage within their market sector and do not contribute to the fair and effective operation of the marketplace.

The net quantity declaration provides important information that consumers use in making their purchasing decisions. Since the declaration helps consumers to know how much food is in a container, it enables them to compare prices. Consumers rely on net quantity declarations, trusting manufacturers to provide the quantity declared on a product's label.

Canada has adopted an international measurement standard, the Average System of Net Quantity Determination, as its method of determining the accuracy of net quantity declarations. The Average System is set out in section 39 of the Consumer Packaging and Labelling Regulations and section 52 of the Weights and Measures Regulations.

Assessment Criteria

  • The manufacturer has controls in place to ensure that the product's net quantity, as stated on the label, is in compliance with section 39 of the Consumer Packaging and Labelling Regulations and section 52 of the Weights and Measures Regulations.
  • Production procedures that directly affect net quantity are identified and described. Measures are in place to ensure that these procedures are performed in controlled conditions in order to minimize the possibility of net quantity errors. Examples of the process control elements to be considered include:
    • sequence of operations;
    • equipment type;
    • work environment;
    • procedure control points and monitoring methods used at these control points;
    • name(s) of person(s) in charge of operations;
    • documentation;
    • data recording methods;
    • acceptance numbers; and
    • description of corrective action to be taken in cases of nonconformity.
  • Inspection and testing during production permits the identification of causes of nonconformity before the final control stage and increases the overall effectiveness of the process by preventing the continued production of non-compliant products.
  • Working procedures and instructions critical to compliance with the requirements set out in the Consumer Packaging and Labelling Regulations and the Weights and Measures Regulations, known as the Average System of Net Quantity Determination, are documented. These working procedures and instructions have been approved by the designated person in charge. Examples of information to be considered include:
    • equipment used;
    • equipment checks to be performed;
    • number of weighings;
    • frequency of weighings;
    • place of sampling;
    • acceptance numbers (tolerance, average);
    • name(s) of person(s) in charge;
    • description of corrective action to be taken in cases of non-compliance;
    • data recording methods;
    • density of checked product (for products declared by volume);
    • environmental conditions (e.g. hot filled products, product temperature requirements of certified volumetric standards); and
    • availability of Certificates of Analysis.

NOTE: Control of scales, gravimetric and volumetric standards, and other measuring equipment is covered in Section 2.1 - General Equipment.

1.3 Process Design

1.3.1 Process Design

The manufacturer demonstrates that foods do not develop any safety hazards (biological, physical or chemical) and labelling inaccuracies are prevented.

Rationale

Written verification is necessary to demonstrate that each process adequately ensures uniform composition and a safe product. An inadequate process could result in unsatisfactory incorporation of ingredients and nutrients, or in the lack of control of pathogenic organisms, toxins and other hazards.

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. Details of actual experimental methods are available.
  • All critical control points (CCPs) for each product, including the critical limits for each CCP, are identified, tested and evaluated in the development of the process. Note that the degree of testing and evaluation required is relative to the risk of the operation.
  • 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.

See Section 7.2.1 - Process Design Records, for further information.

1.4 Incoming Material Control

1.4.1 Ingredients

The manufacturer controls incoming ingredients so that foods are not exposed to safety hazards (biological, physical and chemical) and remain both safe and correctly labelled.

Rationale

Prevention of health hazards and fraud begins with control of incoming materials. Inadequate incoming product controls, such as a lack of appropriate product testing and sorting or a failure to verify labels, could result in the sale of contaminated product, misrepresented product or product that does not meet grade, composition or quality standards.

NOTE: The degree of control exercised is appropriate to the level of risk posed by the ingredient to the safety or compositional integrity of the food.

Assessment Criteria

  • The manufacturer has written specifications and ensures that all components of the ingredients are declared.
  • Purchasing specifications include a provision for compliance with the Food and Drugs Act and the Food and Drug Regulations.
  • Nutrition information accompanies each shipment of incoming ingredients.

NOTE: 

  1. The nutrition information may be conveyed on a hard copy document which accompanies the delivery of the food.
  2. In the case of foods that are shipped to a purchaser on a continual basis with no change to the formulation, documentation may be provided to the purchaser with the first shipment. The purchaser is advised of any change to the nutrition information as a result of formulation changes or other influences.

Control of Incoming Products: Options 1 - 4

The manufacturer controls incoming ingredients through one of the four control processes outlined below. The first three options apply to ingredients that may be critical to safety (further processing is not likely to eliminate a hazard.)  The fourth option applies only to ingredients that do not pose a safety risk.

NOTE: Section 1.1.3 and Section 1.1.4 provide guidance for assessing specifications for food additives and nutrients.

Option 1:  Periodic Evaluation of Incoming Products

  • The manufacturer obtains a Certificate of Analysis for each lot.
  • A representative sample is taken at a scheduled frequency (e.g. monthly) and analyzed to verify the accuracy of the Certificate of Analysis.
  • The manufacturer maintains a documented history of adherence to specifications for each supplier, such as analytical results.
  • A new history of adherence to specifications is established when a manufacturer changes suppliers, purchases ingredients from a new supplier or purchases a new ingredient from an existing supplier.

Option 2:  100% Lots Inspected

  • Each incoming lot is sampled according to a pre-determined sampling plan and analyzed for adherence to specifications.

Option 3:  Vendor Certification

  • When the manufacturer relies on vendor certification, the manufacturer has documentation to demonstrate adequate knowledge of the supplier'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 supplier's process to consistently manufacture within specifications. This may include process capability studies. Statistical process control charts for each critical control point are available upon request from each supplier.
  • Prior to implementing a periodic monitoring program, the manufacturer analyzes an appropriate number of consecutive lots to establish an historical database 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 (to be utilized only when food safety risks are unlikely)

  • Where incoming ingredients are not likely to impact the safety of the food, the manufacturer conducts periodic monitoring to verify adherence to specifications (e.g. annually) or obtains a Certificate of Analysis.

Non-Conforming Ingredients

  • When ingredients fail to meet specifications, the manufacturer investigates and identifies the root cause. If the ingredients do not meet specifications but have not been used, it is not considered a deviation. However, if it is possible that ingredients not meeting specifications have been used, the manufacturer initiates corrective action (see Section 1.10 - Deviations and Corrective Action).

1.4.2 Incoming Packaging Material Control

The manufacturer controls incoming packaging materials to meet the requirements of the Food and Drugs Act and the Food and Drug Regulations and to prevent the introduction of biological, physical or chemical hazards.

Rationale

Controls are necessary to ensure that packaging materials meet the manufacturer's specifications. Inadequate controls could result in the use of containers that may contaminate the product or may permit physical, chemical or biological contamination of the product.

Assessment Criteria

  • The manufacturer demonstrates that the packaging material is appropriate for the intended use and is used in accordance with the packaging manufacturer`s instructions. The appropriateness of packaging material will vary with the product and process and the associated contamination risks.
  • The manufacturer has written specifications for packaging materials, including physical dimensions, material specifications and performance specifications.

NOTE: Additional requirements for evaluation of incoming packaging materials will depend on the type of product, the process and the sensitivity of the product.
           
Control of Incoming Packaging Material

See Options 1 - 4 of Section 1.4.1 - Control of Incoming Products.  

See Section 7.2.2 - Incoming Material Control Records.

1.5 Packaging Material Control

1.5.1 Packaging Material

Handling and use of packaging material is controlled to prevent product contamination.

Rationale

Inadequate control of packaging may result in the use of damaged, defective or contaminated packaging material, which may lead to contamination of the product.

Assessment Criteria

  • The manufacturer has an effective system in place to prevent the use of contaminated, damaged or defective packaging material. This can be accomplished using a variety of controls to minimize damage, to prevent contamination and to ensure cleanliness. Examples are listed below.
  • The manufacturer has controls in place to minimize damage and verifies the effectiveness of these controls through periodic audits. Controls might include:
    • receiving controls (e.g. driver handling, unloading, identification of damage problems and corrective action);
    • storage controls (e.g. stacking restrictions related to heights and spacing, protection from damage and contamination);
    • depalletizing and conveying controls (e.g. careful loading, removal of damaged packaging, effectiveness of damage control, synchronization of line speeds, transfer points);
    • visual examination (i.e. prior to use, packaging is examined for damage and contamination); and
    • careful handling/transfer (i.e. to minimize damage and contamination by careful handling at conveyors, transfer points, etc.)
  • The manufacturer has controls in place to prevent contamination of clean packaging (i.e. packaging is used for its intended purpose only).
  • Where appropriate, the manufacturer has in place an effective sanitation program.

1.6 Product Preparation and Blending

1.6.1 Control of Preparation, Composition and Blending

Critical factors specified in the formulation are controlled during preparation and blending to minimize physical, chemical, nutritional and biological hazards, and to ensure accuracy of composition, nutrient content, product claims and net quantity.

Rationale

Inadequate control of critical factors associated with product preparation and blending could result in inadequate processing, the formation of toxins or the presence of undeclared allergens. The product may violate permissible levels of food additives, or may fail to meet compositional standards and/or the product's nutrient content declaration may be inaccurate.

Assessment Criteria

  • The manufacturer has controls in place to prevent hazards associated with the preparation or blending of the product. Critical areas are outlined below.

Microbial control during preparation and blending

  • The manufacturer controls conditions (e.g. time, temperature, pH, water activity) during preparation, blending and holding of in-process materials to prevent undesirable microbial growth or the production of metabolic by-products of microbial growth. Critical factors which may require control include the following:
    • size control: dicing, grinding, slicing;
    • temperature treatment control: heating, blanching (textural changes), defrosting, cooling;
    • moisture control: rehydration, concentration (e.g. viscosity, brix);
    • proportion control: weighing, volumetric control (e.g. metering);
    • pH/acidity control: pH measurement, titratable acidity; and
    • control of preservatives, such as nitrite.

Allergens

  • The manufacturer has controls in place to prevent the presence of undeclared allergens. Manufacturers may require controls to prevent the following:
    • misdirection of ingredients;
    • use of rework;
    • contamination by undeclared ingredients;
    • ingredient carryover;
    • ingredient substitutions; and
    • carryover from equipment (e.g. product changeovers).

Food additives

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

Nutrient addition

  • The manufacturer has controls in place to ensure that nutrient levels comply with regulatory and label requirements. Specifically, controls ensure:
    • clear identification of nutrients;
    • proper storage and handling to maintain nutrient potency;
    • accurate measurement; and
    • adequate blending for homogeneity.

Composition

  • The manufacturer has controls in place to ensure that the composition of the product accurately reflects the formulation. Manufacturers may require controls to prevent the following:
    • misdirection of ingredients;
    • use of rework;
    • ingredient carryover;
    • ingredient substitutions; and
    • carryover from equipment (e.g. product changeovers).

See Section 7.2.3 - Product Preparation and Blending Records.

1.6.2 Cleaning and Sorting Contamination Control

Raw materials and ingredients are cleaned, sorted and/or prepared in such a manner as to prevent contamination.

Rationale

Adequate cleaning and sorting of raw materials and ingredients is necessary to prevent or remove contamination with biological, physical or chemical hazards.

Assessment Criteria

  • The manufacturer controls biological, physical and chemical hazards (where appropriate).

Biological hazards

  • The manufacturer may utilize the following:
    • inspection controls: visual, sensory, etc. (e.g. removal of decomposed product);
    • control by washing (e.g. reduction of the microbial load).

Physical hazards

  • The manufacturer may utilize the following:
    • metal contamination controls (e.g. magnets, metal detectors);
    • other extraneous matter controls (e.g. sifting, sorting/cleaning by gravity, air or water).

Chemical hazards

  • The manufacturer may control natural toxins by sorting. Examples include sorting by colour (e.g. glycoalkaloids in potatoes).

1.7 Product Coding Control

1.7.1 Product Coding

Each prepackaged food, where required, is identified with code marks or lot numbers on the label or container.

Rationale

Coding control permits products to be traced through the distribution chain and provides information on shelf life. Controls are also necessary to prevent damage that could compromise the container as the coding is being applied.

NOTE: Mandatory coding requirements vary, depending on the specific legislation that applies to the commodity. It is suggested that manufacturers consult with inspection authorities in order to confirm specific requirements applicable to products.

Assessment Criteria

  • The manufacturer ensures that, where required or applicable, prepackaged food has been permanently marked with a legible code or lot identification.
    • The coding system allows for the identification of the establishment where the food was processed, and the day, month and year in which the food was produced.
    • The exact meaning of all code marks used is available.
    • Where used, case codes are legible and represent the container code within.
    • Where applicable, the code accurately reflects the best-before date, expiration date or shelf life of the food.
    • Where applicable, the manufacturer controls the application of codes to ensure that the integrity of the container is not compromised.

1.8 Process Control

1.8.1 Processing Controls

All critical processing factors are controlled to ensure the safety and compositional integrity of the product.

Rationale

Inadequate process control of critical processing factors could result in microbial, chemical, nutritional or physical hazards.

Assessment Criteria

  • The manufacturer evaluates the process and identifies all critical factors.
  • The manufacturer ensures that all appropriate critical processing factors are addressed and that they are controlled within acceptable limits.
  • The manufacturer monitors the critical factors at a scheduled frequency. The frequency of monitoring will depend on the type of process and the associated risk.

See Section 7.2.4 - Process Control Records.

1.9 Labelling Control

1.9.1 Prevention of Mislabelling

The manufacturer has controls in place to prevent mislabelling.

Rationale

Control of labelling is important to ensure that the correct label is applied to each product. Use of incorrect labels could mislead the consumer and could pose a potential health hazard to segments of the population who may be allergic to certain foods or who are monitoring their diet to treat certain diseases in which nutrition plays a role.

Assessment Criteria

  • The manufacturer has controls in place to prevent the mislabelling of products. Typical controls are listed below.
    • Product types are effectively separated during changeovers (e.g. appropriate breaks between products, use of marked containers or visual inspection to ensure products are not mixed prior to labelling).
    • Different product labels or prelabelled packaging are effectively separated, and the number of product label types is kept to a minimum.
    • Identifying marks and/or colours are utilized on labels to ensure correct labels are being loaded into the labeller or manually put on the product.
    • Tops and bottoms of label bundles are visually checked for mixed labels prior to use.
    • During storage, care is taken to prevent mixing of individual labels or bundles of labels (e.g. labels are stored in separate boxes; no labels are loose; unused labels are returned to the correct boxes).
    • Procedures are in place to ensure the product being supplied or added to the labelling operation corresponds to the labels in use.

1.10 Deviations and Corrective Action

1.10.1 Deviation Control

When critical limits are exceeded or defects occur that could affect product safety, composition or net quantity, procedures are in place to identify, isolate and evaluate the affected product.

Rationale

Deviations from critical limits and procedures, or the occurrence of defects, may affect the safety, authenticity and quality of the product. Inadequate deviation procedures or non-adherence to procedures could result in the sale of unsafe product, misrepresented product or product of inferior quality.

Assessment Criteria

  • The manufacturer has a pre-determined and documented deviation procedure to identify deviations in either the product and/or the procedures, and isolate defective products. 

Identification of deviation

  • The manufacturer has a system in place to identify deviations when they occur.

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. firmly attached tags contain the following information: hold number, product, the amount, the date held, the reason for the hold and 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. process deviations are evaluated by qualified personnel).
  • Evaluation is adequate to detect potential health hazards, or to identify misrepresentation or product that does not meet quality or grade requirements. For example,
    • 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 the product is in compliance with appropriate legislation.
  • Disposition of affected product (e.g. sorting of suspect lots, disposal) is conducted in an appropriate manner by adequately trained personnel.

1.10.2  Corrective Action

Corrective action taken following any deviation is effective to rectify and to prevent recurrence of the deviation.

Rationale

Corrective action procedures are necessary to determine the cause of the problem and to take action to prevent recurrence. It is essential to follow-up any corrective action with monitoring and reassessment to ensure that the correction has been effective. Appropriate corrective action will address the root cause of any deviations of critical control points, thereby minimizing health risks and product misrepresentation.

Assessment Criteria

  • As part of the deviation procedure, the manufacturer documents corrective actions, including:
    • an investigation to determine the cause of the deviation;
    • effective measures taken to prevent recurrence of the deviation; and
    • verification by the manufacturer of the effectiveness of the corrective action taken.

See Section 7.2.5 - Deviations and Corrective Action Records.

1.11 Verification of Product Safety

1.11.1 Verification Procedures

The manufacturer uses supplementary methods of evaluation to verify the effectiveness of controls affecting product safety, composition, representation, quality and compliance with Canadian legislation.

Rationale

The purpose of verification is to assess the effectiveness of existing controls and to indicate areas where improvements are required.

Assessment Criteria

  • The manufacturer verifies the effectiveness of controls affecting product safety.

NOTE: The verification methods will vary with the product and process, since the methods must be appropriate to the specific hazards and risks that may be encountered.

Examples of verification methods

  • Verification methods may include the following:
    • sampling and analysis of in-process and finished product for the appropriate chemical, microbiological or physical hazards and for composition and nutrient profile;
    • sampling and analysis to verify that specific manufacturing controls are effective (e.g. microbiological checks of treated cooling water, microbiological checks of surfaces);
    • independent, external audits;
    • internal audits;
    • incubation testing to confirm commercial sterility/hermetic seal;
    • visual/mechanical/electronic screening;
    • analysis of consumer complaint trends; and
    • vendor audits.

Frequency of verification

  • The manufacturer conducts verification of the manufacturing controls at a frequency appropriate to the hazards associated with the product and process.

Responsibility for verification

  • Individuals or organizations responsible for verification are identified. These individuals or organizations are suitably qualified.

See Section 7.2.6 - Verification Records.

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