Fresh Fruit and Vegetable Establishment Inspection - Procedures for Inspectors

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Table of Contents

1.0 Introduction

This document describes the procedures involved in inspecting establishments of fresh fruits and vegetables. These procedures include tasks which are based on the International Standards Organization (ISO) standards and the Codex Alimentarius Commission's good manufacturing practices (GMP) and good handling practices (GHP). The procedures also describe the rating process used to assess industry's compliance with the task, which is based on food safety.

1.1 Objectives

The objectives of these procedures are to provide inspectors with comprehensive inspection procedures, tasks and ratings in order to promote uniform establishment inspections. It should be used to assess industry's implementation of food safety systems/programs (e.g., GMP, GHP) and their compliance with the Canadian regulatory framework.

These procedures are also intended to assist inspectors for training purposes.

1.2 Scope

The scope of establishment inspection is focused on packers and repackers of following fresh fruits and vegetables that are traded in export, import or interprovincially:

  • leafy green vegetables
  • peppers
  • berries
  • tomatoes
  • green onions
  • herbs
  • fresh-cut fruits and vegetables (including sliced mushrooms)
  • raw nuts
  • melons

Note: The scope of establishment inspections may vary from year to year, these procedures will be updated accordingly.

1.3 Frequency and Duration

The inspection frequency of an establishment should be at least once per year.

Follow-up inspections may be required to verify industry's compliance with corrective actions taken to resolve deficiencies found during the initial inspection (as per section 8.0).

Depending on the size and complexity of the establishment, the duration of the inspection will vary. Sufficient time must be given to adequately conduct the inspection.

1.4 Acts and Regulations

The regulatory authority for this activity is derived from the Canada Agricultural Products Act, Fresh Fruit and Vegetable Regulations, Organic Products Regulations, Food and Drugs Act and Food and Drug Regulations and Consumer Packaging and Labelling Act and Consumer Packaging and Labelling Regulations.

Inspection staff should review their authorities and industry's responsibilities under these Acts and Regulations prior to conducting establishment inspections.

Specially, inspectors should review the following health and safety requirements:

  • Fresh Fruit and Vegetable Regulations 3.1 (1)
  • Food and Drugs Act 4. (1), 5.(1) and 7

Canada Agricultural Products Act, paragraph 21 (1) gives authority to inspection staff to enter and inspect an establishment dealing in fresh produce and the authority to collect samples free of charge.

1.5 National FFV Establishment List

To assist inspection staff with identifying establishments which fit the scope, a National FFV Establishment List has been created. The list is divided by Area and may be further divided by Region.

The list is not exhaustive and should be managed by inspection staff in order to maintain an accurate reflection of the fresh fruit and vegetable industry in the respective Regions.

1.6 Required Qualifications and Training

In order to conduct establishment inspections, the Canadian Food Inspection Agency (CFIA) employee must be designated as an inspector under the Food and Drugs Act, the Canada Agricultural Products Act, and the Consumer Packaging and Labelling Act.

It is at the discretion of the Operations Branch as to whether and inspector is qualified to conduct establishment inspections, which may be based on the individual inspector's:

  • Experience dealing with fresh produce safety issues
  • Understanding of inspection principles
  • On the job training/experience
  • Knowledge on food safety hazards

2.0 Inspection Process

The inspection process is divided into seven (7) steps as outlined below. This document provides direction to CFIA inspectors on how to deliver each step of the inspection process.

  1. Preparation for an Inspection (section 3.0)
  2. Gather Information (section 4.0)
  3. Assign Task Rating (section 5.0)
  4. Communicate Results (section 6.0)
  5. Corrective Action Plan (section 7.0)
  6. Follow-Up Inspection (section 8.0)
  7. File Maintenance (section 9.0)

Although this document explains the procedures for planned inspections conducted as part of the CFIA FFV Establishment Inspection, the same procedures may be used when conducting unplanned inspections (i.e., inspections conducted as a result of complaints, referrals, outbreaks, etc).

3.0 Preparation for an Inspection

The importance of adequate preparation cannot be overemphasized, as it will make the inspection efficient and assist in achieving accurate inspection results.

3.1 Document Review

The inspector should familiarize themselves with the establishment file (as per section 9.0) in order to:

  • Identify the establishment's manager and key personnel by name
  • Be aware of the size and complexity of the establishment
  • Become familiar with the establishment's schedule, product(s) being prepared, the processes and the equipment in use
  • Review previous inspection information, if available
  • Review previous consumer complaints, if available (i.e. Issues Management System (IMS) files)

If applicable, outstanding deficiencies should be identified from previous inspections and examined during the inspection to verify compliance.

The inspector should also review the relevant legislation, standards and procedures, and any other relevant documentation prior to the inspection.

3.2 Determining the Regulated Party to Be Inspected

In order to determine the regulated party:

  • Select the commodity (based on the scope)
  • Identify the regulated party using the National FFV Establishment List (as per section 1.5)

In some situations, the population of regulated parties to be inspected exceeds the number of planned inspections (as defined by the National Standard Work Plan). In such situations, regulated parties representing greater risk should be prioritized for inspection. The following criteria should be used to identify which regulated party represents the greater risk:

  • History of compliance
  • Date of last inspection
  • Number/frequency of inspections previously completed

3.3 Inspection Team

Inspections may be conducted individually or in teams. The size of the inspection team is a Regional decision, which may be based on the:

  • Complexity of the process(es)
  • Size of the establishment
  • Time frame in which the inspection is to be conducted
  • Experience of the inspector(s)

Additional experts and/or specialists may be utilized when necessary.

In some cases, inspections may be conducted in conjunction with provincial inspectors or inspectors from other food programs. Inspectors should consult with their immediate Supervisor prior to conducting a joint inspection to ensure that it is within their legal authority to do so.

3.4 Notifying the Establishment

In most cases, notification should be given to the regulated party's management of an upcoming inspection to ensure that the appropriate representatives are available on the inspection date. Notification should be considered especially in cases where the establishment does not operate regularly or the inspector has a need to see a specific process.

When contacting the establishment to notify of an upcoming inspection:

  • Contact the appropriate regulated party's establishment representative/management by phone or email to arrange date and time for the inspection
  • Confirm tombstone information in the establishment profile

There may be circumstances which warrant an unannounced inspection (i.e., follow-up on a complaint or issue).

3.5 Inspection Equipment

It is recommended that each inspector carry the appropriate inspection equipment, which should include but is not limited to the following items:

Identification

  • Designation card
  • Inspection badge
  • Business cards

Attire

  • Clean lab coat or coveralls
  • Hair net and if applicable, a beard net
  • Sanitized Canadian Standards Association (CSA) approved non-slip footwear;
  • Health and safety protective equipment, if applicable (e.g., eye protection, ear protection, hard hat)
  • Clean freezer coat/insulated vest

Equipment

  • A pen without a cap
  • Bound notebook
  • Non-porous clipboard that can be easily sanitized
  • CSA approved flashlight
  • Calibrated light meter
  • Calibrated thermometer with steel shaft
  • Sampling supplies, sterile and non-sterile as required (e.g., Whirl-Packs, gloves, cooler with ice packs)
  • Disinfectants (e.g. Dettol, 70% ethyl alcohol)
  • CFIA official seal tape

Forms and References

Inspectors should discuss with their immediate Supervisor the necessary tools required to conduct the inspection.

3.6 Professionalism

The inspector is an official representative of the CFIA and must exhibit a professional image, attitude and behaviour when conducting inspection activities.

All information discussed and obtained from establishments must remain confidential. Any persons requesting information can make a formal request under the provisions of the Access to Information Act.

4.0 Conducting the Inspection

This document outlines some basic inspection procedures which should be used while conducting an establishment inspection.

4.1 Opening Meeting

Upon arrival at the establishment, the inspector(s) should conduct an opening meeting with the establishment management. The purpose of the opening meeting is to introduce the inspector (or inspection team) to the management at the establishment and to set out the expectations for the duration of the inspection. The inspector must ask for the regulated party's manager or person in charge to be present at the opening meeting.

The opening meeting should include the following:

  1. Introduce CFIA inspector(s), present identification;
  2. Explain the inspection objective, scope and plan;
  3. Determine the establishment's operation schedule and facility layout;
  4. Inform establishment representative/management that personnel may be interviewed;
  5. Confirm establishment representative(s) to accompany the CFIA inspector(s) during the inspection;
  6. Confirm any bio-security and health and safety requirements;
  7. Review any outstanding compliance issues (i.e., previous inspection results);
  8. Confirm meeting facilities, suitable area for document reviews, closing meeting, etc;
  9. Confirm to whom official communications (e.g. inspection report, corrective action requests) should be directed; and
  10. Discuss the time/date for the closing meeting (as per section 6.2).

Keep complete and accurate notes of all items discussed during the opening meeting.
The Opening Meeting Checklist for Inspection/Audit has been developed to help the inspectors facilitate the opening meeting; the use of this checklist is optional.

4.1.1 Health and Safety

The inspector must be aware of any specific health and safety requirements, as well as bio-security protocols and follow them accordingly. For more information, refer to CFIA's Occupational Health and Safety information.

4.2 Gathering Information

Information can be gathered using four basic inspection tools: examination of documentation and records, visual on-site inspection, interviews and product/environmental sampling.

The predetermined inspection tasks (as described in section 5.0), should be used to direct the establishment inspection. An inspection work sheet is available for printing from Multi Commodity Activities Program (MCAP) and can be used by inspector(s) during the inspection to record inspection notes and observations. The inspection work sheet within MCAP contains the complete list of inspection tasks as well as columns to record ratings and inspection comments. Refer to section 7.03, Inspection Worksheet of the MCAP User Manual Agri-Food Division.

4.2.1 Examination of Documentation and Records

Record keeping is not a regulatory requirement for the FFV Program. However, the use of documentation and records should be encouraged and provided by regulated parties to demonstrate their ability to control food safety hazards and compliance with the relevant regulatory requirements.

The purpose of examining documentation is to verify the validity of information gathered during visual inspections and interviews, and to verify and validate that the regulated party's processes are effective and monitored appropriately.

If available, review documents and records:

  • Assess written procedures based on the inspection task objectives
  • Review records to confirm that the written procedures in place have been implemented effectively and that the regulated party's system is under control
  • Review a representative cross-section of the records to identify any deviations
  • Determine whether internal corrective actions have dealt with deviations or if there is an underlying, systemic problems

Inspectors may obtain photocopies of documents, when the inspector believes on reasonable grounds that the documents are directly related to non-compliance with applicable legislation.

4.2.2 Visual Inspection

The purpose of the visual inspection is to gather information to determine:

  • The acceptability of the food being produced
  • If the conditions of the establishment may impact on food safety or compliance
  • If the employees are conducting their work activities in a hygienic manner and, when applicable, as per written procedures

The establishment's operation schedule and facility layout should be used to help the inspectors plan their visual inspection. Effort should be made to assess equipment prior to operation start-up, when equipment is disassembled, during cleaning and sanitizing activities and during production. Inspectors should observe establishment employee's conduct, which may include starting and finishing shifts, traffic patterns, equipment cleaning, etc.

To reduce the risk of contamination, the inspection should be conducted from the cleanest areas of the establishment to the least clean areas (e.g., start in the finished product area and work towards raw receiving and/or establishment exterior). Inspectors should try to avoid touching food contact surfaces and product unnecessarily and utilize hand washing/sanitizing facilities as frequently as possible.

When possible, inspectors should complete the visual inspection prior to conducting the record review to increase the efficiency of the inspection.

The regulated party's establishment management should be encouraged to provide a knowledgeable representative to accompany the inspector(s) throughout the inspection. This allows for questions to be asked on the spot and potentially serious issues can be addressed immediately.

4.2.3 Interview Employees

It is recommended that the majority of the questions during the inspection be directed to management or the designated representative rather than to employees or non-plant personnel (e.g. truck drivers). However, interviewing employees is a valuable tool and should be used during the inspection. Prior to directing questions to an employee, obtain permission from the establishment representative/management since the employee may need to step away from their work.

The purpose of the interview is to confirm that the employee:

  • Understands the procedures that they are to follow to produce safe and compliant food and put these into practice
  • Is aware of the importance of record keeping, where applicable
  • Has received the appropriate technical and general hygiene training

If, during the course of an inspection, the inspector encounters a deficiency that may have a serious or critical impact on food safety or consumer protection, the inspector must take immediate action to control the affected food product and inform the regulated party (refer to section 5.2.1).

4.2.4 Sample Collection

During the establishment inspection, finished product could be sampled to determine the microbiological profile in order to support the inspection findings. Use the appropriate sampling plan and associated numbers as per the Guidelines for National Microbiological Sampling Plans & Assessment Criteria - Fresh Fruit and Vegetables. If a suspected food safety concern was identified during the inspection, it is recommended to sample the produce from the process or line of concern.

If feasible, incorporate chemical residue monitoring sampling at the time of the inspection as per the Guidelines for the National Fresh Fruit and Vegetables Chemical Residue Program.

At the time of sampling, collect all pertinent product information including where the product was grown, who it was imported from, lot code identifications and other marks on packages to ensure sample traceability. Enter all relevant information into the Laboratory Sampling Tracking System (LSTS) as per the Procedures for Sampling Fresh Fruit and Vegetables and the LSTS User Services Guide.

4.3 Product Label Verification

During the establishment inspection, inspectors are encouraged to conduct product label verification(s) in order to verify compliance. Inspectors should use the Fresh Fruit and Vegetables Label Verification checklist to record their findings and refer to the Labelling Guide for Fresh Fruit and Vegetables posted on CFIA web site for more information.

4.4 Data Entry

Establishment inspections are to be recorded in the Facility Inspection module of the MCAP application. It is imperative that the inspection is recorded using the inspection type FFV Establishment Inspection GMP/GHP. All applicable information from the establishment inspection must be captured in MCAP to ensure accurate reporting.
The worksheet is used to record the following:

  • The inspection tasks conducted to assess compliance
  • Any relevant inspection comments
  • The level of rating assigned to each task

The information must be clear, concise and accurately reflect the conditions observed during the inspection. Refer CFIA's Note Taking Fact Sheet posted on Merlin for more information.

For more information regarding data entry, refer to Part II: Facility Inspection of the MCAP User Manual Agri-Food Division.

5.0 Inspection Tasks and Ratings

The Fresh Fruit and Vegetable Establishment Inspection Tasks are designed to provide guidance to the inspector for determining industry's compliance with regulatory requirements. Each inspection task includes a task description which outlines the outcome that is to be met in order to receive a satisfactory rating. Each task should be completed once during the inspection.

The inspection tasks are divided into seven (7) chapters, which include:

  1. Premises
  2. Transportation, Receiving and Storage
  3. Equipment
  4. Personnel
  5. Sanitation and Pest Control
  6. Complaints and Recalls
  7. Operational Programs

Each chapter is further broken down into sections, subsections and tasks.

Chapter: Major divisions of the establishment inspection.

Section: A specific section within the chapter.

Subsection: A specific element for assessment within the subsection.

Task Description: The inspection element to be evaluated to determine if an establishment is in compliance with Canadian legislation.

References: Reference to legislation, if applicable.

Program Standard: Additional information relating to the inspection task, if applicable.

Example:

Chapter 1. Premises

Section 1.2 Interior of Buildings

Subsection 1.2.2 Lighting

Task Description 1.2.2.1 Lighting is appropriate for the intended preparation and handling activity. The lighting does not affect food colour or its quality and safety.

References: Not applicable for this task.

Program Standard: The lighting is not less than the following intensity at the surface of the produce:

  • 550 lux in grading areas;
  • 540 lux in inspection areas (e.g., produce sorting and/or inspection);
  • 220 lux in work areas.

For a complete listing of the establishment inspection tasks, refer to the FFV Establishment Tasks list.

Each task must be evaluated and rated by the inspection team during the establishment inspection (as per section 5.1, Ratings) to determine if there is a deficiency.

Deficiency:
The establishment's conformity to the task assessment criteria is inadequate.

5.1 Ratings

Each task requires a rating based on the information gathered during the inspection. In case of uncertainties in the determination of the rating, the inspector(s) must consult with their immediate Supervisor, Regional Program Officer and/or Area Specialist.
The following ratings should be used to evaluate the establishment's conformity with the predetermined inspection tasks.

Critical:
A deficiency where product is affected (food safety) and needs to be controlled before the CFIA inspector leave the premises.

For example,

  • The product does not comply with 4. (1) of the Food and Drugs Act (e.g., is unfit for human consumption)

Serious:
A deficiency which could potentially result in product being affected (food safety).
For example,

  • The inspector has reason to believe that the product may not have been prepared in a sanitary manner

Minor:
A deficiency which will not or is unlikely to have an effect on the product's food safety.

For example,

  • Records not mandated by Regulation are missing or incomplete; however, the process or system is under control.

Satisfactory:
No deficiency observed against the inspection task.

For example,

  • No direct or potential contamination or adulteration of product was observed
  • No non-food safety non-compliances were observed

Not Applicable (N/A):
The task is not applicable to the establishment.

Not Inspected (N/I):
The task cannot be inspected at the time of the visit (ex., because equipment and/or part of the establishment is not in operation).

5.1.1 Inspection Comments

Inspection comments are the records of the conditions and practices observed at the time of the inspection and are used to determine ratings. Care must be taken to ensure that inspection comments are clear, concise, accurate, unbiased, relevant and sufficient, in order to assign an accurate rating.

Comments may be recorded for each task, however each deficiency rating (minor, serious, and critical) must have a comment.When a not applicable and/or not inspected inspection rating applies, the situation should be described in the inspection comments.

The following recommendations should be used when recording inspection comments:

  • Adequately describe all deficiencies including the location and specific details in order to determine the severity of the problem
  • Include the title/code and date of the records reviewed and the deficiency notes.
  • If company representatives are interviewed, include the name/title of the corresponding representative.
  • If the regulated party took action to control a produce or deficiency, include a summary of the actions taken by the regulated party.
  • If CFIA took action to control a product or deficiency, include a summary of the action taken by CFIA.
  • Do not make recommendations for correction
  • State only objective facts, avoiding personal opinions and speculations
  • Review the comments and ensure that they correspond to the correct task
  • Each deficiency rating must have a comment(s) associated with the task
  • Include any applicable legislative reference(s)

5.2 Assessing Deficiencies and Assigning Ratings

When all the inspection tasks have been assessed, it is recommended that the inspector(s) meet in private to review the inspection findings, identify deficiencies, and determine ratings.

The inspector(s) should review all recorded inspection comments and assign a rating (i.e., satisfactory, minor, serious, critical, not inspected, or not applicable) to each task. The information below for assigning a rating should not be used to assess whether a health risk exists, it should only be used to determine the classification of the deficiency in terms of food safety. That is, is the product's safety affected (critical) or could its safety potentially become affected if the deficiency is not corrected (serious). If an inspector suspects that public health may be at risk see section 5.2.1

The following steps should be used to asses the deficiencies and assign an appropriate rating:

  1. Identify the deficiency and area of concern, i.e. biological, chemical, and physical, etc.
  2. Assess the controls in place and other relevant information.
  3. Identify whether the product has been affected (critical) or could potentially be affected (serious).
  4. Apply the flow chart below to determine whether the rating is satisfactory, minor, serious, or critical.
  5. Identify the applicable legislation under which the deficiency is rated.
Flow Chart for assessing whether a task is rated as satisfactory or deficient
Flow Chart - Flow Chart for assessing whether a task is rated as satisfactory or deficient. Description follows.
Description of Flow Chart

This is an image of a flow chart describing how to assign a rating to a task from the FFV Establishment Inspection Task List. The first box in the flow chart asks the question has product been affected. If the answer is yes then the task is rated as a Critical deficiency. If the answer is no then the next box asks the question is there a potential for product to be affected? If the answer to that question is yes then the task is rated as a serious deficiency. If the answer is no then the next box asks the question is there a deficiency against the inspection task criteria? If the answer to that question is yes then the box below indicates that the task is rated as minor. If the answer to that question is no then the next box indicates that the task is rated satisfactory.

If you need assistance assessing deficiencies and assigning ratings, contact your immediate Supervisor, Regional Program Officer and/or Area Specialist.

All deficiencies should be assigned the appropriate rating and supported by clear, concise, accurate and complete inspection comments.

5.2.1 Deficiencies with Potential Health and Safety Implications

If during the course of an inspection a critical and/or serious deficiency is observed, where there is a direct source of contamination/adulteration which could potentially cause harm, the following steps should be initiated immediately by the inspector(s):

  1. Notify the establishment management of the deficiency.
  2. Request that the establishment implement corrective action(s) immediately or as soon as possible.
  3. Contact your immediate Supervisor, Regional Program Officer and/or Area Specialist to inform them of the situation.
  4. Determine the potential cause(s) of the deficiency.
  5. Determine when the deficiency first occurred.
  6. Detain all unsafe products. If the cause of the deficiency cannot be determined immediately or if product safety cannot be evaluated, place the affected product under detention. If satisfactory corrective action is implemented, ensure to have the evidence that products are not a health risk before to release the detention.
  7. Contact the Regional/Area Recall Coordinator if the products have been distributed.
  8. Collect samples for lab analysis, if necessary (in consultation with your Supervisor and Area Program Specialist).
  9. Evaluate the establishment's proposed corrective action(s) and ensure it is implemented immediately or as soon as possible. If full corrective action(s) cannot be implemented immediately, then temporary corrective measures must be implemented.

If the regulated party refuses to correct the immediate food safety issue(s), the inspector must take the necessary enforcement action and document the actions taken.

The inspector(s) must ensure that all aspects of potential health and safety issues are addressed by the regulated party before the inspector(s) leave the premise.

6.0 Communicate Results

Inspectors must communicate inspection results to industry in a timely manner.

6.1 Wrap-Up Meeting

If possible, a wrap-up meeting with the regulated party's representative/management should occur at the end of each inspection day, providing a verbal report of the inspection results to date. This meeting does not replace a closing meeting (as per 6.2), but may address similar topics that will be covered in the closing meeting.

The wrap-up meeting should cover the following points:

  • Summarize and request immediate action on any critical deficiencies identified
  • Address outstanding questions and note feedback from regulated party's representative/management
  • Set a date for closing meeting and request attendance from appropriate regulated party personnel

Keep completed and accurate notes of the discussion.

6.1.1 Exit Meeting with Management

After the establishment inspection and before the formal closing meeting, the inspection team may have a meeting to:

  1. review the inspection;
  2. highlight the key observations; and,
  3. establish the closing meeting's date and time.

The inspector responsible for the establishment inspection conducts an exit meeting with plant management at the time arranged. At the meeting with management the responsible inspector will:

  1. review the purpose of the inspection (to assess GMPs/GHPs and verify compliance with the applicable legislation);
  2. review the inspection:
  3. begin with general remarks pointing out positive observations;
  4. as appropriate, highlight the key observations;
  5. summarize the deficiencies by severity i.e. Critical, Serious or Minor;
  6. describe the follow up action expected i.e. corrective action plan.

6.2 Establishment Inspection Report

A complete establishment inspection report should include a:

  1. Cover letter; and
  2. Detailed Inspection Report.

The establishment inspection report is a written record and should be an accurate reflection of the results from the inspection. The results of the inspection must be clear, concise, complete, accurate and presented in a professional manner. Once the establishment inspection report has been prepared, the inspection team should review it for accuracy. The inspector(s) should then discuss the inspection results with their immediate Supervisor, Regional Program Officer, and/or Area Specialist.

The establishment inspection report can be presented to the establishment's management in person or sent by mail as a record of the inspection. Once the report is presented to industry it should be considered a permanent record to which no additional changes should be made.

6.2.1 Cover Letter

A written cover letter should accompany the establishment inspection report. The cover letter should include the following information:

  • Establishment name, establishment representative/management and date of inspection
  • Description of non-compliances with reference to applicable legislation
  • Request for corrective actions to address any deficiencies according to the appropriate timeframes (as per section 7.1)
  • Inspection team signatures and date of issuance

Cover letter templates can be found in Appendix 1 of these Procedures.

6.2.2 Detailed Inspection Report

Once all the data entry has been entered into MCAP and reviewed for accuracy, a Detailed Inspection Report can be accessed and printed via MCAP, Facility Inspection Module. This report represents all tasks assessed during the inspection, deficiencies found during the inspection; and their rating. This report should be given to the establishment along with the cover letter.

For more information on how to access this report, refer to section 8.0 of the Agri-Food MCAP User Manual.

6.3 Closing Meeting

Upon conclusion of the inspection and creation of the inspection report, the inspector(s) should meet with the appropriate member(s) of the establishment management for a closing meeting. The purpose of the closing meeting is to provide the regulated party with the inspection report and to discuss any deficiencies. The closing meeting must take place with the appropriate regulated party's representative/management who are responsible and/or accountable for taking corrective action. The meeting can take place in person or on the phone in situations where it is not possible to have the closing meeting in person and should occur within one week of completing the inspection.

The closing meeting should include the following:

  1. Restate inspection objectives, scope and plan and indicate if they were met and/or if there were any changes;
  2. Review the inspection findings and highlight key observations;
  3. Identify deficiencies and explain ratings (as per section 5.1);
  4. When applicable, request a written corrective action plan (as per section 7.0). Establish timelines for the plan(s) submission and implementation for the corrective action(s), according to the appropriate time frames (as per section 7.1);
  5. When applicable, identify further enforcement actions which have been initiated (e.g., detentions, warning letters);
  6. Address any questions and concerns from the establishment representative/management;
  7. When applicable, explain follow-up procedures to assess effectiveness of corrective action (as per section 8.0);
  8. Submit establishment inspection report and/or arrange for its delivery within a reasonable timeframe (i.e., 2-3 business working days).

The Closing Meeting Checklist for Inspection/Audit has been developed to help the inspection team facilitate the closing meeting.

It is important that the establishment management understand the inspection findings and the reasons why the identified deficiencies require correction.

Keep complete and accurate notes of all items discussed during the closing meeting.

7.0 Corrective Action Plan

The purpose of a corrective action plan (CAP) is to identify the root cause of the non-compliance and to implement activities to address the root cause and prevent reoccurrence of the non-compliance. However, failure to submit a CAP is not a contravention of the Act or Regulations. When a regulated party provides a CAP to the CFIA, it demonstrates their commitment to address the issue and market safe and compliant products.

A CAP should be submitted by the establishment which demonstrates their commitment to the resolution of the deficiency(ies). The establishment's CAP should clearly outline the:

  1. Description of the problem;
  2. Person(s) responsible for the corrective action(s);
  3. Description of the immediate/short term measures and their respective timelines;
  4. Identification of root causes(s);
  5. Description of preventative measures; and
  6. Description of activities planned to verify the effectiveness of preventative measures.

For more information on corrective action plans, refer to the Food Safety Enhancement Program (FSEP) Manual posted on CFIA website.

The company's corrective action plan should be submitted to the inspector in writing (or verbally) within the timeframes outlined in section 7.1.

When a CAP is provided verbally by the regulated party, inspectors must record complete and accurate notes of the CAP including the name and position of the person providing the CAP, as well as the time and date of the discussion. Inspectors should confirm with the regulated party that the written notes accurately reflect the verbal CAP provided.

In reviewing the CAP submitted by the regulated party, should the inspector identify concerns with the corrective measures or information that would suggest that the regulated party may have misunderstood the non-compliance, the inspector should contact the regulated party to address the issue.

If the CAP is not received by the due date, the inspector should contact the company to request their CAP within 2 working days. If the CAP is still not received after the 2 days, the inspector should discuss the issue with their immediate Supervisor and determine whether enforcement actions are required. A CAP is not required by legislation or regulation and not submitting one is not a non-compliance. However, if there are unresolved non-compliances in the establishment then further enforcement action may be required.

7.1 Corrective Action Deadlines

The corrective action deadlines should be based on the deficiency rating. The following timeframes should be used:

Corrective action plan submission timeframes for each deficiency rating.
Table Summary

The table outlines the time frames in which an establishment should provide their corrective action plan and when the corrective actions should be completed.

Rating Corrective Action Plan Submission Timeframe Corrective Action Timeframe
Critical Immediate (within 24 hours) Immediate
Serious Less than 2 weeks Less than 1 month
Minor Less than 1 month Less than 1 year

With the exception of Critical deficiencies, the timeframe for corrective action plan submission should begin the day after the establishment inspection report is presented to company management in person or sent by registered mail. When the report is sent by registered mail, the inspector should consider the receipt by the regulated party as the starting date for completion of corrective measures. The dates specified in the report should reflect this delay.

The inspector may request written corrective action plan submission and/or corrective action(s) within a shorter timeframe. Inspectors should use their judgement and determine appropriate timelines that reflect the seriousness of the non-compliance. Timelines for completion of corrective measures should be discussed and agreed upon by the regulated party and the CFIA.

Some factors that may determine appropriate timelines are:

  • The type of non-compliance (health and safety vs. non health and safety);
  • The immediate/temporary controls that have been implemented in order to produce safe, wholesome and compliant product in accordance to regulatory requirements.

It is recommended to work in consultation with the establishment's management to prioritize the corrective actions in order to achieve compliance.

7.2 Corrective Action Plan Evaluation

The corrective action plan submitted by the company should be evaluated by the inspector(s) for completeness and should include the 6 six elements outlined previously under section 7.0.

The inspector(s) should notify the establishment whether their CAP is acceptable or deficient. Refer to Appendix 2 for acceptance letter template.

The CAP should be amended if any of the six aforementioned elements are missing from the company's plan. The inspector should request a revised CAP from the establishment within 10 working days of agreed upon amendments.

If the revised CAP is not received, or if it is deficient, the inspector should discuss the issue and next steps with their Supervisor, Regional Program Officer and/or Area Program Specialist.

When the CAP is accepted, the inspector(s) should begin planning the follow-up inspection as described in section 8.0.

8.0 Follow-Up Inspection

The purpose of conducting a follow-up is to determine if the regulated party has addressed the deficiencies identified during the establishment inspection. This includes both short-term corrective actions and long-term actions that will prevent recurrence of the deficiency.

Follow-up inspection(s) may be required to verify industry's compliance with corrective actions taken to resolve deficiencies found during the initial inspection. Follow-up inspection(s) should be completed in a timely manner to ensure the establishment has implemented their corrective actions as outlined in their CAP. If there are no deficiency ratings as a result of the initial inspection, a follow-up inspection is not required.

The focus of follow-up inspection(s) should be to:

  1. Verify that corrective actions have been implemented as per the company's CAP;
  2. Verify that the corrective actions taken resolve the deficient task; and
  3. Collect directed samples, on a case by case basis (in consultation with your supervisor and Area Program Specialist).

The number of follow-up inspections required will vary according to the number and the severity, as well as the correction timeline of the deficiencies found during the initial establishment inspection. If there are multiple correction due dates, the inspector(s) (in consultation with their supervisor) could plan one inspectionto verify all the establishment's corrective actions.

The following timeframes are based on the deficiency rating and should be used to help plan the timing of the follow-up inspection:

Follow-up Inspection Timeframes for Critical, Serious and Minor Deficiencies.
Table Summary

Follow-up inspections (...for Critical deficiencies?) should = (the Table above refers to "must") be conducted as soon as possible after the correction date. Follow-up inspections for Serious and Minor deficiencies should be conducted within one week of the date corrective actions are due.

Rating Follow-up Timeframe
Critical Due to the severity of these deficiencies, a follow-up inspection must be completed as soon as possible after the proposed correction date.
Minor and Serious A follow-up inspection should be planned within one week of the stated due date for completion of the corrective action.

Prior to conducting a follow-up inspection, inspector(s) should review the deficiencies identified from the initial establishment inspection. Inspector(s) should note any sections that require clarification and discuss these with the regulated party during the follow-up inspection.

In order to conduct a follow-up inspection on the deficiencies identified in the initial establishment inspection, the inspector should:

  • Observe the conditions of the establishment
  • Review any records generated by the corrective actions
  • Review any written programs amended as a result of the corrective actions
  • Interview any affected personnel

Further follow-up inspections may be required on a case by case basis, at the inspector's discretion and in consultation with their immediate Supervisor.

If during the follow-up inspection it is felt that compliance will not be forthcoming from the company, the inspector should contact their immediate Supervisor, in consultation with the Regional Program Officer and/or Area Specialists to determine the necessary enforcement actions.

8.1 Follow-Up Inspection Data Entry

Details from the follow-up inspection should be captured in MCAP within the same record as the initial establishment inspection. For more information, refer to section 9.00 of the Agri-Food MCAP User Manual. Details from the initial establishment inspection should not be changed; only new information should be added to the record in the appropriate follow-up inspection data entry fields.

A new MCAP record should not be created to record details from the follow-up inspection.

8.2 Completing the Establishment Inspection

In order to complete the establishment inspection, the inspector must:

  1. Ensure all details of the initial establishment inspection and follow-up inspection(s) are captured accurately in MCAP;
  2. Verify all deficiencies identified during the inspection have been resolved by the establishment; and
  3. Close the MCAP record as per section 10.00 of the Agri-Food MCAP User Manual.

9.0 File Maintenance

Accurate and complete records maintenance is essential in providing a history of the compliance and verification activities and enforcement actions related to a specific regulated party. Adequate record maintenance is also essential in case of prosecution or for information requested from the public via Access to Information Act.

All the information must be maintained in a way that is easily accessible for all staff that needs to consult the file. Electronic records must be protected and accessible to all staff that may require access (i.e., stored in Records Documents Information Management System (RDIMS) with appropriate access rights; CFIA internal use).

A complete establishment file should be kept on file in the Regional office to compile a profile and history of the company. Records should be retained according to CFIA's record retention policy. Where applicable, the file should contain but is not limited to the following information:

  1. Establishment profile
    1. Establishment Information (e.g., contact names, phone numbers, including after hour contacts, email addresses, etc)
    2. Operating Information
    3. Trade level
    4. Establishment type (e.g., wholesale, fresh-cut processors, etc)
    5. Relevant commodities types
  2. Establishment inspection report(s) (as presented to the establishment):
    1. Cover letter
    2. Detailed Inspection Report
    3. The company's written corrective action plan(s)
    4. Formal communication (e.g., letter of acceptance of the establishment CAP)
    5. Inspectors field notes (e.g., Work Sheet)
    6. Other relevant communication to or from the establishment
  3. Other relevant records, reports and documentation:
    1. Product inspection records
    2. IMS complaints
    3. LSTS submissions and results
    4. Label verification records
    5. Product labels
    6. Process flow diagram and/or other schematics
    7. Pictures of establishment/equipment
    8. Product lists and lot code definitions
    9. Packaging materials information
  4. Compliance and enforcement documents:
    1. Warning letters
    2. Notice of Detentions and Releases
    3. Inspector Non Compliance Report and related records (e.g. prosecution brief)

9.1 Saving Documents

It is encouraged that all documents associated with the establishment inspection be scanned and saved into the Records Documents Information Management System (RDIMS) (CFIA internal use). Refer to Appendix 4, Establishment Inspection RDIMS Naming Convention for more information.

Appendix 1 Cover Letter Templates

Cover Letter Template (Deficiency(s) Identified)

Symbol of Canadian Food Inspection Agency

<CFIA Office Address>

<Month, Date, Year>

<Name of Establishment>
<Establishment Address>

Subject: Establishment Inspection Report for <Establishment name, inspection date>

Dear <Establishment Representative>, <Title>,

The purpose of this letter is to provide you with the results of the inspection conducted on <date> at <Establishment name>. The inspection was completed by <Inspector(s)>. A detailed inspection report is included with this letter.

Below is a summary of the deficiency(s) noted during the establishment inspection:

During the inspection, the following deficiency(s) was/were observed: (example)

  • The establishment does not use potable water for the final rinsing of the <product name>. This deficiency should be corrected no later than <date, based on corrective action timeline>.

You are requested to take corrective actions to address the above mentioned deficiencies by the date indicated. Please sign the attached inspection report and forward it with your written corrective action plan(s), addressing all deficiencies identified, to this office no later than: <date>.

A follow-up inspection will be conducted after the date for completion of the corrective measures. The purpose of this follow-up inspection is to verify that the deficiency(s) has/have been addressed and that corrective measures have been implemented to prevent recurrence of the deficiency.

If you have any concerns regarding this letter and the accompanying documents, please feel free to contact me as indicated below.

<We or I> would like to thank you and your staff for your cooperation during this inspection.

Yours truly,

<Inspector(s) Name and Title>

<Inspector(s) Telephone, Email>

cc: <Area Program Specialist> <Inspection Supervisor> <Regional Program Officer>

Cover Letter Template (No Deficiency(s) Identified)

CFIA ACIA wordmark

<CFIA Office Address>

<Month, Date, Year>

<Name of Establishment>
<Establishment Address>

Subject: Establishment Inspection Report for <Establishment name, inspection date>

Dear <Establishment Representative>, <Title>,

The purpose of this letter is to provide you with the results of the inspection conducted on <date> at <Establishment name>. The inspection was completed by <Inspector(s)>. A detailed inspection report is included with this letter.

If you have any concerns regarding this letter and the accompanying documents, please feel free to contact me as indicated below.

<We or I> would like to thank you and your staff for your cooperation during this inspection.

Yours truly,

<Inspector(s) Name and Title>

<Inspector(s) Telephone, Email>

cc: <Area Program Specialist> <Inspection Supervisor> <Regional Program Officer>

Appendix 2 Action Plan Acceptance Letter Template

Symbol of Canadian Food Inspection Agency

<CFIA Office Address>

<Month, Date, Year>

<Establishment Name>
<Establishment Address>

Subject: Acceptance of Corrective Action Plan

Dear <Establishment Representative>, <Title>

This letter confirms receipt of your corrective action plan to address the deficiency(s) noted in the inspection report sent to <Establishment name> on <date>.

Upon review, the proposed corrective actions have been accepted. Implementation of the corrective actions will be verified via a follow-up inspection(s), within approximately one week of the stated dates of completion.

If you have any concerns regarding this letter, please contact the undersigned.

Yours truly,

<Inspector(s) Name and Title>

<Inspector(s) Telephone, Email>

cc: <Area Program Specialist> <Inspection Supervisor> <Regional Program Officer>

Appendix 3 References

Legislation

Acts and regulations are available to CFIA and the public. They are available from the Department of Justice Canada.

Forms

CFIA forms can be found in the internal forms catalogue or Desktop eForms.

  • Notice of Detention CFIA/ACIA 3256
  • Notice of Release CFIA/ACIA 3257
  • Receipt for Samples Taken CFIA/ACIA 4168
  • Sample Portion (Official Sample) CFIA/ACIA 0072

Appendix 4 Establishment Inspection RDIMS (internal CFIA use) Naming Convention

In order to efficiently search and retrieve all of the documents related to FFV establishment inspections, the Records Documents Information Management System (RDIMS) should be used to save all inspection documentation.

When saving in the RDIMS: the Title, Organization and File Number fields have to be filled with specific information in the Document Profile Creation Form presented in the form as follows:

Title
The established naming convention should be used:

Project Year, Name of the Program, Activity, Area-Region, Document Type, Inspection Date and Establishment Name

Example: 2013-2014 FFVP EI A1 D1 0622 Atlantic Herbs

Program Fiscal Year: YYYY-YYYY

Program:
Fresh Fruit and Vegetables Program (FFVP)
Activity:
Establishment Inspection (EI)

Area-Region Code:

A: Atlantic
1: Nova Scotia
2: New Brunswick
3: Prince Edward Island
4: Newfoundland & Labrador
Q: Quebec
1: Montréal Region
2: Québec Region
O: Ontario
1: North/East Region
2: Toronto Region
3: Central Region
4: South/West Region
W: Western
1: Manitoba
2: Saskatchewan
3: Alberta South
4: Alberta North
5: British Columbia
6: Vancouver Island
Document Type:
D1 – Cover Letter for Inspection Report
D2 – Establishment Corrective Action Plan
D3 – Action Plan Acceptance Letter
D4 – Other (e.g. formal email correspondence to/from the establishment)
Date Format:
MMDD
Establishment Name:
Legal name of the establishment.

Organization
The following number/name must be used: R71MCFS – Fresh Produce Safety.

File Number
The following number/name must be used: 33 33031 – Fresh Fruit & Vegetables – Establishment Inspection.

Under Access Control:
A normal access must be granted to your immediate Supervisor, Regional Program Officer, Area Program Specialist and the National Program Specialists for all the above.

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