Archived - Imported and Manufactured Food Program Inspection Manual
Chapter 6: Establishment Inspection
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Chapter 6 outlines the procedures to be followed when conducting inspections of establishments that fall within the jurisdiction of the IMFP.
An establishment inspection is an assessment of a manufacturer's or importer's compliance with the requirements of the Food and Drugs Act and Regulations, the Consumer Packaging and Labelling Act and Regulations, and the Organic Regulations under the Canada Agricultural Products Act. Inspections are conducted using the General Principles of Food Hygiene, Composition and Labelling (GPFHCL) and/or the Good Importing Practices for Food (GIP) as a guideline. During an inspection, the inspector identifies any deviations from regulatory requirements and guidelines.
Note that this chapter does not cover food safety investigations. During an inspection, situations may arise where an inspector will need to stop his/her inspection to conduct a food safety investigation or take enforcement action in response to an observed food safety hazard. If this occurs, inspectors should reference the Food Safety Investigation Manual.
6.1 Types of Inspections
6.1.1 Full Inspection
In a full inspection, the establishment should be assessed against all subsections of the GIP or GPFHCL. Because of the breadth and depth of a full inspection, and depending on the size and the complexity of an establishment, it may require several days to complete a full inspection.
Inspectors, at the discretion of their supervisor or manager, may decide to conduct a full inspection of an establishment for a variety of reasons. For example, a full inspection may be carried out in cases where the CFIA is in receipt of a number of complaints of varying concerns (both quality and potential food safety concerns) related to a particular company. An increase in the number of complaints may indicate a potential lack or loss of food safety control(s) in an establishment, and warrants a full inspection.
6.1.2 Focused Inspection
A focused inspection assesses a specific area or process of concern. It may be conducted in response to a complaint or as a follow-up to a previous inspection or unsatisfactory sampling result. The goal is to identify the possible root cause or source of an issue, or to verify if the company has put appropriate controls in place to address a minor, major or critical rating. Inspectors assess against the appropriate sections of the GIP or GPFHCL, as necessary.
Inspections conducted as part of Work Specifications are also considered focussed inspections. Work Specifications are developed by the Imported and Manufactured Food Program (IMFP) as a proactive approach to addressing potential risks associated with high-risk commodities or sectors. They provide guidance to inspectors on what commodities to inspect and how to conduct inspections and sampling.
All Work Specifications can be found on the IMFP Merlin web page.
6.2 Inspector Conduct and Personal Hygiene
- 6.2.1 Professionalism
- 6.2.2 Confidentiality
- 6.2.3 Personal Cleanliness
- 6.2.4 Hand Washing
- 6.2.5 Cleanliness of Inspection Equipment
- 6.2.6 Inspector Conduct
- 6.2.7 Compliance with Establishment Policies
- 6.2.8 Contagious Diseases
An inspector is an official representative of the Agency and must project a professional image when dealing with establishment officials. He/she must, therefore, be appropriately dressed and well groomed, respect the rules that establishment employees are required to follow, and have good interpersonal skills. Courteous and professional language must be used when dealing with the industry and public.
All information discussed and obtained from a specific company must remain confidential. Other companies' systems, processes or inspection findings should not be discussed while conducting an inspection. This does not preclude government inspection reports being made available under the Access to Information Act.
6.2.3 Personal Cleanliness
Good personal hygiene includes proper care and cleanliness of hands, fingernails, hair and beards. Nail polish and perfume are not appropriate during inspections. Watches and jewellery, such as rings, chains, etc. must be removed before entering food processing areas. Plain wedding bands may be worn, provided that they are covered by sanitary gloves. Band aids must be covered by sanitary gloves if on hands or fingers. Loose items of clothing (ties, scarves, etc.) must be secured.
Inspectors should bring a lab coat with them to the inspection. The lab coat must be clean when put on, i.e. previously washed by a commercial cleaner. Inspectors may be asked to wear the establishment's lab coat during the inspection, rather than their own personal lab coat. Shoes and/or boots must have been thoroughly washed and disinfected, including the sole, before inspection and transported in a clean disposable bag. The hair and beard net must be new when put on and discarded after each inspection. The protective safety hat must be clean. Consult the manufacturer for appropriate cleaning and disinfection methods that will not affect the integrity of the hard hat.
6.2.4 Hand Washing
Before entering a food-handling area, inspectors must wash their hands properly, and disinfect them if necessary. This practice must be repeated as often as necessary, for example when an inspector has handled material likely to be contaminated.
6.2.5 Cleanliness of Inspection Equipment
All inspection material must be clean and sanitized before each inspection. Do not bring any equipment into the plant that may contaminate food directly. For example, a pen cap could come loose and fall into a food or ingredient; only use click pens during inspections. Refer to Appendix 1 of this chapter for procedures to clean and sanitize inspection equipment.
6.2.6 Inspector Conduct
All non-hygienic practices such as eating, smoking or chewing gum are prohibited in food-handling areas. Inspectors must follow all industry-standard precautionary measures (e.g.: foot bath, hand sanitizer, etc.) while in a food establishment. They must wash and disinfect their hands after every break, after using the toilet, after meals, at the end of an inspection and every time they touch a potential source of contamination (drains, dirty equipment, etc.).
6.2.7 Compliance with Establishment Policies
In general the inspector should abide by and respect establishment policies and procedures, for example, the use of foot baths, hair nets and protective clothing. In the event of a conflict, regulations supersede any establishment policies or procedures.
6.2.8 Contagious Diseases
An inspector known, or suspected, to be suffering from or to be a carrier of a disease or illness likely to be transmitted through food, must not conduct an inspection in a food establishment.
Examples include: jaundice, diarrhoea, vomiting, fever, sore throat with fever, discharges from the ear, eye or nose, hepatitis or any open cuts or wounds. Always notify your supervisor if you are experiencing any of these symptoms.
- 6.3.1 Inspection Frequency and Timing
- 6.3.2 Inspection Team and Joint Inspections
- 6.3.3 Establishment File
- 6.3.4 Process /Product Review
- 6.3.5 Inspection Materials and Equipment (Kit)
- 6.3.6 Prepare for Reporting
- 6.3.7 Notifying the Establishment
An inspection involves much more than simply going to an establishment and inspecting the premises. The foundation of a complete and comprehensive inspection is sound preparation. This involves several steps as outlined below.
- Frequency and timing
- Team/joint inspections
- File review
- Process/product review
- Inspection kit
- Notifying the establishment
6.3.1 Inspection Frequency and Timing
The prioritization of work is a challenge for inspectors working in the IMFP, as responding to complaints and conducting food safety investigations and recalls may consume much of the inspectors' time and are impossible to predict in advance. Inspectors should work with their supervisor to balance the requirement to respond effectively to this work and the activities of the planned work specifications.
Work specifications define the timing and number of inspections. The inspection date must take into account the period scheduled for each work specification, and in some cases, the seasonal availability of the product. For example, maple syrup producers may only be operational in the spring, while apple cider processors may only press in the fall. Also, some imported products are more readily available at certain times of the year. Every effort should be made to ensure that the establishments are fully operational, and products are available to sample (should sampling be necessary), at the time of the inspection.
6.3.2 Inspection Team and Joint Inspections
Inspections may be conducted individually or in teams, as dictated by the requirements of the work specifications and available resources. A team approach may also be used for the following reasons: to improve uniformity, to increase the depth of the inspection by building on the strengths of two or more inspectors, to coach and mentor a new inspector, for safety reasons or to facilitate the inspection of a large or complex establishment.
In some cases, inspections may be conducted in conjunction with provincial inspectors or inspectors from other food programs. In most cases, this will be indicated in the work specification or discussed with the inspector's supervisor. Always consult with your supervisor prior to agreeing to conduct a joint inspection to ensure that it is within your legal authority to do so.
6.3.3 Establishment File
The establishment's file contains the firm's Establishment Profile, the most recent inspection reports and any communications, complaints, legal actions, seizures, infractions or recalls associated with this company. A file for each establishment/facility that the CFIA has inspected should be stored at the appropriate district office. Inspections should not be conducted without first consulting this file. The file should not leave the office; inspectors should review the file in advance of the inspection. Prior to an inspection the inspector should review and note:
- The name of the establishment manager and key personnel.
- Previous inspection reports, action plans and follow-up measures.
- The size and age of the establishment as well as the products packaged or processed.
- Unique features of the establishment, such as equipment, processing schedules, size or product lines.
- Determine if there are any outstanding issues by reviewing: follow-up inspection summaries, consumer and industry complaints, recalls, laboratory reports, etc.
- Review Incident Management System (IMS) reports.
- Review the establishment's flow diagram showing the general movement of raw, in-process and finished product within the establishment.
This information is a useful tool for identifying the sources of concern during previous inspections and noting possible trends. It provides guidance as to what should be given priority during an inspection. If necessary, the inspector should consult with his/her supervisor, colleagues and the program officers.
6.3.4 Process /Product Review
Planning for inspections should also include a review of any available technical and scientific information on the products being processed or imported, the manufacturing methods and the equipment being used in the establishment. This information is essential for any inspector who is not familiar with the type of company to be inspected or for any inspector who needs an update. Program files, web sites, work specifications and scientific journals may be helpful.
6.3.5 Inspection Materials and Equipment (Kit)
Each inspector must have the proper equipment to conduct an inspection and must use or wear it where appropriate. If more than one plant is to be visited during the day or during a trip, the inspector must bring along a sufficient supply of equipment so as to have clean equipment for each visit. Since the CFIA is often scrutinized by industry, it is important to lead by example and ensure that all equipment is cleaned and disinfected as necessary.
126.96.36.199 Protective Clothing
The following protective clothing should be included in the inspection kit:
- Safety hat - clean, CSA approved (Canadian Standards Association), white, marked "CFIA" or CFIA logo
- Hair net and beard net (if applicable) - in good condition, disposable, white and individually wrapped
- Dust mask
- Eye and hearing protection – CSA approved
- Lab coat (or equivalent, e.g. coveralls) - clean, white, front snap or velcro fasteners, no pockets above the waist.
- Coat - for protection from the cold.
- Sterile gloves – several pairs
- Safety shoes - clean, CSA-approved, sanitized, steel-toed, non-slip
- Safety boots - clean, CSA-approved, steel-toed, non-slip
Following the inspection, dirty clothing and footwear must be placed in a plastic bag in order to avoid contaminating the carrying case or vehicle.
188.8.131.52 Inspection Equipment and Tools
The equipment and tools needed to conduct an inspection depend on the product and establishment; however each inspector should have a kit that includes the following:
- Carrying case
- Flashlight (in good working order)
- An accurate thermometer with a steel shaft (not mercury in glass)
- Containers and equipment for sampling, sterile or non-sterile as required (e.g.: bags, plastic containers, spoon, spatula, etc.)
- Bags for taking official samples
- Box or heavy duty plastic or cloth bag for transporting samples
- Pen (without cap)
- Clipboard that can be easily sanitized and that closes to protect documents from splashes
- A notebook – with bound and lined pages (not spiral or perforated)
- Disinfectants; inspectors should carry a disinfectant (e.g.: Dettol, 70% ethyl alcohol) so that they can sanitize their equipment between inspections as necessary.
- Coolers and ice packs
- Sterile gloves
184.108.40.206 Reference Materials and Documents
An inspector should carry the following materials or documents on the inspection:
- Establishment Profile
- GPFHCL or GIP worksheet
- Notice of Detention and Notice of Release from Detention forms which includes the detention labels (CFIA 3256)
- Sealing tape (CFIA 4561)
- A copy of the Food and Drugs Act and Food and Drug Regulations, specifically sections 23 and 24 dealing with the powers of inspectors and sections 4 and 7 of the FDA, which are the sections under which the inspection is conducted.
- A copy of the GPFHCL and the GIP
- A copy of the recall plan
- Any other relevant guidelines or information letters
Each inspector must carry and be prepared to show his/her CFIA inspector identity card (with appropriate delegated authorities), CFIA inspector's badge and business card. The identity card provides proof of the inspectors' delegated legal authority and is required to conduct an inspection.
6.3.6 Prepare for Reporting
Before an inspection, information regarding the establishment should be entered into MCAP. Open a new inspection and choose the appropriate assessment criteria (GIP or GPFHCL) and work specification. The subsections of the GPFHCL or the GIP relevant to the inspection will be pre-populated in the task list. The task list may be printed for easier record-keeping and on-site reporting. The assessment criteria should be reviewed before the inspection.
6.3.7 Notifying the Establishment
In most cases, notification should be given to the establishment's management of an upcoming inspection. This ensures that the appropriate establishment officials are available on the inspection date. Notification should be considered in cases where the establishment does not operate regularly or the CFIA has a need to see a specific process. However, there may be circumstances which warrant an unannounced inspection. The inspector must first check with his/her supervisor to determine whether notification is necessary.
An establishment may be informed of an upcoming inspection by telephone, letter or e-mail. It is recommended that all documentary evidence of notification be placed in the establishment file.
6.4 On-site Inspection
- 6.4.1 Opening Meeting
- 6.4.2 Conducting the Inspection
- 6.4.3 Sampling Products During or After the Inspection
- 6.4.4 Recording Observations
- 6.4.5 Addressing Non-conformance/Non-compliance during the Inspection
6.4.1 Opening Meeting
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.
When meeting with the establishment's management, the inspector should demonstrate courtesy and professionalism. This helps to establish a working partnership.
- Ask for the establishment's manager or person in charge.
- Show your badge, identity card or business card.
- Explain what the inspection will involve and agree on an inspection schedule and time frame.
- Inform management that the results will be discussed once the inspection has been completed, and arrange a time to meet and discuss the results.
- Inquire about any special requirements of the establishment concerning protective equipment and safety measures or changes to processes or products.
- Provide the appropriate documentation if necessary (e.g. Codes of Practice, Letters to Industry, Facts Sheets, etc.)
During the opening meeting, complete or update the Food Establishment Profile. A copy of this form is available at RDIMS #834877 or on the Imported and Manufactured Food Program page on Merlin. The last page of the Food Establishment Profile includes the compliance history, which must be updated following any activity involving the company. At the very least, the region in which the company is located must retain a paper copy of the Food Establishment Profile. Include the establishment Record Number from the Client Management System (CMS) in the activities table at the end of the profile.
6.4.2 Conducting the Inspection
When conducting an inspection, the inspector assesses the establishment's controls against the assessment criteria in the sub-sections of the GIP or GPFHCL. These assessment criteria are not exhaustive and it may be necessary to include other criteria to fully assess the subsection. It is important for the inspector to follow the plan created while at the same time knowing when to stop and respond to serious food safety hazards, if observed.
It is preferable to have a representative (establishment's manager, foreman or quality assurance person) accompany the inspector as it allows for questions to be asked on the spot and serious deficiencies to be pointed out as observed; this way, immediate action can be taken. At a minimum the inspector has the authority to ask for assistance in reviewing records and programs and dismantling equipment.
Inspectors must not allow accompanying plant personnel to rush the inspection or to lead them away from infractions.
If the company suggests that their lawyer be present during the inspection, the inspector should stop the inspection and contact their supervisor. Their supervisor should contact CFIA legal services who will provide guidance on how to proceed. They may advise to proceed with the inspection with the company lawyer present.
For plants producing high-risk foods, inspections should be conducted following the reverse order of the production sequence. To minimize the risk of cross-contamination, begin the inspection in the cleanest areas (from a microbiological standpoint) and end the inspection in the least clean areas. For example, begin with the finished product packaging section and end with the inspection of raw materials. If the inspector must return to the finished products section, he must disinfect his equipment again before returning to this area.
Ideally, production steps should be evaluated during operations. This approach makes it possible to provide a realistic inspection of the establishment. If certain production steps (including cleaning and sanitizing) are not currently being carried out, consideration must be given to the possibility of returning to complete the inspection at the appropriate time.
220.127.116.11 Information Gathering Tools
Information can be gathered using three basic tools: observation, interviews, and examination of records and documents.
Be thorough when observing processes, products and equipment. Remember to look up, look down and all around. Observations include product and process inspection. Observe employees to verify if a procedure is being followed.
Conduct interviews face to face and try to create a bond between you and the person being interviewed. Ask questions in a normal conversational tone. Open ended questions elicit more information than closed questions. For example, ask: "How do you conduct this procedure?" rather than "Did you do XYZ?" Wherever possible, verify the information gained from an interview with observations and review of documents.
Examine all relevant documents and records. Documents and records should also be used to verify the validity of interviews and observations. Records should be legible, permanent, an accurate reflection of what happened at a specific time, signed and dated. If the record looks "too perfect," that is, the writing all the same and the overall appearance too much the same, there is a possibility that the records are being completed all at one time and do not reflect true data. Errors and/or changes should be clearly identified, i.e., no use of white out. Critical records should be signed by a qualified person. All pertinent records should be available to the inspector upon request. While conducting a work specification-based inspection, it is generally appropriate to examine documents and make notes about them in the inspector's notebook. If a food safety hazard is identified during the inspection, or as part of a complaint follow-up, it may be more appropriate to obtain copies of relevant records. Inspectors have the authority to obtain copies under paragraph 23(1)(c) of the Food and Drugs Act.
18.104.22.168 Communication during the Inspection
The inspector should direct questions to the establishment's management rather than to the employees, except when the inspector wants to determine whether an employee understands what he/she is doing or what procedures he/she has been directed to follow during regular production, or when there is a problem or deviation. Employees should be addressed in the presence of management.
6.4.3 Sampling Products During or After the Inspection
Product samples may be collected during or after an inspection of an establishment, to verify inspection findings. Samples should always be collected in the presence of a company official. Always notify the establishment's management of the exact nature of the samples collected and the purpose of sampling. Collect samples as outlined in the work specifications and Chapter 7: Sampling of this manual.
6.4.4 Recording Observations
Inspection findings can be recorded on an MCAP inspection worksheet or in a notebook referencing the worksheet. Notes should be relevant, factual and accurate. When interviewing people, note their name and position in the company, and quote what was said and their actions. Do not make judgements on what they said or their actions. Notes on observations should include how the observation was made. If working in teams, take turns asking questions with one asking the question while the other records the answer.
6.4.5 Addressing Non-conformance/Non-compliance during the Inspection
In some cases, a non-conformance or non-compliance may be rectified immediately, during the inspection. These findings should be documented and assessed even if they are addressed immediately. Always note observations even if the situation is immediately rectified.
Compliance is defined as 'the state of adherence to regulatory requirements' while conformance is defined as 'the state of adherence to a regulated party's written programs or the assessment criteria in the GPFHCL and/or the GIP'.
6.5 Assessment of Findings
- 6.5.1 Estimating Health Risk and the Rating System
All non-conformances/non-compliances found during the inspection must be indicated in writing on the worksheet or notebook. The inspector must review the deficiencies in private, assign the appropriate ratings (critical, major, minor) and determine the priority of the items to be corrected. In some cases, the inspector may need to consult with his supervisor or program specialist before assigning a rating but in most cases, the inspector should be able to identify critical and major deviations and communicate these immediately to the establishment's management.
When it is difficult to determine a rating, the inspector may need to probe deeper and re-examine the situation to gather additional information that will make it possible to rate the observation.
6.5.1 Estimating Health Risk and the Rating System
The process of estimating health risk is not an exact science. Inspectors in the IMFP should use the following procedures in estimating health risk related to non-conformities which are noted during routine inspections.
22.214.171.124 The Rating System
There are two levels of rating during an inspection:
- The potential health risk resulting from a non-conformity at the subsection level of the Code of Practice (Critical, Major, Minor or Satisfactory) and
- An overall inspection rating (1, 2, 3 or 4).
The first rating is assigned by the inspector based on inspection findings and the second is automatically assigned by MCAP.
126.96.36.199 Assigning a Rating at the Subsection level
Using the Health Risk Estimation Model in Figure 1, estimate the potential risk of non-conformity as follows:
- Identify the hazard created by the non-conformity (physical, chemical, microbiological, allergen or nutrition)
- Identify the severity of consequences (high, medium or low). See section 188.8.131.52.1 below.
- Assess the controls in place, and any other relevant information gathered during the inspection
- Determine the likelihood of occurrence/exposure to the hazard (high, medium, low or remote). See section 184.108.40.206.2 below
- Apply the health risk estimation model below to determine the overall rating of the non-conformity (critical, major, minor or satisfactory)
Health Risk Rating Definitions
The non-conformity represents:
- Satisfactory (Sa): a remote health risk
- Minor (Mi): a low health risk
- Major (Ma): a moderate health risk
- Critical (Cr): a high heath risk
220.127.116.11.1 Severity of Consequences
The severity of consequences (low, medium or high) defines the seriousness of the hazard. It is usually predetermined as a result of scientific knowledge. The three levels of severity of consequences are defined as:
- Low: exposure to the hazard is not likely to cause any adverse health consequences
- Medium: exposure to the hazard could result in temporary or non life-threatening health consequences
High: exposure to the hazard could cause permanent disability or death
If there is not enough information to determine the severity of consequences, always assume that it is high until further information proves otherwise.
With respect to microbiological hazards, the severity of consequences of the most common pathogens and natural toxins known to be associated with foods are classified as outlined in Table 1 below.
The severity of consequence for some chemical hazards is determined on a case-by-case basis. Information on various chemical hazards can be found on the CFIA and Health Canada websites. Table 1 below indicates the severity of consequences for some toxins.
|Severity of Consequences||Pathogen/Disease|
Source: Food Quality and Safety Systems - A training manual on food hygiene and the Hazard Analysis and Critical Control Point (HACCP) system, Food and Agriculture Organization of the United Nations, Rome, 1998
Extraneous Material Hazards
For extraneous materials hazards, use the Injury Risk of Extraneous Materials found in Table 2 below as a guide to determining the severity of consequences. Note that in addition to size, the risk associated with extraneous material is further evaluated through an assessment of elements such as shape, hardness, nature of the extraneous material, source, visual appearance (e.g. colour, visibility in the product), method of consumption/preparation, target population, quantity, etc.
|Severity of Consequences||Commodity||Material|
|High||Infant Foods||Any size|
|Medium||All other foods||2mm or larger in any one dimension|
|Low||All other foods||Less than 2mm in any one dimension|
The severity of consequences of nutrition hazards is determined on a case-by-case basis. In general, the severity of consequence for nutritional hazards is medium to low however, it can be higher in foods that are targeted to very young consumers or those consumers with special dietary needs.
Allergen hazards are also evaluated on a case-by-case basis. However, sulphites at <10ppm and gluten at <20ppm are not considered hazardous.
18.104.22.168.2 Likelihood of Occurrence of Exposure to the Hazard
The likelihood of occurrence of exposure to the hazard refers to the probability that the consumer may be exposed to a hazard. It is assessed by the inspector to be: remote, low, medium or high based on the inspectors' findings of the controls in place by the manufacturer or importer, all other relevant information, and inspector judgement.
It is important to note that it is the likelihood of the consumers' exposure to the hazard that should be assessed, not the likelihood that the non-conformity to specific assessment criteria will occur.
Consider the following example:
While at a large juice processor, an inspector determines that the temperature recording device for the pasteurizer was not properly calibrated and the actual temperature of the product was potentially several degrees lower than indicated. This occurred twice in the last month and the product that was manufactured during that time is in national distribution.
The hazard identified would be 'pathogen survival' and would be rated as a high severity of consequences since the juice did not reach the temperature required to destroy the pathogens of concern. As the product is in national distribution, there is consumer exposure and the likelihood of occurrence is also high. This would result in a critical rating.
In this same example, however, if it is later observed that the temperature of the product in the holding tank of the pasteurizer was also recorded manually and these records indicate that the minimum temperature required to pasteurize the juice was achieved during the period of time in question. This would indicate that the product did achieve the required temperature to destroy any pathogens and the severity of consequences would be changed to remote. The likelihood of occurrence remains the same and the resulting rating is satisfactory.
In general, there is an inverse relationship between the likelihood of occurrence and the degrees of control over the hazard i.e., if there are inadequate process controls in place, the likelihood that the hazard may occur increases.
When a rating of major or critical is assigned to a subsection, inspectors should review their findings in consultation with their Area Program Specialist in order to verify their conclusions.
Note: Use caution when rating deficiencies related to record-keeping. These will typically be rated as minor. On some occasions, a major rating may be assigned where absent or incomplete records are associated with a deviation which is directly related to a health and safety concern e.g. records associated with a critical control point (CPP).
22.214.171.124 Assigning an Inspection Rating to an Inspection
The inspection rating (ranked from 1 to 4) is determined by the relative potential health risk represented by the overall inspection findings, as shown in Table 3. A rating of 1 (the most severe rating; a rating of 4 being the least severe) means that there is a high risk that the deviations noted during the inspection could result in exposure to a hazard which could cause permanent disability or death. Consequently, inspections rated as 1 receive the highest priority for follow-up activities.
The MCAP reporting system will automatically assign a rating to a completed inspection according to the rating scheme in Table 3.
|1||At least one subsection rated Cr|
|2||At least one subsection rated Ma, but no Cr|
|3||At least one subsection rated Mi, but no Ma or Cr|
|4||No subsection rated Mi, Ma or Cr|
6.6 Closing Meeting
The closing meeting should take place with the appropriate plant management representatives (those who are responsible or accountable for taking corrective action) as soon as possible after the inspection. A quiet location, preferably in the establishment, should be chosen for holding the meeting.
During this meeting, the inspector should begin by pointing out any positive comments that are appropriate and then communicate the critical and/or major non-conformances/non-compliances observed during the inspection. The inspector and the establishment should negotiate a reasonable time frame for the establishment to provide the inspector with their Corrective Action Plan (CAP) for all sections rated critical, major or minor. The due date for the CAP should be noted on the inspection report and/or cover letter (see Reporting below). The inspector should highlight the importance of a CAP and indicate essential items for the establishment to include in order to correct all deviations identified. If the inspector does not receive the CAP in the agreed to time frame, they should contact the establishment for clarification and to urge them to provide the plan. Should a CAP not be received by the end of the time frame allowed for CAP implementation and CFIA follow-up (for example; 6 months for a minor non-conformance), then the inspector should return to the establishment. All identified deficiencies should be re-inspected to make sure they are corrected and have not become more serious.
When negotiating these time frames the inspector should keep in mind and ensure that the firm understands that critical non-conformances/non-compliances must be addressed immediately, majors within one month, and minors within approximately six months as per Table 5 in this chapter.
It is important that the management understand the inspection findings. Explain clearly the reason certain assessment criteria were not met and that these items require correction or improvement. Remember to thank the management for their cooperation.
The proper reporting of the results of an inspection is integral to the success of any program. A report should be clearly written, contain all pertinent information and be accessible to everyone involved in the design and implementation of the program. The information in the report is important for tracking and monitoring trends over time and for identifying gaps and/or areas for improvement with regards to further program development.
Once the inspection is completed, the inspector or team writes the inspection report. All inspection findings are reported in MCAP, including comments for each subsection rated minor, major or critical. Comments are optional for subsections rated Satisfactory, but may be useful for documenting changes in ratings from a previous minor, major or critical to a satisfactory rating.
Focus comments on objective evidence, observations and inspector judgement. Use clear and concise statements. State the facts and avoid stating inspector opinions. Write non-conformities/non-compliances in the past tense, in the third person. State the objective evidence, state the non-conformity and quote the appropriate subsection.
Print the inspection report and send it with a cover letter to the establishment within two weeks of completing the inspection. The cover letter will confirm the inspection and any samples taken, communicate inspection findings, confirm any enforcement actions taken and request a CAP for any outstanding non-conformance/non-compliance issues. Indicate the results of the sample analysis if available. If not available, indicate that the results will be forwarded when they are completed. A sample cover letter is available in Appendix 2 at the end of this chapter.
Ensure that all applicable fields in MCAP are completed, and assess your findings to determine whether any additional CAPs and/or other follow-ups are needed before closing the inspection report. All relevant LSTS sample numbers and IMS numbers should be entered into MCAP.
Any critical deviations requiring immediate action to protect the health and safety of the public (e.g. Health Risk Assessments, Recalls) are to be reported in IMS and to the Area Recall Coordinator and Area Program Specialist immediately. For reporting complaint follow-up and/or recalls the inspector may refer to the Food Investigation Response Manual (FIRM) (This document is intended for internal use. CFIA staff can access this document using RDIMS number 4052577.).
6.8 Inspection and Sample Follow-up
- 6.8.1 Procedure
- 6.8.2 Enforcement Actions
- 6.8.3 Time Frames
- 6.8.4 Review and Evaluation of a Corrective Action Plan
Non-conforming/non-compliant samples and establishment inspection results require follow-up action. This section outlines the time frames, procedures, enforcement actions and reporting procedures to follow for non-conforming/non-compliant sample results and establishment inspections. Following these procedures facilitates the national consistency of enforcement actions in the non-federally registered sector.
Figure 2 (Sample and Inspection Follow-up), is a flow chart that outlines the procedures to follow for samples and inspection results. The flow chart begins with receipt of inspection or sample results and ends with no further action required or a referral to Enforcement and Investigation Services.
Consultation between Operations, Programs, including the Office of Food Safety and Recall (OFSR), laboratories and others during the enforcement decision making process is essential. This consultation process must consider the available resources, the health risk assessment, program and policy advice and other Agency priorities. The dotted lines in the flow chart indicate when to consult and the colours indicate who to consult and where they are located (blue represents the Areas, and purple represents the Headquarters activities).
Acronyms for Figure 5
- ND = No Decision
- IMS = Issues Management System
- INCR = Inspectors Non-Compliance Report
- FERM = Food Emergency Response Manual
- IS/IM = Inspection Supervisor, Inspection Manager
- H&S = Health and Safety
- ARC = Area Recall Co-ordinator
- OFSR = Office of Food Safety and Recall
- FDA/R = Food and Drugs Act and Regulations
126.96.36.199 Establishment Inspections rated 1 or 2/Samples judged I or U
For inspections rated 1 or 2 and samples judged investigative or unsatisfactory, the inspector must evaluate the results and determine if there is a violation and/or a potential health and safety concern with respect to product on the market. In other words, "is the consumer at risk?" The inspector should consult with CFIA stakeholders at the Area level to evaluate non-conforming/non-compliant establishment inspections and sampling results to develop appropriate enforcement options and strategies. The CFIA Area stakeholders include the relevant Area Program Specialist, the Area Recall Coordinator (ARC), the Inspection Supervisor or Manager (IS/IM) or designate, and any others as appropriate for resolution of the issue. The degree of consultation between stakeholders may vary depending upon the issue, from notification by e-mail to conference calls and meetings.
A food safety investigation should be conducted to ensure all aspects of the potential health and safety issue are addressed. Follow the guidance in the Food Safety Investigation Manual.
When a potential health and safety issue is identified, the inspector must take immediate enforcement action (e.g. detention) to limit the exposure to the potential health risk or to prevent further violation(s) of the FDA/R. If product(s) on the market pose a potential health and safety concern, the ARC should notify the OFSR. The OFSR coordinates the risk assessment and development of risk management options between Programs and Health Canada at Headquarters.
After consultation with Programs, consideration of the risk assessment and the program/policy advice, the OFSR will determine the need for a recall, and decide on the classification, depth and level of communication of the recall. Recall implementation is described in the FIRM.
When a potential health and safety issue is not identified or a recall is not warranted other enforcement actions may be required to address non-conforming/non-compliant inspections or sample results. See section 6.8.2 for guidance.
188.8.131.52 Establishment Inspections rated 3
For inspections rated 3, the inspector should evaluate the results of the inspection to determine if a potential violation of the FDA/R exists. If a potential violation is identified, appropriate enforcement action should be implemented. The inspector should consult with CFIA stakeholders at the Area level to evaluate non-compliant establishment inspections and develop appropriate enforcement options and strategies. The CFIA Area stakeholders include the relevant Area Program Specialist, the ARC, the IS/IM or designate, and any others as appropriate for resolution of the issue. The degree of consultation between stakeholders varies depending upon the issue, from notification by e-mail to conference calls and/or meetings. See Section 6.8.2 for guidance on enforcement action.
If it is determined that a violation does not exist, the firm should be informed of the reason for the rating and appropriate follow-up should be carried out with the establishment to resolve the non-conformance(s) to the assessment criteria. See section 6.8.3 for guidance.
184.108.40.206 Establishment Inspections rated 4
Send a letter to the firm with the inspection report. No further action is required.
220.127.116.11 Samples Judged Satisfactory
The establishment should be notified, however, no further action is required.
18.104.22.168 Samples Judged as No Decision
For samples judged as no decision, the inspector should discuss the results with the Area Program Specialist who will review the issue with the National Managers, Laboratory Services, if necessary.
6.8.2 Enforcement Actions
Enforcement action should be taken whenever a potential violation of the FDA/R is identified. The type of enforcement action will vary depending on the following factors;
- the seriousness of the violation,
- the seriousness of the health risk, and
- the compliance history of the regulated party.
Other factors may also be taken into consideration depending on the situation. Consultation between Operations, Programs, laboratories and others is essential in developing and implementing appropriate enforcement strategies for non-conforming or non-compliant samples and inspections.
Enforcement actions that may be taken include, but are not limited to:
- letter of non-compliance (see Appendix 3 of this Chapter for a template)
There is a direct relationship between the inspection rating and enforcement as shown in Table 4. Note that when establishments are assigned an inspection rating of 3, there may or may not be a violation of the FDA/R, and the health risk is always low. Where an establishment is assigned an inspection rating of 3 and there is a violation of the FDA/R, enforcement action must be initiated by the CFIA and corrective action must be undertaken by the establishment.
|Inspection Rating 1||Inspection Rating 2||Inspection Rating 3||Inspection Rating 4|
|Violation of FDA/R?||Yes||Yes||Yes or No||No|
|Enforcement Action Required?||Yes||Yes||Yes or No||No|
22.214.171.124 Seizure and Detention
An inspector has the power to seize and detain food products pursuant to subsection 23 (1)(d) of the Food and Drugs Act. Seizure and detention is carried out in order to control the disposition of non-compliant products. However, seizure and detention is not mandatory. An inspector has the discretion as to when to apply this enforcement action. Regardless, it is recommended that inspectors detain products which they believe on reasonable grounds have contravened a provision of an Act or Regulations enforced by the CFIA.
SeizureFootnote 4 is the act or an instance of taking possession of property by legal right or process. Seizure action achieves the objective of obtaining maximum control of a violative product. It also meets the requirements of gathering and securing evidence for the purpose of initiating a prosecution under the FDA and the FDR. (Note that once an investigation is initiated, a warrant is required.)
DetentionFootnote 5 is the custody of property. An article detained by the CFIA remains the possession of the owner but may not be moved or otherwise altered without the consent of the CFIA. Depending on the purpose for seizure/detention, an inspector may choose either to leave the article in the facility where it was seized/detained or to remove it to a place appropriate for controlling the product (FDA section 25).
In practice, seizure and detention are not differentiated. Seizure and detention can be seen as actions taken in sequence: an article is seized and then kept under detention. In the IMFP and all other CFIA programs (with the exception of the Fish Program), seizure and detention are not performed separately (i.e. a product is always both seized and detained, not one or the other).
The power to seize and detain goods without referral to a Court is unusual and must be used with discretion. For the power of seizure and detention of any article under paragraph 23(1)(d), an inspector must believe on reasonable grounds that a provision of the Act or regulations has been contravened. Reasonable grounds to believe that a provision of the Act or regulations has been contravened may take the form of, but is not limited to, the receipt of a credible complaint, the results from inspecting a particular product, the review of documentation, or the test results of a particular product.
There is no prescribed expiry of seizure/detention under the Food and Drugs Act; however, an inspector who has seized /detained any article under the Act has an obligation to release it, in writing, once they are satisfied that the article complies with all the provisions of the FDA and regulations (FDA section 26). As well, although there is no prescribed expiry of seizure/detention, articles may only be seized/detained for what can be considered a reasonable length of time and should not continue indefinitely. Throughout the entire length of time the product is under seizure/detention, the CFIA has the obligation to continue to monitor the product and to impose on industry the requirement to deal with the detained article within a reasonable length of time.
In order to affect a seizure/detention, it is necessary to complete a detention form (see 8.4.1 for more details on this form). If a company wishes to move or destroy the detained products, the owner or representative must first seek approval from a designated CFIA inspector in order to do so and the form must be modified to reflect the authorized movement/destruction.
According to section 26 of the Food and Drugs Act, "an inspector who has seized any article under this Part shall release it when he is satisfied that all the provisions of this Act and the regulations with respect thereto have been complied with."
In order for a product to be released from detention, the owner has the following options:
- bringing the non-compliant product into compliance by re-labelling or modification where possible,
- exporting the non-compliant product out of Canada,
- consenting to the CFIA inspector's request to forfeit ownership of the non-compliant product to the CFIA for destruction or disposal,
- voluntarily destroying the product, where a CFIA inspector must witness the destruction of the product and make a note of this destruction in CFIA records (i.e., IMS).
Note that if and when the owner decides to voluntarily destroy or dispose of the affected product, a voluntary destruction form (see Chapter 8, Section 8.5) must be completed by the owner and submitted to the CFIA inspector.
6.8.3 Time Frames
Table 5 below summarizes the time frame required for corrective action related to the inspection rating. The inspection rating for an establishment always reflects the health risk, for example, a rating of 1 is always associated with a high health risk. The table also shows the criteria used to determine the inspection rating of an establishment.
The inspection rating ranges from 1 to 4, with 1 being the least conforming/compliant and 4 being the most conforming/compliant inspection. The colours in Table 5 match the health risk ratings in the Health Risk Estimation Model in Figure 1 of this Chapter. An inspection rating of 1 is red and matches the Critical health risk, which is also red, in the Model. Where the inspection rating is red ("1"), corrective action must be taken immediately.
|1||at least one subsection rated Cr||immediate|
|2||at least one subsection rated Ma, but no Cr||within one month|
|3||at least one subsection rated Mi, but no Ma or Cr||within six months|
|4||no subsection rated Mi, Ma or Cr||not applicable|
For cases of recurring minor non-conformances with the assessment standard, continue to follow-up with the regulated party. Consult with your IS/IM to develop a follow-up strategy.
Where a firm is unwilling or unable to achieve compliance with the food safety provisions of the FDA/R, refer to the Compliance and Enforcement Operational Policy for guidance on enforcement.
6.8.4 Review and Evaluation of a Corrective Action Plan
126.96.36.199 Purpose of a Corrective Action Plan
During their normal duties, such as inspections and follow-ups to recalls and complaints, inspectors identify non-conformities to the GPFHCL and/or the GIP. To address these non-conformities, the regulated party submits a CAP to the CFIA. The purpose of the CAP is to identify the root cause of the non-conformity, and to implement activities to address the root cause and prevent recurrence of the non-conformity.
If the non-conformity could result in a food safety hazard, the inspector must take immediate action to protect the consumer. This action may include a food safety investigation, product seizure/detention, sampling, or recall.
188.8.131.52 Contents of a CAP
The establishment should include the following items in the CAP:
- A description of the non-conformity to be addressed.
- The root cause of the non-conformity.
- Action to be taken to address the root cause and prevent recurrence of the non-conformity.
- The responsible person(s).
- Activities that the establishment will take to ensure that the action taken addressed and corrected the root cause (verification).
- A requirement for record-keeping.
184.108.40.206 Evaluation of a CAP
220.127.116.11.1 Description of the non-conformity
The establishment should fully describe the non-conformity and link it to the relevant sub-section(s) of the GPFHCL or the GIP. The description should clearly indicate a full understanding of the importance and potential repercussions of the issue and the reason for the non-conformity.
Example: During the cooking process, the temperature readings on the indicating and recording thermometers did not correlate. Corrective action was not taken to address the potential for undercooked product. This occurred because the thermometers were not calibrated at the required intervals. This issue relates to GPFHCL 2.1.4 Instrument Maintenance and Calibration Program.
18.104.22.168.2 Root Cause
The establishment should identify the root cause of the non-conformity by conducting an investigation. The root cause should be plausible and related to the non-conformity.
Example: The root cause of the non-conformity (from the example above) was inadequate operator training. The regular operator was absent for an extended period of time and the replacement was not trained on calibration. The supervisor was not monitoring thermometer calibration and deviation procedures at the required frequency.
22.214.171.124.3 Prevent recurrence
The establishment should identify action(s) that will fully address the root cause and prevent recurrence of the non-conformity. These actions may include process re-design, training, re-formulation, a new procedure or any combination of actions that will achieve the intended result.
Example: The operator will be re-trained on calibration procedures including deviations and documentation. The supervisor will be re-trained on verification and documentation.
126.96.36.199.4 Responsible Person(s)
The establishment will identify person(s) who are responsible to ensure that the CAP is implemented as intended. These persons should be in a position to take action if the CAP is not implemented.
Example: The plant manager is responsible to ensure that this CAP is implemented and verified and has full authority to take action if it is not.
The inspector should review the timelines to ensure that they are realistic. For potential food safety issues, the timelines should be short.
Example: This CAP will be fully implemented within one week.
188.8.131.52.6 Verification of CAP
The establishment should describe the verification procedures taken to ensure that the CAP was implemented as intended and addressed the root cause of the non-conformity.
Example: The Plant Manager will verify that this CAP was implemented and that it addresses the root cause of the non-conformity by signing and dating this CAP.
The establishment should maintain records related to the non-conformity, the development of the CAP and the verification and follow-up of the CAP. The records should be signed and dated by the responsible person and maintained on file.
184.108.40.206 CFIA Verification of the CAP
The inspector will conduct an on-site inspection to verify that the CAP was implemented as written and that it is effective in preventing recurrence of the non-conformity. This inspection should be conducted as soon as possible after the date of implementation of the CAP and within one month of the date of implementation. The inspection should include record review, on-site observations and interviews.
220.127.116.11 CFIA Reporting
If the CAP is the result of a MCAP inspection, the inspector will record the contents of the CAP in the corrective action request section of MCAP. The inspector will use the CAP section of MCAP to record the action detail on the CAP and the activities taken by the CFIA to verify the CAP. The inspector will also record on-site verification in this section of MCAP.
If the CAP is a result of a non-conformity identified through another activity (complaint follow-up, recall follow-up), the inspector will record the CAP and verification activities in IMS.
18.104.22.168 Sample of an Acceptable CAP
A manufacturer uses a preservative in their bottled oil with garlic and herbs. There is no other barrier in this product against bacterial growth. While observing the operator mixing the ingredients during an inspection on June 10, 2007, the inspector noted that the operator did not measure the amount of added preservative. He used a big scoop, sprinkled some preservative into the mixture and recorded the required amount on the formulation sheet. The company has a written procedure for addition of the preservative and a requirement for proper record keeping. When questioned, the operator explained that he has been making this product for so long that he instinctively knows how much preservative to add. The inspector measured the amount that the employee scoops five times and the results were inconsistent and did not meet formulation requirements.
The inspector took immediate action to address the food safety hazard and requested a CAP from the company to prevent recurrence of this food safety issue.
Non-conformity: Inconsistent level of preservative. Preservative level is a CCP. Section of GPFHCL: 1.6.1 Control of Preparation, Composition and Blending.
Root Cause: Employee formulating and mixing product was not adding a consistent or correct amount of preservative. Supervisor was not monitoring employee and verifying the addition of preservative. Preservative levels were not being monitored by analysis.
Corrective Actions: The employee will be retrained on the correct procedures for preservative addition including recording. The supervisor will be re-trained on employee monitoring and verification of CCPs. QC will sample and analyze product monthly to ensure that the correct amount of preservative is being added and will complete an analysis report that will be verified by the Plant Manager.
Date of completion: June 24, 2007
Responsible person: Sam Jones, QA Manager
Records: A training record will be created and verified by the QA Manager. Analysis reports will be created and verified by the Plant Manager.
Appendix 1: Inspection Equipment Cleaning and Sanitizing Procedures
Note: These procedures can be used as a guide. Check with manufacturer's instructions, your IS/IM, and OSH representatives for instructions specific to your equipment.
A) Cleaning and Sanitizing Procedure - Boots and Shoes
- Thoroughly rinse boots or shoes.
- Wash with an industrial liquid detergent according to package instructions, taking care to scrub the sole thoroughly to remove any encrusted dirt.
- Rinse thoroughly with clean water.
- Dry with paper towels.
- Spray the boots or shoes with an industrial sanitizer according to package instructions.
- Shoes: Let air dry.
- Boots: Rinse with water to prevent yellowing.
- Place in a clean plastic bag.
B) Cleaning and Sanitizing Procedure - Safety Hats
- Rinse the safety hat with water.
- Wipe with a paper towel.
- Spray with a sanitizer (e.g.: 70% ethyl alcohol, etc.).
- Let air dry.
- Store in a plastic bag.
C) Cleaning and Sanitizing Procedure - Pocket Thermometers
- Using a clean paper towel, wipe the thermometer clean of any traces of grease, protein or dirt.
- Wipe the handle of the probe with a sanitizer.
- Completely immerse the stainless steel portion of the probe in a cup containing the sanitizer.
- After a few minutes, wipe with a paper towel or let air dry.
- Store in a Whirl-Pak® sterile bag .
- After use, rinse with water to remove any residues.
D) Cleaning and Sanitizing Procedure - Coolers and Ice Packs
Coolers may become a source of contamination if they are not properly cleaned and sanitized before use. Each inspector who borrows coolers is responsible for them. The coolers must be free of all foreign bodies (hair, dust, liquid, etc.).
- Wash with an industrial liquid detergent according to package instructions, taking care to scrub thoroughly to remove any encrusted dirt.
- Rinse the cooler (inside and outside) and the ice packs with water.
- Spray with a sanitizer.
- Wipe with a paper towel.
Appendix 2: Sample Cover Letter for Inspection Report
Canadian Food Inspection Agency
Name of Establishment
Attention: Name of Establishment Contact, Title of Position
Re: Facility Inspection (date)
Para 1: Confirm inspection, location and date.
Para 2: Indicate report of inspection is attached and how to read the report.
Para 2: Outline any major or critical non-conformance/non-compliance issues and any actions taken during the inspection to address these issues.
Para 3: Request a corrective action plan for any subsections rated minor, major or critical and indicate a time frame for receipt.
Para 4: Advise the establishment that if any further information is required to contact you at your telephone number.
Imported & Manufactured Food Program
Canadian Food Inspection Agency
Appendix 3: Example Letter Outlining Non-Compliance
Canadian Food Inspection Agency
Name of Establishment
Attention: Name of Establishment Contact, Title of Position
Re: Non-compliant Sample or Inspection
Para 1: Describe the date that sampling occurred and the product(s) sampled and/or the date that the inspection occurred. State that the sampling/inspection was conducted under the authority of the Food and Drugs Act and Regulations.
Para 2: Describe the non-compliance and section of the Act or Regulations that it violates. Outline the responsibility of the establishment to ensure that the food offered for sale in Canada complies with the requirements of the Food and Drugs Act and Regulations.
Para 3: Describe any enforcement action that has been taken or summarize any corrective action that the establishment has agreed to take and the date by which it will be taken. If corrective action has not been discussed yet, a corrective action plan should be requested by a specific date. Note: the time frame given should be consistent with those in Table 1 in Section 7.9.2.
Para 4: Advise the establishment that if any further information is required to contact you at your telephone number.
Imported & Manufactured Food Program
Canadian Food Inspection Agency
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