Operational procedure: Food preventive control inspection – Implementation verification

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1.0 Purpose

The purpose of this document is to provide guidance to Canadian Food Inspection Agency (CFIA) inspection staff on inspection procedures for preventive control (PC) and export controls for food. The requirements for PC are prescribed in Part 4 of the Safe Food for Canadians Regulations (SFCR). The policy outlining the system based expectations of licence holders eligible to export food is described in the Guide for preparing an Export Control Plan (ECP).

This document is intended to be used in conjunction with other guidance documents as referenced in Section 3.0 of this document.

2.0 Authorities

The inspection powers, control actions and enforcement actions authorized by the above legislation are identified and explained in the Operational guideline: Food regulatory response guidelines.

3.0 Reference documents

References to be used when conducting verification activities of the Implementation Verification tasks are found in the Annexes and:

4.0 Definitions

Unless specified below, definitions are located in either the:

5.0 Acronyms

Acronyms are spelled out the first time they are used and are consolidated in the Food business line acronyms list.

6.0 Operational procedure

This OP provides inspection procedures for verifying the implementation and development of specific control measures. Where more specific guidance is required than what is provided in the SIP, it will be indicated in this section, and is to be followed despite of what is indicated in the SIP.

The annexes include inspection tasks which focus on control measures that must be verified at frequencies as specified in the Program Direction: Preventive control inspection frequencies for food (accessible only on the Government of Canada network – RDIMS 11010733)

6.1 Prepare for inspection

Refer to SIP section 3.0, Step 1 – Prepare for the inspection. In addition to the general guidance provided in SIP, the following applies:

  • Contact the licence holder to gather information regarding product(s) / process(es)
  • Inspectors are encouraged to consult the online PCP interactive tool to determine if a licence holder needs a PCP
  • Where a PCP is required, obtain an up-to-date copy of the licence holder's PCP related to the tasks selected as part of the scope. This can be requested when the announced inspection is scheduled
  • For Implementation Verification tasks within the scope of the inspection, review their respective outcome, performance criteria and verification activities (see applicable Annexes)
  • For PC inspections which are part of a work plan (trigger: Preventive Control Inspection Plan), the required entire Implementation Verification task(s) will be assessed within the prescribed timeframes (Program direction: Preventive control inspections frequencies for food (accessible only on the Government of Canada network – RDIMS 11010733)
  • For PC inspections which are not part of a work plan (trigger: Incident Response, for example following a complaint, a recall or any unscheduled findings while conducting any inspection activities), it may be acceptable to complete only the part of the Implementation Verification task(s) linked to the reason for this inspection
  • When completing the inspection task record into the Digital Service Delivery Platform (DSDP), refer to the tables that are included in the Annexes. Enter the required details identified in the "Inspection Task Details" into the corresponding free text field in DSDP, if applicable
Table 1: Recording inspection data in Digital Service Delivery Platform (DSDP)
DSDP Field DSDP Field Selection
Inspection Trigger
  • Preventive Control Inspection Plan or;
  • Incident Response
Task Type
  • Preventive Control Inspection
Inspection Task Level 1
  • Implementation Verification
Inspection Task Level 2
  • As defined in the tasks in the Annexes
Inspection Task Details
  • As defined in the task details in the Annexes, if applicable

6.2 Conduct the inspection

Refer to SIP, section 4.0, Step 2 – Conduct the inspection. In addition to the general guidance provided in SIP, the following applies.

An initial walk-through is not mandatory for all inspections. The inspector uses their judgement to determine if an initial walkthrough is necessary, taking into consideration the tasks being conducted and the last time a walkthrough took place. In general, if a walkthrough has not occurred in the past 12 months, it should take place as part of the inspection.

6.2.1 Confirm the scope

If a potential non-compliance is observed part way through an inspection, which is not part of the selected scope, the following applies:

  • Where the entire Implementation Verification task has already been completed within the current defined frequency of inspection, only the applicable section(s) of the task related to the observed potential non-compliance will be completed in a separate inspection case. The trigger for that inspection case will be "Incident Response"
  • Where the entire Implementation Verification task has not been completed within the current defined frequency of inspection and, if time permits, the entire task will be completed and added to this inspection case. In the event where the potential non-compliance is observed during a follow-up inspection, the appropriate implementation verification task must be added to a new inspection case with the trigger "Preventive Control Inspection Plan".
  • Where the entire Implementation Verification task has not been completed within the current defined frequency of inspection and where time does not permit (consult with supervisor, if required), only the applicable section(s) of the task related to the observed potential non-compliance may be completed in a separate inspection case. The trigger for that inspection case will be "Incident Response". The entire Implementation Verification tasks still needs to be completed within the defined frequency for that licence holder
  • Where the potential non-compliances identified are directly related to an outstanding inspection report, determine if the interim measures are effective and record any findings in the associated follow-up inspection case by adding an inspection task and creating a non-compliance record to capture the information. The inspector must take appropriate control action, if required. See section 6.4.1 for communication of these inspection findings

6.2.2 Conduct the verification activities

Determine whether the licence holder meets applicable regulatory requirements by reviewing the Acts and Regulations and/or importing country conditions listed in each Implementation Verification task and using the outcome, performance criteria and verification activities as indicated in the Annexes.

Under SFCR, some licence holders are required to have a PCP in place. If during the preparation of the inspection, it is determined that a licence holder is required to have a PCP, but does not have one, this constitutes a non-compliance to SFCR section 86. Refer to SIP, section 4.6 – Determine compliance, for further guidance.

As per section 47 of the SFCR, operators (regardless of whether they require a PCP or not) must identify and analyse biological, chemical and physical hazards that present a risk of contamination of a food and prevent, eliminate or reduce to an acceptable level the identified hazards by using control measures shown by evidence to be effective..

Where a PCP is required, the design and implementation of the PCP should include the requirements of a PCP found in SFCR Part 4, Division 6.

Where a PCP is not required by regulations:

  • The inspector would place more emphasis on conducting observations, interviews and if required, adding another inspection task type, i.e. sample collection or commodity inspection, to ensure the licence holder is meeting the requirements pertaining to PC/export controls
  • If written programs and documents are maintained to show compliance to PC/export controls and for evidence of effectiveness of control measures, a review should be performed to assist in determining compliance

Perform sufficient verification activities to determine whether the outcome(s) for the task(s) have been met. Select the appropriate verification activities as indicated in the Annexes for each task that will allow for the assessment of compliance.

During the course of a PC inspection, other inspection task types (such as sample collection and commodity inspection) can be conducted to support the information gathered to determine compliance. Caution should be exercised when deciding to take samples or conduct a commodity inspection when verifying compliance of PC/export controls. In some cases, sample collection or commodity inspections may not be useful to support an inspection assessment and could lead to a discrepancy between findings of the inspection and the results of the additional inspection task types.

Additionally, when conducting Implementation Verification tasks, there may be situations that would warrant the review of the written program to verify the content meets PC requirements for the development and maintenance of the PCP using the sub-elements. If it is determined that a sub-element should be conducted, follow section 6.2.1 of the Food preventive control and traceability inspection – System verification.

Before considering the use of additional inspection task types to support an inspection finding, consider the following:

  • The purpose for using another inspection task type:
    • Is it to verify that a non-compliance exists?
    • Is it to link the product or commodity to a potential non-compliance?
    • Is it necessary to assess the content of the PCP at this time?
  • Whether action can be taken based on the results
  • Whether the results provide further information regarding compliance with regulatory requirements
  • Consulting with the supervisor to determine the relevance of using other inspection task types as well as laboratory capability and capacity

There may be situations where inspectors are conducting a task where a non-compliance relating to the same task has been observed during a previous inspection and the date for completion of corrective action has not yet passed. In these situations, the inspector must:

  • conduct the entire task as planned, however would not capture the same findings from the outstanding non-compliance in the new case.
  • capture any findings related to the outstanding inspection report in the follow-up case by adding an inspection task and creating a non-compliance record to capture the information.
  • focus on the effectiveness of interim measures and whether or not the licence holder is in control of non-compliant situations when determining if there is a non-compliance that needs to be captured in the follow-up case.
  • take appropriate control action, if required. See section 6.4.1 for communication of these inspection findings

6.2.3 Document the non-compliance

For food, more than one regulatory reference can be captured in a non-compliance record. The regulatory reference(s) will be based on the findings within each task being assessed at the time of inspection. For example:

  • If there is non-compliance with SFCR sections 50 to 81; SFCR section 49 should also be referenced to link the licence holder to the non-compliance. Sections 50 to 81 have details of the requirements for the establishments and section 49 states who (operator) must maintain and operate what (establishment) according to which requirements (SFCR sections 50 to81)
  • If there is a non-compliance with SFCR section 89 (content of preventive control plan); SFCR section 86 should also be referenced in the same non-compliance record as that is the regulation which actually requires the licence holder to prepare, keep and maintain a PCP that meets the provisions of SFCR section 89 in addition to any other applicable regulatory reference that is found to be non-compliant within the sub-element being assessed

For food, when non-compliance(s) are determined when conducting a domestic or slaughter Implementation Verification task, all regulatory reference(s) and the objective evidence which support the non-compliance(s) should be documented in one non-compliance record.

When the Implementation Verification task is assessing importing country conditions, there may not be any regulatory references to identify on the non-compliance record. All objective evidence which supports the non-regulatory non-compliance(s) should be documented in one non-compliance record. Refer to Food export control policy for more information.

For example, when assessing implementation verification tasks:

  • Pre-operational on-site verification; non-compliance was found with SFCR sections 49, 50 and 88 for dirty equipment post sanitation and pre-op
  • Foreign country requirements – Japan (meat); non-regulatory non-compliance for was found with Japanese specific requirements
  • Foreign country requirements – China (meat); non-regulatory non-compliance for was found with Chinese specific requirements

There will be 3 non-compliance records created, one for each of the implementation verification task conducted.

Refer to SIP section A.5 Step 2 – Conduct the inspection for the completion of the inspection case, ensuring only the applicable related permissions verified as part the inspection have been selected.

6.2.4 Categorise the non-compliance

Since a non-compliance record may have more than one regulatory reference with supporting objective evidence, the categorization of non-compliance should be based on the sum of all the documented objective evidence within that non-compliance record.

For non-compliances associated with importing country conditions, where no regulatory non-compliance exists, the categorization of non-compliance should also be based on the sum of all the documented objective evidence within that non-compliance record.

When verifying compliance to importing country conditions using the tasks found in Annex 2 – Export food – Implementation Verification tasks, identified non-compliances can have a maximum timeframe for the completion of corrective measures of 60 days, including non-compliances categorized as minimal.

6.3 Communicate the inspection results

Refer to SIP, section 5.0, Step 3 – Communicate the inspection results. Additionally, licence holders are responsible to implement interim corrective measures to mitigate any risks to human health, animal welfare or food misrepresentation immediately. These interim measures are to be documented in the closing meeting notes.

6.4 Conduct the follow-up inspection

Refer to SIP, section 6.0, Step 4 – Conduct the follow-up inspection. In addition to the general guidance provided in SIP, the following applies to this OP:

  • For every non-compliance record, create a follow–up inspection case in DSDP to record follow-up details by selecting "Create follow up" from the non-compliance record within the parent case. The follow-up should be scheduled as soon as possible following the licence holders Date for Completion of Corrective Action
  • When conducting the follow-up inspection, perform sufficient verification activities to determine if the non-compliance(s) have been addressed and the outcome(s) for the Implementation verification tasks have been met
  • Not all of the verification activities, as outlined in the Implementation Verification task, will need to be conducted, depending on the situation; a number of factors (such as the compliance history of the licence holder, the categories of the non-compliances, etc.) will influence the depth of the follow-up inspection. For example:
    • It may be acceptable to complete only the part of the tasks verification activities linked to the reason for the inspection
    • For an establishment with a history of repeated non-compliances within a certain task, the inspector may need to conduct more verification activities to ensure that the licence holder not only has addressed the non-compliance, but also still meets the outcome of that task

6.4.1 Assess follow-up inspection results

Refer to SIP, section 6.4, Assess follow-up inspection results. In addition to the general guidance provided in SIP, the following applies to this OP:

If a state of compliance is not re-established, then the inspector:

  • takes control actions and/or recommends enforcement actions as per the Standard regulatory response process and/or the Export control policy, as required
  • documents the verification activities which support these findings, in the inspection task record within the follow-up case that was created from the non-compliance record in the parent case
  • creates a non-compliance record in the follow-up inspection case ensuring the objective evidence includes the date and findings from that date
    • this non-compliance record will not be categorized and therefore will not have corrective action date. Any subsequent timelines for the completion of corrective measures will be determined and communicated via the enforcement process

The follow-up inspection case must remain open until compliance is re-established and all follow-up inspection activities and the appropriate control and/or enforcement actions are complete, or until the licence has been cancelled/export privilege has been removed. When a case cannot be closed (deactivated) after a follow-up inspection, the inspection report must be issued by other means than through the portal (such as in person/email/fax). Ensure the end date on the inspection report is correct prior to issuing.

If subsequent follow-up inspections are required, create a new inspection task record within the follow-up inspection case to enter the findings, create another non-compliance record and issue an inspection report after each inspection.

Once compliance has been achieved and control and/or enforcement actions are complete, create a final non-compliance record without an associated task, indicating in the objective evidence that "Licence holder found to be in compliance on [date of inspection]" then issue the report and close (deactivate) the follow-up inspection case.

For general inquiries related to this OP, please follow established communication channels, including submitting an electronic Request for Action Form (e-RAF).

7.0 Annexes: Food Implementation Verification tasks

The information presented for each task within the Annexes is organised as follows:

  • Recording inspection data in DSDP:table describing how to enter the inspection task details into DSDP
  • Legal authorities: the connections to regulatory requirements and supporting information. Other regulatory references not listed may be used, if applicable
  • Outcome: a state where the PC/export controls achieves compliance
  • Rationale: explains the potential impacts of the PC/export controls on the outcome in each task
  • Performance criteria: based on requirements; can be used by industry to help them achieve requirements and by inspectors to help them verify requirements
  • Verification activities: the process that an inspector should follow to verify the licence holder's compliance to requirements via review of the applicable PC/export controls and performance criteria in each task. This section is further sub-divided into:
    • document/record review
    • on-site: observation and interview

Inspectors may use discretion to expand verification of recommended items, as required.

Inspectors will select all available items if it is not possible to select the minimum number of recommended items.

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