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 to assess preventive control (PC) and policy based export controls for food. The requirements for PC are prescribed in Part 4 of the Safe Food for Canadians Regulations (SFCR). The policy requirements for system based export controls are stated in the Food Export Control Policy

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:

Non-adherence

  • A failure to meet the applicable policy requirements

Non-compliance

  • A contravention of the applicable Acts and/or Regulations

Requirements

  • Regulatory requirements are the provisions of acts and/or regulations that must be complied with by a regulated party.
  • Policy requirements are the terms and conditions of a program established by the CFIA, to meet program or trade obligations that must be adhered to by a regulated party in order to benefit from the privileges outlined in the program
  • Permission eligibility requirements are the regulatory, policy or foreign country requirement a regulated party must meet to be eligible for the permission (for example a licence, permit, export or phytosanitary certificate)

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 and export controls to meet importing country requirements. 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 and export controls 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 and/or ECP is required, obtain an up-to-date copy of the licence holder's PCP and/or ECP 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/non adherence 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/non adherence 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/non adherence 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/non adherence may be completed in a separate inspection case. The trigger for that inspection case will be "Incident Response". The entire Implementation Verification task still needs to be completed within the defined frequency for that licence holder
  • Where the potential non-compliances/non adherence 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 an inspection result 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 requirements by reviewing the Acts and Regulations and/or Food export control policy listed in each Implementation Verification task and using the outcome, performance criteria and verification activities as indicated in the Annexes. When the Food export control policy is listed, also review the importing country requirements.

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 4.5 – Assess inspection results, 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/non-adherence 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/non-adherence 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 an inspection result 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/non-adherent situations when determining if there is a non-compliance/non-adherence 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/non-adherence

For food, more than one regulatory or policy reference can be captured in an inspection result record. The 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 inspection result 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 task 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 inspection result record.

When the Implementation Verification task is assessing adherence to importing country conditions all policy reference(s) and objective evidence which supports the non-adherence(s) should be documented in one inspection result record.

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-adherence was found with Japanese specific requirements
  • Foreign country requirements – China (meat); non-adherence was found with Chinese specific requirements

There will be 3 inspection result records created, one for each of the implementation verification task conducted.

Refer to section A.5 Step 2 – Conduct the inspection of SIP, Annex A (RDIMS 23722894) 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/non-adherence

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

For non-adherence, the categorization should also be based on the sum of all the documented objective evidence within that inspection result record.

When verifying compliance or adherence using the tasks found in Annex 2 – Export food – Implementation Verification tasks, identified non-compliances or non-adherences can have a maximum timeframe for the completion of corrective measures of 60 days.

If there is a risk of injury to human health, the inspector should review section 6.1 – Table 1 of the Operational Procedure: Procedures for suspending and lifting the suspension of a Safe food for Canadians licence and should consult with supervisor to determine if management are considering immediate suspension prior to finalizing and issuing the inspection report (if so, no corrective action due date must be given).

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 (if required). In addition to the general guidance provided in SIP, the following applies to this OP:

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
  • Authorities: the connections to regulatory or policy requirements and supporting information. Other regulatory references not listed may be used, if applicable
  • Outcome: a state where the PC/export controls achieve 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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