Operational procedure: Food preventive control inspection – Implementation verification

On this page

• 1.0 Purpose
• 2.0 Authorities
• 3.0 Reference documents
• 4.0 Definitions
• 5.0 Acronyms
• 6.0 Operational procedure
  • 6.1 Prepare for inspection
  • 6.2 Conduct the inspection
    • 6.2.1 Confirm the scope
    • 6.2.2 Conduct the verification activities
    • 6.2.3 Impact assessment
    • 6.2.4 Document the non-compliance
    • 6.2.5 Categorise the non-compliance
  • 6.3 Communicate the results
  • 6.4 Conduct follow-up
    • 6.4.1 Assess follow-up inspection results
• 7.0 Annexes: Food implementation verification tasks
  • Annex 1 – Domestic food - Implementation verification tasks
  • Annex 2 – Export food - Implementation verification tasks

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 Certification Control Program (ECCP) Plan.

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

• Safe Food for Canadians Act (SFCA)
• Safe Food for Canadians Regulations (SFCR)
• Health of Animals Act (HAA)
• Health of Animals Regulations (HAR)
• Food and Drugs Act (FDA) (as it relates to food)
• Food and Drug Regulations (FDR) (as it relates to food)

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:

• Documents incorporated by reference have the same force of law as the regulations in which they are incorporated.
• Standard inspection process (SIP) is required in order to apply this OG
• Industry guidance (IG) provides guidance for inspectors, partners and stakeholders to comply with applicable acts and regulations
• Food export requirements library and the Meat Export Electronic Certification (meat only) outline destination country requirements which a licence holder need to meet when exporting. They include conditions the Canadian government has accepted for issuing export certificates. Their purpose is to facilitate access to overseas markets for Canadian exporters
• Export control policy outlines the principles CFIA follows as Canada's competent authority to verify compliance and certify food commodities for export. The policy also clarifies the responsibilities of exporters of food commodities
• Other references can be consulted when assessing compliance such as the model systems which are examples of a preventive control plan (PCP) approach. For example, the Codex Alimentarius general principles of food hygiene, which is utilized by the international food industry to ensure food is prepared under sanitary conditions and is safe to eat and on which many PCP approaches, including the former Food safety enhancement program (FSEP) and the Quality management program (QMP), are based. The licence holder must ensure that the guidance they choose to follow is relevant to their particular business, product(s) and market requirements

Note:

• Inspectors should consult both the IG documents as well as the OG documents
• Inspectors can search for IG and externally posted OG documents on specific topics using the Guidance Finder: Food
• Although the IG documents are not regulatory, these documents provide guidance to industry to help them achieve compliance and to inspectors to assess compliance against regulations

4.0 Definitions

Definitions are located in the documents listed below or as a defined word where it is intended to supersede the definitions within the glossary documents:

• My CFIA Glossary of terms
• Safe Food for Canadians Regulations: Glossary of key terms

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 operational procedure 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 notwithstanding of what is indicated in the SIP.

The tasks focus on control measures that must be verified at frequencies not informed by the Establishment-based risk assessment (ERA) model. Refer to the Program Direction: Preventive control inspection frequencies for food (accessible only on the Government of Canada network - RDIMS 11010733) to determine when to conduct these tasks.

6.1 Prepare for inspection

Refer to SIP section 3, 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 tool to determine if a licence holder needs a written PCP
• Where a written PCP is required, obtain an up-to-date copy of the licence holder's written 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 inspections which are part of a work plan (trigger: preventive control inspection (PCI) plan), the required entire task(s) will be assessed within the prescribed timeframes
• For inspections which are not part of a work plan (trigger: incident response), it may be acceptable to complete only the part of the implementation verification task(s) linked to the reason for this inspection
• When entering the inspection task 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

6.2 Conduct the inspection

Refer to SIP, section 4, Step 2 – Conduct the inspection. In addition to the general guidance provided in SIP, the following applies.

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 task has already been completed within the current defined frequency of inspection, only the applicable section(s) of the task related to the observed non-compliance will be completed in a separate case. The trigger for that case will be "Incident response"
• Where the entire 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
• Where the entire 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 non-compliance may be completed in a separate case. The trigger for that case will be "Incident response". The entire tasks still needs to be completed within the defined frequency for that licence holder

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 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 written PCP in place. If during the preparation of the inspection, it is determined that a licence holder is required to have a written PCP, however they do not have one, this may constitute a non-compliance to SFCR 86. Refer to SIP, section 4.6 – Determine compliance, for further guidance.

As per SFCR 47, all licence holders (regardless of whether they require a written PCP or not) are required to identify and analyse hazards and prevent, eliminate or reduce the identified hazards to an acceptable level using control measures shown by evidence to be effective.

Where a written 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 written 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 PCI, 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 – Compliance verification of a system.

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

6.2.3 Impact assessment

For Implementation verification tasks, "impact assessment" must be completed in DSDP as it is a mandatory field; DSDP data entry requirement is as follows:

1. In the 'Is Non-Compliance Observed?' field of the inspection task screen:
   • If non-compliance has not been observed:
     • Select 'No'
     • Impact assessment is not conducted
   • If non-compliance has been observed
     • Select 'Yes'
     • Proceed to enter the impact assessment result
2. Select "No Impact" in the 'Impact Assessment' field of the inspection task screen
3. Continue data entry process

6.2.4 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 50 to 81; SFCR 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) needs to maintain and operate what (establishment) according to which requirements (SFCR 50-81)
• If there is a non-compliance with SFCR 89; SFCR 86 should also be referenced in the same non-compliance record as that is the regulation which actually requires the licence holder to have a PCP that meets the provisions of SFCR 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 Verification implementation 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.

6.2.5 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 related to the export of meat products can have a maximum timeframe for the completion of corrective measures of 60 days, including non-compliances categorized as minimal.

6.3 Communicate the results

Refer to SIP, section 5, Step 3 – Communicate the inspection results. In addition to the general guidance provided in SIP, the following applies:

• It is the responsibility of the licence holder to implement interim corrective measures to mitigate any risks to human health, animal welfare, food misrepresentation or trade immediately. These interim corrective measures are documented in the closing meeting notes
• In addition to the inspection report generated from DSDP, if there are regulatory non-compliances identified, complete a cover letter to accompany the inspection report when communicating the results of the inspection to a licence holder
• This letter is a necessary part of the written report that must be provided to a licence holder to satisfy the requirements of SFCR 36(1)
• This cover letter must set out the grounds for a suspension and the period within which corrective action must be taken in order to avoid a suspension
• A Template covering letter for food inspection reports (accessible only on the Government of Canada network – RDIMS 12787033) is available for this purpose
• This cover letter is not required for non-regulatory non-compliances associated with foreign country requirements

6.4 Conduct follow-up

Refer to SIP, section 6, Step 4 – Conduct the follow-up inspection. In addition to the general guidance provided in SIP, the following applies to this OG:

• For every non-compliance record, create a follow–up case in DSDP to record follow-up details by selecting "Create follow up" from the non-compliance record within the parent case. Ensure that the "Due date" in the follow-up case in DSDP matches the "Complete corrective action by" date, found in the non-compliance record. The follow-up should be scheduled as soon as possible following the licence holders corrective action due date
• 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 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

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
• creates a non-compliance record ensuring the objective evidence includes the date and findings from that date
• 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

The follow-up inspection case must remain open until compliance is re-established and can only be closed (deactivated) once follow-up inspection activities and the appropriate control and/or enforcement actions are complete. As the case cannot be closed (deactivated) at this time, the inspection report must be issued by other means than through the portal (such as in person/email/fax).

If subsequent follow-up inspections are required, create a new inspection task record 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.

7.0 Annexes: Food Implementation verification task

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.

• Annex 1 – Domestic food - Implementation verification tasks
• Annex 2 – Export food - Implementation verification tasks