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Archived - The Fish Import Program Regulatory Verification Process

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Table of Contents

1. Purpose

The purpose of this document is to describe the process that is implemented by the CFIA to verify that licenced fish importers are complying with the requirements of the Fish Inspection Regulations. This document also serves to describe the process implemented by CFIA to verify that the fish inspection program is effective in providing reasonable assurance that fish imported into Canada is safe.

2. Scope

This process applies to the holders or applicants of a Fish Import Licence (Basic importers) or Quality Management Program Import Licence (QMPI importer).

The regulatory verification system is applicable to all parties regulated by the Fish Inspection Regulations, however, this document relates only to fish importers.

3. Process Descriptions

3.1 Overview of the Import Program Regulatory Verification System

The Fish Inspection Program Regulatory Verification System outlines the activities CFIA carries out to verify that regulated parties are meeting their responsibilities and to assess the effectiveness of the Fish Inspection Program to meet CFIA's mandate.

The regulatory verification system has two components and each components has two activities as follows:

The schematic located in Appendix A of this document highlights the main aspects of the Regulatory Verification System for the fish inspection program

The following describes the regulatory verification activities as applied to the fish import program.

System Verification (SV)

The SV Process focusses on assessing an individual importer's compliance to the import license application and documentation requirements.

QMPI License

Applicants for a QMPI license must submit a complete QMPI license application package, including a documented Quality Management Program (QMPI Plan), as outlined in the Regulatory Directive for QMPI license holders. The SV process focusses on the assessment of the QMPI Plan to determine if the Plan is written in compliance with the requirements of the QMPI Reference Standard.

Fish Import License (Basic Importer)

Applicants for a fish import license must submit a complete fish import license application package, as outlined in the Regulatory Directive for Fish Import Licence Holders. The SV process focusses on an assessment of the Fish Import License application form, the importer's understanding of their license responsibilities and on the processes to meet regulatory requirements.

Compliance Verification (CV)

The CV Process focusses on assessing an individual importer's compliance to meeting the requirements of their licence.

For QMPI importers, the CV is used to assess if the importer is implementing their Quality Management Program and if it is effective in preventing the importation of non-compliant product. QMPI CVs are performed using a mix of audit and inspection activities.

For Basic importers, CVs consist of activities to verify if importers are complying with their licensing requirements such as importing product that meets FIR requirements, import notification, maintenance of records and documented processes (where required). CFIA will also conduct product inspections, in accordance with the Imported Fish Product Inspection Processes.

Program Verification (PV)

The PV is focussed on the assessment of the overall level of compliance of importers or specific import sectors to meet FIR requirements. On an annual basis CFIA determines the focus and scope of the PV activities. The assessment is done through surveys and monitoring activities.

Program Integrity (PI)

The PI is focussed on assessing the quality and delivery of the fish import program by CFIA. The assessment is done through the Quality Management System and analysis of the data from the CFIA information systems.

3.2 System Verification

3.2.1 Fish Import Licence Applicants

Applicants of a fish import licence (Basic importers) must submit a complete application package and provide information to the CFIA on how they will meet the import license requirements. CFIA will review the application package and additional information to ensure that it meets all the requirements. The CFIA will assess the importer's understanding of the license requirements and the importer's processes to import product that meets regulatory requirements.

3.2.2 QMPI Licence Holders and Applicants

Prior to licencing, QMPI Licence applicants must submit a QMPI Plan that meets the requirements of the QMPI Reference Standard. Once licenced, QMPI importers must submit QMPI plan amendments to CFIA for review and acceptance prior to implementation.

Initial Review

Upon receiving a QMPI Plan, CFIA checks the submission to determine if all 7 elements of the QMPI Reference Standard are included in the Plan. The "Notice of Receipt of a QMPI Plan" form is completed and shows if all 7 elements are included or if any of the elements are missing. The completed form is sent to the QMPI applicant. If any elements are missing, the QMPI plan is not assessed any further. If all elements are included, the CFIA continues reviewing the Plan.

Assessment of the QMPI Plan

The purpose of this assessment is to determine if the written plan meets the requirements of the QMPI Reference Standard. QMPI Plan submissions are deemed to be acceptable if all required control measures are included and if the controls are reasonable for their intended purpose.

Results of the SV

After completing the assessment of the QMPI Plan, a "QMPI Plan Evaluation Form" is completed. The form identifies if the QMPI Plan is acceptable or if revisions are required. If revisions are required, CFIA provides a brief explanation of why the Plan is not acceptable. The form is sent to the QMPI applicant. The QMPI applicant may re-submit the QMPI plan once the required revisions have been made.

System Verification of Amendments

When a QMPI importer submits amendments to their QMPI plan, the CFIA reviews only the amended portions as indicated by the importer. This review is to verify that the amended plan continues to comply with the requirements of the QMPI Reference Standard. QMPI importers are notified in writing whether or not the amendments are acceptable. QMPI importers may only implement amendments after they have been accepted by CFIA.

3.3 Compliance Verification

3.3.1 Fish Import Licence Holders (Basic importers)

At Licence renewal or in response to persistent compliance issues

Compliance verification of Basic importers is conducted once per year prior to the renewal of their import license or when there are concerns with the importer's ability to consistently meet FIR requirements.

The compliance verification consists of reviewing the importer's import product history, the compliance of their imported products and the importer's compliance to FIR requirements. The CV may include an inspection of the importer's records and documentation to verify that they are maintained in Canada and meet all FIR requirements.

If the compliance verification indicates a consistent pattern of not meeting FIR requirements, the importer will be required to take action which may include the development of a corrective action plan. If the importer is unwilling or unable to bring themself into compliance, enforcement actions will be taken which may include suspension, revocation or refusal to renew the license.

If the compliance verification indicates that the importer is complying with the Fish Inspection Regulations or has implemented corrective actions (if required), the import license remains in good standing and can be renewed.

3.3.2 QMPI Licence Holders

After Licencing

Compliance verifications of QMPI Licence holders are conducted on a regular basis. Compliance verifications are performed to verify that QMPI importers are implementing their QMPI Plan as written and that the Plan is effective in ensuring that only fish products meeting Canadian requirements are imported. CVs are performed by inspectors who are supported by other CFIA personnel such as supervisors and technical or program specialists. QMPI importers are usually informed about an upcoming CV in advance, however, the CFIA may perform an unannounced CV at any time.

Before the CV

In preparation for the CV, the CV team determines which elements of the QMPI Reference Standard will be assessed. A CV scope may include some or all of the Reference Standard elements. How long since the last CV was performed, the elements covered during the last CV and current compliance issues are factors used to determine which elements to cover.

After the scope of the CV has been determined, the QMPI importer is contacted to confirm if proposed dates for the CV are agreeable. The CFIA will attempt to work with the importer to establish mutually agreeable dates. If mutually agreeable dates cannot be established, the CFIA will establish the date and time of the CV. Depending on the scope and the complexity of the QMPI importer's operation, a CV may last one or several days.

CV's are conducted at one location. Unless the importer provides justification for another location, the CV is conducted at the address where all records are kept as indicated in the QMPI plan. CV team member(s) may conduct some audit and inspection activities at other locations if required by the CV scope (e.g., cold storages, inspections facilities).

The QMPI importer is sent a CV plan and Opening Letter that formally announces the CV and contains relevant information about the scope, time, dates, location and participants.

During the CV

A CV starts with an Opening Meeting between the CV team member(s) and QMPI importer management and applicable personnel. At the opening meeting, the CV team confirms logistics and explains how the CV will be performed including the issuance of non-conformities, reporting and follow-up.

During the CV, inspectors use a combination of audit and inspection activities to assess if importers are complying with the requirements of the QMPI Reference Standard. Examples of these activities include: Observing, inspecting, testing, measuring, interviewing and reviewing documents. Throughout the CV, QMPI personnel with responsibilities relevant to the scope of the CV must be available for interview and to facilitate the CV process. All QMPI records and documentation for the previous 36 months must be readily available for the duration of the CV.

Throughout the CV inspectors record their observations, results of inspection activities and interview responses in the form of objective evidence. If deficiencies are noted, the CV team informs the QMPI importer of the deficiencies either throughout the day or at the end of the day. QMPI management is encouraged to participate in end of the day meetings to review any deficiencies noted. If a deficiency has resulted or may result in the importation of unsafe or fraudulent product, the CV team will require that immediate corrective action be taken to address the critical non-conformity. If the importer is unable or unwilling to immediately correct the problem, enforcement action such as licence suspension or revocation may be applied.

After the CV

The CV team members review all the objective evidence collected during the CV. If deficiencies are noted, the team assesses the deficiencies and assigns non-conformities for system-related problems. Non-conformities are classified as a non-conformity or a critical non-conformity. The CV team records the non-conformities on a non-conformity report. The CV team also prepares an exit report which summarizes the result of the CV.

Once the exit report and all the non-conformity reports are completed, the CV team, QMPI management and applicable personnel participate in a closing meeting. During the closing meeting, the CV team presents the non-conformity reports and exit report to the QMPI management. The team and QMPI management discuss any questions or concerns regarding the non-conformities and the action required by the QMPI importer. A due date for submission of a corrective action plan (CAP) to CFIA is established. The CV team and QMPI management sign an exit report.

The exit meeting is usually conducted as a face to face meeting. However, if there are no non-conformities or upon request by QMPI management, a conference call may be held in lieu of a face to face meeting. This alternative may only be used if mutually acceptable to both the CFIA and QMPI management.

Corrective Actions and Follow up

If non-conformities are issued during a CV, the QMPI importer is required to develop corrective action plans for each non-conformity and submit them to CFIA. The corrective action plan must address the problems that gave rise to the non-conformity as well as actions to prevent future re-occurrences.

CV team members review corrective action plans submitted to assess if they are sufficient to correct the problem and prevent future re-occurrences. Once complete, the CV team informs the importer in writing whether or not the CAP is acceptable. If the CAP is unacceptable, the importer must amend their CAP and re-submit it for acceptance. The process is repeated until an acceptable CAP is submitted or the CFIA concludes that the importer is unable or unwilling to implement corrective actions. In the case of critical non-conformities, acceptable corrective actions must be implemented immediately.

After a CAP plan has been accepted by the CFIA, the CV team notifies the importer in writing that the CV is closed. The CFIA will verify the implementation of the CAP prior to or at the next scheduled CV. In the case of critical non-conformities, the verification is performed before the initial CV is closed.

3.4 Program Verification

Program Verification is the global compliance assessment of the industry. Program Verification consists of gathering evidence to determine if the program is effective and if the industry as a whole is compliant with the standards.

The CFIA assesses the overall level of compliance of the industry or specific sectors through monitoring programs and surveys. The information gathered through these monitoring programs and surveys provides the CFIA with the objective evidence to determine if the program as designed and delivered provides reasonable assurance that Canadian standards and requirements are met.

QMPI importers are responsible for verifying that their imported product meets regulatory standards. FSPD develops on an annual basis a product monitoring sampling plan to verify the effectiveness of the QMPI program. In accordance with the sampling plan targets, samples are taken at random from QMPI importer's and sent to the laboratories for analysis. Because these are monitoring samples, the lots are usually not detained. FSPD uses the results of the annual product monitoring program to make the appropriate program and sample monitoring plan adjustments.

For the Basic import program, the CFIA conducts product CV inspections to verify that Basic importers are importing product that consistently meets regulatory standards. These product CV inspections are focussed on individual Basic importers. Where a product type has a good product compliance record, FSPD may shift the verification from CV samples of individual importers to monitoring samples as part of Program Verification.

In addition to the annual monitoring sampling plan testing, additional testing may be performed as a survey. Surveys are generally conducted to investigate an area of concern or to collect additional data to gain information. For example, surveys may be used to assist Health Canada in the establishment of appropriate standards and tolerances.

3.5 Program Integrity

Program Integrity is an assessment of the quality of the delivery of the Fish import program by the CFIA. The assessment includes an assessment of: the quality of the documentation (clarity, completeness and up to date); the consistency and effectiveness of enforcement activities; the level and adequacy of training; the timeliness and effectiveness of communication; and the level of program delivery. The assessment is conducted through the Quality Management System and an analysis of the information / data in CFIA information systems.

Appendix A - Regulatory Verification System

Click on image for larger view
Regulatory Verification Process. Description follows.

Graphic - Regulatory Verification Process

This is a schematic of the regulatory verification system. There are two components: regulated parties and Program.

For the regulated parties, the regulatory verification consists of a system verification, which focuses on the assessment of the documented Quality Management Plan and a Compliance Verification to assess the implementation and effectiveness of the written Quality Management Plan, which is done through audits and inspection.

The second component is the global assessment of the industry / sector, i.e. gathering evidence that the program as designed and delivered is effective. This is done through surveys and monitoring programs, in areas such as product, process controls / HACCP, Facility construction, water, vessels, UHHT (unloading, handling, holding and transportation).

Document Type: Process Document / Status: Version 1
Date: April 1, 2009 / Review Date: March 31, 2010

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