Schedule I and II - Regulatory Verification Process

1. Purpose

The purpose of this document is to describe the process that is implemented by the CFIA to verify that registered fish processors are complying with the requirements of Schedules I and II of the Fish Inspection Regulations (FIR).

2. Scope

This process is part of the regulatory verification of all fish processors registered under the authority of the Fish Inspection Regulations.

3. Process Descriptions

3.1 New Establishment Registration

The following describes the regulatory verification activities as applied to new establishment registrations:

System Verification (SV)

The SV process focusses on assessing the Quality Management Program (QMP) documentation requirements for the establishment to be registered. The SV process is described in Chapter 3, Subject 2 of the Facilities Inspection Manual (to be developed).

Schedule I Inspection

Once the submitted QMP has been determined to be acceptable through the SV process, a Schedule I inspection of the facilities will be conducted.

Facilities must achieve a Level of Compliance of "A" on their Schedule I inspection in order to be considered for registration. Processors not achieving a Level of Compliance of "A" on their Schedule I inspection will be given the opportunity to correct the deficiencies found during the inspection.

A registration certificate can be issued once the facilities achieve a Level of Compliance of "A" on the Schedule I inspection.

3.2 Registration Renewal, Re-Activation or Amendment

Although a Schedule I inspection of the facilities is not always required prior to registration renewal, re-activation, or amendments, if it has been determined that the inspection is necessary then it should be scheduled as soon as possible after the application has been received from the processor.

A Schedule I inspection conducted for these purposes must result in a Level of Compliance of "A" or "B" in order to proceed. Processors not achieving a Level of Compliance of "A" or "B" on this Schedule I inspection will be given the opportunity to correct the deficiencies found during the inspection.

3.3 Registered Establishments

The following describes the regulatory verification activities as applied to registered establishments.

Compliance Verification (CV)

A Schedule I and II inspection is a regulatory verification tool used by an inspector during a Compliance Verification that includes the establishment's Prerequisite Plan in the scope. For procedures in conducting a Compliance Verification see "Chapter 3, Subject 3" of the Facilities Inspection Manual.

It should be noted that Schedule I and II deal with requirements found in the "Construction and Equipment", "Sanitation and Personal Hygiene" and "Pest Control" sections of the QMP Plan's Prerequisite Plan. Therefore, all three of these sections are to be included within the scope of the CV.

Conduct Schedule I and II Inspection Task

The Schedule I and II inspection task shall be conducted (refer to Procedures for Schedule I and II Compliance Assessment document). The "Slice Approach" described in the Facilities Inspection Manual, Chapter 3, Subject 3, section 3.1 is not to be used to complete this task. This means that Schedule I and II inspections are to be conducted on the entire registered facilities.

The Facility Inspection Report shall be completed and the resulting Level of Compliance shall be recorded as objective evidence in the CV task list along with any other objective evidence found during the CV as a result of other tasks such as observations, interviews, record reviews, etc.

Level of Compliance of "A" or "B"

A Schedule I and II inspection result of "A" or "B" is considered to be an acceptable Level of Compliance.This Level of Compliance result, along with the completed Facility Inspection Report, will be communicated to the establishment as soon as possible. The inspector will include the Level of Compliance in the objective evidence of their compliance verification and will then complete the remainder of the tasks in their task list in order to complete their assessment of the QMP Plan. The assessment of the QMP plan will continue as per procedures identified in the Facilities Inspection Manual, Chapter 3, Subject 3 and so, for example, if the facility has identified all of the deficiencies and has appropriate corrective actions in place, a non conformity may not be justified. If, however, the QMP has failed to identify some or all of the deficiencies or if no or inappropriate corrections are planned, the deficiencies identified in the inspection report must still be addressed by the establishments' QMP within 30 days from the date that they submit an acceptable Corrective Action Plan (refer to Corrective Action Plan Standard).

Upon completion of the CV, an exit meeting will be conducted in accordance with the Facilities Inspection Manual (Chapter 3, Subject 3, section 3.12). If no non-conformities have been assessed the CV is acceptable.

If one or more non-conformities have been assessed the processor has the right to appeal the results and should they exercise this right, existing appeal procedures should be followed. If no appeal is requested, an acceptable CAP must be submitted within 30 days in accordance with the Corrective Action Plan Standard and evaluation procedures and includes a commitment to correct deficiencies in both the establishment and the QMP within 30 days after the CAP is accepted. If an acceptable CAP has not been achieved, the CV is unacceptable and the CFIA will initiate procedures to suspend the certificate of registration as described by the Procedures for Suspending a Certificate of Registration, Fish Export Licence or Fish Import Licence.

Level of Compliance of "C"

A Schedule I and II inspection result of "C" will be considered to be an unacceptable Level of Compliance and will result in a non conformity because the QMP Plan was ineffective in maintaining compliance with Schedule I and/or II. This Level of Compliance result, along with the completed Facility Inspection Report, will be communicated to the establishment as soon as possible. The inspector will include the Level of Compliance result in the objective evidence of their compliance verification and will then complete the remainder of the tasks in their task list in accordance with the Facilities Inspection Manual (Chapter 3, Subject 3, sections 3.5 to 3.8) to identify the requirements of the QMP Reference Standard that were not met. This will explain why the QMP Plan was not effective in maintaining compliance with the requirements for registration set out by the FIR, Schedule I and II. The inspector may issue a critical non conformity if justified by the additional objective evidence.

When the level of Compliance for Schedule II is assessed as "C", the deficiencies identified must be corrected prior to the exit meeting. At the exit meeting, the processor will provide the CFIA with the "Processors Self Evaluation Form" indicating that the facility has been brought into compliance (Compliance Level A or B) with Schedule II. Failure to submit the self assessment will result in a request for voluntary closure which, if refused, will initiate procedures to suspend the certificate of registration as described by the Procedures for Suspending a Certificate of Registration, Fish Export Licence or Fish Import Licence.

Upon completion of the CV, an exit meeting will be conducted in accordance with the Facilities Inspection Manual (Chapter 3, Subject 3, section 3.12). A Non Compliance Letter (which will contain a warning) will be issued to the processor advising them that they have 30 days from the date they submit an acceptable CAP in order to correct both the system based problems with their QMP Plan as well as the deficiencies in the establishment that will bring their establishment into compliance with Schedule I (they have already identified and corrected those for schedule 2)

The processor has the right to appeal the results and should they exercise this right, existing appeal procedures found in "Procedures for Responding to an Appeal" should be followed. If no appeal is requested, an acceptable CAP must be submitted within 30 days in accordance with the Corrective Action Plan Standard and evaluation procedures and includes a commitment to correct deficiencies in both the establishment and the QMP within 30 days after the CAP is accepted. This is in addition to the self evaluation which was submitted for Schedule 2 at the exit meeting. If an acceptable CAP has not been achieved, the CV is unacceptable and the CFIA will initiate procedures to suspend the certificate of registration as described by the Procedures for Suspending a Certificate of Registration, Fish Export Licence or Fish Import Licence.

If an acceptable CAP is achieved, upon its implementation, the processor must complete a Schedule I and II inspection of their facilities and then complete the "Processors Self Evaluation Form" which will be submitted to CFIA within the 30 day deadline. Failure to submit the "Processors Self Evaluation" will result in the CFIA initiating procedures to suspend the certificate of registration as described by the Procedures for Suspending a Certificate of Registration, Fish Export Licence or Fish Import Licence.

Establishments that have had their certificates of registration suspended as a result of non-compliance with Schedule I and II will have restricted access to certificates until such time as the registration certificate has been re-instated.

An unannounced follow up CV (refer to Evaluation of CAP Implementation Procedures document) which is focussed on that portion of the prerequisite program that had rated "C"(Schedule I, Schedule II or both) will be conducted by CFIA as soon as possible after the 30 day deadline (i.e., 30 days after acceptance of CAP) to verify that the facilities are in compliance and have a Level of Compliance of "A" or "B" and that the QMP systems have been corrected. If this follow up determines that the CAP has not been implemented or was not effective, the CFIA will initiate procedures to suspend the certificate of registration as described by the Procedures for Suspending a Certificate of Registration, Fish Export Licence or Fish Import Licence.

The CFIA will consider extensions to the 30 day time frame described under the following conditions:

• the establishment requires extensive repairs to achieve compliance with Schedule I and II, and these repairs cannot be scheduled during the 30 day time frame.
• the establishment has corrected a sufficient number of deficiencies to attain a Level of Compliance of "A" or "B".
• the establishment has made amendments to their QMP Plan to identify the additional actions that they will take to manage the deficiencies in the interim and protect fish from contamination

Requests for time frame extensions must be made in writing and will be reviewed by the Core Review Group to determine if the request is reasonable.

Level of Compliance of "D"

A Schedule I and II inspection result of "D"will be considered to be an unacceptable Level of Compliance and will result in a critical non conformity because the QMP Plan was ineffective in preventing conditions that could have, or have, resulted in contamination of the fish. This Level of Compliance result, along with the completed Facility Inspection Report, will be communicated to the establishment as soon as possible.

A registered establishment is not permitted to operate with an unacceptable "D" Level of Compliance and must immediately cease all operations. The CFIA will initiate procedures to suspend the certificate of registration as described by the Procedures for Suspending a Certificate of Registration, Fish Export Licence or Fish Import Licence unless the processor agrees to voluntarily cease all operations (Voluntary Closure).

The processor has the right to appeal the results and should they exercise this right, existing appeal procedures found in "Procedures for Responding to an Appeal" should be followed. If no appeal is requested, the "Voluntary Closure" status will be permitted to continue if the critical non conformity can be corrected within 5 business days. This will be determined by the submission of immediate corrective actions which deal specifically with the critical non conformity. If the critical non conformity cannot be corrected within 5 business days, they may request that they be placed into "inactive " status. If they do not request "inactive" status or if the corrective actions submitted are not acceptable, the CFIA will initiate procedures to suspend the certificate of registration as described by the Procedures for Suspending a Certificate of Registration, Fish Export Licence or Fish Import Licence

Once the critical non conformity has been corrected and the establishment has been brought to a Level of Compliance of "A" or "B", the establishment must submit an acceptable Schedule I and II self evaluation (within the terms of the corrective actions) which will initiate a CFIA follow up and completion of any remaining CV activities. The facility can resume operations when CFIA has conducted its follow up and verified that the facility is at the "A" or "B" Level of Compliance.

Upon completion of the CV, an exit meeting will be conducted in accordance with the Facilities Inspection Manual (Chapter 3, Subject 3, section 3.12). The processor has the right to appeal the results and should they exercise this right, existing appeal procedures should be followed. If no appeal is requested, an acceptable CAP must be submitted within 30 days in accordance with the Corrective Action Plan Standard and evaluation procedures and includes a commitment to correct deficiencies in both the establishment and the QMP Plan within 30 days after the CAP is accepted. If an acceptable CAP has not been achieved, the CV is unacceptable and the CFIA will initiate procedures to suspend the certificate of registration as described by the Procedures for Suspending a Certificate of Registration, Fish Export Licence or Fish Import Licence.

The CFIA will consider extensions to the 30 day time frame described under the following conditions:

• the establishment requires extensive repairs to achieve compliance with Schedule I and II, and these repairs cannot be scheduled during the 30 day time frame.
• the establishment has corrected a sufficient number of deficiencies to attain a Level of Compliance of "A" or "B".
• the establishment has made amendments to their QMP Plan to identify the additional actions that they will take to manage the deficiencies in the interim and protect fish from contamination

Requests for time frame extensions must be made in writing and will be reviewed by the Core Review Group to determine if the request is reasonable.