Questions and Answers for Industry on the Compliance with Schedule I and II of the FIR Project

Q1: Why is the CFIA updating guidelines?

Canadians and Canada's trading partners expect the CFIA to maintain an effective program to verify that fish and seafood products on the market here or exported abroad are safe, wholesome, properly identified and produced under sanitary conditions. As part of its ongoing commitment to improve inspection activities, these guidelines were developed by CFIA to help industry maintain a high level of compliance with FIR.

Q2: What is CFIA doing to update the Quality Management Program (QMP)?

The CFIA is updating guidelines to help industry better understand existing regulatory requirements. The industry guidelines describe the acceptable levels of compliance with Construction and Equipment (Schedule I) and Operation (Schedule II) requirements. In addition, guidelines for the development and implementation of effective CAP are being introduced. These guidelines will supplement the materials that already exist in the Facilities Inspection Manual.

Q3: How will the updated guidelines for the construction and operation of registered establishments provide a better understanding of existing requirements?

The updated guidelines for construction and operation of registered establishments provide:

• details of the requirements,
• a description of common deficiencies, and
• the method that CFIA will use to verify that the number and types of deficiencies are within an acceptable level of compliance.

The updated guidelines will be accompanied by a self assessment form that industry can use as part of their QMP monitoring activities to verify that the establishments are constructed and operated in accordance with the regulations.

Q4: How will the updated guidelines for CAP provide a better understanding of existing requirements?

The updated guidelines for CAP describe the criteria for the development and implementation of CAP that industry need to develop when CFIA inspectors identify non-conformities with the QMP Reference Standard. The guidelines clarify the dual role of CAP to fix problems and prevent them from recurring. The new guidelines for CAP set a clear time period for their development of 30 days, and provide clear descriptions of the requirements that must be met for the design and implementation of acceptable CAP.

Q5: Why do the updated methods focus on compliance with construction and operation requirements?

Registered establishments are required to comply with the construction and operation requirements described in Schedules I and II of the FIR. Compliance with the regulations is to be maintained through the application of the establishment's QMP Plan. In the case of construction and operation requirements, the controls through Prerequisite Plan maintain compliance. A well functioning Prerequisite Plan is an important part of the establishment's HACCP Plan as it provides the controls for food safety hazards that are common to all types of food production environments. Furthermore, the evaluation of Canada's Fish Inspection Program during foreign audits, includes visits to establishments to observe the level of compliance to these construction and operation requirements.

Compliance with requirements to maintain effective Prerequisite controls is important for fish processors to be able to provide safe wholesome fish to consumers, both in Canada and those abroad. Additionally, the CFIA's ability to continue to provide export guarantees (i.e., certification and export lists) about the conditions to produce safe fish depends on compliance of the Prerequisite Plan.

Q6: Does this mean that the FIR are changing?

No. There are no changes to the FIR or QMP.

Q7: How will CFIA evaluate compliance with construction and operations requirements?

The CFIA will continue to evaluate the construction and operation of facilities by delivering compliance verification (CV) audits, following the process that is used today. The inspection process has been updated with the introduction of a clearly defined CV task.

The CV task includes a standardized worksheet that all inspectors will use to evaluate compliance with construction and operation requirements. This CV task is designed to verify that the establishment's controls for construction and operation meet the requirements for a Prerequisite Plan described by the QMP Reference Standard. The inspector will perform this task by identifying the numbers and level of severity of deficiencies with the standard for construction and operation of registered establishments set by Schedules I and II of the FIR. The inspector will then determine the level of compliance with the regulations with consideration of the total number of deficiencies and their potential for creating unsanitary processing conditions.

Q8: What is an acceptable level of compliance?

Compliance levels A or B meet the standard set by the FIR, Schedule I and Schedule II. Any deficiencies with the standard set by the regulations must be corrected. Furthermore, CAP may still be required if the QMP Plan did not meet QMP Reference Standard requirements.

Q9: What happens if the level of compliance is unacceptable?

Unacceptable levels of compliance are levels C or D. This indicates that the QMP Plan was not effective in maintaining compliance with Schedules I and II of the FIR. The CV team will evaluate the objective evidence to identify the QMP Reference Standard requirements that were not met in assigning the non-conformity.

The appropriate level of non-conformity will be assigned depending on the objective evidence that the inspector gathered during the CV. In the case of compliance level D, or any other objective evidence that indicates that there is a significant risk of contamination with a resulting critical non-conformity, processing must stop until the conditions have been corrected. This is consistent with the existing procedures that are followed when inspectors identify a critical non-conformity.

Q10: What should operators of registered fish processing establishments be doing?

Establishments must comply with all applicable parts of the FIR to be registered. This includes the requirements for a QMP Plan that complies with the QMP Reference Standard and maintaining the establishment according to the standard for construction and operation set by Schedules I and II of the FIR.

Operators should use the updated guidelines and the self assessment form to ensure that their establishments are constructed and operated at an acceptable level of compliance, and take immediate corrective actions if necessary. Also, as required under their QMP Plans, operators are expected to develop and document the corrective actions that will be taken to correct any deficiencies, as well as any problems with the QMP Plan.

CFIA inspectors are available to assist operators with any questions about the updated guidelines. Please contact your local CFIA Fish Inspection Office if you require assistance.

Q11: Will industry be required to re-write their QMP Plan?

No. This work does not introduce new requirements. The requirements set out by the FIR and the QMP Reference Standard remain the same. The CFIA will continue with its existing regulatory verification approach to verify that the QMP Plan is effective in maintaining compliance with the FIR. However, if the CV team identifies a non-conformity, then the fish processor may need to amend the QMP Plan as part of their CAP to bring the QMP Plan back into conformity with the QMP Reference Standard

Q12: When and how will CFIA implement these changes?

The CFIA will deliver "focused Compliance Verifications (CV)" at all registered establishments, starting April, 2010. The CVs will include the evaluation of the establishment's Prerequisite Plan to verify that controls maintain an acceptable level of compliance with the requirements set out by Schedules I and II of the FIR. The CFIA will then perform follow-up CV's to verify that CAP have been followed, and were effective in maintaining compliance with the regulations.

Q13: How will CFIA take enforcement actions?

Enforcement actions will be taken if the operator of the establishment is not willing or able to develop or implement acceptable CAP.

Procedures to suspend the certificate of registration will be taken if either:

• An acceptable CAP was not developed within the permitted timeframe; or
• The Follow-up CV finds that the CAP was not effective in maintaining the minimum acceptable level of compliance with Schedules I and II of the FIR.

If the facility is assessed as having a Schedule I and II level of compliance that results in a critical non-conformity, processing must cease.

The CFIA will work with operators of establishments who are willing and able to develop and implement CAP that are effective in maintaining compliance with the FIR.

Q14: How will this improve QMP?

The updated methods will improve compliance with Schedules I and II of the FIR and ultimately the implementation of QMP by:

• providing additional guidelines to help industry understand the standard set by Schedules I and II of the FIR in terms that they can include with their QMP Plan;
• allowing industry to improve their monitoring of their Prerequisite Plan controls to maintain compliance with Schedules I and II of the FIR as they will have a better understanding of the conditions that must be met;
• encouraging industry to be proactive and correct problems in advance of CFIA regulatory verification activities;
• reminding establishment management of the obligation to develop and implement CAP that not only repair deficiencies, but also improve the Prerequisite Plan in accordance with the QMP Reference Standard; and
• reinforcing that as a condition of registration, the establishment is to be operated in accordance with its QMP Plan.