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Food Safety Enhancement Program Manual

Chapter 3: Recognition of an Establishment's HACCP System

Section 1 - Introduction

This chapter details the process CFIA staff follows to recognize an establishment's HACCP system under voluntary FSEP. For commodities for which FSEP is mandatory, please refer to Appendix VIII.

When it requests recognition, a registered establishment must already be conducting its operations under a HACCP system for all products in Risk Categories I and II. Within one year from the date of recognition, the company must incorporate non-registered lines and products in Risk Category III into its HACCP system.

The establishment's HACCP system must be reviewed by a CFIA team that includes a responsible inspector and a lead auditor, both of whom are trained in FSEP/HACCP. The team may include other members, and they must also have the appropriate scientific knowledge and commodity expertise.

The purpose of this review is to determine whether the establishment's prerequisite programs, HACCP plans and HACCP system reassessment procedures are complete (i.e. meet FSEP and regulatory requirements, etc.), and are implemented effectively as described.

The Agency recognizes that companies invest time and resources in developing their customized HACCP systems; we treat each system as proprietary to the company that developed it.

For multi-commodity registered establishments that process agri-food, fish and seafood products, the Agency will evaluate their HACCP systems using the FSEP/QMP Audit Policy for Multi-Commodity Establishments, outlined in Appendix VII.

Section 2 - Steps in recognizing an establishment's HACCP system

The process covers nine steps, as follows (for a flow diagram of the recognition process, please see Figure 1):

1. The establishment's management submits a letter of commitment.
2. The CFIA (the Agency) holds a pre-meeting with the establishment's management.
3. The establishment submits a written notice to the Area FSEP/HACCP Coordinator indicating that the self-evaluation has been completed.
4. The establishment submits a documentation package.
5. The Agency reviews the establishment's written prerequisite program.
6. The Agency reviews the establishment's written HACCP plan(s).
7. The Agency reviews the establishment's written reassessment procedures for its HACCP system.
8. The Agency conducts at least two regulatory system audit of the company's HACCP system. A third audit may take place as necessary.
9. The Agency issues official notification recognizing the company's FSEP/HACCP status.

Agency staff will refer to the following criteria as they track the recognition process on Appendix I, FSEP Recognition Tracking Form.

2.1 - The establishment's management submits a letter of commitment

To begin the recognition process, an establishment must submit a letter of commitment to the CFIA's Area FSEP/HACCP Coordinator. The letter must:

• confirm corporate commitment and full support for developing, implementing and maintaining the establishment's HACCP system;
• indicate that adequate training and resources have been provided;
• request recognition by the CFIA; and
• be signed and dated by the establishment's senior management.

2.2 - The Agency holds a pre-meeting with the establishment's management

After receiving the establishment's letter of commitment, the CFIA will schedule a pre-meeting with the establishment to:

• provide information about the recognition process; and
• review a random selection of components from the establishment's written HACCP system.

2.3 - The establishment submits written notice to the Area FSEP/HACCP Coordinator indicating that self-evaluation has been completed

The establishment must conduct an internal audit (and may use Appendices II and IV to do so) in order to ensure that its prerequisite programs and HACCP plans are being implemented and are effective. The company must have documentation available to support the internal audit. The company must submit a written notice to the CFIA (Area FSEP/HACCP Coordinator) indicating that the self-evaluation has been completed, in order to initiate the review of the written HACCP system. The establishment must have corrected any deficiencies identified during the internal audit (e.g. construction or ventilation concerns, etc.) or provided a plan of action to address such deficiencies.

2.4 - The establishment submits a documentation package

The establishment must provide the Agency with a documentation package that includes the following information (see Chapter 2 for details on each item). This package may accompany the letter of commitment.

2.5 - The Agency reviews the establishment's written prerequisite program

The Agency's audit team reviews the establishment's written prerequisite program. The team assesses each of the six documented prerequisite programs to determine if they are complete and presented in a format that can be audited. The written program must include or refer to all pertinent supporting documentation (e.g. equipment manufacturers' calibration instructions).

To be considered "complete", a written program must:

1. Meet FSEP and regulatory requirements
2. Answer the following questions:
   • What procedures (monitoring, deviation and verification) are followed to reduce or control the hazard?
   • How are these procedures conducted?
   • How often are the procedures conducted?
   • Who is responsible for conducting the procedures?
   • What are the records that confirm adherence to the written program?
3. Demonstrate document control by requiring:
   • that the first page of each prerequisite program document be signed by the HACCP coordinator or designated individual; and
   • that all pages be dated.

The CFIA audit team uses the FSEP Prerequisite Program Checklist (Appendix II) to review the establishment's prerequisite programs.

During its review of the written prerequisite programs, the audit team generates an audit checklist for the prerequisite programs. After reviewing all of the written programs, the Agency will use this checklist during its regulatory system audits (Chapter 4) for the on-site review of the establishment's prerequisite programs.

If the establishment's written prerequisite programs need to be amended, the Agency will provide the establishment HACCP coordinator with a detailed list of the written programs' deficiencies. Once the establishment has amended its written programs to meet FSEP and program requirements, the written prerequisite programs will be considered complete and the Agency will begin reviewing the establishment's HACCP plans.

Please note: While prerequisite programs control the environment, Critical Control Points (CCPs) provide in-process controls. Prerequisite programs do not substitute for CCPs, as they do not provide full control over hazards identified in the process (as in cooking, for example).

2.6 - The Agency reviews the establishment's written HACCP plan(s)

The Agency's audit team assesses each of the establishment's written HACCP plans to determine whether they are complete and presented in a format that can be audited.

The team evaluates the following for accuracy and completeness:

1. Product description(s)
2. List of ingredients
3. Incoming materials
4. Process flow diagram
5. Plant schematic
6. Products and processes (appropriately grouped and controlled following the appropriate generic model(s), if applicable)
7. Application of HACCP principles
8. Identification and analysis of hazards
   Please note: if the HACCP plan(s) do not address all hazards identified in the generic model, the establishment must provide documented support for its rationale.
9. Selection of CCPs
   Please note: if the CCPs differ from those identified in the generic model, the establishment must provide documented support for its rationale.
10. Critical limits.
    Please note: if the critical limits differ from those identified in the generic model, the establishment must provide documented support for its rationale.
11. Monitoring, deviation and verification procedures
12. Record keeping procedures

As well, the Agency audit team verifies that each HACCP plan meets the applicable regulatory requirements.

The CFIA audit team reviews the HACCP plan(s) using the FSEP/HACCP Plan Review and HACCP System Reassessment Checklist (Appendix IV).

During its review of the written HACCP plans, the audit team generates an audit checklist for the HACCP system. After reviewing all of the written programs, the Agency uses this checklist during its regulatory system audit (Chapter 4) for the on-site review of the establishment's Critical Control Points.

If the establishment's written HACCP plans need to be amended, the Agency will provide the establishment HACCP coordinator with a detailed list of the written program deficiencies. Once the establishment has amended its written programs to meet FSEP and program requirements, the written HACCP plans will be considered complete and the Agency will begin reviewing the establishment's reassessment procedures for its HACCP system.

Each page of your HACCP plan(s) must be dated and signed by the HACCP coordinator or the designated on-site liaison person. The HACCP plan shall be dated and signed:

1. upon initial acceptance;
2. upon any modification; and
3. at least annually, upon reassessment.

2.7 - The Agency reviews the establishment's written reassessment procedures for its HACCP system

In reviewing the establishment's procedures for reassessing its HACCP system, the audit team verifies that the reassessment procedures meet the guidelines described in Chapter 2, Section 5.

If the establishment's written reassessment procedures need to be amended, the Agency will provide the establishment HACCP coordinator with a detailed list of the written program deficiencies. Once the establishment has amended its written programs to meet FSEP requirements, the written reassessment procedures will be considered complete and the Agency will initiate regulatory system audits.

2.8 - Regulatory System Audit(s) for Recognition of the HACCP System

Regulatory System Audit(s) determine whether the HACCP system has been implemented as described and is effective. The audit(s) are initiated only after the Agency's team has deemed the establishment's written HACCP system complete.

Prior to recognizing an establishment, the Agency must:

• Complete a minimum of two Regulatory System Audits
• Confirm that all CARs for non-conformities are either closed or have an acceptable action plan in place
• Confirm that all Corrective Action Requests (CARs) for major non-conformities are closed.

The first Regulatory System Audit must take place soon (ideally, within one month) after the Agency completes it's review of the written HACCP system. The second Regulatory System Audit should take place approximately one month following the completion of the first audit.

The following conditions apply to Regulatory System Audits conducted for recognition purposes:

1. The audit team must include the responsible inspector
2. The audit scope includes (see Chapter 4):
   • Outstanding Corrective Action Requests (CARs), as required
   • Log Book
   • CCPs
   • Prerequisite Program Sub-elements.

The audit team selects CCPs and prerequisite program sub-elements to review as per Chapter 4, Section 6.2. However, the audit team must cover the following sub-elements prior to granting recognition:

• Sub-element A 2.1 Design, Construction and Maintenance
• Sub-element E 1.1 Sanitation Program
• Sub-element F 1.1 Recall Program

At the conclusion of the Regulatory System Audit, the audit team provides a written audit report to the establishment's management representatives. With it's report, the team includes Corrective Action Requests (CARs) issued as a result of the audit. An establishment may request a review of the results of a Regulatory System Audit (see Chapter 4, Section 3).

If a major non-conformity is identified, it must be closed prior to the second Regulatory System Audit being conducted to ensure that the integrity of the HACCP system has not been compromised.

If a major non-conformity is identified during the second Regulatory System Audit, but can be closed, the establishment is granted FSEP/HACCP recognition. If the major non- conformity cannot be closed, another Regulatory System Audit must be conducted to ensure that the integrity of the HACCP system has not been compromised. If the major non-conformity cannot be closed as a result of the third Regulatory System Audit or an additional major non-conformity is identified, the Area FSEP/HACCP Coordinator issues a notification letter to the establishment. This letter indicates actions the establishment's management must take to correct the non-conformity(ies) in order to be granted FSEP/HACCP recognition. Failure to make these corrections would terminate the recognition process.

Once all the conditions for recognition have been met, the Agency Recognition Team Leader completes the FSEP Recognition Tracking Form (Appendix I) recommending recognition, and forwards the form to the Area FSEP/HACCP Coordinator.

2.9 - The Agency issues official notification recognizing the company's FSEP/HACCP status

The FSEP/HACCP Coordinator reviews and signs Appendix I and forwards a copy to the appropriate Headquarters Program Chief. The Area Coordinator issues a written notice and a CFIA recognition certificate to the establishment's management. The Agency stamps, initials and dates all pages of the HACCP plan(s) and the first page of the prerequisite programs.

The CFIA maintains on file the following information related to the establishment:

• letter of commitment
• list of establishment HACCP team members
• list of products
• CFIA appendices
• CARs, if applicable
• regulatory system audit documentation

The Agency returns all other documents submitted by the establishment.

Figure 1. Recognition flowchart

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