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Food Safety Enhancement Program Manual

Printer-friendly PDF version - Appendix IV

Appendix IV - FSEP/HACCP Plan Review and HACCP System Reassessment Checklist

Section 1. Product Description - Reference Chapter Two, section 4.2

1.1 - All individual products are identified by brand name and/or common name in the HACCP Plan. The like products are grouped in an acceptable manner and this matches the information on the "List of Products" provided in the document package.

1.2 - All characteristics of the product(s) which are important to ensure it's safety are listed e.g., pH and a _w .

1.3 - The HACCP plan includes a description on how the product is to be used, e.g., ready to eat/ready to cook.

1.4 - All types of packaging material and packaging conditions used for the product line(s) are identified e.g., drums, pails, modified atmosphere etc. It is accurate and complete for all products listed in the HACCP plan.

1.5 - The anticipated shelf life of the product(s) listed under normal marketing conditions at given temperatures and/or humidity levels is identified, if applicable.

1.6 - The HACCP plan indicates where the product(s) is to be sold e.g., restaurant, retail, institution, further processing etc. Any sensitive populations/target groups (e.g., senior citizen homes, hospitals and baby food) is identified on the HACCP plan.

1.7 - Any safe handling and usage information pertinent to the product is indicated in the HACCP plan e.g., cold storage instructions, best before date, etc.

1.8 - The HACCP plan includes a description of any special controls required during shipping and storage e.g., temperature and humidity requirements, if applicable.

1.9 - Review Task: The label for each product is available upon request. Select one label at random (choose a formulated product if any are included in the HACCP Plan)and compare the selected label to the following information on Form 1: "Product Name", "Intended Use", "Safe Labeling Instructions" and "Special Distribution Control". If a deviation is found, select at least one more label for review. If an additional deviation is found, stop sampling and ask the company to review all its labels for this HACCP Plan.

1.10 - Review Task: This task applies only when there are formulated products. The formulations are available upon request. Select one formulation/method of preparation that corresponds to the label(s) sampled under 1.9 and review to determine if the "Important Product Characteristics" and "Safe Labeling Instructions" listed on HACCP plan (Form 1) are consistent with the formulation/method of preparation. If a deviation is found, select at least one more label for review. If an additional deviation is found, stop sampling and ask the company to review all its labels for this HACCP Plan.

Section 2. Incoming Materials (Incorporates Principle #1 - Hazard Analysis) - Reference Chapter Two, sections 4.3 and 4.6

2.1 - All ingredients, incoming materials and processing aids coming in contact with the product(s) or used in the preparation of the product(s) are listed.

2.2 - All potential hazards associated with incoming materials are identified as B (Biological), C (Chemical) or P (Physical) in the HACCP plan (Form 2). These hazards are inherent to the incoming material and not a processing step within the establishment.

2.3 - Hazards identified for each incoming material are specific (Salmonella, antibiotics, metallic vs non-metallic) and include a full description for each e.g., microbial growth vs microbial contamination. They are recorded on Forms 5, 6 and 7 or equivalent. Any allergens must be listed (i.e. peanuts, tree nuts (named), sesame seeds, soy, milk, eggs, fish and shellfish (named), wheat and sulphite). Particular attention to the use of reworked product is necessary due to possible inclusion of allergens. All secondary ingredients must be listed (Form 2) e.g., sulphites in dehydrated fruits and vegetables.

2.4- Review Task: This paper review ensures that the information on the 3 different documents (labels, Form 2 and if applicable formulation/method of preparation (recipe)) is consistent. Select the same label reviewed in 1.9 (and corresponding formulation/method of preparation (recipe) if applicable). Review to determine if the information (the "List of Product Ingredients and Incoming Materials" ) is consistent between documents. If a deviation is found, select at least one more label and corresponding formulation/method of preparation (recipe) for review. If an additional deviation is found, stop sampling and ask the company to review all its labels and corresponding formulations/methods of preparation (recipes) for this HACCP Plan.

2.5- Review Task: This task applies only when there are formulated products. This on-site review task verifies the formulation/method of preparation is consistent with the written program. Select the same label reviewed in 1.10 and corresponding formulation/method of preparation (recipe). An on-site ingredient verification indicates consistency with the written procedure. If a deviation is found, select at least one more label and formulation/method of preparation (recipe) for review. If an additional deviation is found, stop sampling and ask the company to review all its labels and formulation/method of preparation (recipe) for this HACCP Plan.

Section 3. Process Flow Diagram (Incorporates Principle #1 - Hazard Analysis) - Reference Chapter Two, sections 4.4 & 4.6

3.1 - The process flow diagram is complete and indicates all pertinent processing steps and where ingredients, packaging material etc. enter at the various steps.

3.2 - All potential hazards associated with the processing steps are to be identified as B (Biological), C (Chemical) or P (Physical) on the Process Flow Diagram at the corresponding process step.

3.3 - Hazards identified for each process step are specific (Salmonella, antibiotics, metallic vs non-metallic) and include a full description for each e.g., microbial growth vs microbial contamination. They are recorded on FSEP Forms 5, 6 and 7 or equivalent.

3.4- Review Task: On-site verification is performed to confirm that the flow diagram is accurate and complete in relation to hazard identification.

Section 4. Plant Schematic (Incorporates Principle #1 - Hazard Analysis)- Reference Chapter Two, sections 4.4 & 4.6

4.1 - The HACCP plan includes a complete plant schematic diagram including the product flow (raw vs finished, if applicable) and employee traffic patterns within the establishment. The location of any hand wash facilities and foot baths are noted.

4.2 - The plant schematic indicates points of possible cross-contamination including potential allergen concerns. All hazards associated with cross-contamination are to be identified as B (Biological), C (Chemical) or P (Physical), in the HACCP plan.

4.3 - Hazards identified for points of cross-contamination are specific (Salmonella, antibiotics, metallic vs non-metallic) and include a full description for each e.g., microbial growth vs microbial contamination. They are recorded on FSEP Forms 5, 6 and 7 or equivalent.

4.4- Review Task: On-site verification is performed to confirm that the plant schematic is accurate and complete in relation to hazards associated with cross-contamination from product flow and employee traffic patterns.

Section 5. Critical Control Point Determination (Incorporates Principle #2 - Determination of Critical Control Points) - Reference, Chapter Two, section 4.7

5.1 - Determination of Critical Control Points is done by individually assessing all B (Biological), C (Chemical), and P (Physical) hazards identified in the HACCP plan using FSEP Form 8 or equivalent.

5.2 - Critical Control Points are properly identified on the HACCP plan (FSEP Form 8) and are entered beside the corresponding process step on the Process Flow Diagram.

5.3 - Hazards that cannot be controlled by the operator must be identified on the HACCP plan. The plan must indicate how these hazards would be addressed outside the establishment (FSEP Form 9) or equivalent.

Section 6. Review of CCPs - CCP #__________ - Reference Chapter Two, section 4.8

Note: one copy of this table, including the checklist, must be completed for each CCP

CFIA Auditor: Review the establishment's written HACCP Plans and complete the checklist below. Assess each CCP for completeness using the Complete Written Program Guidelines. Indicate all written incomplete in the appropriate section of the checklist and/or comments section. Use the FSEP audit Worksheet (Appendix VI) to note objective evidence identified during the Regulatory System Audit.

Establishment HACCP Coordinator: During the self-evaluation, assess each CCP for completeness using the Complete Written Program Guidelines and if your written programs are complete check off the "complete" box. If they are incomplete, the written procedures must be corrected immediately. Use the comments section to note any deficiencies identified during the self-evaluation (internal audit), if no deficiencies are identified, note N/A. Long term action plans must accompany the written notification (Chapter Three, Section 2.4) indicating the self assessment is completed.

6.1 - Critical Limits (Principle #3 - Establish Critical Limits)

6.1.1 - Measurable critical limits have to be established to define acceptable parameters for all hazards controlled by the CCP.

6.1.2 - Critical limits must meet or exceed relevant regulatory and program requirements. Critical limits which exceed relevant regulatory or program requirements become the standard against which the written program is audited.

6.2 - Monitoring Procedures (Principle #4 - Establish Monitoring Procedures)

6.2.1 - Monitoring procedures exist for each critical limit.

6.2.2 - Monitoring procedures must be complete (Who, What, When and How). When applicable, the monitoring procedures meet or exceeds regulatory/program requirements.

6.2.3 - Monitoring procedures must ensure that adequate control is maintained for the CCP.

6.3 - Deviation Procedures (Incorporates Principle #5 - Establish Deviation Procedures)

6.3.1 - Deviation procedures exist for the CCP.

6.3.2 - Deviation procedures must be complete (Who, What, When and How). When applicable, the deviation procedures meet regulatory/program requirements.

6.3.3 - Deviation procedures must state corrective action to be taken to correct the non-compliance, control any non-compliant product (i.e. product produced since the last satisfactory monitoring) and prevent the reoccurence of the deviation.

6.4 - Verification Procedures (Incorporates Principle #6 - Develop Verification Procedures)

6.4.1 - Verification procedures exist for this CCP.

6.4.2 - Verification procedures must be complete (Who, What, When and How). Includes an on-site assessment of the monitoring procedures, a record review for completeness and deviation procedures.

6.4.3 - Verification procedures must ensure that the CCP is implemented as described and is used to assess the effectiveness of the CCP (e.g. microbiological testing).

6.5 - Record Keeping (Principle #7 - Establish Record Keeping Procedures)

6.5.1 - The name of the records to be kept for monitoring, deviation and verification procedures are identified in the written program.

Section 7. Validation and Reassessment of the HACCP System Procedure - Reference Chapter Two, section 5

7.0 - Validation by the Establishment of it's HACCP plan(s) to confirm adequacy in controlling the food safety hazards identified during the hazard analysis, verification that the plan(s) are being effectively implemented and the documentation is available for review

7.1 - Procedures to ensure that all changes to the HACCP system are documented in a log book. The log book must describe the changes, state the location where they occurred in the HACCP system, and the date on which the changes were implemented. The log book must also identify the individual responsible for ensuring that the changes have been implemented and, if necessary, validated.

7.2 - Procedures to review all sub-elements within the prerequisite program to ensure that the procedures reflect current processes and equipment at your establishment, as well as regulatory requirements, and that they continue to be effective.

7.3 - Procedures to review the accuracy of your HACCP system's product descriptions, lists of incoming ingredients, process flow diagrams and schematic diagrams.

7.4 - Procedures to review all hazards identified in the HACCP system, to ensure that they are accurate and reflect your establishment's current processes, equipment, and operating procedures. When new hazards are identified, your HACCP team must analyze them appropriately according to your HACCP system. Hazards that are not controlled by CCPs, should continue to be controlled by other measures identified in the HACCP system (e.g. prerequisite programs, letters of guarantee, etc.)

7.5 - Procedures to review, including validation studies (such as microbiological sampling, challenge studies, process validation), each CCP to ensure that it continues to control the identified hazard(s).

7.6 - Procedures to evaluate critical limits to ensure that they meet current program and regulatory requirements.

7.7 - Procedures to review the monitoring, deviation and verification procedures for each CCP, to ensure that they continue to be implemented effectively.

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