Food Safety Enhancement Program Manual

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The Food Safety Enhancement Program (FSEP) Manual has been prepared in order to provide assistance to:

• the workforce of the Canadian Food Inspection Agency (CFIA);
• the management and employees of the food industry.

Table of Contents

• Glossary of Terms
• Chapter 1: Introduction and Background
  • Section 1 - Introduction to FSEP
  • Section 2 - Benefits of FSEP
    • 2.1 - International and national
      • 2.1.1 - International acceptance
      • 2.1.2 - National acceptance
    • 2.2 - Industry and government
      • 2.2.1 - Responsibilities
      • 2.2.2 - Communication
      • 2.2.3 - Resources
      • 2.2.4 - Product recall/destruction
      • 2.2.5 - Equivalency
  • Section 3 - Background
  • Section 4 - Public perception of food safety
  • Section 5 - FSEP and the marketplace
  • Section 6 - Program description
    • 6.1 - References
  • Section 7 - Program responsibilities
• Chapter 2: Developing a HACCP System
  • Section 1 - Purpose of Chapter 2
  • Section 2 - Prerequisite programs
  • Section 3 - Generic models
    • 3.1 - How to select a generic model
    • 3.2 - Limitations of generic models
    • 3.3 - Products or processes not covered
  • Section 4 - Developing HACCP plan(s)
    • 4.1 - Assemble your HACCP team
    • 4.2 - Description of product and identification of intended use (Form 1)
      • 4.2.1 - Process/product type name
      • 4.2.2 - Product name(s)
      • 4.2.3 - Important product characteristics
      • 4.2.4 - How the product will be used
      • 4.2.5 - Packaging
      • 4.2.6 - Shelf life
      • 4.2.7 - Where the product will be sold
      • 4.2.8 - Labelling instructions
      • 4.2.9 - Special distribution control
    • 4.3 - List of product ingredients and incoming material (Form 2)
    • 4.4 - Process flow diagram and plant schematic
      • 4.4.1 - Process flow diagram (Form 3) 
      • 4.4.2 - Plant schematic diagram (Form 4)
    • 4.5 - On-site verification of process flow diagram and plant schematic
    • 4.6 - Hazard identification and analysis
      • 4.6.1 - Preparing for hazard identification and analysis
      • 4.6.2 - Identifying and analyzing hazards
        • 4.6.2.1 - Review incoming material
        • 4.6.2.2 - Evaluate operations for hazards
        • 4.6.2.3 - Observe operating practices
        • 4.6.2.4 - Take measurements
        • 4.6.2.5 - Analyze measurements
    • 4.7 - Determination of CCPs (decision tree)
      • 4.7.1 - Introduction to determining CCPs
        • 4.7.1.1 - Cooking
        • 4.7.1.2 - Chilling
        • 4.7.1.3 - Formulation
        • 4.7.1.4 - Microbiologically sensitive areas
        • 4.7.1.5 - Reassessing CCPs
      • 4.7.2 - Decision tree: using Form 8
        • 4.7.2.1 - Form 8, Column 1
        • 4.7.2.2 - Form 8, Column 2
        • 4.7.2.3 - Form 8, Question 1
        • 4.7.2.4 - Form 8, Question 2
        • 4.7.2.5 - Form 8, Question 3
        • 4.7.2.6 - Form 8, Question 4
        • 4.7.2.7 - CCP nomenclature
      • 4.7.3 - Hazards not controlled by the establishment
      • 4.7.4 - Controlling identified hazards
    • 4.8 - Critical control points (CCP)
      • 4.8.1 - Establish critical limits - HACCP Principle 3
      • 4.8.2 - Establish monitoring procedures - HACCP Principle 4
      • 4.8.3 - Establish deviation procedures - HACCP Principle 5
      • 4.8.4 - Establish verification procedures - HACCP Principle 6
      • 4.8.5 - Establish record keeping and documentation - HACCP Principle 7
  • Section 5 - Validation and reassessment of the HACCP system
  • Section 6 - FSEP forms
• Chapter 3: Recognition of an Establishment's HACCP System
  • Section 1 - Introduction
  • Section 2 - Steps in recognizing an establishment's HACCP system
    • 2.1 - The establishment's management submits a letter of commitment
    • 2.2 - The Agency holds a pre-meeting with the establishment's management
    • 2.3 - The establishment submits written notice to the Area FSEP/HACCP Coordinator indicating that self-evaluation has been completed
    • 2.4 - The establishment submits a documentation package
    • 2.5 - The Agency reviews the establishment's written prerequisite program
    • 2.6 - The Agency reviews the establishment's written HACCP plan(s)
    • 2.7 - The Agency reviews the establishment's written reassessment procedures for its HACCP system
    • 2.8 - Regulatory System Audit(s) for Recognition of the HACCP System
    • 2.9 - The Agency issues official notification recognizing the company's FSEP/HACCP status
• Chapter 4: Regulatory System Audit
  • Section 1 - Background
  • Section 2 - Frequency of audits
    • 2.1 - Risk categories
      • 2.1.1 - Category I
      • 2.1.2 - Category II
      • 2.1.3 - Category III
      • 2.1.4 - Audit frequencies
    • 2.2 - Non-Conformity Flow Diagram
  • Section 3 - Request for review
  • Section 4 - Review of new HACCP plans
  • Section 5 - Changes to a HACCP system
  • Section 6 - Conducting a regulatory system audit
    • 6.1 - Preparing for the audit
    • 6.2 - Establishing the audit scope
      • 6.2.1 - FSEP Audit Scope Worksheet (Appendix VI)
      • 6.2.2 - Order of selected tasks
        • 6.2.2.1 - Outstanding CARs
        • 6.2.2.2 - Log book review
        • 6.2.2.3 - Critical Control Points (CCPs)
        • 6.2.2.4 - Prerequisite program sub-elements
        • 6.2.2.5 - HACCP system review tasks
    • 6.3 - Holding an opening meeting
    • 6.4 - Gathering information
      • 6.4.1 - Record review
      • 6.4.2 - On-site evaluation
    • 6.5 - Holding a private meeting
      • 6.5.1 - Evaluating objective evidence
        • 6.5.1.1 - Audit observation
        • 6.5.1.2 - Non-conformity
        • 6.5.1.3 - Major non-conformity
      • 6.5.2 - Corrective Action Request (CAR)
        • 6.5.2.1 - Part A: Description of Non-Conformity
        • 6.5.2.2 - Part B: Corrective Action
        • 6.5.2.3 - Part C: CFIA Assessment and Follow-up
    • 6.6 - FSEP Audit Report
    • 6.7 - Closing meeting
    • 6.8 - Conducting follow-up   
  • Section 7 - Loss of recognition
• Appendices    
  • Appendix I - FSEP Recognition Tracking Form
  • Appendix II - FSEP Prerequisite Program Checklist
  • Appendix III - Guidelines for Use of the Health Risk Assessment Model
  • Appendix IV - FSEP/HACCP Plan Review and HACCP System Reassessment Checklist
  • Appendix V - FSEP Prerequisite Program Generic Model
  • Appendix VI - Regulatory System Audit Documentation:
    • "Complete" Written Program Guidelines
    • FSEP Audit Scope Worksheet
    • FSEP Audit Worksheet
    • Corrective Action Request (CAR) Guidelines
    • FSEP Corrective Action Request Form
    • FSEP CAR Tracking Table Form
    • FSEP Audit Report
  • Appendix VII - FSEP/QMP Audit for Multi-Commodity Establishments Policy
  • Appendix VIII - Mandatory FSEP/HACCP

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