Canadian Partners in Quality (C-PIQ)

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Table of Contents

• 1. General Program Information
  • 1.1 Introduction
  • 1.2 Acceptance Process
  • 1.3 Verification/Audit Process
  • 1.4 Compliance and Enforcement
  • 1.5 Special Circumstances
• 2. General Requirements for C-PIQ Establishments
  • 2.1 Quality Policy Statement
  • 2.2 Declaration of Commitment
  • 2.3 Organization
    • 2.3.1 Quality Assurance Manager
    • 2.3.2 Other Key Quality Assurance Positions
  • 2.4 Maintenance of Reference Materials
  • 2.5 Training
  • 2.6 Floor Plan of Facility and Process Flow Diagram
    • 2.6.1 Floor Plan
    • 2.6.2 Process Flow Diagram
  • 2.7 Calibration of Equipment
  • 2.8 Facility and Operational Requirements
  • 2.9 Traceability and Lot Identification
    • 2.9.1 Incoming Product
    • 2.9.2 Finished Product
  • 2.10 Information and Document Control
    • 2.10.1 Export Document Control
    • 2.10.1.1 Issuance of Export Documents
    • 2.10.1.2 Identification of Staff
    • 2.10.1.3 Control of Export Documents
    • 2.10.1.4 Requesting Export Documents
    • 2.10.1.5 Completion of Export Documents
    • 2.10.1.6 Cancellation of Issued Export Documents
    • 2.10.1.7 CFIA Control of Export Documents 2.10.2 Transfer Documents
    • 2.10.3 Notification Requirements
    • 2.10.4 Amendments to Company QA Manual
  • 2.11 Internal Audits
• 3. Production Controls
  • 3.1 Introduction
  • 3.2 Quality Factors
  • 3.3 In-Line Verification of Product
    • 3.3.1 Process Analysis and Planning
    • 3.3.1.1 Identification of Quality Factors
    • 3.3.1.2 Identification of Control Points for Each Quality Factor
    • 3.3.1.3 Identification of Sampling Sites
    • 3.3.1.4 Identification of Limits for Quality Factors at Each Sampling Site
    • 3.3.1.5 Identification of Monitoring Procedures for Each Quality Factor at Each Sampling Site
    • 3.3.1.6 Identification of Corrective Actions for Each Limit Exceeded
    • 3.3.1.7 Identification of Records for Each Sampling Site
    • 3.3.1.8 Identification of Verification Procedures
    • 3.3.2 Process Analysis Worksheet
    • 3.3.3 Finished Product Sampling
    • 3.3.4 Verification of Received Lots
    • 3.3.5 Storage Area Controls
  • 3.4 Lot Verification of Product
    • 3.4.1 Performing Lot Verification
      • 3.4.1.1 Identification of Quality Factors
      • 3.4.1.2 Identification of Sampling Site
      • 3.4.1.3 Identification of Limits for Quality Factors
      • 3.4.1.4 Identification of Monitoring Procedures for Each Quality Factor
      • 3.4.1.5 Identification of Corrective Actions for Failed Lots Due to Exceeded Limits
      • 3.4.1.6 Identification of Records
      • 3.4.1.7 Identification of Verification Procedures
    • 3.4.2 Detail/Work Sheet
    • 3.4.3 Procedures for End Product Monitoring
    • 3.4.4 Storage Area Controls
    • 3.4.5 Notification Requirements
• 4. Audit and Monitoring Activities
  • 4.1 General
  • 4.2 Pre-Validation
  • 4.3 Validation
  • 4.4 Verification
  • 4.5 Follow-up Audits
  • 4.6 Inspection of Returned Shipments by CFIA
• 5. Non-Conformities, Audit Ratings and Enforcement
  • 5.1 General
  • 5.2 Types of Non-Conformities and Audit Ratings
    • 5.2.1 General
    • 5.2.2 Category "A" Non-Conformities and Unsatisfactory Audit Rating
    • 5.2.3 Category "B" Non-Conformities and Unsatisfactory Audit Rating
    • 5.2.4 Category "C" Non-Conformities and Satisfactory Audit Rating
    • 5.2.5 Cumulative and Repetitive Non-Conformities
  • 5.3 Suspension and Cancellation of Registration
    • 5.3.1 Suspension of Registration
    • 5.3.2 Cancellation of Registration
    • 5.3.3 Re-instatement of Registration

Appendices

• Appendix A Operation and Maintenance of the Establishment
• Appendix B Definitions
• Appendix C Application for Consideration as a C-PIQ Registered Establishment
• Appendix D Establishment Inspection Report
• Appendix E Industry Checklist for Development of Company QA Manual
• Appendix F C-PIQ Registration Number/Logo
• Appendix G C-PIQ Export Document
• Appendix H Request for Export Documents for C-PIQ Establishments
• Appendix I C-PIQ Establishment Transfer Document
• Appendix J Process Analysis Worksheet
• Appendix K CFIA Sampling Plan
• Appendix L Procedures for End Product Monitoring

Next page: C-PIQ - Section 1-3