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Annex E - Industry checklist for development of company QA manual

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Industry checklist
No. Required program elements (Sections of C-PIQ program manual within brackets) Included in QA Manual
Included in QA Manual
Compliance with C-PIQ Program Requirement
Compliance with C-PIQ Program Requirement
1 Company QA manual (1.2)
  • In acceptable electronic format
  • Paper copy also provided
2 Amendments (2.10.4)
  • Procedures for amendments to QA Manual
  • Amendment page
3 Quality policy statement and declaration of management commitment (2.1 & 2.2)
  • Quality policy statement
  • Declaration of management commitment to implementation of C-PIQ and compliance with C-PIQ program requirements, signed by Chief Executive of company
4 Organization (2.3)
  • Name of QA Manager
  • Name of persons in key QA positions (e.g. Grade/lot verifiers, certificate controllers)
  • Identification of back-up personnel for each key QA position
  • Identification of duties for each key QA position
5 Training (2.5)
  • Title and name of person responsible for training program
  • Training program covers:
    • Safe preparation and handling of food
    • QA system implemented within establishment (production controls, etc.)
    • U.S. import requirements
    • Defect identification and tolerances
    • Inspection procedures
    • Control and completion of C-PIQ export documents and transfer documents
  • Identification of training frequency, who will be trained
  • Training records
6 Maintenance of reference material (2.4)
  • Title and name of person responsible for maintenance of reference material
  • List of reference material available (e.g. Relevant Acts and Regulations, U.S. import requirements, Potato Inspection Manual, etc.)
  • Procedure for ensuring reference material current and available
7 Floor plan of facility (2.6.1)
  • Copy of floor plan with all rooms/areas
  • Flow of product indicated
  • All production steps/processes identified
  • All sampling sites identified
  • Location of major equipment identified
8 Process flow diagram (2.6.2)
  • All production steps identified from receiving to shipping
  • Flow of product indicated
  • All control points identified
  • All sampling sites identified
9 Calibration of equipment (2.7)
  • List of equipment used to grade product and monitor control points
  • Calibration procedures for equipment that impact on product quality such as thermometers and scales
10 Traceability and lot identification (2.9)
  • Policy and procedure for identification and traceability of all produce (both incoming product and finished product) from receiving to shipment
  • Lot identification for incoming product
  • Lot identification for final graded product (C-PIQ #, date of preparation/monitoring, unique pallet/ container ID, C-PIQ logo (for exports))
  • Lot identification for final product that is not graded (e.g. product that is only washed)
  • Procedure for rework
11 Production controls (3.1)
  • Identification of control method used (in-line verification, lot verification, or both)
12 A. In-line verification (if applicable): (3.3)
  • Process flow diagram (in #8 above) must include 3 sampling sites, at a minimum, including:
    • 1 sampling site at beginning of preparation process
    • 1 sampling site for finished product
    • at least 1 sampling site during preparation process
13 A. In-line verification (if applicable):
  • Process Analysis includes: (3.3.1)
    • Identification of quality factors to be controlled
    • Identification of sampling sites for each quality factor
    • Identification of limits for each quality factor at each sampling site
    • Identification of monitoring procedures for each quality factor at each sampling site
    • Identification of corrective actions for each limit exceeded
    • Identification of verification procedures to verify effectiveness of corrective action
    • Identification of records
14 A. In-line verification (if applicable):
  • Finished product sampling: (3.3.3)
    • Corrective action procedure for out of tolerance sample at the finished product sampling site meets C-PIQ program requirements.
15 B. Lot verification (if applicable): (3.4)
  • Identification of: (3.4.1)
    • Quality factors to be controlled
    • Limits for each quality factor
    • Monitoring procedures for each quality factor
    • Corrective actions for each limit exceeded
    • Verification procedures to verify effectiveness of corrective action
16 B. Lot verification (if applicable):
  • Detail/work sheet, (3.4.2) used for recording of monitoring results, captures the following items:
    • Unique Detail / Worksheet identifying number
    • Lot (identification, size, # and kind of packages, # samples to be examined)
    • Intended market (interprovincial or export), if lot verification also used for interprovincial shipments
    • Start of inspection (date and time)
    • Temperatures (product and warehouse)
    • Vehicle information (vehicle #, cleanliness, general condition, refrigeration/heating units functional)
    • Marks on packages
    • Color (skin and flesh), cleanliness and maturity
    • Lot identification number for each sample
    • Minimum size, maximum size, special lot tolerance requirements for size and actual findings per sample and per lot
    • Findings in relation to special lot tolerance for maturity and sprouts
    • Defects for each sample including decay
    • Internal, external and total defects per lot
    • Declaration statement (lot meets or fails to meet the Safe Food for Canadians Regulations and/or US Import, and samples examined represented the lot)
    • End of inspection (date and time)
    • Person responsible for monitoring (signature and date)
    • Person responsible for verification (signature and date)
17 B. Lot verification (if applicable):
  • Procedure for notification of CFIA (3.4.5)
    • minimum 4 hours prior to export of any lot verified using the Lot Verification method
18 C. Also, for both In-line verification and Lot verification, the following storage area controls: (3.3.5 & 3.4.4)
  • Procedure for identification and segregation of product failing or suspected of failing quality requirements
  • Procedure for control of graded product that originated from another establishment (if applicable)
  • Policy and procedure for up-to-date quality check
19 Control of C-PIQ export and transfer documents (2.10.1 & 2.10.2)
  • Title and name of person(s) authorized to request and complete C-PIQ Export Documents
  • Procedure for control and completion of C-PIQ Export Documents
  • Procedure for completion of transfer documents
20 Returned shipments (2.10.3 & 4.6)
  • Procedure for notification of CFIA of any returned shipments
21 Internal audit (2.11)
  • Policy and procedure for internal (self) audit, covering all aspects of QA system
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