Written Corrective Action Plan (CAP) Evaluation Checklist

CAP submission/version no.:
Date of closing meeting:
Date CAP Received:

Timelines for CAP submissions

Yes/No/Not Applicable

• For a N/C, the CAP was received within 30 days of the exit interview (unless extension was given).
• For a critical N/C, the CAP was received within 24 hours (unless extension was given).
• This is the 3rd (or fewer) time the CAP has been submitted.
• An exemption was requested and granted. If yes, new submission deadline:

Criteria for an Acceptable Written CAP (element 3 - Corrective Action Standard)

Description of the non-conformity

• A description of the Non-conformity (N/C) is recommended.

Immediate Corrective Action

• Details on identification, segregation, evaluation and any action taken on non compliant product (culling, reworking, relabelling, re-exporting destroying).
• If critical non-conformity or product safety is an issue, ceased production and distribution, considered recall and notified CFIA.
• Immediate CA taken on deficiencies which may cause production of non-compliant product.

Root Cause of the Non-conformity

• Details on the process and results of the internal analysis to determine the root cause of the N/C. Analysis is not focussed on the deficiencies (objective evidence) identified in the CV but on the system based weakness that allowed the N/C to occur.

Details of the "control system fix" which will address the root cause and prevent reoccurrence.

• The system changes that will be taken to prevent the N/C from reoccurring.
• The Person(s) or Position(s) responsible for these changes.
• The Date(s) these changes will be completed.

Interim Control Measures (if applicable)

• The interim control measures and monitoring procedures to be put in place where system changes can not be completed immediately (long term corrective action).
• The Person(s) or Position(s) responsible for these control measures.
• The Date these changes will be completed.

Verification of implementation and effectiveness (how the regulated party will determine that the corrective action or control measure was effective).

• The actions that will be taken to verify that the measures taken to correct the system weaknesses identified in the N/C were completed and effective.
• The Person(s) or Position(s) responsible for completing the verification.
• The Date the verification be completed.

The steps that will be taken to correct deficiencies (objective evidence) identified.

• The actions that will be taken to correct the deficiencies (objective evidence) identified.
• The Person(s) or Position(s) responsible for these actions.
• The Date these changes will be completed.

Interim Control Measures (if applicable)

• The interim control measures and monitoring procedures to be put in place where system changes can not be completed immediately (long term corrective action).
• The Person(s) or Position(s) responsible for these control measures.
• The Date these changes will be completed.

Verification of implementation and Effectiveness (how the regulated party will determine that the corrective action or control measure was effective).

• The actions that will be taken to verify that the measures taken to correct the system weaknesses identified in the N/C were completed and effective.
• The Person(s) or Position(s) responsible for completing the verification.
• The Date the verification be completed.

Commitment complete self assessment and submit attestation within 30 days

• If a Schedule I and II compliance level "A" or "B" was obtained the CAP includes a commitment to correct deficiencies in both the establishment and the QMP within 30 days after the CAP is accepted. (See Schedule I and II Regulatory Verification Process).
• If a Schedule I compliance level "C" was obtained, the CAP includes a commitment to correct deficiencies in both the establishment and the QMP within 30 days after the CAP is accepted and to conduct a self assessment and attestation using the "Processors Self Evaluation Form" and submit it to the CFIA within the 30 day deadline. (See Schedule I and II Regulatory Verification Process). (Schedule II compliance level "C" must be corrected prior to exit meeting. If not, will be treated as per "D")
• If a Schedule I and II compliance level "D" was obtained, the CAP includes a commitment to correct deficiencies in both the establishment and the QMP prior to resuming operations and to conduct a self assessment and attestation using the "Processors Self Evaluation Form" and submit it to the CFIA. (See Schedule I and II Regulatory Verification Process).

Result of Evaluation

Yes/No

Written CAP is acceptable

Comments

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Evaluator:
Date of Evaluation: