Corrective Action Plan (CAP)

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Corrective Action Plan (CAP) Implementation Evaluation Checklist

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Corrective Action Plan (CAP) Implementation Evaluation Checklist. Description follows.

Description - Corrective Action Plan (CAP) Implementation Evaluation Checklist

Criteria for an Acceptable Implemented CAP (elements 4, 5 and 6 - Corrective Action Process Standard)

1. Amendments to agreed upon CAP

Yes/No/Not Applicable

  • An extension was granted for the implementation of this CAP. If yes, new completion due date.
  • Amendments were made to the agreed upon CAP.
  • These amendments were approved by CFIA.

2. Immediate Corrective Action

Yes/No/Not Applicable

Appropriate action was taken with non compliant product (as per the CAP)

3. The "control system fix" which will address the root cause and prevent reoccurrence.

Yes/No/Not Applicable

  • The system changes that were outlined in the CAP have been implemented.
  • The Person(s) or Position(s) responsible for these changes was documented.
  • The Date(s) these changes were completed was documented.
  • The Date(s) that changes were completed met deadlines specified in the CAP.
  • The verification of effectiveness procedures outlined in the CAP were conducted, and the date completed and person or position responsible were documented.
  • The regulated party determined that the "system changes" were/will be effective in preventing reoccurrence of the N/C.
  • Are there outstanding long term corrective actions for system "fixes"? (specify in comment section).

3. Details on the interim control measures and monitoring procedures to be put in place to deal with hazards introduced where system weaknesses can not be corrected immediately.

Yes/No/Not Applicable

  • The interim control measures that were outlined in the CAP were implemented and monitored.
  • The Person(s) or Position(s) responsible was documented.
  • The verification that the procedures outlined in the CAP were conducted and effective.
  • The date verified and person or position responsible were documented.
  • The regulated party determined that the interim control measures were effective.

4. The steps taken to correct deficiencies (objective evidence) identified.

Yes/No/Not Applicable

  • All deficiencies have been corrected as per the CAP plan.
  • The Person(s) or Position(s) responsible for these changes was documented.
  • The Date(s) these changes were completed was documented.
  • The Date(s) that changes were completed met deadlines specified in the CAP.
  • The correction each deficiency was verified, and the date verified and person or position responsible were documented.
  • For registered processors which received a C or D assessment for Schedule I and II - have they achieved a B level as per their self assessment and attestation (see Schedule I and II Regulatory Verification Process)?
  • Are there outstanding long term corrective actions for deficiencies? (specify in comment section).

4. Details on the interim control measures and monitoring procedures to be put in place to deal with hazards introduced where deficiencies can not be corrected immediately.

Yes/No/Not Applicable

  • The interim control measures that were outlined in the CAP were implemented and monitored.
  • The Person(s) or Position(s) responsible was documented.
  • The verification that the procedures outlined in the CAP were conducted and effective.
  • The date verified and person or position responsible were documented.
  • The regulated party determined that the interim control measures were effective

Comments

Evaluation Result

  • CAP has been implemented.
  • CAP implementation is effective

Yes/No

Evaluator:
Date of Evaluation:

PDF (21 kb)

Written Corrective Action Plan (CAP) Evaluation Checklist

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Written Corrective Action Plan Evaluation Checklist. Description follows.

Description - Written Corrective Action Plan 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

Company:
Evaluator:
Date of Evaluation:

PDF (23 kb)

Written Corrective Action Plan Template

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Flowchart - Processes involved in the regulation of plants with novel traits in Canada. Description follows.

Description - Corrective Action Plan (CAP) Implementation Evaluation Checklist

(Element 3 Corrective Action Plan Standard)

N/C no. of

Description of the Non-Conformity:

Root Cause of the Non-Conformity:
(Section 5.2.1 Corrective Action Process Standard)

Immediate corrective action - critical non-conformity:
(Section 5.1 Corrective Action Process Standard)
Details on: identification, segregation and any actions to be taken to deal with non compliant product (culling, reworking, relabelling, re-exporting, destroying). If safety of product is an issue, cease production and distribution, notify CFIA and consider recall. (any immediate corrective action on deficiencies which may cause production of non-compliant product)

The corrective actions to be taken to address the non-conformity
(Section 5.3.1 Corrective Action Process Standard)

Type of Corrective Action
a)i). the "control system fix" that will address the root cause.
Note: not every root cause is system related. These must also be fixed.
ii) the system fix that will prevent recurrence of the N/C / root cause
b) the steps that will be taken to correct any deficiencies (objective evidence) identified.
c) the control measures and monitoring procedures to be put in place to deal with hazards introduced where deficiencies can not be corrected immediately (long term corrective action).

Action to be Taken
Date of completion
Person(s) or position(s) responsible for completion
Method of verification of effectiveness (how will you know the corrective action was effective)?
Person(s) or position(s) responsible for verification
Date

N/C no. 1 of 1 - Guide to the Written Corrective Action Plan Template

Description of the Non-Conformity
A description of the N/C can be obtained from the non-conformity report issued to the processor. A good description of the non-conformity is required to determine the root cause.

Root Cause of the Non-Conformity
Identify the root cause of the N/C. Describe the analysis used to determine the root cause.
The establishment conducts an analysis to find the root cause for the N/C. Identification of the root cause is essential preventing recurrence of the N/C. The investigation should not focus on the deficiencies identified by the inspector but on the QMP system based weaknesses that allowed the N/C to occur. Possible causes include; inadequate equipment, lack of training, poor procedures or standard operating procedures (SOPs), not following procedures (employee commitment), management commitment, among others. If it is determined that the root cause is not system related, this must also be corrected.

Immediate corrective action - critical non-conformity
Details on: identification, segregation and any actions to be taken to deal with non compliant product (culling, reworking, relabelling, re-exporting, destroying). If safety of product is an issue, cease production and distribution, consider recall and notify CFIA (any immediate corrective action on deficiencies which may cause production of non-compliant product).

In the case of a critical non-conformity, the company must prevent possible distribution of non-compliant product and re-establish product compliance. An analysis must be conducted to determine if any product has been compromised as a result of the non-conformity or deficiencies identified. If product safety may be involved action taken may include:

  • cease production
  • halt distribution of product
  • determine amount of product in marketplace
  • initiate recall procedures and notify CFIA.

Actions taken on suspect product could include:
identification and segregation, evaluation, analysis, inspection, culling, reworking, relabelling, destruction of non compliant product.

The corrective actions to be taken to address the non- conformity

Type of Corrective Action

a) i) The "control system fix" that will address the root cause.
Note: not every root cause is system related. These must also be fixed.
ii) The control system fix that will prevent recurrence of the N/C / root cause

Description of Action to be Taken

Describe how the root cause(s) will be addressed.
i) The "control system fix" should focus on the root cause identified above, not on the deficiencies identified by the inspector.
Possible "control system fixes" may include rewriting SOPs, retraining employees (specify what they will be trained on, by who, when), reassigning duties or other actions that will improve the effectiveness of the monitoring procedures.
ii) Non system related root causes must also be dealt with.
iii) Corrective actions must prevent reoccurrence (fixes for root cause, fixes for control system, etc.). Must allow for the detection and correction of problems (take action) before loss of compliance.

Date of completion
Person(s) or position(s) responsible for completion

Method of verification: a) implementation and b) effectiveness
(how will you know the corrective action was fully implemented and effective)

Describe the method to verify / determine that corrective action is
a) fully implemented and
b) effective.
"Fully implemented" is when corrective actions are taken, reflected in written system control documents, and the required changes are made (people know of corrections in what / when / where / how; changed practices are in place e.g., new forms are used, changed ways of doing. "Effective" is when corrections address root causes, control system fixes and deficiencies; reestablish and maintain compliance; prevent reoccurrence; control hazardous product.

If the same non-conformity occurs repeatedly it indicates that either the corrective action taken was not effective or the true root cause was not found.

For registered processors which received Schedule I and II compliance level C or D, this section would include a description of the self assessment and attestation that will be completed. See Schedule I and II Regulatory Verification Process.

b) The steps that will be taken to correct any deficiencies (objective evidence) identified.
All deficiencies (objective evidence) identified will be corrected as part of the CAP. Deficiencies which may cause the production of unsafe product are dealt with immediately. Long term corrective actions may require interim control measures to ensure sanitary production of compliant product.

c) The control measures and monitoring procedures to be put in place to deal with hazards introduced where deficiencies can not be corrected immediately (long term corrective action).
Where corrective actions may take time to implement, interim actions are put in place to control the risks that non compliant product can be produced. These measures must be documented, monitored and after a period of time, have their effectiveness verified.

Person(s) or position(s) responsible
Date

PDF (100 kb)

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