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N/C # - of - Written Corrective Action Plan Template

This document provides a template for a written corrective action plan to address a non-conformity. The template includes sections for describing the non-conformity, identifying the root cause, detailing any immediate corrective actions needed, and outlining the long-term corrective action plan including the specific actions to be taken, completion dates, responsible parties, and methods for verifying the effectiveness of the corrective actions. Guidance is provided for each section to help ensure all necessary aspects of an effective corrective action plan are addressed.

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mmammer
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Download as PDF, TXT or read online on Scribd
116 views

N/C # - of - Written Corrective Action Plan Template

This document provides a template for a written corrective action plan to address a non-conformity. The template includes sections for describing the non-conformity, identifying the root cause, detailing any immediate corrective actions needed, and outlining the long-term corrective action plan including the specific actions to be taken, completion dates, responsible parties, and methods for verifying the effectiveness of the corrective actions. Guidance is provided for each section to help ensure all necessary aspects of an effective corrective action plan are addressed.

Uploaded by

mmammer
Copyright
© Attribution Non-Commercial (BY-NC)
Available Formats
Download as PDF, TXT or read online on Scribd
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N/C #___ of ___

Description of the Non-Conformity

Written Corrective Action Plan Template

(element 3 Corrective Action Plan Standard)

Root Cause of the Non-Conformity


(Section 5.2.1 Corrective Action Process Standard)

Immediate corrective action critical nonconformity


(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) Person(s) or position(s) responsible for verification

Type of 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)?

Date

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.

The corrective actions to be taken to address the nonconformity

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.
(Section 5.3.1 Corrective Action Process Standard)

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)

N/C # 1 of 1
Description of the Non-Conformity

Guide to the Written Corrective Action Plan Template


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 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. 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.

Immediate corrective action critical nonconformity

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)

Type of Corrective Action

Description of Action to be Taken

Date of completion

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

Method of verification of 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 & 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 & II Regulatory Verification Process.

Person(s) or position(s) responsible

Dat e

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. The corrective actions to be taken to address the nonconformity ii) the control system fix that will prevent recurrence of the N/C / root cause

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.

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.

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