(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:
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