Appendix 2.4 Procedure to Evaluate Corrective Action Plans (CAP) CHAPTER 2 SAMPLING

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1 1.0 Purpose To provide Honey Program inspectors with a procedure to evaluate corrective action plans submitted by a regulated party to address identified non-compliant actions. The following forms are available at end of this procedure: Form 2.4.A Corrective Action Plan (CAP) Tracking Sheet Form 2.4.B Corrective Action Plan (CAP) Assessment Form Form 2.4.C Template Action Plan Rejection Letter Form 2.4.D Template Action Plan Acceptance Letter 2.0 Corrective Action Plan (CAP) Regulated parties are required to submit a corrective action plan (CAP) to address non-compliance identified during in-depth inspections, after unsatisfactory laboratory results, follow up to complaints or any other concern. The purpose of the CAP is to: identify the root cause of the non-compliance, implement activities to address the root cause, and prevent recurrence of the non-compliance. An acceptable corrective action plan is to be submitted by the regulated party to the CFIA as per the Honey Establishment Inspection Manual (HEIM), Honey Product Inspection Manual (HPIM), or any other Honey Program guidelines. If the non-compliance could result in a food safety hazard, the inspector must take immediate action to protect public health. This action may include a food safety inspection, product seizure/detention, sampling or recall. 3.0 Contents of a CAP The regulated party should include the following items in the CAP: A description of the non-compliance to be addressed. The determined root cause of the non-compliance. Action to be taken to address the root cause and prevent recurrence of the non-compliance; including any interim measures if applicable. The responsible person(s). Timelines. Activities that the regulated party will take to ensure that the implemented corrective action has addressed and corrected the root cause (verification). Evidence that the regulated party developed and now maintains records of the non-compliance that includes the development, verification and follow-up to the CAP. 4.0 Evaluation of the Corrective Action Plan (CAP) Issued: September 2012 Page 1 of 7

2 When a corrective action plan is submitted, it needs to be reviewed to determine if there are any missing components or if further clarification is needed. Refer to Form 2.4.A to help you track the status of a CAP and Form 2.4.B to evaluate the CAP found at the end of this document. 4.1 Description of the non-compliance The regulated party should fully describe the non-compliance and link it to the relevant sub-section(s) of the Honey Regulations, Food and Drug Regulation or other federal regulation or policy. The description should clearly indicate a full understanding of the importance and potential consequences of the issue and the reason for the non-compliance. 4.2 Root Cause The establishment should identify the root cause of the non-compliance by conducting an investigation. The root cause should be reasonable and related to the non-compliance. 4.3 Prevent recurrence The regulated party should identify action(s) that will fully address the root cause and prevent recurrence of the non-compliance. 4.4 Responsible Person(s) The establishment should identify person(s) who are responsible to ensure that the CAP is implemented as intended. The person(s) should be in a position to take action if the CAP is not implemented. 4.5 Timelines The inspector should review the timelines to ensure that they are realistic and comply with the timelines in the Honey Establishment Inspection Manual or other specified guidelines. For potential food safety issues, the timelines should be short so that there is immediate action to protect consumer health and safety. 4.6 Verification of CAP The establishment should describe the verification procedures taken to ensure that the CAP was implemented as intended and addressed the root cause of the non-compliance. 4.7 Records The establishment should maintain records related to the non-compliance, the development of the CAP and the verification and follow-up of the CAP. All records should be signed and dated by the responsible person and maintained on file. 5.0 Notice of an Unacceptable Corrective Action Plan If minor changes are needed, work with the regulated party to clarify minor details. If this approach fails or if critical components are missing, issue a Notice of Unacceptable Corrective Action Plan specifying which part(s) of the corrective action plan is incomplete or unacceptable. Currently, this Notice can take the form of a letter outlining concerns with the submitted corrective action plan with a date for submitting an amended corrective action plan (see Form 2.4.C Rejection Template Letter at end Issued: September 2012 Page 2 of 7

3 of this document). The turn-around time for re-submitting a corrective action plan must be quick, but reasonable. If the amended corrective action plan still does not contain all the components, or if the regulated party is unwilling to submit an acceptable corrective action plan by the specified date, record the following in Multi Commodity Activities Program (MCAP)/company file: A Notice of an Unacceptable Corrective Action Plan was issued < date> and not all noncompliances identified on the notice have been addressed by the regulated party. Note any reasons for inability of the regulated party to provide an acceptable corrective action plan. Further compliance and enforcement actions may be considered (see Chapter 3 of the HEIM). 6.0 CFIA Verification of Corrective Action Plan An on-site inspection to verify that the CAP was implemented as written and that it is effective in preventing the recurrence of the non-compliance will be required. This inspection should be conducted as per Table I, Chapter 2 of the HEIM or other specified guidelines. The follow-up inspection should include record review, on-site observations and interviews. 7.0 CFIA Reporting If the CAP is the result of an inspection, record the contents of the CAP in the corrective action request section in MCAP. In addition, record the on-site verification results in MACP. If the CAP is a result of a non-compliance identified through another activity (e.g., laboratory results, complaint follow-up or product recall), record the CAP and verification activities in Issues Management System (IMS). Issued: September 2012 Page 3 of 7

4 Form 2.4.A: Corrective Action Plan (CAP) Tracking Sheet Establishment Name: Address: Registration No. Contact Name: Phone: Fax: Activity Date 1 In-depth Inspection, Laboratory Result, Product Verification, Complaint, etc. 2 CAP Requested 3 CAP Received 4 CAP Evaluated (refer to Form 2.4.B) Acceptable (go to 8) Unacceptable (go to 5) 5 Notice of Unacceptable Corrective Action Plan sent (see Form 2.4.C template letter) 6 Amending CAP Due 7 Received Amended CAP Acceptable (go to 8) Unacceptable (go to 9) 8 Follow Up Inspection Satisfactory (go to 10) Unsatisfactory (go to 9) 9 Compliance Action State what compliance was taken 10 MCAP Updated Issued: September 2012 Page 4 of 7

5 Form 2.4.B: Corrective Action Plan (CAP) Assessment Form Establishment Name Registration # Date Received CAP Revision # Assessment Criteria Yes No N/A If No, Task #; Observation # Does the CAP include the non-compliance(s) and all evidence identified that was provided with the non-compliance report? (Summarized versions are acceptable) Does the CAP address actions to be taken that will correct the problem that was noncompliant? Does the CAP describe adequate changes to prevent recurrence of the non-compliance? Has product been affected? If yes, does the CAP include controls for identification and segregation? If yes, does the CAP include controls for evaluation, analysis, and/or testing? If yes, does the CAP include other actions to deal with non-compliant products (culling, reworking, re-labelling, destruction, etc)? Is the Date for Corrective Action acceptable? Does the process require extended time frames for correction? If yes, does the CAP address sufficient short term procedures to control risk arising from the problem and enhanced monitoring to ensure continued compliance with the regulations? Does the CAP acknowledge who/position is responsible for changes/corrections? Does the CAP identify person(s) or position(s) that will verify both the problem and corrective action have been completed and are effective? CAP Accepted? Date Reviewed: Comments: Signature of Inspector(s) Issued: September 2012 Page 5 of 7

6 Form 2.4.C: Template Corrective Action Plan Rejection Letter Canadian Food Inspection Agency <Office address> <Date> <Establishment representative> <Title> <Establishment address> Subject: Rejection of Corrective Action Plan from Establishment Inspection Results for Establishment <##>, <inspection date > Dear <Establishment Representative>: Thank you for your Written Corrective Action Plan, received <Date>. The inspection team, consisting of <names of inspectors>, has reviewed the action plan and must reject it for the following reasons: <List reasons for the rejection; do not make recommendations.> You are reminded that you may be in contravention of the Honey Regulations under the Canada Agricultural Products Act. <NOTE: Identify the critical deficiencies and refer to the appropriate section(s) of the Regulations.> Please submit a revised Written Corrective Action Plan by <Date>. Please do not hesitate to contact me at <telephone number> if you have any questions. Yours truly, <Name and title> cc: <Regional or Area Program Officer, if necessary> <Inspection Supervisor> Issued: September 2012 Page 6 of 7

7 Form 2.4.D: Template Corrective Action Plan Acceptance Letter Canadian Food Inspection Agency <Office address> <Date> <Establishment representative> <Title> <Establishment address> Subject: Acceptance of Corrective Action Plan from Establishment Inspection Results for Establishment <##>, <inspection date > Dear <Establishment Representative>: Thank you for your Written Corrective Action Plan, received <Date>. The inspection team, consisting of <names of inspectors>, has reviewed the action plan and accepted your proposed corrective actions. Shortly after your stated dates of completion, we will verify through [packers/pasteurizing establishments GMP/Directed] [producer-grader before or during next year s in-depth inspection]. Please do not hesitate to contact me at <telephone number> if you have any questions. Yours truly, <Name and title> cc: <Regional or Area Program Officer, if necessary> <Inspection Supervisor> Issued: September 2012 Page 7 of 7