Corrective Action Process Standard

1. Purpose

This document sets out the elements of the Corrective Action Process (CAP)that are required for Regulated Parties to demonstrate they are in compliance with the Fish Inspection Regulations (FIR).

2. Scope

This standard is designed for use by any Regulated Party required to respond to a non-conformity identified during regulatory verification activities, as well as by CFIA Inspectors to evaluate a Regulated Party's Corrective Action Plan (CAP) and the effectiveness of its implementation.

3. Background

Regulated Parties are subject to Regulatory Verification (RV) activities performed by the CFIA to determine compliance with the requirements of the Fish Inspection Regulations (as well as other acts and regulations). During the course of performing RV activities, inspectors may identify non-conformities with the applicable Reference Standard, Regulatory Directives or FIR requirements. Regulated Parties are required to submit, within a negotiated time frame, an acceptable written CAP.

The written CAP must be implemented and then the Regulated Party must verify that the corrective actions taken were effective in preventing the non-compliance from re-occurring.

4. Definitions

4.1 Control System

• For Registered Fish Processors - QMP Plan
• For QMPI Importers - QMPI Plan
• For Basic Importers - Affirmative Actions or Importer Controls

4.2 Corrective Action Process

A process by which a Regulated Party takes immediate action on non-compliant product, conducts an analysis to determine the root cause of each non-conformity, submits a written Corrective Action Plan, implements the plan and verifies that the implementation was effective.

4.3 Non-conformity

A deficiency in the Regulated Party's Control System that results in a deviation from the QMP or QMPI Plan, the applicable Reference Standard, Regulations or Directive.

4.4 Critical non-conformity

A critical non-conformity is a failure of the QMP system that could result, or has already resulted, in the production of unsafe or fraudulent product.

4.5 Regulated Party

Any person subject to the requirements of the Fish Inspection Act, Fish Inspection Regulations and other applicable legislation.

4.6 Root Cause

The source of the problem or reason that the non-conformity occurred. The condition(s) or action(s) that prevent compliance with the requirements of the QMP or QMPI Plan, applicable Reference Standard or Directive. Not to be confused with symptoms such as "deficiencies" with construction or operation requirements. Instead, this is the system failure that allowed the deficiencies to go undetected or unresolved.

5. Elements of the Corrective Action Process

A Corrective Action is considered acceptable when each non-conformity identified has been addressed and the following elements are completed:

• element 1 - immediate action when critical non-conformities are identified and/or non-compliant product is involved.
• element 2 - an analysis has been conducted by the Regulated Party to determine the root cause of the non-compliance(s).
• element 3 - an acceptable written CAP was submitted to the Canadian Food Inspection Agency (CFIA).
• element 4 - all corrective actions were implemented as specified in the CAP.
• element 5 - the Regulated Party verified that the implementation was effective.
• element 6 - agreed upon time frames for submission of an acceptable written CAP and implementation of the corrective actions were met.

5.1 Element 1 - Immediate Corrective Action - Critical Non-conformities

5.1.1 The identification of a Critical non-conformity will require the processor to:

1. initiate corrective actions to eliminate the non-conformity and bring the process back under control. These actions may include, but are not limited to:

• correcting the immediate problems(s);
• voluntarily closing the plant or halting processing;
• identifying and segregating all affected product for culling, reworking, or disposal;
• investigating why the problem occurred; and
• making the necessary system or control changes to eliminate or prevent a recurrence.

2. immediately develop an interim Corrective Action Plan (CAP) (see 5.3.5)

5.2 Element 2 - Identification of the "Root Cause"

5.2.1 This element is used to identify the problem(s) that gave rise to each Non-conformity. The Regulated Party must conduct an analysis to determine why the non-compliance happened. The analysis should not focus on the deficiencies identified in the Non-conformity but on the weaknesses in the control system that allowed the non-compliance to occur.

The analysis should include but is not limited to a review of:

• the SOPs and other documents in the QMP or QMPI Plan to determine if they are sufficient to ensure compliance.
• the level of staff knowledge and/or training.
• the requirement for further research or technical advice from experts or service people to resolve problems that require technical or managerial support from outside parties.
• the level of management support towards employees which would enable them to implement and maintain the control system in compliance with the applicable Directive or Reference Standard.
• the non-conformity and its relation to all other parts of the control system.

In some instances, the analysis of the root cause of a non-conformity may take time if further research or technical advice from experts is required. These details would be outlined in the submitted CAP.

5.3 Element 3 - The Written Corrective Action Plan

5.3.1 The CAP must identify the actions taken to bring the system back under control (compliance is re-established) and the steps to be taken to prevent a re-occurrence (compliance is maintained). This includes the corrective measures that have been or will be taken to deal with the objective evidence identified during RV activities. Items documented in the CAP are detailed descriptions of:

• the non-conformity (recommended);
• any product action taken or planned;
• the root cause analysis conducted to determine the cause of each Non-conformity;
• the control system change(s) that will fix the root cause of each Non-conformity;
• the control system change(s) that will prevent a recurrence (will allow detection and correction of problems before loss of compliance);
• the actions taken to correct any deficiencies (objective evidence) identified during RV activities.

5.3.2 Where corrective actions may take time to implement, the CAP must specify:

• what interim measures or activities that will maintain satisfactory control until the necessary changes (or repairs) are completed;
• additional monitoring to ensure the temporary measures are working properly, are maintaining effective control, and compliance is achieved.

5.3.3 The CAP must have a description of the verification activities that will take place after the implementation of the corrective measures. For registered processors which receive a Schedule I and II compliance level of "C" or "D", this would include a self assessment and attestation of compliance (see Schedule I and II Regulatory Verification Process).

5.3.4 The written plan must also document:

• reasonable completion dates (for registered processors with Non-conformity relating to Schedule I and II, see Schedule I and II Regulatory Verification Process).
• the person(s) or position(s) who will be responsible for the implementation of:
  • all product actions;
  • control system corrective actions (short term and long term)
  • interim measures;
  • identified deficiency corrective actions;
  • verification activities.

5.3.5 Where a critical non-conformity is identified the Regulated Party must take immediate action. The action(s) taken must be documented in an interim CAP. The main purpose of the interim CAP is to provide a summary of the investigation into the possibility that product was affected by the critical non-conformity and if so, any actions taken or planned to address this product. Where the critical non-conformity is related to a Schedule I or II inspection and the Regulated Party can address it immediately (see Schedule I & II Regulatory Verification Process document section 3.2.3), the interim CAP should also include:

• the deficiency corrective action(s); and
• the interim control measures put into place to ensure that any risk introduced as a result of the critical Non-conformity will be addressed until a QMPI system fix is put into place.

It is possible that the root cause analysis conducted to determine the cause of each Non-conformity, and the control system change(s) required to address them, can not be developed by the interim CAP submission deadline. In this case, the details will be included in the final CAP (see 5.3.1 to 5.3.4) due after the CV exit meeting with the Regulated Party.

5.4 Element 4 - Implementation of the Written CAP

5.4.1 The Regulated Party must implement the corrective actions within the time frames documented in their accepted CAP.

5.4.2 The Regulated Party must perform any interim procedures, as well as their additional monitoring activities that have been set out in the written CAP, to control any risks that may be created by long term corrective actions.

5.4.3 When implementation of a corrective action has been completed, the completion date and the signature of the person responsible to over see the implementation of the entire CAP, shall be documented.

5.4.4 Where deadlines for implementation of corrective actions can not be met due to extenuating circumstances, requests for extensions must be made to CFIA in writing. The request must be received by the CFIA prior to the expiration of the CAP completion due date. Extensions may be granted on a case by case basis as long as the Regulated Party can demonstrate:

• some corrective actions have been undertaken to ensure compliance to FIR;
• products continue to be safe and not fraudulent
• The completion dates will not be met due to circumstances beyond to Regulated Party's control or the dates have proven to be unrealistic.

5.5 Element 5 - Verification of Corrective Action Implementation and Effectiveness

5.5.1 After implementation, the Regulated Party must conduct verification activities to confirm that the corrective actions implemented are effective in preventing recurrence of the Non-conformity(s) they were designed to resolve. These verification activities were detailed as part of the written CAP plan submission (see 5.3.4). The date the verification occurred and the signature of the person responsible must be recorded.

5.5.2 If verification activities indicate that the actions taken have not been effective then the Regulated Party must re-evaluate the analysis performed at step 5.2.1 and adjust their actions as needed. Recurrence of a Non-conformity could suggest that the corrective action was not effective or that the root cause of the Non-conformity was not found.

All additional actions taken to address the Non-conformity must be documented.

5.6 Element 6 - Maximum Time Frames and Number of Submissions to Achieve an Acceptable CAP

5.6.1 If non-conformity(s) are issued to a Regulated Party as a result of RV activities, they must submit an accepted written CAP within 30 calendar days of the exit meeting. This deadline includes time required for CFIA review, and for any revisions of plans assessed as unacceptable. A maximum of two revisions (3 submissions total including the original) are permitted.

5.6.2 For critical non-conformities a written interim CAP must be submitted within 24 hours (as per 5.3.5).

5.6.3 Actions under the CFIA Compliance and Enforcement Policy will be initiated if an acceptable plan has not been achieved within 30 calendar days and/or by the 3rd submission unless an extension has been granted.

5.6.4 Where the deadline for submission of a CAP can not be met due to extenuating circumstances, requests for extensions must be made to CFIA in writing. The request must be received by the CFIA prior to the expiration of the CAP submission due date. Extension applications may be granted on a case by case basis.

5.7 CAP Implementation Extension Requests

The CFIA will consider extensions of CAP time frames under the following conditions:

• a written request is received before the expiration of the 30 day CAP deadline;
• the establishment requires extensive repairs to achieve compliance with Schedule I and II, and these repairs cannot be completed during the 30 day time frame;
• the establishment has made amendments to their QMP Plan to identify the additional actions that they will take to manage the deficiencies in the interim, and to protect fish from contamination; and
• the establishment must be able to operate at an "A" or "B" level of compliance. This includes the deficiencies for which long term corrective actions have been granted.

Requests for time frame extensions must be made in writing to the inspector responsible for accepting the original CAP.

6. Tools

• Written Corrective Action Plan (CAP) Evaluation Checklist
• Corrective Action Plan (CAP) Implementation Evaluation Checklist
• Written CAP Requirements Template and Guidance.

7. References

Relevant Reference Standards and Directives:

1. QMP Reference Standard
2. QMPI Reference Standard
3. Canadian Regulatory Requirements for Fish Import Licence Holders (Basic Importers)
4. Canadian Regulatory Requirements for Quality Management Program Import Licence Holders (QMPI Importers)
5. Schedule I & II Regulatory Verification Process