OAG – Audit of Canada’s Food Recall System

CFIA Management Response to Recommendations and Action Plan

Report Reference – Para. Number	Management Response	Responsible Lead	Current Status
Recommendations
1) (28) To facilitate its food safety investigations, the CFIA should clarify the information it needs and should require industry to maintain this information in a complete, accessible, and immediately useable format. For registered establishments, inspectors should regularly validate that the information maintained by the establishment is complete and accessible.	1 As of May 15, 2013, it is a regulatory requirement that federally registered meat establishments maintain product distribution records in a useable and accessible format that can be produced for CFIA in a timely manner during an investigation or recall. 2 By December 31, 2013, CFIA inspectors will have verified that all registered meat establishments have updated their food safety protocols in accordance with these new requirements. Where companies have not complied with this new regulatory requirement, corrective measures will be taken by CFIA. The Safe Food for Canadians Act, which received Royal Assent on November 22, 2012, will further strengthen regulatory requirements for traceability and the provision of documents to CFIA by regulated parties by extending this requirement to all food commodities. We anticipate that this Act will come into force in 2015.	*Action Item #1:* Agrifood, Meat and Seafood Safety Directorate, Policy and Programs Branch *Action Item #2:* Operations Strategy and Delivery Directorate, Operations Branch	*Action Item #1: Complete* Requirements related to product distribution records were updated and published on May 15, 2013, as part of Chapter 3, Meat Hygiene Manual of Procedures (MHMOP). *Action Item #2: Complete* CFIA inspectors inspected all active registered meat establishments to verify that the updated requirements have been implemented. 95% of establishments inspected were found to be in compliance. Where companies had not complied with this new regulatory requirement, CFIA requested corrective actions and have since conducted all necessary follow-up inspections.
2) (43) The CFIA should review and update its guidance for monitoring and documenting the correction or disposal of recalled products. This should include steps necessary to provide the Agency with assurance that the appropriate disposal or corrective activities have been determined and acted upon.	1 CFIA is developing comprehensive operational guidance in order to provide inspection staff with greater clarity on the disposition of noncompliant food products, including product subject to recall. This guidance, which will be completed by December 31, 2013, will assist inspectors in the assessment of the regulated party’s activities and documentation related to the: • Reprocessing or further processing within or outside the establishment, as per applicable regulatory requirements, to ensure that the hazard is eliminated or reduced to acceptable levels, or • Destruction and/or disposal as waste. 2 Through this guidance we will ensure that these activities are applied consistently across CFIA. This will be reinforced through improved documentation and by clearly communicating procedures nationally and providing training to staff by January 31, 2014.	*Action Item #1:* Operations Strategy and Delivery Directorate, Operations Branch *Action Item #2:* Office of Food Safety and Recall, Operations Branch	*Action Item #1: Complete* Operational guidance for the Assessment, Monitoring and Documenting the Disposition of Affected Food Products Identified through Food Safety Investigations, including Recalled Products was approved on December 20, 2013. *Action Item #2: Complete* Updates to the Food Recall Training have been finalized and include operational guidance on the assessment and documentation of disposition activities. Product disposition was covered in lessons related to Verification and Follow-Up at the initial Train-the-Trainer session held January 21-23, 2014.
3) (49) The CFIA should clarify its policies and procedures for following up on the underlying causes of a recall in the non-registered sector.	1 The CFIA is reviewing its procedures for following up on the underlying causes of a recall in the non-registered sector and will implement revised operational guidance by April 30, 2014, including thorough documentation of corrective measures that firms implement in order to address the underlying causes of a recall. In addition, the CFIA is modernizing its legislative and regulatory framework with the passage of the Safe Food for Canadians Act, and the development of new regulations to support the Act. These initiatives will align the Agency’s regulatory tools across all food commodities, including those in the non-registered sector.	*Action Item #1:* Operations Strategy and Delivery Directorate, Operations Branch	*Action Item #1: Complete* The Operational Procedure for Following up on the Underlying Causes of a Food Recall was approved on April 24, 2014.
4) (50) The CFIA should monitor its corrective action requests in the registered meat establishments to confirm that they are completed within the required 60-day period.	1 In March, 2013, CFIA enhanced its monitoring and oversight of open Corrective Action Requests (CARs) in response to recommendations of an internal audit related to the management of CARs that remain open past the scheduled date of closure. Weekly reports are submitted to responsible managers to enable appropriate action to be taken to ensure that past due CARs are closed or, in cases when a CAR remains open, that the rationale for the extension as well as interim measures to mitigate food safety risk are implemented and documented. Through quarterly reporting, Senior CFIA officials are also made aware of the status of CARs.	*Action Item #1:* Operations Strategy and Delivery Directorate, Operations Branch	*Action Item #1: Complete* Frequency of regular reporting of CARs to Regional Directors and senior executives was increased in March 2013 to enhance monitoring and oversight of open CARs.
5) (54) CFIA should reassess its time standards for verifying that registered meat establishments have reviewed and updated their food safety systems and recall plans following a recall. CFIA should verify that the firm has completed this work on a timely basis and document the results of this review.	1 CFIA is reviewing operational guidance for implementation by March 31, 2014, to ensure that there are clear instructions for inspectors on the closure of a recall. CFIA will ensure that the process, and associated timelines, to be followed by inspectors on the closure of a recall are clear and feasible. 2 CFIA has reviewed the delivery of its Quality Management System (QMS) and identified a number of areas for improvement. This has led to the development of a QMS enhancement plan. Under the plan, QMS is targeting high risk inspection activities, such as those related to food recall and follow-up activities, and will verify that inspectors have delivered the operational guidance as intended.	*Action Item #1:* - Office of Food Safety and Recall, Operations Branch - Operations Strategy and Delivery Directorate, Operations Branch *Action Item #2:* Business Management and Planning Office, Operations Branch	*Action Item #1: Complete* Updates to clearly define the process, and associated timelines, for inspectors to follow up on recalls as captured in Chapter 18 of the Meat Hygiene Manual of Procedures as well as in the Food Safety Enhancement Program Manual were approved on March 31, 2014. *Action Item #2: Complete* QMS enhanced plan has been developed. High risk inspection activities are targeted in QMS and incorporated into operational workplans for FY 2014-15.
6) (66) The CFIA should evaluate its emergency processes for food safety and finalize its procedures. This should include clearly defining roles and responsibilities and the communication channels required to keep all key stakeholders informed when emergency procedures are activated. In particular, the roles of those parties responsible for investigations and recalls that are conducted through non-emergency procedures should be clarified. The approved procedures should be communicated, tested and updated on a regular basis.	1 The Food Safety Emergency Response Functional Plan (FSERFP) was finalized on September 30, 2013. The plan describes how the Incident Command System (ICS) supersedes day-to-day roles and how it is used in conjunction with existing guidance materials to enhance coordination and management of an event. 2 Orientation and training will be completed by December 31, 2013, and exercises will be conducted by May 31, 2014, for staff identified as potential members of the National Emergency Response Team (NERT). This will enable the CFIA to implement and test the FSERFP. Ongoing updates will be made to the FSERFP following a response as required.	*Action Item #1:* Operations Strategy and Delivery Directorate, Operations Branch *Action Item #2:* Operations Strategy and Delivery Directorate, Operations Branch	*Action Item #1: Complete* The final version of the FSERFP was approved by VP Operations on September 30, 2013. *Action Item #2:* Complete A NERT Staff Orientation session to provide information on the recently approved Food Safety Emergency Response Functional Plan was delivered December 19, 2013. Exercises are being held May 26-28, 2014.
7) (79) The CFIA should finalize and implement its directive for post incident reviews and implement it after any food recall that activates emergency response procedures. These reviews should include the perspectives of key stakeholders and should examine the strengths and weaknesses of the investigation, the recall process, and the emergency management process.	1 The Food Safety Emergency Response Functional Plan (FSERFP), finalized on September 30, 2013, includes the process for post incident reviews. CFIA has developed operational guidance related to this process which will be finalized by December 31, 2013. 2 CFIA will develop a post incident process to include the perspectives of key stakeholders in a recall by March 31, 2014.	*Action Item #1:* Operations Strategy and Delivery Directorate, Operations Branch *Action Item #2:* Operations Strategy and Delivery Directorate, Operations Branch	*Action Item #1: Complete* The FSERFP was approved on September 30, 2013. The Directive on the After Incident Report (AIR), After Action Report (AAR) and Capabilities Improvement Process (CAIP) was approved on December 12, 2013. *Action Item #2: Complete* A post incident tool for use in conjunction with the CAIP process to include the perspectives of key stakeholders in a recall was approved on March 24, 2014.
8) (83) The CFIA should regularly review, update and approve its policies and procedures for food safety investigations and recalls. This review should include determining the needs of staff implementing the policies and the information that the Agency requires to provide it with assurance that key steps in the recall process have been carried out by the recalling firms. These documents should clearly indicate how they apply when the emergency response process is activated.	1 CFIA has four manuals to guide inspection activities related to food safety investigations and recall. Three of these manuals are finalized; the Food Safety Emergency Response Functional Plan, the CFIA Framework for Food Safety Investigation and Response and the Food Investigation and Response Manual. The fourth, the Food Complaint Manual, will be finalized by March 31, 2014. 2 CFIA is committed to reviewing these manuals every 2 years with the aim of continuously meeting the current operating environment.	*Action Item #1:* Operations Strategy and Delivery Directorate, Operations Branch *Action Item #2:* Office of Food Safety and Recall, Operations Branch	*Action Item #1: Complete* The Food Safety Emergency Response Functional Plan, the CFIA Framework for Food Safety Investigation and Response and the Food Investigation and Response Manual have been finalized. *Action Item #2: Complete* The final version of the Food Complaint Operational Procedure was approved on March 31, 2014.
9) (86) The CFIA should identify the information that it must collect and record to provide it with assurance that it has adequately carried out its oversight responsibilities for the investigation and recall process. It should then make sure that this information, including key decisions, underlying rationales and key analysis, is collected and recorded on a timely basis.	1 CFIA is undertaking a comprehensive review of how it documents information including recall related decisions. Specifically, this review will enhance the thoroughness and improve access to documentation. By December 31, 2013, this initiative will result in the development of operational policy and procedures to be applied to key operational decisions including those associated with routine and non-routine food safety investigations and recalls.	*Action Item #1:* Operations Strategy and Delivery Directorate, Operations Branch	*Action Item #1: Complete* Operational guidance for Documenting Key Decisions during Routine and Non-Routine Food Safety Investigation and Recalls was approved on December 30, 2013.
10) (91) The CFIA should investigate the reasons that quality verifications for food investigations and recalls are not being delivered as planned and should identify options to improve delivery rates. When quality verifications have identified policies and procedures that could be improved or clarified, these issues should be resolved on a timely basis.	1 CFIA has reviewed the delivery of QMS and identified a number of areas for improvement. This has led to the development of a QMS enhancement plan. Under the plan, QMS is targeting high risk inspection activities such as those related to food recall and follow-up activities. By March 31, 2015, these verifications will be conducted by specialized staff. This enhanced process will strengthen the quality management, including the establishment of a systematic reporting and performance Targeting process.	*Action Item #1:* Business Management and Planning Office, Operations Branch	*Action Item #1: Complete* QMS enhanced plan has been developed. High risk inspection activities are targeted in QMS and incorporated into operational workplans for FY 2014-15.
11) (96) The CFIA should determine what information is needed by key stakeholders to allow them to take appropriate actions during a recall. Based on this determination, the Agency should adapt the information it currently provides.	1 In response to recommendations of the Independent Review of XL Foods Inc. Beef Recall 2012, revised warnings to the public have been developed and tested with focus groups and the Consumer Association Roundtable. These templates, written in a manner that is clearer to the public, are being finalized and will be implemented by December 31, 2013. CFIA is committed to the timely exchange of important information with key stakeholders during emergency and routine food safety events. This is subject to the provisions of the Privacy Act and takes into account confidential business information. Also in response to recommendations of the Independent Review of XL Foods Inc. Beef Recall 2012, CFIA has enhanced its communication with industry during national emergency responses by ensuring appropriate technical expertise is available.	*Action Item #1:* Strategic Communication Directorate, Public Affairs Branch	*Action Item #1: Complete* Food recall warnings were tested with focus groups and the Consumer Association Roundtable and have been implemented. The Honourable Rona Ambrose, Minister of Health, announced this improved communications tool on October 30, 2013.

Report Reference – Para. Number

Management Response

Responsible Lead

Current Status

Recommendations

1) (28) To facilitate its food safety investigations, the CFIA should clarify the information it needs and should require industry to maintain this information in a complete, accessible, and immediately useable format. For registered establishments, inspectors should regularly validate that the information maintained by the establishment is complete and accessible.

1 As of May 15, 2013, it is a regulatory requirement that federally registered meat establishments maintain product distribution records in a useable and accessible format that can be produced for CFIA in a timely manner during an investigation or recall.

2 By December 31, 2013, CFIA inspectors will have verified that all registered meat establishments have updated their food safety protocols in accordance with these new requirements. Where companies have not complied with this new regulatory requirement, corrective measures will be taken by CFIA.

The Safe Food for Canadians Act, which received Royal Assent on November 22, 2012, will further strengthen regulatory requirements for traceability and the provision of documents to CFIA by regulated parties by extending this requirement to all food commodities. We anticipate that this Act will come into force in 2015.

Action Item #1:

Agrifood, Meat and Seafood Safety Directorate, Policy and Programs Branch

Action Item #2:

Operations Strategy and Delivery Directorate, Operations Branch

Action Item #1: Complete

Requirements related to product distribution records were updated and published on May 15, 2013, as part of Chapter 3, Meat Hygiene Manual of Procedures (MHMOP).

Action Item #2: Complete

CFIA inspectors inspected all active registered meat establishments to verify that the updated requirements have been implemented. 95% of establishments inspected were found to be in compliance. Where companies had not complied with this new regulatory requirement, CFIA requested corrective actions and have since conducted all necessary follow-up inspections.

2) (43) The CFIA should review and update its guidance for monitoring and documenting the correction or disposal of recalled products. This should include steps necessary to provide the Agency with assurance that the appropriate disposal or corrective activities have been determined and acted upon.

1 CFIA is developing comprehensive operational guidance in order to provide inspection staff with greater clarity on the disposition of noncompliant food products, including product subject to recall. This guidance, which will be completed by December 31, 2013, will assist inspectors in the assessment of the regulated party’s activities and documentation related to the:

• Reprocessing or further processing within or outside the establishment, as per applicable regulatory requirements, to ensure that the hazard is eliminated or reduced to acceptable levels, or

• Destruction and/or disposal as waste.

2 Through this guidance we will ensure that these activities are applied consistently across CFIA. This will be reinforced through improved documentation and by clearly communicating procedures nationally and providing training to staff by January 31, 2014.

Action Item #1:

Operations Strategy and Delivery Directorate, Operations Branch

Action Item #2:

Office of Food Safety and Recall, Operations Branch

Action Item #1: Complete

Operational guidance for the Assessment, Monitoring and Documenting the Disposition of Affected Food Products Identified through Food Safety Investigations, including Recalled Products was approved on December 20, 2013.

Action Item #2: Complete

Updates to the Food Recall Training have been finalized and include operational guidance on the assessment and documentation of disposition activities. Product disposition was covered in lessons related to Verification and Follow-Up at the initial Train-the-Trainer session held January 21-23, 2014.

3) (49) The CFIA should clarify its policies and procedures for following up on the underlying causes of a recall in the non-registered sector.

1 The CFIA is reviewing its procedures for following up on the underlying causes of a recall in the non-registered sector and will implement revised operational guidance by April 30, 2014, including thorough documentation of corrective measures that firms implement in order to address the underlying causes of a recall.

In addition, the CFIA is modernizing its legislative and regulatory framework with the passage of the Safe Food for Canadians Act, and the development of new regulations to support the Act. These initiatives will align the Agency’s regulatory tools across all food commodities, including those in the non-registered sector.

Action Item #1:

Operations Strategy and Delivery Directorate, Operations Branch

Action Item #1: Complete

The Operational Procedure for Following up on the Underlying Causes of a Food Recall was approved on April 24, 2014.

4) (50) The CFIA should monitor its corrective action requests in the registered meat establishments to confirm that they are completed within the required 60-day period.

1 In March, 2013, CFIA enhanced its monitoring and oversight of open Corrective Action Requests (CARs) in response to recommendations of an internal audit related to the management of CARs that remain open past the scheduled date of closure. Weekly reports are submitted to responsible managers to enable appropriate action to be taken to ensure that past due CARs are closed or, in cases when a CAR remains open, that the rationale for the extension as well as interim measures to mitigate food safety risk are implemented and documented. Through quarterly reporting, Senior CFIA officials are also made aware of the status of CARs.

Action Item #1:

Operations Strategy and Delivery Directorate, Operations Branch

Action Item #1: Complete

Frequency of regular reporting of CARs to Regional Directors and senior executives was increased in March 2013 to enhance monitoring and oversight of open CARs.

5) (54) CFIA should reassess its time standards for verifying that registered meat establishments have reviewed and updated their food safety systems and recall plans following a recall. CFIA should verify that the firm has completed this work on a timely basis and document the results of this review.

1 CFIA is reviewing operational guidance for implementation by March 31, 2014, to ensure that there are clear instructions for inspectors on the closure of a recall. CFIA will ensure that the process, and associated timelines, to be followed by inspectors on the closure of a recall are clear and feasible.

2 CFIA has reviewed the delivery of its Quality Management System (QMS) and identified a number of areas for improvement. This has led to the development of a QMS enhancement plan. Under the plan, QMS is targeting high risk inspection activities, such as those related to food recall and follow-up activities, and will verify that inspectors have delivered the operational guidance as intended.

Action Item #1:

- Office of Food Safety and Recall, Operations Branch

- Operations Strategy and Delivery Directorate, Operations Branch

Action Item #2:

Business Management and Planning Office, Operations Branch

Action Item #1: Complete

Updates to clearly define the process, and associated timelines, for inspectors to follow up on recalls as captured in Chapter 18 of the Meat Hygiene Manual of Procedures as well as in the Food Safety Enhancement Program Manual were approved on March 31, 2014.

Action Item #2: Complete

QMS enhanced plan has been developed. High risk inspection activities are targeted in QMS and incorporated into operational workplans for FY 2014-15.

6) (66) The CFIA should evaluate its emergency processes for food safety and finalize its procedures. This should include clearly defining roles and responsibilities and the communication channels required to keep all key stakeholders informed when emergency procedures are activated. In particular, the roles of those parties responsible for investigations and recalls that are conducted through non-emergency procedures should be clarified. The approved procedures should be communicated, tested and updated on a regular basis.

1 The Food Safety Emergency Response Functional Plan (FSERFP) was finalized on September 30, 2013. The plan describes how the Incident Command System (ICS) supersedes day-to-day roles and how it is used in conjunction with existing guidance materials to enhance coordination and management of an event.

2 Orientation and training will be completed by December 31, 2013, and exercises will be conducted by May 31, 2014, for staff identified as potential members of the National Emergency Response Team (NERT). This will enable the CFIA to implement and test the FSERFP. Ongoing updates will be made to the FSERFP following a response as required.

Action Item #1:

Operations Strategy and Delivery Directorate, Operations Branch

Action Item #2:

Operations Strategy and Delivery Directorate, Operations Branch

Action Item #1: Complete

The final version of the FSERFP was approved by VP Operations on September 30, 2013.

Action Item #2: Complete

A NERT Staff Orientation session to provide information on the recently approved Food Safety Emergency Response Functional Plan was delivered December 19, 2013.

Exercises are being held May 26-28, 2014.

7) (79) The CFIA should finalize and implement its directive for post incident reviews and implement it after any food recall that activates emergency response procedures. These reviews should include the perspectives of key stakeholders and should examine the strengths and weaknesses of the investigation, the recall process, and the emergency management process.

1 The Food Safety Emergency Response Functional Plan (FSERFP), finalized on September 30, 2013, includes the process for post incident reviews. CFIA has developed operational guidance related to this process which will be finalized by December 31, 2013.

2 CFIA will develop a post incident process to include the perspectives of key stakeholders in a recall by March 31, 2014.

Action Item #1:

Operations Strategy and Delivery Directorate, Operations Branch

Action Item #2:

Operations Strategy and Delivery Directorate, Operations Branch

Action Item #1: Complete

The FSERFP was approved on September 30, 2013.

The Directive on the After Incident Report (AIR), After Action Report (AAR) and Capabilities Improvement Process (CAIP) was approved on December 12, 2013.

Action Item #2: Complete

A post incident tool for use in conjunction with the CAIP process to include the perspectives of key stakeholders in a recall was approved on March 24, 2014.

8) (83) The CFIA should regularly review, update and approve its policies and procedures for food safety investigations and recalls. This review should include determining the needs of staff implementing the policies and the information that the Agency requires to provide it with assurance that key steps in the recall process have been carried out by the recalling firms. These documents should clearly indicate how they apply when the emergency response process is activated.

1 CFIA has four manuals to guide inspection activities related to food safety investigations and recall. Three of these manuals are finalized; the Food Safety Emergency Response Functional Plan, the CFIA Framework for Food Safety Investigation and Response and the Food Investigation and Response Manual. The fourth, the Food Complaint Manual, will be finalized by March 31, 2014.

2 CFIA is committed to reviewing these manuals every 2 years with the aim of continuously meeting the current operating environment.

Action Item #1:

Operations Strategy and Delivery Directorate, Operations Branch

Action Item #2:

Office of Food Safety and Recall, Operations Branch

Action Item #1: Complete

The Food Safety Emergency Response Functional Plan, the CFIA Framework for Food Safety Investigation and Response and the Food Investigation and Response Manual have been finalized.

Action Item #2: Complete

The final version of the Food Complaint Operational Procedure was approved on March 31, 2014.

9) (86) The CFIA should identify the information that it must collect and record to provide it with assurance that it has adequately carried out its oversight responsibilities for the investigation and recall process. It should then make sure that this information, including key decisions, underlying rationales and key analysis, is collected and recorded on a timely basis.

1 CFIA is undertaking a comprehensive review of how it documents information including recall related decisions. Specifically, this review will enhance the thoroughness and improve access to documentation. By December 31, 2013, this initiative will result in the development of operational policy and procedures to be applied to key operational decisions including those associated with routine and non-routine food safety investigations and recalls.

Action Item #1:

Operations Strategy and Delivery Directorate, Operations Branch

Action Item #1: Complete

Operational guidance for Documenting Key Decisions during Routine and Non-Routine Food Safety Investigation and Recalls was approved on December 30, 2013.

10) (91) The CFIA should investigate the reasons that quality verifications for food investigations and recalls are not being delivered as planned and should identify options to improve delivery rates. When quality verifications have identified policies and procedures that could be improved or clarified, these issues should be resolved on a timely basis.

1 CFIA has reviewed the delivery of QMS and identified a number of areas for improvement. This has led to the development of a QMS enhancement plan.

Under the plan, QMS is targeting high risk inspection activities such as those related to food recall and follow-up activities. By March 31, 2015, these verifications will be conducted by specialized staff. This enhanced process will strengthen the quality management, including the establishment of a systematic reporting and performance Targeting process.

Action Item #1:

Business Management and Planning Office, Operations Branch

Action Item #1: Complete

QMS enhanced plan has been developed. High risk inspection activities are targeted in QMS and incorporated into operational workplans for FY 2014-15.

11) (96) The CFIA should determine what information is needed by key stakeholders to allow them to take appropriate actions during a recall. Based on this determination, the Agency should adapt the information it currently provides.

1 In response to recommendations of the Independent Review of XL Foods Inc. Beef Recall 2012, revised warnings to the public have been developed and tested with focus groups and the Consumer Association Roundtable. These templates, written in a manner that is clearer to the public, are being finalized and will be implemented by December 31, 2013.

CFIA is committed to the timely exchange of important information with key stakeholders during emergency and routine food safety events. This is subject to the provisions of the Privacy Act and takes into account confidential business information.

Also in response to recommendations of the Independent Review of XL Foods Inc. Beef Recall 2012, CFIA has enhanced its communication with industry during national emergency responses by ensuring appropriate technical expertise is available.

Action Item #1:

Strategic Communication Directorate, Public Affairs Branch

Action Item #1: Complete

Food recall warnings were tested with focus groups and the Consumer Association Roundtable and have been implemented. The Honourable Rona Ambrose, Minister of Health, announced this improved communications tool on October 30, 2013.