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CHAPTER 1 - INTRODUCTION, POLICIES PROTOCOLS AND PROCEDURES

1.8 Audit Protocol

The following is the protocol for the audit of the delivery of the Meat Hygiene program. This protocol is in line with the Food Inspection Directorate (FID) audit protocol. The FID audit protocol is based on ISO 10011 principles with modifications necessary to reflect the requirements of the FID. The ISO 10011 principles are internationally recognized auditing techniques.

Within the Meat and Poultry Products Division the objectives of an audit are as follows:

1. To evaluate the degree of accuracy and uniformity of delivery of establishment and product inspection programs on the basis of established criteria, and to identify nonconformance requiring corrective action.
2. To evaluate training needs and to discuss appropriate measures to correct deviations recorded.
3. To define industry and inspector concerns and problems which may impact on program delivery for resolution by the appropriate program officials.

To achieve the above objectives, the audits will serve to determine:

1. the accuracy of acts, regulations, manuals and directives in relation to the current national version;
2. the conformance (including interpretation and application) of establishment inspection, product inspection procedures with those described in appropriate procedures/ inspection manuals;
3. the precision and the comprehensiveness of inspection reports and the completeness of all pertinent files;
4. the timeliness and thoroughness of the correction of deviations that were observed during an audit and of follow-up activities on auditors' findings; and
5. training needs for program delivery.

It is important to understand that audit is not inspection. It is incorrect to use the term audit when referring to plant inspections or reviews (see section 1.7 - Inspection protocol). An inspection is performed to detect deficiencies in products or plant operations at the establishment level. The main objective of an audit is to permit the auditors to make a statement regarding their judgement of the auditees conformance with a specified standard and the adequacy of existing controls for maintaining conformance. The specified standard in the case of the Meat Hygiene Program would be the Meat Inspection Act and Regulations, the Meat Hygiene Manual of Procedures, the Inspection Program guide (TIP), other manuals and memorandum concerning National policy and procedures sent out by headquarters. The written standard being audited against will always be defined to the auditee prior to the audit.

1.8.1 National audit protocol

The National audits will be performed by auditors at the headquarters level and will be in line with the FID audit protocol. The main objective of these audits is to obtain enough information to allow the national auditors to make a judgement as to whether the regions (auditee) are conforming with the specified standards. As mentioned above, the standards being audited against will always be defined in the audit plan prior to the audit.

1. Select a lead auditor and the audit team member(s)
2. Select the area of the meat hygiene program to be audited. The Meat Hygiene program has been divided into seven program areas. Two (2) of these areas will be audited each year so that each program area should be audited approximately every 3-4 years. The seven program areas are as follows:
   1. Red Meat Slaughter/ Cutting and Boning
   2. Poultry Slaughter/ Cutting and Boning
   3. Prerequisite programs
   4. Processed Products - Ready to eat (shelf stable and non shelf stable)
   5. Processed Products - Raw (includes MSM, ground meat and assembled meals)
   6. Export/Import
   7. Training programs for CFIA employees working within the Meat Hygiene Program
3. Write the audit plan. This includes the following:
   • location of the audit (region)
   • dates of the audit
   • members of the audit team
   • language of the audit
   • who is being audited (auditee)
   • identify the audit objectives and scope
   • specified standard audited against
   • audit report distribution
   • develop the audit schedule including agenda for opening and closing meetings.
4. Prepare the audit plan cover letter addressed to the Regional Director General (RDG) and signed by the Chief, Audit Programs. This cover letter outlines general audit information.
5. Send the audit plan and cover letter to the RDG and copy to the Regional program manager, Director MPPD, Associate Director Policy Development and Organization, Chief of Program being audited.

1.8.1.2 Audit execution

Draw up a checklist, to be used by the audit team, using the most current specified standard for the area being audited. This checklist is a tool to be used by the auditor as a guide and is designed so that it does not restrict additional activities or investigations considered necessary as a result of information gathered during the audit.

Steps involved in the audit:

1. Opening meeting: The purpose of this meeting is to lay the groundwork for the audit by identifying members, reviewing scope and objectives, establishing the communication and other linkages required to ensure an effective and efficient audit and confirming the audit schedule.
2. At the regional office, the national auditors will review documents, regional procedures and arrangements related to the specific meat hygiene program activities that are being audited and compare these with the national reference standard for the program, as set out in the most current version of the Meat Inspection Act & Regulations, the Meat Hygiene Manual of Procedures, the Inspection Program Guide (TIP), memoranda or manuals from headquarters and other reference documents as identified in the specific audit plans. As well, the auditors may gather information about roles, program responsibilities and staffing of the program activities with a view of gauging their resource requirements.
3. The national auditors will conduct on-site verifications at establishments identified in the audit schedule to ensure that the specified standards are being followed and are effective. The focus will be on the work performed by the inspection staff.

   At the regional office and during on-site verifications, the national auditors will collect evidence through the effective use of interviews, observation, and document examination. This evidence is collected to assist in the assessment of the inspection program. Where necessary, audit checklists may be modified to permit additional investigation required to clarify potential areas of concern.

   All observations will be recorded and reviewed by the audit team, with non conformities clearly identified and supported by appropriate evidence.

4. Closing meeting: During the closing meeting the audit team will meet with the auditee to present audit findings. All non conformities and areas that need improvement should be reviewed with the auditee. Where appropriate, auditors may present recommendations for improvements on the program.

It is anticipated that each audit will be completed within 5 days. However, there may be a need for the auditors to extend the length of the audit or return to a given region in order to gather further information.

The region is asked to identify a regional contact person (usually the Program Manager, Meat Hygiene) to help coordinate audit activities and to arrange for facilities required for the audit (meeting room, working room, provision of records, photocopying, etc...). This contact person should be available during the entire audit in order to act as the communication contact for the regional auditee and to resolve any difficulties which may arise. It is the lead auditors responsibility to keep the regional contact up-to-date with the audit findings at the end of each day.

As well, it is the responsibility of the region to ensure that during on-site verification of procedures, the inspector responsible for inspection activities at the establishment and a representative from the region (if possible) are present and operational/inspection activities are taking place at the time of the on-site verification.

1.8.1.3 Audit Report

The Audit Report is the official report of the auditor and is used to record the conformance and uniformity of program delivery according to the specified standards. It should be dated and signed by the lead auditor and audit team members.

The Audit Report should be completed within two weeks of the audit.

The Audit Report should contain the following information:

• the scope and objectives of the audit;
• details of the audit plan including audit team members, auditee representatives, date and location (include any changes made to the original audit schedule);
• reference documents against which the audit was conducted;
• audit findings (observations of nonconformity or areas which need improvement) and any Corrective Action Request's issued;
• the distribution of the audit report.

The following steps are to be taken when preparing an audit report:

1. The lead auditor will draft the audit report with the help of the audit team.
2. A draft memo to the responsible Program Chief (s) with a list of any concerns found during the audit is prepared. These may be concerns of the auditor, regional staff or industry.
3. A copy of the draft audit report and memo(s) to the responsible Program Chief(s) is sent to the Chief Audit Programs, Chief Program audited and Associate Director Policy Development and Organization and any others to be involved in the peer review.
4. Peer review of the draft audit report and memo(s) to the Program Chief(s) takes place within MPPD.
5. If necessary following the peer review, the draft audit report and memo(s) to the Program Chief(s) are amended.
6. The memo(s) to the responsible Program Chief (s) is finalized. This memo is to be copied to the Director of MPPD, the Associate Director Policy Development and Organization, the Chief Audit Programs and the National Training Co-ordinator, National training Section.
7. The draft audit report is sent to the Regional Program Manager for feedback and comments. A specific due date for the regions comments will be identified.
8. If necessary, the draft audit report is amended following comments from the region.
9. The final version of the audit report is distributed. Where appropriate, any Corrective Action Requests (Annex H) will be appended to the report. Only Part A of the Corrective Action Request (CAR) needs to be filled in at this time.

The cover letter of the audit report is addressed to the Director of MPPD and signed by the Chief Audit Programs. The audit report is copied to:

Director General, FID
Regional Director General, appropriate region
Program Manager, Meat Hygiene, appropriate region
Associate Director Policy Development and Organization, MPPD
Chief, Audit Programs, MPPD
Chief, responsible program, MPPD
National Training Coordinator, National Training Section

1.8.1.4 Evaluation of the delivery of the program by the region

Following an audit, prior to the closing meeting, the national auditor will establish if the regions delivery of the specified standards is "In conformance" (C), "needs improvement" (NI) or "not in conformance" (NC). The auditors findings must be based on objective evidence which was collected during the audit.

If an item within the program audited is evaluated as "In conformance", the region meets the program requirements.

If an item within the program is evaluated as "needs improvement", the region still meets the program requirements; however, there are improvements that need to be made.

If an item within the program is evaluated as "not in conformance", the region does not conform to the program requirements.

When the national auditor finds an item in the program being audited is "not in conformance" with the program requirements (NC), a Corrective Action Request (CAR) is issued and presented to the auditee during the closing meeting. The description of the non-conformance is completed by the lead auditor (Part A of the form) prior to the closing meeting. The decision target date for providing the written corrective action is also completed by the lead auditor but in consultation with the auditee, during the closing meeting. The auditee has until the decision target date to complete and forward to the lead auditor at headquarters the description of the corrective action to be taken, along with target date for implementation of the corrective action in the region (Part B of the form).

All CAR's issued will be numbered to include the year, the region, the program being audited and the consecutive number of the CAR issued during the audit.

1.8.1.5 Follow-up of National audits

1.8.1.5.1 Follow-up by the Program Chief

The responsible Program Chief(s) will review and consider all comments and recommendations made by the auditors, and where necessary, modify the national policy (legislation or program).

Once the CAR's with Part B completed (written corrective action to be taken by the region) are received by the lead auditor, they are copied to the responsible Program Chief(s) for acceptance with a covering memo. This covering memo is copied to the Chief Audit Programs and Associate Director of the responsible Chief. If the Program Chief finds the regions corrective action not to be acceptable, it is the Program Chiefs responsibility to contact the region to obtain an acceptable written corrective action. The Program Chief should reply to the audit section within 2 weeks, as to the acceptability or non acceptability of the regions written corrective action. The Program Chiefs acceptance/non acceptance is documented on the "tracking sheet for corrective action requests" (annex I). Any correspondence the Program Chief has with the region should be copied to the audit section. This information is required when the National auditors perform follow-up audits.

The responsible Program Chief must be kept informed of all progress in the regional implementation of the corrective action taken by the region (eg: memos issued by the regional office).

1.8.1.5.2 Follow-up by the National auditor

Within 12 months of an audit, any CAR's issued to a region should be followed-up (verified) by a National auditor. Follow-up by the National auditor involves visiting the appropriate Regional office to collect evidence through the use of interviews and document examination and performing on-site verifications to determine if the written corrective action on the CAR form has been taken by the auditee and is effective.

When follow-up findings indicate that the deviation noted on the CAR has not been corrected effectively in the Region, a memorandum signed by the Chief, Audit Programs is sent to the Regional Program Manager requesting an explanation and a new written action plan. The Regional Program Manager must submit to the Chief, Audit Programs, the written action plan indicating how the region is going to correct this deviation. This regional action plan will be assessed by the National auditors during a subsequent visit in the non conforming region.

Areas which have been rated NI must also be followed-up by the National auditor during a follow-up audit. If an area was assessed as NI during the initial audit and is found to not have been corrected during a follow-up audit, a corrective action request (CAR) will be issued by the auditor performing the follow-up audit.

Part C on the CAR form is to be filled out with the auditors follow-up findings. As well, an audit report of the follow-up audit findings (with CAR's appended) must be prepared. The cover letter for this follow-up audit report is addressed to the Director of MPPD and signed by the Chief Audit Programs. The audit report is copied to:

Director General, FID
Regional Director General, appropriate region
Program Manager, Meat Hygiene, appropriate region
Associate Director Policy Development and Organization, MPPD
Chief, Audit Programs, MPPD
Chief, responsible program, MPPD
National Training Coordinator, National Training Section

Finally, the "tracking sheet for corrective action requests" (annex I) must be completed by the auditor when a CAR has been verified.

Follow-up may be conducted by a National auditor during a visit to the Region for USDA reviews or may be performed when the auditors are in the Region for other reasons (eg: auditing a different area of the meat hygiene program). It is anticipated that each follow-up to an audit will be completed within 2 to 3 days.

1.8.1.6 Audit Records

All audit records (audit plans, audit reports, follow-up audit reports, CAR's etc.) must be kept on file at headquarters.

1.9 Cancellation of registration of an establishment; Cancellation or suspension of licence to operate a registered establishment

Applicable procedures are prescribed in the Meat Inspection Regulations, 1990. The following is to clarify the responsibilities of all concerned.

1.9.1 Cancellation of the registration of an establishment

The protocol for the cancellation of the registration of an establishment is prescribed in section 27 of the Meat Inspection Regulations, 1990.

There are three instances where cancellation procedures will be considered, namely:

(1) Establishment closure

(2) Non-operating status of a registered

(3) Failure to meet minimum construction requirements

1.9.1(1) Establishment closure

When a decision is reached to close a registered establishment, the owner or another responsible person (e.g. a receiver) shall notify the appropriate Regional Director General (RDG) in writing. A copy of the notification shall be forwarded by the RDG to the Chief, Regulations and Procedures of the Meat and Poultry Products Division (MPPD). The Chief, Regulations and Procedures, will then proceed with the cancellation of registration of that establishment.

1.9.1(2) Non-operating status of a registered establishment

The registration of an establishment lapses under subsection 27(4) of the Meat Inspection Regulations, 1990, when operations, for which an establishment is registered, are not carried out for a period of 12 consecutive months.

It should be noted that the lapse of registration may be complete or partial.

A partial lapse of registration would occur when an establishment that is registered for slaughter of food animals discontinues slaughter operations, but continues to carry out processing, packaging and storage operations. The lapse of registration in that establishment would be partial, and would result in a change of registration (function codes) without a change in the registration number. In cases where an establishment registered for the slaughter of food animals, or an establishment registered for the processing and packaging of meat products, discontinues those operations, but continues to store edible meat products as an registered storage, the change of operations would result in a change of registration as well as a change of the registration number. In the case of discontinuation of all operations (slaughter, processing, packaging and storage), a complete lapse of registration takes place.

Regional Directors General should encourage owners of registered establishments to request a change in registration status, whenever applicable, well in advance of lapse of registration under subsection 27(4) of the Meat Inspection Regulations, 1990.

In all instances where an establishment does not carry out the operations for which it is registered, for a period of 10 consecutive months, the appropriate RDG shall alert the owner of the registered establishment that registration will (partially or completely) lapse under subsection 27(4) of the Meat Inspection Regulations, 1990, unless operations are resumed within a period of two months. A copy of that letter should be forwarded to the Chief, Regulations and Procedures, MPPD. In all cases where operations, for which the establishment is registered, are not resumed within the specified period of time, the RDG shall notify the owner of the registered establishment that registration has lapsed (partially or completely). A copy of the notice shall be sent to the Chief, Regulations and Procedures, MPPD, who will then proceed with cancellation or amendment of registration as applicable.

In all cases of partial lapse of registration, a new licence to operate a registered establishment will be issued to reflect the new status of the registered establishment. The operator shall surrender the old licence to the inspector in charge.

1.9.1(3) Failure to meet minimum requirements

Once the procedures outlined in the Audit Protocol to achieve compliance have been exhausted, and the stage has been reached whereby it is deemed that the registered establishment cannot or will not be brought into compliance, then a recommendation for cancellation of registration shall be made to the Director, MPPD. If the decision to proceed with cancellation is taken, the responsible RDG will write a report identifying all provisions of section 28 that have not been complied with and specify the period of time for compliance in order to prevent the cancellation of registration. The report shall be delivered to the owner of the registered establishment and to the operator, where the owner is not the operator and copies shall be forwarded to the Director, MPPD. If the establishment has not been brought into compliance within the specified period of time, the Director, MPPD will issue a letter to the owner of the registered establishment indicating that a recommendation for cancellation has been made and that arrangements have been made to conduct a final hearing prior to cancellation.

This letter will specify the date and time of the hearing and will give an opportunity to the owner to attend, along with legal representation. The Food Production & Inspection (FPI) Branch will be represented at the hearing by representatives of the appropriate regional office and MPPD, together with a legal advisor.

Once the final decision to cancel registration has been reached, written notification of the effective date of cancellation of registration will be sent to the owner by the Director MPPD.

1.9.2 Suspension of licence to operate a registered establishment

The protocol for the suspension of a licence to operate a registered establishment is prescribed in subsection 29(8) of the Meat Inspection Regulations, 1990.

This procedure may be used when the operator fails to comply with any provision of the Meat Inspection Act and its Regulations and when there is reasonable grounds to believe that such failure to meet the requirements would constitute a risk to public health.

Once the decision to suspend the licence is taken, the responsible RDG will write a report setting out the reasons for the proposed suspension and the immediate corrective action required. The report shall be forwarded to the operator and copies shall be sent to the Director, MPPD.

If the operator does not take immediate corrective actions required, the appropriate Regional Director General will send a notice of suspension of Licence to Operate a Registered Establishment to the operator.

The suspension of the licence will remain in effect until the required corrective action is taken (see 1.7.9), or until resolution of the cancellation issue should such be the case.

1.9.3 Cancellation of licence to operate a registered establishment

The protocol for the cancellation of a licence to operate a registered establishment is prescribed in subsection 29(11) of the Meat Inspection Regulations, 1990.

This category would include practices or activities in contravention of the Meat Inspection Act or its Regulations.

Upon receiving notification of a contravention, the responsible RDG, in consultation with the Chief, Regulations and Procedures, MPPD and other appropriate chiefs, will make a determination if the contravention will be classed as minor or major. This notification may originate from regional staff, investigators, National Veterinary Auditors (NVA), laboratory analysts, law enforcement officers, etc.

If it is determined that the contravention is minor in nature, and previous requests for compliance have failed to produce corrective action, then the appropriate RDG will prepare a letter of warning. This letter will refer to the failure to take corrective action and will indicate that future similar or repeat contraventions may lead to cancellation of licence to operate the registered establishment. Copies of this letter will be sent to DG FI and the Director, MPPD.

In the case of contraventions where the above letter of warning goes unheeded, or in the case of a major contravention, following consultation with the Director, MPPD, the responsible RDG will write a report identifying the provision(s) of the Meat Inspection Act or the Regulations that has (have) not been complied with and specifying the period of time for compliance to prevent cancellation of the licence. The report will be delivered to the operator and copies will be forwarded to the Director, MPPD. If the operator fails to comply with the provision(s) of the Act or the Regulations within the period of time specified, the Director, MPPD will issue a letter informing the operator that a decision to cancel licence has been made and indicating a date and time for a hearing where he will have the opportunity to attend along with legal representation. The Food Production & Inspection (FPI) Branch will be represented at the hearing by representatives of the appropriate regional office and MPPD, together with a legal advisor.

Once the final decision to cancel the licence has been reached, written notification of the effective date of cancellation of licence will be sent to the operator by the Director MPPD. A copy of the notification will be sent to the RDG concerned.

The action taken to cancel or suspend the licence to operate the registered establishment will be independent of any court action that may be taken as a result of the contravention.

1.9.4 Additional action

Following cancellation of licence or registration, the licence to operate a registered establishment must be surrendered to an inspector, who will forward the licence together with any stamp bearing the Meat Inspection Legend and any export stamp or sticker to his regional office. The licence and any stamp identified with the establishment registration number shall then be forwarded to the Administrative Support Specialist, Meat and Poultry Products Division, Ottawa. See: 4.1.6(3). Export stickers are to be stored in the regional office or destroyed under supervision. All labels bearing the Meat Inspection Legend should remain under the control of an inspector until a satisfactory disposal is made. In all cases, an inventory and disposition report is to be forwarded to the Chief, Plants and Equipment Evaluation, MPPD.

In the case of suspension of licence to operate a registered establishment, all operations are suspended and all items bearing the Meat Inspection Legend and the licence must be under the control of the inspector in charge until corrective action is taken.