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Food Safety Enhancement Program Manual

Chapter 4: Regulatory System Audit

Section 6 - Conducting a regulatory system audit

For each regulatory system audit, the Agency performs the following:

• preparing for the audit
• establishing the audit scope
• holding an opening meeting
• gathering information
• holding private meeting(s)
• developing the audit report
• holding a closing meeting
• conducting follow-up activities

6.1 - Preparing for the audit

Prior to conducting an audit, the Agency:

• sets the language of the audit;
• identifies the members of the audit team;
• identifies the reference documents;
• sets the date of the audit (the establishment may or may not be notified in advance);
• determines the expected duration of the audit;
• determines the audit scope.

6.2 - Establishing the audit scope

The audit scope includes tasks associated with the following:

• outstanding Corrective Action Requests (CARs), if applicable
• log book entries
• CCP(s)
• prerequisite program sub-elements
• HACCP system review tasks

The audit scope may be influenced by factors such as the results of previous audits (e.g. outstanding CARs, audit reports and audit observations), previous inspection results, food safety complaints and other relevant information.

6.2.1 - FSEP Audit Scope Worksheet (Appendix VI)

The audit team uses the FSEP Audit Scope Worksheet (Appendix VI) when compiling tasks for the audit. Once complete, this worksheet summarizes the scope of the audit. The purpose of this worksheet is to list the selected tasks in the order in which they will be evaluated.

6.2.2 - Order of selected tasks

The tasks are to be listed and audited in the order presented below.

6.2.2.1 - Outstanding CARs

Outstanding Corrective Action Requests (CARs) are those CARs that were generated in previous regulatory system audits, for which the completion date has passed, and that have not been closed.

The auditors' first task is to review outstanding CARs. The audit team will evaluate the company's corrective action(s), and may also need to review the written program, in order to determine whether to close each outstanding CAR. The team documents the results of this review on Part C.2 of the CAR form.

6.2.2.2 - Log book review

The auditors' second task is to review the company's record (log book) of changes to its processes or HACCP system. On the FSEP Audit Scope Worksheet, the auditors list changes noted in the log, as described below. The auditors will normally review only the revised description in the written program and the implementation of the change in the plant. The auditors will not normally review the entire sub-element or CCP affiliated with the change.

Any log book entries that coincide with CCP(s) or sub-element(s) already selected by the team for review are not listed on the audit scope worksheet. The auditors will evaluate these changes during their review of the related CCP(s) or sub-element(s).

Log book entries related to outstanding CARs are not listed on the worksheet. The auditors will evaluate these changes during their review of the outstanding CAR(s).

Any log book entries associated with new HACCP plans are listed on the Audit Scope Worksheet. The auditors will evaluate them using Appendix IV.

The audit team will select a minimum of two entries that have the greatest impact on food safety or the HACCP system. If, during subsequent audits, no entries have a significant impact on food safety or the HACCP system, the team will not select any for review.

During its log book review, if the audit team determines that the company has not amended its HACCP system appropriately, the team may add the task of reviewing the establishment's reassessment procedures to the FSEP Audit Scope Worksheet.

After completing the review of the log book, the auditor underlines the last entry in the log book (to indicate the point at which the review terminated), enters the review date and signs his or her name.

6.2.2.3 - Critical Control Points (CCPs)

The auditors choose to review a certain number of CCPs based on the total number of recognized CCPs. CCPs are randomly selected from among the operating CCPs, if possible. The audit team may, however, target specific CCPs if necessary.

The following guide is used to determine the number of CCPs selected for review:

• 1 recognized CCP audit the CCP
• 2-8 recognized CCPs: randomly select 2 CCPs
• 9-15 recognized CCPs: randomly select 3 CCPs
• 16-25 recognized CCPs: randomly select 5 CCPs
• 26-50 recognized CCPs: randomly select 8 CCPs
• 51-99 recognized CCPs: randomly select 13 CCPs
• If 100 CCPs or more are recognized, the audit team will consult with the Area FSEP/HACCP Coordinator for instructions on selecting CCPs.

If there are not enough recognized CCPs operating at the time of the audit, the audit team will review the records and interview the personnel responsible for the selected non-operating CCPs, if possible.

6.2.2.4 - Prerequisite program sub-elements

Prerequisite program sub-elements have been grouped according to their impact on food safety (see Table 1), with Group 1 having the most impact and Group 3 having the least. The auditors will select the prerequisite program sub-elements to be audited according to the following guide:

• Group 1 sub-elements: randomly select 2
• Group 2 sub-elements: randomly select 2
• Group 3 sub-elements: randomly select 2, once per year.

While the selections are normally random, the audit team may target specific sub-elements as necessary.

The following guidelines will be utilized by the auditor during the evaluation process:

C 1.2 Equipment Maintenance and Calibration - Select a maximum of two pieces of equipment for general maintenance and two for calibration as identified in the company's written program (e.g. the whole pasteurizer or its individual parts [plates, pumps, recording thermometers, etc.]) and not selected from the previous audit.

E 1.1 Sanitation Program - Select one room or area and select a sample of the equipment located in that room or area.

Table 1. Grouping of prerequisite program sub-elements

6.2.2.5 - HACCP system review tasks

The audit team members must audit, at a minimum of once per year, each item listed in the following task list for HACCP system review. These items may be audited separately over the year. The criteria to be evaluated appears in parentheses below. The auditors record the results of their review on the FSEP Regulatory System Audit Worksheet (Appendix VI).

The HACCP system review consists of the following:

6.3 - Holding an opening meeting

The purpose of the opening meeting is to:

• introduce the members of the audit team to the management representatives;
• establish official communication links between the auditor and the establishment's representative (e.g. HACCP coordinator);
• confirm that the needed resources and facilities are available;
• confirm the time and date of the closing meeting and any necessary interim meetings;
• obtain the company's written prerequisite programs and HACCP plans;
• confirm which CCPs are operating;
• obtain access to the company's log book;
• discuss previous audit findings (e.g. outstanding CARs); and
• finalize the audit scope.

6.4 - Gathering information

Prior to conducting its on-site audit, the audit team evaluates the company's written programs to ensure that they are complete. During this review, the team develops or updates its FSEP checklists (Appendix II or IV) for the prerequisite program and HACCP plan.

When an establishment has developed written procedures that exceed regulatory requirements, the audit team evaluates the written program on the basis of the higher standard.

If the auditors determine that the company's written procedures are incomplete, they note this deficiency on the FSEP Audit Worksheet. Once the establishment has amended its written program(s), the audit team reviews the amended version to ensure that it is complete. Only then will the team conduct the on-site evaluation of that selected task. If the written program cannot be amended during the audit, the auditors may select another task to evaluate. They note the incomplete sub-element or CCP in their audit report. This task will then be selected in the next regulatory system audit.

The audit team uses the checklists found in Appendix II and Appendix IV while reviewing records and conducting an on-site evaluation of CCPs and prerequisite programs.

The audit team gathers information to ensure that the company's HACCP system is effective in meeting food safety objectives. It gathers objective evidence to confirm that the procedures, documents and other information describing the HACCP system:

• are implemented as described;
• are up to date; and
• continue to meet commodity and FSEP program requirements.

Objective evidence is collected by conducting the following activities.

6.4.1 - Record review

The audit team examines company records (e.g. monitoring, deviation and verification records) to confirm that they have been completed and filed as indicated in the written procedures.

6.4.2 - On-site evaluation

The on-site evaluation may include two components:

• Interviewing designated personnel responsible for carrying out activities outlined in the written program. The interview should confirm that these employees have access to, understand and are using the current written procedures.
• Visually confirming the information gathered through the above interviews, by observing on-site activities and/or environmental conditions in the establishment.

Should the auditors find objective evidence that is not in the audit scope, they may add the associated audit task to the audit scope or note those observations in the audit report. This audit task would then be selected in the next regulatory system audit.

The audit team documents its objective evidence on the FSEP Audit Worksheet (Appendix VI) and communicates this evidence to representatives of the establishment during the audit. One or more company representatives should be available to accompany the audit team members during their gathering of objective evidence. If company staff cannot be present, the audit will continue.

6.5 - Holding a private meeting

The audit team discusses its objective evidence in a private meeting. The team assesses the evidence to determine whether each item:

• conforms to the appropriate criteria
• warrants an audit observation
• constitutes a non-conformity (Figure 2)
• constitutes a major non-conformity (Figure 2)

During the private meeting, the auditors may seek advice from other experts to help them assess the objective evidence (e.g. CFIA commodity specialists, FSEP/HACCP specialists).

6.5.1 - Evaluating objective evidence

In assessing the objective evidence, the audit team determines whether any existing conditions put food safety at risk. If a food safety issue is identified and the establishment does not initiate immediate corrective action (e.g. hold products or initiate recall procedures), the audit team will take regulatory compliance action to control the food safety issue. If the auditors take regulatory compliance action, they will also generate a CAR indicating that a major non-conformity has occurred (Chapter 4, Section 6.5.13, Figure 2).

6.5.1.1 - Audit observation

An audit observation is a deviation that is identified during an audit but has no impact on the integrity of the HACCP system and does not requiring a written action plan (e.g. a signature missing on one record). The auditor may note these as "audit observations" on the audit report. If similar observations were noted on past audit reports, the audit team may decide to rate this observation as a non-conformity.

6.5.1.2 - Non-conformity

A non-conformity is a deviation identified during an audit that impacts on the integrity of the HACCP system and necessitates a written corrective action plan (e.g. the written program continues to control the sub-element effectively). Non-conformities may occur within:

• the sub-element of a prerequisite program;
• a CCP of the HACCP plan; or
• the HACCP system reassessment procedures.

For each non-conformity, the Agency requires a written corrective action plan from the establishment.

6.5.1.3 - Major non-conformity

A major non-conformity is identified when the following are observed:

• An incident putting food safety at risk, where the establishment has not taken effective corrective action and the CFIA takes regulatory compliance action on the product.
• Failure to implement effective corrective action from a previously identified non-conformity.

For each major non-conformity, the Agency requires a written corrective action plan from the establishment.

Figure 2. Evaluation of objective evidence diagram

6.5.2 - Corrective Action Request (CAR)

When a non-conformity is identified during a regulatory system audit, the auditors complete a CAR form describing:

• the non-conformity;
• the company’s written corrective action plan; and
• subsequent follow-up observations by the Agency.

Each CAR is numbered using the establishment registration number followed by the year and the consecutive CAR number (e.g. 111-2005-01).

The CAR form is divided into three parts as follows (Appendix VI).

6.5.2.1 - Part A: Description of Non-Conformity

Part A of the CAR form is completed by the audit team. The information must include the following:

6.5.2.2 - Part B: Corrective Action

Part B is completed by the establishment. The information must include details of the corrective action(s) and preventative measure(s) that it has taken to address the non-conformity identified in Part A.

If the establishment does not submit Part B to the audit team at the time the CAR is presented, the establishment must submit Part B by the date indicated in Part A, "date for submission of corrective action."

The establishment’s representative must sign and date Part B of the CAR and submit it to the audit team, who will determine if it is acceptable (Appendix VI, Corrective Action Request Guidelines).

The establishment must identify the date by which it will complete its corrective action(s). It is the responsibility of the establishment to ensure that its corrective action(s) are implemented effectively by the date that it has indicated.

For major non-conformities, an action plan is to be requested from the operator within 24 hours, including implementation of immediate appropriate corrective actions, and up to 10 days for implementation of preventative measures.

For all other non-conformities, an action plan is to be requested from the operator within 10 days. The operator has up to 60 days for implementation of corrective actions, including preventative measures.

The Agency may grant an extension to the agreed "date for completion of corrective action" under the following circumstances:

• Food safety is not compromised.
• The establishment will not meet its "date for completion of corrective action" due to reasons beyond its control (e.g. a part is on back order).

Please note: If the above criteria apply, it is the establishment’s responsibility to contact the CFIA prior to the current completion date indicated in Part B in order to request an extension. If the extension is granted, the new date is entered in Part B of the CAR form and initialled by the auditor.

6.5.2.3 - Part C:  CFIA Assessment and Follow-up

The auditor completes Part C.1 while reviewing the corrective action plan submitted by the establishment (Part B). If the corrective action plan (Part B) is acceptable, the auditor signs and dates Part C.1. If the corrective action is not acceptable, the auditor returns the CAR form to the establishment’s representative for correction.

The auditor completes Part C.2 whenever a follow-up review is conducted at the establishment to determine whether corrective actions have been implemented effectively. If the auditor finds that corrective actions have been implemented effectively, the auditor signs and dates the CAR and closes it. If the corrective actions have not been implemented effectively, the CAR remains open and the following actions are taken:

• For a non-conformity: a major CAR is issued
• For a major non-conformity: a follow-up regulatory system audit is scheduled, as indicated in the Non-Conformity Flow Diagram (Section 2.2, Figure 1)

6.6 - FSEP Audit Report

The FSEP Audit Report (Appendix VI) is completed by the audit team. It includes the following information:

• scope of the audit
• name(s) of the audit team member(s)
• name(s) of the company representative(s)
• reference documents used (e.g. prerequisite programs, HACCP plans, standard operating procedures (SOPs), etc.)
• audit findings
• CAR information (attach CAR form(s))
• conclusions (overall comments on the results of the audit)

The audit report, including any applicable CARs, must be provided to the establishment’s management with a copy sent to the Agency inspector responsible for follow-up action. The audit report is also copied to the Agency’s Area FSEP/HACCP Coordinator and HQ Program Chief.

6.7 - Closing meeting

The audit team conducts a closing meeting with management representatives (e.g. HACCP coordinator, plant manager, plant supervisor, etc.). At this meeting, the auditors present the company representatives with the audit report and any CARs. The auditors review the results of their audit and clarify their audit findings. At this time, the establishment is expected to provide target dates for completing any necessary corrective actions.

6.8 - Conducting follow-up

All CARs are followed up on by the auditor or the responsible inspector. The auditor reviews all written corrective action plans submitted by the company and determines whether they are acceptable. Part C.1 of the CAR is completed at this time.

After the "date for completion of corrective action" has passed, the auditor and/or inspector follows up at the establishment in the presence of the company representative to ensure that the corrective actions have been completed as described and are effective. The follow-up to the non-conformity may be performed during the subsequent audit, or sooner, if required.

A follow-up to a non-conformity must be performed as soon as possible after the date for completion of corrective action identified in Part B of the CAR form.

When the auditor and/or inspector determines that the corrective action is completed and effective, Part C.2 of the CAR is completed and the CAR is closed.

If the action plan has not been effectively implemented and the CAR cannot be closed, the CFIA will take action as per the Non-Conformity Flow Diagram (Section 2.2, Figure 1).

Section 7 - Loss of recognition

Loss of recognition will render the establishment ineligible for Regulatory System Audits. In this case, the establishment will no longer be eligible to use any labels or advertising associated with FSEP or make claims regarding FSEP/HACCP recognition.

When an establishment loses recognition, the Area Executive Director sends a letter to the company’s management, with a copy to the Agency’s Program Chief, informing it that the establishment is no longer recognized under FSEP. This letter voids the original recognition letter.

Following loss of recognition, if an establishment wishes to re-apply for recognition, it must begin the process by re-submitting a letter of commitment and following the steps outlined in Chapter 3.

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