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Food Safety Enhancement Program Manual

Chapter 4: Regulatory System Audit

Section 1 - Background

The CFIA (the Agency) conducts regulatory system audits to verify that an establishment's HACCP system, including its prerequisite programs, HACCP plans and reassessment procedures, is implemented as described and is continuously effective. These audits are consistent with the International Organization for Standardization (ISO) approach to auditing: "a systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives."

Regulatory system audits may be unannounced. However, notice of an audit may be given to an establishment to confirm its continued operation and/or the availability of company staff.

Auditors conduct a partial review of the company's HACCP system. Their objective is to confirm that:

• written procedures are up-to-date and continue to meet commodity program and FSEP requirements; and
• the HACCP system is being implemented as described and is effective.

Members of the CFIA audit team must have commodity-specific knowledge in order to identify deviations, assess their impact on food safety and take compliance action if the applicable acts and regulations are not being complied with.

Section 2 - Frequency of audits

Audit frequency for any establishment is determined by the risk category of its products and/or its manufacturing processes.

In the event that an establishment's products fall into more than one risk category, the higher risk category (e.g. Category I) must always determine the frequency of audits.

2.1 Risk categories

Risk categories are determined on the basis on a multitude of factors. The following examples are not comprehensive. If you are not sure which category applies to your company's products or processes, contact your Area FSEP/HACCP Coordinator.

2.1.1 - Category I

Category I products or processes may involve any of the following, among other criteria:

• The process requires a number of possibly complex control procedures to ensure product safety.
• The process involves a kill step to eliminate microbial contaminants, or another step to reduce them to an acceptable level.
• The production involves a complex recipe. It may involve the use of chemical hazards (e.g. nitrates) or involve a product that addresses serious nutritional concerns.
• Raw material procurement is a critical step. Well-defined hazards can be controlled through incoming raw material (e.g. aflatoxin in nuts).
• Hazards are inherent to the processes, and the products are considered ready to eat, without further processing by the consumer.
• Similar products have been responsible for serious outbreaks of food-borne illness.
• Loss of control within these establishments could result in a significantly high health risk.

Category I includes the following processes, among others:

• Pasteurization, heat treating, drying, freezing (e.g. dairy products, processed egg)
• Thermal processing (e.g. low-acid canned foods)
• Aseptic processing (e.g. aseptically-packaged low-acid foods)
• Cooking or drying (e.g. ready-to-eat meat and dairy products)
• Fermentation or acidification (e.g. meat and dairy products, other acidified or fermented low-acid foods)
• Grinding (e.g. meat)
• Slaughtering

2.1.2 - Category II

Products in Category II pose a lower risk than those in Category I. They have inherent hazards, but the processing controls are not designed to eliminate these hazards. The process does not generally involve a kill step. Rather, the controls (such as proper sanitation and temperature control) are meant to prevent an increase to existing biological, chemical or physical hazards.

The inherent qualities of the raw product entering the establishment are an important factor.

Most products in Category II will be further processed by the consumer, who may need to follow specific handling and storage instructions. While it is necessary to minimize these risks, deviations will only moderately increase the health risks associated with the final product.

Category II includes the following processes, among others:

• Washing, grading, packing (e.g. shell eggs)
• Fresh cutting, modified atmosphere packaging (e.g. vegetables)
• Freezing (e.g. vegetables)
• Cutting (e.g. butter, cheese)
• Cold packing (e.g. cheese)

2.1.3 - Category III

Products in Category III do not pose significant health hazards on their own, and the processing and other activities to which they are exposed represent little or no additional risk. Products may be ready to eat or they may be further processed by the consumer prior to consumption.

Category III includes the following processes, among others:

• Thermal processing or aseptic processing (e.g. high-acid foods)
• Maple products processing (includes maple syrup producers and processors)
• Honey processing
• Freezing, drying, packaging (e.g. fruits)
• Drying, packaging (e.g. vegetables)
• Registered storages (e.g. dry storages, freezer storages)

2.1.4 - Audit frequencies

For each risk category, the audit frequencies are as follows:

2.2 - Non-Conformity Flow Diagram

The Non-Conformity Flow Diagram (see Figure 1) illustrates the steps that the Agency will take when a non-conformity is identified in a regulatory system audit. The steps include the following:

• A follow-up evaluation of corrective actions to close the CAR associated with the non-conformity or non-conformities.
• If the non-conformity cannot be closed a major CAR is issued .
• If the major non-conformity cannot be closed a follow-up regulatory system audit is performed as soon as possible.
• If the initial major non-conformity cannot be closed during the follow-up regulatory system audit or if another CAR is issued for a mojor non-conformity a warning letter is issued.  This letter must be completed and signed by the Area FSEP/HACCP Coordinator.
• If the major non-conformity cannot be closed, the establishment will lose FSEP/HACCP recognition.

The follow-up regulatory system audit is an additional audit conducted when the integrity of the HACCP system is in question. Its scope resembles that of a planned regulatory system audit, but the audit team may target specific CCPs, prerequisite program sub-elements or HACCP reassessment procedures.

Figure 1 Non-Conformity Flow Diagram

Section 3 - Request for review

An establishment may request a review of the results of a regulatory system audit within 30 days of receiving a Corrective Action Request (CAR). The company must submit its reasons, in writing, to the Area FSEP/HACCP Coordinator. The Area FSEP/HACCP Coordinator may contact the appropriate CFIA authorities (National FSEP/HACCP Coordinator, Program Chief) for the decision process. A decision, in writing, is forwarded back to the establishment with a copy sent to the National FSEP/HACCP Coordinator. If the company is not satisfied with the decision, it may contact its national association, which may further discuss the decision with the Agency's National Program Manager for that commodity.

Section 4 - Review of new HACCP plans

When an establishment adds a new HACCP plan to its system, by the CFIA team must conduct a review similar to that performed during the initial recognition process (by completing Appendix IV). Before commencing the new processes, the company must develop and implement its new HACCP plan fully, identify the plan in its log book and notify the CFIA.

Section 5 - Changes to a HACCP system

When an establishment changes its recognized HACCP system (e.g. removes a CCP), it must enter the changes in the company log book and support them with scientific data. This data must be available for future review by the CFIA.

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