Archived - Facilities Inspection Manual
3 - Quality Management Program

Subject 1 - Quality Management Program

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1. Scope

This subject provides an introduction to the Quality Management Program (QMP) and Regulatory Verification. The definitions of terms used in this Chapter are included under "Definitions" at the beginning of this manual. Subjects 2, 3 and 4 of this chapter outline the policies and procedures governing the QMP and Regulatory Verification activities carried out by the Canadian Food Inspection Agency (CFIA).

2. Authorities

• Fish Inspection Act, R.S., c. F-12
• Fish Inspection Regulations, C.R.C., c. 802
• Food and Drugs Act, R.S., c. F-27
• Food and Drug Regulations, C.R.C., c. 870
• Consumer Packaging and Labelling Act, R.S., c. 38
• Consumer Packaging and Labelling Regulations, C.R.C., c. 417

3. The Quality Management Program

3.1 Introduction

The Quality Management Program is a fish inspection and control system that includes procedures, inspections and records, for the purpose of verifying and documenting the processing of fish and the safety and quality of fish processed in and exported from Canada. All federally registered fish processing establishments in Canada are legally required under the Fish Inspection Regulations to adhere to the QMP.

Note: The term "Quality Management Program" refers both to the overall program operated by the CFIA, and the individual program operated in a fish processing establishment. An individual establishment's documented program is usually referred to as a QMP plan.

A QMP Plan is a document prepared by a registered fish establishment, in accordance with the Facilities Inspection Manual, that outlines the controls implemented to ensure that fish products are processed under sanitary conditions and that the result is a safe fish product that complies with federal regulations.

3.2 Objective of the Quality Management Program

The CFIA's objective for the QMP is to promote the production of safe and wholesome fish and seafood products, protect consumers of Canadian fish and seafood, meet international trade requirements and maintain open access to international markets.

3.3 History of the QMP

The Quality Management Program, developed as a result of co-operation between the Government of Canada and the fish processing industry, became mandatory for all federally registered fish processing establishments in 1992. At the time, federal fish inspection was under the authority of Fisheries and Oceans Canada (DFO). QMP was originally based on 5 out of 7 principles of HACCP (Hazard Analysis Critical Control Point), an internationally recognised system for ensuring safe food production.

By 1996, several reviews of the QMP had been conducted, by the processing industry, the federal government and an international panel. A QMP re-engineering project was begun in June, 1996, to assess and implement many of the recommendations of these reviews, including adopting all seven HACCP principles.

The re-engineering process continued when federal fish inspection was transferred to the new Canadian Food Inspection Agency, created on April 1, 1997. The re-engineered QMP model (described below in section 3.6) was produced in 1998, after extensive consultation with the fish processing industry. Implementation then began on a voluntary basis, and the program became mandatory in April, 1999.

3.4 Roles and Responsibilities of Government

3.4.1 The CFIA is responsible for developing, in consultation with the fish processing industry, regulations, standards, policies and procedures which set out the requirements for industry compliance with federal legislation. The CFIA is also responsible for verifying that the fish processing industry operates within regulatory requirements.

3.4.2 The CFIA assesses the fish processing industry's compliance through regulatory verification. Regulatory verification focuses on assessing the adequacy of an establishment's QMP plan and verifying that the establishment applies the system as described and that it is effective in maintaining compliance with the regulatory requirements.

3.4.3 The CFIA is responsible for taking the appropriate enforcement action, as necessary, to ensure compliance with regulations.

3.5 Roles and Responsibilities of Industry

3.5.1 Each federally registered fish processing establishment is responsible for designing and implementing an appropriate QMP plan to ensure compliance with the applicable legislation and regulations.

3.5.2 Fish processing establishments are responsible for ensuring that they have the personnel, on staff or under contract, with the necessary knowledge and skills required to develop, implement and maintain their QMP plans and to ensure that their operation is in compliance with all applicable legislation and regulations.

3.5.3 Fish processing establishments are solely responsible and liable for the fish products they produce, sell and/or import.

3.6 The QMP Model

There are three basic control components to a QMP plan: the Prerequisite Plan, the Regulatory Action Point (RAP) Plan, and the HACCP (Hazard Analysis Critical Control Point) Plan.

3.6.1 Prerequisite Plan: This section of the QMP plan consists of programs that ensure compliance with the Fish Inspection Regulations, and an acceptable environment for food processing, through controls for construction and equipment, sanitation and hygiene and an effective recall system. The Prerequisite Plan is an essential foundation for a HACCP plan, since it includes aspects of plant operations, necessary to the production of safe food, that must be in place before processing begins.

Plant Construction and Equipment Program

Describes how the physical plant facilities are designed, constructed and maintained in a condition to allow for the sanitary production of food.

Plant Sanitation and Employee Hygiene Program

Describes the control of all sources of contamination, and includes written Sanitation, Personnel Hygiene and Pest Control Programs.

Recall Program

Describes the procedures used to allow the processing establishment to rapidly identify the first shipping destination of any food product.

3.6.2 Regulatory Action Points (RAP) plan: This section deals with controls established to ensure compliance with the Fish Inspection Regulations and other relevant regulations. These controls are targeted at three elements of fish processing:

• minimum acceptable fish product quality;
• input materials; and
• labelling.

3.6.3 HACCP Plan: This section consists of a plan prepared in accordance with the seven principles of the HACCP system to ensure that any significant health and safety hazards identified are controlled during the processing of fish.

3.7 The QMP Reference Standard

The QMP Reference Standard sets out the requirements for the documentation and application of a fish processing establishment's QMP plan. The standard is based on the Fish Inspection Regulations. For a description of the Reference Standard, and Interpretive Guidelines explaining the requirements of the standard, refer to Subject 4 of this Chapter.

4. Regulatory Verification

Regulatory Verification encompasses the activities carried out by CFIA Inspectors to verify that a federally registered fish processing establishment's QMP meets the requirements set out in the Fish Inspection Regulations.

Regulatory Verification is intended to answer two fundamental questions about an establishment's QMP:

1. Is the QMP plan adequate for the products that are being processed in the registered establishment?
2. Is the registered establishment complying with its own QMP plan as written?

4.1 Elements of Regulatory Verification

4.1.1 Regulatory Verification includes a combination of audit and inspection activities. Audit activities will be carried out in accordance with recognised audit principles.

4.1.2 Regulatory Verification activities include verifying the documented QMP Plan, verifying the application of the QMP plan in the registered establishment, inspecting plant conditions and product, taking samples, investigating corrective actions, and performing tests.

4.1.3 Regulatory Verification is divided into the following components:

Systems Verification (SV)

Systems Verification is an evaluation of a federally registered fish processing establishment's documented QMP plan against the QMP Reference Standard to verify that it contains all the necessary components and has the necessary controls to ensure compliance with the Fish Inspection Regulations. The emphasis is on verifying documentation. For a description of CFIA policies and procedures governing Systems Verification, refer to Subject 2 of this Chapter.

Compliance Verification (CV)

Compliance Verification consists of activities carried out by CFIA Inspectors to verify that a federally registered fish processing establishment has implemented its QMP plan as written and that it meets the requirements set out in the Fish Inspection Regulations and the QMP Reference Standard. These activities may include: verifying the operation of the QMP; inspecting plant conditions and product; taking samples; investigating corrective actions; and performing tests. The emphasis is on verifying implementation. For a description of CFIA policies and procedures governing Compliance Verification, refer to Subject 3 of this Chapter.

Subject 3 Compliance Verification Policies and Procedures for Registered Establishments

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1. Scope

This subject outlines the policy and procedures governing the Compliance Verification activities to be conducted in federally registered fish processing establishments. Subject 1 of this Chapter contains an introduction to Regulatory Verification. The definitions of the terms used in Compliance Verifications are included in "Definitions" at the front of the manual.

2. Policy

2.1 Guiding Principles

2.1.1 All registered establishments shall be evaluated for compliance with regulatory requirements through Compliance Verifications, performed as prescribed by these policies and procedures. The CFIA will usually commence scheduling Compliance Verifications for a registered establishment when the Systems Verification of its documented QMP plan is completed.

2.1.2 The Compliance Verification approach is based on working co-operatively with establishments as they implement and make incremental changes to their QMP plan to meet the QMP Reference Standard and comply with the Fish Inspection Regulations. The Fish Inspection Program Compliance Management Process is intended to deal with those establishments that are unwilling or unable to implement or maintain an effective QMP.

2.1.3 Compliance Verifications will be conducted using internationally recognised principles and methods of auditing.

2.1.4 Compliance Verifications are intended to evaluate an establishment's QMP as a whole, not just individual operations or operation types. However, a single CV will not involve an assessment of every process or activity in an establishment's QMP.

2.1.5 The scope of a Compliance Verification outlines the boundaries or limits of activities planned for the CV, i.e., what parts of the QMP will be investigated. The scope of a CV on an establishment may cover the implementation of all elements of the establishment's QMP (i.e., Prerequisite plan, RAP, and HACCP plan). However, the scope of some CVs will be more focussed and will not cover all elements.

2.1.6 Where a Compliance Verification identifies non-conformities, the processor will be required to develop a Corrective Action Plan (CAP) acceptable to the CFIA that outlines a schedule for addressing the non-conformities.

2.1.7 In keeping with the co-operative approach outlined in 2.1.2, if a CV team leader and a processor are unable to reach agreement on the findings of a CV or the resulting Corrective Action Plan, the CV team leader should inform the processor that further clarification or guidance may be sought from the Operational supervisor/manager.

2.2 Organisation and Scheduling of CVs

2.2.1 A Compliance Verification includes:

• pre-notification of the CV to the processor;
• identification of a CV team leader and team members;
• a CV plan, schedule and time frames;
• a review of establishment background information, including previous CVs;
• development of CV checklists specific to the establishment;
• an evaluation of the establishment conducted on-site in the processing facility;
• completion of Non-conformity Reports if required, and a Compliance Verification Exit Report; and
• follow-up activities, where necessary, to confirm that corrective actions have been completed.

2.2.2 CFIA will normally inform the processing establishment in advance of the date on which a Compliance Verification will be carried out. However, CFIA inspectors retain the right to perform inspection activities at federally registered fish processing establishments at any time, as authorized by the Fish Inspection Act.

2.2.3 The selection of appropriate CV team leaders and team members will be at the discretion of individual CFIA Operations Managers and Supervisors.

2.2.4 To conduct Compliance Verifications, CFIA inspectors must have successfully completed all applicable training courses. Inspectors must also be participating in, or have completed, the QMP Mentorship Program.

Mentorship is a supportive on-the-job training, coaching and assessment process, in which a more experienced inspector shares their knowledge and experience with a less experienced inspector, with the goal of achieving consistent application of CV policy and procedures.

2.2.5 As stated in 2.1.4 above, a single Compliance Verification will not assess every process or activity in an establishment's QMP. Instead, for each CV a representative sample or "slice" of the QMP will be chosen. Within the boundaries of the CV scope, the "slice" will outline the specific processes or activities that will be examined. For each "slice" chosen:

• the significant points for health & safety or regulatory compliance are selected;
• a thorough, focussed evaluation is completed to confirm that the system controls are in place and that they adhere to the QMP plan; and
• once evidence is gathered and a conclusion is reached, the CV team member moves on to the next element in the CV.

2.2.6 Each Compliance Verification of an establishment (except for the initial CV) will take previous results into account, so that the CV can examine products and processes that were not previously evaluated and, if necessary, concentrate on progress made on long-term corrective actions and areas of concern previously identified. With the goal of developing and maintaining a "Continuous Record", the results of CVs conducted over time will flow together to form a "compliance picture" of the establishment.

2.2.7 CV teams will conduct Follow-up activities to verify that Corrective Action Plans have been followed. When the short-term corrective actions have been completed, and the plans for long-term corrective actions have been found to be acceptable, this will lead to closure of the Compliance Verification.

2.2.8 The scheduling of Compliance Verifications will be based on Establishment CV Priorities, determined as described in section 3.2.

2.2.9 CFIA Operations Managers and Supervisors will be responsible for developing overall Compliance Verification plans for their respective areas of responsibility. These plans will be based on the target CV frequencies set out in section 3.3. From these plans, individual CVs can then be scheduled for each processing facility within the area of responsibility.

2.3 Product Action

Where the acceptability of fish products is brought into question through the identification of a non-conformity during a CV, and the establishment cannot resolve the problem as part of a Corrective Action Plan, inspectors are to take appropriate product action. Detention or seizure may be necessary to control fish products that are tainted, decomposed or unwholesome, fraudulently presented or otherwise fail to meet the requirements of the Fish Inspection Act, Fish Inspection Regulations or other applicable legislation.

3. Procedures

3.1 The "Slice" Approach

3.1.1 For each Compliance Verification, a representative sample or "slice" approach will be taken. This means that each CV will focus on one or a limited number of products and/or processes.

To illustrate the "slice" approach, consider a ready-to-eat plant processing shrimp and crab as an example. Using the "slice" approach, an example of a typical CV in this processing plant would:

• look at the shrimp operation, but not the crab;
• for plant sanitation, look at the state of cleanliness, the effectiveness of the clean-up procedures, and the training instructions for the cleanup crew working in the shrimp processing room;
• for employee hygiene, look at the controls, practices, level of knowledge and understanding of personnel working in the shrimp processing room;
• look at a proportional number of SOPs (that would not be covered under the HACCP plan) and/or control measures associated with the safety of the product as an example, or areas of poor compliance based on establishment history; and
• if there are eight ingredients used in the process, look at three of these ingredients.

3.1.2 When the HACCP element is included in the Scope of the CV and that element includes CCPs, then all CCPs related to the product being produced within the scope of the CV are to be fully assessed, along with any associated SOPs.

3.2 Establishment CV Priorities

3.2.1 Establishment CV Priorities are determined using establishments' compliance profiles and product profiles.

3.2.2 An establishment's compliance profile is assessed as either High (i.e., good) or Low, based on its overall ability to maintain controls within its operations and maintain compliance with regulatory requirements.

This ability is evident from the quality and level of resources, including buildings and equipment, and the levels of staff training, knowledge, expertise and competence available for the specific operation. In addition, an establishment's ability to maintain controls and meet regulatory requirements relates to its commitment to its QMP. Commitment is demonstrated by the establishment's historical and current compliance records.

3.2.3 Product profiles will be assessed as either High or Low based on:

• the level of health and safety risk for the product (i.e., inherent microbiological, chemical and marine toxin risks); and
• the economic factors related to trade and marketing (e.g., large volumes to single source export markets, speciality products to niche markets).

3.2.4 Where there is a mixture of both high and low levels for each assessment criteria, the assessment will reflect the highest product profile and lowest compliance level. For example, if an establishment has a good historical compliance for canned products, but has a poor compliance for fresh/frozen products, the compliance profile would be rated as low.

3.2.5 An establishment's CV Priority will be set at either 1, 2 or 3 based on its Establishment Compliance Profile and Product Profile as shown in the following table:

3.3 Compliance Verification Frequency

Compliance Verifications will be conducted at different frequencies on different establishments, based on Establishment CV Priorities, with a minimum frequency of once per year. The following table is a guide to target scheduling frequencies for CVs, based on Establishment CV Priorities:

If an establishment operates on a full-time, continuous basis, the frequency should be based on the number of months of operation. For example, if a processing plant with a CV Priority of 2 operated full-time for five months each year, two CVs would be scheduled, since its operating period exceeds four months.

If an establishment is not operating continuously, operating days can be used. For example, a seasonal processing plant (with a CV Priority of 1) operating for 15 days in the spring and 20 days in the fall would be evaluated once a year, as its total number of operating days is less than 45.

These frequencies will be subject to review on a continuing basis.

3.4 Conducting a Compliance Verification

3.4.1 A Compliance Verification is comprised of three separate phases:

1. Planning and preparation
2. Conducting the in-plant evaluation & report writing
3. Follow-up verification of the Corrective Action Plan

3.4.2 The planning phase is considered a critical component to ensuring a successful CV. As a general guideline, the time allocations for a typical CV would be 40% for planning, 50% for conducting the in-plant activities, and 10 per cent for follow-up.

3.5 The Planning Phase

3.5.1 The Planning Phase of the Compliance Verification includes the following:

• the selection of the CV team leader and team members;
• identifying the CV scope;
• determination of date and time frames;
• completion of a CV plan to assign responsibilities & schedule activities;
• a review of background information (this could include inspection or sampling activities before the in-plant phase of the CV); and
• development of a checklist of activities to be conducted in the processing plant.

In planning for the CV, the CV Plan Pre-verification tasklist section should, as a minimum, identify the responsible team member(s) for each element (e.g., pre-requisite) and section (e.g., pest control) of the QMP Reference Standard identified in the scope and also identify activities, and responsible inspector, such as:

• product and water sample collection, analysis and submission;
• product inspections;
• retrieval of up-to-date QMP plan; and
• review of past non-conformities.

3.5.2 The CV team size and composition will be determined by the scope of the CV, the size and complexity of the processing establishment and its operations, the need for specialised personnel, and the geographic location and resources available.

Normally, the number of persons involved full time throughout the CV should not exceed three (i.e., the team leader and two team members). The team may include specialists such as microbiologists, process specialists or persons providing language interpretation, who may join the team to perform specific functions or provide additional support but may not be present for the entire CV.

3.5.3 The Team Leader's role is to co-ordinate and lead the Compliance Verification, and to be responsible for:

• determining the objective and scope of the CV;
• acting as the principal contact with the plant management;
• assigning tasks to individual team members;
• convening and chairing team meetings to review the individual checklists;
• ensuring the task assignments are complete, to avoid overlap or omissions;
• developing a CV plan as a schedule or checklist to avoid duplication or omissions (see Appendix A of this Chapter for the CV Plan form). When completed, the CV Plan forms a part of the final CV file;
• leading the opening meeting and exit meeting with the plant management;
• extending an invitation to plant management to meet at the end of each day of the CV to review issues encountered during the day;
• reviewing results and findings of team members;
• guiding and directing the preparation of the CV report;
• facilitating team decisions on non-conformities and contentious issues;
• final editing and preparation of reports;
• co-ordinating Follow-up activities; and
• closing the CV, or recommending enforcement action, as appropriate.

3.5.4 In the assignment of tasks, the team leader should exercise flexibility in order to achieve the most efficient completion of the Compliance Verification. For instance, it may be more efficient to assign each team member a section of the facility, or a specific portion of the process, etc., rather then assigning an element of the QMP reference standard (prerequisite, RAP, etc.). Where overlap might occur as a result, (e.g., evaluating a prerequisite program), a clear separation of team member's tasks is required to avoid duplication.

3.5.5 Team Members are responsible for completing the following activities:

• reviewing all relevant background information about the establishment. This entails reviewing the establishment's QMP plan (with updates), Systems Verification report file, previous CV reports, and historical data (product and certification results, recall information, consumer complaints, previous corrective action reports) in order to determine the best approach to assess the QMP;
• preparing individual checklists of questions to ask and activities to complete;
• for new processing methods, ensuring that they are knowledgeable about the critical food processing issues involved, in order to develop appropriate activities or questions for the checklist;
• assembling the necessary technical equipment required to carry out tests or measurements;
• undertaking inspections as directed by the team leader; and
• having copies of the necessary standards and reference materials available.

3.5.6 Sampling and testing of products, water or ice during a CV is an appropriate tool to verify that the controls in place are effective in meeting the requirements of the Fish Inspection Regulations. Samples may be taken before or during the in-plant portion of the CV. As part of the CV plan, the team should identify which items will be sampled during the CV.

A guide to suggested targets for sampling and testing is included as Appendix L of this Subject.

Samples may also be withdrawn and analysed to verify the following parameters:

1. content - examination to evaluate conformity with all weight declarations (e.g., net and/or drained weight, as appropriate), and to evaluate conformity with all other content declarations such as style, count, composition, etc.;
2. sensory - examination to evaluate compliance with sensory standards for taint, decomposition, and unwholesomeness; and
3. container integrity - to determine compliance with standards.

All analyses must be performed according to appropriate methods and procedures described in the applicable manuals (e.g., Fish Products Inspection Manual, Fish Products Standards and Methods Manual).

3.6 The CV Checklist

CV team members will use their individual checklists, prepared using the CV Checklist form, as their main worksheet when carrying out their assigned tasks (the CV Checklist form is included in this Chapter as Appendix C). The checklist provides a structure that allows team members to approach their tasks in a logical and systematic way. The development of a good checklist takes time and is a crucial step to ensure a successful CV.

3.6.1 CV Checklists will contain the following elements:

1) QMP Requirement

QMP Reference Standard: For the Reference Standard or regulations statement, precise terminology is to be used. A reference tool (copy-n-paste Reference Standard summary for CV checklist) is available for this purpose.

2) Task List - includes the questions to be asked, procedures to be monitored, processes to be verified, samples to be taken, things to be measured or tested, people to be interviewed, records to be reviewed, and inspections to be undertaken;

3) Objective Evidence - the factual information collected as a result of completing the task list; and

4) Findings - conclusions that are determined as a result of the objective evidence obtained. A number of pieces of objective evidence may be needed in order to arrive at a single finding.

3.6.2 The tasks prepared in the checklist must permit a thorough, in-depth evaluation of the processor's implementation of their QMP plan, within a limited time frame. The "slice" approach (outlined in Section 3.1) is the key to achieving this objective.

3.6.3 The establishment's QMP plan determines how the system controls are evaluated. The checklist tasks will determine if:

• the control measures are implemented and effective in achieving compliance with the requirements of the Fish Inspection Regulations;
• the monitoring procedures are being conducted as outlined in the plan, and the frequency of monitoring is sufficient to ensure compliance;
• corrective action procedures are initiated consistently each time monitoring indicates a deviation;
• the corrective action taken results in control over the process being maintained and products remaining in compliance; and
• the corrective action records are complete and accurate.

3.6.4 The tasks outlined in the checklist will collect objective evidence from:

• observation (e.g., watching the cleanup crew at work)
• inspection (e.g., evaluating equipment cleaning, product quality)
• testing (e.g., sampling for laboratory analysis)
• measuring (e.g., chlorine levels or cold storage temperatures)
• interviewing/questioning (e.g., talking to Quality Control supervisor)
• reviewing documents (e.g., review of procedures available to staff)

3.6.5 The checklist must contain sufficient detail, and be complete enough, that it can be used by the team member as an effective guide for the assigned areas to be evaluated during the CV. The information on each team member's checklist will be different, reflecting the specific elements of the QMP plan they have been assigned to evaluate.

3.6.6 The checklist is considered a tool for the team member to use in conducting the CV. While it may be shown to the processor on request, it is not intended to be part of the summary report given to the establishment. When completed, however, the checklist forms part of the CFIA file record of the CV.

Further guidance on developing a CV checklist may be found in Appendix M of this Subject.

3.7 Conducting the In-plant Portion of the Compliance Verification

3.7.1 Opening meeting

At the opening meeting with plant management, the CV team leader will introduce the team members to plant representatives, explain the purpose of the meeting, outline the scope and objective of the CV, and explain the mechanics of the CV process to ensure that there are no "surprises", including outlining the specific areas that will be covered in the slice chosen for the CV (see Appendix B of this Chapter for the Opening Meeting Checklist form).

Topics to be discussed during the opening meeting include the need to ask questions of employees in the plant (emphasising that this will be done in a way that minimises interruption); an invitation to have plant representatives accompany team members; a tentative CV schedule; the confidentiality of the CV and its documents; applicable plant safety or hygiene standards to follow; room for the team to meet in the establishment; and any significant changes to the QMP plan; and getting copies of them.

In consultation with the plant management, the team leader will determine the appropriate processing plant personnel to be interviewed, or to accompany the team members, and with whom the team may discuss results, issues, etc. at the end of each day.

3.7.2 Normally, a CV's scope would not change. However, there may be situations where a team leader would find it necessary to revise the scope. One example would be when a Critical non-conformity is determined that has implications beyond the original scope of the CV.

If a situation develops that makes it necessary to revise the CV scope, the team leader will advise the plant management and outline the reasons for this decision. Revisions to the CV scope should be limited, to permit adequate examination of other areas of the establishment's system where a team member notices, or has evidence of, a lack of controls.

3.8 Gathering Objective Evidence during the Compliance Verification

3.8.1 Using the task list outlined on their checklist, each team member will conduct their assessment, collecting objective evidence to determine whether the procedures outlined in the QMP plan are being followed. Where discrepancies between QMP procedures and observed activities are noted, the team member will try to answer the following questions:

• are the differences significant in relation to the establishment's overall system and its controls?
• do the discrepancies impact on regulatory requirements or affect health and safety?

Following the slice approach, when enough evidence has been gathered to answer these questions, the investigation should conclude and the team member move on to the next point. If these questions cannot be answered, deeper investigation is needed. There may be instances where objective evidence is obtained that suggests a problem is present, but a conclusion cannot be reached. In these situations, it is useful to review the information with other members of the CV team. There may be a relationship to other portions of the establishment's system, and a pattern may develop that will steer the investigation until a conclusion can be reached.

3.8.2 Records will be examined for completeness and accuracy, and to find any anomalies. It is not necessary to examine all the documentation that is available; a sample of the records produced since the last assessment of this section shall be taken for review.

3.8.3 Notes made during the CV must be clear, concise and accurately reflect the condition observed or the answer to a question. As the completed checklist forms part of the Compliance Verification file, subjective comments, personal opinions, etc. are inappropriate.

3.8.4 Where language comprehension is a concern, team members should ask for someone in the plant to interpret or obtain the services of an interpreter to complete the activity.

3.9 Determining Non-Conformities from Information Found During a CV

3.9.1 Before a decision on a non-conformity can be made, the findings must be linked back to the QMP requirement. The following questions should be asked to confirm whether the findings indicate a non-conformity:

1) Do the findings relate to the QMP system controls?
QMP systems may have insufficient controls when:

• controls are not complete,
• controls are not being followed, and/or
• controls are not effective.

If system controls are significantly affected, then the findings would result in the conclusion that there are non-conformities.

2) Do the findings relate to regulatory requirements or the QMP Reference Standard?
If the findings relate to regulatory requirements or the QMP Reference Standard, then the findings would result in the conclusion that there are non-conformities.

3.9.2 Processors are accountable for all aspects of their QMP plans. However, these plans may include requirements that exceed those in the Fish Inspection Regulations. While the processor is responsible for applying the QMP plan as it is written, CV team members will exercise discretion in ensuring that non-conformities are related to system problems and violations of regulatory requirements.

Over time, processors are expected to develop their QMP plans to be practical, realistic and focussed on the important areas for compliance with regulatory requirements.

3.9.3 All team members will evaluate CV findings, and the team leader will coordinate the process of reaching decisions regarding non-conformities.

3.9.4 There may be situations where there are a number of findings all related to a single, system-related problem. Wherever possible, these findings should be summarized together into a single Non-conformity Report.

3.10 Identification of a Critical Non-conformity during a Compliance Verification

3.10.1 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.

When a critical non-conformity is identified, the Team Leader will prepare a Non-conformity Report with the classification identified as "Critical". The report will detail the Findings and Objective Evidence that led to the issuing a Critical Non-conformity. The report must be issued to the facility as soon as possible. Hand written non-conformity reports are acceptable in cases where data entry in CFIA systems is impractical in short time frames.

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 problem(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 a Corrective Action Plan

3.10.2 The Corrective Action Plan developed must be acceptable to the team leader, and the results of the corrective actions must be verified by the CV team, before the Critical non-conformity will be considered to have been satisfactorily dealt with. Since a Critical non-conformity is system related, team members must conduct a thorough investigation across the entire QMP plan to ensure that all aspects of the Critical non-conformity have been addressed.

The CV Team Leader is required to respond to the facility in writing as to the decision reached by the team with respect to the acceptability of the Corrective Action Plan.

In circumstances where geographical location or other factors prevent the Inspector from accessing appropriate forms and presenting a formal written reply to the facility, a verbal response may be provided until such time as a formal reply is drafted and presented.

3.10.3 Activities of the Compliance Verification may be suspended if the Critical non-conformity is not dealt with satisfactorily.

3.10.4 The team leader should consult the Fish Inspection Program Compliance Management Process and initiate any other action that may be appropriate to ensure that the Critical non-conformity has been addressed.

3.10.5 Failure to develop an acceptable Corrective Action Plan or to meet the terms of a Corrective Action Plan to correct a Critical non-conformity will result in enforcement action being taken as per the Fish Inspection Program Compliance Management Process.

3.10.6 Any product action initiated by the CFIA as a result of a Critical Non-conformity will be documented in the appropriate section of the CFIA data systems.

3.11 Completing a Non-conformity Report (Appendix D)

3.11.1 The Non-conformity Report consists of the following elements:

1) Non-conformity identified - outlines the non-conformity, which is linked back to a systemic problem with the QMP requirement;

2) Classification of the non-conformity as Critical or not;

3) QMP element - the section in the processor's QMP which references the standard or regulation to be met; and

4) Objective Evidence - the factual evidence collected in support of the finding of a non-conformity.

3.11.2 In writing a Non-conformity Report, CV team members will use wording which reflects the objective nature of the evidence used to arrive at the decision. Subjective terms such as "unacceptable" or "inadequate" should be avoided.

3.12 Exit Meeting

3.12.1 The purpose of the exit meeting is to:

• present the results of the CV to the plant management and ensure that they are clearly understood;
• discuss the non-conformities found;
• respond to any concerns expressed by plant management;
• establish a time frame for submitting a Corrective Action Plan (CAP); and
• explain the follow-up procedures that will occur to assess the CAP and close the CV.

3.12.2 The following procedures will be followed during the exit meeting (see Appendix G of this Chapter for the Exit Meeting Checklist form):

• the meeting is chaired by the CV team leader;
• a copy of the CV report should be made available for the management representatives present;
• the team leader restates the CV objective and indicates whether or not the objective was met;
• the team leader restates the CV scope and, if the scope changed during the CV, gives the reasons for changing the scope;
• the team leader describes the components of the slice chosen for the CV;
• the CV team leader presents the results of the Compliance Verification, clearly identifying each non-conformity;
• team members should also report on any positive and commendable features that they have observed during the CV;
• for each non-conformity, team members outline the objective evidence gathered to support the conclusion;
• the team leader explains to the management representatives that all non-conformities must be corrected;
• the team allows the management representatives the opportunity to give their perspective on the results and express any concerns they may have;
• the team addresses any questions or concerns that plant management has;
• the team negotiates a reasonable time frame for the establishment to submit a CAP to the CFIA. This date is entered in the QMP CV Exit Report;
• the team leader explains the Follow-up procedures that will occur to assess the CAP;
• the management representatives are asked to sign the QMP Compliance Verification Exit Report; and
• the CV team keeps the original report and copies are given to the establishment.

3.12.3 The Compliance Verification documentation presented to the establishment will consist of the Non-conformity Report page(s) and the QMP Compliance Verification Exit Report.

The comment section of the CV Exit Report may be used to convey information not provided in the Non-conformity Report.

If applicable, the general comments section of the CV Exit Report may be used to identify the following:

• information related to the verification of implementation of corrective actions from a previous CV;
• indicate the right to appeal, as per Section 5 of this subject;
• if applicable, provide positive reinforcement to company personnel in their efforts to implement their QMP.

3.12.4 It is not required for the processor to have corrective actions or CAPs completed for the exit meeting. In most cases, time is needed to develop long-term solutions. In situations where the non-conformity has a straightforward solution, the processor may wish to present a completed corrective action at the exit interview. This is acceptable, but it is at the discretion of the team leader as to when the verification assessment of the corrective action takes place.

3.12.5 When the CV team leader is unable to reach an agreement with the processor on a time frame for completing a Corrective Action Plan, the CV cannot be closed. The team leader will take action as described in section 3.16, Assessment of the QMP.

3.13 Evaluating a Corrective Action Plan

3.13.1 A written Corrective Action Plan will be considered acceptable when, for each non-conformity identified, the plan describes:

• actions to be taken that will correct the problem that gave rise to the non-conformity, including, when product is involved:
  • identification and segregation of all affected product,
  • evaluation, analysis and/or testing of all affected product, and
  • appropriate actions to deal with any non-compliant product (e.g. culling, reworking, re-labelling, destroying, etc.);
• the system changes to be made to prevent a recurrence of the non-conformity;
• where an action involves long-term construction changes or equipment replacement, interim procedures that are to be put in place to control any risk arising from the problem, with monitoring procedures that are sufficient to ensure continuing compliance with the regulations;
• the person(s) or position(s) responsible for implementing the corrective actions;
• a section for the processor to acknowledge that the corrective action was implemented and the date the action was taken; and
• a reasonable time frame for implementation of the corrective actions. The processor must ensure that the CAP addresses the non-conformities promptly to ensure they do not lead to the production of unsafe product.

3.13.2 Each corrective action will be assessed for adequacy prior to acceptance of the Corrective Action Plan. If the corrective action(s) is (are) not found to be acceptable, they must be returned to the processor with a description of what is not acceptable and a request for the necessary changes. This process may occur a number of times until the CAP is found to be acceptable.

3.13.3 The QMP Compliance Verification - Corrective Action Assessment form (see Appendix H) is to be used when the submitted Corrective Action Plan has been assessed as unacceptable. Every unacceptable CAP assessment must be documented using this form. The Assessment Comment section within the form must be identical to those in CFIA data systems.

3.13.4 The processor is responsible for investigating each non-conformity to resolve the system-related problem. As a result of their investigation, the processor may conclude that the corrective action to be taken does not require a change to the QMP. In following up, the CV team member will investigate to confirm that the processor's rationale for their conclusion is sound, and that all parameters were taken into consideration and all reasonable options were explored.

3.13.5 Where it is not possible to reach agreement with the processor on the adequacy of the proposed Corrective Action Plan or a reasonable time frame for corrective actions, the CV cannot be closed. The CV team leader will take action as described in section 3.16, Assessment of the QMP.

3.13.6 Where the processor fails to develop an acceptable Corrective Action Plan within a reasonable period of time, the CV cannot be closed. The CV Team Leader will take action as described in section 3.16, Assessment of the QMP.

3.14 Follow-up and Verification of the Corrective Action Plan

3.14.1 Once the Corrective Action Plan has been evaluated and accepted by the CFIA, the Follow-up phase of Compliance Verification will be scheduled for sometime after the completion date for the short-term corrective actions (see Appendix K for the Follow-up Checklist form). The purpose of the Follow-up phase is to:

• verify that the agreed-upon corrective actions have been completed and are effective, which will lead to closure of the compliance verification; or
• recommend the appropriate enforcement action, in cases where the processor has failed to meet the terms of the Corrective Action Plan.

3.14.2 The Follow-up should be carried out as soon as possible after the planned completion date of the short-term corrective actions to determine if the action was timely.

3.14.3 The CV team leader is responsible for co-ordinating Follow-up activities, and the Follow-up will normally be conducted by members of the CV team. In some cases it will not be possible or practical for all members of the CV team to participate in the Follow-up.

3.14.4 The participating CV team member(s) will gather objective evidence, using CV techniques, to confirm the changes made to the QMP (i.e., to procedures, control measures, standards, repairs, etc.) to complete the corrective action(s). Specific activities could include:

• reviewing the problem areas and/or revised procedures;
• reviewing new or revised documentation submitted as part of the corrective action; and
• sampling of fish products, ice or water.

3.14.5 Long-term corrective actions, which have longer time-frames for implementation (e.g., next operating season), may be evaluated for completeness and effectiveness at subsequent Compliance Verifications.

3.14.6 If at any time during the Follow-up, a Critical non-conformity is discovered, the CV team leader will ensure that the processor initiates action under Section 3.10 of these procedures.

3.14.7 When an establishment can demonstrate that actions have been taken, and the terms of the Corrective Action Plan have not been reached (or will not be reached) through circumstances beyond the establishment's control or because of time deadlines that have proven to be unrealistic, then the establishment may continue operating with new time frames for completion of the Corrective Action Plan, if the non-conformities are not likely to result in unsafe or fraudulent product.

3.14.8 Where an establishment has failed to meet the terms of the Corrective Action Plan, with the exception of the circumstances described in 3.14.7, the CV cannot be closed. The CV Team Leader will take action as described in section 3.16, Assessment of the QMP.

3.15 Compliance Verification Closure

3.15.1 The Compliance Verification is closed when the following occurs:

• there are no non-conformities identified as a result of the Compliance Verification; or
• in the Follow-up phase, the CV team verifies that the short-term corrective actions have been completed and any interim measures have been implemented, and for any elements of the corrective actions having long-term implementation time-frames, the Corrective Action Plan is found to be acceptable.

3.16 Assessment of the Quality Management Program

3.16.1 The establishment's QMP will be assessed as Acceptable when the Compliance Verification has been closed by the CFIA.

3.16.2 The establishment's QMP will be assessed as Unacceptable when either of the following conditions applies:

• non-conformities exist, and the processor has failed to develop an acceptable Corrective Action Plan or to meet the terms of a Corrective Action Plan and reach closure of the Compliance Verification; or
• non-conformities exist, and the establishment has a history of operating without proper controls and is unlikely to initiate an effective Corrective Action Plan.

3.16.3 Where a QMP has been assessed as Unacceptable, the CV team leader will forward the Non-Conformity Report(s), CV Summary Report, and Corrective Action Plan (if one exists) to the appropriate Operational supervisor/manager, and recommend action as per the Fish Inspection Program Compliance Management Process.

4. CFIA Compliance Verification File

The completed Compliance Verification file retained in the CFIA office will include:

Copy of CV announcement (on CFIA letterhead)

• CV Plan
• Opening Meeting Checklist
• CV Checklist (as completed by each team member)
• Completed CV Non-conformity Report
• CV Exit Report
• Corrective Action Checklist - follow-up from prior CVs
• Exit Meeting Checklist
• Corrective Action Plan Assessment Form (when CAPs are rejected)
• Documents related to Product Inspection (Fish Inspection Report, LSTS Report of Analysis, MCAP Product Report)
• Enforcement Reports (all associated documents, including INCRs and warning letters)
• CV Closure Letter (on CFIA letterhead)
• Compliance Verification Filing Cover Sheet
• results of the Follow-up to verify completion of the Corrective Action Plan.

5. Appeals

An appeal process is available to processors, whereby they may request a review of any CV decision. Appeals must be made, in writing, to the appropriate CFIA Regional Director, stating the reason(s) why a decision should be given further consideration. The appeal must be received within 30 days of the decision that is being appealed.

The CFIA will send a written response acknowledging receipt of the appeal as quickly as possible. The CFIA will then investigate the appeal and respond to the processor within 30 days of receiving the appeal. To maintain an objective approach, appeals will be investigated by CFIA staff that were not part of the original team that conducted the CV.

Pending the outcome of the appeal, the original decisions will remain valid.

6. Forms/Documents

The following are the forms to be used during Compliance Verification audits.

• Appendix A - Compliance Verification Plan
• Appendix B - Opening Meeting Checklist
• Appendix C - Compliance Verification Checklist
• Appendix D - Compliance Verification Non-conformity Report
• Appendix E - Compliance Verification Exit Report
• Appendix F - Corrective Action Checklist
• Appendix G - Exit Meeting Checklist
• Appendix H - Corrective Action Plan Assessment Form
• Appendix I - CV Closure Letter - no non-conformities
• Appendix J - CV Closure Letter - acceptable CAP
• Appendix K - Follow-up Checklist
• Appendix L - Guide to Sampling and Testing during a CV
• Appendix M - Compliance Verification Checklist (information and examples)

Copies of forms are provided for information/reference only. Individual forms may be available from alternate locations, and may not be exactly as shown here.

Subject 4 QMP Reference Standard and Compliance Guidelines

Scope

This subject sets out the requirements for the documentation and application of a federally registered fish processor's Quality Management Program (QMP) Plan. The QMP Reference Standard, hereafter called the "Reference Standard" is based on the Fish Inspection Regulations.

Field of Application

Each federally registered fish processing establishment, as a condition of registration, must develop, document and apply a specific QMP Plan for the products and processes carried out in the establishment.

The purpose of the Reference Standard is to guide the development, implementation, and maintenance of a Quality Management Program to assure the production of fish and seafood products which meet the requirements of the Fish Inspection Regulations and to ensure that such processing is conducted in establishments which also meet regulatory requirements.

The Reference Standard is the blueprint for the development of the QMP Plan by a processor: it sets out the requirements for the documentation and application of a fish processing establishment's Quality Management Program. CFIA personnel use the Reference Standard during the systems verification and compliance verification.

This document is organised according to the seven elements of the Reference Standard. For each element, the document identifies:

1. The Reference Standard Requirements - these are the mandatory requirements established during the re-engineering of the QMP (1996-1998). Since the element(s), sub-element(s), and sub-sub-element(s) requirements are general in description, this document provides additional guidance for interpretive purposes.
2. The Intent Statement - indicates the primary objective of the Reference Standard Requirement. It is the stated intent of the Reference Standard Requirement which is key for CFIA personnel using this document in an assessment of a QMP Plan.
3. Compliance Guidelines - provide acceptable options to meet the intent of the Reference Standard Requirements.
4. For some elements, or parts thereof, Compliance Notes provide guidance on specific points.
5. The Appendices provide detailed guidance and options for the development of QMP controls to meet the requirements of the Reference Standard and the Fish Inspection Regulations. Additional appendices may be developed as needed.

The controls and methods described in this document are not necessarily the only valid means of achieving the desired results. Alternative strategies to those described in the Compliance section and/or the Appendices, that address the Reference Standard Requirement such that the Intent is satisfied, should be considered when assessing compliance.

A food production facility may be subject to a wide range of applicable legislation at the municipal, provincial and federal level. Quality system controls respecting acts, regulations and/or standards, other than those identified within this document, are not required to be addressed in the QMP Plan. Notwithstanding, processors should ensure that all processing operations and products meet other applicable legislation and market requirements.

Contents

Reference Standard Requirements and Guidelines for Compliance

1. Management Roles and Responsibilities
2. Background Product and Process Information
3. The Prerequisite Plan
4. The Regulatory Action Points (RAP) Plan
5. The Hazard Analysis Critical Control Point (HACCP) Plan
6. Verification and Maintenance of the QMP Plan
7. Record Keeping

Appendices

• Appendix A - Guidelines for the Development of a Product Description
• Appendix B - Guidelines for the Development of a Sanitation Program
• Appendix C - Guidelines for the Development of a Pest Control Program
• Appendix D - Guidelines for the Development of a Personnel hygiene Program
• Appendix E - Criteria for an Acceptable Supplier Quality Assurance Agreement
• Appendix F - Guidelines for the Use of Electronic Records and Signatures
• Appendix G - Guidelines for the Verification and Maintenance of the QMP
• Appendix H - Guidelines for Effective HACCP Controls for Molluscan Shellfish Processing Establishments
• Appendix I - Guidelines on the Control Measures for Preventing the Contamination and Growth of Listeria Monocytogenes
• Appendix J - Guidelines for the Development of an Environmental Sampling Program
• Appendix K - Guidelines on measures to control the risk of Vibrio parahaemolyticus in live oysters
• Appendix L - HACCP Validation of Controls for Vibrio parahaemolyticus

1. Management Roles and Responsibilities

Reference Standard Requirement:

1.1 The position responsible for the QMP Plan must be identified.

1.2 It is recommended that the processor describe how the QMP was developed and how it will be implemented.

Intent:

Management commitment is critical to the successful development, implementation, and maintenance of the QMP Plan.

Compliance Guidelines:

1. The name, business address, business telephone number and the title of the person responsible for the QMP at the establishment must be identified.
2. It is not mandatory but it is strongly recommended that senior management of the establishment demonstrate their commitment to the QMP in writing.

Managers can demonstrate commitment by taking on responsibilities under the QMP, supporting training knowledge, and encouraging and motivating establishment personnel in the development, implementation and maintenance of the QMP. Management participation will set a good example, promote quality management, and foster cooperation in the establishment.

Managers can perform tasks such as explaining the QMP to personnel; allocating equipment, materials, staff and space to QMP activities; and assigning quality management duties.

The following are some options for demonstrating management roles and responsibilities:

1. an organisation chart;
2. a written description of each manager's accountability;
3. a written description of company dispute-resolution processes, e.g., between production staff and quality management staff;
4. a vision statement or mission statement that emphasizes quality management;
5. a QMP Plan internal audit schedule, with management roles indicated;
6. documentation of management's role in corrective and preventive actions;
7. a written statement of commitment signed by all management staff;
8. Prerequisite Plan, RAP Plan and HACCP Plan procedure manuals; and/or
9. a signed statement of management commitment to quality management training, accompanied by a list of training opportunities for personnel, broken down by job requirements.

2. Background Product and Process Information

Reference Standard Requirements:

2.1 Processors are required to identify product and process information in the form of a Product Description, Process Flow Diagram and where applicable, an Establishment Floor Plan.

2.1.1 The Product Description must identify those product attributes and characteristics that are important in ensuring a safe and acceptable fish product.

2.1.2 The Process Flow Diagram must outline all of the production steps and assists in identifying those steps that are important in processing a safe fish product meeting all regulatory requirements.

2.1.3 The Establishment Floor Plan identifies cases where hazards are controlled through the application of sanitary or restricted access zones.

Intent:

In order to develop the Prerequisite and RAP Plans and to conduct the hazard analysis and determination of critical control points, the establishment's QMP development team will need to identify and assess product/process information and the establishment layout.

The purpose of a product description is to identify and document all product attributes including those process and packaging characteristics which influence the safety and acceptability of the fish product.

The purpose of a process flow diagram is to verify and document the process steps to aid in determining when and where control measures and monitoring procedures should be established.

The purpose of an establishment floor plan is to document where sanitary zones or restricted access areas are being used as control measures for identified hazards.

Compliance Guidelines:

1. Product Description

For each product or groups of products processed in the establishment, a product description should include:

1. a descriptive product name;
2. the source of raw material used in producing the product;
3. important characteristics of the final product which may affect product safety;
4. all ingredients;
5. product packaging;
6. end product use;
7. product shelf life;
8. market destination;
9. labelling instructions for safe product storage (where applicable);
10. special distribution controls or instructions (where applicable);

Information contained in the product description must be supportable. In particular, physical characteristics, composition, packaging, and/or shelf-life attributes which impact on the risk of a hazard or its likelihood of occurrence must be substantiated. This data is usually found in association with the HACCP Plan.

The development of an accurate and complete product description is essential to the further development of the QMP Plan including the HACCP and RAP Plans. More detailed guidelines and references for the development of an accurate product description can be found in Appendix A of this document.

2. Process Flow Diagram

A process flow diagram must be included in the QMP Plan for each of the products or groups of products that are produced in the establishment. The process flow diagram must outline all the production steps and must be complete and accurate.

Dependent on the nature of the product, product-specific regulations (e.g., for molluscan shellfish), and the product holding conditions and time before shipping, the final step of shipping may or may not be an important process step. Normally this final step would be included, and if this step is excluded, justification should be provided in the hazard analysis documentation.

Note: When the RAP and HACCP Plans are completed, the RAP and Critical Control Points (CCP) should be indicated on the process flow diagram.

3. Establishment Floor Plan

If the application of sanitary zones or restricted access areas has been identified as a control measure during the development of a HACCP Plan, then an establishment floor plan must be included in the QMP Plan. The plan must clearly show the flow of materials, personnel and product within the establishment and outline all sanitary zones and restricted access areas.

The term "sanitary zone" refers to that part of a processing area with sensitive processing steps or high risk products, for which a set of controls meeting specified criteria have been established to control all vectors of potential contamination or cross contamination, including air movement, personnel hygiene and sanitation procedures.

The term "restricted access zone" refers to that part of a processing area where personnel movements are restricted and personnel hygiene and sanitation procedures are in place to control potential contamination or cross contamination, but that does not meet the specific requirements of a sanitary zone.

3. The Prerequisite Plan

Reference Standard Requirements:

3.1 Establishment Environment Program

Processors are required to identify:

3.1.1 the establishment environment standard that is applied in the facility; as a minimum the standard must meet the requirements of the Fish Inspection Regulations;

3.1.2 the actions that are taken by the processor to ensure the standard is met;

3.1.3 the record keeping system to record corrective actions when problems are identified;

3.1.4 the corrective action system in place to address deficiencies when they are identified.

3.2 Lot Accountability and Notification Program

3.2.1 For the purposes of carrying out a product recall, processors are required to have a product identification and distribution system that allows for the rapid identification of the first shipping destination.

3.2.2. As part of the Lot Accountability and Notification Program the processor is also required to have procedures to notify the CFIA of any valid health and safety complaints.

Intent:

Processors are required to identify controls on establishment design, construction and maintenance in order to provide assurance, that the food will be produced under sanitary conditions, of control of all potential sources of significant contamination, and that will allow the rapid recall of product from first shipping destinations.

Compliance Guidelines:

The Prerequisite Plan has two components: the Establishment Environment Program; and the Lot Accountability and Notification Program

The Establishment Environment Program includes Construction and Equipment and Sanitation and Personnel Hygiene.

1. The Construction and Equipment section describes the controls to ensure that the establishment facilities and equipment are suitably designed and built and maintained in a state appropriate for safe food processing.
2. The Sanitation and Personnel Hygiene section describes the cleaning and sanitizing procedures, the hygiene procedures for personnel and visitors, as well as pest control measures and procedures.

Each section must include:

1. the standard that is applied in the facility. At a minimum, the standard must meet the requirements of Schedules I and II of the Fish Inspection Regulations as described in the Facilities Manual. A copy of the standard must be included or, where the standard is a part of the laws, regulations or other documents published by the Government of Canada, it may simply be referenced. In either case, the standard must be in the establishment and readily available for review in printed or electronic format.

   Where fresh fish is unloaded, handled, held or transported at a registered establishment, conveyances and equipment must comply with Schedule V of the Fish Inspection Regulations, "Requirements For Conveyances And Equipment Used For Unloading, Handling, Holding And Transporting Fresh Fish".

2. the control measures that are employed to ensure the processing facility is in compliance with the standard.

   For the Construction and Equipment section, the control measures ensure that the processing facility is suitably designed, built, and maintained. Control measures can include: training production personnel on the standard so that they can identify deficiencies; routine inspection of the facility; maintenance schedules; procedures for scheduled equipment maintenance and calibration; controls for a safe water supply.

   For the Sanitation and Personnel Hygiene section, the control measures ensure the facility is operated and maintained in compliance with the standard. Control measures must include written sanitation, personnel hygiene, and pest control programs. Guidelines for developing these written programs can be found in the Appendices of this document.

3. The monitoring procedures that are used to ensure that the control measures are being correctly and consistently carried out. The monitoring procedures must clearly specify what is being monitored, how it is being monitored, at what frequency, and by whom. The frequency of each monitoring action must be sufficient to ensure that the standard is being met.

   In the Prerequisite Plan, processors are not required to record the results of monitoring unless a problem is identified. In these cases, the processor must record the problem and the corrective action information.

4. The corrective actions to be taken when monitoring identifies a deviation from the standard. The corrective action should include actions to fix the immediate problem and to prevent a recurrence of the problem.
5. The record-keeping system for recording the results of monitoring and corrective actions when problems are identified. The corrective action record should allow for the recording of a description of the deviation, the part of the standard not complied with, the corrective action taken, the person(s) responsible for the action, the date the action was taken, the date it was verified as effective, the person responsible for verifying and, if applicable, any interim preventative measures for long-term corrective actions. A copy of the corrective action record must be included.

Lot Accountability and Notification Program

a) Processors must provide a written description of the system used to trace fish to their first shipping destination. For each shipment of fish this must include:

• the name and address of the person to whom each shipment was sent;
• the type of fish;
• the quantity of fish;
• the method of transportation, including manifest and container numbers or other information that is sufficient to identify or trace the location of the fish;
• the date on which the fish was shipped; and
• the date on which the fish was processed.

b) Processors should establish specific procedures to address the requirement for notification of CFIA, within 24 hours, in the event of any valid health and safety complaints. A "valid" complaint means where the initial investigation indicates the health of consumers is at risk.

c) For health and safety complaints the following records must be kept:

• the date and time when the processor received information questioning the safety of fish processed or exported by the registered establishment, and a description of the information;
• in cases where the complaint is confirmed: the date and time it was confirmed; the name, address and telephone number of the informant; the method of investigation and the results obtained; the corrective actions taken; and the date and time when the CFIA was notified.

Compliance Notes

1. Construction Materials

Where the suitability of construction materials is in question, the Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products (also called the Reference Listing) should be consulted.

Construction materials used for construction, renovation, and maintenance should be selected on the basis of chemical and physical suitability of the materials in relation to their intended use.

2. Chemicals

All non-food chemicals are controlled under the Establishment Environment Program. Non-food chemicals include, bleaches, cleaners, deodorizers, desiccants, disinfectants, denaturing agents, floor-drying compounds, industrial antifreeze, inks, lubricants, pesticides, protective oils, refrigerating brine additives, refrigerants (immersion freezing), sanitizers, and water-treatment compounds. These compounds include chemicals which may be acceptable for food contact and those that are not.

Processors must ensure that these chemicals are approved for their intended use and must have controls to ensure that these chemicals are applied according to their intended use and stored to prevent unintentional contact with food products. The acceptability of chemicals for their intended use must be documented in the QMP Plan. Chemical acceptability is substantiated by inclusion in the Reference Listing.

Non-food chemicals used outside of the fish processing and support areas need not be substantiated in the Reference Listing; however, the processor must have controls in place to ensure these products do not enter into, or contaminate, areas where fish and/or input materials are handled or stored.

Examples of chemicals exempt from the requirement for inclusion on the Reference Listing include, pesticide products for outdoor use only, products used in offices or similar non-regulated areas, products used in cafeterias or lunch rooms, products used in heating systems, products used outdoors only for sewage or waste water systems, products used in cooling towers or evaporator condensers, products used for the cleaning or maintenance of the exterior of vehicles, and products for use in the maintenance shop on non-food contact equipment.

3. Ice

When ice is used for processing, as a processing aid or as an ingredient, and that ice is manufactured in the registered facility, the processor will set out control measures under the Establishment Environment Program. Control measures to address requirements for the ice manufacturing equipment, holding, storage, and the quality of the water source and supply should be considered.

When ice is used for processing, as a processing aid or as an ingredient, and that ice is manufactured outside of the registered processing establishment, the controls under the QMP are two-fold. The processor will set out controls under the Establishment Environment Program for requirements relating to the holding and storage of the ice. Secondly, the processor will establish controls for the transport and the quality of ice under the RAP Plan.

4. Standard Operating Procedure (SOP)

A Standard Operating Procedure (SOP) is an effective means for establishing, documenting, and communicating a control measure associated with the Prerequisite Plan, RAP Plan, or HACCP Plan. A SOP is a detailed set of instructions which describes how to carry out a repetitive task. Trained personnel can use a SOP for a specific task to carry out that task with little further direction.

4. The Regulatory Action Points (RAP) Plan

Reference Standard Requirements:

4.1 The RAP Plan must describe the controls to ensure that:

• fish is handled properly during processing and results in a final product that is not tainted, decomposed or unwholesome and meets all applicable sections of the Fish Inspection Regulations;
• any ingredients added to the fish product or packaging material used are acceptable for food and meet all regulatory requirements as specified in the Fish Inspection Regulations and the Food and Drugs Act and Regulations; and
• labelling and coding of all fish products meet the requirements of the Fish Inspection Regulations and is not false, misleading or deceptive.

As part of the RAP Plan the processor must identify:

4.1.1 The fish product standard(s) and the ingredient and packaging requirements to which they must comply.

4.1.2 The controls that are implemented in production to ensure the standards and requirements are met.

4.1.3 The record keeping system to record corrective actions when problems are identified.

4.1.4 The corrective action system in place to address deficiencies when they are identified.

Intent:

Within the RAP Plan, processors are required to document and apply controls that ensure the fish is handled properly while under the control of the registered establishment and result in a final product that meets all requirements of the applicable sections of the Fish Inspection Regulations. The three areas that must be addressed are minimum acceptable product quality, input materials, and labelling.

Compliance Guidelines:

1. Minimum acceptable product quality

This section of the RAP Plan describes the controls to ensure that fish will be handled properly while under the control of the registered establishment and will result in final products that meet all applicable sections of the Fish Inspection Regulations.

2. Input materials (Ingredients and Packaging Material)

This section of the RAP Plan describes the controls to ensure that any ingredients added to the fish product and any packaging material used are acceptable for food and meet all regulatory requirements.

3. Labelling and Code Markings

This section of the RAP Plan describes the controls to ensure that the labelling and code markings of fish products is accurate, legible, and not misleading.

Each section must include:

a) The standard that is applied at the facility. The standard may be the CFIA standard as set out in the Fish Products Standards and Methods Manual, applicable sections of the Regulations, or another standard equivalent or superior to these. The standard must outline the accept/reject criteria which identifies compliance.

A copy of the standard must be included or, where the standard is a part of the laws, regulations or other documents published by the Government of Canada, it may simply be referenced. In either case, the standard must be in the establishment and readily available for review in printed or electronic format.

For minimum acceptable product quality, the standard identifies minimum compliance parameters for product safety (tainted, decomposed and unwholesome) and quality, if applicable.

For input materials (ingredients and packaging material), the standard identifies the minimum compliance parameters for input material acceptability for use in food processing or production and compliance to all applicable regulatory requirements specified in the Fish Inspection Regulations and the Food and Drugs Act and Regulations.

For packaging material, primary considerations include that all packaging materials must be new, clean and sound and approved for food use. Packaging material must not impart any undesirable substance to the food product, either chemically or physically and should protect food sufficiently to avoid contamination. The acceptability of packaging materials for their intended use must be documented in the QMP Plan. For packaging materials which contact (or may contact) food, the acceptability is substantiated by inclusion in the Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products.

Ingredients must be identified and acceptable for food use. Ingredient acceptability can be substantiated by several methods: a manufacturer's attestation; documentation from a recognised government or non-governmental authority; results of analysis from an accredited laboratory; and ingredients commercially prepared and labelled for food preparation use. Where product additives are used, their identity and concentration is in compliance with the Food and Drug Regulations. Guidance on additives for fish and fish products for sale in Canada can be found on the CFIA Internet site, in the Guide to Additives Permitted in Fish and Fish Products.

For labelling and code markings, the standard identifies the minimum compliance parameters to ensure that the labelling and coding of all fish products is accurate, legible, not misleading and meets the requirements of the Fish Inspection Regulations. These requirements include any specific species requirements found in the body of the regulations, as well as those set out in Part II – Labelling.

b) The control measures applied to ensure that final product will meet the standard(s) and that any product not meeting the standard will be removed from production.

Control measures can include inspections, evaluations, sampling, pre-printing label evaluations, pre-use review and final product label and coding inspections. For information on supplier quality assurance (SQA) as a control measure, refer to the Appendices of this document. Sampling plans must be at least equivalent to those used by the CFIA.

c) The monitoring procedures used to ensure that the control measures are being correctly and consistently carried out. The monitoring procedures must clearly specify what is being monitored, how it is being monitored, at what frequency, and by whom. The frequency identified for each monitoring activity must be sufficient to ensure that the standard is being met.

Under the RAP Plan processors are not required to record the results of monitoring unless a problem is identified. In these cases, the processor must record the problem and the corrective action information.

d) The corrective actions to be taken when monitoring identifies a deviation from the standard. These actions must include both fixing the immediate problem and preventing the problem from happening again. This section must describe how all product not meeting the standard is identified and segregated, culled, and reworked or disposed of in an appropriate manner.

e) The record-keeping system for recording the result of monitoring and corrective actions when problems are identified. The corrective action record should allow for the recording of a description of the deviation, the part of the standard not complied with, the corrective action taken, the person(s) responsible for the action, the date the action was taken and the long-term preventative steps (if applicable). A copy of the corrective action record must be included.

Compliance Notes

Note 1. Receipt of incoming fish and other input materials from suppliers

Where the processor receives fish from suppliers, the processor must establish control measures to ensure, protect, and preserve the quality of that fish. An effective type of control measure is the use of a Supplier Quality Assurance (SQA) agreement. A SQA can be an effective control measure to address many types of situations where an understanding between business parties is required. For example, for transport requirements (i.e., transport vehicles are clean, proper care has been taken, and the vehicles have not been used to transport hazardous materials), temperature control requirements, withdrawal from medicated feeds (i.e., for cultured species) as well as many other requirements.

Guidelines for developing a SQA as a control measure are outlined in the Appendices of this document.

Note 2. Standard Operating Procedures

A standard operating procedure (SOP) is an effective means for establishing, documenting and communicating a control measure associated with the Prerequisite Plan, RAP Plan, or HACCP Plan. A SOP is a detailed set of instructions which describes how to carry out a repetitive task. Trained personnel can use a SOP for a specific task to carry out that task with little further direction.

Note 3. Identification of Input Materials (ingredient and packaging materials)

Processors should consider all processing steps to identify ingredients. Some components to the final product may not be immediately recognisable as "an ingredient" because they are added to the product indirectly (i.e., as a processing aid) rather than by formulation. For example, when wood chips or sawdust is used in smoking fish product, the processor must identify and consider the input material (sawdust) which is the precursor to the ingredient, natural wood smoke. Also, when ice used for processing is received from facilities outside of the registered establishment (i.e., the ice is not under the Establishment Environment Program), the processor must identify and consider the input material (ice) which is the precursor to the ingredient, added water or ice.

Packaging material includes cartons, wrapping materials, films, synthetic casings, netting, trays, pouches, bags and any other material used in the shipping of food products which may come into contact with the food product shipped.

Note 4. Regulatory requirements other than the FIR

Processors are not required to establish controls within the QMP Plan to ensure that regulatory requirements outside of the FIR are met. Nonetheless, processors must ensure all final products are in compliance with all applicable regulations including, Food and Drug, Consumer Packaging and Labelling, and Weights and Measures, and foreign country legislation for exported products.

Note 5. Documentation associated with the RAP Plan

Documents must be included in the QMP Plan which substantiate the acceptability of the packaging materials. (e.g., their listing in the Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products).

Processors must document any specialised packaging requirements, such as oxygen permeable packaging for ready-to-eat chilled products, set out in the Food and Drug Regulations.

5. The Hazard Analysis Critical Control Point (HACCP) Plan

Reference Standard Requirement:

5.1 Processors must develop, document and implement a HACCP Plan to control any health and safety hazards related to the product or process. The processor must apply the seven principles of HACCP to identify any significant hazards and for those significant hazards identified, develop a HACCP Plan to prevent, eliminate or reduce the hazard to an acceptable level.

The HACCP system consists of the following seven principles:

• 5.1.1 Principle 1 – Conduct a hazard analysis.
• 5.1.2 Principle 2 – Determine the Critical Control Points (CCPs).
• 5.1.3 Principle 3 – Establish critical limit(s).
• 5.1.4 Principle 4 – Establish a system to monitor control of the CCP.
• 5.1.5 Principle 5 – Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control.
• 5.1.6 Principle 6 – Establish procedures for verification to confirm that the HACCP system is working effectively.
• 5.1.7 Principle 7 – Establish documentation concerning all procedures and records appropriate to these principles and their application.

Intent:

Every processor must analyse their products and processes to determine if any health and safety hazards are present and, where significant hazards are identified, appropriate controls are put in place. The application of the HACCP principles must be consistent with the Recommended International Code of Practice – General Principles of Food Hygiene, CAC/RCP 1-1969, Rev.3 (1997), Amd. (1999).

Compliance Guidelines:

1. Conduct a Hazard Analysis

1. The hazard analysis and the development of the HACCP Plan is conducted by a HACCP team, including at least one member who has knowledge of HACCP from either formal training or experience.
2. The hazard analysis is conducted at each process step for every product type. Process steps where a significant hazard may be introduced or where a hazard may increase to an unacceptable level must be identified.
3. The hazard analysis includes the identification of all potential hazards (biological, chemical, physical), the determination of the significance of the hazard identified, i.e., consideration of its severity and the likelihood of occurrence and, if applicable, justification for a determination of non-significance of a hazard.
4. The processor demonstrates that they have considered all process steps in conducting their hazard analysis. A Hazard Analysis Worksheet, or equivalent, is used to organise and document the hazard analysis.
5. The processor considers all activities and materials in the establishment, including incoming fish, ingredients, packaging materials, establishment personnel, the establishment itself, product descriptions, the process flow diagram documented in the Background Product and Process Information section, as well as consumer complaint information, and epidemiological and technical literature available when conducting the hazard analysis.
6. For some establishments, the hazard analysis will not identify any significant hazards. The HACCP component of the QMP Plan would therefore only include the hazard analysis and other applicable documentation (examples are given in number 7 below Establish a Documentation and Record-Keeping System.) The determination of CCPs and associated controls would not be applicable.

2. Determine Critical Control Points (CCPs)

1. For each significant hazard identified in the first step, there is an appropriate preventive measure in place to prevent or eliminate the hazard or reduce it to an acceptable level.
2. The method and results of the CCP determination are documented and CCPs are indicated on the process flow diagram.

3. Establish Critical Limits

1. Critical limits are established for each CCP identified. A critical limit means the maximum or minimum value to which a hazard must be controlled at a critical control point. For example, a temperature or time which must be achieved to ensure destruction of a pathogenic bacteria, a specific pH to prevent the growth of bacteria, a level of a preservative, a size of detectable shell pieces, or the presence of acceptable product analysis documentation from a SQA supplier of raw materials.
2. The critical limits are validated to demonstrate that they are effective and the validation is documented.

4. Establish Monitoring Procedures

1. At each CCP, the processor has established monitoring procedures to determine that the system is operating within the critical limits identified. It is important to have monitoring procedures which produce immediate measurable results to which action can be initiated since there may be potential food safety implications.
2. The monitoring procedures include what will be monitored, if applicable how the critical limits and preventive measures will be monitored, how frequently monitoring will be performed, and who will perform the monitoring.
3. For each monitoring activity, the processor has established that personnel performing the monitoring have the knowledge and ability to conduct the procedure. Where specialised skills are required in order to adequately monitor a process or perform an activity which is critical to ensure product safety, appropriate training requirements, experience, and/or skills are identified. For example, the following positions are recognised as requiring specialised skills: retort operator, can closing machine operator, can screening machine operator, and container integrity inspector. Personnel in these positions require special knowledge and experience.

5. Establish a Corrective Action System

1. Corrective action procedures are established to be initiated when monitoring indicates that the process is operating outside the defined critical limits. The corrective action procedures are established in advance so the personnel conducting the monitoring will have direction on the steps to take when a deviation is identified.
2. The corrective action procedures address: the correction of the deficiency that gave rise to the problem; the identification and segregation of all affected product; the culling, re-working, and/or disposition of affected product in an appropriate manner.
3. The corrective action procedures address: the prevention or reduction in likelihood of reoccurrence of the problem (e.g., by investigating how the problem developed); if a review of the QMP Plan (e.g., to determine where changes of procedures, control measures, standards, etc., are needed) is needed; the implementation of necessary changes; identification of changes in the QMP amendment log.
4. The corrective action procedures include a record system to document at least the details of the problem, including the date the problem was identified, the corrective action taken, the person(s) responsible for the action, the date the action was taken and the changes needed to eliminate or prevent re-occurrence of the problem.

6. Establish Verification Procedures

1. Verification activities are an additional level of control and monitoring to ensure the HACCP Plan is operating as it was designed. The verification activities are conducted in addition to the CCP monitoring, but on a less frequent basis, in order to review the implementation of the plan through the records or through additional tests or analysis. For each monitoring activity, the processor must establish and document verification procedures to ensure that the CCP is working as designed.
2. The verification procedures include what will be verified, how it will be verified, how frequently verification will be performed, and who will perform the verification.
3. Verification activities are performed by qualified personnel and usually by personnel not associated with monitoring of the CCP.

7. Establish Documentation and Record Keeping

1. Processors keep two types of records associated with HACCP, "documentation" and "records". Documentation refers to those records which are created as a result of the development of the HACCP Plan, and records, which are created as a result of the implementation of the HACCP Plan.
2. Documentation is maintained as a record of HACCP Plan development, recognising the support and input from many individuals and usually over a considerable period of time. During this phase there are numerous decisions taken and authorities referenced. This information is essential to justify, if necessary, to regulatory agencies or customers why certain actions or activities are taken and also to assist in future development and evolution of the plan. Documentation includes the QMP and HACCP Plans as well as component parts such as SOPs. It also includes the hazard analysis, product attribute data, CCP determination, critical limit validation data, personnel training records, and manufacturer specifications for operation and maintenance of specialised equipment.
3. Records are generated by the procedures or activities performed and any corrective actions taken. The processor establishes a record-keeping system that ensures that CCP monitoring records, corrective action records and verification records are complete, accurate, legible, and available for review. These records include all information required in the QMP Plan and are initialled or signed and dated by the person responsible for monitoring and by the person responsible for reviewing to verify the monitoring or corrective actions where this review is identified in the QMP Plan as a verification activity. A copy of each record is included in the HACCP Plan.

Additional guidance on electronic records system can be found in the Appendices of this document.

6. Verification and Maintenance of the QMP Plan

Reference Standard Requirements:

6.1 Processors are required to perform the following verification activities to ensure that their QMP Plan is functioning correctly.

6.1.1 Before implementation the processor is required to validate the critical limits of CCPs.

6.1.2 Before implementation the processor is required to review the QMP Plan to ensure that all of the necessary controls are in place and that it meets the requirements of the Reference Standard.

6.1.3 Once the QMP Plan is implemented the processor is required to perform routine verification of the HACCP Plan to ensure it is functioning effectively.

6.1.4 Once the QMP Plan is implemented the processor is required to verify or validate any changes to the QMP Plan or to critical limits that may occur in the ongoing development of the QMP Plan.

6.1.5 Once the QMP Plan is implemented the processor is required to review the QMP Plan at least once per year.

6.1.6 To ensure that the QMP Plan is accurately documented, processors are required to maintain a list of amendments of any changes to their QMP Plan.

Intent:

The QMP Plan is a dynamic document and verification is a systematic and comprehensive approach to ensure continuous maintenance and improvement to the QMP Plan in order to confirm that the QMP meets the needs of the fish processor in producing a safe, wholesome, fairly traded product.

Compliance Guidelines:

There are five main activities that a processor is required to perform to verify the QMP Plan.

Before implementation of the QMP Plan, the processor is required to:

1. Validate the critical limits for all identified Critical Control Points. The processor must obtain supportive evidence or documentation to confirm that the parameters of the critical limit for each CCP are sufficient to prevent, eliminate or reduce to an acceptable level, food safety hazards in the final product. There are two components to this supportive evidence or documentation:

• sound and reliable scientific evidence, standards from an accepted authority, advice from an accepted authority, or a regulatory standard to demonstrate that the process, if operated within the established critical limits, will result in a safe product, and
• sufficient technical data, gathered through testing and measurement of the process in a processing establishment, to demonstrate that the process can operate within the chosen critical limits.

2. Review the QMP Plan to ensure that it complies with the requirements of the Reference Standard. This includes:

• reviewing the Prerequisite and RAP Plans to confirm that all the necessary controls and documentation are in place. This includes the strategy for monitoring, the taking of records when required, and the implementation of appropriate corrective actions, as outlined in the QMP Plan; and
• reviewing the HACCP Plan to confirm that all the necessary controls and documentation are in place. This includes the strategy for monitoring and recording at CCP, the implementation of appropriate corrective actions, and the verification of the HACCP Plan to ensure the system is working effectively.

Once the QMP Plan is implemented, the processor is required to:

3. Perform routine verification procedures to confirm that the HACCP system is working effectively (HACCP principle 6). For CCP verification, the processor must complete independent tests, measurements, sampling, review of monitoring procedures and records etc., as necessary and at an appropriate frequency, to verify that the control measures implemented at each CCP are effective and being implemented as described in the plan.

4. Re-validate QMP controls or CCP critical limits as changes are made to raw materials, products, processes, equipment, or in response to adverse review findings, recurring deviations, new information on hazards or control measures, on-line observations, and/or new distribution or consumer handling practices where potential hazards may be encountered.

5. Review the QMP Plan, at least once per year, including:

• verifying the HACCP Plan, to confirm that it is complete, accurately reflects current products and processes (product descriptions, process flow, and establishment layout), has effective controls over the significant hazards, and the monitoring of the critical limits is at a frequency sufficient to ensure that products remain in compliance. This verification should include, as appropriate, product sampling and testing, a review of process deviations, corrective actions, audit findings, and consumer complaints. The HACCP Plan is also verified following a system failure or, when there is a significant change in the product or process.
• conducting a review of the QMP Plan, including Prerequisite and RAP Plans, to confirm that these programs are complete and functioning effectively. Verification activities for the Establishment Environment Program can use a combination of visual observation, record review, surface swabs or other methods of microbiological analysis of surfaces such as contact plates, or adenosine triphosphate (ATP) bioluminescence. Mock recall exercises are effective verification of the traceability system. Verification of the RAP Programs can include product and incoming material testing and label inspection at atypical inspection points or using more stringent sampling regimes.

This review would confirm that all corrective actions, problems and consumer complaints have been evaluated to ensure the results were effective and that all amendments and other required written changes have been made to the QMP Plan.

The processor should consider the yearly operating schedule in order to best schedule the annual review of the QMP Plan. Some verification activities require the establishment to be in typical production mode in order to assess (for example, swab samples for microbiological analysis), whereas some verification activities, such as equipment calibrations may better be scheduled during shutdown periods. All elements of the QMP Plan should be reviewed in the course of each year, however, each element need not be reviewed simultaneously. The QMP Plan should describe the schedule and method by which each element will be reviewed.

7. Record Keeping

Reference Standard Requirements:

7.1 Records must be kept for the QMP Plan as follows:

7.1.1 For all Prerequisite and RAP Plans, record keeping may be "by exception".

7.1.2 For the HACCP Plan, record keeping is mandatory for all testing, measurements, and monitoring at CCPs and for corrective actions when the critical limits are exceeded.

7.1.3 For all verification activities and results, record keeping is mandatory.

7.1.4 For amendments or changes to the QMP Plan, a record must be maintained.

Intent:

Two types of records are components of the QMP Plan, the record of the development and the components of the quality management program, referred to as "documents" or "documentation" and those records taken as a result of the implementation of the quality management program, simply termed "records".

It is important to balance the volume of record keeping with the true needs of the organisation and the resources available to deliver the system. The development, usage and maintenance of documentation and records should be sufficient to provide evidence that the system was developed properly, is being implemented as written, and can demonstrate trends to identify a problem.

Compliance Guidelines:

1. Copies of all of the records (e.g., blank examples) described in the QMP Plan, including monitoring, verification, corrective action and personnel training records, are part of the QMP Plan documentation.
2. When records by exception are permitted, records are only required when a deficiency is identified during the monitoring procedures. In these cases the processor is required to record the deficiency and document it using a Corrective Action Record.
3. When a QMP Plan or any part of its documentation is amended, the date and the changes and the date they are made must be recorded. An accepted practice is to include an amendment log in the QMP Plan. This will ensure that the written QMP Plan continues to reflect the controls that are being applied in the processing operation.
4. The effectiveness of record keeping is improved by ensuring that personnel understand why they are taking records, when, and how to complete the record accurately. The processor should review records periodically to ensure they are current and relevant. Records may contain information outside of the scope of the QMP Plan and processors may combine records to reduce paper load.
5. Records remain current, legible, readily identifiable and retrievable. The location of all files and records in respect of the QMP Plan must be identified. The retention time for records is a very important issue. Records must be retained for at least 36 months and should be retained for a period of time which is relevant to the product shelf life. Records should be stored in a manner which is secure, easily accessible, and which protects the integrity of the record.
6. Consideration can also be given to technology to allow for continuous monitoring or automatic capture of data through computers or remote sensors. When microprocessor technology is used, specific controls must be developed to control the creation and maintenance of electronic records and electronic signatures. Further guidance on this subject is provided in the Appendices of this document.

Appendix A - Guidelines for the Development of a Product Description

The importance of the product description, including the intended use, distribution, and consumer information should not be underestimated.

The product description has two major roles:

1. it contains sufficient information regarding the product which is essential to the hazard analysis and the development of safety and regulatory controls in the QMP Plan;
2. to describe the scope of the QMP Plan, i.e., all of the documentation, controls, reports, corrective actions, etc., in the QMP Plan that pertain specifically to the product described in this section.

Information contained in the product description must be supportable. In particular, physical characteristics, composition, packaging, and/or shelf-life attributes which impact on the risk of a hazard or its likelihood of occurrence must be substantiated. This data is usually found in association with the HACCP Plan.

The product description can be developed using the following 3-step approach:

Step 1 - Describing the product in consumer terms

The product should be described in consumer terms, including:

a) the product name

This should use the acceptable common name associated with the species, and the manner of processing or intended preparation.

For example, fresh aquaculture raised Atlantic salmon, canned chinook salmon, salt cod, etc.

The List of Canadian Acceptable Common Names for Fish and Seafood is available on the CFIA Internet.

b) the type of product packaging

This should describe the packaging of the final product and may include multiple types of packaging.

Key issues associated with food safety are selective barrier films, vacuum packaging, recycled packaging materials, the acceptability of food contact materials, and identification of potential sources of physical contamination (i.e., product packed in glass represents a potential source of contamination from broken glass).

Any characteristics of the packaging which may affect the multiplication of microbial pathogens and/or the formation of toxins should be identified. For example, the potential for growth and toxin production of Clostridium botulinum in products packaged in selective barrier (i.e., oxygen permeable) films, and vacuum or modified atmospheric packaging and the potential growth of Listeria monocytogenes in products packaged for extended shelf-life.

Step 2 - Describe any factors which may result in the addition of ingredients or other compounds to the product

Consider and identify any sources of intentional and/or unintentional additions to the product which may affect product safety, including:

a) the source of incoming fish where it could affect product safety

Fish, whether migratory or non-migratory may be disposed to naturally occurring or man-made contaminants or other compounds in the environment.

In general, Canadian products should be identified by the waters where the fish was harvested or the location closest to it. However, where a known risk exists, it is important to identify any source(s) that is not acceptable. For example, a fisheries exclusion zone or area closed to harvesting as a food safety precautionary measure.

Bivalve molluscs must be identified by specific harvest area or areas.

Imported fish must be identified by the country of origin, and where geographic risks apply, by more specific localities.

b) processing steps or processing aids which could affect product safety or regulatory compliance

Any compounds that are added to the product, either directly or indirectly, such that they are part of the product whether or not the component is listed on the label, must be identified.

Fish culture, harvesting, processing, and/or transport operations should be considered. For example, consider the following ingredients, processing aids, or residual compounds that may be added to the product:

• aquaculture therapeutants
• sawdust used to naturally smoke fish
• ice used to pack fresh fish during transport, processing or in the final product
• boiler compounds in steam used to pre-cook fish
• water used to flume or wash fish
• traditional ingredients (salt, sugar, spices, vinegar, etc.) must also be listed.

c) the important characteristics of the final product which are intended to affect product safety or influence the growth of disease-causing pathogens, such as additives, salt concentration, water activity (a_w), or pH.

Step 3 - Describe the conditions of distribution, intended use, and consumers of the food

Consider and identify the factors which impact on product safety and regulatory compliance, including:

1. the product market, i.e., within Canada or outside Canada;
2. special distribution controls or instructions for safe product distribution, e.g., "Keep Refrigerated" or "Keep Frozen";
3. labelling instructions that may be applicable for safe product storage and preparation, e.g., "Keep Refrigerated";
4. the intended end product use which may effect the product safety.

   For example, consider: Will the food be heated by the consumer? Will there likely be leftovers? Is the food intended for the general public? Is the food intended for consumption by a population with increased susceptibility to illness (e.g., infants, the aged, the infirm, immuno-compromised individuals)? Is the food for institutional use or for the home?

5. the product's shelf life.

   For example, consider: the potential growth of Listeria monocytogenes in extended shelf-life products; the potential effect of shelf life on the integrity of sensitive packaging materials.

Appendix B - Guidelines for the Development of a Sanitation Program

An effective sanitation program is an essential support for any food safety program. While it is not an integral part of the HACCP Plan, which is restricted to process steps, the sanitation program must be in place before a HACCP Plan can be properly introduced.

Cleaning is the removal of dirt or debris by physical and/or chemical means.

Sanitizing is the process used to rid or reduce the number of microbes (microorganisms) on the surface. Sanitizing cannot be accomplished until surfaces are clean. Sanitizing cannot be effective without a good pest control program as described in Appendix C.

The food processing establishment is a distinctive environment and a sanitation program should be designed to meet the specific needs of that environment to ensure that fish and fish products are prepared under sanitary conditions.

Cleaners and sanitizers should be selected to be effective in the processing conditions found at the establishment. These products are known to have differences in activity relative to ambient temperature, cleaning water characteristics, and the level and type of processing debris present. The method of product use, i.e., the application method, concentration and contact time will affect the performance of cleaning and sanitizing products.

An effective written sanitation program includes the following:

1. Procedures for equipment sanitation which specify step-by-step instructions for equipment to be cleaned and sanitized, including:

• person(s) or positions responsible;
• identification of equipment and utensils;
• disassemble/reassemble instructions when required for cleaning, disinfecting, lubrication, and inspection;
• methods of cleaning, disinfecting, and rinsing;
• chemicals and concentrations used;
• time and temperature requirements for cleaning and disinfecting;
• lubricants used where applicable; and
• frequencies for cleaning and sanitizing.

2. Procedures for establishment sanitation which specify step-by-step instructions for premises, processing, and storage areas to be cleaned and sanitized, including:

• person(s) or position(s) responsible;
• identification of premises, processing, and storage areas;
• methods of cleaning, disinfecting, and rinsing;
• chemicals and concentrations used;
• time and temperature requirements for cleaning and disinfecting;
• frequencies for cleaning and sanitizing; and
• methods to prevent the contamination of food or packaging materials during, or subsequent to, cleaning and sanitizing.

3. The identification of acceptable cleaning and sanitizing equipment and its intended use.

4. The identification of acceptable cleaning chemicals and/or compounds, their intended use, and instructions for proper application.

Appendix C - Guidelines for the Development of a Pest Control Program

Sanitizing cannot be effective without a good pest control program. Pest Control is the reduction or eradication of pests (macro organisms). These include flies, cockroaches, mice and rats, as well as weevils and other animals and insects that can target food products. Pest control cannot be effectively accomplished unless and until proper cleaning and establishment maintenance has occurred. If no pests are present, cleaning followed by sanitizing is sufficient. If, however, pests are present, they must be controlled before the sanitizing step. This is because the pests will re-contaminate any surface that may have been sanitized.

Establishment management is responsible for identifying a competent person to develop a pest prevention and control program and to give them the necessary support to carry out the program and ensure that pesticides are used in accordance with label instructions. Persons who apply pesticides in industrial and institutional settings have a responsibility to use the needed pesticide, to apply it correctly (according to label instructions), and to be certain there is no hazard to man or the environment.

An effective written pest control program includes the following:

1. Controls to prevent the entrance of pests to the facility, including:

• measures to prevent the entry of pests and animals, through proper construction and layout of facilities
• measures to control the opening and closure of doors and windows
• measures to exclude animals such as dogs, cats and birds.

2. Controls to eliminate or prevent the harbourage of pests in and around the facility, including:

• measures to maintain an outside establishment environment that does not provide a habitat for pests (i.e., establishment surroundings must be free of debris, stagnant water or improperly disposed of offal),
• where applicable, a list of chemicals and devices used for pest control, the concentration applied, the locations where applied, and the method and frequency of application,
• where applicable, a plan of bait and trap locations,
• where applicable, a system to record the date of chemical or device applications, chemicals or devices used, results of the application, corrective actions taken, and
• the name of the responsible person.

3. Identification of properly maintained pest control equipment and its intended use.

4. The identification of acceptable chemicals and/or compounds, their intended use, and procedures for proper application.

5. Procedures to ensure that the pest control program is carried out in a manner that does not contaminate food or packaging materials during, or subsequent to, pest control applications.

6. The name or position of persons responsible for pest control, including, where applicable, the name of the pest control company or the name of the person contracted for the pest control program.

Appendix D - Guidelines for the Development of a Personnel Hygiene Program

Anyone who works in a food handling area must maintain a high degree of personal cleanliness, and the way in which they work must also be clean and hygienic.

In developing the QMP Plan, management must:

• decide what training or supervision their food handlers need by identifying the areas of their work most likely to affect food hygiene. Food handlers must receive adequate supervision, instruction, and/or training in food hygiene.
• take care to ensure that no persons, while known or suspected to be suffering from, or to be a carrier of, a disease likely to be transmitted through food or while afflicted with infected wounds, skin infections, sores, or with diarrhoea, is permitted in any food handling areas in any capacity in which there is a likelihood of that person directly or indirectly contaminating the food with pathogenic micro-organisms.

The Codex Alimentarius General Principles of Food Hygiene lists the following illnesses and injuries which should be reported to management so that any need for medical examination and/or possible exclusion from food handling can be considered: jaundice; diarrhoea; vomiting; fever; sore throat with fever; visibly infected skin lesions (boils, cuts, etc.); and discharges from the ear, eye, or nose.

The Prerequisite Plan should contain an effective written personnel hygiene program, which addresses the following:

1. Communication of the company policy on personnel hygienic practices, including communicable diseases, to employees, visitors and guests.
2. Cleanliness and conduct of personnel, including hand washing, use of hand and/or foot dips, clothing or jewellery which could contaminate food, unsanitary behaviour or practices
3. The health of personnel, including prevention of personnel suffering from a communicable disease or with open cuts or wounds from being employed in a processing area of an establishment.
4. Prevention of contamination and cross-contamination of the food product by control over the storage of employee personal belongings, and the control of personnel and visitor traffic.

Appendix E - Criteria for an Acceptable Supplier Quality Assurance Agreement

See Criteria for an Acceptable Supplier Quality Assurance Agreement.

Appendix F - Guidelines for the Use of Electronic Records and Signatures

Electronic Records

When QMP records are created and/or stored using microprocessor technology, these electronic systems can be classified as "open" or "closed" systems. A closed system is an environment where the system access is controlled by the persons who are responsible for the content of the electronic records on the system. An open system is an environment in which the system access is not controlled by the persons who are responsible for the content of the electronic record on the system. For example, a processor has purchased off-the-shelf HACCP software to record and store data, and generate reports of CCP monitoring. If the processor does not have access to the data storage files generated by the software, this system is considered closed. If the processor has access to the content of those data files generated by the software the system is considered open. The distinction between open and closed governs who is responsible for implementing controls to ensure the authenticity and integrity of electronic records. If the system is closed then the software manufacturer is responsible, otherwise the food processor is responsible.

When fish processors use electronic records in place of paper records required for QMP, they must develop and implement additional controls to demonstrate the reliability of the electronic records.

Processors should be able to demonstrate compliance with the following requirements:

1. Documentation of the computer system operation, maintenance, and modifications is part of the QMP Plan.
2. Computer systems are validated to ensure their accuracy, reliability, consistency and ability to discern invalid or altered records.
3. Computer systems are able to generate accurate and complete copies of records in a readable text format for inspection purposes.
4. Computer systems contain an adequate means to protect records for accurate and timely retrieval throughout the record retention period. This may include systems to maintain appropriate backup records.
5. Computer systems limit record access to authorised individuals.
6. Computer systems have a rigorous security protocol to ensure that only authorised individuals can use the system, electronically sign a record, access the operation or computer system, alter a record, or perform operations.
7. Management establishes and implements policy that holds individuals responsible and accountable for data recorded and/or actions taken under their electronic signatures.

Electronic Signatures

When a QMP record is made it should be signed or initialled by the responsible party. Similarly, when an electronic record is created, the computer systems will require identification of the person who created the record, this identification is called the "electronic signature".

When electronic signatures are used in association with QMP records, the following characteristics should be associated with the electronic signature:

1. The electronic signature contains a unique identifier for the signer, the date and time of signing.
2. The electronic signature is clearly linked with one (or more) electronic record(s).
3. Controls are in place to ensure that electronic signatures and their links to records cannot be removed, copied, or otherwise manipulated.
4. Each electronic signature is unique to only one individual and is not re-used or re-assigned at any time.
5. Identity of persons authorised to use electronic signatures are documented in the QMP Plan

Appendix G - Guidelines for the Verification and Maintenance of the QMP

Purpose

This document provides guidelines about the requirements set out by Element 6 of the QMP Reference Standard - Verification and Maintenance of the QMP Plan; and specific requirements set out by Element 5 of the QMP Reference Standard - the HACCP plan.

Key Criteria

The objective in developing a verification and maintenance program is to use all available information to confirm that the QMP meets the needs of the fish processor in producing a safe, wholesome and fairly traded product. The key criteria for such a program are:

1. Written outline - The plan must have enough detail to clearly outline the "what" and "how" actions that will be completed when assessing each Verification and Maintenance element component. The plan should also outline "who" is responsible for carrying out the plan.
2. Appropriate timing - Verification and Maintenance activities should be timed so that changes can be made and implemented to ensure the QMP functions correctly and remains effective during production. The frequency of each Verification and Maintenance activities should be linked to the amount of change occurring in the operation (i.e., more often for rapidly changing products versus more stable production).
3. Records - Records must be kept for all verification and maintenance activities to demonstrate what took place, the extent of these activities, and the results.
4. Amendments - the processor must keep a list of all amendments made to the QMP (i.e., amendment log).

Compliance Guidelines

There are 4 main requirements to be met:

1. Complete review of QMP prior to implementation
2. Validation - before starting a process and when changes are made to the process
3. HACCP Verification while operating (Codex HACCP Principle 6)
4. Verification/maintenance activities for the entire QMP plan with specific requirements for the HACCP plan.

1) Complete Review

When submitting a QMP Plan for System Verification, the processor must provide evidence that the QMP Plan has been reviewed to confirm that it is complete and all the necessary controls and documentation for all elements of the Reference Standard are in place. One way to ensure this is accomplished is by using a checklist completed in sufficient detail to demonstrate that an assessment was carried out and the plan met the criteria (an example is available in Chapter 2, Subject 1, Appendix C of this manual).

2) Validation

Before implementation of the QMP, validation of HACCP controls and CCP critical limits must be completed and submitted as part of the initial QMP submission for System Verification. There are two parts to this validation:

1. scientific evidence - must be collected to establish that the parameters for the critical limits for each CCP are sufficient to prevent, eliminate or reduce to an acceptable level, the food safety hazards in the final product (examples of scientific evidence include a process authority (NFPA), published research data, Health Canada regulatory standard).
2. in-plant testing - sufficient tests and measurements must be conducted during test trials of the process to clearly demonstrate that the process is able to consistently meet the chosen critical limits.

Once production has started, revalidation of HACCP controls or CCP critical limits is required where changes are made to raw materials, products, or processes, or in response to adverse audit findings, recurring deviations, new information on hazards or new distribution and consumer-handling practices where potential hazards may be encountered:

For each Critical Control Point on the production line, the critical limits are based on stable conditions, i.e., the raw materials, the equipment and all the process steps remain the same. If any of these change, control measures must be evaluated to confirm they are still effective, and critical limits must be re-validated to ensure safe food is still being produced.

Other events such as, but not limited to, the following may point to a need to re-validate QMP controls or CCP critical limits:

• adverse findings from a CV or other external audit which found problems with the process or controls.
• deviations from critical limits which keep occurring and cannot be eliminated.
• a new hazard is identified or a new time/temperature process is published by a process authority.
• changes to distribution/marketing, e.g., extended shelf life or consumer packaging (oxygen permeable packaging).

3) Codex HACCP Principle 6 - verification during production (Reference Standard 5.1.6)

Once production is underway the processor is required to perform two ongoing verification procedures to confirm that the HACCP system is working effectively (Principle 6 - Codex HACCP model). These activities would normally be completed by someone not directly involved in the production process, such as a supervisor, manager or some other person (e.g., Quality Control) with the authority to review the production.

a) Records Review of the monitoring actions for CCP critical limits and corrective actions taken must be verified frequently to confirm they are occurring as described in the plan. This includes calibration records of instruments used in the measurement of Critical Control Point parameters (e.g., temperatures, pH, weight, flow rate).

The Records Review is intended to verify that:

• monitoring activities were performed at the frequency required by the HACCP plan and all results were within the Critical Limits;
• no monitoring activities were missed and all records were completed accurately and correctly;
• all deviations were followed up immediately with Corrective Actions.

HACCP plans rely on accurate measurements (e.g., temperatures, pH, weight, flow rate) to ensure the CCPs are operating within critical limits. The instruments or equipment that require calibration for accurate CCP monitoring should be described in the HACCP plan. The recommended frequency of calibration is dependant on the likelihood that the instrument will go out of calibration and, if it does, the likelihood that a Critical Limit will not be met.

b) Independent checks must be completed to verify that the control measures implemented at each CCP are adequate and effective. This verification step must be done on a routine basis, at an appropriate frequency so that corrective action could be successfully initiated and final product controlled if a problem were to be discovered.

Independent Checks are observations, measurements, analytical tests, samples, etc. These are completed separately from the monitoring activities and are intended to be an additional level of control to demonstrate that the identified hazard is being controlled adequately. Observations might involve a second individual watching the monitoring activity being performed. Measurements might involve a second individual performing the monitoring activity separately from the production monitoring.

The verification plan must include a description of the independent checks, the timing of the activity, the individual performing the checks, and the corrective action to be taken if the results indicate a problem with the monitoring.

4) Specific requirements for the HACCP plan and verification/ maintenance activities for the rest of the QMP

a) Specific requirements for the HACCP plan

The purpose of a HACCP is to prevent food safety hazards from occurring and to accomplish this, the entire HACCP plan must be evaluated at least once each year to confirm that it:

• is complete;
• accurately reflects current products and processes;
• has effective controls over all significant hazards;
• has monitoring of the critical limits at frequencies sufficient to ensure that products remain in compliance; and
• has corrective action procedures that work efficiently and effectively.

For processes that do not currently have significant hazards, it is crucial that the Hazard Analysis is reviewed to confirm that there have been no changes in the product formulation or process steps that might require a re-evaluation of hazards for significance.

b) Verification/maintenance activities for the rest of the QMP

The processor must review all other elements of the QMP Plan, (i.e., Management Roles and Responsibilities, Product Descriptions, Process Flow Diagram, Prerequisite Programs, RAP Controls) at least once every year. This review must verify that the QMP Plan is current, complete and accurate, such that the written document matches what is actually occurring during production.

This review would confirm that all corrective actions and any problems or consumer complaints that occurred over the year have been analysed with written amendments or other appropriate changes made to the QMP Plan.

The processor should consider their yearly operating schedule in order to best schedule the annual review of the QMP Plan. Some review activities require the establishment to be in full production mode in order to assess (for example, swab samples for microbiological analysis), while other review activities, such as equipment or instrument calibrations may better be scheduled during shutdown periods. All elements must be reviewed in the course of each year, but they need not all be reviewed at the same time.

The types of Annual Review activities can be found in Table 1.

Table 1 - Types of Review Activities

Examples of verification and maintenance activities include, but are not limited to, the examples provided in the following table.

Appendix H - Guidelines for Effective HACCP Controls for Molluscan Shellfish Processing Establishments

PDF (246 kb)

1. Purpose

The purpose of this document is to advise registered shellfish processing establishments of the minimum expected HACCP controls for processing live molluscan shellfish. The criteria listed below is intended to assist in the determination of compliance with the requirements of the Quality Management Program (QMP) Reference Standard, Section 5: The Hazard Analysis Critical Control Point (HACCP) Plan and related QMP requirements.

2. HACCP Controls for the Processing of Live Molluscan Shellfish

The Canadian Shellfish Sanitation Program (CSSP) is administered by the Canadian Food Inspection Agency, Environment Canada and Fisheries and Oceans Canada and provides the basis for determining which areas are acceptable for shellfish harvesting in most circumstances. The CSSP provides information to interested stakeholders about which shellfish areas are open and closed to shellfish harvesting. The use of open and closed status as a critical limit when receiving shellfish may not be an adequate or appropriate control measure for some hazards or certain situations. Alternative or additional control measures are discussed in more detail within these guidelines.

It is the responsibility of each registered shellfish processing establishment to use the information provided by the CSSP and any other applicable information source to develop the required control measures which will ensure shellfish are safe for consumption.

Registered shellfish processing establishments that purchase shellfish from other registered shellfish processing establishments must ensure that appropriate HACCP controls are being applied. Shellfish processing establishments must consider any other activities that occur prior to receipt (e.g. relay by harvesters under a Management of Contaminated Fisheries Regulations (MCFR) licence, time-temperature controls for Vibrio parahaemolyticus, on board human waste containment, surface aquaculture bird contamination control measures, etc.) and incorporate appropriate control measures into their QMP plan. The development and routine verification of a Supplier Quality Assurance (SQA) agreement may be part of an appropriate control measure for these situations. Further guidance on the development of an SQA can be found in Appendix E of the QMP Reference Standard, Criteria for an Acceptable Supplier Quality Assurance Agreement.

Registered shellfish processing establishments that receive shellfish from integrated multi-trophic aquaculture sites may require special control measures as described in appendix XII of CSSP Manual of Operations - Procedure for Development, Approval and Review of an Integrated Multi-trophic Aquaculture Management Plan.

All control measures developed must be clearly documented in each establishment's QMP.

An acceptable HACCP plan requires the appropriate application of the seven principles of HACCP by the operator of the processing establishment. The first step in developing an effective HACCP plan is to accurately describe the product and processing through a product description and process flow chart. A HACCP plan (and related documents) for live molluscan shellfish shall comply with the following requirements.

2.1 Product Description

In order to conduct a hazard analysis and a determination of critical control points, the product description must identify all product attributes that influence the safety and acceptability of live molluscan shellfish. Product descriptions shall indicate:

• which harvest area(s) and/or registered establishments (if applicable) shellfish are sourced from;
• whether the harvesting is subject to a conditional management plan, or a decontamination plan;
• whether the shellfish are wet stored near shore or on shore (including the water source)
• all culturing, pre-harvest, harvesting, holding, wet storage and transportation practices that may influence safety;
• special labelling instructions; and
• intended use (i.e. consumed raw or cooked).

More detailed information on product descriptions can be found in Appendix A of the QMP Reference Standard, Guidelines for the Development of a Product Description.

2.2 Process Flow

The process flow diagram must outline all production steps under the control of the registered shellfish processing establishment (e.g. pre-harvest, harvest, buy stations, buy trucks, transportation, near shore or on shore wet storage, relay, receiving, heat shock, depuration). The process flow diagram must be complete and accurate.

Note: Registered shellfish establishments must also be aware of production steps that are under the control of a third party and occurr prior to receipt at the establishment. A supplier quality assurance agreement may be required (see Section 2).

2.3 Conduct a hazard analysis (Principle 1)

The hazard analysis is conducted at each process step identified in the process flow diagram. This will assist the establishment in identifying the process step(s) where a significant hazard may be present, introduced or increase to unacceptable levels. For molluscan shellfish, hazards related to natural toxins and chemical contamination cannot be eliminated, reduced or controlled by cooking or heat processing, therefore these hazards must be considered as significant and controlled prior to or at receiving.

There may be hazards present at process steps that are not under direct control of the registered molluscan shellfish processing establishment. These hazards must be identified for consideration at the step where the shellfish comes under the processor's control (e.g. at receiving).

Significant hazards to be considered for molluscan shellfish include, but are not limited to, the following:

a) The presence of microbiological pathogens in harvest, wet storage or relay areas. Sources of microbiological contamination can be from:

• human sources (e.g. wastewater treatment plants, direct discharges from boats or homes, malfunctioning septic systems);
• agricultural animals;
• natural sources (e.g. wildlife, marine mammals, birds, etc.);
• natural events such as herring spawning which can attract birds or mammals; and
• birds which are roosting on aquaculture equipment (e.g. floating Vexar® bags, buoys, etc.)

b) The presence and growth of naturally occurring pathogenic microorganisms such as Vibrio parahaemolyticus where applicable.

c) The presence of marine biotoxins in all harvest areas and in areas where shellfish are wet stored (either near shore or on shore).

d) The presence of chemical contamination (e.g. heavy metals, hydrocarbons, etc.)

2.4 Determine the critical control points (CCP) (Principle 2)

For each significant hazard, a critical control point (CCP) must be identified at which appropriate control measures are applied to prevent or eliminate or reduce the hazard to an acceptable level.

a) It is required that all shellfish processing establishments will have a critical control point at receiving.

1. The processor must be able to determine that shellfish are harvested from an approved or conditionally appproved area in the open status, or are harvested under an appropriate MCFR licence and where the conditions of the licence have been met.
2. The processor must be able to determine that the shellfish are from harvest vessels that have adequate control measures to prevent contamination of shellfish by human waste and that have sanitary practices on the use of human waste receptacles or washroom facilities.

b) Shellfish harvested under an MCFR licence must be subject to a decontamination process. A CCP must be established at the processing step where the decontamination occurs (e.g. relay, depuration, or shucking of scallops).

c) In some circumstances shellfish may be exposed to hazards before the harvest area is closed. Shellfish may be harvested in offshore areas which are not subject to routine CSSP monitoring. Additional or alternate CCPs must be identified to control potential hazards in such situations. Some examples include:

• shellfish sourced from harvest areas subject to a conditional management plan based on the operation of a waste water treatment plant (WWTP) and are harvested inside the response line as identified on the classification map for those areas;
• shellfish sourced from harvest areas where biotoxin levels are known to rapidly rise above action levels;
• harvesting and processing the shellfish species which are being used as the sentinel species for biotoxin monitoring and the harvest areas are subject to periodic closures; and
• monitoring marine biotoxin levels in shellfish from offshore harvest areas on a lot by lot basis

d) In certain situations, a critical control point(s) to limit time-temperature exposure may be required to control specific microbiological hazards (such as Vibrio parahaemolyticus) from harvesting to final product shipping.

e) Shellfish that are subject to near shore wet storage, on shore wet storage or depuration may need a CCPs to control the introduction of microbiological, biotoxin or chemical hazards. For additional guidance on wet storage refer to chapter 5 of the CSSP manual of operations.

2.5 Establish critical limits (Principle 3)

One or more critical limits must be established for each CCPs as determined by established control measures. As a minimum, critical limits in a shellfish processing establishment must address the following:

a) Shellfish are harvested from approved or conditionally approved areas and are in the open status.

b) Shellfish are sourced from harvest vessels that have adequate control measures to prevent contamination of shellfish by human wastes and that have sanitary practices on the use of human waste receptacles or washroom facilities.

c) Shellfish harvested under a MCFR licence are decontaminated (e.g. relayed, depurated, shucked) as per the conditions stipulated in the MCFR licence. For relay and depuration applicable requirements of Chapter 10 of the CSSP must be met.

d) Shellfish can be harvested and received by a processor before the harvest area is closed. This may include conditionally classified areas that are based on the operation of a WWTP or areas that are subject to a rapid rise in marine biotoxin levels. Shellfish can be harvested from offshore areas not subject to routine CSSP monitoring for marine biotoxins.

e) Levels of naturally-occurring microbiological pathogens (e.g. Vibrio parahaemolytics) must meet identified standards in the final product. For example, critical limits are identified to address the level of microbiological pathogens at the time of harvest and limit time/temperature exposure from harvest to final product shipping. These critical limits must be established during warmer months if the shellfish are destined for raw consumption.

f) Near shore wet storage areas must be in the open status prior to removing shellfish from a wet storage site.

g) Source water for on shore wet storage or depuration systems must originate from shellfish harvest areas that are approved or conditionally approved in the open status or be treated by a validated water treatment system and approved by the CFIA.

Each water treatment system must be validated to ensure it can eliminate or reduce the potential microbiological or biotoxin hazards to acceptable levels.

• Ultraviolet (UV) water treatment systems used to eliminate microbiological hazards in source water must ensure that:
  • the turbidity does not exceed the manufacturer's specifications, or in the absence of the manufacturer's specifications, must be less than 20 Nepholometric turbidity units;
  • the UV intensity meets the manufacturer's specifications for adequate disinfection; and
  • the water flow rate does not exceed the manufacturer's specifications.
• Water filtration systems designed to filter toxic phytoplankton from source water must ensure that the toxic phytoplankton of concern are eliminated or reduced to an acceptable level (as measured in post filtered water samples).

2.6 Establish a system to monitor control of the CCPs (Principle 4)

At each CCP, the processor shall establish monitoring procedures to determine that the system is operating within the identified critical limits.

a) For CCPs identified to prevent the processing of shellfish from restricted, prohibited, unclassified areas or from areas in the closed status, monitoring procedures must be able to demonstrate that the area is classified as approved or conditionally approved and in the open status for every lot of shellfish received. Examples of acceptable monitoring procedures may include but are not limited to:

• checking the harvest area status for sanitary closures, biotoxin closures, emergency closures posted by Fisheries and Oceans Canada on websites or by other means of communication with DFO;
• maintaining lists of licensed commercial harvesters that the processor will only accept shellfish from;
• checking tags or questioning harvesters at receiving to identify the harvest location;
• buying at the harvest location;
• having a representative of the processor at the harvest area to observe harvesting practices (e.g. master harvester for wild harvest); and
• establishing harvest plans that identify, in advance, the harvesters and location of harvest;

Use of multiple monitoring procedures will increase confidence that a critical limit has been met.

b) For CCPs identified to prevent the sourcing of shellfish from harvest vessels that do not have adequate controls to prevent contamination of shellfish by human waste or sanitary practices on the use of human waste receptacles or washroom facilities:

• monitoring procedures must demonstrate that the shellfish are sourced from harvesting vessels that have adequate controls to prevent the contamination of shellfish by human waste (list of acceptable harvesters).
• monitoring procedures must demonstrate that the shellfish are sourced from harvesting vessels that have sanitary controls to ensure that all persons sanitize their hands after using or cleaning an on board waste receptacle or using a washroom facility.

c) For CCPs identified for shellfish harvested under a MCFR licence, monitoring procedures must be able to demonstrate that the terms of the decontamination plan have been achieved. Minimum decontamination plan requirements for depuration and relay can be found in Chapter 10 of the CSSP manual of operations. Each depuration facility will have specific requirements that are based on species specific validated depuration processes. Examples of acceptable monitoring procedures may include but are not limited to:

• monitoring shellfish relay times to ensure all lots of shellfish are relayed for the required amount of time (e.g. 14 days);
• monitoring shellfish depuration times to ensure all lots of shellfish are depurated for the required amount of time (e.g. 44, 48 or 72 hours);
• monitoring key depuration parameters that affect depuration performance; and
• monitoring the shucking of scallops to ensure the adductor muscle is free of viscera.

d) For CCPs identified where shellfish are received and can be potentially affected by a hazard before an area is closed or from offshore areas that are not routinely tested, monitoring procedures must be able to demonstrate that the shellfish are safe at time of harvest.

• For harvest areas under a CMP, monitoring procedures must be in place to check that the conditions described in the CMP were in place at time of harvest.
  • Where the CMP is for the operation of a WWTP, monitoring procedures must take into account the time required for processors to become aware that the WWTP is not operating normally as described in the CMP. Acceptable monitoring procedures, for every lot of shellfish received, may involve checking the status of the harvest area inside the response line only after the detection, notification and response (DNR) time identified in the CMP has elapsed.
• For open harvest areas known to have biotoxin events that can rapidly rise above the action level or shellfish species that are used as the sentinel species in biotoxin monitoring, monitoring procedures must be in place to confirm the action levels have not been exceeded. Examples of additional acceptable monitoring procedures may include but are not limited to:
  • hold product until a biotoxin monitoring result from the same harvest date or subsequent harvest date is available; and/or
  • analyze product using a rapid test kit or by other means.
• For offshore harvest areas monitoring procedures must be in place to confirm biotoxin levels are acceptable.

e) For CCPs identified for the conditions during the holding and transport of shellfish from the harvest site to the processor, monitoring procedures must be able to demonstrate that shellfish are not exposed to sources of contamination or conditions allowing microbiological pathogens to grow to unacceptable levels (i.e. Vibrio parahaemolyticus). One example of an acceptable control measure may be to monitor time and temperatures (e.g. reviewing records, measuring temperatures, etc.).

f) For near shore wet storage, monitoring procedures must ensure that the wet storage site is in the open status when shellfish are removed.

g) When source water for on shore wet storage or depuration systems originates from shellfish harvest areas, monitoring procedures must ensure that harvest area is in the open status or the water treatment system is functioning as designed.

• Monitoring of ultraviolet (UV) water treatment systems used to eliminate microbiological hazards in source water must ensure that:
  • the turbidity does not exceed the manufacturer's specifications, or in the absence of the manufacturer's specifications, must be less than 20 Nepholometric turbidity units;
  • the UV intensity meets the manufacturer's specifications for adequate disinfection; and
  • the water flow rate does not exceed the manufacturer's specifications.
• Monitoring of water filtration systems designed to filter toxic phytoplankton from source water must ensure that the toxic phytoplankton of concern are eliminated or reduced to an acceptable level (as measured in post filtered water samples).

2.7 Establish the corrective action to be taken when monitoring indicates that a particular CCPs is not under control (Principle 5)

When monitoring indicates that a critical limit has not been met, corrective action procedures must be initiated. The written corrective action procedures must address:

• how the deficiency that gave rise to the problem will be corrected;
• how affected product will be identified and segregated;
• how affected product will be disposed of in an appropriate manner. When the safety of shellfish is in question, it must be returned to the harvest area or destroyed.
• how reoccurrence of the problem will be prevented. This will likely include:
  • a review of the QMP Plan and identification of necessary changes (e.g. changes of procedures, control measures, standards, etc.);
  • the implementation of necessary changes;
  • identification of changes in the QMP amendment log.
• a record keeping system to document the details of the problem, including the date the problem was identified, the corrective action taken, the person(s) responsible for the action, the date the action was taken and the changes needed to eliminate or prevent re-occurrence of the problem.

Unacceptable shellfish sample results can be an indication that existing CCPs are not effective in ensuring that shellfish received for processing originated from the identified harvest areas. In response to unacceptable laboratory results, the processor is required to re-evaluate their HACCP plan and make modifications as required.

• Where the investigation determines that the problem is related to inadequate controls under the QMP, the processor shall take appropriate steps to review, modify and implement effective controls to bring the QMP into compliance.
• Where the investigation determines that the problem is linked to the harvest area then the processor shall modify controls to ensure that harvest practices are adjusted to take into account any potential sources of contamination.

2.8 Establish procedures for verification to confirm that the HACCP system is working effectively (Principle 6)

The HACCP plan must identify the verification activities designed to demonstrate that the HACCP controls are implemented effectively. Processors are required to have two types of ongoing verification procedures:

a) Records of the monitoring actions for CCPs critical limits and corrective actions taken must be verified at an established frequency to confirm that they are occurring as described in the QMP plan.

b) For each monitoring procedure there must be verification procedures in place to ensure that the control measures implemented at each CCP are adequate and effective.

• For shellfish that is delivered to registered establishments by harvesters, procedures must be in place to verify that harvest area information on tags and/or information provided by the harvester is accurate.
• Microbiological analysis, at specified frequencies, is required for shellfish before and after depuration, and for shellfish after relay if the relay period is less than 21 days.
• For depuration systems or on shore wet storage systems where water treatment is required, microbiological analysis of water is required to verify the ongoing effectiveness of the treatment system.
• For filtration systems that are used to remove toxic phytoplankton, biotoxin analysis of shellfish is required.

Note: Re-validation is required after any alteration to the treatment system or a change in source water is made.

More detailed information on verification can be found in Appendix G of the QMP Reference Standard, Guidelines for the Verification and Maintenance of the QMP.

2.9 Establish documentation concerning all procedures and records appropriate to these principles and their application (Principle 7)

Some examples of documentation and records that may be part of a shellfish QMP or be readily available (internet access) include:

• for shellfish harvested from a WWTP conditional area, a copy of the conditional management plan;
• for shellfish harvested under a MCFR licence, a copy of the decontamination plan;
• supplier Quality Assurance (SQA) agreements;
• records of all testing, measurements, and monitoring at CCPs;
• records of all corrective actions when the critical limits are exceeded;
• records of all verification activities;and
• records of wet storage history.
• growing area documents showing where shellfish are harvested; and

current DFO shellfish prohibition orders which delineate what areas are closed to shellfish harvesting.

Appendix I - Guidelines on the Control Measures for Preventing the Contamination and Growth of Listeria Monocytogenes

PDF (309 kb)

Table of Contents

1. Purpose
2. Scope
3. References
4. Guidelines
   • 4.1 The Biological Hazard Listeria Monocytogenes
   • 4.2 Control Measures for Listeria Monocytogenes
     • 4.2.1 Knowledge and Identification of Factors Required for Establishment Specific Control Measures
     • 4.2.2 General Control Measures - Linkages between HACCP, Supporting Programs [Prerequisites, Regulatory Action Points (RAP) and SOPs], and Control Measures
     • 4.2.3 Product Related Control Measures
     • 4.2.4 Process Related Control Measures
     • 4.2.5 Establishment-Related Control Measures
   • 4.3 Verifying Control Measures

1. Purpose

This document provides guidelines for federally registered establishments with respect to the requirements set out by the Quality Management Program (QMP) Reference Standard and their application to prevent the contamination and growth of Listeria monocytogenes in RTE fish products.

2. Scope

These guidelines are to be considered by operators of federally registered fish processing establishments who produce RTE fish products subject to the Health Canada Policy on L. monocytogenes in RTE foods as part of their requirement to design, implement and maintain a QMP Plan that meets the requirements of the QMP Reference Standard.

3. References

Canadian Food Inspection Agency (2005) Fish Products Standards and Methods Manual (FPSMM)

Canadian Food Inspection Agency (2010) Food Safety Facts on Listeria

Canadian Food Inspection Agency (2011) Process Control Document Requirements

Codex Alimentarius Commission (CAC/GL 61-2007) Code of Hygienic Practice for Refrigerated Packaged Foods with Extended Shelf life (accessed May 10, 2011)

Health Canada, (2010) Policy on Listeria monocytogenes in Ready-to-Eat Foods (2011), (Hereafter referred to as the "HC Listeria Policy")

Huss, H. H. et al. (2000) Control Options for Listeria Monocytogenes in Seafoods. International Journal of Food Microbiology 62:267-274

National Fisheries Institute and National Food Processors Association Smoked Seafood Working Group (2002). Listeria Monocytogenes Control Manual, Draft 9

Tompkin, R.B. et al. (1999) Guidelines to Prevent Post-Processing Contamination from Listeria Monocytogenes. Dairy, Food and Environmental Sanitation 19(8):551-562

Tompkin, R.B. (2002) Control of Listeria Monocytogenes in the Food Processing Environment. Journal of Food Protection 65(4):709-725

US Food and Drug Administration, Center for Food Safety and Applied Nutrition (2008). Guidance for Industry: Control of Listeria Monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods; Draft Guidance

4. Guidelines

4.1 The biological hazard L. monocytogenes

L. monocytogenes is a pathogenic bacteria commonly found in the environment that can cause Listeriosis, an illness that can lead to death. Healthy adults and children can develop Listeriosis, but it is more likely to develop amongst pregnant women, the elderly (>60 years old) and immuno-compromised individuals (e.g., cancer patients, people affected with the Acquired Immune Deficiency Syndrome (AIDS), people with liver problems, etc.). Food products contaminated with L. monocytogenes at levels exceeding 100 CFU/g (of bacteria per gram of product) have been implicated in outbreaks of Listeriosis. L. monocytogenes is normally destroyed by cooking therefore, only ready-to-eat (RTE) products are considered a risk for contamination with L. monocytogenes since these products are intended for consumption without additional cooking.

L. monocytogenes is a unique food pathogen that can grow at refrigeration temperatures, is found everywhere in the environment and has a high tolerance to salt. Contamination of the incoming materials, growth of the pathogen during processing and/or during storage of the final product, as well as cross-contamination during processing must all be considered as potential hazards when conducting the hazard analysis of a RTE product as part of the Hazard Analysis Critical Control Point (HACCP) component of the Quality Management Program (QMP).

These hazards must be addressed through the application of Critical Control Points (CCPs) or enhanced control measures in the prerequisite programs and associated Standard Operating Procedures (SOPs). An establishment is required to document all CCPs and control measures in their HACCP plan and other relevant sections of the QMP plan.

When a final product supports the growth of L. monocytogenes, the use of a regular prerequisite program is not sufficient to prevent cross-contamination and pathogen growth in the final product. CCPs and/or enhanced control measures must be included to address the risks associated specifically with L. monocytogenes.

4.2 Control Measures for "Listeria monocytogenes"

Control measures for L. monocytogenes are implemented to prevent, eliminate or reduce L. monocytogenes to an acceptable level as well as control and prevent conditions that will enable growth and/or contamination. Prerequisite programs, sanitation and employee training are essential in controlling L. monocytogenes and preventing recontamination. Controlling the presence of L. monocytogenes in the environment will reduce the risk of contamination.

Establishments producing RTE foods must implement controls to ensure that their products are in compliance with the L. monocytogenes guidelines for fish and fish products (Appendix 2, FPSMM). Control measures should be developed using regulatory requirements and relevant scientific information from current literature. Assistance from recognized authorities (e.g., processing experts) is recommended to obtain and evaluate this information given that, ultimately, it is the responsibility of the processor to demonstrate that such control measures will reduce the risk to an acceptable level.

The control of L. monocytogenes is product, process and establishment specific (National Fisheries Institute, 2002). The history of known contamination in an establishment should be considered when designing control measures.

The following control measures are recommendations. Processors may use other control measures, provided they validate and verify the effectiveness of the control measures and critical limits.

4.2.1 Knowledge and identification of factors required for establishment specific control measures

Knowledge specific to the process flow of the establishment, product characteristics, method of product manufacturing, processes such as lethality treatments, equipment and the establishment structure should be acquired to:

• determine the applicable RTE product category as per the Health Canada Listeria Policy; (see Appendix 2 of the Fish Products Standards and Methods Manual
• identify the impact of each location and step in the process on the pathogen content of the food (includes areas in the product flow that pose the greatest risk of product contamination, areas that are difficult to clean); and
• establish effective control measures for L. monocytogenes.

The identification of establishment specific factors that pose potential risk of contamination is important for these factors to be managed by the control measures. Problems with respect to L. monocytogenes (e.g., potential signs of a control measure not working resulting in a loss of control) and the appropriate response should be identified.

4.2.2 General Control Measures - Linkages between HACCP, Supporting Programs [Prerequisites, Regulatory Action Points (RAP) and SOPs], and Control Measures

QMP supporting programs (i.e. Background Product and Process Information, Prerequisite Program, RAP and associated SOPs) provide ongoing support for the HACCP system and the production of safe food. Compliance to supporting programs provides the basic operating conditions and processing environment required to ensure the HACCP plan is effective.

The intent of HACCP is to focus control at Critical Control Points (CCPs). Therefore programs to support the HACCP systems must be effective in achieving their intended purpose related to food safety. These programs support the HACCP system in practice by:

• functioning as intended, especially at CCPs;
• preventing contamination (pest control, construction and equipment maintenance, employee hygiene, etc.);
• achieving their food safety objectives; and
• assuring effective treatments (e.g., equipment functions as intended).

The Prerequisite Program and associated SOPs provide protection from hazards from the surrounding environment, and keep low-risk potential hazards from becoming serious problems that could adversely impact on food safety. The RAP plan identifies processing steps where control measures are applied to ensure that the product complies with the Fish Inspection Regulations (FIR).

4.2.3 Product Related Control Measures

Incoming Materials

Control of incoming material is essential to ensure a final product is safe for human consumption. Incoming materials must be separated from the semi-finished and finished products. RTE food processors should implement procedures that are validated and verified to eliminate or reduce L. monocytogenes in incoming materials.

Recommended procedures include, but are not limited to:

• separating incoming materials from semi-finished and finished products;;
• sourcing from reputable supplier(s);
• monitoring the temperature of incoming materials;
• handling and washing of incoming materials; and
• testing and verifying initial load of bacteria.

Product Formulation:

Control of product formulation is essential to ensure that the enhanced control measures, CCPs and associated critical limits address the risk of L. monocytogenes.

In accordance with the HC Listeria Policy, safety parameters such as pH, salt content or water activity (a_w) can be used to control microbial growth in a variety of RTE foods. Establishments may consider adjusting these product characteristics based on scientific information or expert advice to reduce or eliminate growth of L. monocytogenes. A RTE product will not support growth of L. monocytogenes when:

• pH <4.4 regardless of a_w
• a_w <0.92 regardless of pH or
• factors are combined approximately (e.g., pH <5.0 and a_w <0.94).

Food Additives and/or Processing Aids

Certain food additives and processing aids may be used as a control measure to limit or inhibit the growth of L. monocytogenes in specific foods.

Health Canada's Lists of Permitted Preservatives identify which preservatives are legally permitted for use on fish and fish products and their maximum levels of use. The Health Canada table of Food Additives that May Currently be Used as Class 2 Preservatives to Potentially Control the Growth of Listeria monocytogenes in Ready-to-Eat Foods Sold in Canada identifies which approved preservatives have been demonstrated to potentially control the growth of L. monocytogenes in ready-to-eat foods. Appendix C of the Health Canada Policy on Listeria monocytogenes in Ready-to-Eat Foods (2011) offers additional information on anti-listerial treatments for ready-to-eat foods.

Processing aids are not subject to mandatory pre-market approval however their use must be consistent with that of a processing aid and not that of a food additive. Health Canada's Policy for Differentiating Food Additives and Processing Aids provides guidance for determining whether a substance is a food additive or a processing aid in a given context of use.

Freezing of Finished Product

The growth of L. monocytogenes is inhibited at freezing temperatures; therefore, freezing can be used as a control measure to prevent pathogen growth. In this case, the product label must have the statement "Keep Frozen" on the principal display panel. The temperature of the freezer storage area in the establishment must also be monitored to prevent temperature abuse which could result in the partial or complete thawing of the product which could allow L. monocytogenes to grow.

Restricting the Refrigerated Shelf Life of the Finished Product

The processor is responsible for establishing a product shelf life and must validate that the product will remain safe for consumption for the duration of the stated shelf life. To establish a safe shelf life, scientific evidence can be obtained from a recognized authority in the form of a product-specific reference or challenge study on the probable survival and growth of L. monocytogenes.

The duration of a product's shelf life is affected by many factors including product characteristics (a_w, pH, intrinsic microbiology), use of additives, temperature exposure during processing, packaging, post-lethality treatments and final product storage conditions (refrigeration, freezing).

L. monocytogenes can grow at refrigeration temperatures. Depending on the combination of factors for a particular product, establishments may need to restrict the refrigerated shelf life to ensure product safety. Reducing the refrigerated shelf life of RTE products ensures there is insufficient time for pathogen growth to exceed the L. monocytogenes guidelines (Appendix 2, Fish Products Standards and Methods Manual).

4.2.4 Process-Related Control Measures

Temperature/Time Controls During Processing

The proliferation of L. monocytogenes can be reduced by controlling the amount of time (from successive processing steps) that the product is exposed to temperatures which are optimal for the growth of this pathogen. Processors should focus on managing the time and temperature conditions for the actual product rather than the room temperature controls.

Lethality treatment ("kill step")

In general terms, thermal lethality refers to the ability of a heating process to kill bacteria and is typically expressed as the amount of time at a certain internal temperature necessary to achieve a given logarithm (log) reduction of a pathogen. Cooking, retort procedures and pasteurization are examples of lethality treatments or "kill steps".

A lethality treatment such as cooking is an effective control measure for L. monocytogenes. To be a valid lethality treatment, the cooking must result in a 5 log reduction or more of L. monocytogenes. The length of time at the designated internal product temperature needed to accomplish the 5 log reduction will vary depending on the product.

Because of the prevalence of L. monocytogenes, the potential for re-contamination following a kill step is quite high. Lethality treatments that do not occur in the final container must have additional control measures after cooking to prevent re-contamination. Lethality treatments in the final container must have control measures to address potential recontamination during cooling; water used for cooling can be a source of microbial contamination.

A lethality treatment in a process would constitute a Critical Control Point (CCP) which requires validation to demonstrate effectiveness against the target organism, in this case L. monocytogenes, and to show that the treatment results in the required amount of pathogen reduction. The kill step must be delivered consistently within critical limits and have monitoring procedures in place. It is recommended that establishments hire a competent authority to conduct validation studies and establish critical limits for lethality treatments. Establishments may also use reliable information obtained through literature searches, regulatory standards and guidelines to gain knowledge about the hazards of L. monocytogenes and effective critical control limits.

Containers, Packaging and Filling

Control measures must be in place to avoid possible contamination of the product during filling. Use of unsanitary equipment (e.g., spouts, dispensers) utensils or containers could re-introduce pathogens, particularly in RTE foods which receive no further heat processing (see Enhanced Sanitation Controls in 4.2.5).

Establishments may choose to use sterile containers or aseptic filling techniques as control measures to prevent the contamination or re-contamination of the final product. Aseptic processing and packaging involves putting a commercially sterile product in to sterile containers which are then hermetically sealed with a sterilized closure in a manner which prevents recontamination of the product. While effective for L. monocytogenes, aseptic techniques are highly complicated and even slight modifications or deviations from the prescribed process may have a significant impact on product safety. Aseptic processing and packaging techniques must be developed and validated by a competent authority.

Post-Process Lethality Treatments

Post-process lethality treatments are used to reduce or inactivate any L. monocytogenes which may be present on the final product as a result of post-process contamination.

Post-process lethality treatments are discussed in the HC Listeria Policy (Appendix C, Part ii). The effectiveness of different post-process lethality treatments (e.g., surface heat pasteurization, high pressure processing) varies depending on the product type. In most cases, proposed post-process treatments must undergo a comprehensive assessment and be approved by Health Canada prior to use.

4.2.5 Establishment-Related Control Measures

Prevention of Cross-Contamination

Cross-contamination can occur as a result of traffic flow (e.g., movement of people, equipment etc. in processing / packaging areas) or unscheduled maintenance. To prevent the reintroduction of L. monocytogenes into the processing environment, the control of cross-contamination is essential. Areas where the exposed food is most likely to be contaminated during the process flow should be assessed.

Identification of sanitary and/or restricted access zones will facilitate control of traffic flow patterns between the incoming ingredients and the processed product sides of the operation. Failure to establish and/or observe established traffic flow patterns, especially between processing and packaging areas, can transport L. monocytogenes back into a clean environment. The risk of contamination is highest between product cooking/pasteurizing and packaging.

Enhanced control measures and possibly CCPs are necessary to prevent cross-contamination given the prevalence of L. monocytogenes in the environment. Hand washing frequency, footwear cleaning protocols, outer clothing protocols and movement of carts and/or equipment between different processing areas are examples of measures that should be enhanced to ensure L. monocytogenes specific control measures.

Enhanced Sanitation Controls

L. monocytogenes is known to form biofilms, which are colonies of the bacterium attached to a surface and surrounded by a protective sheath of proteins and sugars. Biofilms are commonly found in niches such as closed systems, areas where moisture accumulates and between close fitting materials. As biofilms are more difficult to eliminate using basic cleaning and sanitization procedures, enhanced sanitation controls should be implemented specifically for L. monocytogenes and biofilms.

Enhancements to the sanitation controls include the use of different types of sanitizers on a rotational basis to prevent resistance. The periodic use of sophisticated detergents such as quaternary ammonium compounds or peracetic acids combined with mechanical action (i.e. scrubbing) will improve the removal of proteins, fats, and oils from equipment and other surfaces. The concentrations of sanitizers used and the length of time the sanitizer is left in contact with each surface type (food contact and non-food contact surfaces, floors, boots) should be in accordance to the manufacturer's instructions to achieving proper sanitation.

Sanitizing with high temperatures may be particularly useful for biofilms when manufacturers' instructions permit such application. Hot water and/or steam sanitation is an effective alternative to chemical sanitation and should be used as much as possible as a final step when equipment is difficult to clean.

Sanitation controls can be further enhanced by designating cleaning equipment (e.g., brushes, scrubbers and carts) for use only in specific areas where the risk of L. monocytogenes contamination and/or transport is the highest and ensuring that the equipment does not become a source of contamination by maintaining it in proper condition between uses and replacing it often.

Support equipment such as floor scrubbers, fork lifts, pallet jackets, wheeled trash bins etc. should be included in the cleaning and sanitization process. Equipment such as slicers or brining equipment and any equipment with removable parts should receive special attention.

The frequency of cleaning and sanitizing of the equipment and environment should be based on the history and microbiological data of each establishment. The use of an environmental sampling program allows an establishment to acquire sufficient information to develop a baseline, make comparisons over time, observe trends, and possibly identify the source of emerging sanitation problems.

Equipment Design and Maintenance

Due to the nature and prevalence of L. monocytogenes, equipment design and maintenance will require extra consideration for establishments processing RTE foods. Quality Control and sanitation personnel should be included in equipment design and purchase decisions.

Equipment should be designed to facilitate cleaning and minimize the potential for breakdowns. Processors should consider the ease of cleaning as well as compatibility with the cleaners and sanitizers that will be necessary to combat L. monocytogenes. They should also strive to prevent "harbourage sites", small niches where L. monocytogenes can persist and multiply, such as cracks, seams, drain covers or other sites where water and debris can collect.

Personnel Hygiene and Training Programs

While employee hygiene and training are covered in the Quality Management Program prerequisite programs, establishments need to identify the prevention and elimination of L. monocytogenes as an objective of their training program.

Control measures are more effective when personnel are trained to understand the necessity of the measures. Incorporating L. monocytogenes specific training and assessing the effectiveness of personnel training are ways to enhance the basic prerequisite programs.

Visitors, Maintenance and Cleaning Staff

Processors should ensure that visitors, maintenance staff and cleaners are made aware of the necessary hygiene requirements and consider the increased risk of contamination when unscheduled maintenance involves outside contractors.

4.3 Verifying Control Measures

Environmental sampling programs and product testing can be used to verify the effectiveness of the control measures.

Data obtained from an environmental sampling program helps identify the source of contamination when results are positive, which will enable timely corrective actions and trend analysis. The CFIA has produced Guidelines for the Development of an Environmental Sampling Program.

Product testing is a second option. While it may determine whether or not a product is contaminated, it will not provide any indication on the cause of contamination, which control measure should be improved, if a new measure should be added nor how to prevent future occurrences. In addition, when present, pathogens will not be distributed evenly within a product or a lot, therefore end-product testing alone cannot ensure product safety. Product testing will be most useful if restricted to verification of product-related control measures such as shelf life determination or assessing the effectiveness of additives.

Appendix J - Guidelines for the Development of an Environmental Sampling Program

PDF (59 kb)

Table of Contents

• 1. Purpose
• 2. Scope
• 3. Definitions
• 4. References
• 5. Guidelines
  • 5.1 Factors to consider when developing an environmental sampling program
    • 5.1.1 Type of RTE product
    • 5.1.2 Type of process/operation
    • 5.1.3 Consumer/Target groups
    • 5.1.4 Historical information
  • 5.2 Elements of an environmental sampling program
    • 5.2.1 The sampling procedures
    • 5.2.2 The testing method
    • 5.2.3 Target organism
    • 5.2.4 The sampling sites
    • 5.2.5 The sampling frequency
    • 5.2.6 Review
  • 5.3 Response to FCS samples testing positive for Listeria
    • 5.3.1 Corrective Actions
    • 5.3.2 Verification of the Corrective Actions
  • 5.4 Persistent Contamination
    • 5.4.1 Determining the Cause and Source
    • 5.4.2 Additional Corrective Actions
• 6. Listeria Environmental Sampling Program Checklist

1. Purpose

The purpose of this document is to provide guidelines with respect to design and implementation of an environmental sampling program for L. monocytogenes that meets the requirements of the Quality Management Program Reference Standard.

2. Scope

These guidelines are intended for federally registered fish processing establishments that produce Ready-to-Eat (RTE) fish products subject to the Health Canada Policy on Listeria monocytogenes in Ready-To-Eat Foods.

3. Definitions

Environmental sampling: Activity that consists of collecting environmental samples, i.e., samples of Food Contact Surfaces and Non Food Contact Surfaces, using swabs (e.g. sterile sponges or cotton swabs).

Food Contact Surfaces (FCS): Any surface or object that comes into contact with the RTE product (i.e. after the food has been subjected to some form of processing to render it RTE - e.g. cooking, smoking, etc.)

Listeria spp: The abbreviation "spp" means "species" and refers to any of the seven species in the genus Listeria.

Non-Food Contact Surface (Non-FCS): Any surface or object that does not normally come into contact with the RTE product (e.g., floors, ceilings, walls, drains, etc.).

Production Line: A number of pieces of equipment (e.g., slicers, tables, conveyors, packaging or filling machines) used in series in the post-lethality environment, as applicable, to prepare RTE foods for final packaging.

4. References

Listeria Environmental Sampling Program Checklist

Health Canada, Policy on Listeria monocytogenes in Ready-to-Eat Foods (2011), (Hereafter referred to as the "HC Listeria Policy")

Health Canada, Compendium of Analytical Methods, (Volumes 2 and 3)

Codex Alimentarius Commission (CAC/GL 61-2007) Guidelines on the application of general principles of food hygiene to the control of listeria monocytogenes in food. Annexes I and III.

Appendix 2 - Bacteriological guidelines for Fish and Fish Products of the Fish Products Standards and Methods Manual

5. Guidelines

An environmental sampling program is a verification tool by which the processing environment and equipment are tested for the presence of microorganisms to verify the effectiveness of the control measures used to eliminate sources of contamination.

The inclusion of an environmental sampling program as a monitoring procedure under the Sanitation and Personnel Hygiene sections of the Quality Management Program is strongly recommended in order to be able to adequately verify the effectiveness of the control measures in controlling Listeria spp. and potential sources of product contamination.

The test results from environmental sampling provide valuable information for establishing a frequency of cleaning and sanitizing which is adequate and determining which cleaning and sanitizing materials and methods are effective. Testing of the environment also provides information on the prevalence of Listeria spp. in the establishment which can be used as a baseline to identify trends over time and help identify the source of an emerging sanitation problem(s) which would require an increase, review or amendment in the sanitation control measures.

5.1 Factors to consider when developing an environmental sampling program

It is important for the personnel who develop and implement the environmental sampling program to have a strong knowledge of microbiology, as well as hygienic practices, aseptic techniques and food processes used in the establishment.

The environmental sampling program needs to be reflective of the risk to consumers if the RTE product becomes contaminated. The following factors need to be considered and the thought process documented when developing each element of an environmental sampling program:

5.1.1 Type of RTE product

The characteristics of the RTE foods produced and whether or not it supports the growth of L. monocytogenes – category 1, 2a or 2b;

5.1.2 Type of process/operation

The processing steps (e.g., L. monocytogenes lethality step, addition of growth inhibitors, pH adjustments, freezing, etc.) and the likelihood of cross-contamination with L. monocytogenes, based on the layout of the facility, the design of the equipment, the product flow, the employees flow, the use of restricted movement of workers or sanitary zones, etc.

5.1.3 Consumer/target groups

The likely consumers of the RTE product. Some groups of the population such as the elderly, pregnant women and immunocompromised individuals are much more at risk if exposed to L. monocytogenes.

5.1.4 Historical information

Test results collected over time constitute an important source of knowledge on the history of the presence of Listeria in the processing environment. This data will facilitate the analysis of trends (in terms of potential sources of contamination, fluctuations over time, etc.) and can be used to improve Listeria controls.

5.2 Elements of an environmental sampling program

5.2.1 The sampling procedures

A description of the sampling materials (sterile swabs or sponges) used and how they are handled, the procedures used to collect samples from the environment, the personnel training, and a description of how the collected samples are handled, labelled, stored and shipped for testing. The method recognized by the Canadian Food Inspection Agency (CFIA) for conducting environmental sampling, MFLP-41, can be found in Health Canada's Compendium of Analytical Methods.

5.2.2 The testing method

A description of the method used to test for Listeria spp. The methods recognized by the CFIA to test for the presence of Listeria spp. can be found in Health Canada's Compendium of Analytical Methods. Note that the methods to be used must fit the intended purpose. The CFIA recognizes the results of testing conducted by laboratories accredited under ISO/IEC 17025. The testing method may use composite sampling, when validated, by which up to 10 environmental samples of the same type (FCS or Non-FCS) may be combined and tested as one composite sample.

5.2.3 Target organism

A description of the microorganisms the samples are tested for. In the case of an Environmental Sampling Program for Listeria spp., including L. monocytogenes, the samples would be tested for all Listeria spp.. Monitoring the processing environment for the presence of all Listeria spp. may provide a better indication of the effectiveness of the control measures in place than would testing for L. monocytogenes alone.

5.2.4 The sampling sites

A description of the sites which are to be sampled per production line based on the process flow chart, traffic flow and critical control points.

The sampling sites consist of Food Contact Surfaces (FCS) and Non-Food Contact Surfaces (Non-FCS). These sites need to be identified on a schematic of the process flow for each RTE production line. Examples of FCS and Non-FCS are provided in MFLP-41. Testing Non-FCS is a valuable tool to detect potential sources of contamination in the plant before it expands to FCS and becomes a risk to consumers.

Sponge or swab samples should be collected, per production line, from at least 10 surfaces that come into contact with the exposed foods before final packaging. A reduced number of sites could be used if there is a rationale for it (e.g., RTE food exposed to the environment only in a very limited number of steps and/or areas). Follow the instructions included in MFLP-41.

5.2.5 The sampling frequency

A description of when and how often environmental samples are taken.

Samples from the surface areas of equipment should be collected during production, typically after 3 hours of start up operation. Samples can also be collected before operation, to focus more specifically on the effectiveness of the cleaning and sanitation procedures applied at the end of a shift. The sampling frequency recommended, per production line, based on 5 production days per week is:

• Once per week for category 1 products
• Every other week for category 2A products
• Once per month for category 2B products

When sufficient data has been compiled, a trend analysis, along with a review of the sampling frequency and the number and location of sites should be conducted to identify any gaps in the program, as well as areas that need improvement.

Special circumstances such as construction in the facility, or the installation of previously used or modified equipment, can compromise Listeria control. In circumstances like these, an increase in the frequency of sampling or in the number of sample sites may be warranted.

5.2.6 Review

A description of the process followed to review the suitability of the sampling sites selected and the sampling frequency. The sites selected are subject to review, on a regular basis, to ensure that the they are adequate in verifying the effectiveness of the Sanitation Program in eliminating L. monocytogenes from the processing environment. This includes provisions for when major changes or disruptions take place (e.g., construction, installation of new or modified equipment, major maintenance, unusual weather events, etc.), which could result in the loss of control for Listeria.

An example of an Environmental Sampling Program is provided in Listeria Environmental Sampling Program Checklist

5.3 Response to FCS samples testing positive for Listeria spp.

A description of the process followed in response to the presence of Listeria spp. on a FCS sample.

5.3.1 Corrective actions

A description of the corrective actions to be taken to eliminate the source of contamination depending on:

1. whether this is a first or persistent finding;
2. the type of sample in which Listeria spp. was detected (i.e. FCS or Non-FCS);
3. the category of the food processed by the establishment; and
4. whether L. monocytogenes or Listeria spp. has been detected.

Examples of appropriate corrective actions which would be expected, after the initial finding of Listeria spp. on a FCS sample, include but are not limited to:

• increased, intensified cleaning and sanitizing;
• equipment disassembly (beyond FCS if applicable);
• correction of sanitation design, address any required corrective measures;
• consultation with chemical supplier to determine if chemicals used are appropriate (concentration, contact time, water temperature) and which alternate sanitisers can be applied;
• determining through observations and/or employee interviews whether sanitation and operations procedures are being adhered to, and if not, correcting the situation;
• review of process flow and plant floor diagram to ensure that the potential for cross-contamination is controlled;
• review of the sanitary control measures to prevent cross-contamination (e.g. restrict employees flow, establish sanitary zones, etc.).

5.3.2 Verification of the Corrective Actions

A description of the process for verifying the effectiveness of the corrective actions taken, which includes taking new FCS samples from the same FCS as soon as possible within 5 production days after Listeria spp. were detected. The samples are to be tested individually (no composite) to verify the effectiveness of the corrective actions in eliminating the source of contamination. The following should also be implemented:

A) Line producing Category 1 RTE products

The holding of Category 1 RTE products produced during this sanitation shift.

Negative FCS results:

• The release of Category 1 RTE products held.

Positive FCS results:

• Determining the cause and source of persistent contamination in order to take new corrective actions.
• Refer to section 5.4.

B) Line producing Category 2 RTE products

Positive FCS results:

• Taking additional corrective actions.
• Taking new FCS samples after the new corrective actions have been completed.
• Holding Category 2 RTE products produced during this sanitation.

If the FCS are found positive again for Listeria spp.:

• Determining the cause and source of persistent contamination in order to determine the new corrective actions to be taken.
• Refer to section 5.4.

5.4 Persistent Contamination

A description of the process followed when Listeria spp. is detected on the follow-up FCS samples taken after the corrective actions.

5.4.1 Investigation

Determining the cause and source of persistent contamination by conducting an in-depth review of the control measures in place for eliminating and preventing the growth of Listeria in the processing environment which may include but is not limited to:

• additional FCS sampling to identify the exact sources of contamination;
• review of the written Sanitation program - has anything changed (i.e. new staff, different cleaning chemicals, new equipment, etc.)?
• on-site observation of cleaning and sanitizing procedures, with particular attention to areas identified as positive for Listeria spp. What tools/equipment are being used? Are they used appropriately? Are written procedures being followed - if yes, are they effective? Are the chemicals identified in the written plan being used and are they mixed properly and applied according to manufacture's instructions?
• discussion with sanitation crew - do they have any ideas on what may be resulting in the contamination; have they noticed anything different; has there been a change in shift or members of the crew?
• review of previous weekly and monthly test results (trend) in relation to the product and environmental swabs - are there any trends that could identify a possible source or reason for positive result(s)? Does the sampling frequency need to be increased? Are the sampling sites adequate?
• historical perspective - has this happened before? Where? When?
• what product may be affected - scope (how many days production since last negative result; status of inventory and shipments for period in question; shipping data, etc.);
• review of the HACCP plan including the process and product flow (sources of cross-contamination);
• review of the controls for incoming material and ingredients;
• review of the equipment design.

The CFIA should be contacted for assistance with determining the potential causes for the contamination and the additional corrective actions needed to address the situation.

5.4.2 Additional Corrective actions

• The testing of products, which were held when the follow up FCS samples were taken, for L. monocytogenes using appropriate procedures and methods. Approved methods can be found in the Health Canada Compendium of Analytical Methods.
  The "application" section of the method chosen must be appropriate for the intended purpose.
  • Notifying the CFIA when FCS samples were taken, if L. monocytogenes is detected in a Category 1 RTE product or exceeds 100 CFU/g in a Category 2 RTE product.
• For plants producing Category 1 products, the hold and testing of products for L. monocytogenes and FCS for Listeria spp. (including L. monocytogenes) until they are found to be compliant for at least three consecutive production days.
  • Taking additional corrective actions each time Listeria spp. are detected in follow-up FCS samples.
  • Notifying the CFIA when FCS samples were taken, if L. monocytogenes is detected in a Category 1 RTE product or exceeds 100 CFU/g in a Category 2 RTE product.

6. Listeria Environmental Sampling Program Checklist

Appendix K - Guidelines on measures to control the risk of Vibrio parahaemolyticus in live oysters

PDF (261 kb)

Purpose

The purpose of this document is to provide information on options for controlling the risk of Vibrio parahaemolyticus (Vp) in live oysters. This will help federally registered establishments and importers understand and control the risk of Vp in oysters they process or import for raw consumption. This document covers some generic best practices and example control measures. It is not intended as an exhaustive list of measures. Always ensure that the control(s) chosen are tailored to the uniqueness of your business and shown to be effective for your situation.

Requirements for controlling the risk of Vp

If you are a federally registered establishment, you are required to do the following:

• Do a hazard analysis on the processing of live oysters in your establishment.
• Implement control measures to prevent or eliminate the significant hazards identified so that the oysters meet the Canadian guideline for Vp found in Appendix 2 - Bacteriological Guidelines for Fish and Fish Products (end product).

If you are an importer, you are required to understand the risk(s) associated with the oysters you import. You must do the following:

• Take appropriate actions to source product only from suppliers that can provide assurances that the oysters meet the Canadian guideline for Vp.
• Ensure proper temperature control during the transportation and storage of your oysters.

Understanding Vp

3.1 Why Vp is a hazard in live oysters

Vp can cause food-borne illness in humans.

• Vp is a food-borne pathogen that is commonly found in shellfish such as oysters.
• Vp has been linked to gastroenteritis ("stomach flu") outbreaks associated with people consuming shellfish that is raw or insufficiently cooked.

3.2 How oysters can become contaminated with Vp

Vp is a naturally occurring bacteria found in estuaries throughout the world.

• It is known to occur in some Canadian coastal waters.
• It can be present in shellfish growing areas, regardless of their regulatory classification as suitable for the harvesting of shellfish according to accepted water quality standards and general sanitary conditions in the shellfish area.

3.3 When can Vp levels increase to an unacceptable level in the harvest sites?

The level of Vp in the harvest waters can change quickly. This is due to a variety of factors such as a rise in temperature, heavy rainfall, flood or plankton blooms.

• Vp levels in shellfish harvest sites are at their highest:
  • during summer months
  • at the end of the low tide cycle after the oysters are out of the water and have been exposed to the warm air and the sun.
• Vp can multiply rapidly in live oysters in their marine environment. It can increase in numbers to a level that cause gastroenteritis when the water temperature is at 15°C or higher.
  • Vp is at its highest level during the warmer months. It is present in Canadian Pacific and Atlantic waters, usually from June until September. But it has been detected in the Pacific Ocean in May and October.
  • Oysters completely submerged in deep water have also been found to have Vp levels that greatly exceed Canadian guidelines. This is likely due to the growth of Vp in the warmer marine environment.
• Vp has been found to attach itself to zooplankton. When zooplankton increases in the water as the temperature rises, Vp levels in the waters can also increase.

3.4 Factors favourable to the growth of Vp

• Vp can grow:
  • in the water and oysters at the harvest areas when:
    1. the water temperature is 15°C and above
    2. the water salinity is between 0.5% and 8%.
  • in harvested oysters that are maintained at a temperature of 5°C or higher. Vp can double in number in under 2 hours when the oysters are maintained at 25°C
  • in final oyster products that have a pH of 4.8 or higher or a water activity of 0.93 or higher.

Controlling the risk of Vp in live oysters

4.1 Control the risk of Vp at the harvest site

Vp is a significant hazard when detected in the oysters at a harvest site and:

• the levels are persistently near or exceed the limit set by the Canadian guideline for Vp in the oysters, or
• the water temperature is 15°C or higher

Measures are needed at harvest to ensure that the oysters that will be harvested meet the Canadian guideline for Vp.

The following are example measures that could contribute to acceptable levels of Vp in oysters at harvest time. You can use these alone or in combination.

• Monitor the water temperature in the harvest sites, at the same area and level where the oysters are. This will help determine the site-specific season for Vp becoming a significant hazard in a given harvest area.
• When the water temperature rises to 15°C or above during Vp season, and when weather conditions are favorable to the growth of Vp, consider the following:
  • Test levels of Vp in oysters regularly at the harvest sites, at a frequency that provides reasonable assurance that oysters harvested would meet the Canadian guideline for Vp.
    • Base the frequency of Vp testing on an assessment of the combined factors that influence the level of Vp such as the water temperature, air temperature, water salinity, and water depth.
    • Sample several oysters. Because Vp levels can vary, broad sampling will give you test results that better reflect the levels that would be found in the oysters in the harvest site.
    • Do additional oyster testing when:
      1. there is a change in the conditions that affect the Vp level (such as storms, dredging, construction, accidents)
      2. Vp illnesses have been reported.
      3. Vp levels are persistently near or exceed the limit set by Canadian guideline for Vp.
    • Take samples that are representative of the lot, location and method of harvest. Take the samples consistently.

      Examples on how to achieve this include the following:

      • For deep water harvest sites (10 to 30 feet below surface), take samples of oysters closest to the surface so that the sample represents the worst case scenario.
      • When both deep water and beach/intertidal oysters are harvested from a site, take a sample that represents the "worst case scenario" from both areas of the site.
      • Take 10 to 12 oysters per sample.
    • Cool the samples rapidly, maintain them at a temperature below 4°C and send them to the laboratory for testing within 24 hours.
  • Harvest oysters from intertidal or beach harvest sites only:
    • When Vp test results meet the Canadian guideline for Vp and are low enough to account for the potential growth that can occur in the oysters after harvest.
    • On a high tide, a receding tide or after the incoming tide has covered the oysters long enough so that the temperature of the oysters is at its lowest

When the level of Vp in the oysters is close to or exceeds the Canadian guideline for Vp you may apply measures to reduce the Vp level as long as they are validated to be effective in reducing Vp to an acceptable level. The following are examples of measures that may be considered:

• Re-submerging the oysters for the number of tidal cycles determined to be effective.
• Placing the oysters in cool water during wet storage or relay.

4.2 Control the risk of Vp after harvest

The presence of Vp in oysters is a significant hazard when the temperature of the oysters or surrounding air after harvest and during handling, storage and transportation become favorable to its growth. Measures are needed after harvest to prevent the growth of Vp. These focus on controlling temperatures.

The following are examples of measures that could prevent Vp from increasing to an unacceptable level in the oysters after harvest. You can use them alone or in combination,

• Cover the oysters onboard the harvest vessel with ice slurry immediately after harvest to reduce the internal temperature of the oysters to 4°C. Place the oysters in a refrigerator at 4°C or lower within 5°hours of harvest.
• The cooling measures need to take into consideration the temperature of more than one oyster at more than one area within the middle of the lot and the surrounding air.
  • When the water or oyster temperature is 15°C or higher, the cooling measures should reduce the internal temperature of the oysters to 10°C within 20 minutes.
  • When the water or oyster temperature is 15°C or lower, the cooling measures should reduce the internal temperature of the oysters to 10°C within 3 hours of harvest.
• Maintain the internal temperature of oysters at 4°C or lower during transportation.
• Place the oysters uniformly in a refrigerated transport truck to allow air circulation for more effective cooling. If using an unrefrigerated transport truck, place the oysters in insulated containers with flake/slush ice for transport
• Protect the oysters from exposure to the sun.

4.3 Control the risk of Vp during wet storage or relay

When Vp is present in the waters used for wet storage or relay, or present in the oysters placed there, it is a significant hazard if the conditions become favorable to its growth. To prevent the growth of Vp, use measures similar to those applied at harvest (see section 4.1).

If you use wet storage or relay to reduce the level of Vp in oysters, you must do this in accordance to the requirements outlined in chapter 5 and 10 of the Canadian Shellfish Sanitation Program and the methods must be validated as effective in reducing Vp to an acceptable level.

4.4 Control the risk of Vp at the receiving step

The presence of Vp in oysters should have been controlled by measures taken during and after harvest. If these measures are not implemented directly by you, Vp is a significant hazard in the oysters received. Measures are then needed at the receiving step to prevent oysters with an unacceptable Vp level from being received for processing as live oysters.

The following are examples of measures you could use to prevent receiving oysters that have an unacceptable Vp level. You can use them alone or in combination.

• Have in place a Supplier Quality Assurance Agreement with the independent harvesters or aquaculturists that outlines:
  • the control measures they implement at the harvest sites and after harvest to ensure that the oysters comply with the Canadian guidelines for Vp, and
  • the process to notify you when there is information that indicates the oysters you received may have an unacceptable Vp level.
• Measure and record the internal temperature of the oysters received.
  • Accept only oysters which have been rapidly cooled to an internal temperature of 10°C or lower.
• Get a copy of the records which demonstrate that the oysters comply with the requirements of the SQA. For example, records of temperature and Vp levels at the harvest sites and records of the time and temperature controls measured after harvest. Do this for each lot of oysters you receive.
• Store oysters received at 4°C or lower.

4.5 Control the risk of Vp during processing at the establishment

Vp is a significant hazard during processing when the oysters are exposed, for a prolonged period, to a temperature favorable to its growth.

Measures are needed during processing to prevent the growth of Vp.

The following are examples of measures that could prevent Vp from increasing to an unacceptable level in oysters during processing.

• Maintain the oysters at a temperature of 10°C or lower for the duration of the processing steps.
• Control the cumulative duration of exposure to temperatures above 10°C in the processing environment to no more than 3 hours.
  • Record the time and temperature at the start of each processing step.

Verifying your control measures

You must routinely verify that your control measures are being implemented as you intended and that they are effective. Verification activities are typically carried out by someone other than the person in charge of monitoring. You must document your verification activities.

Examples of verification activities include the following:

• Review records to make sure they are being completed and that the critical limits are being met consistently.
• Interview and observe staff (for example at the cooling shellfish step) to make sure they understand the procedures and that they are following them correctly.
• Take measurements to confirm that you are operating within your pre-defined time/temperature limits. These include time and temperatures checks, additional to those done during monitoring if applicable.
• Follow the verification procedures described in your Supplier Quality Assurance agreement (if you have one), for example:
  • Review aquaculturists or harvesters' records.
  • Inspect products and materials (for example, how product is stored and maintained at cold temperatures).
  • Sample products at supplier and analyse for Vp.
  • Observe how procedures are followed and interview staff.
• Test the oysters at a set frequency and at specific steps of the process, to verify that they comply with the Canadian guidelines for Vp.
  • Note that the methods recognized by the Canadian Food Inspection Agency (CFIA) for decision making can be found in Health Canada's Compendium of Analytical Methods.
  • As per the Policy on the Use of Third Party Laboratories for Testing Fish and Fish Products Under the Fish Inspection Program, the CFIA recognizes the results of testing conducted by laboratories accredited under ISO/IEC 17025.

Depending on the risk, you may need to do different verification activities at different levels of frequency. You should increase the monitoring and verification frequency when operational conditions change (for example, change in production volume, fluctuating weather, rapidly increasing water and air temperatures), or when Vp illnesses are known to be occurring in your region. This will confirm that control measures are continuing to be practical and effective.

Changes to your control measures must be validated following one or a combination of approaches as illustrated in Codex guidance and Appendix L of the QMP reference standard on HACCP Validation of Controls for Vibrio parahaemolyticus.

References

1. U.S. Food and Drug Administration. 2014. The Bad Bug Book. http://www.fda.gov/Food/FoodborneIllnessContaminants/CausesOfIllnessBadBugBook/
2. Nordstrom, J. L., C. A. Kaysner, G. M. Blackstone, M. C. L. Vickery, J. C. Bowers, and A. DePaola. 2004. Effect of Intertidal Exposure on Vibrio parahaemolyticus Levels in Pacific Northwest Oysters. Journal of Food Protection, Vol. 67: 2178-2182.
3. Buenaventura, E., K. Schallié, et al. 2000. Study presented at 2001 Pacific Fisheries Technologist conference in LaPaz, Mexico.
4. Herwig, R. P. and D. P. Cheney. 2000. Presented at the April 2000 Pacific Rim Shellfish Sanitation Meeting, Oregon.
5. Food and Agriculture Organization of the United Nations. 2010. Codex Guidelines on the Application of General Principles of Food Hygiene to the Control of Pathogenic Vibrio species in Seafood (CAC/GL 73-2010). www.fao.org/input/download/standards/11565/CXG_73e.pdf
6. European Commission. September 2001. Opinion of the Scientific Committee on Veterinary Measures relating to Public Health on Vibrio vulnificus and Vibrio parahaemolyticus (in raw and undercooked seafood).
7. Food and Agriculture Organization of the United Nations. Fisheries Technical Paper No. 444. 2004. Assessment and management of seafood safety and quality. ftp://ftp.fao.org/docrep/fao/006/y4743e/y4743e00.pdf
8. International Commission on Microbiological Specifications for Food (ICMSF). 1996. Micro-Organisms in Foods 5.
9. Connecticut Department of Agriculture, Bureau of Aquaculture. March 21, 2015. USA Techniques and Practices for Vibrio Reduction: Connecticut Final Report to the Interstate Shellfish Sanitation Conference.
10. Government of Canada. Fish Inspection Regulations (C.R.C., c. 802)
11. US Food and Drug Administration. National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish: 2013 Revision Section IV. Guidance Documents, Chapter IV: Naturally Occurring Pathogens, .01 Vibrio parahaemolyticus (V.p.) Control Plan Guidance. http://www.fda.gov/Food/GuidanceRegulation/FederalStateFoodPrograms/ucm2006754.htm
12. USFDA Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition, Chapter 12, Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM252415.pdf
13. Food and Agriculture Organization of the United Nations. Codex Guidelines for the Validation of Food Safety Control Measures (CAC/GL 69 - 2008).

Appendix L - HACCP Validation of Controls for Vibrio parahaemolyticus

PDF (245 kb)

Purpose

The main purpose of this document is to illustrate the application of the Codex Guideline for the Validation of Food Safety Control Measures (CAC/GL 69-2008) as it relates to Vibrio parahaemolyticus in bivalve shellfish. The Codex validation guidelines are comprehensive in nature and describe the interrelationships between validation, monitoring, and verification. Therefore, it is recommended to read and understand those concepts prior to reading this document.

Process Design and Control – Microbiological – Vibrio parahaemolyticus (Vp)

The following provides an example only of how validation of a process designed to control Vp might be structured. The technical details in this document are not exhaustive. The use of scientifically valid experimental data or harvest to shipping validation studies under controlled conditions (collecting and analyzing one's own scientific data) to demonstrate the adequacy of the control measures is required.

I. Tasks Prior to Validation of Control Measures

1. Description of the food commodity:

a) Product Name:

Live Oysters

b) Source of Raw Material:

Oysters harvested from shellfish areas classified as approved or conditionally approved in subarea XX-XX; landfile # 1234, lease 9876, BC, NB, PE, NS

c) Important Product Characteristics

Needs refrigeration

d) Ingredients

No ingredients

e) Product Packaging

Mesh bags, waxed cardboard boxes

f) End Product Use

Consumed raw

g) Product Shelf Life

7-14 days, refrigerated

h) Where the Product will be sold

Retail stores and restaurants, in Canada

i) Labelling Instructions Related to Food Safety

Keep refrigerated: < 5°C

j) Special Distribution Controls

Keep refrigerated: < 5°C

2. Hazard to be controlled:

Vibrio parahaemolyticus

3. Intended outcome:

To ensure that the controls to manage the risk of Vibrio parahaemolyticus in live oysters are effective and that products meet the CFIA bacteriological guideline for Vibrio parahaemolyticus.

4. Control measure(s) (process design) to be validated:

• Shellstock temperature at harvest is reduced in a time frame to effectively limit Vp growth.
• Relay of shellstock to ensure consistent Vp levels after relay are below X/g
• Onshore wet storage of shellstock to ensure Vp levels are below X/g.

II. Validation Process

1. Approach to Validate the Control Measure

• Validation study - Validation of Time-Temperature Controls for Vibrio parahaemolyticus conducted at the registered Shellfish Processing Establishment XYZ.
• Validation study - Validation of X days relay on Lease # XYZ prior to harvest for direct consumption.
• Validation study - Validation of X days in a controlled onshore wet storage environment at registered shellfish processing establishment XYZ.

2. Defining the Control Measure Parameters and Acceptance Criteria

1. Control Measure Parameters: According to the most recent scientific literature rapidly cooling shellfish to below 10°C limits Vp growth. The goal is to have the shellfish reach an internal temperature of X°C within Y hours of harvest. Assuming some growth may occur during the cooling phase, the Vp target at harvest will be set at a maximum of X/g.
2. Control Measure Parameters: When handling product where the harvest area is not directly monitored by the processor or the harvest area has historically high Vp levels, relay product for X days in water < X°C to ensure Vp levels at harvest are less than X/g as stipulated in (a).
3. Control Measure Parameters: When handling product from harvest areas with historically high Vp levels (list areas and time of year) product is wet stored in a controlled environment in a registered establishment for X days in water <X°C to ensure Vp levels are less than those referenced in section I.3.

Control Measure Acceptance Criteria: Final product meets the CFIA bacteriological guideline for Vibrio parahaemolyticus.

3. Assemble Relevant Validation Information and Conduct the Validation Studies

a. Obtain and review scientific literature/data on Vp growth and control.

b. Identify the level of the hazard(s) to be used in the validation study.

Example: Vp at <X/g at harvest, ≤ CFIA bacteriological guideline upon shipment.

c. Design and document the steps involved in conducting the validation study.

Time-Temperature Control Validation

• A lot of shellfish is harvested and placed uniformly in trays/sacks
• Temperature of shellstock and water is measured upon harvest
• Date and time of harvest is recorded.
• A sample is taken and sent for Vp analysis
• Shellstock containers are uniformly placed in a refrigerated truck to allow air circulation (document spacing and take photographs of loading arrangement) or shellfish is placed in insulated containers in truck with flake/slush ice. Note air temperature in truck.
• Measure internal temperature of shellstock (sample farthest from cooling unit) every hour during transit or continuously using time/temperature recording probes until receipt at processing establishment. Record data.
• Measure time and temperature every hour during processing/packing/storage at registered establishment, record data.
• Analyse this lot for Vp (n=5) just prior shipping.
• Repeat the above steps during high risk Vp season until confidence is established that controls are effective. Statistical analysis of the data may be necessary.
• Determine the outcome of the validation study

Relay validation

• A lot of shellfish (with high Vp levels) is placed on a designated sub-tidal relay lease.
• The lot is sampled for Vp immediately prior to being placed at the relay site. The location of this sample site(s) selection within the lease is noted and is to be used for all subsequent validation samples.
• Temperature of relay water and shellstock is recorded at the zero hour.
• Water/shell stock temperature at the sites within the relay lease is recorded daily throughout the proposed relay period.
• Relayed lot is sampled representatively at predetermined days from start of relay and until X/g target for harvest is achieved consistently throughout the lot.
• Repeat the above steps during high risk Vp season until confidence is established that controls are effective. Statistical analysis of the data may be necessary.
• Determine the outcome of the validation study.

Onshore Wet Storage Validation

• A lot of shellfish (with high Vp levels) is placed in a wet storage system.
• The lot is sampled for Vp immediately prior to being placed at the wet storage site. The location of this sample site(s) selection within the wet storage system is noted and is to be used for all subsequent validation samples.
• Temperature of wet storage water and shellstock is recorded at the zero hour.
• Water and shellstock temperature is recorded daily throughout the proposed wet storage period.
• The lot is sampled representatively at predetermined days from start of wet storage process and or until X/g target for harvest is achieved consistently throughout the lot.
• Repeat the above steps during high risk Vp season until confidence is established that controls are effective. Statistical analysis of the data may be necessary.
• Determine the outcome of the validation study.

d. For time/temperature validation, confirm that the initial Vp level at harvest is low enough to be effective. If not, adjust control measures or reset Vp level at harvest to a lower level.

e. Conduct validation study described in part 3c. and verify during the study that the control measure parameters and acceptance criteria are met.

4. Analyze the Results and Confirm the Effectiveness of the Control Measure(s)

1. All data acquired during the validation study must be included in the validation report.
2. Statistical analysis (if required/if necessary).
3. State the Time-Temperature controls (<X°C in Y hours) that are effective at limiting Vp growth when Vp levels are <X /g at harvest.
4. Relay for X days at X°C is effective to reduce Vp levels to X/g prior to harvest when water temperatures below X°C.
5. Onshore wet storage for X days in a controlled environment at X°C is effective to reduce Vp levels to X/g.

5. Document and Review the Validation

The results and analysis for this validation study have been documented and can be found in file # 123.

It is important to note that in some cases Vp levels prior to harvest may be in excess of the bacteriological guideline and that other control measures (other than time/temperature controls) are warranted. These may include shucking and labelling products as "to be cooked" or applying a validated post-harvest treatment process that is designed to reduce Vp to acceptable levels (for example; high pressure processing).

Subject 5 FSEP/QMP Audit Policy for Multi-commodity Establishments

PDF (27 kb)

1. Scope

This policy outlines the procedures for integrating audits of the Food Safety Enhancement Program (FSEP) and the Quality Management Program (QMP). It is intended to be applied in establishments which are federally registered under the Fish Inspection Regulations and the authority of another Act or Regulation administered by the Canadian Food Inspection Agency (CFIA).

2. References

• Canada Agricultural Products Act
• Dairy Products Regulations
• Processed Products Regulations
• Processed Egg Regulations
• Fish Inspection Act
• Fish Inspection Regulations
• Meat Inspection Act
• Meat Inspection Regulations
• FSEP Verification Policy
• FSEP reference manual
• Facilities Inspection Manual (Fish Inspection Program)
• Manual of Procedures (Meat, Dairy, Processed Products, Processed Eggs)

3. Definitions

"HACCP": means Hazard Analysis Critical Control Point - a systematic approach to the identification and assessment of the hazards and risks associated with a food operation and to the identification of the means for their control.

"FSEP": means the Food Safety Enhancement Program - described as a CFIA approach to encourage the development, implementation and maintenance of HACCP systems in all federally registered establishments excluding federally registered fish establishments.

"QMP": means the Quality Management Program - a fish inspection and control system which includes procedures, inspections and records, for the purpose of verifying and documenting the processing of fish and the safety and quality of fish processed in Canada for export.

"Minor non-conformity": An isolated non-conformity within the sub-element of the prerequisite program, Regulatory Action Point, a CCP of the HACCP plan or other regulatory requirements being audited.

"Major non-conformity": A non-conformity that compromises the integrity of the HACCP system or may result in a fraudulent product.

4. Preface

The intent of this policy is to provide the scope and procedures for conducting audits in multi-commodity establishments which are operating under the FSEP and the QMP. This policy seeks to be consistent with the existing audit criteria that are being applied to establishments operating with FSEP or QMP systems.

5. Background

During the early 1990s, HACCP systems were developed by two federal departments: Agriculture and Agri-Food Canada developed the Food Safety Enhancement Program (FSEP) and Fisheries and Oceans Canada developed the Quality Management Program (QMP)

The creation of the CFIA merged the departments; however the two HACCP systems remain. FSEP continues to be utilised in the recognition and auditing of HACCP systems for agricultural commodities, and the Fish Inspection Program continues to implement the QMP. This resulted in two separate system evaluations being conducted by CFIA staff in an establishment registered under the Fish Inspection Regulations with a QMP, that also had FSEP for other products such as meat, dairy or processed fruits and vegetables.

FSEP and QMP share similar requirements for prerequisite programs and HACCP plans. The requirements of the FSEP prerequisite program meet the requirements of the QMP prerequisite program. Both programs require the implementation of regulatory action points (RAP) (note that RAP are dependent on program requirements as described in their respective manuals). Also, both programs use the 7 principles of HACCP.

The policy will serve to satisfy five purposes:

• eliminate duplication of audit activities;
• improve utilisation of CFIA resources;
• provide a uniform approach to auditing HACCP systems;
• complete recognition and the partial audit for FSEP; and
• complete the compliance verification for QMP.

6. Policy

6.1 General

The goal of this policy is to provide procedures for auditing the FSEP and the QMP simultaneously, while maintaining the requirements for both programs. The audit policy will provide the establishment with a consistent and uniform approach toward auditing, reporting of results, and expectations of corrective actions.

This policy will be applied to the following scenarios:

1. An establishment that has been FSEP recognized and is operating under QMP.
2. An establishment that is undergoing FSEP recognition and systems verification of the QMP at the same time. Note: the systems verification will be completed independently by the QMP Auditor if the recognition process is not progressing in a timely manner. The certificate of registration issued under the authority of the Fish Inspection Regulations will not be issued until the systems verification has been completed.
3. An establishment which has been FSEP recognized and has now applied for registration under the Fish Inspection Regulations (QMP). In this case, the QMP Auditor will evaluate the RAP and the fish HACCP plan(s).
4. An establishment that is registered under the Fish Inspection Regulations (QMP) and has now applied for FSEP recognition. Note: the compliance verification will be completed independently by the QMP Auditor if the recognition process is not progressing in a timely manner.

6.2 Record Keeping

Establishments must comply with the most stringent record-keeping requirements as outlined in FSEP and QMP (i.e., records must be kept for all monitoring activities in prerequisite programs as required by the FSEP). For RAP within the QMP, records by exception are permitted (i.e., when a deficiency is identified, the establishment is required to record the deficiency and the corrective action taken).

7. Procedures

The existing FSEP and QMP policies and procedures are to be applied during the audit. Audit criteria and documentation that are similar in nature have been combined. Requirements that are specific to each program have been added to the scope of the audit. Every effort should be made to share results between programs and to avoid duplication of tasks (i.e., plant profile completed by responsible inspector should be shared with QMP auditors).

7.1 Documentation

1. When an FSEP recognition is conducted in conjunction with a QMP Compliance Verification (CV), the following forms (see Appendices) are to be used:

• FSEP/QMP Audit Scope Worksheet
• Opening Meeting Checklist for FSEP/QMP Audits
• FSEP/QMP Prerequisite Program and RAP Worksheet
• FSEP/QMP HACCP Plan Worksheet
• FSEP/QMP Corrective Action Request
• FSEP/QMP Audit Exit Report
• Exit Meeting Checklist for FSEP/QMP Audits

2. When an FSEP partial audit is conducted in conjunction with a QMP CV the following forms (see Appendices) are to be used:

• FSEP/QMP Audit Scope Worksheet
• Opening Meeting Checklist for FSEP/QMP Audits
• FSEP/QMP Prerequisite Program and RAP Worksheet
• FSEP/QMP HACCP Plan Worksheet
• FSEP/QMP Corrective Action Request
• FSEP/QMP Audit Exit Report
• Exit Meeting Checklist for FSEP/QMP Audits

3. When an FSEP verification is conducted in conjunction with a QMP CV, the following forms (see Appendices) are to be used:

• FSEP/QMP Audit Scope Worksheet
• Opening Meeting Checklist for FSEP/QMP Audits
• FSEP/QMP Prerequisite Program and RAP Worksheet
• FSEP/QMP HACCP Plan Worksheet
• FSEP/QMP Corrective Action Request
• FSEP/QMP Audit Exit Report
• Exit Meeting Checklist for FSEP/QMP Audits
• RAP Worksheet of the FSEP Manual (to be used by FSEP auditor)(not included in Appendices)

7.2 Audit Team

The auditor(s) must have the appropriate FSEP and/or QMP training and be designated under the relevant regulations. The audit team should hold a pre-audit meeting to plan the audit (e.g., scope of the audit, checklist, time frames etc.). This could be done in person, by telephone or through e-mail.

7.3 Audit Scope

The scope for each audit will be comprised of the following items to ensure that all required elements are covered as per QMP and FSEP requirements:

• Open Corrective Action Requests (CARs)
• Log book entries
• CCPs from selected HACCP plans
• Random selection of pre-requisite programs with a possibility of targeting

The audit scope will also include those FSEP and QMP tasks that are not audited on every visit but must be completed within a series of audits (i.e., Regulatory Action Points, HACCP plan review tasks, Background Product and Process information, Verification/Validation, and Record Keeping requirements).

Auditing techniques and methodology will be implemented using the existing FSEP and QMP requirements (based on ISO standards). The FSEP/QMP Audit Scope Worksheet will be utilized to record the scope of the audit as described in the policies and procedures of the Facilities Inspection Manual and the FSEP Manual.

7.4 Non conformities

For the purpose of this policy, non-conformities will be identified to the establishment as either minor or major as per the FSEP Manual. Generally, the critical non-conformity from the QMP will be equivalent to a major non-conformity, and a non-conformity from the QMP will be equivalent to a minor non-conformity from the FSEP.

To provide clarification on classifying non-conformities, fraud related non-conformities within the authority of the Fish Inspection Regulations will be rated as major but will not have an affect on the Partial Audit Flow Diagram outlined in the FSEP Manual. Repetitive non-conformities related to the Fish Inspection Regulations may result in enforcement action as described in Chapter 3, Subject 3 of the Facilities Inspection Manual and the Fish Inspection Program Compliance Management Process.

Deficiencies identified in an establishment's written program may result in a non-conformity (QMP) or an incomplete (FSEP). In either case, the establishment would be responsible for amending their written program.

Non-conformities identified in one program must be shared with the auditor from the other program due to possible implications they may have on the other program. This includes non-conformities identified during FSEP Verification when the QMP auditor may not be present.

Establishments may appeal audit results to the Regional Director within 30 days of the decision that is being appealed.

7.5 Data Entry

For the purposes of tracking in CFIA information systems (i.e., Multi-commodity Activity Program (MCAP)), FSEP/QMP joint audits will be considered as two separate and distinct audits that will be captured in MCAP Audit for both the FSEP and QMP, when available.

When a non-conformity is identified, the CAR will reference the affected program (QMP, FSEP or both programs). Those non conformities identified with QMP or both programs will be recorded in the MCAP - Fish Component as either a non-conformity or a critical non-conformity as defined by the Facilities Inspection Manual.

8. Frequencies of Auditing

In multi-commodity establishments, FSEP audits will be conducted at a frequency outlined in the FSEP Manual and QMP audits will be conducted as outlined in the Facilities Inspection Manual. The FSEP/QMP Audit for Multi-Commodity Establishments Policy will be implemented when a compliance verification coincides with an FSEP partial audit.

The coordination of audits will be the responsibility of Area/Regional Operations and should consider the schedule of the plant, products being processed and the availability of CFIA personnel.

8.1 FSEP Verification

FSEP verification will be applied as per the FSEP Verification Policy. Based on trade requirements for meat, the responsible inspector is required to be present in the establishment for two to three days per week. The audit scope, as outlined in the FSEP Manual, will be delivered over the course of a month instead of a consecutive two to three day period as per the Regulatory System Partial Audit procedures.

FSEP Verification presents a new challenge for the scheduling process in that QMP Compliance Verifications have been traditionally conducted over a 2-3 day period. It will be the responsibility of the FSEP contact person to communicate to the QMP Auditor in each of the Areas as each multi-commodity registered establishment initiates FSEP Verification. Communication between the FSEP and QMP Auditors is essential.

The seven elements of the QMP must be evaluated during a two or three year planning cycle through a series of audits. The scope of these audits may vary from one task to many tasks. Due to this flexibility in delivery, CV can easily be coordinated with FSEP Verification audits by conducting many CV, focusing on specific sections or elements of the Reference Standard.

The QMP Auditor and the FSEP Auditor will determine the audit scope. This will allow the QMP Auditor to decide if they will participate in any of the visits that are planned for the month, based on scheduling, production of fish products, and audit tasks that need to be covered in the QMP CV.

9. Forms/Documents

• Appendix A - FSEP/QMP Audit Scope Worksheet
• Appendix B - Opening Meeting Checklist for FSEP/QMP Audits
• Appendix C - FSEP/QMP HACCP Plan Worksheet
• Appendix D - FSEP/QMP Prerequisite Program and RAP Worksheet
• Appendix E - FSEP/QMP Corrective Action Request
• Appendix F - FSEP/QMP Audit Exit Report
• Appendix G - Exit Meeting Checklist for FSEP/QMP Audits

Subject 6 QMP Mentoring Policy

PDF (364 kb)

1. Introduction

Mentoring was introduced to the Quality Management Program (QMP) to compliment traditional Inspector learning methods (e.g., classroom training or self-taught modules). The mentoring process establishes a supportive environment for Inspectors to attain the skills and knowledge that can only be learned through operational experience.

This document describes the policy and procedures for mentoring CFIA personnel to achieve the level of competency necessary to participate as a team member and team lead on a QMP compliance verification (CV) team. Policy and procedures for compliance verification of federally registered fish processing establishments are found in the CFIA's Facilities Inspection Manual published by the Fish, Seafood and Production Division.

2. Scope

This policy applies to all CFIA personnel who participate in compliance verification of federally registered fish processing establishments.

3. Guiding Principles

3.1 In order to prepare for, and conduct compliance verifications, the CFIA trains and mentors a work force with specialised abilities. This work force includes mentors, team leads and team members who are skilled and consistent in the delivery of compliance verifications.

3.2 Operations Branch manages the mentoring process, including the identification of mentors, the delivery of mentoring according to this policy and the assessment of team members and team leads.

3.3 The role of the mentor and supervisor are distinct. The mentor coaches by sharing knowledge and experience and helping the mentee to develop their own expertise in the QMP. The mentor provides the mentee's supervisor with objective evidence for use in the supervisory assessment of the mentee's qualifications.

4. Policy

4.1 For the QMP, mentoring refers to the mandatory process of coaching and assessing new inspectors prior to qualifying as a team member or team lead. The coaching is led by a mentor and the final assessment is conducted by a supervisor.

4.2 The process of mentoring pairs the mentor with an inspector who is new to compliance verifications. Mentoring is a planned, individualised approach, set out in a "mentoring plan" developed by the mentor in consultation with the supervisor and mentee. By following the mentoring plan, the mentee receives knowledge from the mentor, gains practical experience, and receives constructive feedback and support to develop the technical skills necessary to conduct a CV.

4.3 Mentors are operational personnel (i.e., inspectors, supervisors, coordinators, and others) who are selected for the role of mentor on the basis of their possession of the following attributes:

• they have achieved team member and team lead status, and demonstrate substantial knowledge and skill in conducting compliance verifications,
• they have, and demonstrate, the ability to share and communicate their expertise in a way that supports and challenges others,
• they have, and demonstrate, the ability to transfer information in a clear, non biased and constructive manner,
• they have, and demonstrate, the ability to determine to a colleague's accomplishments and communicate with the colleague in a positive manner,
• they are recognised by their peers as possessing these qualities, and
• they are willing to mentor others.

4.4 Operations Branch has the lead role in the identification of mentors, the determination of training needs for mentees, the delivery of QMP mentoring, and the support for mentors. Individuals identified as mentors should be further developed with training on effective mentoring.

4.5 In relation to mentoring, it is the role of the supervisor to:

1. establish access to mentors and, when appropriate, nominate new mentors,
2. determine training requirements for new inspectors,
3. facilitate training for new inspectors, as needed, prior to mentoring,
4. initiate mentoring,
5. review individual mentoring plans,
6. facilitate the accomplishment of the mentoring plan,
7. make the final assessment of achievement for team member and team lead status,
8. hold and/or convey confidential records of mentoring,
9. communicate the names of mentors and personnel qualified as team member and team lead.

4.6 It is the role of the mentor to:

1. develop the mentoring plan, in consultation with the mentee and the supervisor
2. provide guidance to the mentee
3. make a record of the mentee's accomplishments
4. communicate the mentee's progress regularly with both the mentee and supervisor.

4.7 The mentee is responsible for active participation in the mentoring process. The mentee's primary goal is to acquire the skills and knowledge necessary to participate in and lead a CV, thereby achieving team member and then team lead status.

4.8 The mentor/mentee relationship is a partnership of peers. Both parties are responsible to conduct themselves in an open and transparent manner. The relationship should foster the transfer of knowledge and experiences by the mentor and the opportunity to exercise abilities and learn CV skills by the mentee.

4.9 The mentoring plan is a key document. Each mentee will have one or more mentoring plans. The mentoring plan clearly identifies training and/or activities to advance the mentee toward team member or team lead status. The mentoring plan activities usually begin with close interaction between the mentor and mentee and gradually move toward independent actions as the mentee acquires and develops the required skill sets and abilities.

4.10 The Area Training and Organizational Development Coordinator is responsible for entering, in PeopleSoft, the names of inspectors qualified as QMP mentors, team members and team leads.

5. Procedures

5.1 Supervisors nominate individuals to become mentors and provide a QMP Mentor Recommendation Report (Appendix A) to the Inspection Manager. The report describes the individual's attributes which will serve him/her in the mentor role. The Inspection Manager has the responsibility for accepting or declining the mentor nomination and advising the supervisor accordingly. The names of successful mentors are communicated to the Area Training and Organizational Development Coordinator for entry and tracking in PeopleSoft (using code I6D130).

5.2 The supervisor identifies an inspector for mentoring and verifies the inspector is designated under the FIA and has the necessary prerequisite training and skills, as indicated below, prior to beginning the mentoring process.

Knowledge and Skills Requirements for the QMP Mentee

Prerequisite Knowledge and Skills

Required prior to the beginning of the mentoring process

1. The Fish Inspection Act and Regulations
2. The Quality Management Program
3. Auditing techniques and procedures
4. Compliance verification skills
5. HACCP theory and application

Required prior to the completion of the mentoring process

1. Sanitation practices and procedures
2. Pest control practices and procedures

5.3 The supervisor arranges for a mentor to be paired with a mentee and notifies both parties. A list of mentors should be available from the Area Training Officer.

5.4 The supervisor provides the mentor with a completed QMP Mentoring Entry Form (Appendix B) which contains a summary of the mentee's training and experience to be considered in the development of the individual mentoring plan. The mentor collaborates with the supervisor and the mentee to identify the individual needs to be addressed in the mentoring plan.

5.5 The mentoring plan should be developed based on the experience and knowledge of the mentee. The individual mentoring plan is directed at developing the additional skills and experience necessary to conduct a CV in accordance with the QMP policies and procedures. The mentoring plan includes a schedule of mentoring sessions, specific CV participation activities, and training if applicable. The mentoring plan should be designed such that training needs are met before CV activities which require specialised technical knowledge (e.g., sanitation training precedes CV activities for the evaluation of a sanitation program). The mentoring plan sets out activities designed to give the mentee assignments with increasing levels of responsibility. For example, the mentee may begin by observing the CV of all elements of the QMP Plan, then progress to assessing basic areas of the QMP Plan elements (e.g., pest control), and later advance to increasingly more complex elements.

The mentoring plan is designed to ensure that the mentee experiences the complete CV process (i.e., preparation, planning, conducting, closure) and evaluates each of the seven elements of the QMP Reference Standard. The activities in the mentoring plan provide opportunities for the mentee to work with team members, team leads, and the mentor.

A template for a mentoring plan is included as Appendix C.

The mentoring plan sets out the time period for completing the mentoring plan in its entirety as well as the progressive steps defined in the plan.

5.6 The mentor will contact the mentee to schedule an initial meeting with the objective to discuss the mentoring process and the mentoring plan. At the initial meeting, the mentor will explain the mentor-mentee-supervisor relationship, the mentoring process, the mentoring plan, and the final assessment by the supervisor.

5.7 The mentor oversees the completion of the mentoring plan but the mentor is not responsible to accompany the mentee at every exercise; in many cases, it is appropriate and even beneficial for the mentee to work alongside a fully qualified team member or team lead to view another individual's technique.

5.8 The mentor schedules meetings regularly or on an as-needed basis, with the mentee and supervisor. These meetings are an opportunity to discuss the progress of the mentee and to identify issues which may be hindering the mentoring process. The supervisor and/or the mentee may also request meetings as required.

5.9 The mentor uses the QMP Mentoring Achievement Report for Team Member or Team Lead (Appendices D and E) to record the mentee's progress. (The mentor provides objective evidence and constructive remarks only.) Upon completion of the mentoring plan, the mentor will present the report with accomplishments indicated to the supervisor.

5.10 The supervisor uses the completed Mentoring Plan and QMP Mentoring Achievement Report, communication with the mentee and mentor, and other activities as required (e.g., supervisor may chose to do a field review of the mentee) to assess if the mentee has achieved Team Member or Team Lead status. The supervisor may also determine that additional mentoring and/or training is required; this decision initiates another cycle of mentoring including a succeeding mentoring plan.

5.11 The supervisor uses the Mentee Assessment Report (Appendix F) to record and communicate the achievement of Team Member or Team Lead to the mentee and the mentor. A copy clearly indicating the appropriate PeopleSoft (PS) code will be provided to the Area Training and Organizational Development Coordinator for the purpose of tracking the appropriate achievement in PeopleSoft.

5.12 All records of mentoring are confidential. When the mentoring plan is accomplished, the mentor transfers all reports of mentoring to the mentee's supervisor who takes responsibility for handling the file.

6. Forms/Documents

• Appendix A - QMP Mentor Recommendation Report
• Appendix B - QMP Mentoring Entry Form
• Appendix C - QMP Mentoring Plan Form
• Appendix D - QMP Mentoring Achievement Report for Team Member
• Appendix E - QMP Mentoring Achievement Report for Team Lead
• Appendix F - QMP Mentee Assessment Report

Appendix A
QMP Mentor Recommendation Report

(To be completed by the Supervisor for approval by the Inspection Manager)

Inspection Manager Decision (Approved/Declined):

Inspection Manager: Date:

Appendix B
QMP Mentoring Entry Form

(To be completed by the Supervisor)

The above-mentioned Inspector is designated under the Fish Inspection Regulations and is available to begin the QMP mentoring process.

Date

Supervisor Signature

Appendix C
QMP Mentoring Plan

(To be completed by the mentor in consultation with the supervisor)

This mentoring plan was created for (mentee) on (date) with the objective of achieving team (member or lead) status.

Mentor: Supervisor:

Signed and Dated:

  (Mentor, originator)

  (Supervisor, in agreement)

  (Mentee, upon review)

Appendix D
QMP Mentoring Achievement Report for Team Member

(To be completed by the mentor for assessment by the supervisor)

The mentee has participated in the following compliance verifications:

cc: Mentee
Mentee's supervisor
Area Training Officer

Appendix E
QMP Mentoring Achievement Report for Team Lead

(To be completed by the mentor for assessment by the supervisor)

The mentee has participated in the following compliance verifications:

cc: Mentee
Mentee's supervisor
Area Training Officer

Appendix F
QMP Mentee Assessment Report

(To be completed by the Supervisor)

(Name of Mentee),

Check is recommended to continue to be mentored to achieve the level of team member.

Check has achieved the level of Compliance Verification Team Member.

Check is recommended to continue to be mentored to achieve the level of team lead.

Check has achieved the level of Compliance Verification Team Lead.

Supervisor Signature: Date:

I acknowledge having read and discussed this report with my supervisor identified above.

Inspector Signature: Date:

cc: Mentee
Mentee's supervisor
Area Training Officer