Developing a Quality Management Program Plan

A Fish and Seafood Processor's Step-by-step Guide

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Table of Contents

Introduction

Introduction
Definitions
The Step-by-step Approach to Developing your QMP
Developing your QMP is a Team Effort
An Overview of the QMP Plan
Registration Process

Step-by-Step Guide

Element 1: Management Roles and Responsibilities
Element 2: Background Product and Process Information
Element 3: The Prerequisite Plan
Element 4: The Regulatory Action Point (RAP) Plan
Element 5: The HACCP Plan
Element 6: Verification and Maintenance of the QMP Plan
Element 7: Record Keeping
Conclusion

Appendices

Appendix A: Application for Registration of a Fish Processing Establishment
Appendix B: Blank Forms

Introduction

Canada's domestic and international reputation for high standards in fish product safety and quality has been well earned. It has taken the effort of every level of the food production and distribution system to achieve this success.

Canada's Quality Management Program (QMP), which began in February 1992, was the world's first mandatory food inspection program based on Hazard Analysis Critical Control Point (HACCP) principles. The QMP is recognized internationally as an effective system for controlling the production of fish products and has facilitated the export of Canadian fish products around the world.

In order to process fish products for export, Canadian processors are responsible for complying with the Fish Inspection Regulations by:

• Developing a QMP (Quality Management Program) Plan. The QMP Plan must include a Hazard Analysis Critical Control Point (HACCP) Plan.
• Registering the processing facility with the CFIA by properly completing an application form and paying a specified fee. A Certificate of Registration can only take place once a QMP Plan has been completed and accepted by CFIA.
• Ensuring the facility(s) is in compliance with Schedule I of the Fish Inspection Regulations. Facility compliance will be verified by CFIA prior to issuance of the Certificate of Registration.

The CFIA presents Developing a QMP Plan: A Fish and Seafood Processor's Step-by-Step Guide, as a tool to help fish processors develop a Quality Management Program Plan. Using this document as a guide, a processor can tailor their QMP Plan to their products, processes, plant, and specific hazard-avoidance needs.

The following is a list of definitions and terms which relate to the Quality Management Program.

Definitions

Compliance Verification
Activities carried out by CFIA Inspectors to verify that a federally registered fish processing establishment has implemented its Quality Management Program plan as designed and that it meets the requirements set out in the Fish Inspection Regulations and the QMP Reference Standard. This includes a combination of audit and inspection activities.

Control Measure
An action performed to maintain adherence to a standard or to eliminate a hazard or reduce it to an acceptable level. It is also known as a preventative measure.

Corrective Action
The procedure that is to be followed whenever a deviation from a critical limit in a HACCP plan occurs or whenever the results of monitoring procedures in respect of a prerequisite program plan or a regulatory action point plan show that there is non-compliance with the Fish Inspection Regulations.

Corrective Action Plan
A documented plan of corrective actions required, including time frames, persons responsible for implementing the plan and the processor's verification that the corrective action is working. A Corrective Action Plan is prepared in response to a compliance verification or inspection report, and must be reviewed and accepted by the CFIA.

Critical Control Point (CCP)
A point in a process operation at which control is to be applied in order to prevent or eliminate a hazard or reduce it to an acceptable level.

Critical Limit
The maximum or minimum value to which a hazard must be controlled at a critical control point.

Export
Ship from Canada to any other country or from any province to any other province.

Hazard
A biological, chemical or physical agent or factor that has the potential to cause illness or injury to humans in the absence of its control.

Hazard Analysis Critical Control Point (HACCP)
A system which identifies, evaluates and controls hazards which are significant for food safety. HACCP is an internationally recognized approach to food safety management.

Monitoring Procedure
A planned observation or measurement of a parameter, at a specified point or time, which is then compared to a target (i.e., a standard, an operational limit, a critical limit).

Prerequisite Program Plan
A series of steps, measures or procedures that are to be applied to ensure compliance with the Fish Inspection Regulations in respect of:

1. establishment construction and equipment
2. establishment operation and sanitation
3. the cleaning, sanitizing, lubricating and maintenance of establishment equipment and facilities, and insect and animal pest control
4. fish packaging, labelling or ingredient storage rooms or areas in the establishment, and
5. the system for tracking fish to its first destination

Quality Management Program (QMP)
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, exported from or imported into Canada.

QMP Plan
A document describing controls applied in a fish processing establishment to meet requirements under the Fish Inspection Regulations.

QMP Reference Standard
The standard that sets out the requirements for the documentation and application of a fish processing establishment's Quality Management Program. The Reference Standard is based on the Fish Inspection Regulations.

Regulatory Verification
Activities carried out by CFIA Inspectors to verify that a federally registered fish processing establishment's Quality Management Program meets the requirements set out in the Fish Inspection Regulations and the QMP Reference Standard. Regulatory Verification consists of two components: 1) Systems Verification; and 2) Compliance Verification.

Restricted Access Zone
That part of a processing area where personnel movements are restricted and employee hygiene and sanitation procedures are in place to control potential contamination or cross-contamination, but which does not meet the specific requirements of a Sanitary Zone.

Sanitary Zone
That part of a processing area, for 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, employee hygiene and sanitation procedures.

Standard Operating Procedures (SOPs)
A detailed set of instructions which describes how to carry out a task, function or product formulation.

Systems Verification
An evaluation of a federally registered fish processing establishment's documented Quality Management Program 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.

Validation
Supportive evidence or documentation to confirm that the values of the critical limits for each Critical Control Point (CCP) are sufficient to prevent, eliminate or reduce to an acceptable level, food safety hazards in the final product.

Verification
A review of a control system or its records performed on a regular basis to determine whether the controls are working as intended and are functioning effectively to control the relevant hazards. Verification activities may include conducting records checks, reviewing procedures, conducting operational simulations (such as mock recalls), internal audits, tests or measurements (independent of monitoring controls), and product sampling (including microbiological and chemical).

The Step-by-Step Approach to Developing Your QMP

This guide provides you with a step-by-step approach to developing your QMP Plan. The major steps of the process are as follows:

1. The first and most critical step is to get senior company management commitment to the QMP Plan. This is vital to the successful development, implementation, and maintenance of the QMP Plan.
2. Once you have management commitment, management must assign the task of developing the QMP Plan to an individual or a team. Either approach is acceptable, and should depend on the size of your company and plant. In either case, the input of other plant employees will be necessary to develop the best possible QMP Plan.
3. The individual responsible for developing the QMP Plan must then set out a plan identifying the major tasks and target dates on which they will be completed.
4. The training institutions in the area should be contacted to determine whether any QMP Plan development workshops are being held that relate to your products and processes. Participation in a workshop is strongly recommended. If possible, companies should have more than one member attend a workshop. If there are no workshops available, schedule a workshop by contacting local training institutions or the National Seafood Sector Council.
5. The next step is to begin developing your QMP Plan by using the step-by-step process described in this guide.
6. Once you have developed your QMP Plan, verify the written plan to ensure that you have addressed all components of the plan.
7. When you are satisfied with your QMP Plan, submit the self-verification checklist, with the appropriate information, to the local CFIA office; the regulatory verification process will then begin.
8. The CFIA will review the self-verification package and notify you of any further work that is required. Once the QMP plan is found to be acceptable, and the establishment is determined to meet requirements, the CFIA will issue a certificate of registration and advise you to begin operating under your QMP Plan. The CFIA will schedule a compliance verification to assess the program.

Developing Your QMP is a Team Effort

The development of your QMP Plan needs a team approach. Although there may be only one individual designated to develop the QMP Plan, he or she should involve as many of the plant staff as possible. Throughout the development of the plan, bring in the individuals that are responsible for the subject you are working on. For example, if you are documenting the plant sanitation and clean-up procedures, get input from the clean-up crew, the individual responsible for verifying that the clean-up was performed properly, and any other staff involved in this area. Discuss the procedures and controls, and try to find better and simpler ways to meet the goal of achieving a clean and sanitary plant.

The team approach is helpful because when only one person develops the QMP Plan, some key points can be missed or misunderstood. The team approach minimizes the risk that key points will be missed. It also encourages ownership of the plan and builds company involvement.

In small companies, it may be difficult to take a team approach. In these cases, the team approach can be met by attending one of the QMP Plan development training courses offered by local training institutions. Working with a group of processors in a workshop environment can be very beneficial and helpful.

An Overview of the QMP Plan

A QMP Plan is a document describing controls applied in a fish processing establishment to meet requirements under the Fish Inspection Regulations. Each federally registered fish processing establishment must develop, document and apply a specific QMP Plan for the products and processes carried out in their plant.

Let's begin with the QMP Reference Standard.

The QMP Reference Standard is the blueprint for the development of the QMP Plan. It sets out the requirements for the documentation and application of a fish processing establishment's Quality Management Program Plan. CFIA personnel use the Reference Standard during their systems verification and compliance activities. The complete QMP Reference Standard and compliance guidelines can be found at www.inspection.gc.ca.

The QMP Reference Standard consists of the following seven elements:

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

An overview of the requirements for each of the seven elements will be covered in this section followed by detailed guidance in the step-by-step section. The appendices of this guide contain additional information invaluable to the development of a proper and complete QMP plan.

ELEMENT 1: MANAGEMENT ROLES AND RESPONSIBILITIES

Element 1 (Management Roles and Responsibilities) identifies the position responsible for the QMP Plan. It may also describe how the QMP was developed and how it will be implemented.

ELEMENT 2: BACKGROUND PRODUCT AND PROCESS INFORMATION

Element 2 (Background Product and Process Information) identifies product and process information in the form of a Product Description, Process Flow Diagram, and where applicable, and Establishment Floor Plan.

ELEMENT 3: THE PREREQUISITE PLAN

Element 3 (The Prerequisite Plan) requires an Establishment Environment Program and a Lot Accountability and Notification Program. Under the Establishment Environment Program processors need to identify:

• the establishment standard that is applied in the facility
• the actions that are taken by the processor to ensure the standard is met
• the record keeping system to record corrective actions when problems are identified
• the corrective action system in place to address deficiencies when they are identified

Under Lot Accountability and Notification Program, the processors need to identify:

• a product identification and distribution system that allows for the rapid identification of the first shipping destination (for the purposes of carrying out a product recall)
• procedures to notify the CFIA of any valid health and safety complaints

ELEMENT 4: THE RAP PLAN

Element 4 (The RAP Plan) must describe the controls designed 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 the 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;
• Labelling and coding of all fish products meet the requirements of the Fish Inspection Regulations and is not false, misleading or deceptive.

The processor must identify:

• the fish product standard(s) and the ingredient and packaging requirements to which they must comply
• the controls that are implemented in production to ensure the standards and requirements are met
• the record keeping system to record corrective actions when problems are identified

ELEMENT 5: THE HACCP PLAN

Element 5 (The HACCP Plan) requires processors to 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. For those significant hazards identified, the processor must develop a HACCP Plan to prevent, eliminate or reduce the hazard to an acceptable level.

The HACCP System consists of the following seven principles:

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

ELEMENT 6: VERIFICATION AND MAINTENANCE OF THE QMP PLAN

Element 6 (Verification and Maintenance of the QMP Plan) requires processors to perform verification activities to ensure that their QMP Plan is functioning correctly.

Before implementation the processor is required to:

• Validate the critical limits of CCPs;
• 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.

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

• Perform routine verification of the HACCP Plan to ensure it is functioning effectively;
• verify or validate any changes to the QMP Plan or to critical limits that may occur in the ongoing development of the QMP Plan;
• review the QMP Plan at least once a year;
• maintain a list of amendments of any changes to their QMP Plan.

ELEMENT 7: RECORD KEEPING

Element 7 (Record Keeping) requires that records must be kept for the QMP Plan as follows:

• for all Prerequisite and RAP Plans, record keeping may be "by exception" (only deficiencies need to be noted)
• 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
• for all verification activities and results, record keeping is mandatory
• for amendments or changes to the QMP Plan, a record must be maintained

Once the QMP Plan is properly completed, a processing plant may apply to the CFIA for a Certificate of Registration.

To register, complete an application form and submit the specified fee. See Appendix A of this guide for a sample form. Forms can be requested from the CFIA by telephone, or downloaded from the CFIA website.

The form must be signed by an authorized officer of the processing plant. The application must include a self-verification of the QMP Plan in the form of a letter signed by the applicant confirming the Critical Control Points (CCPs). It must also validate the critical limits of the CCPs, and verify that the QMP Plan meets the requirements of the Reference Standard.

The diagram of the processing plant that is included for a new Certificate of Registration must include the measurements of the processing area.

Full payment of the fees for the Certificate of Registration should be included with the application form, and should be sent directly to the designated CFIA office in your region.

Sample of Certificate of Registration

Click on image for larger view

Next page: Element 1