CFIA Framework for Quality Management Oversight of Laboratories Conducting Testing in Areas Under the CFIA Mandate
Table of Contents
- 1. Introduction
- 2. Purpose
- 3. Scope
- 4. Legal Authority for Laboratory Oversight through Accreditation or Approval Programs
- 5. Guiding Principles
- 6. Governance
- 7. Models for Oversight Delivery
- 8. CFIA Deliverables and Commitments
- 9. Measures of Success
- Appendix 1
Science Branch (SB) has responsibility for laboratories conducting testing and related activities that are used by the Canadian Food Inspection Agency (CFIA) to verify that national and international standards for food safety, animal health, and plant protection are met. Monitoring the effectiveness of laboratories in producing valid test results contributes to the overall objectives of the Agency in food safety, animal health and plant protection.
Laboratory testing and related activities are carried out in all CFIA's three business lines (BL) in order to meet:
- national obligations included in the Acts and Regulations that CFIA is responsible for administering and enforcing;
- international obligations from organizations in which Canada participates or is committed to support such as: the World Organisation for Animal Health (OIE), the North American Plant Protection Organization (NAPPO) and the joint Food Agriculture Organization (FAO) and World Health Organization (WHO) Food Standard Programme, in particular the Codex Alimentarius Commission (often referred as Codex); International Seed Testing Association (ISTA)
- obligations that derive from bilateral agreements such as the Canada/United States Shellfish Agreement, Canada/EU trade agreements, and
- additional specific requirements imposed by importing countries.
CFIA laboratories deliver an extensive range of testing services to meet domestic and international standards, requirements and obligations however there is also a significant volume of testing provided by external laboratories. External laboratories may be providing services under contract to the CFIA or they may be providing testing directly to producers who use the results to demonstrate their products' compliance with national or international regulations and obligations.
CFIA is responsible for the validity of laboratory results produced in CFIA laboratories. In its oversight role, the Agency also assumes a degree of responsibility and liability when results from external laboratories are used to verify compliance, e.g. under Hazard Analysis Critical Control Point (HACCP) plans or to authorize exports and issue required certificates. As a Canadian competent authority in food safety, animal health and plant protection, CFIA is accountable nationally and internationally when issues arise in these areas.
This Quality Management Oversight Framework (QMOF) for laboratories that support CFIA's mandate has been developed to help the CFIA's business lines (BL) meet domestic and international requirements and obligations and to help ensure that the laboratory results on which Agency depends are valid and reliable. The QMOF provides guidance and endeavours to harmonize the BL approaches for consistency, while being flexible and taking into account the different requirements of the BL.
In the context of the QMOF, oversight encompasses all activities, policies, and procedures that are in place or being developed to monitor and verify the performance of laboratories in such a manner that the CFIA can have confidence that the results produced by the laboratories are valid for their intended use. This document describes the current status.
To provide guidance and harmonize the approach to quality management oversight of testing laboratories contributing to the CFIA's three strategic outcomes:
- public health risks associated with the food supply and transmission of animal diseases to humans are minimized and managed
- a safe and sustainable plant and animal resource base
- contributes to consumer protection and market access based on the application of science and standards
The QMOF applies to CFIA laboratories and external laboratories in Canada that provide results directly to the CFIA or that are used by industry to demonstrate regulatory compliance or meet other national and international obligations.
Included in a number of the Acts and Regulations that the CFIA administers and has authority to enforce, is the authority to approve or accredit laboratories. This authority is not defined consistently in all legislation, so for any given policy or program developed under this framework it is necessary to work within the limits of the authority that exists in the applicable legislation or regulations. The legislation, specifically the CFIA Act, gives the CFIA authority to enter into arrangements with other government departments in Canada and other organizations in order to carry out its responsibilities under the Acts and Regulations that it administers, including arrangements related to accrediting or approving laboratories. References to specific legislation giving authority to approve or accredit laboratories is included in Appendix 1.
The different laboratory oversight approaches used by CFIA BL are based on these fundamental principles:
To the extent possible all laboratories are held to the same standard and evaluated against the same criteria so that the results they produce are valid, accurate and reproducible.
It is necessary to have a high level of confidence in the testing results used by the CFIA. This confidence is achieved through the use of objective, verifiable criteria to assess the competence of laboratories. The credibility of laboratory results used in CFIA's decision making is essential to sustain the confidence of industry, the public and other countries in the decisions made by the CFIA.
All activities will respect the requirements of legislation or supporting regulations. These requirements will be incorporated into the documentation developed as part of any oversight activity or program, e.g. reporting animal disease test results, or other test results where required.
It is necessary to ensure that the quality of testing being done in Canada in support of food safety, animal health and plant health meets current and future national and international standards and requirements. Agreements, policies and programs are periodically reviewed to ensure their relevance and continual improvement in order for CFIA to sustain its responsibilities.
The CFIA's efforts in its oversight role must be communicated to industry, the public and other countries, periodically and openly. As well, laboratories and those who use laboratory testing services must be made aware of the standards and requirements that have to be met and how conformance is assessed. Assessment is based on objective criteria and the outcome of the assessment is communicated to the laboratory being assessed.
In order to engage in sound risk management, it is necessary to verify that laboratories produce valid, reliable data. A comprehensive oversight framework enhances the level of confidence in the data used in analyzing risk and supports sound decision making.
The development of an oversight framework allows the flexibility to accommodate the changing demands for laboratory services to address emerging risks and different requirements in the different BL, while still maintaining the required confidence level in the results produced by the laboratories.
As a national regulatory authority in food safety, animal health and plant health the CFIA has the lead role in developing and implementing oversight activities for laboratories that produce results used in support of the Agency's mandated activities.
General direction and coordination of the oversight activities for all BL is provided by the Laboratory Quality Assurance and Accreditation unit of the CFIA. In conjunction with representatives from each of the BL (Food Safety, Animal Health and Plant Health), the unit works to develop the necessary policies and procedures and for the oversight of laboratories. The representatives are primarily from within SB, with representation from other Branches as required. The unit is also responsible for developing and maintaining arrangements with the accrediting bodies and managing and training the technical assessors that are provided to the accrediting bodies. A key focus is to maintain consistency among the business lines to the extent possible.
The technical expertise for the laboratory accreditation or approval programs is provided by CFIA laboratory staff. In addition to participating in the development of international standards and test methods, various technical experts may also be responsible for developing the criteria for laboratory approval programs, providing supplementary guidance and interpretation of standards and acting as technical assessors (TA) carrying out assessments of the non-CFIA laboratories. CFIA laboratories also provide and evaluate a number of proficiency testing (PT) programs that are used as a tool in assessing the competence of the participating laboratories and where deemed necessary provide training in mandated methods, and certification of analysts.
|Laboratory Location||Areas of Responsibility and Expertise||Activities|
|St John's||Food and Plant Health||PT provider (plant)|
|St Hyacinthe||Animal Health and Food||
|Fallowfield||Animal Health, Plant Health (including Seeds) and Food||
|Carling||Food, Feeds and Fertilizers||
|Greater Toronto Area||Food||TA provider|
|National Center for Foreign Animal Diseases -Winnipeg||Animal Health||
|Saskatoon||Food, Animal Health, Plant Health (Seeds)||
|Calgary||Food, Feeds and Fertilizers||
DFO laboratories, under a Memorandum of Understanding between CFIA and DFO, provide the technical expertise necessary for the accreditation and approval of laboratories for selected aquatic animal health testing. DFO laboratories develop and validate the test methods, participate in developing the criteria for the laboratory approval program, provide supplementary guidance and interpretation of standards and provide technical assessors (TA) to carry out laboratory assessments. DFO laboratories also provide and evaluate proficiency testing (PT) programs that are used as a tool in assessing the competence of the participating laboratories and where deemed necessary provide training in mandated methods and certification of analysts.
CFIA has adopted conformance to ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories as a basic standard for the acceptability of laboratories carrying out testing under its mandate. This standard provides an internationally accepted basis for the evaluation of laboratory competence, and was developed by the International Organization for Standardization (ISO) in response to an identified global need for a standard that can be used to evaluate testing laboratories. It represents a consensus of international expert opinion and has been widely adopted. Canada is a member of ISO through the Standards Council of Canada (SCC), the national body designated by the government for standardization in Canada. In addition to the ISO/IEC 17025 Standard, the CFIA applies other criteria that have been developed to cover specific requirements in various fields of testing. These include providing PT programs or mandating participation in programs from selected external sources (e.g. participation in AOAC PT program for pesticide residues in fruits and vegetables), along with elaborations or interpretations on the requirements in ISO/IEC 17025 in the context of the three CFIA BL.
Laboratories are accredited by independent accreditation bodies (AB) such as the SCC and most recently the Canadian Association for Laboratory Accreditation (CALA). Both these organizations are signatories to an International Laboratory Accreditation Cooperation (ILAC) mutual recognition arrangement (MRA) which promotes international confidence and acceptance of data from accredited laboratories. Signatories to ILAC are peer reviewed for conformance to an international standard for accrediting bodies, ISO/IEC 17011 Conformity Assessment – General requirements for accreditation bodies accrediting conformity assessment bodies, which demonstrates their competence as accrediting bodies. When a laboratory is accredited by a recognised AB, the laboratory has demonstrated that they have achieved a prescribed level of technical competence to perform specific types of testing. CFIA works in partnership with both SCC and CALA. Both ABs provide expertise in accreditation and administer the accreditation program, while the Agency provides the necessary technical expertise from among Science Branch laboratory staff. This provides external laboratories with a choice of AB while still maintaining the Agency's oversight role.
7.1.1. Standards Council of Canada
Since 1998, the CFIA has had an agreement with the SCC to accredit testing laboratories under a Program Specialty Area (PSA) for Agricultural Inputs, Foods, Animal Health and Plant Protection. The SCC is the accrediting body and incorporates specific CFIA requirements into the assessments. The Agency convenes the SCC working group for the PSA, participates on SCC committees in support of the laboratory accreditation program and provides trained, qualified assessors from our laboratories to carry out the technical part of the assessments of external laboratories.
All CFIA laboratories are also accredited by the SCC with technical assessors being drawn from other government laboratories (federal or provincial) either within Canada or for some highly specialized fields of testing from academia or government laboratories in other countries such as the United States. Each laboratory is directly responsible for maintaining its accreditation with SCC.
7.1.2. Canadian Association for Laboratory Accreditation
In March 2012, the CFIA finalized an agreement with CALA for the accreditation of food, feed and fertilizer testing laboratories. CALA is the accrediting body and incorporates CFIA specific requirements into the assessment process.
The CFIA directly administers a number of programs for the approval of laboratories. Generally the evaluation is based on ISO 17025 with additional CFIA specific criteria. CFIA performs all the functions of an accrediting body including quality management system assessment, technical assessment, and on-site visits. CFIA may also provide proficiency testing schemes, training, analyst certification, and reagents that are used for the test. For some of the foreign animal disease tests (See 7.2.4 and 7.2.5) the approval is focused on the analyst and the provision of PT and test protocols. These directly administered programs will be transitioned to accreditation by an AB with which CFIA has an arrangement wherever possible.
The following are the current laboratory recognition programs directly administered by the CFIA:
7.2.1. Trichinella - certification of in-plant laboratories for export testing is provided by the CFIA Saskatoon Laboratory Center for Food Borne and Animal Parasitology with some cost recovery.
7.2.2. Equine Infectious Anemia (EIA) and Bovine Leucosis Virus (BLV) – approval of private, veterinary college and provincial laboratories is provided by the CFIA St Hyacinthe Laboratory with partial cost recovery for EIA.
7.2.3. Brucella – approval of private, veterinary college and provincial laboratories is provided by the CFIA Fallowfield Laboratory with no cost recovery.
7.2.4. Foreign Animal Diseases – approval of provincial laboratories for specific foreign animal disease testing is provided by the National Center for Foreign Animal Diseases with no cost recovery.
7.2.5. Bovine Spongiform Encephalopathy (BSE) – approval of provincial laboratories is provided by the CFIA Lethbridge Laboratory with no cost recovery.
7.2.6. Chronic Wasting Disease and Scrapie – approval of provincial laboratories is provided by the CFIA Ottawa Fallowfield Laboratory with no cost recovery.
7.2.7. Potato Diseases – approval of private laboratories is provided by the CFIA Charlottetown Plant Health Laboratory with no cost recovery.
7.3.1. CFIA-Canadian Seed Institute Arrangement
Accreditation of seed testing laboratories is provided by the CFIA Saskatoon Laboratory in conjunction with the Canadian Seed Institute (CSI). The Seed Science and Technology Section (SSTS) of the CFIA Saskatoon Laboratory performs all the functions of an accrediting body including quality management system assessment, technical assessment, and the initial on-site visit. Subsequent on-site assessments are carried out by the CSI. The CFIA also provides a proficiency testing program and training.
Among its initiatives, to ensure that quality management oversight provides the appropriate safeguards for food safety, animal health and plant health testing, CFIA develops and manages a series of policies, procedures and guidelines, accreditation and approval programs and proficiency testing programs that serve to communicate requirements and obligations to laboratories, industry, and other stakeholders.
Policies, procedures and guidelines and other supporting documents are developed as needed by the Laboratory Quality Assurance and Accreditation Unit in conjunction with the laboratory technical experts, external accreditation bodies, and other stakeholders. These documents respect the guiding principles outlined in section 5 and are subject to periodic review so they continue to meet current and future requirements and help increase the levels of confidence and consistency.
Delivery responsibilities are defined when specific programs are developed and are included in the arrangements developed with accrediting bodies. Generally however, the Laboratory Quality Assurance and Accreditation Unit is responsible for coordinating activities, ensuring consistency among programs and compatibility with this framework. CFIA laboratory technical experts are responsible for delivery of the technical aspects of the programs in accordance with the program specification. Refer to section 6 of the QMOF.
As part of its laboratory oversight, the CFIA conducts a number of proficiency testing (PT) programs for laboratories that have been approved by the CFIA or accredited through an arrangement with a recognized AB as described in Section 7.1. CFIA provides two types of PT programs; one that's intended to demonstrate the competence of a laboratory, and the other which is intended to certify an individual analyst as competent.
In general, either type of PT program consists of a series or panel of well characterized, standardized samples that are analyzed by participant laboratories or the analysts seeking certification. The laboratories or analysts report their results to the PT provider who analyzes these results and provides a report that compares the individual results with the expected results. When a laboratory's PT results are unsatisfactory according to pre-defined criteria the laboratory must take actions to correct the cause and prevent inaccurate results from being reported. If the PT program is being used to certify individual analysts the actions to be taken following an unsatisfactory result will be specified in the certification program documentation. There will usually be an opportunity to repeat the panel, and possibly some remedial training.
PT results are one of the tools used by ABs and the CFIA to evaluate a laboratory's competence to carry out a particular test.
In order to deliver on its commitments for testing activities, CFIA relies on external laboratories to provide some services. Best management practices of contracted activities include clear delineation of roles, responsibilities and liabilities of the CFIA, industry and the external laboratories, in addition to well defined requirements and deliverables. Engaging on a continuous basis with legal counsel is a key component to ensure the development and maintenance of clear and legally acceptable agreements. Monitoring these contract deliverables is carried out by those designated to manage the contracts within CFIA.
Requirements under QMOF are communicated through several mechanisms depending on the specific program. The requirements for laboratory accreditation, including CFIA specific requirements, are published by the ABs on their websites. Changes in testing requirements, (e.g. agreements with other countries related to acceptable test methods), are communicated to laboratories through bulletins distributed by the AB on behalf of CFIA
The requirements for programs directly administered by the CFIA are provided to interested laboratories by the CFIA. Changes related to these programs are communicated to the participating laboratories directly by CFIA.
Policies and guidelines developed under the QMOF will be made available through the CFIA website (internal or external as appropriate) and/or through other communication mechanisms.
Success of the quality management oversight framework can be evaluated by assessing pre-defined performance indicators for the elements within the framework and their reconciliation with the guiding principles. Below are some of the measures that can be used, however, additional measures will be developed as elements are finalized and implemented.
The successful delivery of these elements can be measured by their development and implementation as the need for them is identified. It can further be assessed by determining whether or not the content of these documents respect the guiding principles.
9.1.1. Number of needed policies, procedures or guidelines identified/ number of new policies, procedures or guidelines developed and implemented
9.1.2. Number of policies, procedures or guidelines reviewed/number of policies procedures or guidelines revised
The level of acceptance of the CFIA laboratory oversight programs during reviews, audits, and inspections by the competent authorities from our trading partners. The basis for these reviews is a combination of international standards and country or trade zone specific requirements. They usually include visits to laboratories (CFIA and external) providing testing in the commodity area being reviewed.
9.2.1. Number of international audits or reviews with minimal or no critical non-conformities related to laboratories
9.2.2. Decreasing number of non-conformances identified during audits
Success can be measured by assessing whether or not the programs provided still meet the needs of the CFIA as a measure for the evaluation of laboratory competency. Where PT programs are used to certify analysts for specific tests, success can be measured in the availability of increased capacity to provide these tests or the availability of external laboratories to provide testing services to industry.
9.3.1. Decreasing ratio of PT non-conformances to PT panels run or offered
9.3.2. Increasing number of PT panels completed successfully
9.3.3. Number of analysts certified/number of certified analysts that maintain their certification
Success can be measured by determining whether the necessary information is available to users on ABs websites and for programs directly administered by the CFIA, whether it is provided to interested laboratories when requested.
9.4.1. Number of requests for information and responses to requests
9.4.2. Number of new private labs providing CFIA services or accredited
1. ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
2. ISO/IEC 17011 Conformity Assessment – General requirements for accreditation bodies accrediting conformity assessment bodies
3. Agreement between the Canadian Food Inspection Agency and the Standards Council of Canada for the Accreditation of Testing Laboratories, 2006
Legal Authority - Health of Animal Act
The authority to approve laboratories for the purposes of animal health testing (aquatic and terrestrial) resides under the Health of Animals Act section 29
29. The Minister may operate, provide or approve any diagnostic, research, laboratory or other services or facilities required for the purposes of this Act or any regulations.
The Minister has delegated this duty to the Executive Director, Animal Health, Science Branch.
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