Requirements for Accreditation of Laboratories Engaged in Test ...

CAN-P-1595:2011

Laboratory Accreditation Program (PALCAN)

Requirements for Accreditation of Laboratories Engaged in Test Method Development & Non-Routine Testing

CAN-P-1595:2011

2011-11-30

Standards Council of Canada 1 / 18

Laboratory Accreditation Program (PALCAN)


CAN-P-1595:2011

2011-11-30 Standards Council of Canada 270 Albert Street, Suite 200 Ottawa, ON K1P 6N7 Telephone: + 1 613 238 3222 Fax: + 1 613 569 7808 Email: [email protected] Website: www.scc.ca Copyright © Standards Council of Canada, 2011 All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical or otherwise, without the prior written permission of the Standards Council of Canada.

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CAN-P-1595:2011


Table of Contents

Foreword ......................................................................................................................... 4

Introduction ..................................................................................................................... 5

1. Scope ........................................................................................................................ 6

2. Introduction ............................................................................................................... 6

3. Presentation Of The Laboratory Scope Of Accreditation ........................................... 7

4. Requirements And Additional Accreditation Criteria................................................... 8

5. Elaboration Of CAN-P-4E Requirements .................................................................. 9

6. References/Bibliography ......................................................................................... 15

7. Definitions ............................................................................................................... 16

Annex A: Performance Characteristics (parameters) to be considered by the laboratory when conducting method development and validation: .................................................. 17


CAN-P-1595:2011


Foreword

The Standards Council of Canada (SCC) is a crown corporation established by an Act of Parliament in 1970 to foster and promote efficient and effective voluntary standardization in Canada. Although financed in part by Parliamentary appropriation, SCC policies and operations are managed at arm’s length from Government. SCC is overseen by a governing Council whose membership includes government and private-sector representation. With the goal of enhancing Canada's economic competitiveness and social well-being, SCC leads the efforts of Canadians in the development and use of national and international standards and offers a range of standardization-related programs and accreditation services to both standards development bodies and conformity assessment organizations. SCC accreditation programs are accessible to all applicants from World Trade Organization (WTO) member economies, as defined by an Order in Council to the Standards Council of Canada Act. In accepting applications from outside Canada, SCC respects the International Accreditation Forum’s (IAF) Cross Frontier Policy. Additionally, under formal agreements, SCC works in cooperation with foreign accreditation bodies to ensure the effective surveillance of accredited client activities. SCC program policies and procedures are designed to meet the impartiality, non-discriminatory and conflict of interest requirements of ISO/IEC 17011, Conformity Assessment – General requirements for accreditation bodies accrediting conformity assessment bodies. Clients who believe the SCC has failed to comply with these requirements should submit an official complaint in accordance with the most recent version of CAN-P-15, available at www.scc.ca. For more information, visit www.scc.ca.

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CAN-P-1595:2011


Introduction

This Canadian Procedural (CAN-P) Document is part of series of publications issued by the Standards Council of Canada (SCC) that define the policy and operational requirements for core programs established in support of its mandate. Requests for clarification, amendments, or additional copies should be addressed to [email protected]. SCC accreditation or recognition is a formal attestation of an organization’s competence to manage and perform activities defined by its specific program scope. Accreditation or recognition does not function as a guarantee that the services provided by the accredited or recognized organization will satisfy the demands of its clients. Business transactions between these organizations and their clients remain legal matters between the two parties. Please be aware of the following directives used within this document: “shall” is used to express a requirement that the user must satisfy in order to be in compliance with the CAN-P; “should” is used to express a recommendation, or that which is advised but not required; and “may” is used to express an optional, permissible, action that the user may undertake within the limits of this CAN-P. Be advised that notes do not contain requirements. The purpose of a note is to simply provide additional information. A list of all SCC programs and accredited bodies, along with their scopes of accreditation, is publicly available at www.scc.ca.

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1. Scope

This program specialty area applies to the accreditation of laboratories that are developing test methods, validating test methods and/or evaluating test kits and/or conducting non-routine testing in one or more testing areas.

2. Introduction

Late in 1996 it was recognized that a need existed to formally recognize the capability of specific laboratories for test method development (TMD) and evaluation of test methods. This was later expanded to include non-routine testing (NRT). The Standards Council of Canada formed a working group to examine the methodologies of formally accrediting these types of capabilities. The working group was formed on 18 May 1998 and within one month, had collectively agreed to the adoption or adaptation of Eurachem / CITAC Guide 2 as the basis for the guidelines needed to accredit laboratories in this new area. The Laboratory Accreditation Program (PALCAN) allows for the development of specific guidelines to facilitate the accreditation of laboratories in specific fields. A Working Group of the Task Group Laboratories (TG Labs) of the Council is responsible for the development and maintenance of this document under TG Labs. CAN-P-1595 serves as an interpretative document to CAN-P-4E in the accreditation of laboratories involved in Test Method Development & Evaluation and Non-routine Testing. No part of this document may be reproduced without the express written permission of the Standards Council of Canada. Laboratory Prerequisites Laboratories seeking accreditation of their test method development, evaluation and non-routine testing capability under this document shall be required to demonstrate their conformance to ISO/IEC 17025.

Restrictions This document is restricted for use within specific disciplines of test methods under development or evaluation and for non-routine testing. It is intended to be used by laboratory managers and staff involved in the planning, performance and management of non-routine testing in science, and test method development and evaluation. Other, broader research and development disciplines are not covered by CAN-P-1595 and some of these disciplines may be the subject of either an expansion of this document or a new document, when specific needs arise.


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3. Presentation Of The Laboratory Scope Of Accreditation

The SCC website (www.scc.ca) contains a search directory for laboratory scopes. Appendix A of CAN-P-1570 is the basis to establish and present scopes of accreditation. The presentation of the scope of accreditation for this program specialty area is in a flexible format such that the scope parameters: techniques, technologies and test parameters that apply to this PSA are identified as described in Appendix A of CAN-P-1570.

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4. Requirements And Additional Accreditation Criteria

4.1 General requirements

For information on the accreditation process, accreditation conditions, and details on preparing an application see: CAN-P-1570 PALCAN Handbook – Program Requirements for Applicant and Accredited Laboratories and its respective appendices. Laboratories must meet all the pertinent provisions of the most recent versions of the PALCAN documents, including but not limited to:

• CAN-P-4E General Requirements for the Competence of Testing and

Calibration Laboratories, (ISO/IEC 17025:2005); the checklist that is used to assess these requirements is the latest version of F0410, Assessment Rating Guide.

• CAN-P-1623 PALCAN Interpretation and Guidance on the Estimation of Uncertainty of Measurement in Testing

• CAN-P-1624 PALCAN Policy on Use of Proficiency Testing as a Tool for Accreditation of Testing

• CAN-P-1625 PALCAN Policy on Guidelines and Procedures for Laboratories with Serious and Critical Non-conformities

• CAN-P-1626 PALCAN Policy on Calibration and Measurement Traceability • CAN-P-1626 Appendix Required Definitions for SCC Accredited Laboratories. • CAN-P-1628 PALCAN Policy on the Use of Information Technology in

Accredited Laboratories • CAN-P-1629 PALCAN Guidance for the Validation of Test Methods • CAN-P_1630 PALCAN Interpretations for Conducting Assessments of

Testing and Calibration Laboratories • CAN-P-1631 PALCAN Guidelines for the Use of Accreditation Body Logos

and for Claims of Accreditation Status 4.1.1 If a laboratory’s test method development, evaluation and non-routine testing fall

under another program specialty area (PSA), then the laboratory must also meet the provisions of the that PSA.

4.2 Specific requirements

Eurachem/CITAC Guide, Quality Assurance for Research and Development and Non-routine Analysis (1998); Also referred to as CITAC Guide 2. In addition to the specific requirements, laboratories performing analyses must also apply the best scientific practices accepted nationally or internationally for each relevant testing field or discipline.


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5. Elaboration Of CAN-P-4E Requirements

All the requirements of the most recent version of CAN-P-4E apply to all accredited laboratories. This section of these requirements is to be used in conjunction with the CAN-P-4E document. It provides guidance in the form of interpretation and/or application of some clauses of CAN-P-4E. Laboratories are also reminded that the references specified this document and annexes also supplement CAN-P-4E by providing specific guidance in their respective fields of testing. Management Elements:

CAN-P-4E (ISO/IEC 17025:2005) Section No:

Elaboration / Application

4.1.5.e Organization The laboratory shall include in its documentation which staff has responsibilities under this PSA.

4.2 .1 Management System The laboratory shall ensure that a project management system is in place for TMD which includes: -research planning -management/ assignment of qualified staff and resources - process monitoring and project management proportionate to size of the project -a project life cycle planning and tracking document (see 4.13 1 below) that may be known as the project plan

4.2.2 Management System Maintain a quality manual that includes or makes reference to all TMD & NRT policies, processes and procedures

4.4.1 Review of requests, tenders and contracts

Provide evidence that policies and procedures related to review of requests, tenders and contracts are established and the project approval process is linked to these policies and procedures

4.6.2 Purchasing supplies and services

All purchased supplies that affect quality are not used until verified compliant with specifications; and maintain records of reference materials as appropriate to work including a process to verify & confirm parameters such as identity, purity and quantity (see also 5.6.3.4).

4.7 Service to the customer Have a communication plan with the customer including background


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scientific information, summary of objectives, experimental findings, results and conclusions

4.13 Control of Records Project life cycle documentation that contains: - Project identification number and title - Customer identification (internal & external) - Project lead, principle investigator, or project manager - Detailed scope and & objective(s) of the project - Start and completion dates - Strategic plan - Timelines for planned activities - Resources (internal & external) - Project approval process - Tracking system - Review process - Progress reports to customer - Deviation reports (where applicable) - Validation and summary report - Project conclusions/recommendations - Final project report (including it’s format) -Project closure, approval and date(s) 4.13.2.1 The variables evaluated such as analyte, matrix, host, organism or strain must be clearly identified in the technical records and any reports. 4.13.2.1 Technical Records “Where SOPs do not already exist or are inappropriate, contemporaneous notes should be made to describe the procedures used in the work. Sufficient detail should be recorded so that at some later time, the procedures used can be reconstructed. Where a number of procedures were attempted before one was found that was satisfactory, records should be kept of the failures so that they can be avoided in future” (CITAC Guide 2: 6.3.3).

4.14 Internal Audits 4.14.1 Internal audit schedule and procedure must include projects and activities related to this PSA.

4.15 Management Review 4.15.1 Provide evidence the management review includes all aspects of the TMD& NRT project plans


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and management processes

Technical Elements:

CAN-P-4E (ISO/IEC 17025:2005) Section No:

Elaboration Interpretation / Application

5.2 Personnel Qualifications 5.2.1 Provide evidence personnel performing specific tasks are qualified on the basis of education, training, experience and/or demonstrated skills. Identify personnel and their selection criteria. The laboratory shall demonstrate that personnel involved in method development or evaluation or non-routine testing, have the skills and knowledge to do testing in the fields associated with the scope of testing; such association to be established through a similarity in procedures and techniques; successfully performing method development, validation based on training and experience. Examples of records include CV’s, peer reviewed publications, relevant experience, conference participation, and training records... 5.2.5 Maintain records to demonstrate on-going proficiency of all staff involved in TMD, as appropriate, including objective evidence.

5.3 Accommodation and Environmental Conditions

Facility 5.3.1, 5.3.3 Provide facilities that are appropriate for TMD., including measures to avoid any cross-contamination

5.4 Test and calibration and method validation

Laboratory-Developed Methods 5.4.3 Laboratory developed methods are planned, and assigned to qualified personnel. For non-routine testing requirements, include limitations as required by the work & approved by the customer.

5.4 Non-standard Methods 5.4.4 For methods in use that are not standard methods, ensure that the method is validated before use, including ruggedness tests with the


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same media as the final test application. The extent of validation, and the consequences in time and cost, is one of the key issues to be agreed upon between the laboratory and customer. The method must be fit for the intended purpose.

5.4 Method Validation 5.4.5.2 The validation is as extensive as necessary to meet the needs of the given application or field of application. There is a validation plan or standard procedure or procedure approved by the customer and that plan or procedure is appropriate to the discipline. Provide evidence of records of the results of the validation, including a validation summary report as outlined in the project management plan. Staff are knowledgeable about best practices appropriate to the discipline. Provide evidence of a statement that the method is fit for the intended use by authorized technical management 5.4.5.3 See Annex A for a list of applicable parameters (characteristics), including how these were evaluated, calculated or defined; interpretation of population results, incorporating statistics, as applicable. The terminology used to describe the performance characteristic may vary among disciplines. Terminology for parameters should be defined by the laboratory as necessary for clarity. In addition to relevant parameters (characteristics), a validation summary report should include: - Reference (e.g., identify technical records for more details): - Measurand: - Type of sample(s), (e.g., description of the tested matrices) - Type of measurement (e.g., qualitative, semi-quantitative,quantitative, ,determinative,)


CAN-P-1595:2011


- Method status (routine or non-routine): - Description of the intended use [e.g., legal, regulation, as agreed with clients (screening, confirmatory, exploratory, process control, others)]:

5.4 Uncertainty of Measurement 5.4.6 Provide evidence the laboratory has a procedure to estimate the uncertainty of measurement that includes relevant uncertainty components and uses appropriate methods, including adequate statistical analysis, and is included in the validation report.

5.5 Equipment Records 5.5.5 Records of equipment are maintained and include: Complete usage, maintenance and calibration records for equipment used for different applications, i.e., especially other than this PSA (See 5.5.5).

5.8 Handling of test and calibration items Handling, protection, and storage of unfamiliar or novel samples to be addressed. (See 5.8.1 and CITAC Guide 2: 6.3.3)

5.9 Assuring the Quality of Test and Calibration Results

Quality Control Provide evidence the laboratory has planned quality control procedures appropriate to test method development. Provide evidence the laboratory has planned quality control procedures for non-routine testing. Any other verification activities, including external.

5.10 Reporting Results 5.10.1 General The results of the project shall be reported to the customer in the agreed upon format. In the context of this PSA “reports” this may include, for example: -a test report, -a test method, a project report (technical or other wise),a yearly report on research work by graduate students, a research thesis, lectures, scientific presentation at local, provincial, national and international seminars and conferences,


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peer reviewed research papers or reviews published in national and international journals, and scientific publication in national and international journals, patents, licenses, standards, training material, etc.


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6. References/Bibliography

Most recent version where applicable

6.1 Accreditation of Microbiology Laboratories, EA-04/10 (European Co-operation for Accreditation,

6.2 OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals: Chapter 1.1.3. - Quality management in veterinary testing laboratories

6.3 AOAC International, Methods Committee Guidelines for Validation of Qualitative and Quantitative Food Microbiology Official Methods of Analyses. J AOAC Int’l 85(5) 2002, p 1187-1200.

6.4 CITAC/Eurachem Guide, Guide to Quality in Analytical Chemistry, An Aid to Accreditation,

6.5 Eurachem Guide, The Fitness for Purpose of Analytical Methods, A Laboratory Guide to Method Validation and Related Topics

6.6 European Communities Decision of 12 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results. Official Journal of the European Communities, Document #C(2002) 3044, and Consolidated Guidelines for implementation of 96/23 December 2008.

6.7 ISO 16140:2003, Microbiology of food and animal feeding stuffs- Protocol for the validation of alternative methods.

6.8 Guidelines for Single-Laboratory Validation of Analytical Methods for Trace-level Concentrations of Organic Chemicals.

6.9 AOAC/FAO/IAEA/IUPAC Expert Consultation in Principles and Practices in Method Validation, Fajgelj, A, and Ambrus, A (Editors), Royal Society of Chemistry, 2000.

6.10 Harmonized Guidelines for Single Laboratory Validations of Methods of Analysis. (IUPAC) - Pure Appl. Chem. 74(5), 2002, p 835-855.

6.11 Requirements for the use of single-laboratory validation for Codex purposes. Codex Alimentarius Committee. Codex Committee on Methods of Analysis and Sampling.

6.12 OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals: Chapter 1. 1. 4 / 5 .Principles and methods of Validation of Diagnostic Assays for Infectious Diseases.


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7. Definitions

7.1 All definitions in CAN-P-4E and VIM 3rd Ed.:2007, e.g. laboratory, testing laboratory, calibration laboratory, calibration, test, calibration method, test method, verification, quality system, quality manual, reference standard, reference material, certified reference material, traceability, proficiency testing, (accreditation) requirements, shall apply. These definitions are reproduced in CAN-P-1626 to ensure clarity and consistency. All required definitions are reproduced for convenience in the document CAN-P-1626 Appendix A (“Required Definitions for SCC Accredited Laboratories”).

7.2 Additional definitions:

Test Method Development: Developing methods and procedures in order to conduct testing or solve an analytical problem. Although this might involve only adaptation of existing, validated test methods, laboratories performing Test Method Development & Evaluation and Non-routine Testing are usually involved in more complex projects. Routine Analysis: the analytical problem has been encountered before and a suitably validated accredited test method for solving the problem exists and is in regular use. The staff training, calibration and quality control used with the method will depend on sample throughput and analysis purpose in order to meet customer’s objectives. Routine Analysis Conducted Infrequently: The analytical requirement has been encountered before. However, the testing is not in regular use or has low or very occasional sample requests, e.g. seasonal. A suitable validated accredited test method for solving the issue exists; however, specific quality assurance and quality control measures are required prior to the commencement (reuse) of the testing on customer samples and need to be defined by the laboratory in a documented procedure. NOTE: To retain the scope listing of an “accredited routine test conducted infrequently” the testing or calibration laboratory shall comply with SCC documents (see CAN-P-1630 section 5.4.1) and the PSA document, if applicable. Non-routine Analysis Ad-hoc or one-of-a-kind work that is carried out for a specific purpose and may reflect a degree of innovation and limited notice. Typically it is used in the context of work on out of the ordinary samples where established methods of analysis are unsuitable. These analyses required either significant adaptation of established methods, new method development or the establishment of innovative approaches. NOTE: Non-routine test methods may only be accredited under the requirements of the SCC PSA-TMD program (CAN-P-1595). See CAN-P-1570, Appendix A


CAN-P-1595:2011


Annex A: Performance Characteristics (parameters) to be considered by the laboratory when conducting method development and validation:

See 5.3 of CAN-P-1629, PALCAN Guidance for the Validation of Test Methods, for a discussion of typical performance characteristics and criteria to be evaluated in method development, optimization and validation. The list below serves as a guide to characteristics or parameters that a laboratory should consider when developing and validating a test method. Performance characteristics (parameters) and the acceptance criteria used to evaluate the performance characteristics shall take in to account:

• the intended use of the test method including customer needs (According to Eurachem/CITAC Guide 2 - Quality Assurance for Research and Development and Non-routine Analysis, 6.8.5.4, “the extent of validation, and the consequences in time and cost, are one of the key issues to be agreed between analyst and customer when commissioning method development)

• the discipline: some characteristics including the definitions are discipline or test

type specific

• the type of test: qualitative, quantitative, and purpose: screening, confirmatory Characteristics or criteria to be considered include, but not limited to:

• Accuracy • Action levels (for regulatory analyses) • Analytical specificity*: selectivity, exclusivity, inclusivity • Calibration (see linearity, range) • Confirmation • Diagnostic selectivity*, Diagnostic sensitivity* • Efficacy • False positive rate, False negative rate • Limit of detection (detection capability, decision limit, level of detection) • Limit of determination, (limit of quantitation) • Linearity (calibration, range) • Measurement bias • Measurement uncertainty • Precision • Predictive value • Range (see calibration, linearity) • Recovery • Relative Sensitivity, Relative Specificity • Repeatability • Reporting limit • Reproducibility • Ruggedness/robustness • Selectivity *,-Sensitivity *, Specificity*


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• Stability (of analyte, organism, sub-samples, extracts) • Target organisms • Test controls (including reference populations) • Thresholds

* Definitions for some terms may vary among disciplines. See references listed in 6.0 and CAN-P- 1626 Appendix A. For example, the term selectivity is recommended for analytical chemistry instead of specificity (see IUPAC definition). Some such as analytical specificity, diagnostic selectivity and diagnostic sensitivity are used in biological testing – see OIE

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