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Legislation Issues

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Legislation or regulation driving PT requirements ... e.g. European Brewery Convention (EBC) represented on LGC's BAPS and MAPS Advisory Groups ... – PowerPoint PPT presentation

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Title: Legislation Issues


1
Legislation Issues
  • Brian Brookman
  • LGC

2
Legislation Issues
  • Legislation or regulation driving PT requirements
  • Legislation or regulation governing PT providers
  • PT Networks National, European, International

3
PT Drivers
  • International legislation
  • Laboratory standards and guides
  • Laboratory accreditation
  • Sector specific regulation and guidance
  • Quality standards and guides
  • Regulatory and standard bodies
  • Business requirements

4
International PT Drivers
  • ISO/IEC 17025
  • General requirements for the competence of
    calibration and testing laboratories
  • 5.9.1. The laboratory shall have quality control
    procedures for monitoring the validity of tests
    and calibrations undertaken
  • A list of potential monitoring mechanisms are
    given, all of which are internal except
  • Participation in interlaboratory comparison or
    proficiency testing programmes
  • PT participation is the only external and
    therefore fully independent monitoring mechanism

5
International PT Drivers
  • ISO 15189 (2003)
  • Medical laboratories Particular requirements
    for quality and competence

6
Sector Specific PT Drivers
  • Specific sectors may drive quality improvements
    through sector regulation, standards or guides
  • Important for PT providers to be aware of such
    sector specific drivers
  • Important analytes
  • Methodology
  • Performance requirements

7
Example - Environment
MCERTS aims to deliver high quality environmental
measurements. The scheme provides for the product
certification of instruments, the competency
certification of personnel and the accreditation
of laboratories based on international standards.
  • A laboratory shall participate in an appropriate
    external quality control or inter-laboratory
    proficiency-testing scheme.

8
MCERTS Standard
9
Examples - Food
  • EU Regulation 882/2004 Official Controls
    Performed to Ensure the Verification of
    Compliance with Feed and Food Law, Animal Health
    and Animal Welfare Rules
  • EU Directive 94/35/EC for sweeteners
  • EU Directive 94/36/EC for colours
  • EU Directive 95/2/EC for all other additives
    including preservatives
  • EU Directive 90/496/EC for nutritional labelling

10
PT Scheme Literature
11
PT Scheme Literature
12
Sector Specific PT Drivers
  • PT providers can also provide valuable input to
    industry bodies e.g. provision of data on method
    performance, problems etc
  • e.g. LGC has provided data from the sugar PT
    scheme to ICUMSA to assist development of new
    methodology

13
Sector Specific PT Drivers
  • PT participation can often be encouraged or
    mandated by regulatory and standard bodies within
    a specific sector
  • e.g. UK National Health Service Quality Assurance
    Committee strongly encourages PT participation
  • e.g. UK Drinking Water Inspectorate mandates
    participation in Cryptosporidium PT scheme

14
Sector Specific PT Drivers
  • Important for PT providers to develop good
    relationships with such bodies
  • e.g. European Brewery Convention (EBC)
    represented on LGCs BAPS and MAPS Advisory
    Groups
  • UK Drinking Water Inspectorate provides an
    advisor to the Aquacheck PT scheme

15
Sector Specific PT Drivers
  • Business requirements or regulation can drive PT
    participation
  • PT can play a part in major business to business
    commercial contracts
  • e.g. Major brewery groups mandate participation
    of their malt providers in the MAPS PT scheme
  • PT provider needs to provide appropriate tools
  • Trend graphs illustrating ongoing performance
  • Certificates of participation

16
PT Provider Guidelines
  • A number of guidance documents available to PT
    providers
  • ISO/IEC Guide 43 Part 11997
  • Proficiency testing by interlaboratory
    comparisons Development and operation of
    proficiency testing schemes
  • ILAC Guide 132000
  • Guidelines for the Requirements for the
    Competence of Providers of Proficiency Testing
    Schemes

17
PT Provider Guidelines
  • ISO 135282005
  • Statistical methods for use in proficiency
    testing by interlaboratory comparisons
  • IFCC/EMD/C-AQ
  • Guidelines for the requirements for the
    competence of EQAP organizers in medical
    laboratories
  • The International Harmonized Protocol for the
    Proficiency Testing of Analytical Chemistry
    Laboratories (2006)

18
PT Provider Guidelines
  • Standards for EQA schemes in laboratory medicine
    (2004)
  • National Occupational Standards for External
    Quality Assessment
  • National guidance documents
  • e.g. UKAS PT1 Accreditation of Providers of
    Proficiency Testing Schemes for Laboratory
    Testing

19
Accreditation of PT
  • Accreditation of PT providers is continuing to
    increase
  • Increasing number of accreditation bodies
    providing the service
  • Increasing number of PT providers (and the number
    of schemes) being accredited
  • Accreditation to ISO/IEC Guide 43 in combination
    with ILAC G13 or ISO/IEC 17025 is the most common

20
PT Networks
  • PT underpins quality assurance and is an
    important requirement for laboratory
    accreditation.
  • Given this crucial role for PT, it is essential
    that an appropriate international infrastructure
    exists to ensure the quality of PT provision, and
    its use in the accreditation process, around the
    world.

21
European PT Network
EURACHEM Executive GA
International European Bodies
EA Laboratory Committee
EURACHEM PT Working Group
EA
EA/EURACHEM/Eurolab PT Working Group
Eurolab
National Representatives
National PT Working Group
22
EURACHEM PT WG- Purpose
  • To improve the organisation of proficiency
    testing in Europe
  • To promote best practice in proficiency testing
    using appropriate mechanisms such as
    publications, workshops etc
  • To provide a forum for organisers and users of
    proficiency testing schemes on issues affecting
    the practice of proficiency testing
  • To provide input and disseminate output, on
    proficiency testing, between EURACHEM and other
    international organisations
  • To provide input into international activities
    related to proficiency testing

23
EURACHEM PT WG Activities - Workshops
  • Organisation of the EURACHEM International
    Workshops on Proficiency Testing in Analytical
    Chemistry, Microbiology and Laboratory Medicine
  • Borås, Sweden, September 2000
  • Bracknell, UK, February 2003
  • Portoro, Slovenia, September 2005
  • Rome, Italy, October 2008
  • Through a series of lectures, working group
    discussions and poster sessions key topics on
    proficiency testing are addressed

24
EURACHEM PT WG Activities - Publications
  • Guide to the Selection, use and interpretation
    of proficiency testing (PT) schemes by
    laboratories, 2000
  • Input into the ILAC document ILAC G222004 Use
    of Proficiency Testing as a Tool for
    Accreditation in Testing
  • Development of an general information leaflet on
    PT
  • Currently translated into various European
    languages including Turkish

25
PT Leaflet
26
EURACHEM PT WG Activities
  • Producing a bibliographic listing of references
    relating to PT
  • Writing a paper on fundamental terms relating to
    PT
  • Preparing a discussion paper on setting the
    Standard Deviation for Proficiency Assessment
    (quality goals for PT)

27
EA/EURACHEM/Eurolab PT WG
  • Working group on Proficiency Testing in
    Accreditation Procedures
  • Aim to develop common policy and technical
    advice covering proficiency testing in all areas
    of testing, measurement and analytical results to
    meet the European needs
  • Purpose to provide a discussion forum in order
    to develop support in the form of guidelines and
    policy papers covering proficiency testing in
    accreditation procedures

28
International PT Network
ILAC PT Consultative Group
External PT Providers
ILAC Committees
Regional Cooperations
Interest Groups
e.g. EA APLAC
E.g. EEE-PTWG
29
ILAC PT Consultative Group
  • Terms of reference
  • To organise or contribute workshops, seminars,
    and conferences dealing with PT issues for all
    parties, particularly accreditation bodies, PT
    providers and laboratories
  • To advise the ILAC Executive, ILAC AMC and
    General Assembly on PT Policy, coordination and
    technical issues relevant to the ILAC Arrangement
    and more generally on the use of PT by
    accreditation bodies and other users
  • To advise ILAC on the relevance of PT providers
    to the ILAC Arrangement

30
ILAC PT Consultative Group
  • To review the policies on PT developed within
    Regional Cooperations for possible adoption by
    ILAC
  • To assist in the coordination of Region to Region
    participation in PT by laboratories and potential
    involvement of unaffiliated bodies in Regional
    PTs
  • To identify needs for PT access for developing
    countries and unaffiliated bodies and cost
    effective mechanisms for including them in PT
    programs operated by, or on behalf, of ILAC
    members

31
ILAC PT Consultative Group
  • To encourage all PT providers to use consistent
    or harmonised international criteria for
    operation of PT programs and to contribute to the
    development in ISO, ILAC, the Regional
    Cooperations of ILAC etc of such criteria
  • To advise ILAC on the appropriate harmonised
    criteria to be used to accredit PT providers
  • To draft documents, policies etc on PT for
    possible adoption by ILAC and other relevant
    bodies
  • To serve as a forum for discussion(s) of
    accreditation oriented items or other issues
    relevant to the collective interests of PT
    Providers

32
Summary
  • PT participation is driven by laboratory
    accreditation and other sector specific
    regulation or guidance
  • Provision of PT is guided by a number of
    international standards and guides
  • Increasing number of PT providers seeking and
    achieving accreditation
  • Comprehensive global network of organisations
    concerned with the development of best practice
    in PT provision
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