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Sibbesen Eurolab TCQA and Reliable Test Results

Sibbesen Eurolab TCQA and Reliable Test Results



Presentation on the role of Eurolab TCQA (Tech. Comm. on QA) in securing reliability of test results used for decision making

Presentation on the role of Eurolab TCQA (Tech. Comm. on QA) in securing reliability of test results used for decision making



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  • Referencer: 1. EAL-P10: ”The Scope of Accreditation and Consideration of Methods and Criteria for the Assessment of the Scope in Testing” Edition 1, EAL/Eurolab, February 1997 2. DS/EN 45002 ”Generelle kriterier for bedømmelse af prøvningslaboratorier”, 2. udgave, Dansk Standard (Maj 1991) 3. ISO/IEC DIS 17025: ”General requirements for the competence of testing and calibration laboratories”. (Revision of Guide 25:1990), ISO/TC CASCO, 1998-07-09 4. H. Ischi ”The effective and efficient assessment of competence of testing laboratories applying for accreditation”. J. Accreditation and Quality Assurance, vol. 3, nr. 7 (July 1998), p. 288-290). 5. WELAC / Eurachem, EURACHEM Guidance Document No. 1 / WELAC Guidance Document No. WGD 2 Accreditation of Chemical Laboratories. Guidance on the interpretation of the EN 45000 series of Standards and ISO/IEC Guide 25", Edition 1, April 1993 (senere registreret som EAL-dokument nr. EAL-G4)

Sibbesen Eurolab TCQA and Reliable Test Results Sibbesen Eurolab TCQA and Reliable Test Results Presentation Transcript

  • Eurolab TCQA - working for reliable test results
      • Presentation at TAIEX Meeting
      • December 10, 2009
      • by/ Lorens P. Sibbesen, LAB Quality, Denmark (member of TCQA)
  • T echnical C ommittee on Q uality A ssurance
    • TCQA – a working group under EUROLAB
    • Technical Committee for Quality Assurance in testing and calibration
    • A horizontal committee composed of one or two experts from the EUROLAB Active and Associated Members
    • At present 17 members from 13 member countries
    • Meeting regularly twice a year + at misc. events
    • Delegating tasks to members to solve between meetings
    • Voluntary work!!
  • Overall aims of TCQA
    • Deal with economic and technical issues regarding Quality Assurance in conformity assessment activities;
    • Support laboratories in developing and maintaining a reasonable quality assurance operation;
    • Collect, analyse and develop knowledge in this field;
    • Share experience gained by laboratories in operating QA systems and make these systems more effective;
    • Identify training and educational needs
  • Overall aims of TCQA (contd.)
    • Plan workshops as well as to produce technical reports and educational material;
    • Request the harmonization of accreditation procedures, the implementation of ISO/CEI 17025 and a broad and suitable application of flexible scope
    • Lead any activities related to the EUROLAB representation in ISO CASCO WGs
  • TCQA coordinating with others TC QA EAAB EUROLAB GA BoA EEE-PT EA LC PLG ILAC GA ILAC LC JTC PTC JWG Eurachem ISO CASCO Other relations: CEN, Euramet, CITAC…
  • … and some acronyms (FYI) !
    • JTCPTC: J oint T echnical C ommittee on P roduct T esting and C ertification (CEOC)
    • CEOC: C onfédération E uropéenne des O rganismes de C ontrôle (Eng.: European Confederation of Inspection Organisations)
    • ILAC: I nternational L aboratory A ccreditation C ooperation (ILAC LC: … L aboratory C ommittee )
    • JWG: J oint W orking G roup
    • EEE-PT: E urolab, E urachem, E uramet cooperation on P roficiency T esting
    • PLG: P ermanent L iason G roup between Eurolab, Eurachem, Euramet, EA & CEOC
    • EA: E uropean co-operation for A ccreditation (EAAB: EA A dvisory B oard / EALC: EA L aboratory C ommittee)
    • ISO CASCO: I nternational S tandard O rganisation C onformity AS sessment CO mmittee
    • Euramet: European Association of National Metrology Institutes
    • Eurachem: … a focus for analytical chemistry and quality related issues in Europe
    • CITAC: C ooperation on I nternational T raceability in A nalytical C hemistry
  • Focus Point: Reliable testresults!
    • Conformity assessment (CA) i many cases based on test results
    • - which again is based on traceable calibrations
    • The right decision about conformity must be based on trust in the reliability of these test results (and the calibrations behind them)
    • Quality Assurance of test results
    • Confidence-building documentation for the results being reliable!
    … ... and (possibly) a formal 3rd party approval of the laboratory being in control – e.g. Accreditation!
  • Tools for establishing reliability
    • The laboratories implement a number of tools for establishing reliability of test results - e.g.:
      • Securing technical competence of staff
      • Validating methods
      • Documenting traceability
      • Using Reference Materials
      • Participating in Proficiency Testings
      • Estimating Measurement Uncertainty
      • … a.o.
    • - and documenting all this - i.e. establishing a Quality System
  • TCQA in support for these QA efforts!
    • The group within Eurolab specificly and actively dealing with these important issues on a practical level!
    • Issues picked up and dealt with by a group of experts from member states
    • Discussing subjects of common interest towards a consensus – eventually to be published as an Eurolab Policy on the issue
    • Identifying important issues for preparation of guide-lines (or Cook Books)
    • Making survey on common practices in different countries
  • TCQA playing a role for reliability
    • On the formal level (F)
      • Follow-up on the European Accreditation system and it’s implementation (e.g. Flexible Scope, Cross Frontier Policy, Price policies etc.)
      • Influencing new standards through ISO CASCO
    • On the practical level (P)
      • Elaborating guidelines on interpretation of accreditation requirements
      • Giving “at the lab-desk” common praxis guidance (e.g. Cook Books)
      • Working on transparency and harmonization of practices within the European member states
    • For the benefit of all members in Europe!
  • TCQA – and accreditation (F)
    • Commenting on EA practices etc.
      • Joining EAAB and EALC
      • Discussing new approaches – and giving feed back (both ways)
    • Elaborating guidelines on practical implementation of accreditation requirements
      • In cooperation with other organisations (ILAC, Eurachem a.o.)
    • Following up upon the use – and implications – of an accreditation mark on test reports
    • Dealing with the principles of Flexible Scope
      • Survey on practices within Europe
      • Workshop in Prague, Nov. 2009
  • TCQA – and standardization (F)
    • Eurolab granted A-liaison status with ISO CASCO
      • Giving right to send delegates to WGs
      • TCQA has nominated a member to WG on revision of ISO 17025
      • Following the development of new standard ISO 17043 on PT schemes
    • Following development of new CEN standards
  • TCQA – guiding the laboratories (P)
    • Preparation of a number of Guidelines, Technical Reports and general position papers - E.g.:
      • Measurement uncertainty revisited: Alternative approaches to uncertainty evaluation (2007)
      • Guidance for the management of computers and software in laboratories with reference to ISO/IEC 17025 (2006)
      • Measurement uncertainty arising from sampling (2007)
        • Produced in cooperation with Eurachem a.o.
    • Reading list on Measurement Uncertainty
      • Following the development
  • TCQA – dissemination of good practices (P)
    • Exchange of good practices
      • The Cook Books [as mentioned in previous lecture!]
      • Facilitating contacts between national member organisations (Networking!)
    • Arranging seminars and workshops
      • E.g.
      • Sampling Uncertainty and Uncertainty for Compliance Assessment (Berlin, April 2008)
        • - in cooperation with Eurachem and CITAC
  • TCQA – working for hamonization
    • Surveys on practices in different member states
      • Flexible Scope for Accreditation (summer 2009)
      • Price Policies for Accreditation (planned)
      • a.o.
    • Cooperation on the international scene
      • E.g. commenting on ILAC documents
    • Using position for influencing future, common practices
      • E.g. discussing Cross Frontier Policy
    • Close contact to national member organisations
  • Conclusion: Eurolab TCQA a key player in CA! Reliable testresults! One way of supporting the CA processes in Europe! Follow-up upon Accr. system (EA) Influencing relevant standards Preparation of guidelines ” Cook Books” Seminars and Workshops Networking
  • Thank you for your attention!
  • My background…
    • Lorens P. Sibbesen ( [email_address] )
    • Chemical Engineer
    • Worked with analytical laboratories and QA in laboratories since 1987
    • Self-employed with LAB Quality since 2000 ( www.labqa.dk )
    • Secretary of Eurolab Denmark
    • Member of TCQA since 2007
    • Member of Eurachem GA, AOAC a.o.
    • Working on projects for improvement of Quality Infrastructure in e.g. Turkey, Jordan, Latvia a.o.