Sibbesen Eurolab TCQA and Reliable Test Results


Published on

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

  • Be the first to comment

  • Be the first to like this

No Downloads
Total views
On SlideShare
From Embeds
Number of Embeds
Embeds 0
No embeds

No notes for slide
  • 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

    1. 1. Eurolab TCQA - working for reliable test results <ul><ul><li>Presentation at TAIEX Meeting </li></ul></ul><ul><ul><li>December 10, 2009 </li></ul></ul><ul><ul><li>by/ Lorens P. Sibbesen, LAB Quality, Denmark (member of TCQA) </li></ul></ul>
    2. 2. T echnical C ommittee on Q uality A ssurance <ul><li>TCQA – a working group under EUROLAB </li></ul><ul><li>Technical Committee for Quality Assurance in testing and calibration </li></ul><ul><li>A horizontal committee composed of one or two experts from the EUROLAB Active and Associated Members </li></ul><ul><li>At present 17 members from 13 member countries </li></ul><ul><li>Meeting regularly twice a year + at misc. events </li></ul><ul><li>Delegating tasks to members to solve between meetings </li></ul><ul><li>Voluntary work!! </li></ul>
    3. 3. Overall aims of TCQA <ul><li>Deal with economic and technical issues regarding Quality Assurance in conformity assessment activities; </li></ul><ul><li>Support laboratories in developing and maintaining a reasonable quality assurance operation; </li></ul><ul><li>Collect, analyse and develop knowledge in this field; </li></ul><ul><li>Share experience gained by laboratories in operating QA systems and make these systems more effective; </li></ul><ul><li>Identify training and educational needs </li></ul>
    4. 4. Overall aims of TCQA (contd.) <ul><li>Plan workshops as well as to produce technical reports and educational material; </li></ul><ul><li>Request the harmonization of accreditation procedures, the implementation of ISO/CEI 17025 and a broad and suitable application of flexible scope </li></ul><ul><li>Lead any activities related to the EUROLAB representation in ISO CASCO WGs </li></ul>
    5. 5. 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…
    6. 6. … and some acronyms (FYI) ! <ul><li>JTCPTC: J oint T echnical C ommittee on P roduct T esting and C ertification (CEOC) </li></ul><ul><li>CEOC: C onfédération E uropéenne des O rganismes de C ontrôle (Eng.: European Confederation of Inspection Organisations) </li></ul><ul><li>ILAC: I nternational L aboratory A ccreditation C ooperation (ILAC LC: … L aboratory C ommittee ) </li></ul><ul><li>JWG: J oint W orking G roup </li></ul><ul><li>EEE-PT: E urolab, E urachem, E uramet cooperation on P roficiency T esting </li></ul><ul><li>PLG: P ermanent L iason G roup between Eurolab, Eurachem, Euramet, EA & CEOC </li></ul><ul><li>EA: E uropean co-operation for A ccreditation (EAAB: EA A dvisory B oard / EALC: EA L aboratory C ommittee) </li></ul><ul><li>ISO CASCO: I nternational S tandard O rganisation C onformity AS sessment CO mmittee </li></ul><ul><li>Euramet: European Association of National Metrology Institutes </li></ul><ul><li>Eurachem: … a focus for analytical chemistry and quality related issues in Europe </li></ul><ul><li>CITAC: C ooperation on I nternational T raceability in A nalytical C hemistry </li></ul>
    7. 7. Focus Point: Reliable testresults! <ul><li>Conformity assessment (CA) i many cases based on test results </li></ul><ul><li>- which again is based on traceable calibrations </li></ul><ul><li>The right decision about conformity must be based on trust in the reliability of these test results (and the calibrations behind them) </li></ul>
    8. 8. QUALITY ASSURANCE in CA ! <ul><li>Quality Assurance of test results </li></ul><ul><li>Confidence-building documentation for the results being reliable! </li></ul>… ... and (possibly) a formal 3rd party approval of the laboratory being in control – e.g. Accreditation!
    9. 9. Tools for establishing reliability <ul><li>The laboratories implement a number of tools for establishing reliability of test results - e.g.: </li></ul><ul><ul><li>Securing technical competence of staff </li></ul></ul><ul><ul><li>Validating methods </li></ul></ul><ul><ul><li>Documenting traceability </li></ul></ul><ul><ul><li>Using Reference Materials </li></ul></ul><ul><ul><li>Participating in Proficiency Testings </li></ul></ul><ul><ul><li>Estimating Measurement Uncertainty </li></ul></ul><ul><ul><li>… a.o. </li></ul></ul><ul><li>- and documenting all this - i.e. establishing a Quality System </li></ul>
    10. 10. TCQA in support for these QA efforts! <ul><li>The group within Eurolab specificly and actively dealing with these important issues on a practical level! </li></ul><ul><li>Issues picked up and dealt with by a group of experts from member states </li></ul><ul><li>Discussing subjects of common interest towards a consensus – eventually to be published as an Eurolab Policy on the issue </li></ul><ul><li>Identifying important issues for preparation of guide-lines (or Cook Books) </li></ul><ul><li>Making survey on common practices in different countries </li></ul>
    11. 11. TCQA playing a role for reliability <ul><li>On the formal level (F) </li></ul><ul><ul><li>Follow-up on the European Accreditation system and it’s implementation (e.g. Flexible Scope, Cross Frontier Policy, Price policies etc.) </li></ul></ul><ul><ul><li>Influencing new standards through ISO CASCO </li></ul></ul><ul><li>On the practical level (P) </li></ul><ul><ul><li>Elaborating guidelines on interpretation of accreditation requirements </li></ul></ul><ul><ul><li>Giving “at the lab-desk” common praxis guidance (e.g. Cook Books) </li></ul></ul><ul><ul><li>Working on transparency and harmonization of practices within the European member states </li></ul></ul><ul><li>For the benefit of all members in Europe! </li></ul>
    12. 12. TCQA – and accreditation (F) <ul><li>Commenting on EA practices etc. </li></ul><ul><ul><li>Joining EAAB and EALC </li></ul></ul><ul><ul><li>Discussing new approaches – and giving feed back (both ways) </li></ul></ul><ul><li>Elaborating guidelines on practical implementation of accreditation requirements </li></ul><ul><ul><li>In cooperation with other organisations (ILAC, Eurachem a.o.) </li></ul></ul><ul><li>Following up upon the use – and implications – of an accreditation mark on test reports </li></ul><ul><li>Dealing with the principles of Flexible Scope </li></ul><ul><ul><li>Survey on practices within Europe </li></ul></ul><ul><ul><li>Workshop in Prague, Nov. 2009 </li></ul></ul>
    13. 13. TCQA – and standardization (F) <ul><li>Eurolab granted A-liaison status with ISO CASCO </li></ul><ul><ul><li>Giving right to send delegates to WGs </li></ul></ul><ul><ul><li>TCQA has nominated a member to WG on revision of ISO 17025 </li></ul></ul><ul><ul><li>Following the development of new standard ISO 17043 on PT schemes </li></ul></ul><ul><li>Following development of new CEN standards </li></ul>
    14. 14. TCQA – guiding the laboratories (P) <ul><li>Preparation of a number of Guidelines, Technical Reports and general position papers - E.g.: </li></ul><ul><ul><li>Measurement uncertainty revisited: Alternative approaches to uncertainty evaluation (2007) </li></ul></ul><ul><ul><li>Guidance for the management of computers and software in laboratories with reference to ISO/IEC 17025 (2006) </li></ul></ul><ul><ul><li>Measurement uncertainty arising from sampling (2007) </li></ul></ul><ul><ul><ul><li>Produced in cooperation with Eurachem a.o. </li></ul></ul></ul><ul><li>Reading list on Measurement Uncertainty </li></ul><ul><ul><li>Following the development </li></ul></ul>
    15. 15. TCQA – dissemination of good practices (P) <ul><li>Exchange of good practices </li></ul><ul><ul><li>The Cook Books [as mentioned in previous lecture!] </li></ul></ul><ul><ul><li>Facilitating contacts between national member organisations (Networking!) </li></ul></ul><ul><li>Arranging seminars and workshops </li></ul><ul><ul><li>E.g. </li></ul></ul><ul><ul><li>Sampling Uncertainty and Uncertainty for Compliance Assessment (Berlin, April 2008) </li></ul></ul><ul><ul><ul><li>- in cooperation with Eurachem and CITAC </li></ul></ul></ul>
    16. 16. TCQA – working for hamonization <ul><li>Surveys on practices in different member states </li></ul><ul><ul><li>Flexible Scope for Accreditation (summer 2009) </li></ul></ul><ul><ul><li>Price Policies for Accreditation (planned) </li></ul></ul><ul><ul><li>a.o. </li></ul></ul><ul><li>Cooperation on the international scene </li></ul><ul><ul><li>E.g. commenting on ILAC documents </li></ul></ul><ul><li>Using position for influencing future, common practices </li></ul><ul><ul><li>E.g. discussing Cross Frontier Policy </li></ul></ul><ul><li>Close contact to national member organisations </li></ul>
    17. 17. 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
    18. 18. Thank you for your attention!
    19. 19. My background… <ul><li>Lorens P. Sibbesen ( [email_address] ) </li></ul><ul><li>Chemical Engineer </li></ul><ul><li>Worked with analytical laboratories and QA in laboratories since 1987 </li></ul><ul><li>Self-employed with LAB Quality since 2000 ( ) </li></ul><ul><li>Secretary of Eurolab Denmark </li></ul><ul><li>Member of TCQA since 2007 </li></ul><ul><li>Member of Eurachem GA, AOAC a.o. </li></ul><ul><li>Working on projects for improvement of Quality Infrastructure in e.g. Turkey, Jordan, Latvia a.o. </li></ul>