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Assuring the Quality of Your External Quality Assessment Scheme (EQAS)

Assuring the Quality of Your External Quality Assessment Scheme (EQAS). Aim of presentation. To explain how to ensure the quality of your External Quality Assessment Scheme (EQAS). Plan of Talk. EQAS and Proficiency Testing Standards and Guidelines The EQAS Process

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Assuring the Quality of Your External Quality Assessment Scheme (EQAS)

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  1. Assuring the Quality of Your External Quality Assessment Scheme (EQAS)

  2. Aim of presentation • To explain how to ensure the quality of your External Quality Assessment Scheme (EQAS)

  3. Plan of Talk • EQAS and Proficiency Testing • Standards and Guidelines • The EQAS Process • Planning and documenting EQAS • EQAS technical requirements • Management System requirements • Gaining accreditation

  4. EQAS and Proficiency Testing • Proficiency Testing (PT) • sanctions linked to inadequate performances • “Traditional” EQAS • no sanctions for poor performance • “Educational” EQAS • emphasis on quality improvement

  5. International Standards • ISO 9001 and 2000 • Quality management (certification) • ISO/IEC 17025:1999 • Quality of laboratory processes / technical aspects (accreditation) • ILAC-G13:2000 • Guidelines for the Requirements for the Competence of Providers of Proficiency Testing Schemes

  6. ILAC-G13:2000 • International Laboratory Accreditation Co-operation (ILAC) • Members are accrediting bodies • Guidelines based on: • ISO Guide 43-1:1997 • and relevant elements of: • ISO/IEC 17025:1999 • ISO 9000:1994

  7. Quality in administering an EQAS Laboratory QMS -ISO 9001 -ISO 17025 EQAS ILAC-G13

  8. Aims of an EQAS • To provide an inter-laboratory comparison: • allows participants to identify problems with their testing process • identifies improvement opportunities • increases awareness of quality benefits

  9. What is a quality EQAS? • Well planned • Follows a Quality Management System • Traceable • Good quality samples • Poor laboratory process is reflected in the EQAS results

  10. 1A.Questionnaire 1B.NewParticipants EQAS Process 2.Preparation of Panels 3.Panel Distribution 4.Data Collection 5.Preliminary report 6.Data Analysis 7.Final report

  11. Planning and documenting EQAS • For every step of the EQAS process try to decide: • Who? • What? • Where? • When? • Why? • How?

  12. Planning and documenting EQAS Select a provider and type of scheme • Where will the funding come from? • Who is the provider and what staff need to be involved? • What will the scope of the EQAS be? • What is the nature and purpose of the scheme (why?)

  13. Planning and documenting EQAS Starting an EQAS • Ensure the Quality of the EQAS provider • Staff and collaborators must be experienced and understand the laboratory processes • Train staff for EQAS • Ensure that testing is done by a technically competent laboratory

  14. Planning and documenting EQAS Collaborators • Decide if you will need the help of any collaborators (subcontractors) • must demonstrate competency • document your expectations and terms • keep a list of collaborators and their accreditation

  15. Planning and documenting EQAS • Which staff are to be involved (who)? • Who are the likely participants and how are they to be selected? • How are specimens to be obtained, processed and distributed?

  16. Planning and documenting EQAS • Describe what information will be provided to participants • Select a time scale for the program (when) • Documentthat participants must use their routine testing strategy (what) • Detail what statistical analysis will be used

  17. Planning and documenting EQAS • Describe what reports and data will be returned to participants • Document how the performance of laboratories will be evaluated • Decide the extent that results and conclusions will be made public (what)

  18. 1A. Questionnaire 1B. New Participants EQAS Process 2.Preparation of Panels 3.Panel Distribution 4.Data Collection 5.Preliminary report 6.Data Analysis 7.Final report

  19. The EQAS Process 1. Instructions to participants • Provide participants with early warning of intention to conduct the scheme • Tell everybody to be ready: • to receive the samples • to store the samples • to test the samples and report the results

  20. 1A.Questionnaire 1B.NewParticipants EQAS Process 2. Preparation of Panels 3.Panel Distribution 4.Data Collection 5.Preliminary report 6.Data Analysis 7.Final report

  21. The EQAS Process 2. Sample production • Select appropriate samples • Ensure the traceability of sample production • who did the testing and aliquotting? • Test materials must be preserved throughout the whole process.

  22. 1A.Questionnaire 1B.NewParticipants EQAS Process 2.Preparation of Panels 3. Panel Distribution 4.Data Collection 5.Preliminary report 6.Data Analysis 7.Final report

  23. The EQAS Process 3. Panel distribution • Packaging and marking process needs to be controlled • checklists useful • Transport safety requirements must be observed • infectious goods

  24. 1A.Questionnaire 1B.NewParticipants EQAS Process 2.Preparation of Panels 3.Panel Distribution 4. Data Collection 5.Preliminary report 6.Data Analysis 7.Final report

  25. The EQAS Process 4. Data collection - Instructions and test details • Participants are usually instructed to use their routine testing strategies • EQAS providers need to request details of the test methods used

  26. The EQAS Process 4. Data collection (2) • Ensure data processing equipment and software are adequate • Validate data entry

  27. 1A.Questionnaire 1B.NewParticipants EQAS Process 2.Preparation of Panels 3.Panel Distribution 4.Data Collection 5. Preliminary report 6.Data Analysis 7.Final report

  28. The EQAS Process 5. Preliminary report • Decide what results will be distributed initially and when • Reference testing results should not be disclosed to participants until all results are returned

  29. 1A.Questionnaire 1B.NewParticipants EQAS Process 2.Preparation of Panels 3.Panel Distribution 4.Data Collection 5.Preliminary report 6. Data Analysis 7.Final report

  30. The EQAS Process 6. Data analysis • Validate the statistical analyses used • Generate summaries and performance statistics • Document criteria and methods for dealing with extreme or outlying results

  31. 1A.Questionnaire 1B.NewParticipants EQAS Process 2.Preparation of Panels 3.Panel Distribution 4.Data Collection 5.Preliminary report 6.Data Analysis 7. Final report

  32. The EQAS Process 7. Reports • The identity of participants is usually kept confidential • assign each laboratory a code number • Show statistical data and summaries • use graphs • Include comments on participants’ performances and advice on the interpretation of the statistics used

  33. ISO 9000 • Management standards • can be applied by any organisation • 20 clauses, • e.g. management responsibility, documentation, etc. • ISO 9001: 2000 • more emphasis on business processes

  34. Management System Requirements • QMS with controlled documentation • Periodic audits • Documented methods for dealing with: • corrective and preventive actions • customer feedback • internal audits • document review

  35. Quality System Documentation Definition of the system Quality Manual Increasing Detail Description of the processes Procedures Instructions for the individual Work Instructions Work Functions

  36. Gaining Accreditation for EQAS 1. Use guidelines (ILAC-G13:2000) 2. Define the processes (planning) 3. Management commitment 4. Staff involvement 5. Documentation 6. Document Management 7. Quality Management System in the laboratory

  37. Gaining Accreditation • For every step of the EQAS process try to answer: • Who? • What? • Where? • When? • Why? • How?

  38. 1A.Questionnaire 1B.NewParticipants EQAS Process 2.Preparation of Panels 3.Panel Distribution 4.Data Collection 5.Preliminary report 6.Data Analysis 7.Final report

  39. Quality Management is a Journey……..Not a Destination

  40. ? What to look for in a quality EQAS • Practical things to look for……… • ILAC-G13:2000 • ISO/IEC 17025:1999 • Or • information from the organisers • evidence of planning and confidentiality • comprehensive reports

  41. Summary • Quality EQAS requires quality management, planning and documentation • Use ILAC G-13:2000 • ISO-9001 and ISO-17025 standards are also relevant • EQAS participants should evaluate the quality of schemes before participating

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