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BSMT Microbiology Managers Conference November 2006 Regional Assessors Role and Responsibilities Michael Haldon, Regio

BSMT Microbiology Managers Conference November 2006 Regional Assessors Role and Responsibilities Michael Haldon, Regional Assessor. Introduction. Why did CPA need Regional Assessors? Changing requirements of assessments Reducing pool of peer assessors

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BSMT Microbiology Managers Conference November 2006 Regional Assessors Role and Responsibilities Michael Haldon, Regio

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  1. BSMT Microbiology Managers Conference November 2006 Regional Assessors Role and Responsibilities Michael Haldon, Regional Assessor

  2. Introduction • Why did CPA need Regional Assessors? • Changing requirements of assessments • Reducing pool of peer assessors • Need for conformity of approach to assessments • UKAS/CPA partnership

  3. Schedule for Assessment

  4. Presentation Content • Regional Assessor Teams • Main Assessment • Post Main Assessment • Surveillance Assessment • Annual Management Review

  5. Phil Shread Regional Assessment Manager Fiona Allison Regional Assessor Jan Chatfield Regional Assessor Julie Rogers Regional Assessor Sandra Thickett Accreditation Manager Mid West Team

  6. Mid West Area • Northern Ireland • Wales • West Midlands (North, South, Central) • Avon, Gloucestershire, Wiltshire • Hampshire & IOW • Somerset & Dorset • SW Peninsula • Cheshire & Merseyside

  7. Gwen Guthrie Reg. Assessment Manager Rochelle Brugh Reg. Assessor Jackie Barker Reg. Assessor Rachel Boyer-Blanchard Reg. Assessor Alan Wolfe Accreditation Manager Mid East Team

  8. Mid East Area(1) • Trent • Leicestershire, Northamptonshire & Rutland • Lincolnshire (except NE) • Norfolk, Suffolk & Cambridgeshire • Bedfordshire & Hertfordshire • Thames Valley • Essex

  9. Mid East Area (2) • Surrey & Sussex • Kent • London North Central • London North East • London South East • London South West • National Blood Services (currently)

  10. Ken Rae Regional Assessment Manager Andrew Dowdall Regional Assessor Michael Haldon Regional Assessor John Ringrow Regional Assessor Janet Holmes Accreditation Manager North Team

  11. North Team Area • Scotland • South Yorkshire • Northumbria and Tyne & Wear • County Durham and North Tees • Cumbria and Lancashire • N Yorkshire, York, Hull, N & NE Lincs. • W Yorkshire • Greater Manchester

  12. What are we? • What we ARE • An equal part of the Assessment Team • What we ARE NOT • A Peer Assessor • A “head” Assessor • A consultant/advisor for the laboratory • Status decision makers

  13. Main Assessment Visit

  14. Before the Main Visit (1) • Making initial contact with the laboratories • Agreeing proposeddates for visit • Encouraging laboratories to complete and submit their Application Forms, Annual Reviews and Quality Manuals within schedule

  15. Before the Main Visit (2) • Identifying laboratory contacts • Checking history and paperwork for individual laboratories • Alerting CPA of dates for organisation of suitable peer assessors

  16. Before the Main Visit (3) • Liaising with the laboratory on timetable including meetings with the Chief Executive and User Group • Reviewing available and relevant Quality Management documentation • Produce final time-table for visit

  17. During the Main Visit (1) • Conduct Opening Meeting • Horizontal Audit of Quality Management System • Check and verify clearance evidence for outstanding non-compliances • Chair CE and User meetings • Conduct interview with Qual. Manager

  18. During the Main visit (2) • Ensure consistency • Support peer assessors • Conduct Closing Meeting • Raise any QMS non-compliances for sign off in debrief meeting • Collate all paperwork for sending to CPA Central Office

  19. After the Main Visit • Check on progress of non-compliances • Sign off non-compliance clearance forms • Surveillance visits • Annual Management Review

  20. Surveillance Visits-Why Have Them? (1) • They will add extra value to the assessment process • CPA does not want to continue to provide an Accreditation Certificate long after the assessment visit • CPA needs to fulfil the requirements of ISO 17011 • Allows CPA to stay in touch with laboratory

  21. ISO 17011

  22. Surveillance Visits-Why Have Them? (2) • Will allow CPA to confirm that the actions identified in non-compliance forms have been carried out • Reduce the time scale between assessment visit and the eventual issue of accreditation certificate

  23. Surveillance Visits-Why Have Them? (3) • Clear any outstanding non- compliances • Follow up issues identified from Annual Management Review

  24. Surveillance Visits • What are they? • One day visits to assess the current status of the:- • Organisation and Quality Management System. (Standard A) • Personnel ( Standard B) • Premises and Environments ( Standard C) • Equipment, Information Systems etc ( Standard D) • Evaluation and Quality Assurance (Standard H)

  25. Surveillance Visits • Who will assess? • Regional Assessor and on occasion a peer assessor • What will we assess? • Evidence that the Laboratory is complying with the Standards as set out in “ Standards for the Medical Laboratory” • Evidence of a Plan – Do - Check - Act culture

  26. Surveillance Visits • What might we look at? • Quality manual • Document control • Annual management review • Evidence of recording and addressing any non-conformities identified • Audit programme

  27. Surveillance Visits • What will the outcome be? • building up of links and rapport between Regional Assessors and laboratories • a more streamlined process for all concerned • any findings will be recorded

  28. Reporting Findings for Surveillance Visits • Report findings as mandatory action required or action recommended • Mandatory must be corrected within a 3 month time-scale • Recommended will not affect status but will be picked up at next main visit

  29. Annual Management Review • Regional Assessor will review the AMR summary • Formal Procedure-Review Documented • May request further information from laboratory • Provides a means of staying in touch with the laboratory

  30. Standards • CPA Standards for Medical Laboratories • www.cpa-uk.co.uk • ISO 15189:2003 – Medical laboratories – particular requirements for quality and competence • ISO 22870:2006 POCT - Requirements for quality and competence • ISO 9001:2000 – Quality management systems- requirements

  31. ILACis an international cooperation of laboratory andinspection accreditation bodies. • www.ilac.org • European network for accreditation • www.european-accreditation.org • International Accreditation Forum • www.iaf.nu • UKAS • www.ukas.com

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