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

2. 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. 3 Schedule for Assessment Period 1Period 2Period 3Period 4Period 5 Oct 05- Mar 06 Apr 06- Sept 06 Oct 06- Mar 07 Apr 07- Sept 07 Oct 07- Mar 08 ApplicationMain visitAnn reg Period 6Period 7Period 8Period 1Period 2 Apr 08- Sept 08 Oct 08- Mar 09 Apr 09- Sept 09 Oct 09- Mar10 Apr 10- Sept 10 SurveillanceAnn regApplicationMain visit

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

5. 5 Mid West Team Phil ShreadRegional Assessment Manager Fiona Allison Regional Assessor Jan Chatfield Regional Assessor Julie Rogers Regional Assessor Sandra ThickettAccreditation Manager

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

7. 7 Mid East Team Gwen GuthrieReg. Assessment Manager Rochelle Brugh Reg. Assessor Jackie Barker Reg. Assessor Rachel Boyer-BlanchardReg. Assessor Alan WolfeAccreditation Manager

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

9. 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. 10 North Team Ken RaeRegional Assessment Manager Andrew Dowdall Regional Assessor Michael Haldon Regional Assessor John Ringrow Regional Assessor Janet HolmesAccreditation Manager

11. 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. 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. 13 Main Assessment Visit

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

15. 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. 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. 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. 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. 19 After the Main Visit Check on progress of non-compliances Sign off non-compliance clearance forms Surveillance visits Annual Management Review

20. 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. 21 ISO 17011

22. 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. 23 Surveillance Visits-Why Have Them? (3) Clear any outstanding non- compliances Follow up issues identified from Annual Management Review

24. 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. 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. 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. 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. 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. 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. 30 Standards CPA Standards for Medical Laboratories – www.cpa-uk.co.uk 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. 31 ILAC is an international cooperation of laboratory and inspection accreditation bodies. – www.ilac.org www.ilac.org European network for accreditation – www.european-accreditation.org www.european-accreditation.org International Accreditation Forum – www.iaf.nu UKAS – www.ukas.com