BSMT Microbiology Managers Conference November 2006 Regional Assessors

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

Introduction l 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 2

Schedule for Assessment Period 1 Period 2 Period 3 Period 4 Period 5 Oct 05 Mar 06 Apr 06 Sept 06 Oct 06 Mar 07 Application Main visit Ann reg Period 6 Period 7 Period 8 Period 1 Period 2 Apr 08 Sept 08 Oct 08 Mar 09 Surveillance Ann reg Apr 09 Sept 09 Apr 07 Sept 07 Oct 07 Mar 08 Ann reg Oct 09 Mar 10 Apr 10 Sept 10 Application Main visit 3

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

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

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

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

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

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

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

North Team Area l l l l 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 11

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

Main Assessment Visit 13

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

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

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

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

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

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

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

ISO 17011 21

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

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

Surveillance Visits What are they? l One day visits to assess the current status of the: l – 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) 24

Surveillance Visits l Who will assess? – Regional Assessor and on occasion a peer assessor l 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 25

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

Surveillance Visits l 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 27

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

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

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

l ILAC is an international cooperation of laboratory and inspection accreditation bodies. – www. ilac. org European network for accreditation – www. european-accreditation. org l International Accreditation Forum – www. iaf. nu l UKAS – www. ukas. com l 31