Transcript Creativity Session - British Society for Microbial Technology

BSMT
Microbiology Managers
Conference
November 2006
Regional Assessors
Role and Responsibilities
Michael Haldon, Regional Assessor
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Introduction
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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
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Schedule for Assessment
Period 1
Period 2 Period 3 Period 4 Period 5
Oct 05Mar 06
Apr 06Sept 06
Oct 06Mar 07
Application
Main visit
Ann reg
Period 6
Period 7 Period 8 Period 1 Period 2
Apr 08Sept 08
Oct 08Mar 09
Surveillance
Ann reg
Apr 09Sept 09
Apr 07Sept 07
Oct 07Mar 08
Ann reg
Oct 09Mar10
Apr 10Sept 10
Application
Main visit
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Presentation Content
Regional Assessor Teams
 Main Assessment
 Post Main Assessment
 Surveillance Assessment
 Annual Management Review
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Mid West Team
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Phil Shread
Fiona Allison
Jan Chatfield
Julie Rogers
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Sandra Thickett Accreditation Manager
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Regional Assessment Manager
Regional Assessor
Regional Assessor
Regional Assessor
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Mid West Area
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Northern Ireland
Wales
West Midlands (North, South, Central)
Avon, Gloucestershire, Wiltshire
Hampshire & IOW
Somerset & Dorset
SW Peninsula
Cheshire & Merseyside
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Mid East Team
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Gwen Guthrie
Rochelle Brugh
Jackie Barker
Rachel Boyer-Blanchard
Reg. Assessment Manager
Reg. Assessor
Reg. Assessor
Reg. Assessor
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Alan Wolfe
Accreditation Manager
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Mid East Area(1)
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Trent
Leicestershire, Northamptonshire & Rutland
Lincolnshire (except NE)
Norfolk, Suffolk & Cambridgeshire
Bedfordshire & Hertfordshire
Thames Valley
Essex
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Mid East Area (2)
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Surrey & Sussex
Kent
London North Central
London North East
London South East
London South West
National Blood Services (currently)
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North Team
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Ken Rae
Andrew Dowdall
Michael Haldon
John Ringrow
Regional Assessment Manager
Regional Assessor
Regional Assessor
Regional Assessor
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Janet Holmes
Accreditation Manager
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North Team Area
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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
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What are we?

What we ARE
– An equal part of the Assessment Team
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What we ARE NOT
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A Peer Assessor
A “head” Assessor
A consultant/advisor for the laboratory
Status decision makers
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Main Assessment Visit
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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
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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
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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
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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
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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
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After the Main Visit
Check on progress of non-compliances
 Sign off non-compliance clearance
forms
 Surveillance visits
 Annual Management Review
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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
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ISO 17011
7.11.3 Accreditation bodies shall rely on either reassessment
alone or a combination of reassessment and surveillance, as
follows:
•Surveillance every 2 years
a) if based on reassessment alone, then the reassessment shall take
place at intervals not exceeding 2 years; or
b) if the combination of reassessment and surveillance is relied upon,
then the accreditation body shall undertake a reassessment at least every
5 years. However, the interval between the surveillance on-site
assessments should not exceed 2 years.
•Reassessment every 5 years
It is, however, recommended that the first surveillance on-site
assessment be carried out no later than 12 months from the date
of initial accreditation.
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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
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Surveillance Visits-Why Have
Them? (3)
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Clear any outstanding non- compliances
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Follow up issues identified from Annual
Management Review
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Surveillance Visits
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What are they?
 One day visits to assess the current
status of the:– Organisation and Quality Management System.
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(Standard A)
Personnel ( Standard B)
Premises and Environments ( Standard C)
Equipment, Information Systems etc ( Standard D)
Evaluation and Quality Assurance (Standard H)
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Surveillance Visits
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Who will assess?
– Regional Assessor and on occasion a peer
assessor
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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
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Surveillance Visits
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What might we look at?
– Quality manual
– Document control
– Annual management review
– Evidence of recording and addressing any
non-conformities identified
– Audit programme
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Surveillance Visits
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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
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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
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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
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Standards
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CPA Standards for Medical Laboratories
– www.cpa-uk.co.uk
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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 systemsrequirements
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ILAC is an international cooperation of laboratory and
inspection accreditation bodies.
– www.ilac.org
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European network for accreditation
– www.european-accreditation.org
International Accreditation Forum
– www.iaf.nu
UKAS
– www.ukas.com
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