Setting up Audit

‘The Liverpool Experience’

Alan Clark

Quality ManagerMerseyside & Cheshire Regional Genetics LaboratoryLiverpool Women’s HospitalLiverpool

Introduction

‘Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.’

Audit

D. Burnett, ‘Practical Guide to Accreditation in Laboratory Medicine’ ACB Venture Publications, 2002 ISBN 0-902429-39-6 After ISO 9000:2002- Quality Management Systems

Starting Point

Standards checklist compliance & evidence

Documentation checklist existence status

Internal Audit Tools

Complaints Incidents Suggestions

Sporadic

Internal Quality Control Activity data Inspections (e.g. H&S) Compliance with Standards and S.O.P.s User satisfaction surveys

Scheduled

Activity data

Spreadsheets monthly data conditional formatting (targets) nett change to residual workload rolling projection

Compliance with SOPs & CPA Standards Vertical Audit Horizontal Audit Examination (Witness) audit

Organization of scheduled audit Timetable Personnel involved

Timetable

Who does Audit?

Cytogenetics Sections audited by personnel

from another section QM oversees and documents &

monitors actions Molecular

QM performs audits QM / HOD oversees QM documents & monitors actions

User Satisfaction Survey

HOD/ HOS and QM design questionnaire

QM mail merges and issues HOD receives QM analyses and reports HOD/HOS and QM agree action plan QM monitors

Without Whom….

D. Burnett CPA (UK) Ltd. Roger Mountford (LWH) Peter Howard (LWH) Angela Douglas (LWH) Simon Patton (SMH) Helen Clarke (Christie) Susan Clark (Christie)