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Setting up Audit. ‘The Liverpool Experience’. Alan Clark Quality Manager Merseyside & Cheshire Regional Genetics Laboratory Liverpool Women’s Hospital Liverpool. Introduction. Audit.
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Setting up Audit ‘The Liverpool Experience’ Alan Clark Quality ManagerMerseyside & Cheshire Regional Genetics LaboratoryLiverpool Women’s HospitalLiverpool
Introduction Audit ‘Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.’ 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 Sporadic • Complaints • Incidents • Suggestions Scheduled • Internal Quality Control • Activity data • Inspections (e.g. H&S) • Compliance with Standards and S.O.P.s • User satisfaction surveys
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
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)