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Jeremy Skinner CSci, FIBMS Quality Manager Genetics Centre GSTT (GSTS) . Feedback from EuroGentest Workshop: Annual Management Review, IQC and EQA Berlin 9-10 th Oct 2008. OR. ‘Quality is doing it right when no-one is looking’. EQA.
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Jeremy Skinner CSci, FIBMS Quality Manager Genetics Centre GSTT (GSTS) Feedback from EuroGentest Workshop:Annual Management Review, IQC and EQA Berlin 9-10th Oct 2008
OR ‘Quality is doing it right when no-one is looking’
EQA ‘The main objective of external quality assessment is to establish inter-laboratory compatibility’ External evidence that test gives correct results - Accuracy Participate in as many schemes as possible to cover repertoire Make sure EQA covers Sample reception Sample preparation Key analytical methods Interpretation
IQC WHO definition (1981) ‘The main objective of internal quality control is to ensure day-to day consistency’ Verifying that test is giving consistent results – precision Identify potential errors and then define IQC in SOPs Tests precise and accurate
Accuracy and precision Good precision but poor accuracy Poor assay, Good operator Poor accuracy and precision Poor assay, Poor operator Good precision and good accuracy Good assay, Good operator
Annual Management Review Needed to comply with CPA stds A11 (ISO 15189 4.15.1) Follow-up on previous objectives Review of QMS Quality policy Quality manual Overview of QMS Audits and NCs/QIs Complaints User surveys Quality indicators
Quality Indicators ‘Quality Indicators for monitoring the laboratory’s contribution to patient care’
Results from AMR Formal action plan Quality objectives Improvement to QMS Improvement to processes Resources required Executive summary (for CPA)