QUALITY MANAGEMENT Step Process Map Failure Modes and Effects Analysis (FMEA) Validation Protocol
Residual Risk Log and Benefit-Risk Summary
Description
Develop a detailed process map outlining each step of the method or equipment workflow to identify potential failure points and errors.
Utilise FMEA to systematically evaluate each step identified in
the process map, assessing severity, occurrence, and detectability of potential failures to prioritize risks and focus mitigation efforts.
Draft a validation protocol defining scope, objectives, methodologies, acceptance criteria, and responsibilities, informed by findings from the process map and FMEA, emphasising higher risk areas.
Document any residual risks in a risk log after implementing mitigation
strategies. Conduct a benefit-risk analysis to evaluate if remaining risks are acceptable in the context of the method’s clinical utility.
Table 6. Key components of a common validation approach.
familiar, but it does it with a patient risk focus rather than chasing targets set by manufacturers. We also examined the role of the Sigma metric in assessing analytical performance. While it offers valuable insights, it’s essential to consider its limitations and incorporate it within a broader risk management framework to ensure comprehensive quality assurance. Furthermore, the discussion on
harmonising V&V practices across laboratories, particularly highlighted the benefits of standardisation in improving consistency and efficiency.
Looking ahead, the next article in this
series will delve into Risk-Based Quality Control Design and the role of risk in calibration and metrological traceability. We’ll explore the development of QC plans guided by the CLSI EP23-A and later C24 frameworks, ensuring alignment with performance characteristics and patient safety goals. The discussion will cover techniques for monitoring lot-to-lot variations, the role of EQA in risk mitigation, and the application of Failure Reporting, Analysis, and Corrective Action System (FRACAS) for external data monitoring. This upcoming article will build upon the risk-based principles discussed here, extending the
conversation into the realm of quality control and continuous improvement.
Further reading n Clinical and Laboratory Standards Institute.
CLSI EP23-A:2011. Laboratory Quality Control Based on Risk Management.
n Clinical and Laboratory Standards Institute. CLSI EP18-A2:2009. Risk Management Techniques to Identify and Control Laboratory Error Sources. CLSI.
n Clinical and Laboratory Standards Institute. CLSI C24:2016. Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions. CLSI.
n International Organization for Standardization (ISO). ISO 15189:2022. Medical laboratories – Requirements for quality and competence.
n International Organization for Standardization (ISO). ISO 22367:2020. Medical laboratories – Application of risk management to medical laboratories. ISO.
n US Food and Drug Administration. FDA Guidance for Industry: Process Validation – General Principles and Practices.
Dr Stephen MacDonald is Principal Clinical Scientist, The Specialist Haemostasis Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Hills Road, Cambridge CB2 0QQ.
+44 (0)1223 216746.
WWW.PATHOLOGYINPRACTICE.COM MAY 2025
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