Stephen MacDonald continues his new series on the management of risk in the pathology laboratory environment with a look at three practical approaches, process mapping, failure mode and effects analysis, and fault tree analysis.
Risk management in medical laboratories is essential for ensuring that diagnostic results are accurate, reliable and timely, minimising the potential for clinical harm. The first article in this series introduced ISO 15189:2022 and ISO 22367:2020, which establish structured approaches for risk management, covering risk identification, evaluation, and control throughout the laboratory workflow.
In this second article, we move beyond concepts and frameworks into the practical tools used to analyse risks. Three key methodologies – process mapping, failure mode and effects analysis (FMEA), and fault tree analysis (FTA) – are essential for systematically evaluating laboratory processes, identifying failure points, and implementing corrective measures.
Process mapping serves as the foundation, helping laboratories visualise workflows and pinpoint areas of risk. FMEA provides a structured approach to identifying failure modes before they lead to patient harm, while FTA allows for in-depth analysis of adverse events that have already occurred.
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