RISK MANAGEMENT
Process mapping, FMEA and FTA: practical approaches to risk assessment
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.
Process mapping as the foundation of risk analysis
n Role of process mapping in risk management
Before applying structured risk assessment tools such as FMEA and FTA, laboratories must first understand how their processes function. Without this, risk evaluation efforts are disjointed, incomplete, or reactive, rather than forming a structured and proactive risk management system. Process mapping is a structured
Process mapping, FMEA and FTA are three key practical approaches to the management of risk assessment.
WWW.PATHOLOGYINPRACTICE.COM APRIL 2025
approach to visually representing workflows, making it easier to identify dependencies, inefficiencies, and potential failure points that could compromise quality or patient safety. By dissecting processes into discrete steps and charting their interconnections, laboratories can systematically evaluate where risks are likely to arise. Process mapping serves several critical purposes: n It helps uncover risk-prone areas in laboratory workflows, including
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