Management of risk: an action plan for pulling everything together

This final article is a bit different. It summarises the concepts we have previously spoken about and lays them out as a (kind of!) action plan for putting risk-based quality management into practice in medical laboratories under ISO 15189:2022 and ISO 22367:2020. It says what to do, who does it, how to check progress, and which measures show it’s working. You can lift the suggested steps straight into a local implementation plan.

The earlier articles set the scene: treat risk as a patient-safety issue; map processes and use FMEA/FTA to find and learn from failure; design IQC using APS; add patient-based and system signals (lot-to-lot checks, delta/RCV, patient medians/moving averages); and manage turnaround time (TAT) as a clinical risk, not a production stat.

Here we pull those parts together into one way of working: clear governance and responsibilities, short-term goals to make risk visible, next steps to automate and join the signals; and longer-term steps to bed the system in a focused set of risk-based KPIs.