QUALITY MANAGEMENT
Management of risk: an action plan for pulling everything together
Stephen MacDonald concludes his series of articles on risk-based quality management by drawing together the various elements on which each of the previous seven articles focused.
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:
Focus Policy
Analysis Commissioning IQC External checks TAT Review Goal Risk visible Prioritise risk Local verification Proportionate start Early warnings Clinical timing Close the loop Actions Approve policy
Create live registers Map processes
FMEA, FTA/RCA after incidents Verify new/changed methods;
record residual risk
Set rules & frequency by performance specifications
Lot-to-lot, patient medians/MA, delta checks
Define clinically based timings tiered targets based on risk pre-breach escalation
Short review; issue residual-risk notes; track CAPA
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
Accountability
Owners: Lab Manager, Quality team. Evidence: signed policy, registers in QMS.
Owners: Section Leads, Quality.
Evidence: FMEA filed; RCA actions logged. Owners: Section Leads, Clinical Lead.
Evidence: verification report; risk note. Owners: Section Leads
Evidence: QC plan Owners: Section Leads, IT.
Evidence: alerts logged, thresholds documented. Owners: Lab Manager, Quality, IT, Clinical.
Evidence: % compliance, interventions and deviations are recorded. Owners: Quality, Governance.
Evidence: notes filed; CAPA closed.
Table 1. Short-term implementation of risk to make the risk approach visible. QMS: Quality Management System, MA: Moving Average, FMEA: Failure Modes Effects Analysis, FTA: Fault Tree Analysis, RCA: Root Cause Analysis, IQC: Internal Quality Control, CAPA: Corrective and Preventative Actions
WWW.PATHOLOGYINPRACTICE.COM DECEMBER 2025 15
steps to bed the system in a focused set of risk-based KPIs.
n Plan
Make risk visible and put minimum controls in place
Get the basics in place so risk is visible and actions are clear. Agree a simple risk policy, stand up live risk registers, set a first-pass QC plan that reflects patient risk, switch on a few high-value external checks, and run TAT as a clinical measure from day one. Keep settings modest and review them quickly rather than trying to perfect them (Table 1).
n Do
Join the signals up Tighten QC where risk is highest and automate routine checks so people focus on decisions. Re-estimate Sigma at decision points (if using it), align rules to APS, and use risk-based QC intervals. Expand patient-based monitoring
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