QUALITY MANAGEMENT Aim What to implement


Position risk management Frame actions; link controls to clinical as a practical, staged


decision limits and patient safety;


implementation under ISO use a single integrated review pathway. 15189/22367, signposting


the detailed articles. Make ownership


unambiguous from policy to bench.


Make risk visible;


put minimum viable controls in place.


Tighten controls and automate routine detection.


Risk policy with acceptability criteria; living risk registers; process mapping + FMEA (identification) and FTA/RCA (learning) embedded in QMS.


Section risk registers (top assays); risk-based V&V for new/changed methods; initial QC by APS switch on lot-to-lot, delta/RCV, patient medians; manage TAT as clinical risk with %-compliance and live boards.


Re-estimate Sigma at decision points; set QC intervals by risk, scale PBRTQC (patient medians/MAs), delta and correlation rules in LIS; formalise lot-to-lot and


inter-analyser checks; mature TAT escalation. Embed a single, risk-weighted system across methods and sites.


Prove risk reduction with a small, disciplined set of indicators.


Primary owners Evidence / KPIs Lab Director;


Cross-ref to series Signed risk policy;


Quality Manager live risk registers; integrated review cadence agreed.


Lab Director;


Quality Manager; CAPA close-out Section Leads; IT/Middleware; Clinical Leads


Section Leads;


Approved risk register; timeliness.


EQA/IQC Lead; IQC rule set & frequency IT/Middleware; Ops Leads


Early residual-risk notes; documented; first


external-signal alerts;


Section Leads; IT/Middleware;


TAT compliance dashboards. QC compliance trend;


patient-median stability;


EQA/IQC Lead alert signal-to-noise; lot shift capture; TAT


near-breach interventions.


One monthly integrated review (IQC + external Quality Manager; Residual-risk decisions signals + EQA + TAT); risk-based commissioning Section Leads; & change control; “quality dashboard” view; dynamic audit scheduling by residual risk.


Governance


Analytical: QC performance, time-to-detect; Patient-centred: patient medians/MAs, delta/


System: CAPA on-time, residual-risk trend.


Show joined-up control on high-impact pathways (e.g., troponin, INR/APTT, K⁺, D-dimer).


Create a predictable, defensible decision trail each month.


Implementation that can start now and develop over 18 months.


For each pathway: clinical window & decision limits → SQC by risk then PBRTQC/delta/ correlation, lot-to-lot, TAT %-compliance & escalation


Single forum reviews IQC vs APS, external


Section Leads; Clinical Leads; IT/Middleware


signals (patient medians, delta/RCV, correlation, Lab Director; lot-to-lot, EQA), and TAT; issue one-page residual-risk decision with owners and dates; audit plan follows risk.


Governance


Start with top-impact assays; implement minimum controls; automate and join the signals; govern via residual-risk decisions; adjust audit effort by risk.


Table 6. How each article in the series fits into the whole process.


high-impact pathways first (eg troponin, INR/APTT, potassium, D-dimer), then scale. Table 6 illustrates how each article in the series fits into the whole process.


Previous articles in this series n MacDonald S. Risk-based audit schedules


and periodic review of examinations. Pathology in Practice. 2025 Oct; 26 (7): 23–6.


n MacDonald S. Risk-based monitoring of lot changes, delta checks, critical results, reference range shifts. Pathology in Practice. 2025 Sept; 26 (6): 29–34.


n MacDonald S. Risk-based turnaround time management: a look at some important issues Pathology in Practice. 2025 Aug; 26 (5): 29–33.


n MacDonald S. Risk-based quality control: planning, defining, linking and evaluating. Pathology in Practice. 2025 Jun; 26 (4): 15–8.


Hold one short, scheduled review each month. Look at the single dashboard, decide what changes, and issue a brief residual-risk note per method/pathway with an owner and date


18


n MacDonald S. Risk-based validation and verification in medical laboratories: an overview. Pathology in Practice. 2025 May; 26 (3): 27–31.


n MacDonald S. Process Mapping, FMEA and FTA: Practical Approaches to Risk Assessment. Pathology in Practice. 2025 Apr; 26 (2): 27–30.


n MacDonald S. Introduction to risk management frameworks in clinical laboratories. Pathology in Practice. 2025 Feb; 26 (1): 29–31.


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. DECEMBER 2025 WWW.PATHOLOGYINPRACTICE.COM


Section Leads; IT/Middleware;


per method; audit interval adjusts with risk; CAPA effectiveness evidenced.


KPI dashboard reviewed monthly; downward trend


RCV, correlation alerts, critical-value frequency; Quality Manager in repeat events; tuned Service: TAT %-compliance by tier;


thresholds documented.


Series overview themes through V&V, IQC, TAT, and external signals.


V&V risk tools and local context; commissioning responsibilities.


V&V local risks (May); IQC design (June); TAT framework (Aug); external signals (Sept).


IQC refinement (June); external signals


configuration (Sept); TAT operating model (Aug).


Risk-based audits & periodic review (Oct).


IQC & APS/Sigma


(June); external signals & reference-range monitoring (Sept); TAT KPIs (Aug).


Pathway-level residual-risk notes; TAT clinical context (Aug); proportionate QC intervals; alert resolution within target; TAT compliance by location.


lot-to-lot depth & patient distributions (Sept);


Quality Manager; Signed residual-risk notes; audit frequency changes; CAPA evidenced by KPI movement.


Management/ clinical team; Quality;


Section Leads


Progressive reduction in undetected-error risk;


sustained TAT compliance; fewer repeat events.


IQC interval design (June). Risk-based audits &


periodic review (Oct) with integrated signals (Sept).


V&V (May),


IQC (June), TAT (Aug), external signals (Sept), audits/review (Oct).


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60