QUALITY MANAGEMENT Focus QC design Goal Proportionate QC Actions


Re-estimate Sigma, align to APS, set risk-based intervals, adjust rules/frequency


Patient-based Early warnings that Expand patient medians/MA, monitoring


complement IQC Lot &


comparability programme TAT control


Monthly review


add delta/correlation, automate in LIS/middleware


Routine, risk-based Lot acceptance with bias vs APS, inter-analyser checks, panels/peer data for low volume, trend with IQC/PBRTQC


From visibility to action


Embed it as routine


Proximity-to-breach boards, role-based interventions, report % compliance, escalate via governance if needed


Single forum for QC/APS/Sigma, patient signals, lot/EQA, Accountability Owners: Section Leads. Evidence: updated QC plan,


interval/tolerance list, QC alert profile. Owners: Section Leads, IT.


Evidence: alert audit trail, investigations on time, confirmed (and resolved) drifts.


Owners: Section Leads, EQA/IQC.


Evidence: lot records, bias/shift summary. Owners: Ops, Quality, Clinical, IT.


Evidence: % compliance by tier, interventions logged, decisions minuted.


Owners: Quality, Section Leads. TAT issues residual-risk notes; feed in commissioning outcomes Evidence: signed actions CAPA closed, plans updated.


Table 2. Developing the control processes with QC and external signals. QC: Quality Control, APS: Analytical Performance Specifications, LIS: Laboratory Information System, PBRTQC: Patient Based Real Time Quality Control, EQA: External Quality Assessment, CAPA: Corrective and Preventative Actions.


Focus Standard dashboard


Risk lifecycle for changes


Training & competency


Assurance that follows risk


Goal


templates & data methods/sites Quality


One view for decisions


No “set and


People can run the system


Audits where they matter


Actions


Consistency across Harmonise validation/verification templates, severity scales, data fields, fix TAT definitions


Accountability Owners: Quality, Lab Managers, Section Leads. Evidence: approved templates; common field list; TAT clock SOP.


Deploy a single dashboard showing QC vs APS, Owners: Lab Managers, Quality, IT. PBRTQC, lot/EQA, inter-analyser bias, TAT, CAPA status


forget” schedules, verification, record residual-risk next to evidence, Evidence: change control log, verification reports, constantly review


For new methods/lots/LIS rules: focused local follow-up/effectiveness review scheduled Role-based training


Refreshers after major changes


Set audit schedule by risk score and previous identified trends Check CAPA effectiveness, not just completion of paperwork


Owners: Section Leads, Quality. residual-risk recorded with date.


Owners: Section Leads, Education/Training Lead.


Evidence: training records; competency sign-off; refresher log. Owners: Governance, Quality.


Evidence: risk-based audit schedule, CAPA effectiveness checks; fewer repeat events.


Table 3. Scaling the risk operations. SOP: Standard Operating Procedure, QC: Quality Control, APS: Analytical Perfromance Specifications, PBRTQC: Patient Based Real Time Quality Control, EQA: External Quality Assessment, CAPA: Corrective and Preventative Actions, LIS: Laboratory Information System.


(medians/MAs, delta, correlation) and run it in LIS/middleware. Make lot-to- lot and inter-analyser checks a standing programme. Keep TAT under active control. Review it all together monthly and record residual-risk decisions (Table 2).


n Check


Make it stick and scale Shift from one-off fixes to a consistent way of working across assays and sites. Standardise templates, data fields, thresholds, embed a risk lifecycle for commissioning and change if it occurs,


and make training and audits follow the risk paradigm. Keep proof of effectiveness front and centre (Table 3).


n Check Risk-based KPIs


Use a small set of indicators that link laboratory performance to patient risk and drive action – they must be meaningful and not just KPIs for the sake of it – or “that’s what everyone else looks at”! Keep targets simple, review monthly, and change audit schedule based on the trend if required (Table 4).


n Check and Act Periodic review and residual-risk reporting


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. Close actions on evidence (Table 5).


Implementing risk tools can help laboratories focus on what really matters: reducing error, improving results, and supporting better clinical outcomes.


16


Conclusions This series turns risk management


DECEMBER 2025 WWW.PATHOLOGYINPRACTICE.COM


Evidence: dashboard live; monthly export filed; metric definitions documented.


Baitaal CC BY-SA 3.0 Wikimedia Commons


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