QUALITY MANAGEMENT Area IQC & intervals Patient-based signals Delta / correlation Lot & comparability Metric QC plan compliance Patient medians/ moving averages stability Validated alerts resolved on time


First-pass lot acceptance, inter-analyser bias


Target / trigger Stable/low failure rate Accountability Owners: Section Leads. Evidence: QC plan, monthly QC summary.


Within agreed drift limit, investigation Owners: Section + IT. opened (and actioned!) if exceeded


e.g., ≥95% resolved within target; thresholds tuned after review


≥X% first-pass acceptance, bias within APS


TAT (clinical risk based) % compliance to tiered/risk based targets; e.g., ≥95% by risk based time, near-breach interventions


Residual-risk & CAPA Governance reporting


Actions closed on evidence; repeat events


Single monthly view repeats trending down


Dashboard exported/filed/ presented each month


interventions recorded pre-breach e.g., ≥95% actions closed on time,


Evidence: trend plots, investigation log. Owners: IT, Section.


Evidence: alert audit trail, rule change log. Owners: Section, EQA/IQC.


Evidence: lot records, bias report. Owners: Ops, Quality, Clinical.


Evidence: TAT dashboard, intervention log. Owners: Quality, Section.


Evidence: residual-risk notes; CAPA tracker. Owners: Quality, IT.


Evidence: monthly report


Table 4. Key Performance Indicators (KPI) linked to the risk process. IQC: Internal Quality Control, APS: Analytical Performance Specifications, EQA: External Quality Assessment, CAPA: Corrective and Preventative Action.


Focus Monthly forum Residual-risk note Change control Effectiveness check Audit schedule What happens


Review the dashboard (QC vs APS/Sigma, PBRTQC, lot/EQA, inter-analyser bias, TAT, CAPA status)


One page per method/pathway: current risk, action, owner, due date


Interim check after method/lot/ LIS/threshold change


Close CAPA on evidence Assurance follows risk


Trigger / output 45–60 min meeting,


decisions recorded live Issued/updated every meeting Bring early-use data;


confirm or adjust controls QC within tolerance,


PBRTQC stable, TAT on target Review based on risk, adjust based


on performance, risk can change with implementation of control measures


Accountability


Owners: Quality, Director, Section Leads. Evidence: agenda/minutes filed.


Owners: Section Leads.


Evidence: notes in QMS, tracker updated. Owners: Section + IT. Evidence: change log,


verification addendum. Owners: Quality, Section.


Evidence: KPI trend, closure notes. Owners: Governance, Quality.


Evidence: audit schedule; findings linked to risk notes.


Table 5. Review process of risk-based performance: QC: Quality Control, APOS: Analytical Performance Specifications, PBRTQC: Patient Based Real Time Quality Control, EQA: External Quality Assessment, CAPA: Corrective and Preventative Actions, QMS: Quality Management System, LIS: Laboratory information System, KPI: Key Performance Indicator


from principle into practice. Start by understanding the work (process mapping, FMEA/FTA) and setting a clear risk policy linked to clinical decision limits. Build proportionate controls: design QC by APS and Sigma and treat the QC interval itself as a safety decision. Extend


surveillance beyond IQC with patient- based indicators (patient medians/moving averages, delta and correlation rules) and structured lot-to-lot checks, all automated in LIS/middleware with audit trails. Manage turnaround time as a clinical risk using tiered targets, live monitoring


and early escalation, not averages. Hold one monthly, integrated review that brings QC, external signals, lot/EQA context and TAT into a single decision, issuing a short residual-risk note with owners and dates, and adjusting audit effort to match risk. Adopt the pattern on


WWW.PATHOLOGYINPRACTICE.COM DECEMBER 2025


17


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