Continual Improvement of a Laboratory Management System
What this domain tests
Whether you can distinguish improvement (8.6) from corrective action (8.7), and whether you can show improvement is systematic rather than reactive.
Core rules
- Improvement (8.6) - the lab shall identify and select opportunities and implement necessary actions to meet customer requirements and enhance customer satisfaction. Improvement is proactive: method efficiency, turnaround time, reducing rework, extending capability.
- Corrective action (8.7) - react to a nonconformity: correct and control it, evaluate the need to eliminate the cause so it does not recur, implement the action, review its effectiveness, update risks, and retain records. Root-cause analysis is required; "retrain the analyst" is an action, not a cause.
- Risk-based inputs (8.5) - improvement and corrective actions should both feed the risk register; recurring issues signal that risk controls are inadequate.
- Sources of improvement - internal and external audits, PT performance, complaints, nonconforming work, management review outputs, staff suggestions, equipment and data trends.
Worked example
A laboratory records three consecutive out-of-tolerance intermediate checks on the same balance. The correction is recalibration. The root cause analysis shows the check standard is stored outside its specified conditions. The corrective action is a controlled storage location with daily temperature logging; the effectiveness check is six months of interim check data within tolerance; the risk register entry on equipment is updated. Without the effectiveness review, the case is not closed.
Traps that cost marks
- Writing "remind staff" or "retrain" as a corrective action with no cause analysis.
- Closing a nonconformity without verifying effectiveness - the most common assessment finding.
- Treating equipment purchase as an improvement activity without analysing the underlying process weakness.
- Confusing 8.6 improvement with 8.7 corrective action in scenario questions.
- Failing to update documents and risk assessments after an improvement is implemented.