Chapter 3 · Corrective and preventive action

Corrective action (CA) addresses the root cause of an identified nonconformity. Preventive action (PA) addresses potential nonconformities before they occur. The most common error is addressing the symptom rather than the root cause — ‘re-train the staff member’ is rarely the root cause. Root cause analysis tools include: 5 Whys, fishbone diagram, and fault tree analysis. CA must be verified as effective before the record is closed.

Practical example

A repeat nonconformity occurs: specimens are arriving unlabelled from a ward. Good practice: The QM investigates using 5 Whys and finds the ward uses a different labelling system and staff were never trained on the laboratory’s requirements. Corrective action: joint training session with ward staff and a revised collection guide. The CA is verified effective after 30 days by reviewing rejection data. Poor practice: The QM sends an email saying ‘please label your specimens’ — the root cause is not addressed and the nonconformity recurs.

What this means for your practice: A corrective action that only addresses the immediate symptom will not prevent recurrence. Root cause analysis is the difference between fixing a problem and solving it.