Quality guide

Running a corrective and preventive action (CAPA) process that works

A nonconformity is only useful if it leads to a change. A CAPA process turns each problem into a root cause, an action, an owner and a check that it worked.

Describe the problem precisely

State what happened, where, when and what it affected. Vague descriptions lead to vague fixes. Link the record to the evidence: the specimen, the batch, the equipment.

Find the root cause

The first cause you find is usually a symptom. Keep asking why until you reach something you can change in a process, a document or a training plan, not just a person to blame.

Separate correction from prevention

Correction fixes the immediate problem; corrective action removes its cause; preventive action stops similar problems elsewhere. Record each one, with an owner and a due date.

Check that it worked

Closing a CAPA without verifying effectiveness is the most common gap an assessor finds. Define how you will know the action worked, and look again after an agreed time.

Common questions

Corrective action addresses the cause of a problem that has occurred. Preventive action addresses a potential problem before it occurs.

The number matters less than whether they close on time and whether the same causes recur. Recurring causes show that actions are not effective.

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