Definition
CAPA, corrective and preventive action, is a structured quality management process that identifies the root cause of a non-conformity, eliminates it through a corrective action, and prevents recurrence through preventive action. Required by ISO 9001 clause 10.2.
CAPA is one of the most heavily audited processes in regulated manufacturing. It is the documented evidence that a quality issue was investigated, corrected, and prevented from coming back. ISO 9001, ISO 13485 and FDA 21 CFR Part 820 each require a documented CAPA process and proof that corrective actions were verified for effectiveness.
A CAPA cycle moves through eight typical stages: identification of the non-conformity, evaluation of risk and significance, investigation, root cause analysis (commonly using 5-Why, fishbone or 8D), action plan, implementation, verification of effectiveness, and closure with follow-up.
The pivotal stage is verification of effectiveness: the action cannot be closed until evidence shows the same non-conformity has not recurred over a defined observation window. ISO 9001:2015 clause 10.2 requires organisations to evaluate the effectiveness of any corrective action taken, and the FDA 21 CFR Part 820.100 regulation makes the same requirement for medical device manufacturers.
Inadequate CAPA procedures are the single most-cited finding in FDA inspections of medical device manufacturers, year after year. The same pattern shows up in ISO 9001 audits across other sectors: corrective actions are recorded but not verified for effect, so the same non-conformity recurs and the cost of poor quality keeps compounding.
A working CAPA process is the difference between a quality system that documents problems and one that eliminates them. It is also the audit artefact regulators look at first, because it shows whether the organisation can learn from its own deviations.
CAPA is two distinct activities under one acronym, and audits regularly find them confused. Both are required, and both must be documented separately. Confusing the two is one of the most common reasons CAPA records fail an audit.
Eliminates the cause of an existing non-conformity that has already occurred. Triggered by a defect, a complaint, an audit finding or a deviation. The aim is to stop the same problem from happening again.
Eliminates the cause of a potential non-conformity before it occurs. Triggered by trend analysis, risk assessment, near-miss data or process monitoring. The aim is to stop the problem from happening at all.
References