CAPA stands for corrective and preventive action: the structured process a company follows when something goes wrong, such as a defective product, a customer complaint or an audit finding. The goal is not just to fix the immediate problem, but to find its root cause and make sure it does not happen again.
The CAPA Process
- Identify the problem: a non-conformity, complaint, audit finding or trend in quality data.
- Contain it: stop affected products from reaching customers.
- Investigate the root cause, with methods such as the 5 whys or an Ishikawa (fishbone) diagram.
- Plan actions: corrective actions that remove the cause, and preventive actions that stop similar problems elsewhere.
- Implement the actions with owners and deadlines.
- Verify effectiveness: check, after some time, that the problem really has not come back.
- Close and record, so auditors and future teams can see what was done and why.
CAPA and ISO 9001
ISO 9001 requires organisations to react to non-conformities, determine their causes and take corrective action. The 2015 edition replaced the separate "preventive action" requirement with risk-based thinking throughout the quality management system, but many companies still use the term CAPA. In regulated sectors such as medical devices, CAPA is an explicit, closely audited requirement.
CAPA in Software
Spreadsheets and email make it easy for actions to stall or for root causes to be skipped. CAPA software records each case from the first report, enforces the steps, assigns owners and deadlines, sends reminders, links actions to the products, batches and machines involved, and gives management an overview of open and overdue cases. A related method in automotive is the 8D report. See quality control software.
Frequently Asked Questions
What is the difference between corrective and preventive action?
Corrective action removes the cause of a problem that has occurred. Preventive action removes the cause of a potential problem before it occurs.
Is CAPA only for medical devices?
No. The term is most formal in medical devices and pharmaceuticals, but every quality management system needs a way to handle non-conformities and prevent recurrence.
How long should a CAPA take?
That depends on the problem, but containment should be immediate, and effectiveness can only be verified after enough time has passed to show the problem has not returned.