# Corrective and preventive action (CAPA)

> Corrective and preventive action (CAPA) fixes the root cause of a problem so it does not recur, and prevents likely problems before they happen.

Corrective and preventive action (CAPA) is a structured way to deal with problems so they do not come back. It distinguishes three things that are often confused:

- **Correction**: fixing the problem in front of you, such as reshipping the wrong order.
- **Corrective action**: removing the root cause so the same problem does not happen again.
- **Preventive action**: removing the cause of a potential problem that has not happened yet.

The FDA uses a simple illustration: fixing a misspelled word is a correction, while adding a spell check to the process that produced the document is a corrective action.

### The usual steps

1. Describe the problem with facts and evidence.
2. Contain it.
3. Find the root cause, for example by asking "why" until the answer is a process, not a person.
4. Decide and assign the action, with an owner and a due date.
5. Verify, after some time, that the action worked.
6. Close the record.

In FDA-regulated industries such as medical devices, a documented CAPA process is a formal requirement. Everywhere else, it is simply good practice.

### Example

A warehouse ships the wrong item twice in one month (illustrative). The correction is to reship. The root cause is two similar products in neighboring bins with look-alike labels. The corrective action separates and relabels them, and the preventive action reviews other look-alike products.

### Common pitfalls

- Stopping at the correction.
- "Human error" as the root cause.
- Never checking whether the action worked.

Sources:

- [FDA, CDRH Learn: Corrective and Preventive Actions (transcript)](https://www.fda.gov/training-and-continuing-education/cdrh-learn/corrective-and-preventive-actions-transcript)

Page: https://easy.wf/glossary/corrective-action