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