Corrective and Preventive Actions
A corrective and preventive action is the investigation that stops a problem coming back. Where a non-conformance report deals with the goods in front of you, a CAPA deals with the cause. It carries the problem statement, the root cause and how it was found, the actions taken with their owners and due dates, and a check afterwards that the problem really did stop.
Corrective or preventive
| Type | Use |
|---|---|
| Corrective | Something went wrong. Stop it happening again. |
| Preventive | Something has not gone wrong yet, but will. Stop it before it does. |
A CAPA can be opened from a non-conformance, a customer complaint, an audit finding, a supplier problem, or on its own. Opened from an NCR, the two stay linked and each shows the other.
The stages
| Stage | What happens |
|---|---|
| Open | The problem is written down. Only an open CAPA can be edited. |
| Root Cause | The investigation. Record the cause and the method used to find it. |
| Actions | The actions are listed, owned and worked through. |
| Verification | The effectiveness check: did it work? |
| Closed | Finished, with the outcome on record. |
| Cancelled | Withdrawn. |
Root cause methods
The method is recorded so a reviewer can see how the conclusion was reached: 5 Whys, Fishbone (Ishikawa), 8D or Other. The cause itself is free text — the field records your finding, it does not run the analysis for you.
Actions
Add one row per thing that will be done. Each action has a type, an owner, a due date and a status.
| Action type | Means |
|---|---|
| Correction | Fixing this occurrence. |
| Corrective action | Changing something so the cause cannot recur. |
| Preventive action | Changing something so a similar cause cannot arise elsewhere. |
An action is Open, Done or Cancelled. Only the action's own owner, or a user who can edit CAPAs, may finish it — so an owner can close their own work without being given rights over the whole CAPA.
The effectiveness check
Before a CAPA closes, record the check: the date it was checked on, how it was checked, and the outcome — Effective: the problem has not come back, or Not effective: more actions are needed. Recording it as not effective is the point of having the step; it sends the CAPA back for more work instead of closing a problem that is still live.
Due dates and chasing
The closing due date defaults from Days to Close a CAPA in General settings. The Overview counts CAPAs past that date and, separately, individual actions running late — a CAPA can be inside its own deadline while one of its actions is not.
Closing a CAPA needs Corrective and Preventive Actions permission, and is one of the steps electronic signature covers when it is switched on.