CAPA workflow template (corrective and preventive action)
A corrective and preventive action (CAPA) workflow template covering issue identification, investigation, root cause analysis, corrective action, preventive action, verification of effectiveness, and closure, approval-tracked end to end.
How it works
Define what triggers a CAPA
Write the criterion in before the first decision node: recurrence, risk level, customer impact or a regulatory requirement.
Separate containment from corrective action
The immediate action that stops the damage is not the corrective action.
Make the root-cause method a requirement on the node
State the method you use and who needs to be involved.
Put an owner and a deadline on every action
Both the corrective and the preventive action need a named owner and a date.
Let effectiveness verification be able to fail
Draw the branch where insufficient effectiveness sends the case back to investigation.
Frequently asked questions
What are the typical steps in a CAPA workflow?
Issue identification → containment → investigation and root cause analysis → corrective action plan → preventive action plan → implementation → verification of effectiveness → closure.
Why does CAPA need to be approval-tracked?
Both ISO 9001 (10.2) and ISO 13485 (8.5.2 / 8.5.3) require documented evidence that corrective and preventive actions were reviewed and effective.
What's the difference between corrective and preventive action?
Corrective action removes the cause of the nonconformity that occurred. Preventive action removes the possibility of a similar one arising elsewhere.
When can a CAPA case be closed?
When the actions have been carried out and the effectiveness has been documented — not simply when the actions have been carried out.