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.
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.