Who is this for?
Owner - recording the not-effective outcome
Author - authoring and reprocessing the new version
How to do it
When the effectiveness check concludes that the CAPA was not effective, the system reopens the CAPA automatically so that further corrective and preventive actions can be planned and executed.
In the Effectiveness Check, record Was the CAPA effective? as No, enter the justification and complete the electronic signature.
The system creates a new version (v2) and returns the CAPA to the Planning phase; the previously completed actions are retained. Author the new version, add or revise actions, and process it through Planning and Execution again. A Change Summary is required before the new version can be sent for approval.
A new version created after a not-effective outcome.
❗A not-effective outcome is a finding, not a process failure. The automatic new version keeps the original conclusion and its evidence intact rather than overwriting them, which is what preserves the trail. Use the reopened version to address why the first actions did not work (often the root cause was mis-identified), and capture that reasoning in the Change Summary.
💡Tip: Before reprocessing, revisit the root-cause analysis and formulate new corrective and preventive actions. Reopening to run the same actions again rarely changes the outcome.