A CAPA can be rejected at two stages: while Under Signing by Approver and while Under Signing by QA.
Rejection of CAPA while in Under Signing by Approver status
If a CAPA is rejected by Approver it goes back to Created Status.
Approver must give a reason for rejecting the CAPA so that the Responsible Person can amend the CAPA and push it through the cycle again. Approver will not be asked to off electronically.
Rejection of CAPA while in Under Signing by QA status
When QA rejects the CAPA while in Under Signing by QA status the CAPA goes back to Implementing Status.
If there were no specific Actions added to the CAPA then QA will see the same CAPA Reject window as the Approver. In order to reject the CAPA a reason must be given but it is not necessary for QA to sign off.
If specific Actions have been added to the CAPA, then the CAPA reject window will include a Select Actions field. When clicking on the field, the available Actions will appear and QA can choose which ones need to be carried out again.
It is not mandatory to Select any Actions but it is mandatory for QA to give a reason when rejecting the CAPA.