When can a CAPA be rejected and by who?

A CAPA can be rejected in these tow statuses:

• while Under Signing by Approver.
• while Under Signing by QA.

Rejection of CAPA while in Under Signing by Approver status

When a CAPA is rejected by an Approver it goes back to Created Status.

How to Reject a CAPA as an Approver

1. In the CAPA Details Page, click on the status button showing Under Signing by Approver.
2. Select Reject as Approver.

In the CAPA Reject window:

1. The 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. The Approver will not be asked to off electronically.
2. Save.

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.

How to Reject a CAPA as QA

1. In the CAPA Details Page, click on the status button showing Under Signing by QA.
2. Select Reject as QA.

In the CAPA Reject window:

1. It is mandatory that QA give a reason for rejecting so that the Responsible Person can amend the CAPA and push it through the cycle again. 
2. If Custom Actions have been carried out, QA can select which should be reopened.
   • It is not mandatory to select any Custom Actions.
   • This field will only appear if Custom Actions have been defined. 
3. If Update Document Actions have been carried out, QA can select which should be reopened.
   • It is not mandatory to select any Update Documents Actions.
   • This field will only appear if Custom Actions have been defined. 
4. Save.

If there were no specific Actions added to the CAPA then QA will see the same CAPA Reject window as the Approver, in other words, points 2 and 3 mentioned above will not be shown.

In order to Reject the CAPA, QA will not be asked to off electronically.