This article is only relevant for CAPAs in which Actions have been defined. In a simple workflow CAPA, no Actions have been created, therefore it is not relevant to address how Actions are closed and what happens when they are.
Before a CAPA can proceed from Implementing status to Under Signing by QA all Actions must be marked as closed.
How the Action is closed depends on the type of Action as well on system settings.
Update Document Actions will close automatically once the Documents included in the Action have all completed a full approval Cycle (from Draft to Published).
Custom Actions require that the Responsible User marks the Action as completed.
Depending on system settings it may be required that QA signs off on all Actions before these are marked as closed. This will only be the case for Custom Actions, it is not applicable to Update Documents Actions, in this case, the system verifies that the Documents have gone through the entire approval cycle.
Closing Custom Actions by Responsible User
The Responsible User of the Custom Action must mark the Action as closed:
- Go to the Actions Tab of the CAPA Details Page.
- Close the Action by clicking on the checkmark icon in the Actions Column.
In the Update Action window:
- Sign off electronically.
- Add Remarks.
- If relevant, upload files.
If it is not required for QA to sign off on all Actions then you will get the message: Action closed successfully. In the Action Tab of the CAPA Details Page, the Action will appear as Closed in the Status Column.
Once all Actions have been closed by their Responsible Users the CAPA will automatically go from Implementing to Under Signing by QA status.
If system settings require for QA to sign off on all Actions, you will get the message: Action status set to pending approval successfully. In the Action Tab of the CAPA Details Page the Action will then appear as Pending Approval in the Status column.
QA Action Approval
In order to approve the Action, QA must go to the Actions Tab on the CAPA Details Page:
- Check which Actions are Pending Approval in the Status column.
- Accept or Deny the Action.
If QA Denies the Action the Update Action window will include a Reason field, QA must:
- Sign off.
- Give a Reason for rejecting the Action.
The Responsible User will then have to repeat the Action taking into consideration the reasons given by QA. Once the Action has been completed the Responsible User will then have to set the Action as closed once again.
If QA Accepts the Action then the Update Action window will appear without a reason field, QA must:
- Sign off.
QA will then get the message: Action closed successfully. Thereafter:
- The Action will appear as Closed in the Actions Tab.
- As soon as all the Action(s) in the CAPA are closed, the status of the CAPA will automatically change to Under Signing by QA.
Update Documents Actions
In this case, the Actions will be completed as soon as the Documents included in the Action have gone through a full approval cycle. The Action will be marked automatically as closed by the system once this happens.
It is not necessary for QA to sign off on this Action even if the Action Sign off for QA switch is turned ON.