Approving a CAPA Investigation

Once the CAPA is investigated, the investigation approver assignee receives email notification . Users with the appropriate roles have access to the workspace options on the CAPA/NC Workspace and/or CAPA Coordinator dashboard.

NOTE: Click the Change Task Owner link to assign this task to another user. For additional information, see Changing the Task Owner.

1. From the CAPA/NC Workspace, click the Approve CAPA Investigation link to the appropriate CAPA.
   Result: The Approve CAPA Investigation window is displayed.
2. Review all investigation information.
3. Select either Approve or Reject as the approval decision and enter a comment. The Comment field is required if Reject is selected.

NOTE: If the investigation is rejected, an email is sent to the CAPA Investigator who then repeats the CAPA investigation. All information previously entered in the investigation is maintained. The investigator can view the approver’s notes in the Investigation Approval section of the investigation record.

4. Click the Sign-off button.
   Result: The Sign-off window is displayed.
5. Enter your user ID and password and then click the Sign-off button.
   Result: The Result window is displayed. The Result window is a pop-up window that displays after sign-off and asks the user where they would like to go next, such as to the CAPA Detail or back to the Portal Page. If the user is assigned the role for the next step in the workflow, such as Implement Action Plans or Include in Effectiveness Review Plan, then the user will see the option to enter the next step.

NOTE: If the CAPA investigation is approved and if the CAPA Type is Supplier and the Client is a Quality Portal User, then the CAPA is routed to the action plan implementer in the Supplier Quality Portal. The CAPA Management workflow is then blocked until the SQP task is signed off.