Approving a CAPA Implementation Plan

Once the CAPA implementation has been re-planned, the implementation plan 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 Implementation Plan link to the appropriate CAPA.
   Result: The Approve CAPA Implementation Plan window is displayed.

2. Review all action plan information.
3. Select either Approve or Reject as the approval decision and enter a comment. The Comment field is required if Reject is selected.
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 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 implementation plan is approved, the CAPA moves to the Implement Action Plans task. If the implementation plan is rejected, an email is sent to the CAPA Implementation Planner who then repeats the CAPA implementation planning. All information previously entered in the plan is maintained. The planner can view the approver’s notes in the Implementation Plan Approval section of the implementation record: