Evaluating Failure Modes and/or Root Causes

If the Policy for new failure modes policy in the Verify CAPA Initiation task is set to Route task, then if a new failure mode or root cause is entered in the Investigate CAPA task, an evaluation task is routed. The CAPA Coordinator receives email notification . Users with the appropriate roles have access to the workspace options on the CAPA/NC Workspace and/or CAPA Coordinator dashboard. The example below uses the CAPA/NC Workspace 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 Evaluate Failure Mode (failure mode name) link or the Evaluate Root Cause (root cause name) link.
   Result: The evaluation window is displayed.
2. Review the new failure mode or root cause.
3. Enter a Completion Comment.
4. Click the Sign-off button.
   Result: The Sign-off window is displayed.
5. Enter the 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.