10.6. Check Effectiveness of Vigilance Record

Once all actions items have been completed, the assigned user will receive a notification in their Pending Tasks, prompting them to assess the effectiveness of the vigilance record.

*If any actions triggered a SCAR, this step will take place after the completion of the SCAR Management workflow.

*An email notification will also be sent to alert the reviewer of the task. For more information on email notifications and their role in the application, click here.

Clicking on either the subject in Pending Tasks or the button in the email will direct users to the Check and Effectiveness Vigilance Record form. In this form, users can evaluate the effectiveness of the record’s overall response by examining the root cause analysis and implemented actions. They can then decide whether these actions need to be re-executed, choosing to approve or reject them accordingly.

*For guidance on common form functions, please refer to the dedicated section in the manual.

1. Accordions: The form features a key collapsible section, known as an accordion, which facilitates the evaluation of implemented actions and their potential need for re-execution.
   • Action Items
     

     *Additional information about the record—such as assigned rules, products, related entities, and root cause analysis—can be found in the read-only accordions located higher in the form, which are intended solely for review purposes.

2. Comment(s): This field allows users to provide comments or notes on the record. It also allows them to review and respond to comments left by previous stakeholders.
   

   **The Comment control functions similarly to a discussion board, facilitating collaborative discussions with stakeholders involved in the workflow.

3. Save Form: This button allows users to save their progress in the form.
   • The form will remain in the Pending Tasks folder for further action or review at a later time.
4. Reject Action(s): This button allows users to reject the selected actions.
   • These actions are sent back to their assigned owners for re-execution.
     

     **Actions can be selected for re-execution in the Action Items accordion.

5. Approve All Action(s): This button allows users to approve all actions, indicating that they have been satisfactorily completed.
   • If selected, the assigned resource will be tasked with signing off on the vigilance record.
     

     !!Users should not click this button if action items are set for re-execution; they will not be re-executed if the actions are approved.