9.6. Check Effectiveness and Approve Report

Once all action items have been completed and approved, the assigned reviewer will receive a notification in their Pending Tasks, prompting them to assess the effectiveness and approve the incident report.

Clicking on the subject in Pending Tasks will direct users to the Check Effectiveness and Approve Report form. In this form, users can evaluate the effectiveness of the incident response, examining the root cause analysis and the adequacy of actions taken. Upon concluding their review, users can determine the next course of action.

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

1. Recommendations for Consideration: A rich text field for documenting actionable suggestions based on the incident review, supporting the implementation of improvement measures.
2. Comment: A field for adding, reviewing, and responding to comments related to the incident report.
   

   **This field functions similarly to a discussion board, enabling users to initiate and participate in collaborative discussions with stakeholders involved in the workflow.

3. Escalate the Issue to QE or CAPA?: A single-select dropdown for deciding whether the issue should be escalated to a Quality Event (QE) or CAPA.
   • If QE is selected, the page will adjust as follows:
     
     • Quality Event Reviewer: A mandatory single-select dropdown field for selecting the party responsible for reviewing the quality event. This dropdown dynamically loads the list of active users, roles, and groups in the system.
     • Escalate the Issue: A button for sending the incident to the Quality Event application.
       • Selecting this button concludes the Incident Management workflow and initiates the Quality Event Management workflow.
         
         *

         The assigned reviewer will automatically receive the Review the Issue task, which includes details about the incident.

         • For more information on the Quality Event Management workflow, refer to the Quality Event Application User Manual.
   • If CAPA is selected, the page will adjust as follows:
     
     • CAPA Reviewer: A mandatory single-select dropdown field for selecting the party responsible for reviewing the CAPA. This dropdown dynamically loads the list of active users, roles, and groups in the system.
     • Escalate the Issue: A button for sending the incident to the CAPA application.
       • Selecting this button concludes the Incident Management workflow and initiates the CAPA Management workflow.
         
         *

         The assigned reviewer will automatically receive the Review CAPA task, which includes details about the incidentt.

         • For more information on the CAPA Management workflow, refer to the CAPA Application User Manual.
4. Assigned Approver: A single-select dropdown field for selecting the party responsible for providing additional approval for the incident report. This dropdown dynamically loads the list of active users, roles, and groups in the system.
   

   !!An approver must be selected from this dropdown to submit the report for additional approval. Otherwise, the system will prompt users to authenticate with a digital signature, but the submission will be blocked.

5. Distribute Incident Report To: A multi-select dropdown field for selecting the recipient(s) for the incident report. This dropdown dynamically loads the list of active users, roles, and groups in the system.
   • Upon closure of the Check Effectiveness and Approve Report task, the selected recipient(s) will receive an email including the incident report as an attached PDF.
     
6. Download PDF: A button for downloading a PDF copy of the incident report.
   • If selected, the PDF opens in a new tab in the web browser.
7. Approved, Additional Approval Required: A button for sending the incident report for additional approval.
   • If selected, the assigned approver will be tasked with reviewing and approving the report.
     

     !!In the Review and Approve Report task, the assigned approver can either close the incident or assign another approver for further validation. This process will continue until an approver chooses to close the incident.

8. Close the Incident: A button for closing the incident, bringing the workflow to an end.
   • Once selected, no further actions can be taken, and the incident will be officially marked as resolved.

**Upon form submission, triggered by clicking the appropriate action button, a pop-up window will appear prompting users to authenticate their action with a digital signature. A unique code, sent to the user’s email, must be entered to confirm the signature.


Once the code is entered, the action will be finalized, marking the task as completed. Users can then view their digital signature by accessing a PDF template of the form.