9.2. Review Incident Report

Once the incident report is created and submitted, the assigned reviewer will receive a notification in their Pending Tasks, prompting them to examine the incident report.

*An email notification will also be sent to alert them 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 Incident Report to Review form. In this form, users can review all the information previously entered for the incident and, where necessary, make additions or modifications to the report. 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. Investigator: A mandatory single-select dropdown field for selecting the party responsible for investigating the root cause of the incident. This dropdown dynamically loads the list of active users, roles, and groups in the system.
   
   *

   By default, this field is populated with the ‘Principal Investigator’ role, to which users and groups can be assigned.

   • If the ‘Principal Investigator’ role does not exist or has no user or group assigned, this field will be left empty.

   
   

   Roles are created and managed in the Roles tab of the Organization Management (Admin) application.

2. Recommendations for Consideration: A rich text field for documenting actionable suggestions based on the incident review, supporting the implementation of improvement measures.
3. 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.

4. 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.
5. Download PDF: A button for downloading a PDF copy of the incident report.
   • The PDF will open in a new browser tab.
6. Requires More Details (Send Back to Creator): A button for submitting the incident for further modification or exploration.
   • If selected, the creator of the incident report will be tasked with modifying it.
7. Request a Root Cause Analysis: A button for requesting a root cause analysis of the incident.
   • If selected, the assigned investigator will be tasked with executing the root cause analysis.
     

     **If the investigator is the Principal Investigator, the task will appear in the Pending Tasks folder associated with that role.
     
     

8. Review Completed (Trigger Actions) A button for finalizing the review process.
   • Upon selecting this button, the outcome depends on whether additional action items are linked to the incident report:
     • If no actions are linked, the reviewer will be tasked with checking effectiveness and approving the incident report.
     • If actions are linked, the assigned owners will be tasked with executing them.
       
       *

       If the action item involves a Supplier Corrective Action Request (SCAR), the workflow will bypass the standard execution; instead, the supplier representative will be assigned the task of investigating the SCAR.

       • For more information on the Action Item Management workflow and its connection to the SCAR Management workflow, refer to the Action Items Application User Manual.
9. No Issue (Close Incident): A button for closing the incident if the review determines there is no underlying issue requiring further action.
   • Selecting this concludes the Incident Management workflow.

**Upon clicking either the Review Completed, No Issue, or Escalate the Issue buttons, a pop-up window will appear prompting users to authenticate their approval with a digital signature. A unique code, sent to the user’s email, must be entered to confirm this signature.



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

**If the incident involves any financial impacts, an email notification will be sent to all parties designated in the Financial Report Reviewer dropdown. This email, including a PDF of the incident report, will be dispatched upon closure of the ‘Incident Report to Review’ task.