9.5. Gather Details

If the quality event is submitted for further exploration, the creator will receive a notification in their Pending Tasks, prompting them to gather the necessary details.

*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 Gather Details form. In this form, users can conduct a more in-depth investigation of the quality event, analyzing its root cause, identifying associated risks, and proposing specific action items to rectify the issue. Following this investigation, users can make the decision to either close the quality event or submit it for CAPA assessment.

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

1. Review Notes: This is a rich text field that allows users to provide notes and observations related to the quality event.
2. Accordions: The form includes several collapsible sections, known as accordions, which each serve a specific purpose.
   • Associated Action Item(s)
   • Immediate Containment
     

     **The Immediate Containment accordion is only included in this form if users had previously attempted to immediately contain the issue.

   • Gather Details (Root Cause Analysis)
   • Associated Risk(s)
     

     ** Users can refer to the accordions on the left side of the form to access additional information about the quality event, including any associated documents or related entities. These accordions, like other fields on that side of the form, are set to read-only, functioning solely for review purposes.

3. Comment: This field allows users to add comments or notes relevant to the quality event.
   

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

4. Save Form: This button allows users to save the form.
   • It will remain in the Pending Tasks folder.
5. Send for CAPA Assessment: This button allows users to submit the quality event for CAPA assessment.
   • If selected, the assigned reviewer will be tasked with assessing whether the quality event requires an escalation to CAPA.
6. Close: This button allows users to close the quality event, bringing the workflow to an end.