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.

They will also receive an email notification informing them of the assigned task.

Clicking on either the subject in Pending Tasks or the link in the email will direct the user 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.

1. Accordions: The form includes several collapsible sections, known as accordions, which each serve a specific purpose.
   • Additional Details
   • Immediate Containment
   • Gather Details (Root Cause Analysis)
   • Associated Risk(s)
   • Associated Action Item(s)

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

2. 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.
3. Close: This button allows users to close the quality event, bringing the workflow to an end.
4. Save Form: This button allows users to save the form. It will remain in the Pending Tasks folder.