9.4. Execute the Root Cause Analysis

After the CAPA has undergone review and received approval, the assigned RCA owner will receive a notification in their Pending Tasks prompting them to execute the root cause analysis.

*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 Execute the Root Cause Analysis form. In this form, users can perform an in-depth examination of the issue’s root cause. They can also review associated actions and make any necessary additions or modifications.

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

1. Eff. Start Date: This is a date picker that allows users to enter or modify the date when the effectiveness check period will begin.
2. Eff. End Date: This is a date picker that allows users to enter or modify the date when the effectiveness check period will end.
3. Accordions: The form includes several collapsible sections, known as accordions, which each serve a specific purpose.
   • Associated Action Item(s)
   • Root Cause Analysis

*Users can refer to the accordion on the left side of the form to access information regarding the CAPA’s related entities. This accordion, like most other fields on that side of the form, is set to read-only, functioning solely for review purposes.

4. Comment: This field allows users to provide notes or comments on the CAPA. Users can also review or respond to previous comments left by stakeholders involved in the workflow.
5. Save Form: This button allows users to save the form.
   • It will remain in the Pending Tasks folder.
6. Send for Verification: This button allows users to send the CAPA for verification.