9.6. Modify CAPA

If upon verification the CAPA is rejected, the assigned RCA owner will receive a notification in their Pending Tasks prompting them to make modifications.

*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 Modify CAPA form. This form is largely a duplicate of the Execute the Root Cause Analysis form, with the exception being that the fields are all populated with previously entered information. Users can revise these details, including the root cause analysis and associated actions, before sending the CAPA back for review.

Highlighted below are the key features of the Modify form:

1. Discussion & Collaboration

In this section of the form, users can provide notes or comments on the CAPA. They can also review or respond to previous comments left by stakeholders involved in the workflow.

2. Send Back for Verification
   

At the bottom of the Modify CAPA form, there is the following button:

• Send Back for Verification: This button allows users to send the CAPA back for verification.
  • If upon verification, the CAPA is rejected again, this process will repeat.
  • If upon verification, the CAPA is approved, the assigned action owners (whether internal team members, external parties, or suppliers) will be tasked with executing the action items.

    **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.