9.8. Create SCAR

If any of the action types are external and users were to click the Immediate Containment button in the Gather Details form, the assigned action item owner(s) would receive a notification in their Pending Tasks informing them that they need to create SCAR.

*If any of the action types are external and users were to send the quality event to CAPA, they would also receive a notification informing them that they have to create SCAR. This task, however, would be issued at the Execute Action Items stage of the CAPA workflow.

The assigned action item owner(s) 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 Create SCAR form. Upon its submission, this form will trigger the SCAR workflow. Users will be guided on how to navigate this workflow throughout the Create SCAR portion of this manual.

For the purposes of ease and clarity, the Create SCAR form has been divided into several subsections within this manual.

• For more details on the contents of this form, click here.