8. CAPA Application Forms and Workflows

In the sections of the manual that follow, we will be delving into the various forms and workflows of the CAPA application.

Generally, the workflows of the CAPA application can be divided into two supersets:

1. CAPA

This workflow consists of nine primary stages: New CAPA, Review CAPA, Modify CAPA (1), Execute the Root Cause Analysis, Verify CAPA, Modify CAPA (2), Execute Action Items, Check Effectiveness & Approve, and Sign Off.

*A CAPA can triggered independently, via the Quality Event application, or via the Audit application. When triggered from the Quality Event application, the first step of the CAPA workflow is Execute the Root Cause Analysis. When triggered from the Audit application, the first step of the CAPA workflow is Review CAPA.

** Although both Modify CAPA forms are part of the workflow, they are only issued if the CAPA is rejected by the reviewer.

*If any action items are rejected in the Check Effectiveness & Approve stage of the workflow, the Execute Action Items task will be re-issued to the assigned action item owner(s).

2. SCAR

This workflow consists of four primary stages: New SCAR, Create SCAR, Submit to Supplier, and Review SCAR.

*A SCAR can be triggered either independently or via an external action item. When triggered from an action item, the first step of the SCAR workflow is Create Scar.