In the sections of the manual that follow, we will delve into the various forms and workflows of the CAPA application.
The CAPA application comprises a single central workflow.
This workflow consists of nine primary stages: New CAPA, Review CAPA, Modify CAPA (1), Execute the Root Cause Analysis, Verify CAPA, Modify CAPA (2), Action Item Management, Check Effectiveness & Approve, and Sign Off.
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Action Item Management, the central workflow of the Action Items application, operates as a subprocess in this context. Once triggered, the CAPA Management workflow cannot proceed until this subprocess is completed—meaning all associated actions must be executed, reviewed, and approved.
- If applicable, Supplier Corrective Action Requests (SCARs), which are handled in parallel through an adapted SCAR Management workflow within Action Item Management, must also be addressed and approved before the CAPA Management workflow can continue.
For more information on the Action Item Management workflow, refer to the Action Item Application User Manual.
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A CAPA can be initiated either independently or through applications like Audit, Quality Event, Incident, and Management Review.
- When triggered from these application sources, the first step of the CAPA Management workflow is Review CAPA.
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