In the sections of the manual that follow, we will delve into the forms and workflows of the Quality Event (QE) application.
The Quality Event application comprises a single central workflow.
This workflow consists of eight primary stages: New Quality Event, Review the Issue, Modify Quality Event, Contain/Correct Issue, Gather Details, Review the Issue – Escalate to CAPA?, Action Item Management, and Check Issue Correction.
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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 QE 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 QE 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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Triggering Quality Events & Escalating to CAPA
- A quality event can be initiated either independently or through applications like Audit, Incident, and Management Review.
- When triggered from these application sources, the first step of the QE Management workflow is Review the Issue.
- If further action is required to address the problem, the quality event can be escalated to a CAPA at the Review the Issue – Escalate to CAPA? stage.
- This transition initiates the CAPA Management workflow, with the assigned resource tasked with reviewing the CAPA.
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