8. Quality Event Application Forms and Workflow

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

The Quality Event application is comprised of one central workflow.

• Quality Events

This workflow consists of seven primary stages: New Quality Event, Review the Issue, Modify Quality Event, Contain/Correct Issue, Gather Details, Review the Issue – Needs CAPA, Correct the Issue with Actions, and Check Issue Correction.

*A quality event can be triggered either independently or via the Audit application. When triggered from the Audit application, the first step of the Quality Events workflow is Review the Issue.

** Although the Modify Quality Event form is part of the workflow, it is only issued if the quality event is rejected by the reviewer.
** Likewise, although the Contain/Correct Issue form is part of the workflow, it is only issued if the quality event is immediately contained upon first review.

*If the quality event is sent to the CAPA application at the Review the Issue – Needs CAPA stage, it will trigger the CAPA workflow. The assigned user will be tasked with completing the root cause analysis (RCA). For more details on the CAPA workflow, see the User Manual for the CAPA Application.