Quality event is an event that can have an adverse impact from a quality, safety and/or product/process performance perspective. The adverse impact may be immediate, potential, or can happen in the future.
The following figure shows the many sources of quality events. Each of these have the potential to initiate cross-functional quality workflows.
Not every quality event instance warrants using a comprehensive quality issue workflow. But each instance should be evaluated for severity and frequency and when appropriate should kickoff cross-functional quality issue workflows.