シナリオ
A customer complaint enters the quality system and is triaged for severity, then either closed as routine or escalated into a formal corrective and preventive action (CAPA) investigation with effectiveness verification.
この図に含まれるもの
図の背後にある意思決定を読み解く。
01
Severity / regulatory impact triage
02
Whether a CAPA investigation is required
03
Whether the implemented CAPA actions are effective
Use this flow for ISO 9001 or GMP complaint handling and CAPA workflows, including medical device, pharmaceutical, and manufacturing quality systems.