Part 8. The Audit Architecture
8.1 NCR Workflow: Detect, Quarantine, Disposition, Close
A Non-Conformance Report (NCR) is not a bureaucratic punishment; it is the immune system of the f...
8.2 Internal MRB & Quarantine Discipline
The Material Review Board (MRB) process is not a "repair shop" or a storage room for mistakes; it...
8.3 Root Cause Analysis (RCA) & CAPA
If you are fighting the same fire this week that you fought last month, your CAPA system is broke...
8.4 Containment Playbook: Suspect Lots, Line Stop Triggers & Escape Handling
When a defect is detected, the immediate priority is not Root Cause Analysis; it is Containment. ...
8.5 RMA Processing & Field Failure Analysis
Field returns (RMA) are the only source of truth in manufacturing. Internal yield metrics only me...