02 — Capability · BC-550.40
Nonconformance & Corrective Action
Deal with what fails to meet the standard, decide what to do with it, find out why it happened, and change something so it stops happening.
- NCR and CAPA
- Root Cause Analysis
- Deviation Management
In scope
- Nonconformance capture and containment
- Disposition of nonconforming product including deviations and waivers
- Root cause analysis
- Corrective and preventive action tracking to closure
Out of scope
- Engineering changes that result from a corrective action (see BC-540)
- Safety incident investigation (see BC-810)
Decomposes into · 4
- BC-550.40.10Nonconformance CaptureRecord every departure from specification where it is found, contain the affected product and stop it from traveling further.
- BC-550.40.20Disposition & DeviationDecide whether nonconforming product is reworked, used as is under a documented deviation, returned or scrapped, and by whose authority.
- BC-550.40.30Root Cause AnalysisInvestigate why the failure happened until the answer is a cause that can be changed rather than a person who can be blamed.
- BC-550.40.40Corrective & Preventive ActionDefine, assign and track actions that remove the cause and check later that they actually worked.