Quality & Non-Conformance Management

Context

Non-conformance lifecycle management in regulated manufacturing (FDA 21 CFR 820, IATF 16949, AS9100, ISO 13485). Integrates with QMS (MasterControl, ETQ, Veeva), SPC software (Minitab, InfinityQS), ERP (SAP QM, Oracle Quality), CMM/metrology, and supplier portals.

When to Use

• Investigating a non-conformance (NCR) from incoming inspection, in-process, or final test
• Performing root cause analysis using 5-Why, Ishikawa, or fault tree methods
• Determining disposition for non-conforming material (use-as-is, rework, scrap, return to vendor)
• Creating or reviewing a CAPA (Corrective and Preventive Action) plan
• Interpreting SPC data and control chart signals for process stability assessment
• Preparing for or responding to a regulatory audit finding

How It Works