quality-nonconformance

Manage non-conformance by automating structured NCR identification, containment, investigation, and disposition across FDA, IATF, AS9100, and ISO13485 contexts to ensure regulatory alignment and evidence-based closure.

Conduct root cause analysis using structured 5 Whys, Ishikawa, or 8D methodologies with built-in templates. This guides the investigation process to identify core supplier quality failures before planning corrective actions.

Plan and verify CAPA by following encoded workflows for corrective action implementation and evidence-driven closure criteria. This ensures CAPA lifecycle management meets ISO13485 regulatory alignment requirements through structured verification steps.

Handle supplier corrective action requests through dedicated SCAR and RTV workflows with ASL considerations. This supports supplier quality management within FDA, IATF, AS9100, and ISO13485 regulated manufacturing contexts.

Containment guidance is encoded directly into the NCR lifecycle management workflow. It supports immediate non-conformance identification and containment actions to halt defective processes before full investigation and disposition.

Support for 8D and 5 Whys is included as structured root cause analysis options with guidance and templates. Ishikawa diagrams are also supported to comprehensively investigate non-conformance causes.