Issue Management

Issue Management is the process of recording, triaging, dispositioning, and closing problems found anywhere in the product lifecycle — internal nonconformances, customer complaints, audit findings, supplier defects, software bugs, and field events. It is the day-to-day quality reflex that feeds the bigger formal workflows of CAPA and change management.

Scope

The process includes intake (forms, hotlines, automated telemetry), classification and priority, root-cause investigation, immediate disposition (use-as-is, rework, scrap, hold), corrective action assignment, verification, and closure. Issue management acts as a funnel: most issues are handled and closed locally, while patterns and severe single events escalate into CAPA, ECO, or product-recall workflows. Modern PLM/QMS platforms unify issue management with the rest of the change discipline.

Relationships (see sidebar)

• Realizes Product Quality and First Time Right.
• Supported by the CAPA and Deviation data objects, the QMS capability, and ALM Traceability for software-side issues.
• Hands escalations to Change Management (ECO/ECN) and Quality Management.