GAMP 5 - Good Automated Manufacturing Practice O4: Appendix O4 Incident Management and Problem Management

Unplanned interruptions or reductions in service quality are logged, looked into and fixed by support teams so that incidents are effectively managed, and problems, the root causes of one or more incidents, are determined and resolved to minimize recurrence. Incidents arrive by telephone, email, service desk or automated monitoring, are categorized and prioritized to set response times per the service level agreement and captured in an incident tool; level 1 support gathers information and resolves common issues, level 2 assesses in depth and identifies solutions or raises a problem, level 3 experts including developers, DevOps, architects or the supplier investigate design and implementation issues, and major incidents are handled with urgency by a team of business, technical and quality expertise, possibly invoking continuity and disaster recovery plans. Problem management is integrated with change, configuration, training and disaster recovery and may involve CAPA, and communication keeps users and the quality unit aware of disruptions. Because incidents reach technical staff who may not judge GxP impact, the configuration management database or another mechanism identifies the configuration items that impact GxP, the GxP determination process is agreed between the process and data owners and the quality unit, which is told of incidents and problems potentially affecting product quality or patient safety and may raise a deviation and CAPA, and all parties cooperate on resolution. Incident and problem records in tools capture the event, impact assessment, root cause analysis, actions and workarounds, and any resulting changes to life cycle documentation or configuration are made and tested under change management.