Artifacts: Incident & Problem Management

Plan documenting corrective actions required to address incidents or problems impacting the validated state of a computerized system, data integrity, or patient safety.

Record documenting unexpected events encountered during CS operations, including investigation details, root cause analysis, GxP impact assessment, and resolution outcome, with references to quality management records if applicable.

A structured record created when a problem has a documented root cause and/or workaround, updated throughout investigation and solution phases, and closed upon successful solution implementation.

Stakeholder communications issued by the Major Incident Manager throughout the major incident lifecycle, written in business language to keep senior management and key stakeholders informed of status and business impact.

A post-closure review document produced by the Major Incident Manager and impacted Service Owners, assessing the application of major incident criteria, business impact verification, and timeliness of resolution.

A review document produced by the Problem Manager upon closure of a major problem to capture lessons learned, identify improvement recommendations, and document agreed actions to prevent reoccurrence.

A record created when a service or service offering is down (unavailable) or degraded to the point of being unusable, tracking the duration of the outage against service availability targets.

A record created when incidents have unknown root causes, exhibit multiple recurring occurrences, or are triggered by major or master incident post-closure activities, initiating root cause investigation through Problem Management.