avviksloggen

The avviksloggen (the deviation log) is a formal record used in quality management to document deviations from approved procedures, specifications, or performance criteria. It provides a structured means to capture non-conformances and their handling, ensuring traceability and accountability.

It is used across industries such as manufacturing, pharmaceuticals, healthcare, and software development, and is commonly integrated with standards like ISO 9001, ISO 13485, GMP, and similar regulatory frameworks. An avvikslog typically contains fields such as deviation ID, date and time, reporter, description of deviation, location or process, affected product or batch, potential impact, severity or risk, containment actions, and referenced documents.

The log also records the investigation, root-cause analysis, and the proposed and implemented corrective and preventive actions (CAPA), including responsibilities, deadlines, and verification of effectiveness. Status updates (open, in-progress, closed) and closure dates are tracked to ensure timely resolution and auditability.

In practice, avviksloggen may be kept in paper form, an electronic database, or integrated into a broader quality management system with workflows for approval, investigation, CAPA, and management reviews. Benefits include improved traceability, regulatory readiness, data-driven process improvement, and the ability to identify recurring issues and trends. Challenges can include ensuring timely reporting, maintaining data quality and consistency, and sustaining effective CAPA follow-up.

Related terms include avvikelse, avvikelsehantering, CAPA, and audit.