Avviksrapport

An avviksrapport, or deviation report, is a formal document used within organizations to record deviations from approved processes, specifications, or standards. It is created whenever an observed event or condition could affect quality, safety, delivery, or regulatory compliance. The report typically describes what happened, when and where it occurred, and which product, service, or process was affected. It also identifies the person responsible, assesses the severity and potential impact, notes any immediate containment actions, and outlines proposed corrective and preventive actions.

Key elements commonly included are a clear description of the deviation, dating and location, affected items or processes, root cause analysis, risk assessment, and the plan for implementation. The document also assigns ownership for corrective actions, sets deadlines, and records verification steps to confirm that actions are effective before closing the report. It may reference relevant procedures, work instructions, or quality systems documents and include supporting evidence such as logs, photos, or test results.

Process and governance: The typical workflow begins with detection and reporting, followed by registration in a deviation management or quality management system. This is followed by containment, investigation, approval of corrective actions, implementation, effectiveness verification, and final closure. In regulated sectors—such as manufacturing, healthcare, and pharmaceuticals—avvikitsrapportering is a core component of compliance and the broader CAPA (corrective and preventive actions) framework. The practice supports traceability, audits, and continual improvement by preventing recurrence of non-conformities.