Avviksregistrering

Avviksregistrering is the formal process of recording deviations from defined requirements, procedures, standards or plans. It is used to document any event or condition that diverges from the expected, with potential impact on quality, safety, delivery or regulatory compliance. The purpose is to create traceability, facilitate root-cause analysis, and drive corrective and preventive actions (CAPA).

Scope and application: avviksregistrering applies across industries that operate with formal processes, such as manufacturing, development, healthcare, and public administration. It covers deviations detected during operations, inspections, audits, or testing, including near-misses and actual non-conformities. It complements other incident reporting but specifically focuses on deviations from defined requirements.

Process: deviations are typically logged in a deviation register or deviation management system. Common fields include a unique identifier, date detected, location or process, description of the deviation, reference to the applicable requirement, assessed severity or impact, person reporting, and any immediate containment actions. An initial assessment determines priority, regulatory implications, and responsibility. Root-cause analysis is conducted, and a corrective action plan is proposed. Actions are approved by a designated authority, implemented, and followed up with verification of effectiveness. The record is closed when conformity is restored and the solution is validated.

Data and governance: avviksregistrering records should be stored within the quality management system, with appropriate access control, retention policies, and audit trails. Metrics commonly tracked include number of deviations, time to resolve, root causes, corrective actions taken, and recurrence rates.

Relation to standards: aligns with quality management frameworks such as ISO 9001 and GMP, which emphasize traceability, risk management, and continual improvement.