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,
Process: deviations are typically logged in a deviation register or deviation management system. Common fields include
Data and governance: avviksregistrering records should be stored within the quality management system, with appropriate access
Relation to standards: aligns with quality management frameworks such as ISO 9001 and GMP, which emphasize