avvikssertifikat

Avvikssertifikat is a formal document used in quality management to record a deviation from specified requirements for a product, service, or process. It serves to document that a departure from the agreed standards has been identified, assessed, and authorized under controlled conditions, while maintaining traceability and accountability.

A typical avvikssertifikat includes: a clear description of the deviation and the reference standard or specification it concerns; identifiers such as batch or lot numbers; an assessment of the deviation’s potential impact on safety, performance, and compliance; the reason for the deviation and any containment actions taken; proposed corrective and preventive actions (CAPA); and names, roles, and dates of those responsible for review and approval. The certificate may also specify disposition for affected items, such as rework, use as-is under concession, or rejection, and it often cross-references related documentation like non-conformance reports and audit trails.

Process and usage: When a deviation is detected, a deviation report or similar record is initiated, reviewed by quality assurance or a designated authority, and approved before any downstream decision (such as shipment or release) is made. Depending on the industry and regulatory regime, an avvikssertifikat may require additional approvals from customers or regulators and is retained as part of the product’s traceability record.

Relation to standards: Avvikssertifikat is commonly associated withQuality management systems and regulatory frameworks found in manufacturing, pharmaceuticals, medical devices, and other sectors where formal deviation handling is required (for example, ISO 9001-based systems and industry-specific GMP or GxP guidelines).