avviksteam

Avviksteam is a team dedicated to investigating deviations from approved procedures, processes, or specifications within an organization. The aim is to determine root causes, assess risk, and implement actions to prevent recurrence. Avviksteam functions are common in quality management, safety, and regulatory compliance programs; in English contexts the term is often translated as deviation investigation team or nonconformity team.

Activation occurs when a deviation is detected through incident reports, audits, inspections, or customer or internal complaints. The avviksteam documents the deviation, classifies its severity, assigns roles, and collects relevant data. They may interview staff, review logs and records, and assess whether the deviation affects product quality, safety, or regulatory compliance.

The core process includes root cause analysis, development of corrective actions (to address the immediate issue) and preventive actions (to prevent recurrence), risk assessment, and action planning. The team verifies the effectiveness of actions, closes the deviation, and updates procedures as needed. Common analytical methods include the 5 Whys, fishbone diagrams, and failure mode and effects analysis. All steps are documented to maintain traceability and learning.

Organization and scope: avviksteam typically comprises quality assurance managers, process owners, subject-matter experts, and safety or regulatory officers. They operate within the organization’s quality management system and are often aligned with standards such as ISO 9001 or ISO 13485. The team coordinates with internal auditors and regulators, and its work aims to reduce recurrence, improve compliance, and enhance overall safety and reliability.