CAPAregeling

CAPAregeling, often written as CAPA-regeling, is a term used in Dutch-language quality management to denote the set of policies, procedures and controls for Corrective and Preventive Action (CAPA). The goal is to systematize the identification, investigation and correction of non-conformities and incidents, and to implement preventive measures to reduce the risk of recurrence and to ensure compliance with applicable standards and regulations.

The CAPAregeling is applicable in a range of sectors, including manufacturing, pharmaceuticals, medical devices, healthcare and other industries with quality or safety requirements. It is typically part of a broader quality management system and may be mandated at organizational, plant or site levels, or be emphasized by regulatory inspections. The exact scope can vary between industries and jurisdictions, but the core objective remains the same: prevent recurrence of problems and improve overall quality.

Key elements commonly found in a CAPAregeling include: clear documentation of non-conformities or incidents; assignment of responsibilities; root cause analysis using methods such as root cause trees or 5 Whys; development of corrective actions to address existing issues and preventive actions to stop recurrence; risk assessment and impact analysis; change control and implementation planning; verification and validation of effectiveness; thorough recordkeeping and management review; and ongoing monitoring to ensure sustained improvement.

Typical process steps involve detection and reporting, evaluation and risk assessment, investigation of root causes, approval of CAPA plans, implementation, effectiveness verification, closure, and learning for future prevention. Challenges often focus on timely closures, maintaining data integrity, and ensuring sustained effectiveness.