CAPAtiltak

CAPAtiltak are measures taken within a quality management framework to address both corrective and preventive actions. Corrective actions aim to eliminate the root causes of detected nonconformities or undesirable events, while preventive actions seek to prevent potential issues from occurring in the first place. Together, CAPAtiltak are used to reduce risk, improve product and process quality, and support regulatory compliance.

CAPAtiltak are common in industries such as manufacturing, pharmaceuticals, and medical devices, and are a core element of standards like ISO 9001 and ISO 13485, as well as GMP and FDA requirements. They involve a structured process designed to identify, investigate, implement, and verify improvements. The typical lifecycle includes detecting or reporting a problem, assessing its impact, performing root cause analysis, planning appropriate corrective and preventive actions, implementing those actions, and conducting effectiveness verification before formal closure. Documentation and traceability are important, with CAPA records often assigned a unique identifier and linked to the related nonconformity or risk assessment.

Common methods used in CAPAtiltak include root cause analysis techniques such as the 5 Whys or Ishikawa diagrams, as well as risk assessment tools and change-control procedures. CAPA activities may involve design changes, process adjustments, supplier changes, updated work instructions, retraining, or improved monitoring and maintenance.

Effective CAPAtiltak require clear ownership, timely execution, and robust verification to ensure that actions prevent recurrence and do not introduce new issues. Ongoing review and trend analysis help organizations identify areas for systemic improvement.