CAPAprocedures

CAPA procedures are a systematic process used in quality management to identify, investigate, and correct actual or potential quality problems, and to prevent recurrence. They are central to industries such as pharmaceuticals, medical devices, manufacturing, and healthcare. The aim is to improve product quality, safety, and compliance.

A CAPA process includes detection and reporting of nonconformities or deviations; assessment of risk and impact; root cause analysis using methods like fishbone diagrams or the 5 Whys; development of corrective actions to eliminate root causes and prevent recurrence; preventive actions to address potential issues before they occur; implementation planning; verification and validation of effectiveness; documentation and change control; assignment of responsibilities; training; and timely closure. Ongoing monitoring and metrics are used to verify sustained improvement and to drive management review.

Regulatory and standards context: CAPA is required or expected by ISO 9001, ISO 13485, FDA QSR 21 CFR Part 820.100, and other quality systems. Organizations typically maintain a CAPA log or use a CAPA management system; post-closure review ensures effectiveness and triggers escalation if actions are not effective. CAPA procedures are part of a broader quality management system and support risk-based decision making and continuous improvement.