Abstract
Medical device manufacturing requires rigorous attention to quality and safety due to its direct impact on patient health. Failures in this sector can lead to significant harm, regulatory penalties, and loss of trust, making risk management a central concern for manufacturers. Two established approaches—Six Sigma and Corrective and Preventive Action (CAPA)—offer complementary pathways to achieve excellence in quality management. Six Sigma provides a data-driven, structured methodology for minimizing defects and variability, while CAPA ensures regulatory compliance by systematically addressing nonconformances and preventing their recurrence.
This research examines the integration of Six Sigma and CAPA into a unified framework for risk management in medical device manufacturing. By aligning Six Sigma’s DMAIC methodology with CAPA processes, organizations can enhance their ability to identify problems, analyze root causes, implement corrective measures, and sustain improvements. The integration not only improves operational efficiency but also embeds process improvements within quality management systems, strengthening compliance with international standards such as ISO 13485 and ISO 14971.
The analysis reveals three primary outcomes of integration. First, manufacturers achieve measurable reductions in defects by leveraging statistical tools to support CAPA investigations. Second, compliance and sustainability are improved as Six Sigma-driven improvements are institutionalized within regulatory frameworks. Third, operational efficiency increases through faster CAPA cycle times and a shift toward proactive quality management.
Overall, integrating Six Sigma and CAPA creates a robust, sustainable, and proactive risk management system. It enables medical device manufacturers to balance efficiency, compliance, and safety while fostering a culture of continuous improvement. The findings provide a strategic model for companies aiming to strengthen resilience in a highly regulated industry.