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Redesigning an FDA-compliant medical device Corrective action & preventive action process utilizing design for Lean Six Sigma
Date
2026-05-06
Abstract
This study aims to improve the efficacy and efficiency of a Corrective Action and Preventive Action (CAPA ) process within a medical device organization by utilizing Design for Lean Six Sigma. The primary objectives are to mitigate compliance risks and reduce the time required to complete a CAPA . This project illustrates the application of Design for Lean Six Sigma (DFLSS) principles and the structured Define, Measure, Analyze, Design, and Verify (DMADV) methodology in the redesign of a CAPA process. The use of the DMADV methodology reduced the average duration of CAPA s by just under 60%. This improvement was attributed to the data-driven structured problem-solving approach employed. To sustain these improvements, new processes and training documentation were developed, and metrics were defined for monitoring and further improvements. All changes were achieved in compliance with 21CFR Part 820 and without any non compliance to regulations. The study was conducted within a single organization; however, the findings can be leveraged by other regulated organizations to ensure compliance. Future research should consider applying the DMADV approach to other quality system processes in diverse organizational settings to validate its broader benefit. This study represents the first application of the DMADV DFLSS methodology outside of a manufacturing process; and to redesign a CAPA process within the highly regulated MedTech sector and also if one of the few applications of DFLSS to a regulated QMS process. The findings have broad implications for benchmarking that extend beyond other elements of quality systems and into numerous sectors.
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Description
Publisher
Taylor & Francis Group
Citation
Quality Management Journal
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Funding Information
Sustainable Development Goals
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License
Attribution-NonCommercial-ShareAlike 4.0 International