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May 18, 2026Open Access

Redesigning an FDA-compliant medical device Corrective action & preventive action process utilizing design for Lean Six Sigma

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Authors

JCJonathan CurranOMOlivia McDermottATAnna Trubetskaya

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Overview

Randomized trial demonstrates improved CAPA efficiency in a medical device organization, suggesting broader applications for compliance enhancement.

Key Points

  • The study aims to enhance the efficacy of the CAPA process in medical device organizations using Lean Six Sigma principles.
  • Utilized Design for Lean Six Sigma (DFLSS) and DMADV methodology for process redesign
  • Developed new processes and training documentation
  • Monitored metrics for ongoing improvements
  • Reduced average duration of CAPAs by nearly 60%
  • Achieved improvements in compliance with 21CFR Part 820
  • Findings have potential applications in other regulated organizations

Cite This Study

Curran et al. (2026) studied this question.

synapsesocial.com/papers/6a0aad145ba8ef6d83b7089ehttps://doi.org/10.34961/19429
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