Finished Goods Failure Reduction in a Wound Closure Medical Device Product Family

Abstract

A corrective action and preventive action plan was developed to address the increase of Finished Goods failures in a wound closure medical device product family. Following a DefineMeasure-Analyze-Improve-Control Six Sigma approach, process failure modes were successfully identified and mitigated. Results show Finished Goods nonconformances decreased by 93 percent during the first four months of the action plan effectiveness period increasing the process sigma level from 5.51 to 6.35. Key Terms - Corrective Action, Failure Investigation, Root Cause, Six Sigma.