What is it about?
We study manufacturing plant audit data in the medical device industry. We show that plant specific experience seems to reduce the accuracy of an audit, making these audits less informative. As a result, the overall risk of a recall increases the longer an inspector has been assigned to a specific plant. The solution is relatively simple - rotate inspectors.
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Why is it important?
Recalls are on the rise, and can have very serious health consequences in the medical device sector. If recalls can be reduced by rotating inspectors, this would be a relatively low cost way to increase patient health.
Read the Original
This page is a summary of: Do Plant Inspections Predict Future Quality? The Role of Investigator Experience, Manufacturing & Service Operations Management, August 2017, INFORMS,
DOI: 10.1287/msom.2017.0661.
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Resources
7-Year FDA Review Reveals Importance of Rotating Plant Inspectors
An article describing my research
BFFs With FDA? Repeat Visits From Investigators Can Lead To Poor Device Quality, Recalls, Study Suggests
Another good article in the media that really digs in depth, and contains new information from the FDA
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