The study, which was recently published in the INFORMS journal Manufacturing & Service Operations Management, examined 4,767 FDA plant inspection outcomes and 2,863 medical device recalls from 2,244 different plants.
George Ball, Operations and Decision Technologies Department, Kelley School of Business, Indiana University, told us the basis of the study was to explore the connection between US Food and Drug Administration (FDA) medical device plant inspection outcomes and future medical device recalls risks.
“The study started with an idea to try and measure how effective these inspections really are,” he examined.
The study found there is a 21% increase in the risk of a future recall following the second time an investigator inspects a plant, and this risk increases to 57% after an investigator's third inspection of the same plant.
“The inspector’s outcomes are highly predictive of future recall risks when they inspect a plant for the first time, but once they return to a plant for repeat visits, their inspections are not nearly as predictive,” Ball said. “In addition to this, the overall recall risk of the plant increases with repeat visits from the same inspector, independent of the inspection outcome they give to the plant.”
The findings suggest a risk of inspector complacency, Ball explained.
According to the researchers, if the FDA rotates inspectors it could significantly improve the predictability of inspections outcomes on future recall risks as well as reduce overall recall levels.
Source: Manufacturing & Service Operations Management
Do Plant Inspections Predict Future Quality? The Role of Investigator Experience
Authors: George Ball, Enno Siemsen, and Rachna Shah