Corrective Actions Must Be Applied Systemically, FDA Warns Manufacturers
This article was originally published in The Silver Sheet
Executive Summary
CORRECTIVE ACTIONS STEMMING FROM FAILURE INVESTIGATIONS must be applied systemically across a manufacturer's organization, FDA says. "Go beyond the immediate correction of the issue or the nonconformance, which means going beyond the product," says FDA/GMP quality systems expert Kim Trautman. "Get to the processes and the systems that may have allowed a certain practice or incident to happen." Trautman says the agency isn't particularly concerned about which tools or techniques a firm uses during a failure investigation; rather, FDA investigators will focus on the entire investigation report when conducting a facility inspection. Meanwhile, device manufacturers Philips Medical Systems, Covidien, Hitachi Chemical Diagnostics and NeuroWave explain how they perform failure investigations and reveal how investigations can help a company save time and money. Experts also discuss when a failure investigation should be elevated to the CAPA system