Corrective Actions Must Be Applied Systemically, FDA Warns Manufacturers

摘要

FDA is reminding device manufacturers to systemically apply corrective actions to ensure that problems don't recur or migrate to different product lines."Probably the biggest broad-stroke comment that I can make is that many [firms] stop at the correction, or go to the immediate corrective action of the product and are not getting to the systemic corrective action," says FDA/GMP quality systems expert Kim Trautman."Go beyond the immediate correction of the issue or the nonconformance, which means going beyond the product," she told "The Silver Sheet." "Get to the processes and the systems that may have allowed a certain practice or incident to happen.