The results of an eight-year program at Amgen to improve its deviation investigations and follow-up actions demonstrate how concentrating on finding and addressing root causes can have a substantial impact on a firm’s quality assurance and bottom-line.
Amgen’s learnings on its continuous improvement journey have strong relevance to the current discussions on manufacturing metrics – shedding light on which can more clearly reflect the process improvements that matter to product quality.
At an ISPE conference on “pro-active compliance” in New Brunswick, New Jersey in January, Amgen Quality Science Senior Specialist Jill Peirick provided a revealing look at the progression of her company’s deviation investigation program and how the changes Amgen has made are reflected in highly significant declines in the number of errors per lot, distribution cycle times, and scrap.
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