A Change in Focus

Abstract:The life-sciences industry is lagging in its use of quality management systems (QMS). A traditional QMS is focused on regulatory compliance, not product quality improvement. A product-based QMS should focus on mining data to facilitate root cause analysis and global consistency. One approach that accelerates innovation and quality optimization is closed-loop quality execution, a holistic, enterprisewide process characterized by predictive warning, intelligent root cause analysis, risk-based management, concurrent process and product development, proactive enforcement of actions, automated effectiveness assurance and global coordination. An effective closed-loop approach must cover the entire product …

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I believe many of the issues raised in this article are addressed in the changes to ISO 9001 from the 2000 version to the 2008 version. ISO 9004 also speaks to the effectiveness of the QMS. Of course, it remains for organizations to actually implement the principles. As has been noted, the distance from awareness to action is much greater than that from ignorance to awareness.

--Jon Fadely, 08-15-2011

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