A Change in Focus

Article

Lokas, Karim   (ASQ)   Camstar Systems Inc., Charlotte, NC

Quality Progress    Vol. 44    No. 8
QICID: 33265    August 2011    pp. 46-52
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Article 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 cycle.

Keywords

Healthcare industry, Process improvement, Product quality, Quality improvement (QI), Quality management (QM), Quality management systems (QMS), Root cause analysis (RCA)


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