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HBOK 1-508

Title A Change in Focus
Author(s) Karim Lokas
Source Quality Progress
Topic Strategic Management

Performance Measurement

Performance Improvement

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, enterprise-wide 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.
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Reference Code 1-508

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