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Application Of Lean Six Sigma To Reduce The Cost Of Regulatory Noncompliance., Reham Nour, Chad Laux
Application Of Lean Six Sigma To Reduce The Cost Of Regulatory Noncompliance., Reham Nour, Chad Laux
International Conference on Lean Six Sigma
1. Purpose
This research focused on the adoption of Six Sigma within FDA-regulated pharmaceutical companies to create an effective CAPA system for reducing the cost of noncompliance and supporting organizational performance.
2. Design/Methodology/Approach
This study utilized the DMAIC methodology, in a case study, to improve the CAPA process within a medical device company regulated by the FDA. All the critical requirements for compliance CAPA system was being defined from the FDA sources and the DMAIC model was be applied to improve and maintain CAPA performance.
3. Findings
Using the DMAIC approach supported identifying the bottlenecks and process variation. within CAPA. …