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Managing Quality Events in Life Science Manufacturing: Improving the Incident-To-Resolution Process
by Mark Kovacs and Ed Sullivan, EnteGreat

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Paper Overview
The management of manufacturing quality events from incident to resolution is a critical process within Life Science organizations that is often performed in an over-complicated and inefficient manner. This unnecessary complexity and inefficiency can have significant adverse effects on overall business performance by diverting critical resource to address inappropriate and non-value adding activities. By applying lean principals and value stream analysis to the incident to resolution process, substantial waste can be eliminated from the process while at the same time maintaining complete regulatory compliance. When applied properly, the value stream mapping process identifies and quantifies the non-value adding activities (waste) in an unbiased manner that brings manufacturing and quality assurance together to focus on results which drive business value - specifically the resolution of individual incidents and the prevention of future manufacturing quality events.

Paper Outline

• Introduction
• Using Proven Methodologies
• Value Stream Mapping for Quality Events
• Execution
• Keys to Success
• Conclusion

About the Authors
Mark Kovacs has over 22 years of total experience with more than 10 years in the Life Science sector. As Director of Information Technology with a pharmaceutical company, Mark established both enterprise and manufacturing systems standards. In addition to his pharmaceutical experience, Mark's Life Sciences experience also include Biotechnologies and Medical Device manufacturing, ranging from simple point solutions to complex multinational deployments involving various governmental regulatory agencies.

Ed Sullivan has over 19 years experience designing, developing, and implementing manufacturing and supply chain system solutions in both North America and Europe. This experience includes roles ranging from consulting to system design and implementation across a variety of industries including Life Sciences, Food, Beverage, Chemical, and Metals. He has a BS IE and MBA from the University of Pittsburgh and an MS IE from Arizona State University. He is a registered professional engineer with membership in both ISPE as well as APICS, with both CPIM and CIRM certifications.

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