Pharmaceutical Processing - July 2008 - cResults - (Page 5) July 2008 5 About the Authors: Mr. Joe Barbarite is the Vice President of Quality Assurance and Compliance at Par Pharmaceuticals, located at One Ram Ridge Road in Spring Valley, New York. Mr. Rafi Maslaton, President, cResults, has more than 16 years of diversified experience in operations, manufacturing engineering, information systems, and business management issues for fortune 500 firms. Prior to joining cResults, he served as COO of Sparta Systems, the maker of TrackWise, overseeing the complete project life cycle for clients. Mr. Maslaton has managed projects for Fortune 500 clients such as: Abbott, Amgen, Baxter, Bausch and Lomb, Bayer, Centocor/OBI, C.R. Bard, Eli Lilly, Fort Dodge, Genentech, J&J, Novartis, Par, Pfizer, Pharmacia, Roche, Sandoz, Shire, Schering-Plough, Teva and Wyeth, Agere Systems, Alpha Industry, Anadigics, HADCO, IBM, Intel, Lucent, Motorola, Nortel Network, Philips, Raytheon, and Siemens. The authors co-led the operational excellence efforts at Par Pharmaceutical. References: 1 5 Pillars of the Visual Workplace by Hiroyuki Hirano 2 Implementing a Mixed Model Kanban System, Subtitle: The Lean Replenishment Technique for Pull Production, by Vatalaro, James C./ Taylor, Robert E. 3 Toyota Production System: An Integrated Approach to Just-In-Time, by Yasuhiro Monden 4 Creating Mixed Model Value Streams: Practical Lean Techniques for Building to Demand, by Kevin J. Duggan 5 Lean Six Sigma: Combining Six Sigma Quality with Lean Production Speed by Michael L. George 6 Learning to See: Value Stream Mapping to Add Value and Eliminate Muda, by Mike Rother Figure 7: Documentation Errors by Month and Area QA activities via cME’s visibility to valueadded/non-value-added activities (i.e., reduce excessive reviews, enhance clearances and audit frequencies and content). (See Figure 7) Summary The increased pressure on cost and overall efficiency improvement is continuing and in light of some of the recent news related to right sizing from industry leaders, these trends will continue. Our industry is required to increase its manufacturing and quality value-added contribution to the bottom line. Both QC and QA are complicated areas in which to manage efficiency and require a detailed and innovative approach supported by computerized tools that enable managing quality operation efficiencies. Par answered the challenge given by its executive leadership and demonstrated that efficiency improvement is no longer a vision in quality operation - it is now a reality. What Is Next? As the journey for operational excellence continues, Par intends to further leverage its robust compliance management efficiency software (cME) to continue the effort of eliminating NonValue-Added activities performed by QA techs, refine the frequencies of these activities and their contents. Leveraging risk-based approach will further enhance the non value-added activities and improve the overall focus of the quality organization. Using automation, Process Analytical Technologies (PAT), and Electronic Batch Records will further improve efficiency, real time detection capabilities, and shorten the response time to the developing trends. The goal is to reach the highest level of value added compliance contribution to the business.■ Posted from Pharmaceutical Processing, July 2008. Copyright © Advantage Business Media. All rights reserved. #1-24628441 Managed by The YGS Group, 717.399.1900. For more information visit www.theYGSgroup.com/reprints. www.theYGSgroup.com/reprints
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