Applying Lean Six Sigma in the Pharmaceutical Industry


Book Description

Bikash Chatterjee emphasizes the criticality of applying the principles of Lean and Six Sigma within the paradigm of the drug development process. His guide to operational excellence in the pharmaceutical and biotech industries is a focused summary of the application of Lean Six Sigma theory to the regulated life sciences. From molecule discovery to the application of PAT Applying Lean Six Sigma in the Pharmaceutical Industry will highlight the importance of framing these initiatives within the key deliverables of drug development manufacturing and quality. Challenging conventional wisdom the author offers a quality and efficiency perspective as a foundation for the principles of Quality by Design, PAT and the new philosophies underlying Process Validation. Each chapter includes discussion around the considerations for applying Lean manufacturing and Six Sigma principles and their tools, culminating in a case study to illustrate the application. The book is organized to reflect the major work centers involved in the drug development lifecycle. Each chapter is stand-alone but together they illustrate the necessary synergy between Lean, Six Sigma and compliance sensibilities required to be successful in the pharmaceutical industry. These design, manufacturing and management techniques are not without their challenges. Bikash Chatterjee's book offers the roadmap for an industry that is struggling to reinvent many of its development and business processes.




Applying Lean Six Sigma in the Pharmaceutical Industry


Book Description

Bikash Chatterjee emphasizes the criticality of applying the principles of Lean and Six Sigma within the paradigm of the drug development process. His guide to operational excellence in the pharmaceutical and biotech industries is a focused summary of the application of Lean Six Sigma theory to the regulated life sciences. From molecule discovery to the application of PAT Applying Lean Six Sigma in the Pharmaceutical Industry will highlight the importance of framing these initiatives within the key deliverables of drug development manufacturing and quality. Challenging conventional wisdom the author offers a quality and efficiency perspective as a foundation for the principles of Quality by Design, PAT and the new philosophies underlying Process Validation. Each chapter includes discussion around the considerations for applying Lean manufacturing and Six Sigma principles and their tools, culminating in a case study to illustrate the application. The book is organized to reflect the major work centers involved in the drug development lifecycle. Each chapter is stand-alone but together they illustrate the necessary synergy between Lean, Six Sigma and compliance sensibilities required to be successful in the pharmaceutical industry. These design, manufacturing and management techniques are not without their challenges. Bikash Chatterjee's book offers the roadmap for an industry that is struggling to reinvent many of its development and business processes.




Applying Lean Six Sigma in Health Care


Book Description

Written to address the growing demand for Lean Six Sigma expertise, this text provides a step-by-step Define-Measure-Analyze-Improve-Control (DMAIC) process, that describes how to use the tools appropriate for each phase and provide data where tools can be practiced by students. Applying Lean Six Sigma in Health Care trains students on performance improvement techniques and current terminology so that they will be prepared to conduct Lean Six Sigma projects in large health care systems and support the physicians and nurses running these projects. With a focus on application, students learn and utilize the DMAIC process, by applying it to an improvement project that is carried through the text.




Six Sigma in the Pharmaceutical Industry


Book Description

Six Sigma in the Pharmaceutical Industry is the first book to introduce the fundamentals of Six Sigma, examine control chart theory and practice, and explain the concept of variation management and reduction applied specifically to the pharmaceutical industry. The first half lays out a conceptual framework for understanding variation, while the second half introduces control chart theory and practice. Using case studies and statistics, the book illustrates the concepts and explains their application to actual workplace improvements. Providing the basis for a complete operating philosophy, this book focuses on core concepts and their implementation to improve the existing products and processes in the pharmaceutical industry.




Lean Six Sigma in the Pharmaceutical Industry


Book Description

Lean manufacturing focuses on speed, while traditional Six Sigma focuses on quality. Striking a perfect balance between these two business paradigms, Lean Six Sigma in the Pharmaceutical Industry introduces key lean six sigma principles to help readers improve the quality and efficiency of medical products and the predictability of supply chains. Rich with forms and charts, the book pharma companies and biotech industry professionals with an indispensable tool for implement a lean six sigma program internally rather than hiring an outside consulting firm.




Operational Excellence with Lean Six Sigma


Book Description

Lean Six Sigma is the global standard for organizing the design, data-based improvement and control of business processes. Well-designed and controlled processes are key in achieving and sustaining operational excellence. They ensure the quality of service and care, the reliability and safety of work that is done, and a timely processing with short waiting times. High quality processes will at the same time improve the operation’s flexibility. Thereby allowing one to adjust to changes in demand and other circumstances. An organizational capability to harness data-based process improvement, finally, facilitates organizational learning and is foundational for the fruitful implementation of ever increasing digitization and automation opportunities. Lean Six Sigma offers a complete model for shaping modern continuous improvement programs in organizations. The methodology is built on principles and methods for fact-based process improvement that have proven themselves over the last decades, and will continue to do so in the decades to come. Having emerged in manufacturing, the approach continuously evolved and gained tremendous momentum in the services and healthcare industries. This book offers a thorough and pragmatic account of Lean Six Sigma project- and programme implementation with a special focus on applications in services and healthcare organizations.




An Integrated Company-Wide Management System


Book Description

This book offers a comprehensive guide to implementing a company-wide management system (CWMS), utilising up-to-date methodologies of lean-six sigma in order to achieve high levels of business excellence. It builds the foundation for quality and continuous improvement, which can be implemented in any organization. The book begins with an introduction to and an overview of CWMSs, and reviews the existing literature on various management systems. It then discusses the integration and implementation of lean-six sigma in supply chain management. The integration approach presented highlights the link between the existing management systems and shows how continuous improvement methodologies are incorporated. The book then examines the components of CWMS, comparing them to other systems. It also explores Kano-based six sigma and concludes with further recommendations for reading. This book covers five management systems integrated into one novel approach that can be followed by organizations wishing to achieve quality and business excellence. Covering lean-six sigma – an essential element of management systems – it is a valuable resource for practitioners and academics alike.




Lean Manufacturing and Six Sigma


Book Description

Lean Manufacturing, also called lean production, was originally created in Toyota after the Second World War, in the reconstruction period. It is based on the idea of eliminating any waste in the industry, i.e. any activity or task that does not add value and requires resources. It is considered in every level of the industry, e.g. design, manufacturing, distribution, and customer service. The main wastes are: over-production against plan; waiting time of operators and machines; unnecessary transportation; waste in the process itself; excess stock of material and components; non value-adding motion; defects in quality. The diversity of these issues will be covered from algorithms, mathematical models, and software engineering by design methodologies and technical or practical solutions. This book intends to provide the reader with a comprehensive overview of the current state, cases studies, hardware and software solutions, analytics, and data science in dependability engineering.







Lean Six Sigma Case Studies in the Healthcare Enterprise


Book Description

This book provides a detailed description of how to apply Lean Six Sigma in the health care industry, with a special emphasis on process improvement and operations management in hospitals. The book begins with a description of the Enterprise Performance Excellence (EPE) improvement methodology developed by the author that links several methodologies including systems thinking, theory of constraints, Lean and Six Sigma to provide an enterprise-wide prioritization and value-chain view of health care. The EPE methodology helps to improve flow at the macro or value-chain level, and then identifies Lean Six Sigma detailed improvements that can further improve processes within the value-chain. The book also provides real-world health care applications of the EPE and Lean Six Sigma methodologies that showed significant results on throughput, capacity, operational and financial performance. The Enterprise Performance Excellence methodology is described, and also the Six Sigma DMAIC (Define-Measure-Analyze-Improve-Control) problem solving approach which is used to solve problems for health care processes as they are applied to real world cases. The case studies include a wide variety of processes and problems including: emergency department throughput improvement; operating room turnaround; operating room organization; CT imaging diagnostic test reduction in an emergency department; linen process improvement; implementing sepsis protocols in an emergency department; critical success factors of an enterprise performance excellence program.