Download or read book The Impact of Lean Six Sigma on the Pharmaceutical and Medical Device Industries written by Estela Niazi and published by . This book was released on 2013 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Applying Lean Six Sigma in the Pharmaceutical Industry written by Bikash Chatterjee and published by CRC Press. This book was released on 2016-04-08 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Medical Device Design for Six Sigma written by Basem El-Haik and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 556 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first comprehensive guide to the integration of Design for Six Sigma principles in the medical devices development cycle Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness presents the complete body of knowledge for Design for Six Sigma (DFSS), as outlined by American Society for Quality, and details how to integrate appropriate design methodologies up front in the design process. DFSS helps companies shorten lead times, cut development and manufacturing costs, lower total life-cycle cost, and improve the quality of the medical devices. Comprehensive and complete with real-world examples, this guide: Integrates concept and design methods such as Pugh Controlled Convergence approach, QFD methodology, parameter optimization techniques like Design of Experiment (DOE), Taguchi Robust Design method, Failure Mode and Effects Analysis (FMEA), Design for X, Multi-Level Hierarchical Design methodology, and Response Surface methodology Covers contemporary and emerging design methods, including Axiomatic Design Principles, Theory of Inventive Problem Solving (TRIZ), and Tolerance Design Provides a detailed, step-by-step implementation process for each DFSS tool included Covers the structural, organizational, and technical deployment of DFSS within the medical device industry Includes a DFSS case study describing the development of a new device Presents a global prospective of medical device regulations Providing both a road map and a toolbox, this is a hands-on reference for medical device product development practitioners, product/service development engineers and architects, DFSS and Six Sigma trainees and trainers, middle management, engineering team leaders, quality engineers and quality consultants, and graduate students in biomedical engineering.
Download or read book Six Sigma for Medical Device Design written by Jose Justiniano and published by CRC Press. This book was released on 2004-11-15 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt: For designers of medical devices, the FDA and ISO requirements are extremely stringent. Designers and researchers feel pressure from management to quickly develop new devices, while they are simultaneously hampered by strict guidelines. The Six Sigma philosophy has solved this dichotomous paradigm for organizations in other fields, and seeks to do
Download or read book Lean Six Sigma in the Pharmaceutical Industry written by William Botha and published by . This book was released on 2013-07-19 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Impact of Lean Six Sigma on Operational Performance written by and published by . This book was released on 2019 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Six Sigma in the Pharmaceutical Industry written by Brian K. Nunnally and published by CRC Press. This book was released on 2007-06-13 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Basics of Health Care Performance Improvement written by Donald Lighter and published by Jones & Bartlett Publishers. This book was released on 2011-11-15 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: Basics of Health Care Performance Improvement: A Lean Six Sigma Approach prepares future healthcare administrators to meet the challenges of a changing marketplace through the proven Lean Six Sigma method of quality improvement—straightforward principles and procedures that enhance how healthcare organizations operate. With an eye toward meeting consumers’ increasing demand for value in health care, this new volume provides in-depth information on planning and implementing a “Define-Measure-Analyze-Improve-Control” (DMAIC) initiative to reduce errors and improve performance in healthcare settings, and serves as an essential reference on the basics of Lean Six Sigma and its application in augmenting the quality of care. Key Features: Lean Six Sigma case studies drawn from the industry; A thorough exploration of DMAIC approach to quality improvement; Discussion questions in every chapter Instructor Resources: Instructor's Manual, PowerPoint Presentations, and a TestBank
Download or read book Lean Six Sigma Approaches in Manufacturing Services and Production written by Erdem Gerard Tetteh and published by IGI Global. This book was released on 2014-11-30 with total page 365 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This book presents emerging research-based trends in the area of global quality lean six sigma networks and analysis through an interdisciplinary approach focusing on research, cases, and emerging technologies"--Provided by publisher.
Download or read book We Don t Build Cars The Art of Sustained Competitive Improvement in the Drug and Medical Device Industries written by William Botha and published by Lulu.com. This book was released on 2012-11-28 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt: An incisive and value-packed insight into the practical application of the Toyota Production System (or Lean) within the biopharmaceutical, pharmaceutical and medical devices industries. Written by a gifted trainer and leader in the niche, it is filled with tricks and traps on how best to navigate the treacherous minefield of regulations while generating significant and sustained benefit to the business and the patient. The Leanership model; integrating dynamic leadership behaviors with robust control systems and effective TPS tools, is described within the covers. The author, as a result of his time as a leader, manager, trainer and consultant is able to tell relevant personal stories to illuminate the key concepts and philosophies that will enable the reader to replicate his results. Illustrated with profound quotes from world leaders and salted with a quirky sense of humor, this treasure of a work is an easy, fast read.
Download or read book Operational Excellence with Lean Six Sigma written by Bart A. Lameijer and published by Van Haren. This book was released on 2022-01-06 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book The Executive Guide to Understanding and Implementing Lean Six Sigma written by Robert M. Meisel and published by Quality Press. This book was released on 2007-01-02 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a fundamental introduction to the concepts of lean enterprise and Six Sigma to executives, personnel new to quality, or organizations interested in introductory information on quality and process improvement. It is intended to be a helpful guide on implementing and optimizing an integrated Lean Six Sigma approach focused on realizing return value and bottom line impact. The principles of Lean and Six Sigma are introduced and discussed separately and through an integrated approach across the book’s three chapters.Manufacturing and non-manufacturing firms who are just getting started or contemplating a Lean Six Sigma initiative will find this book especially valuable. To aid in illustrating the application of these principles to diverse and global businesses, various case studies have been selected and included to demonstrate how the prescribed tools and techniques can accommodate and enhance a wide variety of customer relationships throughout the value chain. Examples taken from manufacturing, banking, and local government sectors demonstrate the broad spectrum across which Lean Six Sigma can be used as a framework to foster improved performance and ensure continued customer satisfaction and loyalty.
Download or read book Six Sigma written by Abdurrahman Coskun and published by BoD – Books on Demand. This book was released on 2011-07-14 with total page 198 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the new millennium the increasing expectation of customers and products complexity has forced companies to find new solutions and better alternatives to improve the quality of their products. Lean and Six Sigma methodology provides the best solutions to many problems and can be used as an accelerator in industry, business and even health care sectors. Due to its flexible nature, the Lean and Six Sigma methodology was rapidly adopted by many top and even small companies. This book provides the necessary guidance for selecting, performing and evaluating various procedures of Lean and Six Sigma. In the book you will find personal experiences in the field of Lean and Six Sigma projects in business, industry and health sectors.
Download or read book Lean Six Sigma for Healthcare written by Chip Caldwell and published by Quality Press. This book was released on 2008-12-05 with total page 239 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book’s unique focus on the role of healthcare leaders and the lessons learned were uncovered during the authors’ research of over 200 U.S. hospitals’ performance. It was written specifically for CEOs, the “C-Suite,” and senior leaders who desire to harness the power of Lean-Six Sigma as their major strategic weapon for progress, as well as those charged to coach them. It is intended for those organizations that operate active Lean-Six Sigma initiatives, but have yet to successfully attack high leverage processes like “In Quality Staffing” and recovering significant Cost of Quality from throughput improvements. It is also intended for senior leaders who have yet to tackle Lean-Six Sigma as their major organization-wide strategic weapon. However, it is also a must-read for managers at all levels, quality professionals, and Lean-Six Sigma Black Belts who desire to aid in assuring that their organizations’ improvement efforts attack strategically versus the all-to-common tactical, project-by-project approach that suboptimizes the power of Lean-Six Sigma. Further, the book and supporting website is full of electronic checklists, tools, templates, suggestions for additional reading, and many recommended 1-hour and 2-hour learning sessions for senior leaders and managers. The changes in this second edition include the following: Many more examples of “In Quality Staffing”, a healthcare translation of one of the seven categories of Lean waste found in the Toyota Production System and one of the most powerful concepts applicable to healthcare. This concept has been described as “the language of nursing” versus a more manufacturing-speak described in other leading Lean-Six Sigma books. Expanded dialogue of the role of Lean in healthcare. Additional embedded case examples.
Download or read book The Medicine of Lean Six Sigma written by Hayden Barker and published by . This book was released on 2021-04-02 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book GMP Audits in Pharmaceutical and Biotechnology Industries written by Mustafa Edik and published by CRC Press. This book was released on 2024-06-28 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fact that good manufacturing practice (GMP) audits in the pharmaceutical and biotechnology industries have to be evaluated, and with very limited resources, has created a gap in this field. The lack of trained and qualified GMP auditors is on the rise in all organizations that are required to implement FDA, EMA, MHRA, WHO, TGA, and PIC/S regulations. This volume is an essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. The author also provides useful tips and a selection of samples about GMP audits that are indispensable for professionals and health inspectors working in industry and health authorities. Features • An essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. • Anyone working in the manufacturing sector needs to be aware of GMP, be able to identify operational flaws as well as legal violations, and have a clear understanding of how to meet GMP standards. • Assists readers in understanding the importance of GMP and how they can apply each aspect in their working environment. • Covers a global regulatory landscape. • Suitable for relevant degree courses including industrial pharmaceutics and pharmaceutical biotechnology.
Download or read book Essentials for the Improvement of Healthcare Using Lean Six Sigma written by D.H. Stamatis and published by CRC Press. This book was released on 2012-02-02 with total page 391 pages. Available in PDF, EPUB and Kindle. Book excerpt: Essentials for the Improvement of Healthcare Using Lean & Six Sigma is all about real and immediate quality improvement. Written by D.H. Stamatis, a renowned expert in organizational development and quality, the book addresses concerns that can be ameliorated with minimal government intervention. Detailing immediate paths for improvement fundamental to primary care, hospitals, and managed care, the book: Introduces much-needed mechanics of change, including transitioning from hierarchical groups to interactive inclusionary teams Focuses on customer satisfaction as a key indicator of quality Explains how Lean and Six Sigma tools can be readily applied to healthcare Spotlights primary care, including how to define and redesign its process and develop better metrics Presents IT applications that will improve billing, documentation, and patient care Examines Malcolm Baldrige National Quality Award criteria as it applies to healthcare Illustrates quality improvements and best practices through real world case studies Includes a companion CD with Six Sigma forms and formulas, Lean improvement tools, and other quality tools and worksheets Whether you think advances in technology and medicine, coupled with freedom of choice, makes the U.S. healthcare system the best in the world, or whether you believe growing costs, regulatory morass, and a tort-obsessed culture drop it to the bottom; it is evident that the processes currently employed and the subsequent defensive medicine philosophy that has resulted will not be able to meet the future demands of our aging society. Through Six Sigma and Lean, this text moves the focus from reactive controls to the proactive efficiency required to implement real and sustainable quality improvements that will allow us to forge a system that is all about wellness.
