This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.
The topics in the body of knowledge (BOK) of this ASQ certification cover compliance with GMPs, as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, ectoparasitacides, and dietary supplements (alternatively called nutraceuticals where regulated as drug products), as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients) and packaging and labeling operations.
The intent of this book is to provide background and examples on the application of gage R&R methodology (test method validation) for variable and attribute data, help for those who work with devices that don’t fit the usual approach, and ideas for measurement devices that require innovation to assess their performance under off-line, static conditions. The ultimate objective is to determine how best to improve the control and performance of a process. The reader is assumed to be familiar with basic control charting methodology since assessment of statistical control of the measurement process is important.
One may wonder why performing a gage R&R is so important; the simple answers are profit, public health, and safety. Companies that are shipping product that is out of specification can be subjected to expensive litigation, especially in the aviation, pharmaceutical, and medical device industries.
This book will be a useful reference when preparing for and taking many of the ASQ quality certification examinations, including the Certified Quality Technician (CQT), Certified Calibration Technician (CCT), Certified Quality Inspector (CQI), Certified Six Sigma Green Belt (CSSGB), Certified Quality Engineer (CQE), Certified Six Sigma Black Belt (CSSBB), and Certified Reliability Engineer (CRE).
The intent of this book is to provide manufacturing quality professionals working in virtually any industry a quick, convenient, and comprehensive guide to properly conduct process validations that meet regulatory and certification requirements. It will aid quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities.
This is a practical introduction to the basics of DOE, intended for people who have never been exposed to design of experiments, been intimidated in their attempts to learn about DOE, or have not appreciated the potential of this family of tools in their process improvement and optimization efforts.
In addition, this book is a useful reference when preparing for and taking many of the ASQ quality certification examinations, including the Certified Quality Technician (CQT), Certified Six Sigma Green Belt (CSSGB), Certified Quality Engineer (CQE), Certified Six Sigma Black Belt (CSSBB), and Certified Reliability Engineer (CRE).
For those who slept through Stats 101, this book is a lifesaver. Wheelan strips away the arcane and technical details and focuses on the underlying intuition that drives statistical analysis. He clarifies key concepts such as inference, correlation, and regression analysis, reveals how biased or careless parties can manipulate or misrepresent data, and shows us how brilliant and creative researchers are exploiting the valuable data from natural experiments to tackle thorny questions.
And in Wheelan’s trademark style, there’s not a dull page in sight. You’ll encounter clever Schlitz Beer marketers leveraging basic probability, an International Sausage Festival illuminating the tenets of the central limit theorem, and a head-scratching choice from the famous game show Let’s Make a Deal—and you’ll come away with insights each time. With the wit, accessibility, and sheer fun that turned Naked Economics into a bestseller, Wheelan defies the odds yet again by bringing another essential, formerly unglamorous discipline to life.
“[Taleb is] Wall Street’s principal dissident. . . . [Fooled By Randomness] is to conventional Wall Street wisdom approximately what Martin Luther’s ninety-nine theses were to the Catholic Church.”
–Malcolm Gladwell, The New Yorker
Finally in paperback, the word-of-mouth sensation that will change the way you think about the markets and the world.This book is about luck: more precisely how we perceive luck in our personal and professional experiences.
Set against the backdrop of the most conspicuous forum in which luck is mistaken for skill–the world of business–Fooled by Randomness is an irreverent, iconoclastic, eye-opening, and endlessly entertaining exploration of one of the least understood forces in all of our lives.
From the Trade Paperback edition.
This textbook provides a comprehensive introduction to forecasting methods and presents enough information about each method for readers to use them sensibly.
Based on the author's personal experience with Toyota’s master teachers and with companies in the midst of great change, Andy & Me: Crisis & Transformation on the Lean Journey, now in its second edition, is a business novel set in a failing New Jersey auto plant focusing on the tribulations of Tom Pappas, the plant manager. The situations, characters, and plant politics will ring true with many readers.
In a cool, readable style, this highly popular work follows Tom's relationship with Andy Saito, a reclusive retired Toyota guru whom Tom persuades to help save his plant through the teaching of the legendary Toyota Production System (TPS).
On this journey, the reader learns that TPS is more than just a collection of tools; it entails a new way of thinking and behaving. Though Tom finds success — both in his plant and in his personal life — he learns from Andy that successful improvement is endless and eternal.This edition includes study questions after each chapter to support your learning and help you tell some of your own stories.
Pascal Dennis discusses the 2nd edition of his Shingo Prize-winning book Andy & Me.
Notably flexible and brief, the A3 report has proven to be a key tool In Toyota’s successful move toward organizational efficiency, effectiveness, and improvement, especially within its engineering and R&D organizations. The power of the A3 report, however, derives not from the report itself, but rather from the development of the culture and mindset required for the implementation of the A3 system.
In Understanding A3 Thinking, the authors first show that the A3 report is an effective tool when it is implemented in conjunction with a PDCA-based management philosophy. Toyota views A3 Reports as just one piece in their PDCA management approach. Second, the authors show that the process leading to the development and management of A3 reports is at least as important as the reports themselves, because of the deep learning and professional development that occurs in the process. And finally, the authors provide a number of examples as well as some very practical advice on how to write and review A3 reports.
Just as he did with the bestselling ISO 9001 in Plain English Cochran has written a comprehensive yet easily understandable guide to ISO 9001:2015. ISO 9001:2015 in Plain English was written so that anyone at any level of the organization can get to the heart of the standard’s requirements and how they apply to the organization quickly and simply. Plus, Cochran shows what has changed between the 2008 and 2015 version.
This straightforward book is ideal for people who are new to ISO 9001:2015, experienced ISO coordinators who want to get more out of an established system as they transition to the new standard, and for employees who just need a basic understanding of what ISO 9001:2015 is and how it applies to them.
Cochran explains each of ISO 9001:2015’s sections and clauses using real-world examples and frequently asked questions.
Currently Americans spend a staggering $200 billion each year on prescription drugs. As Dr. Angell powerfully demonstrates, claims that high drug prices are necessary to fund research and development are unfounded: The truth is that drug companies funnel the bulk of their resources into the marketing of products of dubious benefit. Meanwhile, as profits soar, the companies brazenly use their wealth and power to push their agenda through Congress, the FDA, and academic medical centers.
Zeroing in on hugely successful drugs like AZT (the first drug to treat HIV/AIDS), Taxol (the best-selling cancer drug in history), and the blockbuster allergy drug Claritin, Dr. Angell demonstrates exactly how new products are brought to market. Drug companies, she shows, routinely rely on publicly funded institutions for their basic research; they rig clinical trials to make their products look better than they are; and they use their legions of lawyers to stretch out government-granted exclusive marketing rights for years. They also flood the market with copycat drugs that cost a lot more than the drugs they mimic but are no more effective.
The American pharmaceutical industry needs to be saved, mainly from itself, and Dr. Angell proposes a program of vital reforms, which includes restoring impartiality to clinical research and severing the ties between drug companies and medical education. Written with fierce passion and substantiated with in-depth research, The Truth About the Drug Companies is a searing indictment of an industry that has spun out of control.
Complexity surrounds us. We have too much email, juggle multiple remotes, and hack through thickets of regulations from phone contracts to health plans. But complexity isn’t destiny. Sull and Eisenhardt argue there’s a better way. By developing a few simple yet effective rules, people can best even the most complex problems.
In Simple Rules, Sull and Eisenhardt masterfully challenge how we think about complexity and offer a new lens on how to cope. They take us on a surprising tour of what simple rules are, where they come from, and why they work. The authors illustrate the six kinds o f rules that really matter - for helping artists find creativity and the Federal Reserve set interest rates, for keeping birds on track and Zipcar members organized, and for how insomniacs can sleep and mountain climbers stay safe.
Drawing on rigorous research and riveting stories, the authors ingeniously find insights in unexpected places, from the way Tina Fey codified her experience at Saturday Night Live into rules for producing 30 Rock (rule five: never tell a crazy person he’s crazy) to burglars’ rules for robbery (“avoid houses with a car parked outside”) to Japanese engineers mimicking the rules of slime molds to optimize Tokyo’s rail system. The authors offer fresh information and practical tips on fixing old rules and learning new ones.
Whether you’re struggling with information overload, pursuing opportunities with limited resources, or just trying to change your bad habits, Simple Rules provides powerful insight into how and why simplicity tames complexity.
The new and revised edition of this modern day classic provides the critical piece that will make any lean transformation a dynamic continuous success. It shows you how to implement a transformation that cannot fail by developing a culture that will have all your stakeholders involved in the process and invested in the outcome. It will teach you how to build success from the top down and the bottom up at the same time. If you are a leader at any level in an organization undergoing or considering a lean transformation, this is where you should start and finish ... and start again.
Praise for the First Edition of the Shingo Prize Winning International Bestseller. . .
... an excellent review of one of the most common implementation issues in a lean transformation -- the essential day to day work practices of team leaders/supervisors/value stream managers that enable the lean system.
-- George Koenigsaecker, President, Lean Investments, LLC
. . . reprinted seven times
The purpose of lean systems is to make problems glaringly obvious. If implementation does not include standard leadership and cultural support systems to constantly address problems, the point of the system is missed. Many books address lean tools and initial conversion, but if you want the system to stick, read David's book.
--Robert (Doc) Hall, Editor-In-Chief, Target, Association for Manufacturing Excellence
. . . now being translated into Russian, Thai, and Chinese...
Mann's book is an excellent start toward Lean Leadership as 'process-dependent' rather than 'person-dependent' in style.
--Ross E. Robson, Executive Director, Shingo Prize for Excellence in Manufacturing
Now empowered with five more years of accumulated knowledge and experience, David Mann’s seminal work:
Offers new insights on applications of lean management in administrative, technical, and professional environments Provides new guidance on how to begin implementing lean management in discrete manufacturing, office, and process manufacturing environments. Details specifics on how to engage executives through gemba walks* Shows the difference between measuring improvement through results and through processes Adds new case studies throughout Expands the lean management assessment based on actual use, and now offers up two separate versions (both available online) one for manufacturing and one for administrative, technical, and professional settings
*In a gemba walk, a teacher, or sensei, and student walk the production floor. The teacher asks the student to tell what he or she sees and, depending on the answer, asks more questions to stimulate the student to think differently about what is in front of him or her. This includes learning to see what is not there...Gemba walks often include assignments to act on what the student has come to see. ...
The authors also provide a more complete perspective on the concept of availability. While they discuss availability of equipment in transactional processes, they extend the concept by elaborating on availability as it applies to employees. The calculation of process lead time for work queues is taken to an advanced level – not only is the calculation of this lead time explained, but the text also covers the very real possibility of having more work in the queue than available time.
While previous books have focused on only production process VSM or transactional process VSM, this work meets the real needs of both manufacturers and service sector organizations by dealing with both types. It goes beyond explaining each scenario, to teach readers what techniques are commonly applicable to both, and also explains areas of difference so that mappers will be able to readily adapt to whatever unique situations present themselves.
Based on an MBA course Provost has taught at New York University over the past ten years, Data Science for Business provides examples of real-world business problems to illustrate these principles. You’ll not only learn how to improve communication between business stakeholders and data scientists, but also how participate intelligently in your company’s data science projects. You’ll also discover how to think data-analytically, and fully appreciate how data science methods can support business decision-making.Understand how data science fits in your organization—and how you can use it for competitive advantageTreat data as a business asset that requires careful investment if you’re to gain real valueApproach business problems data-analytically, using the data-mining process to gather good data in the most appropriate wayLearn general concepts for actually extracting knowledge from dataApply data science principles when interviewing data science job candidates
This book shows you how to validate your initial idea, find the right customers, decide what to build, how to monetize your business, and how to spread the word. Packed with more than thirty case studies and insights from over a hundred business experts, Lean Analytics provides you with hard-won, real-world information no entrepreneur can afford to go without.Understand Lean Startup, analytics fundamentals, and the data-driven mindsetLook at six sample business models and how they map to new ventures of all sizesFind the One Metric That Matters to youLearn how to draw a line in the sand, so you’ll know it’s time to move forwardApply Lean Analytics principles to large enterprises and established products
In the late 1980s, Japanese scientists were trying to figure out the economic damage that would be caused if a catastrophic earthquake destroyed Tokyo. The answer was bleak, but not for Japan. Kaoru Oda, an economist who worked for Tokai Bank, speculated that the United States would end up paying the most. Why? Japan owned trillions of dollars’ worth of foreign liquid assets and investments. These assets, which the world depended on, would be sold, forcing countries into the precarious position of having to return large amounts of money they might not have. After the recent earthquake, Michael Lewis reexamined this hypothesis and came to a surprising conclusion. With his characteristic sense of humor and wit, Lewis, once again, explains the inner workings of a financial catastrophe.
“How a Tokyo Earthquake Could Devastate Wall Street” appears in Michael Lewis’s book The Money Culture.
The new edition of this Shingo Prize-winning bestseller provides critical insights and approaches to make any Lean transformation an ongoing success. It shows you how to implement a sustainable, successful transformation by developing a culture that has your stakeholders throughout the organizational chart involved and invested in the outcome. It teaches you how to successfully navigate the politics in cross-functional process improvement projects, and to engage executives in ways that are personally meaningful to them. If you are a leader at any level in an organization undergoing or considering a Lean transformation, this is where you should start and finish ... and start again.
Read the Reviews:
"This book became an instant classic in the literature of professional operations. In this third edition, David Mann updates and expands his teaching with five additional years of valuable experience and expertise derived from his very active, multi-industry consultancy. I have benefitted greatly from his writing and wholeheartedly recommend this book to be top-of-the desk of any serious Lean practitioner or performance transformation leader."
— Raymond C. Floyd, two-time Shingo Prize Winner, President and CEO, Plasco Energy Group
"David Mann builds substantially on his seminal work on the Lean management system. The book is full of new insight and polishes the most important ideas about Lean management. The new chapter on engaging executive leadership alone is worth the price of the book."
— Peter Ward, Richard M. Ross Professor and Chair, Department of Management Science, Fisher College of Business, The Ohio State University
"This book has long been my ‘go-to’ guide on Lean management practices that help create a culture of continuous improvement and excellence. I have recommended the book to countless healthcare leaders who rave about how helpful it is in translating Lean principles into daily management behaviors. The healthcare examples make it even more relevant as a must read for any hospital leader who aims to move beyond Lean tools.."
—Mark Graban, author of Lean Hospitals, co-author of Healthcare Kaizen and The Executive Guide to Healthcare Kaizen
"As more companies outside the manufacturing sector pursue Lean transformations, Creating a Lean Culture is as critical a resource as ever. Breaking down silos and navigating tricky internecine politics remain a momentous challenge, and Mann’s case-based insights are an invaluable tool."
— Peg Pennington, Executive Director, Center for Operational Excellence, Fisher College of Business, The Ohio State University
"David has once again taken the topics that trip us up and put structure and guidance around them. His new work on executive involvement is worth the price of the book all by itself. Many of us have struggled with this topic and David provides a path to success."
— Elizabeth M. King, Vice President Organizational Effectiveness, ESCO Corporation
New in the Third Edition:
Contains new chapter on engaging executives in Lean initiatives Includes 21 new case studies Presents new examples from the healthcare and process industries Includes additional gemba worksheets for learning and teaching Lean Provides expanded coverage of Lean applications in complex cross functional value stream process improvement projectsWatch David Mann discuss how the latest edition of Creating a Lean Culture can help you and your organization succeed. http://www.youtube.com/watch?v=zX7jrtV3cBA&feature=youtu.be
“The leading indicators” shape our lives intimately, but few of us know where these numbers come from, what they mean, or why they rule the world. GDP, inflation, unemployment, trade, and a host of averages determine whether we feel optimistic or pessimistic about the country’s future and our own. They dictate whether businesses hire and invest, or fire and hunker down, whether governments spend trillions or try to reduce debt, whether individuals marry, buy a car, get a mortgage, or look for a job.
Zachary Karabell tackles the history and the limitations of each of our leading indicators. The solution is not to invent new indicators, but to become less dependent on a few simple figures and tap into the data revolution. We have unparalleled power to find the information we need, but only if we let go of the outdated indicators that lead and mislead us.
New to the fourth edition are the topics of common and special causes, outliers, and risk management tools. Besides the new topics, many current topics have been expanded to reflect changes in auditing practices since 2004 and ISO 19011 guidance, and they have been rewritten to promote the common elements of all types of system and process audits.
The handbook can be used by new auditors to gain an understanding of auditing. Experienced auditors will find it to be a useful reference. Audit managers and quality managers can use the handbook as a guide for leading their auditing programs. The handbook may also be used by trainers and educators as source material for teaching the fundamentals of auditing.
"At Frito Lay, we have applied many of the concepts and tools in this book, and we are realizing a five to seven times return on our annual Lean Six Sigma investment."
—Tony Mattei, Lean Six Sigma Director, Frito Lay
"Ecolab has experienced a sustainable, competitive advantage through Lean Six Sigma. The principles in this book are helping us drive greater value for our share-holders, better service for our customers, and talent development opportunities for our associates."
—Jeffrey E. Burt, Vice President and Global Deployment Leader, Lean Six Sigma, Ecolab
"This book gives excellent insights into Lean Six Sigma and its strong impact within different industries. We used Lean Six Sigma in numerous process improvement projects, which, in turn, helped to create momentum and set up a process improvement culture. Amid a challenging economic environment, we are accelerating this initiative globally."
—Satheesh Mahadevan, Directeur des Processus, Société Générale
"Our Lean Six Sigma deployment of the concepts and tools described in this book is transforming our business—with tangible benefits for our employees, customers, suppliers, and shareholders."
—Jeffrey Herzfeld, Sr. Vice President and General Manager, Teva Pharmaceuticals USA
"We have deployed the holistic Lean Six Sigma strategy described by Mark George across our enterprise. It is providing remarkable returns for Unum."
—Bob Best, Chief Operating Officer, Unum
"The Lean Six Sigma Guide to Doing More with Less presents a comprehensive view of operations transformation, the approaches required for success, leadership's role, and the competitive advantage that results. Transformational changes are enabling us to do more with less, by investing and working smarter."
—Ted Doheny, President and COO, Joy Mining Machinery
The book provides an overview of the function of the pharmaceutical microbiologist and what they need to know, from regulatory filing and GMP, to laboratory design and management, and compendia tests and risk assessment tools and techniques. These key aspects are discussed through a series of dedicated chapters, with topics covering auditing, validation, data analysis, bioburden, toxins, microbial identification, culture media, and contamination control.Contains the applications of pharmaceutical microbiology in sterile and non-sterile productsPresents the practical aspects of pharmaceutical microbiology testingProvides contamination control risks and remediation strategies, along with rapid microbiological methodsIncludes bioburden, endotoxin, and specific microbial risksHighlights relevant case studies and risk assessment scenarios
Illuminating a clear path to lean IT, the authors integrate more than two decades of combined experience to provide you with a proven method for creating and sustaining a true lean IT workplace. This field guide not only highlights the organizational techniques of more agile and lean processes, but also the leadership work required to help management adopt these new approaches.
Based on proven methods from different industries, including banking, manufacturing, insurance, food and beverage, and logistics, the book details a clear model that covers all the components you need to achieve and sustain a favorable work environment and culture in support of lean IT.
Filled with anecdotes and case studies from actual businesses, the book includes pictures, templates, and examples that illustrate the application of the lean methods discussed.
Developed as a practical reference for metrology and calibration professionals, The Metrology Handbook provides a foundation for understanding basic metrology and calibration principles and practices, and is appropriate for those with intermediate or advanced experience seeking to increase their knowledge. This book is a collection of valuable information compiled by experts in the field to serve as a single resource for metrology and calibration professionals. The supplemental CD-ROM contains acronyms and abbreviations, a glossary of terms, tables and formulas, and common conversions.
Sponsored by ASQs Measurement Quality Division, this handbook serves as an excellent desktop reference for calibration technicians, supervisors, managers, quality inspectors, auditors, those in calibration and/or testing laboratories, consultants, and teachers. Whether youre changing disciplines in your career field, helping to becoming certified to a new or different standard, accepting more responsibilities as a supervisor or manager, training your fellow calibration practitioners, or using it to prepare for ASQs Certified Calibration Technician (CCT) exam, this handbook provides the information, guidance, and knowledge to help you achieve your goals.
So why is it so hard to make sound decisions? In Think Twice, now in paperback, Michael Mauboussin argues that we often fall victim to simplified mental routines that prevent us from coping with the complex realities inherent in important judgment calls. Yet these cognitive errors are preventable.
In this engaging book, Mauboussin shows us how to recognize and avoid common mental missteps. These include misunderstanding cause-and-effect linkages, not considering enough alternative possibilities in making a decision, and relying too much on experts.
Through vivid stories, the author presents memorable rules for avoiding each error and explains how to recognize when you should “think twice”—questioning your reasoning and adopting decision-making strategies that are far more effective, even if they seem counterintuitive. Armed with this awareness, you'll soon begin making sounder judgment calls that benefit (rather than hurt) your organization.
This completely revised reference provides a comprehensive look at software testing as part of the project management process, emphasizing testing and quality goals early on in development. Building on the success of previous editions, the text explains testing in a Service Orientated Architecture (SOA) environment, the building blocks of a Testing Center of Excellence (COE), and how to test in an agile development. Fully updated, the sections on test effort estimation provide greater emphasis on testing metrics. The book also examines all aspects of functional testing and looks at the relation between changing business strategies and changes to applications in development.
Includes New Chapters on Process, Application, and Organizational Metrics
All IT organizations face software testing issues, but most are unprepared to manage them. Software Testing and Continuous Quality Improvement, Third Edition is enhanced with an up-to-date listing of free software tools and a question-and-answer checklist for choosing the best tools for your organization. It equips you with everything you need to effectively address testing issues in the most beneficial way for your business.
“Create Marketplace Disruption is as thought-provoking as it is entertaining. Adam Hartung offers business managers and leaders new insights to long-term success that apply across markets and industries.”
–Steve Burke, President, Comcast Cable Communications, Philadelphia, PA
"Talking innovation is easier than practicing innovation. Adam offers an excellent approach for corporations to identify how to innovate to gain competitive advantage. A must read.”
–Praveen Gupta, Editor-in-Chief, International Journal of Innovation Science and Chairman, Accelper Consulting, Schaumburg, IL
Some companies can’t change in response to market disruptions. Those companies die. Other companies do respond...eventually. They survive, but they see their profits squeezed, their growth flattened. Then,there are the long-term winners: companies that create their own disruptions and thrive on change. In Create Marketplace Disruption, Adam Hartung shows how to become one of those rare companies, creating lasting growth and profits.
This book reveals why so many companies behave in ways that are utterly incompatible with long-term success...and why even “good to great” companies are struggling for air. You’ll discover how to reposition your organization away from the Flats and Swamps of traditional Defend and Extend Management and back into the Rapids of accelerated growth. Hartung demonstrates how to attack competitors’ Lock-ins, make their Success Formulas obsolete, and create the White Space needed to invent your own new formulas for success.
Create Marketplace Disruption shows how disrupting yourself is critical to reaping the benefits of market changes, and part of a process that executives and strategists can reproduce over and over again for improved results.
How we got into this mess—and how to get out of it
The myth of perpetuity and the dark side of success
Reinventing success: no more Defend and Extend
Creating your new Success Formulas and keeping them competitively advantaged
Why “thinking outside the box” doesn’t work
First, get outside the box. Then, think!
Maintaining ”The Phoenix Principle” for long-term success
Practicing Disruption until it comes naturally
Bridging the kata/TWI nexus, the book lays out a road map for Lean success. It devotes a chapter to each of the Seven Kata and suggests possible courses of action dependent on your organization’s strengths and constraints. Bringing together valuable information on many of the disjointed Lean practices, it explains key Lean concepts, including gemba walks, genchi gembutsu, and PDCA.
After introducing kata, it reveals the different kata inherent in the three major TWI courses and the TWI Job Safety course. It illustrates the value stream analysis relationship to the kata and the kata relationship to TWI. It also demonstrates how to use kata to solve the problems identified in your value stream analysis while simultaneously conditioning your employees’ adaptive thinking patterns.
Supplying a clear understanding of exactly where the seven kata apply in your Lean journey, the authors include helpful guidelines for coaching a kata. They also highlight mistakes they have experienced or witnessed so you can avoid the same pitfalls. As globalism continues to make management’s organizational skills a competitive differentiator, this book provides you with the tools to use the seven kata to place your organization on a discernible path towards operational excellence.
Listen to what Pat Boutier has to say about The Seven Kata.Part One — Part Two
This pocket guide is designed to be a quick, on-the-job reference for anyone interested in making their workplace more effective and efficient. It will provide a solid initial overview of what quality is and how it could impact you and your organization. Use it to compare how you and your organization are doing things, and to see whether whats described in the guide might be useful.
The tools of quality described herein are universal. People across the world need to find better, more effective ways to improve the creation and performance of products and services. Since organizational and process improvement is increasingly integrated into all areas of an organization, everyone must understand the basic principles of process control and process improvement. This succinct and concentrated guide can help.
Unlike any other pocket guide on the market, included throughout are direct links to numerous free online resources that not only go deeper but also to show these concepts and tools in action: case studies, articles, webcasts, templates, tutorials, examples from the ASQ Service Divisions Service Quality Body of Knowledge (SQBOK), and much more. This pocket guide serves as a gateway into the wealth of peerless content that ASQ offers.
But Hand is no believer in superstitions, prophecies, or the paranormal. His definition of "miracle" is thoroughly rational. No mystical or supernatural explanation is necessary to understand why someone is lucky enough to win the lottery twice, or is destined to be hit by lightning three times and still survive. All we need, Hand argues, is a firm grounding in a powerful set of laws: the laws of inevitability, of truly large numbers, of selection, of the probability lever, and of near enough.
Together, these constitute Hand's groundbreaking Improbability Principle. And together, they explain why we should not be so surprised to bump into a friend in a foreign country, or to come across the same unfamiliar word four times in one day. Hand wrestles with seemingly less explicable questions as well: what the Bible and Shakespeare have in common, why financial crashes are par for the course, and why lightning does strike the same place (and the same person) twice. Along the way, he teaches us how to use the Improbability Principle in our own lives—including how to cash in at a casino and how to recognize when a medicine is truly effective.
An irresistible adventure into the laws behind "chance" moments and a trusty guide for understanding the world and universe we live in, The Improbability Principle will transform how you think about serendipity and luck, whether it's in the world of business and finance or you're merely sitting in your backyard, tossing a ball into the air and wondering where it will land.
Positioning Lean as a management operational philosophy far beyond the traditional set of improvement tools, the book explains how managers at all levels of the organization can integrate Lean into their daily management activities. It defines the Lean philosophy as well as the beliefs and behaviors required to develop a thriving Lean company culture.
The book captures the essence of Lean learning and Lean doing and illustrates practical applications of Lean management. It begins by covering the basics that encompass Lean management and leadership in two critical areas: maintenance/control and improvement.
After reading this book, you will better understand how to see waste, measure waste, eliminate waste, and develop an active change improvement workplace. You will also gain the practical understanding required to determine which Lean tool is best suited to your particular need for supporting an organization-wide management system.
Expounding on essential Lean concepts, this is an ideal guide to help new managers and leaders make the transition from theory to successful application in the field. Complete with brief summaries and examples of the most important tools in Lean management systems development in each chapter, the book provides a reliable roadmap for deploying a Lean management system across your organization, and subsequently across your entire value stream.
The successful application of Lean methodologies to improve process workflows is an efficient way to simplify operations and prevent mistakes. In Lean Six Sigma for the Office, Six Sigma guru James Martin presents proven modifications that can be deployed in offices, particularly those offices involved with global operations. Making use of Kaizen and Six Sigma concepts, along with Lean manufacturing principles, this book instructs managers on how they can improve operational efficiency and increase customer satisfaction.
The author brings experience gleaned from his application of these methodologies in a myriad of industries to create a practical and hands-on reference for the office environment. Using a detailed sequence of activities, including over 140 figures and tables as well as checklists and evaluation tools, he demonstrates how to realize the rapid improvement of office operations, and how to eliminate unnecessary tasks through value stream mapping (VSM).
The book also emphasizes the importance of strategic alignment of Kaizen events and the impact of organizational culture on process improvement activities. Latter chapters in the book discuss key elements of a change model in the context of transitional improvements as they relate to the process owner and local work team. By applying the proven principles found in this book, effective and sustainable organizational change can be accomplished, efficiency can be improved, and mistakes can be eliminated.
Lean Connections: Making Information Flow Efficiently and Effectively isdesigned to help you rethink the way your organization views information flow. It provides the building blocks of a comprehensive information-flow system, showing you calculations and methods that will allow you to get the necessary information to those individuals who need it, when they need it.
Following a logical and detailed progression, this manual shows how to make information flow in lean production facility—
From the end customer through materials control to the production floor On the production floor at the operator, team, and value stream level And then from the production floor to the management of the facility
Employing a workbook format, this manual follows RNA Manufacturing, a fictional company, through its implementation of a comprehensive lean production system. As the authors outline RNA’s methods and thought processes, they employ exercises that ask questions about your own production system. Your challenge is to think deeply about the answers, as well as the changes that need to be made to effectively make information flow through your facility.
Make certain that everyone gets the information that they need when they need it
Written by the system's creator, Amoeba Management: The Dynamic Management System for Rapid Market Response provides a comprehensive introduction to this unique and time-tested method of management control and accounting. Explaining the management philosophy and principles, it unveils fresh and pragmatic insights on how to foster a culture of leadership and responsibility in your organization. Dr. Kazuo Inamori, director and chairman emeritus of Japan Airlines, founder and chairman emeritus of Kyocera Corporation, and honorary adviser of KDDI Corporation, delves into decades of experience creating and implementing this system to supply you with invaluable operational guidance on how to monitor and manage every aspect of your company.
Facilitating the understanding required to divide your organization into small units with self-supporting accounting, this book supplies the tools to achieve a system of management by all whereby all amoeba members focus their strengths on accomplishing common goals. It provides a means for making the concept of "value-added" truly operational for every employee and describes the features and use of the Hourly Efficiency Report, the primary mechanism used to control profits. Even companies with stagnating profitability will be able to transform themselves into high-profit enterprises using the methods described in this book.
This updated edition of a Shingo Research Award recipient begins with an overview of Lean methods. It explains how Lean practices can help reduce various frustrations for caregivers, prevent delays and harm for patients, and improve the long-term health of your organization.
The second edition of this book presented new material on identifying waste, A3 problem solving, engaging employees in continuous improvement, and strategy deployment. This third edition adds new sections on structured Lean problem solving methods (including Toyota Kata), Lean Design, and other topics. Additional examples, case studies, and explanations are also included throughout the book.
Mark Graban is also the co-author, with Joe Swartz, of the book Healthcare Kaizen: Engaging Frontline Staff in Sustainable Continuous Improvements, which is also a Shingo Research Award recipient. Mark and Joe also wrote The Executive’s Guide to Healthcare Kaizen.
Achieving Lean Changeover: Putting SMED to Work is about the practical implementation of the single minute exchange of die (SMED) philosophy developed by Shigeo Shingo at Toyota. Although the book is principally about changeover of manufacturing, packaging, and assembly processes, the general concepts and examples are also applicable in lighter industries that require turnover of processes—including airlines, hospitals, operating rooms, and food service.
Filled with practical examples, the book shares proven methods that can help you convert changeover downtime to productive uptime. It explains why reducing changeover time is important financially and provides a structured methodology to help you identify and implement improvement opportunities.
The author addresses both the machinery issues with changeover/ SMED and the associated operational issues such as costs, waiting times, material movement, documentation, and product/component design. He also devotes a chapter to discussing, in detail, how to calculate the cost of changeover downtime, an area that remains a mystery to many.
Taking a holistic approach to changeover, the text includes a chapter devoted to organizing changeover improvements, keeping them on track, and developing and implementing a formal changeover reduction program. Presenting time-tested methods and practical examples from a variety of industries, it offers you the opportunity to reduce changeover time and cost and provide your organization with the flexibility needed to better satisfy your customers in three important dimensions: product variety, responsiveness, and price.
Crunch Big Data to optimize marketing and more!
Overwhelmed by all the Big Data now available to you? Not sure what questions to ask or how to ask them? Using Microsoft Excel and proven decision analytics techniques, you can distill all that data into manageable sets—and use them to optimize a wide variety of business and investment decisions. In Decision Analytics: Microsoft Excel, best selling statistics expert and consultant Conrad Carlberg will show you how—hands-on and step-by-step.
Carlberg guides you through using decision analytics to segment customers (or anything else) into sensible and actionable groups and clusters. Next, you’ll learn practical ways to optimize a wide spectrum of decisions in business and beyond—from pricing to cross-selling, hiring to investments—even facial recognition software uses the techniques discussed in this book!
Through realistic examples, Carlberg helps you understand the techniques and assumptions that underlie decision analytics and use simple Excel charts to intuitively grasp the results. With this foundation in place, you can perform your own analyses in Excel and work with results produced by advanced stats packages such as SAS and SPSS.
This book comes with an extensive collection of downloadable Excel workbooks you can easily adapt to your own unique requirements, plus VBA code to streamline several of its most complex techniques.Classify data according to existing categories or naturally occurring clusters of predictor variables Cut massive numbers of variables and records down to size, so you can get the answers you really need Utilize cluster analysis to find patterns of similarity for market research and many other applications Learn how multiple discriminant analysis helps you classify cases Use MANOVA to decide whether groups differ on multivariate centroids Use principal components to explore data, find patterns, and identify latent factors
Register your book for access to all sample workbooks, updates, and corrections as they become available at quepublishing.com/title/9780789751683.
Identify development waste Assess an organization’s current state and develop a Current State Map Apply Lean principles to create a Future State Map
New to This Edition
*Updated throughout to incorporate important developments in latent variable modeling.
*Chapter on Bayesian CFA and multilevel measurement models.
*Addresses new topics (with examples): exploratory structural equation modeling, bifactor analysis, measurement invariance evaluation with categorical indicators, and a new method for scaling latent variables.
*Utilizes the latest versions of major latent variable software packages.
Toyota Kaizen Methods: Six Steps to Improvement focuses on the skills and techniques practiced inside Toyota Motor Corporation during the past decades. This workbook focuses on the actual training course concepts and methods used by Toyota to develop employee skill level, a core element of Toyota’s success. It is not a book about holding Western-style five-day Kaizen events, which were in reality quite rare during the development of Toyota’s production system and are virtually nonexistent today inside Toyota. Written by two of Toyota’s most revered and experienced trainers, the book —
Traces the origins of Kaizen since the inception of Toyota Motor Corporation Articulates the basic six-step Kaizen improvement skills pattern taught inside Toyota Helps practitioners of Kaizen improve their own skill level and confidence by simplifying concepts and removing any mystery in the process Provides homework assignments and a wealth of forms for analyzing work processes
If you take the time to study the concepts detailed here, you will be reviewing the same methods and techniques that were harnessed by generations of Toyota supervisors, managers, and engineers. These techniques are not the secret ingredient of Lean manufacturing; however, mastery of these timeless techniques will improve your ability to conduct improvement in almost any setting and generate improvement results for your organization.
The primary layout of the handbook follows the ASQ Body of Knowledge (BoK) for the Certified Six Sigma Green Belt (CSSGB) updated in 2015. The authors were involved with the first edition handbook, and have utilized first edition user comments, numerous Six Sigma practitioners, and their own personal knowledge gained through helping others prepare for exams to bring together a handbook that they hope will be very beneficial to anyone seeking to pass the ASQ or other Green Belt exams.
In addition to the primary text, the authors have added a number of new appendixes, an expanded acronym list, new practice exam questions, and other additional materials
Filling this need, The SAP Materials Management Handbook provides a complete understanding of how to best configure and implement the SAP MM module across various types of projects. It uses system screenshots of real-time SAP environments to illustrate the complete flow of business transactions involved with SAP MM. Supplying detailed explanations of the steps involved, it presents case studies from actual projects that demonstrate how to convert theory into powerful SAP MM solutions. Includes tips on the customization required for procurement of materials and inventory management Covers the range of business scenarios related to SAP MM, including the subcontracting cycle and consignment cycle Provides step-by-step guidance to help you implement your own SAP MM module Illustrates the procure to pay lifecycle Depicts critical business flows with screenshots of real-time SAP environments
This much-needed reference explains how to use the SAP MM module to take care of the range of business functions related to purchasing, including purchase orders, purchase requisitions, outline contracts, and request for quotation. It also examines all SAP MM inventory management functions such as physical inventory, stock overview, stock valuation, movement types, and reservations—explaining how SAP MM can be used to define and maintain materials in your systems.
The prediction of failures involves uncertainty, and problems associated with failures are inherently probabilistic. Their solution requires optimal tools to analyze strength of evidence and understand failure events and processes to gauge confidence in a design’s reliability.
Reliability Engineering and Risk Analysis: A Practical Guide, Second Edition has already introduced a generation of engineers to the practical methods and techniques used in reliability and risk studies applicable to numerous disciplines. Written for both practicing professionals and engineering students, this comprehensive overview of reliability and risk analysis techniques has been fully updated, expanded, and revised to meet current needs. It concentrates on reliability analysis of complex systems and their components and also presents basic risk analysis techniques. Since reliability analysis is a multi-disciplinary subject, the scope of this book applies to most engineering disciplines, and its content is primarily based on the materials used in undergraduate and graduate-level courses at the University of Maryland. This book has greatly benefited from its authors' industrial experience. It balances a mixture of basic theory and applications and presents a large number of examples to illustrate various technical subjects. A proven educational tool, this bestselling classic will serve anyone working on real-life failure analysis and prediction problems.
Lawrence Weinstein and John Adam present an eclectic array of estimation problems that range from devilishly simple to quite sophisticated and from serious real-world concerns to downright silly ones. How long would it take a running faucet to fill the inverted dome of the Capitol? What is the total length of all the pickles consumed in the US in one year? What are the relative merits of internal-combustion and electric cars, of coal and nuclear energy? The problems are marvelously diverse, yet the skills to solve them are the same. The authors show how easy it is to derive useful ballpark estimates by breaking complex problems into simpler, more manageable ones--and how there can be many paths to the right answer. The book is written in a question-and-answer format with lots of hints along the way. It includes a handy appendix summarizing the few formulas and basic science concepts needed, and its small size and French-fold design make it conveniently portable. Illustrated with humorous pen-and-ink sketches, Guesstimation will delight popular-math enthusiasts and is ideal for the classroom.
By adhering to the time-tested framework outlined in the book, your organization will be able to commit to the precepts and practices that lead to successful implementations. Supplying an innovative and fast-track, yet comprehensive, approach to ERP implementation success, the book provides practical guidance to help executive leadership do the right things along the ERP journey. Explains how to engineer a project plan, generate requirements, and obtain a results-oriented commitment Details the practical deployment framework essential for success and includes a variety of tools to position an organization for success Describes how to ensure proactive involvement by the project team, executive sponsors, stakeholders, and working-level systems champions
Highlighting the essential planning ingredients that are frequently omitted from ERP implementation start-ups, the book provides readers with the planning framework and proven foundational methods and principles to ensure smooth planning and systems deployment, product quality, and maximum ROI.
The book covers everything from software selection and integration to common snags, traps, and black holes. Best practice tool sets include proven methods such as information workmanship standard, which defines quality; conference room piloting, which assists in matching teams to objectives seamlessly; education, training, and implementation framework, which addresses preparing the operating production environment; and project monitoring and deployment, covering project and risk management.
Quality guru John Oakland’s famous TQM model, in many ways a precursor to these frameworks, has evolved to become the ultimate holistic overview of performance improvement strategy. Incorporating the frameworks that succeeded it, the revised model redefines Quality by:
Oakland’s popular, practical, jargon-free style, along with ten case studies eight of which are brand new, effortlessly ties the model to its real-life applications, making it easy to understand how to apply what you’ve learned to your practices and a achieve sustainable competitive advantage.
Total Quality Management and Operational Excellence: Text with Cases (Fourth Edition)is supplemented for the first time with a suite of online teaching aids for busy tutors. This exciting update of a classic text is perfect for all students studying for professional qualifications in the management of quality, or those studying science, engineering or business and management who need to understand the part TQM may play in their subjects.
Rising costs are making healthcare unaffordable for millions, and 100,000 people die every year due to medical error. Healthcare must change–dramatically. Many leading healthcare institutions are discovering a powerful toolset for addressing both quality and cost: Six Sigma. In this hands-on, start-to-finish guidebook, four leading experts introduce Six Sigma from the unique standpoint of the healthcare professional, showing exactly how to implement it in real-world environments.
Drawing on their unsurpassed experience, the authors offer step-by-step methodologies, tools, and metrics–all thoroughly adapted to the unique realities of healthcare. They demonstrate how to utilize Six Sigma’s Define, Measure, Analyze, Improve, and Control (DMAIC) process to address even the most challenging problems. They also offer realistic guidance on rolling out Six Sigma initiatives that deliver rapid and sustainable value.
The authors show Six Sigma at work in every area of the hospital: clinical, radiology, surgery, ICU, cardiovascular, laboratories, emergency, trauma, administrative services, staffing, billing, cafeteria, even central supply. You'll learn why Six Sigma can produce better results than other quality initiatives, how it brings new rigor and discipline to healthcare delivery, and how it can be used to sustain ongoing improvements for the long term.
· Adapting Six Sigma methodology, tools, and measurements for healthcare
· Designing more successful experiments
· Rolling out your Six Sigma initiative successfully
· Case studies from every area of the hospital, from the ICU to billing
· Six Sigma templates modified fully for the healthcare environment
Comprehensive and user-friendly, this book will be indispensable to everyone concerned with quality or cost: administrators, managers, physicians, and quality specialists alike. Where Six Sigma is already in use or being considered, it will serve as a shared blueprint for the entire team.
New in the fourth edition of Latent Variable Models:
*a data CD that features the correlation and covariance matrices used in the exercises;
*new sections on missing data, non-normality, mediation, factorial invariance, and automating the construction of path diagrams; and
*reorganization of chapters 3-7 to enhance the flow of the book and its flexibility for teaching.
Intended for advanced students and researchers in the areas of social, educational, clinical, industrial, consumer, personality, and developmental psychology, sociology, political science, and marketing, some prior familiarity with correlation and regression is helpful.