Bøger udgivet af ASQ Quality Press

The purpose of this expanded field guide is to assist organizations, step-by-step, in implementing a quality management system (QMS) in conformance with ISO 13485:2016, whether "from scratch" or by transitioning from variations of the ISO 13485 family. In keeping with ISO 9000:2015's definition of quality as the "degree to which a set of inherent characteristics fulfills requirements," Myhrberg, Raciti, and Myhrberg have identified the requirements and inherent characteristics (distinguishing features) for this expanded field guide. Within the guide, each subclause containing requirements is the focus of a two-page visual spread that consistently presents features that fulfill the requirements listed below.This guide will:Provide a user-friendly guide to ISO 13485:2016's requirements for implementation purposes-Identify the documents/documentation required, along with recommendations on what to consider retaining/adding to a QMS during ISO 13485:2016 implementation-Guide internal auditor(s) regarding what to ask to verify that a conforming and effective QMS exists-Direct management on what it must do and should consider to satisfy ISO 13485:2016's enhanced requirements, as well as on the responsibilities for top management-Depict step-by-step in flowchart form what must occur to create an effective, conforming QMS

This ground-breaking book addresses the critical, growing need among health care administrators and practitioners to measure the effectiveness of quality improvement efforts. Written by respected healthcare quality professionals, Measuring Quality Improvement in Healthcare covers practical applications of the tools and techniques of statistical process control (SPC), including control charts, in healthcare settings. The authors' straightforward discussions of data collection, variation, and process improvement set the context for the use and interpretation of control charts. Their approach incorporates "the voice of the customer" as a key element driving the improvement processes and outcomes. The core of the book is a set of 12 case studies that show how to apply statistical thinking to health care process, and when and how to use different types of control charts. The practical, down-to-earth orientation of the book makes it accessible to a wide readership. "Only authors who have used statistics and control charts to solve real-world healthcare problems could have written a book so practical and timely." - Barry S. Bader, Publisher The Quality Letter for Healthcare Leaders "Many clinicians and other healthcare leaders underestimate the great contributions that better statistical thinking could make toward reducing costs and improving outcomes. This fascinating and timely book is a fine guide for getting started." - Donald M. Berwick, M.D. President and CEO, Institute for Healthcare Improvement Associate Professor of Pediatrics, Harvard Medical School Contents: Planning Your CQI Journey, Preparing to Collect Data, Data Collection, Understanding Variation, Using Run and Control Charts to Analyze Process Variation, Control Chart Case Studies, Developing Improvement Strategies, Using Patient Surveys for CQI, Formulas for Calculating Control Limits

This book was written to aid quality technicians and engineers. It is a result of 30 years of quality-related work experience. To that end, the intent of this book is to provide the quality professional working in virtually any industry a quick, convenient, and comprehensive guide to properly conducting design of experiments (DOE) for the purpose of process optimization.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).

ISO 9001:2015 includes many changes that not only affect the companies aiming to achieve certification to it, but also auditors. This book is the resource auditors need to fully understand ISO 9001:2015 and help them perform audits to it.This book integrates two different types of audit strategies, conformance audits and performance audits, into one process approach audit. Conformance audits confirm that the organization is meeting the requirements of the standard, while performance audits confirm that the QMS is achieving its intended results. The book includes:An introduction to ISO 9001:2015An auditing strategy for ISO 9001:2015How to conduct a Stage 1 audit for ISO 9001:2015How to conduct a Stage 2 on-site audit for ISO 9001:2015Appendices include an introduction to process focus, an assessment report template for Stage 1 audits, a confidential assessment report template for Stage 2 audits, and an example of the format for an ISO 9001:2015 conformance checklist.

This handbook was developed to help small and medium-sized organizations better understand ISO 9001:2015. It is intended to facilitate implementation and improvement. The establishment, implementation, and maintenance of an ISO 9001-compliant quality management system (QMS) should allow the organization to experience multiple benefits beyond the achievement of certification. Organizations should also see improvements in the quality of products, customer satisfaction, and process effectiveness-all of which ultimately have a positive impact on the bottom line.It is expected that some readers will have already established a QMS. This handbook will serve to reinforce good practices and will help you better understand the intent and value of some of the requirements of ISO 9001. Since the handbook is especially focused on small and medium-sized organizations, the examples that are provided will have greater applicability and will enhance comprehension, again resulting in increased value.Implementing a QMS in a small organization is not easier or harder than it is in a large one. Resources are different; each organization has its own unique challenges, constraints, and advantages. The thing to always bear in mind is that this is your organization and these are your processes.ISO 9001:2015 defines the requirements, but it does not dictate the method of application. Utilizing this handbook should allow you to develop or rejuvenate your QMS so that it is a benefit to both you and your customer.

Synchrony is the ability of a healthcare process to control the pace of the physician process and the pace of the patient process such that the physician and patient are ready for each other at the same time, without waste or delay. When a process achieves synchrony, the patient does not wait for the doctor, nor does the doctor wait for the patient.Dr. Dennis Han is an ophthalmologist specializing in diseases of the retina at the Medical College of Wisconsin and Froedtert Memorial Hospital; Aneesh Suneja is an engineer and lean consultant who worked with Dr. Han to transform his practice. With the help of Suneja, Han's patients experienced an 85% reduction in non-value added wait times, and a corresponding 97% "top box" rating on patient satisfaction surveys ("strongly agree to recommend this doctor's office to others"). Financially, his practice saw a 25% year-over-year increase in relative value units (RVU) production and a 41% increase in payments due to increased physician availability.If you are a physician, clinic manager, administrator, technician, or provider of health services in a clinic setting, you can use the guidelines described in this book to effect a transformation as well."Thank you, doctor Dennis Han, MD, and co-author Aneesh Suneja, MBA, for this marvelous work that applies Lean principles in healthcare settings. The focus on physician medical clinics is a brave venture into this complex, hectic world that has traditionally been dominated by physicians with a predominant emphasis on patient volume, and subsequent billing volume, versus caring for their customers... This important work is essential for just about all existing physician clinics." Dale Farris Healthcare quality improvement specialist with 25 years experience."Lean principles have opened up more slots for patient care allowing better clinic and staff utilization, and have increased patient throughput while reducing employee overhead and burnout. There is a joy on the faces of the staff when they get to leave the office earlier than expected because lean principles have been deployed." Jose Martinez, MD Practicing physician and beneficiary of the "Synchrony" "Physician office managers and their medical staffs would be the primary targets for this book. However, I also see it being applicable to the higher educational setting...[such as in colleges and institutions teaching healthcare improvement.]" Jim Bente Vice President, Planning and Institutional Effectiveness, College of duPage Adjunct Faculty, Carnegie Mellon University

This book - a result of 30 years of quality-related work experience - was written to aid quality technicians and engineers. It provides the quality professional working in virtually any industry a quick, convenient, and comprehensive guide to properly conducting measurement systems analysis (MSA).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).

Probability is tough - even those fairly well versed in statistical analysis balk at the prospect of tackling it. Many probability concepts seem counterintuitive at first, and the successful student must in effect train him or herself to think in a totally new way. Mastery of probability takes a lot of time, and only comes from solving many, many problems.The aim of this text and its companion, The Probability Workbook (coming soon), is to present the subject of probability as a tutor would. Probability concepts are explained in everyday language and worked examples are presented in abundance. In addition to paper-and-pencil solutions, solution strategies using Microsoft Excel functions are given. All mathematical symbols are explained, and the mathematical rigor is kept on an algebra level; calculus is avoided.This book is written for quality practitioners who are currently performing statistical and probability analyses in their workplaces, and for those seeking to learn probability concepts for the American Society for Quality (ASQ) Certified Quality Engineer, Reliability Engineer, Six Sigma Green Belt, Black Belt, or Master Black Belt exams.

The number of FDA regulations and the agency's increased expectations is staggering and their content tedious, creating a regulated industry need for compliance insight and appropriate detail. This book is the reference needed to successfully navigate through the FDA maze!The target audiences for this desk reference include:Regulatory professionals, who know their responsibility to keep their firm's employees trained and competent on FDA device regulations and who need a preliminary desk reference that can be used throughout their enterprise to help train and ensure complianceNeophytes, who know nothing about FDA but need a resource that provides both broad and specific information in sufficient detail to be usefulBeginners, who know a little about FDA, need to know more, and need a reference tool to help them be more effective and productive on the jobIntermediates, who knows enough about FDA to know they need to know more and who need a reference tool that provides them with both more basics and executable detailBusy managers, who need to know regulatory requirements and FDA expectations in order to manage compliance in their specific activityBusy executives (CEOs, COOs, and operations managers, whom FDA holds responsible for all regulatory compliance), who also need a desk reference with specific information to quickly assess regulatory compliance, identify potential noncompliance, and review corrective, preventive, and compliance actions

For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. This poses a substantial problem for the medical device industry and is the reason why the authors wanted to write this book. The authors will share their collective knowledge: to help organizations improve patient safety and increase profitability while maintaining a state of compliance with regulations and standards.This book was written to assist quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities. To that end, the intent of this book is to provide the quality professional working in virtually any industry a quick, convenient, and comprehensive guide to properly conducting process validations that meet regulatory and certification requirements. It provides an introduction and background to the requirements necessary to perform process validations that will comply with regulatory and certification body requirements.

AS9100, AS9110, and AS9120, the quality management system (QMS) standards for the aerospace industry, are written in the most ambiguous language possible. Indeed, they don't outline how they should be implemented. Those decisions are left to the organization implementing their requirements or, in some cases, to a consultant. Although some consultant firms for aerospace systems are excellent, there are many that purport to be experts yet proffer systems and processes that are either in contravention to the standards' requirements or so unwieldy that they render the process impotent. In an effort to simplify these issues, this book proposes practices that have been described as opportunities for improvement or best practices by registration auditors in the past. It includes a discussion of each of the three standards' clauses, suggests best practices to comply with them, outlines common findings associated with them, and provides an overview of the changes to AS9100C from AS9100B.

¿This best-seller is fully revised and updated! Its goal is still to give readers practical insight into how they can create a coherent business process improvement system. Author Bjørn Andersen works from the premise that consistently working on improving various aspects of how things are done, large and small, is the key to success for any organization.The first half presents an overall business process improvement model, with the ensuing chapters dealing with topics of understanding and modeling your current business processes, using performance measurement in improvement work, creating a business process improvement roadmap, and organizing for improvement work. The second half of the book presents the overall toolbox, followed by one chapter for each phase of the overall improvement model. For each of these phases, a selection of suitable tools is presented with background, steps to use them, and an example of their use. The final two chapters contain two more extensive case studies illustrating the use of the full methodology. And finally, a number of templates can be found at the very end of the book, templates that support most of the tools presented.This book is suitable for employees and managers at any organizational level in any type of industry, including service, manufacturing, and the public sector. It should also be useful as a textbook for students in courses relating to quality management and continuous improvement.

The eight discipline (8D) problem-solving methodology includes the following: Select an appropriate team Formulate the problem definition Activate interim containment Find root cause(s) Select and verify correction(s) Implement and validate corrective action(s) Take preventive steps Congratulate the teamThis unique book provides an overview of the 8D process, gives guidance on tools for finding root causes, shows 8D in action in eight case studies, and gives five unsolved problems for readers to apply 8D themselves for practice.Anyone who wants to improve quality, regardless of the industry they come from, will benefit from the 8D approach. It has been successfully applied in healthcare, retail, finance, government, and manufacturing.

As organizations strive to remain ahead of the competition, there will inevitably and often come the need for change. All successful organizations regularly use change to improve processes and increase performance. While these times of change can be a great opportunity for an organization, it also can be a time of stress and angst for all involved. Not all organizations are in a position to make these changes effectively and efficiently, and for many their efforts often fall short of the intended goals.Making Change Work: Practical Tools for Overcoming Human Resistance to Change was written to help organizations prepare for and successfully implement change. The price of a failed change effort can be steep, both monetarily and in a loss of credibility. Making Change Work will first provide tools to measure your organization's readiness to change, helping make sure that the efforts will not be doomed to fail from the beginning. The book then provides many tools to apply sequentially and logically in order to gain acceptance of the change throughout the organization. In helping your organization make change successfully, Making Change Work addresses buy-in, acceptance, motivation, anticipation, fear, uncertainty, and all the other messy human considerations that cause change to fail in the real world.

This book is an implementation manual for lean tools and principles in a healthcare environment. Lean is a growth strategy, a survival strategy, and an improvement strategy. The goal of lean is, first and foremost, to provide value to the patient/customer, and in so doing eliminate the delays, overcrowding, and frustration associated with the existing care delivery system. Lean creates a better working environment where what is supposed to happen does happen. On time, every time. It allows clinicians to spend more of their time caring for patients and improves the quality of care these patients receive. A lean organization values its employees and encourages their involvement in organizational initiatives which, in turn, sustains hospital-wide quality improvements. The opportunities for lean in healthcare are limitless.This is not a book to be read and forgotten, nor is it meant to sit on a book shelf as another addition to an impressive but underutilized collection of how-to books. As the name implies, it is a guide; a companion to be referenced again and again as the organization moves forward with its lean transformation."This is a well-researched, well-written work by an individual who understands the current healthcare environment. It provides a practical and sound understanding of the concepts and application for Lean and Six Sigma." James R. Bente Vice President, Quality & Organizational Development Memorial Health System"Healthcare quality professionals in the U.S. and abroad could benefit from the content of this book...Comprehensive discussion of lean and its relevance to healthcare, excellent description of techniques and tools, and excellent examples and figures." Luc R. Pelletier, MSN APRN BC FNAHQ FAAN Editor in Chief Journal for Healthcare QualityCOMMENTS FROM OTHER CUSTOMERS Average Customer Rating (4.5 of 5 based on 4 reviews) "This book is easy to read and demystifies the complex world of Lean by clearly explaining what Lean is, what it does, and the tools used; all in the context of healthcare. Because examples illustrate the benefit of Lean not just to the healthcare industry, but to us as patients, the business case is especially compelling. Instructions address technical challenges and draw from best practices in change management. The guide provides a road map for implementation and seasoned insights that leave one trusting that Lean is very doable, and a necessity." A reader in Seattle, Washington "I thoroughly enjoyed this book as it provides concrete and detailedexamples of Lean principles applied to a healthcare environment. I myself am new to healthcare and am overwhelmed at the wealth of opportunities for improvement. I plan on using some lean principles to demonstrate that improvements don't have to be complex or costly to achieve results" A reader in Montreal, Quebec "This is an excellent resource. I consider it 'required reading' for all that are new to Lean / Process Improvement. In my role, I facilitate 5-10 concurrent process improvement projects. This book has been invaluable as a teaching tool. I've asked each project leader to buy, read and study this book. All have commented that it has an easy read, helped them to understand the Lean concepts, and quickly implement the tools. As a group, we're better able to speak the same language and have a common understanding of the tools.brI highly recommended this book. I would also recommend the website (www.leanhospitals.org), wh..." A reader in Wausau, Wisconsin

Innovation management can provide a competitive edge in the business world, and research shows a major correlation between profitability and innovation. The challenge, however, is how to integrate innovation management with quality management. Enter the ISO 56000 series of standards on innovation management systems (IMS). Specifically, ISO 56002 provides guidance on how to develop a systems approach to managing innovation. In this book, author Peter Merrill shares with readers the thinking behind each of the clauses in the standard. He explains real-life, practical applications of the guidance the standard provides and shows how to integrate an IMS with a quality management system based on ISO 9001 and be prepared for the future. In this book, you will discover how it:Details the strategy and leadership necessary to manage innovation using ISO 56002 and explaining the cultures of creativity and execution that must coexistDefines the competences, tools, processes, and assessments that are needed to build an IMS in your organization in order to succeed at innovationExplains the principles that are the basis of innovation managementShows the vital role of innovation and creativity in the progression of organizations in today's Industry 4.0/Quality 4.0 eraUnderlines the idea that innovation management and quality management must work together from practical and financial standpointsPeter Merrill has been a quality professional for many years and is an expert on simplifying complex ideas. Currently, he helps companies develop their approach to innovation. He writes extensively on innovation, including the Innovation Imperative, column for Quality Progress magazine. His previously published books include Innovation Generation, Innovation Never Stops, Executive Guide to Innovation.

In today's competitive environment, it's no longer enough to satisfy your customers. To sustain success, you must meet the needs and expectations of all relevant interested parties of your organization.The journey is a process in which those needs and expectations are inputs, and sustained success is the output. To transform the inputs into sustained success, the organization must establish and implement the right processes. This represents 'what' must be done. The organization also must ensure that it has the behaviors and competences needed to maintain these processes, representing 'how' things should be done.This book covers both the 'what' and 'how' aspects of achieving sustained success and is a guide for top managers ready to embark on this journey. The chapters serve as a sequential checklist that elaborates on the key elements of the process, with each element building on the next as readers are guided through their journey.

The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first edition (2012), the emphasis on risk-based processes has growth exponentially across all sectors, and risk management is now considered as significant as quality management. ISO 9001 was revised and now requires that top management promote the use of risk-based thinking. ISO 13485:2016, which specifies the requirements for a quality management system specific to the medical devices industry, also now shows a greater emphasis on risk management and risk-based decision making. In addition, the FDA Food Safety Modernization Act (FSMA) is the most important reform of U.S. food safety laws in more than 70 years.This indispensable book presents a systematic and comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practice or good laboratory practice.All chapters have been updated and revised, and a new chapter has been added to discuss some of the most common pitfalls and misunderstandings regarding risk management, specifically those related to the use of FMEA as the only element of risk management programs. One of the appendices includes 12 case studies, and the companion CD-ROM contains dozens of U.S. FDA and European guidance documents as well as international harmonization documents (ICH and GHTF-IMDRF) related to risk management activities, as well as a 30-question exam (with answers) on the material discussed in the book.

If a business expects to be a player in their market segment, their product(s) must have the quality expected by their customers. This can only be accomplished with test equipment that produces repeatable, accurate, and traceable measurements and/or outputs. Without a quality calibration system in place, this cannot and will not happen. This book is about how to design, implement, maintain, and continuously improve a quality calibration system, with all the required documentation, traceability, and known uncertainty for each and every item of test equipment owned and used by any company, large or small. It will benefit companies that want to implement a program and also those that already have one in place. Some industries have tighter requirements than others on how they treat calibration; some are more specific about how their standards are read, while being vague about what is needed to meet calibration. Is there one tried-and-true quality calibration system that every organization can use as a foundation for its personalized program? There certainly is, and The Quality Calibration Handbook describes it. By using the quality calibration system outlined and demonstrated, any organization can put together its own version to meet its specific requirements and/or regulations. Quality calibration systems are the very foundation for improving research and development (R&D), production, and quality assurance arenas through accurate, reliable, and traceable calibrations of their test equipment. By ensuring the calibration of test equipment used in the production of genetic identity kits used by law enforcement at crime scenes, the guilty are often caught and the innocent exonerated. Calibrated test equipment used in support of the airline and automotive industries helps prevent disasters. At pharmaceutical companies, calibration technicians quietly lay the foundation for quality treatments that help keep us healthy, cure diseases, and sometimes prevent death. This book explains why a quality calibration system can be the difference between life and death, success and failure, andmost important to shareholders and boards of directorsprofit and loss. COMMENTS FROM OTHER CUSTOMERS Average Customer Rating (5 of 5 based on 4 reviews) "This book offers me the information I need to upgrade the quality of the service I provide to customers. It makes the quantum leap between the theory and practice in calibration. I needed this applicable and practical information a long time ago." A reader in Anchorage, Alaska "This book is a great and simple reference guide for developing a world class calibration system. If you are thinking about revamping your calibration system or developing one, this book is a must. This book is written by a person sharing his practical experience to less experienced people." A reader in Austin, Texas "Excellent reference for setting up a calibration program or improving your current operations. This book is a must read for anyone working in the metrology field." A reader in Springboro, Ohio "This book is for anyone who wants to learn more about the requirements of a good calibration program. It gives easy to understand guidelines and practical advice to help you make your calibration program world class." A reader in Putnam, Connecticut

The field guide depicts step by step what must occur for organizations to create an effective environmental management system (EMS) in conformance with a ISO 14001:2015/a, whether from scratch or by transitioning from ISO 14001:2004. In keeping with ISO 9000:2015's definition of environmental as the degree to which a set of inherent characteristics fulfills requirements, the authors have identified the requirements and inherent characteristics (distinguishing features) for this field guide. Within the guide, each sub-clause containing requirements is the focus of a two-page spread that consistently presents features that fulfill ISO 14001's requirements. What separates this field guide from most other books on ISO 14001:2015 and its implementation are flowcharts showing the steps to be taken in implementing an EMS to meet a sub-clause's requirements.This field guide has been created to foster an inner reliance between senior management, middle management, functional teams, and the individual. Users of the field guide will find within it practical tools, tips, and techniques useful for not only implementing an environmental management system (EMS) but also maintaining one.The revised ISO 14001:2015 standard is both useful to the organization and here to stay. May this logistical field guide serve you and your organization well!

Change can be hard. It is often difficult to conceive performing tasks in a different order, in a different place, at a different time, or in a different manner altogether. And this is only for the individual. When we talk about organizational change the difficulty increases exponentially with each individual that is added to the equation.This book uses as its basis a fable - the story is not untrue, but it is not fact either. It is a story in which the group dynamics are real, the problems are valid, and the solutions legitimate. It asks you to consider a complex environment with multiple classes interacting between functional units with requirements that are perceived as exclusive and unique, and personalities that reinforce presumed boundaries. It asks you to follow along as all these individuals work together using the basics of four quality methodologies (Lean, Six Sigma, Theory of Constraints, and Business Process Reengineering) to address the problems they face, discover solutions together, and move forward in their continuous performance improvement journey."Lean Acres is fantastic in its appeal and innovative in its writing style. Jim Bowie introduces an amazing convention by using talking animals on a farm ("Lean Acres Farm") to represent "real" stakeholders and teach Strategy and Process Improvement methodologies (Balanced Scorecard, the StrateTree, Lean Manufacturing, Six Sigma, the Theory of Constraints, and Business Process Reengineering) in ways that are easy to understand and enjoyable to learn. His step-by-step guidance through the each tool and philosophy make this book essential for Leaders, Managers, Quality Professionals, and anyone interested in improving performance in any industry. The message is simple, the illustrations are an excellent complement to the story, and the Reader interaction (Pre- and Post-Tests coupled with Rest, Reflect, and Relate sections at the end of each chapter) reinforce education, application, and relevance. Take a trip to Lean Acres today - you will be better for it." Mikel J. Harry Co-creator of Six Sigma and best-selling author.

In 1917, we split the atom and released an incredible force for destruction. In 2019, we split the DMAIC and released an even bigger force for improvement.There is no doubt that the various improvement methods work. Whether it is PDCA or 7-Step problem-solving or A3 or IIs Not or DMAIC or any other tool, it has been used to great success in many organizations stretching back over decades. But why have some organizations been wildly successful with these and others not?The reason is that much of today's continuous improvement (CI) training is focused on tools. Training includes days or even weeks working through every possible tool a practitioner of CI might need. But rather than teach people about a set of tools that they might or might not use, why not teach them how to accomplish a specific objective? Why not give them a path for solving a particular type of problem that works most of the time? This way, anyone anywhere can make CI work by splitting the DMAIC.This book shows four typical paths through the DMAIC process to accomplish four different objectives: Reduce variability of a characteristic Reduce failures of a machine Reduce waste in a process Reduce the frequency of a defectFor each path, the following is presented: -an overview of the purpose and actual steps through the DMAIC process for that path. -Step Details-a detailed description of each step including specific tools used. -Checklist-a simple one-page sheet that anyone can use as a guide along the path. Think of these as a new app called DMAIC Maps, which helps people get around the DMAIC world the same way Google Maps helps in the real world.Project selection and team management are also discussed, since the choice of projects is crucial to creating context and therefore success.

This publication introduces a portable audit model to facilitate a simple, flexible, and effective audit of single or multiple quality system standards and achieve both compliance and initiation of improvement initiatives. This model is similar to a universal adaptor plug, allowing easy connection and interchangeability of the multiple standards even under rapid system changes typical of modern day operations. This universal plug will allow focus on compliance verification and improvement at a high level of consistency with minimum process disruption and cost.Emphasis is not only on compliance but also on improvement partnership with operations through the use of strategy models. These strategy models will help accentuate the internal audit role as a dynamic element and catalyst for improvement. Real life-based challenges (masked identity) are used in case studies to demonstrate the application of typical internal audit methodologies combined with an implementation engine such as Lean auditing strategies. This will clarify theories that are commonly viewed as abstract by the novice and, in some cases, misunderstood by experienced professionals.This is the breakthrough from a dormant internal audit program into a proactive tool for added-value improvement. Lean methodology is integrated through simple models that don't require one to be a Lean or Black Belt guru. The focus is using logical sense to understand and apply the concept.

Six Sigma Green Belts need support in applying new skills after training, yet there is little research about how this works and even less advice about what support looks like in the field. This book is that missing link in providing coaching tips to support Green Belt projects.There is an abundant amount of information on the technical, "hard skills" aspects of Six Sigma, while considerably less about the interpersonal side of DMAIC. Research has shown that desirable Green Belt project outcomes are greatly influenced by collaboration issues between the coach and the Green Belt team member, and therefore this text focuses on tips for effective collaboration practices.Besides being a comprehensive discussion about how to coach Green Belts on their first project, it may also be used to coach subsequent Green Belt projects. A case study of Louisville Metro demonstrates this book's ideas in the field and includes an example of one of its actual Six Sigma Green Belt projects.

For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. This poses a substantial problem for the medical device industry and is the reason why the authors wanted to write this book. The authors will share their collective knowledge: to help organizations improve patient safety and increase profitability while maintaining a state of compliance with regulations and standards.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 peerless best-seller is a hands-on, step-by-step workbook of instructions on how to create flowcharts and document work processes. No other book even comes close in teaching practitioners these crucial techniques. The most noticeable change in this second edition is the inclusion of several new types of process maps. While the basic, straightforward flowchart is still extensively used, it has been supplemented by a number of other types, all of which serve different purposes. The authors have therefore expanded the variety of charts taught. All the mapping techniques have also been updated, the mapping exercise itself is put into a larger context, and organizational examples from many different industries are used throughout to help readers understand real-life applications of the material presented. Also new is an example case study carried throughout the entire book to illustrate the construction and use of the different types of process maps.

Good Manufacturing Practices (GMP) for human pharmaceuticals affects every patient taking a medicine. GMP covers all aspects of the manufacturing process, from defining manufacturing processes to systems for recall and investigation of complaints. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective.GMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS.As a bonus, this package contains dozens of FDA guidance documents as well as international harmonization documents (WHO, PIC/S, and ICH). A check list for GMP audit is also included based on risk management criteria. An exam complements the extra material.

Foreword by Michael F. Gutzeit, M.D., Chief Medical Officer and Vice President of Quality, Children's Hospital of WisconsinThis practical, how-to book clearly and succinctly takes the reader through six proven "success steps" for implementing lean in any healthcare environment:1. Create physician flowbr2. Support physician value-added timebr3. Visually communicate patient statusbr4. Standardize everyone's workbr5. Lay out the clinic for minimal motionbr6. Change the care delivery modelWhy go through such a transformation? Because it works. Tell a doctor that he can see the same number of patients, offering the same high quality and personal care, and have an extra 90 minutes at the end of his clinic day - and that means something. Tell the staff that they can look forward to actually ending on time, with satisfied patients, no backlog, and having focused their attention completely on quality patient care - and they will listen.These Lean principles and success steps work in clinics ranging from orthopedics to neurology to cardiac care-the specialty doesn't matter. They work in small practices and large hospital settings. Lean methodology provides the tools to address the frustrations patients and doctors alike experience in the clinic process.Included throughout the book is a case study showing the lean transformation undertaken at the Orthopedic Center at Children's Hospital of Wisconsin, with numerous quotes and insights from those actually involved. This transformation resulted in patient wait times being reduced by more than 70 percent, the clinic being able to see 25 percent more patients in less space, patient satisfaction scores sometimes reaching 100 percent, and staff satisfaction scores improving by more than 25 percent.