Kvalitetssikring og kvalitetsstyring

Etableringen af resultatbaserede ledelsessystemer er blevet en del af de fleste offentlige organisationers hverdag. Der formuleres i stigende grad mål, udvikles indikatorer, indsamles og rapporteres data og mængden af resultatinformation om offentlige organisationers indsatser er vokset markant. Formålene med  resultatbaserede ledelsessystemer og tilvejebringelsen af resultatinformation er mange. Det kan fremme gennemsigtighed og ansvarlighed i den offentlige sektor, skabe fokus og retning i en organisation, have en motiverende effekt på medarbejderne samt skabe et udgangspunkt for bedre styring og kontrol, øget læring, mere oplyste beslutninger og i sidste ende forbedringer af offentlige organisationers indsatserPå trods af de mange gode formål er resultatbaseret ledelse løbende blevet mødt af kritik. Denne kritik kan samles i fem centrale indvendinger. Disse fem indvindinger udgør bogens struktur:  Den offentlige sektors ydelser er så komplekse, at det ikke er muligt at måle resultaterne af indsatserne. Resultatbaserede ledelsessystemer anvendes som udgangspunkt for at kontrollere medarbejderne og kan derved risikere at fortrænge medarbejdernes motivation. En stor del af den information, der tilvejebringes gennem resultatmålingssystemer, bliver aldrig bragt i anvendelse i ledelses- og beslutningssituationer. Resultatbaserede ledelsessystemer fører til en række utilsigtede dysfunktionelle adfærdsmæssige effekter. Resultatbaserede ledelsessystemer har en tendens til at eskalere og miste deres simplicitet over tid.Formålet med denne bog er at dykke ned i kritikken af resultatbaseret ledelse og resultatbaserede ledelsessystemer, forstå baggrunden for kritikken og under hvilke betingelser indvendingerne i særlig grad vil forekomme. På den baggrund diskuteres det, hvordan offentlige ledere kan arbejde med resultatbaseret ledelse med henblik på i højere grad at hæmme eller overkomme udfordringerne.Bogens målgruppe er studerende i statskundskab samt diplom- og masteruddannelser i offentlig ledelse samt andre lederuddannelser, hvor styring og ledelse er centrale temaer.

This book is a compilation of research papers and presentations from the Fourth Annual International Conference on Data Science, Machine Learning and Blockchain Technology (AICDMB 2023, Mysuru, India, 16-17 March 2023).

The Definitive Guide to Using Analytics for Better Business Decisions"A must-read for anyone who is directly or indirectly leading or managing an analytics function--and anyone who wants to make better decisions based on analytics, not just intuition or an 'overemphasis on industry knowledge, which crowds out good analytics.'" -- Charlotte E. Sibley, President, Sibley Associates, a bioPharma consulting company"Over the long term, those who show the greatest imagination, grow the right skills, build the deepest organizations, and follow rigorous statistical practice will reap the greatest rewards from their analytics efforts. A Practitioner's Guide to Business Analytics lights the way." -- Thomas C. Redman, PhD, the Data Doc, Navesink Consulting Group"Executives beware. This is not your typical management book. This book contains real information from analytical professionals who are outside the executive bubble. . . . Hold on to your seat and be prepared to change the way you think about leaders, leadership qualities, and leadership skills needed for future success in the changing business landscape." -- Thomas J. Scott, Director/Advisor, Marketing Sciences Solutions, TGaS Advisors"Randy Bartlett has written an important and useful book, filling at least some of the large void between books that exhort managers to think more analytically without explaining how, and overly technical books that only quantitative analysts would appreciate. Particular strengths are the recommendations about how to organize to integrate analytical expertise into decision-making and the guidance about how managers can assess whether they are getting good analytical advice." -- Douglas A. Samuelson, D.Sc., President and Chief Scientist, InfoLogix, Inc., Annandale, VA; quantitative analyst, inventor, entrepreneur and executiveAbout the Book:The real tragedy of a company failing while using analytics is the fact that its leaders will have the data to explain the failure, but they won't have the capabilities in place to filter the data and convert it into actionable business insights. One implication of Big Data is that we need to adapt . . . quickly. A Practitioner's Guide to Business Analytics integrates powerful strategies for leveraging analytics inside a business with a how-to playbook of tactics to make it happen.The case for competing based on analytics is clear, but until now, there hasn't been authoritative guidance for inciting a corporate community to evolve into a thriving, analytics-driven environment. This hands-on book gives you the tools, knowledge, and strategies to capture the level of organizational commitment you need to get business analytics up and running in your company. It helps you define what business analytics is, quantify the exponential value it brings to an organization, and show others how to harness its power to gain advantage over competitors.Accomplished business information professional Randy Bartlett brings his comprehensive coverage to life with firsthand accounts of using business analytics at brand-name global companies. Through in-depth examinations of success stories and failures in analytics-based decision making and data analyses, he fully prepares you to:Assess your company's analytics needs and capabilities, and develop a strategic analytics plan Steward the three pillars of Best Statistical Practice and accurately measure the quality of analytics-based decisions and data analyses Build and organize a specialized Business Analytics Team to lead infrastructural changes Upgrade the foundation that supports business analytics--data collection, data software, and data management Create the essential synergy for success between the Business Analytics Team and ITEffectively integrating analytics into everyday decision making, corporate

The standard tells you what to implement; this book focuses on how and why.Many organizations implement ISO 9001 and see only mild improvements. This book is a collection of concepts that can assist you in implementing a very successful ISO 9001 quality management system. Its concepts go beyond the basic implementation steps so widely available in the marketplace, instead helping you to use the ISO 9001 standard as a tool for organizational growth and success.Instead of being organized sequentially by the standard's clauses, it is split into three sections that outline how to go about satisfying the standard's requirements: Organize, Scrutinize, and Optimize. Each of these chapters includes sporadic WHAT TO DO action items to transform theory into practice.This book is intended for anyone leading the ISO 9001 implementation effort, including quality managers, management reps, executives, and consultants. It is to be used in addition to ISO 9001 training courses, packages, and consulting assistance.Read this book while you are simultaneously attending ISO 9001 courses, going through purchased how to" packages, or working with a consultant. Review it again as your implementation nears certification. Reread the later sections of the book after certification is achieved.

A crucial element of quality control is inspection, but attempting to inspect every product can be impractical. This book covers both the statistical and practical approaches for selecting a particular sampling plan from the c=0 table. Using the plans found in this book can help ensure that you meet your zero defects objectives while saving your company time and money. Zero Acceptance Number Sampling Plans was originally developed to provide equal or greater consumer protection with less inspection than the Department of Defense's (DoD's) military standard 105 (MIL-STD-105E). This book offers a set of plans for lot-by-lot inspection with the acceptance number in all cases as zero. Although the DoD canceled MIL-STD-105, the c=0 sampling plans have stood the test of time. After years of extensive application by aerospace, defense, medical device, commercial manufacturing, and service industries, these plans are still used today as a standard for many organizations to deliver quality products. This sixth edition includes only the original c=0 table as published in the fourth and all previous editions and eliminates conflicting information in the fifth edition tables.

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 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).

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.

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.

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

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.