Laboratory Quality Management System


Book Description

Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to engage in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook was developed through collaboration between the WHO Lyon Office for National Epidemic Preparedness and Response, the United States of America Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems, and the Clinical and Laboratory Standards Institute (CLSI). It is based on training sessions and modules provided by the CDC and WHO in more than 25 countries, and on guidelines for implementation of ISO 15189 in diagnostic laboratories, developed by CLSI. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. Each topic is discussed in a separate chapter. The chapters follow the framework developed by CLSI and are organized as the "12 Quality System Essentials".




Safety and Health for Engineers


Book Description

SAFETY AND HEALTH FOR ENGINEERS A comprehensive resource for making products, facilities, processes, and operations safe for workers, users, and the public Ensuring the health and safety of individuals in the workplace is vital on an interpersonal level but is also crucial to limiting the liability of companies in the event of an onsite injury. The Bureau of Labor Statistics reported over 4,700 fatal work injuries in the United States in 2020, most frequently in transportation-related incidents. The same year, approximately 2.7 million workplace injuries and illnesses were reported by private industry employers. According to the National Safety Council, the cost in lost wages, productivity, medical and administrative costs is close to 1.2 trillion dollars in the US alone. It is imperative—by law and ethics—for engineers and safety and health professionals to drive down these statistics by creating a safe workplace and safe products, as well as maintaining a safe environment. Safety and Health for Engineers is considered the gold standard for engineers in all specialties, teaching an understanding of many components necessary to achieve safe workplaces, products, facilities, and methods to secure safety for workers, users, and the public. Each chapter offers information relevant to help safety professionals and engineers in the achievement of the first canon of professional ethics: to protect the health, safety, and welfare of the public. The textbook examines the fundamentals of safety, legal aspects, hazard recognition and control, the human element, and techniques to manage safety decisions. In doing so, it covers the primary safety essentials necessary for certification examinations for practitioners. Readers of the fourth edition of Safety and Health for Engineers readers will also find: Updates to all chapters, informed by research and references gathered since the last publication The most up-to-date information on current policy, certifications, regulations, agency standards, and the impact of new technologies, such as wearable technology, automation in transportation, and artificial intelligence New international information, including U.S. and foreign standards agencies, professional societies, and other organizations worldwide Expanded sections with real-world applications, exercises, and 164 case studies An extensive list of references to help readers find more detail on chapter contents A solution manual available to qualified instructors Safety and Health for Engineers is an ideal textbook for courses in safety engineering around the world in undergraduate or graduate studies, or in professional development learning. It also is a useful reference for professionals in engineering, safety, health, and associated fields who are preparing for credentialing examinations in safety and health.




Standards for Management Systems


Book Description

This book guides readers through the broad field of generic and industry-specific management system standards, as well as through the arsenal of tools that are needed to effectively implement them. It covers a wide spectrum, from the classic standard ISO 9001 for quality management to standards for environmental safety, information security, energy efficiency, business continuity, laboratory management, etc. A dedicated chapter addresses international management standards for compliance, anti-bribery and social responsibility management. In turn, a major portion of the book focuses on relevant tools that students and practitioners need to be familiar with: 8D reports, acceptance sampling, failure tree analysis, FMEA, control charts, correlation analysis, designing experiments, estimating parameters and confidence intervals, event tree analysis, HAZOP, Ishikawa diagrams, Monte Carlo simulation, regression analysis, reliability theory, data sampling and surveys, testing hypotheses, and much more. An overview of the necessary mathematical concepts is also provided to help readers understand the technicalities of the tools discussed. A down-to-earth yet thorough approach is employed throughout the book to help practitioners and management students alike easily grasp the various topics.




Agile in ISO 9001


Book Description

Do you ask yourself what this ‘agility hype’ is actually about and in what cases agility really creates benefits? Would you like to know how to make processes more agile? Do you fancy the idea of using agile methods but don't know how to explain it to your ISO 9001 auditor? This is the book you’ve been waiting for! Written from a quality management professional’s point of view, it offers useful solutions and practical advice concerning the use of agile practices in ISO 9001-based quality management systems. Agility for organisations is defined and described in a structured way. It is shown in detail how agile practices can be integrated into a QM system while maintaining the ISO 9001 certification. You will find out what needs to be considered when systemically incorporating agile practices, and how to balance the benefits and limitations of agility in organisations. Based on a qualitative, intersectoral research initiative, this book provides unique, state-of-the-art information and valid arguments for focused organisational development. It is intended for professionals such as quality managers, innovation managers, auditors of ISO management standards, organisational developers and managers who lead ISO 9001-certified companies.




The Future of Software Quality Assurance


Book Description

This open access book, published to mark the 15th anniversary of the International Software Quality Institute (iSQI), is intended to raise the profile of software testers and their profession. It gathers contributions by respected software testing experts in order to highlight the state of the art as well as future challenges and trends. In addition, it covers current and emerging technologies like test automation, DevOps, and artificial intelligence methodologies used for software testing, before taking a look into the future. The contributing authors answer questions like: "How is the profession of tester currently changing? What should testers be prepared for in the years to come, and what skills will the next generation need? What opportunities are available for further training today? What will testing look like in an agile world that is user-centered and fast-paced? What tasks will remain for testers once the most important processes are automated?" iSQI has been focused on the education and certification of software testers for fifteen years now, and in the process has contributed to improving the quality of software in many areas. The papers gathered here clearly reflect the numerous ways in which software quality assurance can play a critical role in various areas. Accordingly, the book will be of interest to both professional software testers and managers working in software testing or software quality assurance.




The Adventurous and Practical Journey to a Large-Scale Enterprise Solution


Book Description

The high failure rate of enterprise resource planning (ERP) projects is a pressing concern for both academic researchers and industrial practitioners. The challenges of an ERP implementation are particularly high when the project involves designing and developing a system from scratch. Organizations often turn to vendors and consultants for handling such projects but, every aspect of an ERP project is opaque for both customers and vendors. Unlocking the mysteries of building a large-scale ERP system, The Adventurous and Practical Journey to a Large-Scale Enterprise Solution tells the story of implementing an applied enterprise solution. The book covers the field of enterprise resource planning by examining state-of-the-art concepts in software project management methodology, design and development integration policy, and deployment framework, including: A hybrid project management methodology using waterfall as well as a customized Scrum-based approach A novel multi-tiered software architecture featuring an enhanced flowable process engine A unique platform for coding business processes efficiently Integration to embed ERP modules in physical devices A heuristic-based framework to successfully step into the Go-live period Written to help ERP project professionals, the book charts the path that they should travel from project ideation to systems implementation. It presents a detailed, real-life case study of implementing a large-scale ERP and uses storytelling to demonstrate incorrect and correct decisions frequently made by vendors and customers. Filled with practical lessons learned, the book explains the ins and outs of adopting project methodologies. It weaves a tale that features both real-world and scholarly aspects of an ERP implementation.




Project Management by ICB4 - IPMA


Book Description

IPMA observes an increasing number and importance of projects in business, public and people’s lives, also known as ‘projectification’. In the world of globalisation, an increasing number of organisations are working project-based to cope with the challenges of modern times. Especially now, society is on the brink of such significant changes as global warming and artificial intelligence. Projects drive the development of new products and services, expansions, new capabilities, implementation of new strategies and new generations of infrastructure, and major maintenance and upgrade of existing facilities and infrastructure. This book provides a knowledge base for developing individual competencies for managing projects as described in the IPMA Individual Competence Baseline version 4, which encompasses: - Perspective competencies - People competencies - Practice competencies As projects become increasingly important, we must continue to realise that projects begin and end with people and that their competent performance within the broader context of the environment is at the heart of any successful project. In this book, theories and practices for all ICB4 competencies are described. They are logically sequenced, explained and enriched with practical approaches, which can be learned and applied in the daily project management practice. As such, it aligns entirely with IPMA's vision: to strengthen competence across society to enable a world in which all projects succeed. This book also supports obtaining an IPMA certificate as proof of your competence in projects.




New Perspectives in Software Engineering


Book Description

This book contains a selection of papers from the 2021 International Conference on Software Process Improvement (CIMPS’21), held between the 20th and 22th of October in Torreón Coahuila, México as virtual venue. The CIMPS’21 is a global forum for researchers and practitioners that present and discuss the most recent innovations, trends, results, experiences and concerns in the several perspectives of Software Engineering with clear relationship but not limited to software processes, Security in Information and Communication Technology and Big Data Field. The main topics covered are: Organizational Models, Standards and Methodologies, Software Process Improvement, Knowledge Management, Software Systems, Applications and Tools, Information and Communication Technologies and Processes in non-software domains (Mining, automotive, aerospace, business, health care, manufacturing, etc.) with a demonstrated relationship to Software Engineering Challenges.




Radar for Fully Autonomous Driving


Book Description

This is the first book to bring together the increasingly complex radar automotive technologies and tools being explored and utilized in the development of fully autonomous vehicles – technologies and tools now understood to be an essential need for the field to fully mature. The book presents state-of-the-art knowledge as shared by the best and brightest experts working in the automotive radar industry today -- leaders who have “been there and done that.” Each chapter is written as a standalone "master class" with the authors, seeing the topic through their eyes and experiences. Where beneficial, the chapters reference one another but can otherwise be read in any order desired, making the book an excellent go-to reference for a particular topic or review you need to understand. You’ll get a big-picture tour of the key radar needs for fully autonomous vehicles, and how achieving these needs is complicated by the automotive environment’s dense scenes, number of possible targets of interest, and mix of very large and very small returns. You’ll then be shown the challenges from – and mitigations to – radio frequency interference (RFI), an ever-increasing challenge as the number of vehicles with radars – and radars per vehicle grow. The book also dives into the impacts of weather on radar performance, providing you with insights gained from extensive real-world testing. You are then taken through the integration and systems considerations, especially regarding safety, computing needs, and testing. Each of these areas is influenced heavily by the needs of fully autonomous vehicles and are open areas of research and development. With this authoritative volume you will understand: * How to engage with radar designers (from a system integrator / OEM standpoint); * How to structure and set requirements for automotive radars; * How to address system safety needs for radars in fully autonomous vehicles; * How to assess weather impact on the radar and its ability to support autonomy; * How to include weather effects into specifications for radars. This is an essential reference for engineers currently in the autonomous vehicle arena and/or working in automotive radar development, as well as engineers and leaders in adjacent radar fields needing to stay abreast of the rapid developments in this exciting and dynamic field of research and development.




Handbook of Research on Improving Engineering Education With the European Project Semester


Book Description

Engineering education aims to prepare engineering undergraduates for their future professional journey where they will be called on to solve challenges affecting individuals, companies, and society. The European Project Semester (EPS) exposes students to project- and challenge-based learning, paying special attention to international multidisciplinary teamwork, sustainable design, innovative thinking, and project management in order to develop a set of desired professional skills. The Handbook of Research on Improving Engineering Education With the European Project Semester shares the best practices in engineering education through close examination of the EPS. It describes the adopted learning framework, analyzes how it contributes to the development of skills, reports on the types of challenges proposed to teams, and delivers a set of team-project cases from the network of providers. Covering topics such as engineering ethics, project management, and sustainable behavior, this book is essential to students in engineering, engineers, engineering educators, educational researchers, academic administration and faculty, and academicians.