Challenged by stringent regulations, vigorous competition, and liability lawsuits, medical device manufactures must develop safe, reliable, and cost-effective products, and managing and reducing risk is a vital element of reaching that goal. These guidelines focus on Failure Modes and Effects Analysis (FMEA) and its application throughout the life cycle of a medical device. It outlines the major U.S. and E.U. standards and regulations and provides a detailed yet easy-to-read overview of risk management and risk analysis methodologies, common FMEA pitfalls, and FMECA-Failure Mode, Effects, and Criticality Analysis.

Guidelines for Failure Modes and Effects Analysis for Medical Devices is written as a practical guide to achieving corporate consistency while dramatically cutting the time required for studies. It will help you prevent patient injuries, costly product recalls, and production department down-time.

Discover how the FMEA methodology can help your company achieve a more cost-effective manufacturing process by improving the quality and reliability of your products. This new FMEA manual from the experts at Dyadem is the ultimate resource for you and your colleagues to learn more about Failure Modes and Effects Analysis and then teach others at your facility. This comprehensive manual is sure to become a standard reference for engineering professionals.

What distinguishes great leaders? Exceptional leaders capture passion. They lead for real: from the heart, smart and focused on the future, and with a commitment to being their very best. As Annie McKee and Richard Boyatzis have shown in their bestselling books Primal Leadership and Resonant Leadership, they create resonance with others. Through resonance, leaders become attuned to the needs and dreams of people they lead. They create conditions where people can excel. They sustain their effectiveness through renewal. McKee, Boyatzis, and Frances Johnston share vivid, real-life stories illuminating how people can develop emotional intelligence, build resonance, and renew themselves. Reflecting twenty years of longitudinal research and practical wisdom with executives and leaders around the world, this new book is organized around a core of experience-tested exercises. These tools help you articulate your strengths and values, craft a plan for intentional change, and create resonance with others. Practical and inspiring, Becoming a Resonant Leader is your hands-on guide to developing emotional intelligence, renewing and sustaining yourself and your relationships, and taking your leadership to a whole new level. This book is ideal for anyone seeking personal and professional development and for consultants, coaches, teachers, and faculty to use with their clients or students.

"Operational Risk Management" offers peace of mind to business and government leaders who want their organizations to be ready for any contingency, no matter how extreme. This invaluable book is a preparatory resource for when times are good, and an emergency reference when times are bad. "Operational Risk Management" is destined to become every risk manager's ultimate weapon to help his or her organization survive ? no matter what.

'Knowledge Management Foundations' is just what it claims, the first attempt to provide a secure intellectual footing for the myriad of practices called "knowledge management." A breath of fresh air from the usual KM gurus, Fuller openly admits that the advent of KM is a mixed blessing that often amounts to the conduct of traditional management by subtler means. However, Fuller's deep understanding of both the history of management theory and knowledge production more generally enables him to separate the wheat from the chaff of the KM literature.
This ground-breaking book will prove of interest to both academics and practitioners of knowledge management. It highlights the ways in which KM has challenged the values associated with knowledge that academics have taken for granted for centuries. At the same time, Fuller resists the conclusion of many KM gurus, that the value of knowledge lies in whatever the market will bear in the short term. He pays special attention to how information technology has not only facilitated knowledge work but also has radically altered its nature. There are chapters devoted to the revolution in intellectual property and an evaluation of peer review as a quality control mechanism. The book culminates in a positive re-evaluation of universities as knowledge producing institutions from which the corporate sector still has much to learn.
A KMCI Press book - a definitive title from the leading, standard-setting KM organizationOnly book to describe fundamental KM concepts and theoriesApproach roots theory in current state of the procession/discipline

Managing Risk in Organizations offers a proven framework for handling risks across all types of organizations. In this comprehensive resource, David Frame— a leading expert in risk management— examines the risks routinely encountered in business, offers prescriptions to assess the effects of various risks, and shows how to develop effective strategies to cope with risks. In addition, the book is filled with practical tools and techniques used by professional risk practitioners that can be readily applied by project managers, financial managers, and any manager or consultant who deals with risk within an organization. Managing Risk in Organizations is filled with illustrative case studies and

• Outlines the various types of riskpure, operational, project, technical, business, and political
• Reveals what risk management can and cannot accomplish
• Shows how to organize risk management efforts to conduct risk assessments, manage crises, and recover from disasters
• Includes a systematic risk management processrisk management planning, risk identification, qualitative impact analysis, quantitative impact analysis, risk response planning, and monitoring control
• Provides quantitative and qualitative tools to identify and handle risks

This much-needed book will enable organizations to take risk seriously and act proactively.

Contents:
1. Introduction The Context in Which Toxic Risk Analysis Takes Place 2. What Risk Management Covers 3. Legal and Organisational Frameworks 4. Philosophical Frameworks for Handling Risk 5. The Importance of Risk Perception and Risk Communication for Toxicological Risk Assessment The Principles and Practice of Toxic Risk Analysis 6. Introduction - Royal Society and National Academy of Science 7. Toxicological Assessment 8. Evaluation of Human Health Effects: Toxicity 9. Evaluation of Human Health Effects: Exposure 10. The Special Case of Major Accident Hazards 11. Evaluation of Effects on the Environment 12. Effects on the Atmosphere

A Practical Guide to Understanding, Managing and Reviewing Environmental Risk Assessment Reports provides team leaders and team members with a strategy for developing the elements of risk assessment into a readable and beneficial report.
The authors believe that successful management of the risk assessment team is a key factor is quality reports. Leadership first clarifies the roles of each participant and the unique technical factors of their respective disciplines. Teamwork is achieved through an emphasis on common language and procedures.
Belluck and Benjamin explore a variety of techniques for creating accurate and useful reports. An example is Proactive Risk Assessment, which breaks a project into discrete parts to be delivered on an interim basis. This method, based on iterative review, drastically increases the chance of detecting errors while they can still be corrected.
The authors emphasize rigorous standards by which reports are audited, evaluated and critiqued. The goal is to create reports that are accurate, useful and, adaptable on an industry-wide basis.

The Springboard: How Storytelling Ignites Action in Knowledge-Era Organizations is the first book to teach storytelling as a powerful and formal discipline for organizational change and knowledge management. The book explains how organizations can use certain types of stories ("springboard" stories) to communicate new or envisioned strategies, structures, identities, goals, and values to employees, partners and even customers. Readers will learn techniques by which they can help their organizations become more unified, responsive, and intelligent. Storytelling is a management technique championed by gurus including Peter Senge, Tom Peters and Larry Prusak. Now Stephen Denning, an innovator in the new discipline of organizational storytelling, teaches how to use stories to address challenges fundamental to success in today's information economy.

This practical resource shows business professionals how to improve their decision-making skills and enhance their ability to develop effective interpersonal relationships with co-workers and clients. The book covers a wide range of topics -- identifying tastes and preferences, personal skill assessment, cost-benefit analysis, risk and uncertainty, multi-tasking, human resource management, time constraints, data collection, and more. Designed to help busy professionals make the most effective use of time and energy, it will also be useful in the study of organizational behavior and business psychology.

Risk management is considered a vital business tool, and one that is complex and difficult to master. This text is part of a series that examines and applies the principles of risk management to a variety of business operations.

The Knowledge Management Yearbook is the most current and comprehensive resource available for knowledge management professionals; no other source of information so thoroughly surveys the state of the knowledge management discipline and industry and how they impact businesses and other organizations. Featuring both definitive articles and cutting-edge knowledge management techniques and research contributed by authorities, The Knowledge Management Yearbook covers the nature of knowledge and its management, knowledge-based strategies, knowledge management and organizational learning, and knowledge tools, techniques, and processes. The reference section includes a set of up-to-date directories detailing on-line knowledge management resources, KM publications and organizations, and notable KM Quotes. The glossary of KM terms is increasingly perceived by the industry as a benchmark by which this evolving discipline is defined. The Knowledge Management Yearbook is an indispensable volume for any professional helping to shape his or her organization's knowledge strategy.

Exploring the management of innovation is a largely interdisciplinary endeavour. It requires scholars to address problems from a variety of perspectives that include strategic, operational, technological and behavioural. The problem domain includes the management of innovation, technology strategy, research and development, information technologies, technology-based entrepreneurship, and the commercialization of scientific research. Behavioural theories of innovation have developed in multiple directions over the years, and this collection of chapters takes stock and provides examples of new developments at the intersection of innovation studies, and studies of managerial and organizational cognition. This is the third volume in the New Horizons in Managerial and Organizational Cognition series and comprises a collection of contributions that reflects the rich and encouraging developments at the intersection of cognition and innovation. The book explores the frontiers of socio-cognitive and socio-psychological research as it relates to innovation management and innovation processes. Major topics covered include attention, decision making, information processing, learning, cognitive frames, ecosystems and business model innovation, perceptual and interpretive processes, ethics and social dilemmas, power, and change.

Offering a planned approach for determining cause and effect, DOE Simplified: Practical Tools for Effective Experimentation, Third Edition integrates the authors' decades of combined experience in providing training, consulting, and computational tools to industrial experimenters. Supplying readers with the statistical means to analyze how numerous variables interact, it is ideal for those seeking breakthroughs in product quality and process efficiency via systematic experimentation. Following in the footsteps of its bestselling predecessors, this edition incorporates a lively approach to learning the fundamentals of the design of experiments (DOE). It lightens up the inherently dry complexities with interesting sidebars and amusing anecdotes. The book explains simple methods for collecting and displaying data and presents comparative experiments for testing hypotheses. Discussing how to block the sources of variation from your analysis, it looks at two-level factorial designs and covers analysis of variance. It also details a four-step planning process for designing and executing experiments that takes statistical power into consideration. This edition includes a major revision of the software that accompanies the book (via download) and sets the stage for introducing experiment designs where the randomization of one or more hard-to-change factors can be restricted. Along these lines, it includes a new chapter on split plots and adds coverage of a number of recent developments in the design and analysis of experiments. Readers have access to case studies, problems, practice experiments, a glossary of terms, and a glossary of statistical symbols, as well as a series of dynamic online lectures that cover the first several chapters of the book.

Risk Analysis: A Quantitative Guide is a comprehensive guide for eh risk analyst and decision maker. based on the author's extensive experience in solving real-world risk problems, this book is an invaluable aid to the risk analysis practitioner. by providing the building blocks of risk-based thinking the author guides the reader through the steps necessary to produce a realistic risk-based thinking the author guides the reader through the steps necessary to produce a realistic risk analysis and offers general and specific techniques to cope with most common and challenging risk modelling problems. A wide range of solved examples is used to illustrate these technique and how they can be put together to make the best possible risk-based decisions.

The third edition of this highly regarded text has been thoroughly updated and expanded considerably with five new chapters for the risk manager, including how to plan and assess the quality of risk analysis, as well as new chapters for this risk analysis, as well as new chapters for the risk analysis modeller on summation of random variables, causality, optimization, insurance and finance modelling, forecasting, model validation and common errors, capital investment and microbial risk assessment. This new edition provides a greater focus on business and includes applications in a wide range of different settings.

Key Features: Breaks down techniques into types of modelling issues (like distribution fitting, correlation and time series forecasting) and then applies them with easy-to-follow examples. Explains powerful and proven Monte Carlo simulation and numerical techniques for dealing with uncertainty. Includes recent innovations inmodelling like fast Fourier transforms and copulas. Over 150 examples models and over 400 illustrations. Written in an informal manner with a practical rather than academic focus. Discusses the planning, uses and abuses of risk analysis. Includes a compendium of almost eighty distribution types and their uses.

In a category saturated with breezy, self-help volumes, Russell Korobkin's long-awaited The Five Tool Negotiator stands apart as a revelatory guide for anyone eager to improve their bargaining skills. The nationally renowned author, who has spent three decades studying successful negotiations, now shares five distinct "tools" that we can all readily utilise: Bargaining Zone Analysis, Persuasion, Deal Design, Power and Fairness Norms. Drawing on his academic research, Korobkin incorporates lively anecdotes that bring to life concepts from the disparate fields of psychology, economics and game theory, along with fascinating social science experiments. These invaluable tools can be applied to everyday negotiations and transactions-from consumers hoping to obtain the best price for a used car to executives trying to close a multimillion-dollar deal. Intuitively accessible and reassuringly persuasive, this is a vital guide to mastering the critical skills of negotiation at the social, cultural and human level.

This volume explores and presents challenges that "traditional" organisations experience once they take off towards self-managing organisations (or Teal Organisations). The concept of Teal Organisations is not surprising nowadays, but strangely enough it remains a dream concept: the majority of modern organisations represent hierarchical managerial constructions, with little to no evidence of self-management. The main characteristics of self-management are well-known: whole tasks; organisational actors equipped with a certain skill portfolio that is required to accomplish these tasks; work organised in teams that have autonomy for decision-making and performance management. Self-management is often accompanied by greater flexibility, better use of employees' creative capacities, increased quality of work life, and decreased employee absenteeism and turnover, eventually resulting in increased job satisfaction and organizational commitment. In this volume, we suggest that self-managing teams require a new way forward in modern organisations. Particularly, we offer a new roadmap for leaders who are responsible for the implementation of self-managing teams.

The tapestry of human behaviour in the marketplace today is turbulent, unpredictable, and chaotic. Yet it is also so diverse, rich and global that it presents a rare ethical and moral opportunity, and challenge, to out-behave competition and create enduring value. This is corporate ethics for corporate advantage. Corporate Ethics for Turbulent Markets: The Market Context of Executive Decisions focuses on the HOW of doing business - the economic, social, ethical, moral and spiritual values we bring to our business ventures - and how thereby we impact the world. The book focuses on the LEMS (legality, ethicality, morality, and spirituality) technique that we submit as a prescriptive benchmarking tool for all corporate thinking, deliberation, explanation, evaluation, choices, strategic implementation, accountability and moral responsibility. It demonstrates that by going beyond the legal obligation (legality) to do the "right thing" (ethicality), to do the "right thing rightly" (morality), and doing the "right thing rightly and for the right intentions" (spirituality), we can create a sure strategy for good decision making and implementation that can heal the world from its current addictions to corporate fraud in all its evil forms. Envisioning a moral reawakening, this book will challenge business students and executives alike to re-evaluate the moral justification of business choices, decisions, actions and their consequences. LEMS as a four-dimensional cross-checking skill for all that we think, do, become and be takes time and patience but it can surely heal an otherwise divided and broken world.

A source for anyone - from mid-level through to top-level executives - who needs to implement business decisions on time and within budget. The author illustrates that change needs to be made quickly, effectively, economically and with as little political fallout as possible. His methods should teach today's managers to negotiate these transitions by teaching them what distinguishes resilient people from those who suffer future shock and why major change is difficult to assimilate. It teaches the key elements and the flow of events involved in human transition; what roles are central to change in organizational settings; how people become committed to change; why organizational culture is so important to a change's success; and why teamwork is at the heart of achieving change objectives. Organizations need to start managing at the speed of change to meet today's challenges with confidence. The book is based on case studies from leading international organizations such as AT&T and Pepsi-Cola.

This Element synthesizes the current state of research on organizational learning from performance feedback and develops a new perspective that deals with the influence of multiple goals. In keeping with the centrality of motives in Cyert & March's influential model, this new perspective rests on a foundation of individual level behaviors that are responsive to mechanisms at the organizational and environmental level of analysis. A key aim is to lay out an agenda for a new wave of empirical research on the interconnections of decision-makers, organizations, and the environment that influence organizational responses to performance.

Providing a comprehensive framework for building an effective fraud prevention model, "Fraud Risk Assessment: Building a Fraud Audit Program" presents a readable overview for developing fraud audit procedures and building controls that successfully minimize fraud. An invaluable reference for auditors, fraud examiners, investigators, CFOs, controllers, corporate attorneys, and accountants, this book helps business leaders respond to the risk of asset misappropriation fraud and uncover fraud in core business systems.

The information technology manager's role has changed significantly over the past decade. The performance of an organization is increasingly dependent on the performance of the information technology unit and its top executive. Here the author offers a fly on the wall view of the executive level activities of five Chief Information Officers (CIOs), operating in different industries. Profiles of these CIOs provide valuable insights into the strategic impact of this new role. Profiles of these CIOs, developed from over 200 hours of direct observation, provide valuable insights into the strategic impact of this new role. Other CIOs, executives, information technology researchers, information technology students in upper level or graduate courses, managers of technology and innovation, systems managers, and those interested in organizational behavior will all gain a greater understanding of the CIO's critical role within today's organizations.

The day-to-day work habits of each CIO are observed for one work week, including meetings, mail, phone calls, and travel. The CIOs represent five distinct industries: utilities, manufacturing, government agency, insurance, and university. Despite very different work cultures, all demonstrate a remarkable ability to think on their feet and remain detached from highly charged turf battles. These high tech executives have the playwright's high touch; they are keenly aware of the power of figurative language and the timing of events.

The Decision Maker's Playbook is an easy-to-use, “how-to” toolkit to improve managers' decision making, using visualisations, relevant examples and actionable checklists that cater to its main target group: analytically interested, busy managers and entrepreneurs.

The Decision Maker's Playbook will help readers navigate a complex world. Along the five chapters of the books, it will help you in:

1. Overcoming Blindness (How to See What's Hidden)

2. Connecting the Dots (How to Understand Causes and Effects)

3. Sharpening Projections (How to Think About Tomorrow)

4. Improving Decisions (How to Enhance Judgment)

5. Shaping the Future (How to Act Smartly)

The Decision Maker's Playbook is your personal toolbox to help you make better decisions. It offers practical advice to help you understand, analyse and shape your world. As simplified representations of reality, the 33 models portrayed in this book allow us to see patterns, identify relationships, and view the world from different vantage points. They help us understand and break up complex phenomena into tractable pieces.

This book is dedicated to the systematization and development of models, methods, and algorithms for queuing systems with correlated arrivals. After first setting up the basic tools needed for the study of queuing theory, the authors concentrate on complicated systems: multi-server systems with phase type distribution of service time or single-server queues with arbitrary distribution of service time or semi-Markovian service. They pay special attention to practically important retrial queues, tandem queues, and queues with unreliable servers. Mathematical models of networks and queuing systems are widely used for the study and optimization of various technical, physical, economic, industrial, and administrative systems, and this book will be valuable for researchers, graduate students, and practitioners in these domains.

Every educator knows that the most effective way to learn is by 'doing' - and nowhere is that truth more clearly seen than in management development. This wide-ranging book explains what is involved in planning and running project-based management development programmes and demonstrates the benefits for both the individuals and the organizations concerned. Drawing on the unrivalled experience of PA-Sundridge Park Management Centre in this field, the authors: c show how to set up the necessary frameworks c describe programmes for different levels of management, including 'top teams' c examine the role of the sponsor c point out the potential pitfalls and indicate how to avoid them c look at the influence of national culture. With summaries and checklists, and case studies focusing on ICI, Allied Domecq, Volvo, Gestetner, Lloyds Bank Insurance Services, The Inland Revenue, London Underground and others, the emphasis throughout is very much on the practical. For anyone concerned with improving managerial performance, this is a book that will repay careful study.