Medical Device Use Error

Root Cause Analysis

Author: Michael Wiklund,Andrea Dwyer,Erin Davis

Publisher: CRC Press

ISBN: 1498705804

Category: Technology & Engineering

Page: 245

View: 4743

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Medical Device Use Error: Root Cause Analysis offers practical guidance on how to methodically discover and explain the root cause of a use error—a mistake—that occurs when someone uses a medical device. Covering medical devices used in the home and those used in clinical environments, the book presents informative case studies about the use errors (mistakes) that people make when using a medical device, the potential consequences, and design-based preventions. Using clear illustrations and simple narrative explanations, the text: Covers the fundamentals and language of root cause analysis and regulators’ expectations regarding the thorough analysis of use errors Describes how to identify use errors, interview users about use errors, and fix user interface design flaws that could induce use errors Reinforces the application of best practices in human factors engineering, including conducting both formative and summative usability tests Medical Device Use Error: Root Cause Analysis delineates a systematic method of analyzing medical device use errors. The book provides a valuable reference to human factors specialists, product development professionals, and others committed to making medical devices as safe and effective as possible.

Medical Device Use Error

Root Cause Analysis

Author: Michael E. Wiklund,Andrea M. Dwyer,Erin Davis

Publisher: CRC Press

ISBN: 9781498705790

Category: Medical

Page: 224

View: 5953

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Root Cause Analysis of Use Error delineates a systematic method of analyzing medical device use errors. The book is to the specific needs of people developing medical devices, people studying to serve this role, and the folks responsible for evaluating device use error (including the regulators).

Usability Testing of Medical Devices, Second Edition

Author: Michael E. Wiklund, P.E.,Jonathan Kendler,Allison Y. Strochlic

Publisher: CRC Press

ISBN: 1466595892

Category: Medical

Page: 455

View: 3301

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Usability Testing of Medical Devices covers the nitty-gritty of usability test planning, conducting, and results reporting. The book also discusses the government regulations and industry standards that motivate many medical device manufacturers to conduct usability tests. Since publication of the first edition, the FDA and other regulatory groups have modified their regulations and expectations regarding how medical device manufacturers should approach usability testing. Reflecting these changes, this Second Edition provides updated guidance to readers with an interest or direct role in conducting a usability test of a medical device or system. Key updates involve the 2011 FDA guidance on human factors engineering, requirements set forth by the third edition of IEC 60601 and closely related IEC 62366-1:2015, linking usability test tasks to risk analysis results, and analyzing root causes of use errors that occur during usability tests. Written by seasoned human factors specialists, Usability Testing of Medical Devices, Second Edition is an informative, practical, and up-to-date handbook for conducting usability tests of medical devices. The book helps ensure a smooth and painless development process—and thus, safe and effective medical devices.

Handbook of Human Factors in Medical Device Design

Author: Matthew Bret Weinger,Michael E. Wiklund,Daryle Jean Gardner-Bonneau

Publisher: CRC Press

ISBN: 9781420063516

Category: Technology & Engineering

Page: 844

View: 4097

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Developed to promote the design of safe, effective, and usable medical devices, Handbook of Human Factors in Medical Device Design provides a single convenient source of authoritative information to support evidence-based design and evaluation of medical device user interfaces using rigorous human factors engineering principles. It offers guidance on user-centric design supported by discussions of design issues, case studies, and examples. The book sets the foundation with coverage of fundamental topics such as aligning the interactive nature of medical devices to the expected use environments ranging from hospitals and ambulances to patients’ homes, drawing on anthropometric and biomechanical data to ensure that designs match the intended users’ bodies and physical abilities, and conducting usability tests and other evaluations to ensure that devices perform as intended. It then focuses on applied design issues, offering guidance on the design of specific types of devices and designing devices for particular use environments. Adapted in part from established design standards and conventions, the design guidance presented in this work distills professional judgment extracted from the contributing authors’ years of experience in applied analysis and design. Written in true handbook style, each chapter stands alone and includes tables, illustrations, and cross references, allowing you to quickly find the exact information you need. Most chapters begin with a general introduction to the selected topic, followed by the presentation of general and special design considerations and then specific, numbered design guidelines. The book also presents a listing of resources, literature, and website references. It not only focuses on the human factors issues that arise when developing medical devices, it supplies the necessary guidance to resolve them.

Usability Testing of Medical Devices, Second Edition

Author: Michael E. Wiklund, P.E.,Jonathan Kendler,Allison Y. Strochlic

Publisher: CRC Press

ISBN: 1466595892

Category: Medical

Page: 455

View: 3682

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Usability Testing of Medical Devices covers the nitty-gritty of usability test planning, conducting, and results reporting. The book also discusses the government regulations and industry standards that motivate many medical device manufacturers to conduct usability tests. Since publication of the first edition, the FDA and other regulatory groups have modified their regulations and expectations regarding how medical device manufacturers should approach usability testing. Reflecting these changes, this Second Edition provides updated guidance to readers with an interest or direct role in conducting a usability test of a medical device or system. Key updates involve the 2011 FDA guidance on human factors engineering, requirements set forth by the third edition of IEC 60601 and closely related IEC 62366-1:2015, linking usability test tasks to risk analysis results, and analyzing root causes of use errors that occur during usability tests. Written by seasoned human factors specialists, Usability Testing of Medical Devices, Second Edition is an informative, practical, and up-to-date handbook for conducting usability tests of medical devices. The book helps ensure a smooth and painless development process—and thus, safe and effective medical devices.

Handbook of Investigation and Effective CAPA Systems, Second Edition

Author: José Rodríguez-Pérez

Publisher: ASQ Quality Press

ISBN: 0873899261

Category: Business & Economics

Page: 234

View: 8931

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Understanding and improving the CAPA system as a whole is the focal point of this book, the only of its kind dealing exclusively with this critical system within highly regulated industries. Features include: Information about the importance of the CAPA system within the quality system for the medical products regulated industry. Fully updated with current versions of regulations (U.S. FDA, EU, ISO 13485, and so on), and a new section covers the regulatory expectation of customer complaint investigations. Investigation and CAPA elements of the 2015 revision of the ISO 9001 standard. New coverage on the investigation plan and the new U.S. FDA quality metric guidance, as well as a section discussing the tight relationship between CAPAs and FMEA. A new chapter fully devoted to human errors and human factors, and their impact in the investigation and CAPA system. Discussion of a dozen of the most common pitfalls commonly encountered in the investigation and CAPA world of regulated companies. An example of an investigation and CAPA expert certification program being used for many companies. Forms and examples of the different elements (investigation report, root causes checklist, human error investigation, CAPA plan, and so on) covered in the book. Fully usable forms are also included in the companion CD in Microsoft Word format. While the first edition of this book was aimed solely at the FDA-regulated industry, the title of this second edition reflects the importance of the investigation/root cause analysis stage as the necessary preceding step of any effective corrective and preventive action system. Investigation and CAPA are concepts used in many sectors besides the FDA-regulated industry, such as: automotive, electronics, aerospace, telecommunications, process industry, and many more. This book will become an essential reference for those in these other industries.

Patient Safety

The PROACT Root Cause Analysis Approach

Author: Robert J. Latino

Publisher: CRC Press

ISBN: 9781420087284

Category: Technology & Engineering

Page: 192

View: 5536

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Are you ready and willing to get to the root causes of problems? As Medicare, Medicaid, and major insurance companies increasingly deny payment for never events, it has become imperative that hospitals and doctors develop new ways to prevent these avoidable catastrophes from recurring. Proactive tools such as root cause analysis (RCA), basic failure mode and effects analysis (FMEA), and opportunity analysis (OA) are useful in preventing error, but in healthcare, such tools are often constrained by reticence to share information about mistakes and other problems inherent to the industry. ...well written and extremely applicable to health care. Every healthcare professional should have a copy. - Matthew C. Mireles, President / CEO, Community Medical Foundation for Patient Safety, Bellaire, Texas Patient Safety: The PROACT® Root Cause Analysis Approach addresses the proactive methodologies and organizational paradigms that must change in order to support and sustain such activities in the interest of patient safety. Written by reliability expert Robert J. Latino, this book provides a perspective on patient care from outside the health industry and culture. It teaches a proven approach that measures its effectiveness based on patient safety results, rather than compliance, and demonstrates the Return-On-Investment for using RCA to reduce and/or eliminate undesirable outcomes. Addressing the contribution of human error to physical consequences, Latino explores ways to identify conditions that are more prone to result in human error. It also uses FMEA to proactively identify unacceptable risks, and then uses the concepts of RCA to prevent risks from materializing. Are you ready to be tenacious in your approach and completely honest in your assessment? Root Cause Analysis requires courage and honesty. When properly applied RCA will point out the problems and lead you to solutions. Visit the author's website; find out if RCA is right for your organization Robert J. Latino has spent the past 10 years researching the differences in industrial culture versus the healthcare culture. In this book, he expertly makes the appropriate modifications to proven methodologies to successfully bridge the proactive technologies from industry to healthcare. Additional information, including an audio-visual presentation by the author, is available on the PROACT website at http://www.proactforhealthcare.com

To Err Is Human:

Building a Safer Health System

Author: Committee on Quality of Health Care in America,Institute of Medicine

Publisher: National Academies Press

ISBN: 0309068371

Category: Medical

Page: 312

View: 6661

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Experts estimate that as many as 98,000 people die in any given year from medical errors that occur in hospitals. That's more than die from motor vehicle accidents, breast cancer, or AIDS--three causes that receive far more public attention. Indeed, more people die annually from medication errors than from workplace injuries. Add the financial cost to the human tragedy, and medical error easily rises to the top ranks of urgent, widespread public problems. To Err Is Human breaks the silence that has surrounded medical errors and their consequence--but not by pointing fingers at caring health care professionals who make honest mistakes. After all, to err is human. Instead, this book sets forth a national agenda--with state and local implications--for reducing medical errors and improving patient safety through the design of a safer health system. This volume reveals the often startling statistics of medical error and the disparity between the incidence of error and public perception of it, given many patients' expectations that the medical profession always performs perfectly. A careful examination is made of how the surrounding forces of legislation, regulation, and market activity influence the quality of care provided by health care organizations and then looks at their handling of medical mistakes. Using a detailed case study, the book reviews the current understanding of why these mistakes happen. A key theme is that legitimate liability concerns discourage reporting of errors--which begs the question, "How can we learn from our mistakes?" Balancing regulatory versus market-based initiatives and public versus private efforts, the Institute of Medicine presents wide-ranging recommendations for improving patient safety, in the areas of leadership, improved data collection and analysis, and development of effective systems at the level of direct patient care. To Err Is Human asserts that the problem is not bad people in health care--it is that good people are working in bad systems that need to be made safer. Comprehensive and straightforward, this book offers a clear prescription for raising the level of patient safety in American health care. It also explains how patients themselves can influence the quality of care that they receive once they check into the hospital. This book will be vitally important to federal, state, and local health policy makers and regulators, health professional licensing officials, hospital administrators, medical educators and students, health caregivers, health journalists, patient advocates--as well as patients themselves. First in a series of publications from the Quality of Health Care in America, a project initiated by the Institute of Medicine

Patient Safety Workshop

Learning from Error

Author: World Health Organization

Publisher: N.A

ISBN: 9789241599023

Category: Medical

Page: 28

View: 7736

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This booklet which includes a CD-ROM should enable any health-care worker to facilitate a workshop on patient safety. This workshop explores how multiple weaknesses present within the hospital system can lead to error. It aims to provide all health-care workers and managers with an insight into the underlying cause of such events. Although the workshop materials revolve around an error involving the inappropriate administration of vincristine, the underlying principles of why an error occurs are universal and the learning objectives can be applied in any error-related situation.

Medication Errors

Author: Michael Richard Cohen

Publisher: American Pharmacist Associa

ISBN: 1582120927

Category: Medical

Page: 680

View: 2616

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In the second, expanded edition of the acclaimedMedication Errors(1999), Michael R. Cohen brings together some 30 experts from pharmacy, medicine, nursing, and risk management to provide the best, most current thinking about medication errors. Their contributions make this the most comprehensive, authoritative examination in print of the causes of medication errors and strategies to prevent them.Medication Errorsprovides the health care communityacute care, long-term care, ambulatory care, the pharmaceutical industry, regulatory affairs, and academiawith practical guidance to make patients who take or receive medications safer.

Root Cause Analysis

Basic Tools and Techniques

Author: Denise Robitaille

Publisher: Paton Professional

ISBN: 1932828028

Category: Business & Economics

Page: 104

View: 4751

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Behind Human Error

Author: David D. Woods,Sidney Dekker,Richard Cook,Leila Johannesen,Nadine Sarter

Publisher: CRC Press

ISBN: 1317175530

Category: Technology & Engineering

Page: 292

View: 9936

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Human error is cited over and over as a cause of incidents and accidents. The result is a widespread perception of a 'human error problem', and solutions are thought to lie in changing the people or their role in the system. For example, we should reduce the human role with more automation, or regiment human behavior by stricter monitoring, rules or procedures. But in practice, things have proved not to be this simple. The label 'human error' is prejudicial and hides much more than it reveals about how a system functions or malfunctions. This book takes you behind the human error label. Divided into five parts, it begins by summarising the most significant research results. Part 2 explores how systems thinking has radically changed our understanding of how accidents occur. Part 3 explains the role of cognitive system factors - bringing knowledge to bear, changing mindset as situations and priorities change, and managing goal conflicts - in operating safely at the sharp end of systems. Part 4 studies how the clumsy use of computer technology can increase the potential for erroneous actions and assessments in many different fields of practice. And Part 5 tells how the hindsight bias always enters into attributions of error, so that what we label human error actually is the result of a social and psychological judgment process by stakeholders in the system in question to focus on only a facet of a set of interacting contributors. If you think you have a human error problem, recognize that the label itself is no explanation and no guide to countermeasures. The potential for constructive change, for progress on safety, lies behind the human error label.

Registries for Evaluating Patient Outcomes

A User’s Guide

Author: Agency for Healthcare Research and Quality/AHRQ

Publisher: Government Printing Office

ISBN: 1587634333

Category: Medical

Page: 356

View: 8350

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This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

CAPA in the Pharmaceutical and Biotech Industries

How to Implement an Effective Nine Step Program

Author: J Rodriguez

Publisher: Elsevier

ISBN: 1908818379

Category: Medical

Page: 248

View: 3808

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CAPA in the Pharmaceutical and Biotech Industries: How to Implement an Effective Nine Step Program contains the most current information on how to implement, develop, and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a nine step closed-loop process approach for medical devices and pharmaceutical and biologic manufacturers, as well as any anyone who has to maintain a quality system.This book addresses how companies often make the mistake of fixing problems in their processes by revising procedures or, more commonly, by retraining employees that may or may not have caused the problem. This event-focused fix leads to the false assumption that the errors have been eradicated and will be prevented in the future. The reality is that the causes of the failure were never actually determined, therefore the same problem will recur over and over. CAPA is a complete system that collects information regarding existing and potential quality problems. It analyzes and investigates the issues to identify the root cause of nonconformities. It is not just a quick-fix, simple approach, it is a process and has to be understood throughout organizations. Provides an understanding of the principles and techniques involved in the effective implementation of a CAPA program, from the identification of the problem, to the verification of preventive action Emphasis is placed on the practical aspects of how to perform failure investigations and root cause analysis through the use of several types of methodologies, all explained in detail Provides effective methods to use with a Corrective Action system to help quality professionals identify costly issues and resolve them quickly and appropriately

Root Cause Analysis Handbook

A Guide to Efficient and Effective Incident Investigation

Author: ABS Consulting,Lee N. Vanden Heuvel,Donald K. Lorenzo,Laura O. Jackson,Walter E. Hanson,James J. Rooney,David A. Walker

Publisher: Rothstein Publishing

ISBN: 1931332827

Category: Business & Economics

Page: 296

View: 3096

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Are you trying to improve performance, but find that the same problems keep getting in the way? Safety, health, environmental quality, reliability, production, and security are at stake. You need the long-term planning that will keep the same issues from recurring. Root Cause Analysis Handbook: A Guide to Effective Incident Investigation is a powerful tool that gives you a detailed step-by-step process for learning from experience. Reach for this handbook any time you need field-tested advice for investigating, categorizing, reporting and trending, and ultimately eliminating the root causes of incidents. It includes step-by-step instructions, checklists, and forms for performing an analysis and enables users to effectively incorporate the methodology and apply it to a variety of situations. Using the structured techniques in the Root Cause Analysis Handbook, you will: Understand why root causes are important. Identify and define inherent problems. Collect data for problem-solving. Analyze data for root causes. Generate practical recommendations. The third edition of this global classic is the most comprehensive, all-in-one package of book, downloadable resources, color-coded RCA map, and licensed access to online resources currently available for Root Cause Analysis (RCA). Called by users "the best resource on the subject" and "in a league of its own." Based on globally successful, proprietary methodology developed by ABS Consulting, an international firm with 50 years' experience in 35 countries. Root Cause Analysis Handbook is widely used in corporate training programs and college courses all over the world. If you are responsible for quality, reliability, safety, and/or risk management, you'll want this comprehensive and practical resource at your fingertips. The book has also been selected by the American Society for Quality (ASQ) and the Risk and Insurance Society (RIMS) as a "must have" for their members.

The Root Cause Analysis Handbook

A Simplified Approach to Identifying, Correcting, and Reporting Workplace Errors

Author: Max Ammerman

Publisher: SteinerBooks

ISBN: 9780527763268

Category: Business & Economics

Page: 135

View: 4690

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The answer is root cause analysis, a process that allows you to find the cause of single events/problems in the workplace. The Root Cause Analysis Handbook presents a walkthrough example that illustrates the method and shows how to implement it. Because poor initial problem definition can (and often does) undermine the problem-solving process, Ammerman places special emphasis on this area to build a solid foundation for effective analysis. He also provides guidance on preparing the final report. The need for clear documentation on dealing with problems makes this book especially valuable for quality managers, engineers, safety managers, and teams implementing the ISO or QS standards. Written in a simple, user-friendly style, you will grasp the core concepts quickly and begin applying them to your work.

Patient Safety

Investigating and Reporting Serious Clinical Incidents

Author: Russell Kelsey

Publisher: CRC Press

ISBN: 1498781179

Category: Law

Page: 222

View: 4535

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At a time of increasing regulatory scrutiny and medico-legal risk, managing serious clinical incidents within primary care has never been more important. Failure to manage appropriately can have serious consequences both for service organisations and for individuals involved. This is the first book to provide detailed guidance on how to conduct incident investigations in primary care. The concise guide explains how to recognise a serious clinical incident, how to conduct a root cause analysis investigation, and how and when duty of candour applies covers the technical aspects of serious incident recognition and report writing includes a wealth of practical advice and 'top tips', including how to manage the common pitfalls in writing reports offers practical advice as well as some new and innovative tools to help make the RCA process easier to follow explores the all-important human factors in clinical incidents in detail, with multiple examples and worked-through cases studies as well as in-depth sample reports and analysis. This book offers a master class for anyone performing RCA and aiming to demonstrate learning and service improvement in response to serious clinical incidents. It is essential reading for any clinical or governance leads in primary care, including GP practices, 'out-of-hours', urgent care centres, prison health and NHS 111. It also offers valuable insights to any clinician who is in training or working at the coal face who wishes to understand how serious clinical are investigated and managed.

Root Cause Analysis

The Core of Problem Solving and Corrective Action

Author: Duke Okes

Publisher: ASQ Quality Press

ISBN: 0873897641

Category: Business & Economics

Page: 200

View: 4314

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This book provides detailed steps for how to solve problems, focusing heavily on the analytical process involved in finding the actual causes of problems. It does so using a large number of figures, diagrams, and tools useful for helping make our thinking visible. The primary focus is on solving repetitive problems, rather than performing investigations for major incidents/accidents. Most of the terminology used is everyday language and can be used for both workplace and personal applications. Many of the examples will involve situations with which the reader will likely be familiar. The focus of the book is not on statistics but instead on the logic of finding causes. It has sometimes been described in training workshops as “Six Sigma lite”…problem solving without the all the heavy statistics.

Root Cause Analysis

Improving Performance for Bottom-Line Results, Fourth Edition

Author: Robert J. Latino,Kenneth C. Latino,Mark A. Latino

Publisher: CRC Press

ISBN: 1439851271

Category: Technology & Engineering

Page: 279

View: 7954

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What is RCA? It seems like such an easy question to answer, yet from novices to veterans and practitioners to providers, no one seems to have come to agreement or consensus on an acceptable definition for the industry. Now in its fourth edition, Root Cause Analysis: Improving Performance for Bottom-Line Results discusses why it is so hard to get such consensus and why various providers are reluctant for that to happen. See what’s new in the Fourth Edition: Human Error Reduction Techniques (HERT) – new chapter Failure Scene Investigation (FSI) – Disciplined Evidence Gathering Categorical versus Cause-and-Effect RCA Tools Analysis Tools Review The Germination of a Failure Constructing a Logic Tree Introduction of PROACTOnDemandSM The Advantages of Software-as-a-Service (SaaS) The Pros and Cons of RCA Templates Three New Client Case Histories The authors discuss evidence collection and strategy, failure scene investigation techniques, the human element, and the contribution of human performance and human factors to poor decision making. They clarify definitions that can be considered ambiguous and underscore the distinctions between applying PROACT manually using a paper-based system versus using an automated software tool. Written by practitioners for practitioners, the book outlines an entire RCA system which involves a cultural paradigm change about how failure is perceived and acted upon in an organization. The authors’ trademark, down-to-earth style provides a step-by-step action plan for how to construct and implement a root cause analysis system that can be applied to any industry. Read MRI Safety 10 Years Later, co-authored by Robert Latino.

The Art of Application Performance Testing

Help for Programmers and Quality Assurance

Author: Ian Molyneaux

Publisher: "O'Reilly Media, Inc."

ISBN: 0596551053

Category: COMPUTERS

Page: 158

View: 3456

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This practical book provides a step-by-step approach to testing mission-critical applications for scalability and performance before they're deployed -- a vital topic to which other books devote one chapter, if that. Businesses today live and die by network applications and web services. Because of the increasing complexity of these programs, and the pressure to deploy them quickly, many professionals don't take the time to ensure that they'll perform well and scale effectively. The Art of Application Performance Testing explains the complete life cycle of the testing process, and demonstrates best practices to help you plan, gain approval for, coordinate, and conduct performance tests on your applications. With this book, you'll learn to: Set realistic performance testing goals Implement an effective application performance testing strategy Interpret performance test results Cope with different application technologies and architectures Use automated performance testing tools Test traditional local applications, web-based applications, and web services (SOAs) Recognize and resolves issues that are often overlooked in performance tests Written by a consultant with 30 years of experience in the IT industry and over 12 years experience with performance testing, this easy-to-read book is illustrated with real-world examples and packed with practical advice. The Art of Application Performance Testing thoroughly explains the pitfalls of an inadequate testing strategy and offers you a robust, structured approach for ensuring that your applications perform well and scale effectively when the need arises. "Ian has maintained a vendor-agnostic methodology beautifully in this material. The metrics and graphs, along with background information provided in his case studies, eloquently convey to the reader, 'Methodology above all, tools at your discretion...' Ian's expertise shines through throughout the entire reading experience."-- Matt St. Onge, Enterprise Solution Architect, HCL Technologies America / Teradyne