Alka Jarvis, Luis Morales, Ulka Ranadive

Achieving Customer Experience Excellence through a Quality Management System (eBook, ePUB)

• Format: ePub

Produktbeschreibung

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

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Produktdetails

• Verlag: ASQ Quality Press
• Seitenzahl: 181
• Erscheinungstermin: 4. Juli 2016
• Englisch
• ISBN-13: 9781953079688
• Artikelnr.: 66984588

Autorenporträt

Alka Jarvis has 30 years of experience in software engineering, including 19 years spent in implementing quality management principles. Her background encompasses telemetry, cloud, IoT, customer experience, product and process quality, industry standards, corporate knowledge management, and training. Cisco's first and only Distinguished Quality Engineer and a Fellow of American Society for Quality (ASQ), Alka has worked in a variety of capacities for Fortune 500 companies such as Apple, Bank of America, and AT&T, and she is a 22-year veteran of Cisco. A frequently invited speaker on quality assurance topics at international as well as domestic events, she has been an adjunct lecturer at Santa Clara University in computer engineering for the past 23 years. Her subject matter expertise is reflected in the eight books she has authored on the topics of customer experience and expectations, software engineering, quality management standards, and telemetry. Alka is also an instructor for the software engineering courses at the University of California Santa Cruz and Berkeley extensions and won Silicon Valley's "Corporate Woman Advocate of the Year" award for her accomplishments in the software quality field. ASQ recognized Alka by publishing her achievements in their "Who Is Who in Quality" article. In her role as the chair for nine years, representing the United States to the Technical Committee 176 for the International Organization for Standardization(ISO), she has been instrumental in the development of the 2000, 2004, 2008 versions of ISO 9001 and 9004 quality management standards. Alka was a member of the drafting committee and contributed in the writing of the latest ISO 9001:2015 version and is an ISO lead auditor, certified by Exemplar Global of United States for the past 23 years. Named as an expert on Industry 4.0/Smart Manufacturing, she represented the American National Standards Institute (ANSI) and the United States in the strategic advisory group to the ISO's Technical Management Board at an international level. Alka serves as the chair for the U.S. Standards Group Council; was a member of ASQ's Learning Institute Advisory Board; served as president ofthe Bay Area Quality Assurance Association (BAQAA); has been an Applied Total Quality Advisory Board member for University of California Berkeley Extension; an advisory board member to the Certificate Program in Continuous Improvement & Quality Management at the University of California Santa Cruz Extension; board member of the Quality Assurance Institute; an advisory member for ASQ's 2015 and 2016 International Conference on Quality Standards; and Vice President of Indian Business and Professional Women. In her spare time, Alka enjoys mentoring and coaching students and young professionals to achieve their full potential in their aspirations. Having passion for food and fine wine, she spends endless hours on weekends discovering elegant restaurants in San Francisco and nearby Napa Valley with friends.