Transforming Quality Organizations

Ian Wells, Matthew P. Wictome

Description

Is your Quality organization holding your business back? Is regulatory compliance seen as more important than product or service quality? Do you feel the needs of your customers are lost in a sea of regulations?

Transforming Quality Organizations: A Practical Guide questions whether the current approach to managing quality is fit for purpose and, using the latest organizational thinking provides fresh, practical ways to balance a quality system to:

• Manage risk for better patient, customer, regulator, and stockholder outcomes.
• Achieve balance between ensuring compliance and supporting innovation.
• Transform your Quality organization through a roadmap of change.

Applicable to all businesses where quality is paramount, the content is based on practical experience of executing transformational change in the healthcare sector resulting in:

• Product recall rates cut by 50%.
• Product development cycle-times cut by 50%.
• Significant cost savings in quality system execution.

This book is invaluable for business leaders who want to transform their Quality organization and increase the value it delivers for their business.

Sujets

• Business
• Qualité, hygiène, sécurité, environnement
• Gestion et management
• Economics
• Management

Informations

• Publié par: Business Expert Press
• Date de parution: 26 avril 2023
• Nombre de lectures: 0
• EAN13: 9781637424414
• Langue: English

Extrait

Transforming Quality Organizations
Transforming Quality Organizations
A Practical Guide
Matthew P. Wictome and Ian Wells
Transforming Quality Organizations: A Practical Guide
Copyright © Business Expert Press, LLC, 2023.
Cover design by Shutterstock / Theromb
Interior design by Exeter Premedia Services Private Ltd., Chennai, India
All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means—electronic, mechanical, photocopy, recording, or any other except for brief quotations, not to exceed 400 words, without the prior permission of the publisher.
First published in 2023 by
Business Expert Press, LLC
222 East 46th Street, New York, NY 10017
www.businessexpertpress.com
ISBN-13: 978-1-63742-440-7 (paperback)
ISBN-13: 978-1-63742-441-4 (e-book)
Business Expert Press Supply and Operations Management Collection
First edition: 2023
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All the authors’ proceeds from this book will go to Patient Safety Movement, a charity that funds research into preventable harm and death in healthcare: www.psmf.org
Description
Is your Quality organization holding your business back? Is regulatory compliance seen as more important than product or service quality? Do you feel the needs of your customers are being lost in a sea of regulations?
Transforming Quality Organizations: A Practical Guide questions whether the current approach to managing quality is fit for purpose. It takes a fresh look at how quality can be more effectively managed and will show you practical ways to:

• Manage risk for better patient, customer, regulator, and stockholder outcomes.
• Achieve balance between ensuring compliance and supporting innovation.
• Transform your Quality organization through a roadmap of change.
Applicable to all businesses where quality is paramount, the content is based on practical experience of executing transformational change in a range of healthcare businesses resulting in the following:

• Product recalls rates cut by 50 percent.
• New product development cycle time cut by 50 percent.
• Significant cost savings in quality system execution.
This book is invaluable for business leaders who want to transform their quality organization and increase the value it delivers for your business.
Keywords
quality management; quality organizations; organizational transformation; business success; lean quality; organizational complexity; systems thinking; complexity science
Contents
Testimonials
Preface
Chapter 1 Quality
Chapter 2 Balancing the QMS
Chapter 3 Change
Chapter 4 Risk
Chapter 5 Worldviews and the QMS: Systems Thinking
Chapter 6 Worldviews and the QMS: Complexity
Chapter 7 Organization
Chapter 8 Implementing a Quality Organization Transformation
References
About the Authors
Index
Testimonials
“This book offers a unique perspective on managing your quality system, with both strategic and practical advice for leaders who are looking to maximize their business impact.” —Jennifer Paine, Senior VP, Global Regulatory Affairs, Medical Devices
“The first quality management systems book I have read that focuses more on solving problems and achieving opportunities and provides frameworks and methodologies to achieve these goals.” —Thomas Stevenson, Chief Operating Officer, Medical Devices
“The book describes the integration of quality theory to practical application in a refreshing way, that’s an excellent reference book for those driving operational transformation in their business.” —Ian Elliott, Retired Chief Operations Officer, Medical Devices
“Highlights the importance of balancing quality with healthcare compliance and shows how you can transform your quality organization and system to help your business be more effective and efficient.” —Àngels Roma VP QRA, In Vitro Diagnostics
Preface
Quality of product or service is the critical success factor in the healthcare industry. Driven by an increasing number of healthcare issues over recent years, governments worldwide have increased their focus on regulating businesses designing, manufacturing, and distributing medical products and services. Ever more demanding regulatory requirements and standards have been issued and the enforcement powers of agencies responsible for patient safety have increased. This response is understandable but has thrown up several unique and critical dilemmas for businesses in the healthcare sector.
Whether increased regulation translates into improved patient safety is yet to be seen. It can certainly be argued that the effort and resources required to comply with increased regulation competes with those needed to understand and meet customer expectations and comes at a significant financial cost to a business.
We will argue that regulatory compliance has now become potentially confused with the concept of quality. Quality resources are, at times, seen as primarily focused on ensuring the business meets its compliance responsibilities, as opposed to improving quality. There is now a danger of organizations creating goods and services that are compliant but fall short of meeting customer needs and are potentially financially nonviable options for a business.
Secondly, control and standardization are at odds with the agile, flexible, and innovative capabilities that organizations need to meet continuously increasing customer expectations. It can be argued that compliance is now out trumping quality and innovation.
In this book, we do not argue against increased regulatory compliance. What we argue for is a renewed focus on the purpose of Quality organizations and offer some practical approaches to meet the challenges of how to comply with the regulations while ensuring customer expectations are met and businesses are financially viable.
We have based the material in the book on the application of modern management theory to the quality system; looking at the way businesses really operate and questioning not only the role of Quality organizations but also how effectively they support businesses today and in the future. It is also based on experience of applying such approaches in businesses over the past 25 years, from small to large corporations.
So, who is this book for?

1. It is for Quality professionals who want to play an active part in creating effective Quality organizations that satisfy multiple competing needs.
2. It is aimed at C-suite executives, who want their Quality organizations to do more than just meet regulatory compliance needs.
3. It is also for those in other functions to help them understand the remit of the Quality organization and its untapped potential.
In this book, we will focus on the importance of thorough problem investigation and resolution, scalable management of change, and the importance of pragmatic flexible risk management. In the context of a heavily regulated industry, we will argue that pragmatic risk management is a vital requirement and, in our opinion, the foundation of effective management of quality within all organizations.
We will also cover some modern concepts of how organizations really behave; primarily, the need for Quality professionals to be aware that they are part of a complex, ever-changing system. Secondly, they have choices about how to respond to a variety of situations and challenges. This will require them to be more flexible and become more skilled in balancing control and innovation.
We will also cover how Quality organizations will need to evolve to meet changing customer demands, organizational change, and new technology. Finally, we will cover the practical aspects of executing a transformation of a Quality organization.
This book is principally focused on the healthcare industry. However, the concepts and approaches described are equally applicable to any business that needs to manage quality effectively and ensure that its Quality organization is in lockstep with its business partners.
Why did we write this book?
The motivation to write this book came from seeing the same issues in multiple organizations:

• A Quality team that is viewed as too conservative/risk averse.
• Compliant records being more important than customer satisfaction.
• Quality being seen as inhibiting innovation.
• Despite multiple corrective actions, product quality often remaining unchanged.
While we would not claim that this book offers a magical solution to any of the challenges listed above, we have seen that the application of the concepts described within this book have brought about significant changes in how quality is perceived and executed within a number of businesses.
This book seeks to move the Quality organization from the execution of a quality system to a place where they are fully integrated into the business process; innovatively managing process and product quality in a complex, ever-shifting regulatory landscape.
How is the book constructed? We set out our thinking as follows:

• Understanding the concept of quality and the challenges that are typically seen in the healthcare industry.
• Recognizing that the needs of customers, regulators, and business health need to be carefully balanced.
• Arguing change and pragmatic risk management are at the heart of successfully managing a business that puts patient safety first.
• Recognizing that you cannot succeed as a Quality professional unless you appreciate that you are working with immense complexity every day.
• Understanding that the situations you face cannot be addressed with “local” solutions; you need a systems-based approach to succeed.
• Recognizing you need a Quality organization that is embedded in, not apart from, your business, with the right people, processes, and technology to win.
• Arguing that to successfully move from current to future state will take time and you will need a transformation plan to get there.
How should you re