Quality Risk Management in the FDA-Regulated Industry

José Rodríguez-Pérez

Description

The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first edition (2012), the emphasis on risk-based processes has growth exponentially across all sectors, and risk management is now considered as significant as quality management. ISO 9001 was revised and now requires that top management promote the use of risk-based thinking. ISO 13485:2016, which specifies the requirements for a quality management system specific to the medical devices industry, also now shows a greater emphasis on risk management and risk-based decision making. In addition, the FDA Food Safety Modernization Act (FSMA) is the most important reform of U.S. food safety laws in more than 70 years.
This indispensable book presents a systematic and comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practice or good laboratory practice.
All chapters have been updated and revised, and a new chapter has been added to discuss some of the most common pitfalls and misunderstandings regarding risk management, specifically those related to the use of FMEA as the only element of risk management programs. One of the appendices includes 12 case studies, and the companion CD-ROM contains dozens of U.S. FDA and European guidance documents as well as international harmonization documents (ICH and GHTF-IMDRF) related to risk management activities, as well as a 30-question exam (with answers) on the material discussed in the book.

Sujets

• Business
• Qualité, hygiène, sécurité, environnement
• Techniques
• Automatisation et Contrôle
• Contrôle des processus
• Automatisation
• Automate
• Food and Drug Administration
• Engineering
• Technology
• FDA
• risk management
• Sciences et techniques
• Quality Control

Informations

• Publié par: ASQ Quality Press
• Date de parution: 21 février 2017
• Nombre de lectures: 2
• EAN13: 9781953079312
• Langue: English
• Poids de l'ouvrage: 3 Mo

Extrait

Quality Risk Management in the FDARegulated Industry

Also available from ASQ Quality Press:

Handbook of Investigation and Effective CAPA Systems, Second Edition José Rodríguez-Pérez The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals José Rodríguez-Pérez Statistical Process Control for the FDA-Regulated Industry Manuel E. Peña-Rodríguez Proactive Supplier Management in the Medical Device Industry James B. Shore and John A. Freije The ISO 9001:2015 Implementation Handbook: Using the Process Approach to Build a Quality Management System Milton P. Dentch The Certified Six Sigma Yellow Belt Handbook Govindarajan Ramu The Certified Pharmaceutical GMP Professional Handbook, Second Edition FDC Division and Mark Allen Durivage, editor Process Improvement Simplified: A How-To Book for Success in any Organization James B. King, Francis G. King, and Michael W. R. Davis Failure Mode and Effect Analysis: FMEA from Theory to Execution, Second Edition D. H. Stamatis The Art of Integrating Strategic Planning, Process Metrics, Risk Mitigation, and Auditing J. B. Smith Advanced Quality Auditing: An Auditor’s Review of Risk Management, Lean Improvement, and Data Analysis Lance B. Coleman Mastering and Managing the FDA Maze, Second Edition Gordon Harnack Development of FDA-Regulated Medical Products, Second Edition Elaine Whitmore

To request a complimentary catalog of ASQ Quality Press publications, call 800-248-1946, or visit our website at www.asq.org/quality-press.

Quality Risk Management in the FDARegulated Industry

Second Edition

José Rodríguez-Pérez

ASQ Quality Press Milwaukee, Wisconsin

American Society for Quality, Quality Press, Milwaukee 53203 © 2017 by ASQ All rights reserved. Published 2017 Printed in the United States of America 23 22 21 20 19 18 17 5 4 3 2 1

Library of Congress CataloginginPublication Data

Library of Congress Cataloging in Publication Control Number: 2016058370

Names: Rodríguez Pérez, José, 1961– author. Title: Quality risk management in the FDA-regulated industry / Jose  Rodriguez-Perez. Description: Second edition. | Milwaukee, Wisconsin : ASQ Quality Press,  [2017] | Includes bibliographical references and index. Identifiers: LCCN 2016058370 | ISBN 9780873899482 (hard cover : alk. paper) Subjects: LCSH: Pharmaceutical industry—Government policy—United States. |  Food industry and trade—Government policy—United States. | Risk  management—United States. | Total quality management—United States. Classification: LCC HD9666.6 .R637 2017 | DDC 615.1068/4—dc23 LC record available at https://lccn.loc.gov/2016058370

ISBN: 978-0-87389-948-2

No part of this book may be reproduced in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher.

Matthew T. Meinholz: Associate Publisher Paul Daniel O’Mara: Managing Editor Randall L. Benson: Sr. Creative Services Specialist

ASQ Mission: The American Society for Quality advances individual, organizational, and community excellence worldwide through learning, quality improvement, and knowledge exchange.

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To place orders or to request ASQ membership information, call 800-248-1946. Visit our website at http://www.asq.org/quality-press.

 Printed on acid-free paper

Table of Contents

List of Figures and Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acronyms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface to the Second Edition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface to the First Edition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 1 Introduction to Quality Risk Management . . . . . . . 1.1 What Is Quality Risk Management? . . . . . . . . . . . . . . . . . . . 1.2 Taste of Raspberries, Taste of Death: The 1937 Elixir Sulfanilamide Incident. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.3 Seventy Years Later . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.4 Risk Management and Risk Assessment . . . . . . . . . . . . . . . 1.5 Risk-Based Approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FDA’s Strategic Action Plan . . . . . . . . . . . . . . . . . . . . . . . . Risk-Based Model for Inspectional Oversight. . . . . . . . . . . Part 11 Guidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Aseptic Processing Guidance . . . . . . . . . . . . . . . . . . . . . . . 1.6 More Than Safety Risks: From Safety Risks to Quality by Design (QbD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Medication Guides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Quality by Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Design Controls for Medical Devices . . . . . . . . . . . . . . . . . 1.7 ISO 31000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.8 Historical Perspective and Current Situation . . . . . . . . . . . . 1.9 ISO 9001:2015 Risk Requirements. . . . . . . . . . . . . . . . . . . . Risk Management and Preventive Actions . . . . . . . . . . . . . Chapter 2 Current Initiatives . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1 FDA-Wide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

v

xi xiii xv xvii xxi 1 1

5 11 12 12 14 14 14 14

15 16 16 18 19 20 21 24 28 31 31

vi Table of Contents

2.2 Drugs and Biotechnology Products . . . . . . . . . . . . . . . . . . . 2.2.1 ICH Q9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2.2 QbD Guidances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2.3 REMS and Medication Guides. . . . . . . . . . . . . . . . . . 2.3 Medical Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3.1 ISO 13485:2016 Risk Requirements. . . . . . . . . . . . . . 2.3.2 ISO 14971:2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3.3 GHTF/IMDRF Guidelines . . . . . . . . . . . . . . . . . . . . . 2.3.4 Non–U.S. Regulations . . . . . . . . . . . . . . . . . . . . . . . . 2.4 Food Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.4.1 ISO 22000:2005 and Hazard Analysis and Critical Control Points (HACCP) . . . . . . . . . . . . . . . . . . 2.4.2 FDA Food Safety Modernization Act (FSMA): Risk-Based Food Safety Prevention . . . . . . . . . . . . . . . . 2.5 Supply Chain: Risk Consideration for Regulated Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 3 Principles of Quality Risk Management . . . . . . . . . 3.1 Basic Principles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Continual Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . Full Accountability for Risks . . . . . . . . . . . . . . . . . . . . . . . Application of Risk Management in All Decision Making . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Continual Communications. . . . . . . . . . . . . . . . . . . . . . . . . Full Integration into the Organization’s Governance Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2 Science and Risk-Based Approach to Product Quality . . . . 3.3 Quality Systems Approach . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 4 General Quality Risk Management Process . . . . . . 4.1 Introduction to the Quality Risk Management Process . . . . 4.2 Responsibilities and Initiation of the Risk Management Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.3 Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.3.1 Risk Identification. . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.3.2 Risk Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.3.3 Risk Evaluation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Risk Reduction “As Far as Possible” (AFAP) compared to “As Low as Reasonably Practicable” (ALARP). . . . . 4.4 Risk Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.4.1 Risk Reduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.4.2 Risk Acceptance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.5 Risk Documentation and Communication . . . . . . . . . . . . . .

33 33 34 39 41 42 44 51 54 58

58

61

64 69 69 72 72

72 73

73 73 76 79 79

81 83 83 85 91

93 93 94 95 95

Table of Contentsvii

4.6 Risk Monitoring and Effectiveness Review . . . . . . . . . . . . . 4.7 Application of Risk Assessment During Life Cycle Phases. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.8 Enhanced Risk Management . . . . . . . . . . . . . . . . . . . . . . . . Continual Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . Full Accountability for Risks . . . . . . . . . . . . . . . . . . . . . . . Application of Risk Management in All Decision Making . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Continual Communications. . . . . . . . . . . . . . . . . . . . . . . . . Full Integration into the Organization’s Governance Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 5 Integration of Risk Management with Quality Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.1 Risk Management Plans . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.1.1 Scope of the Plan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.1.2 Assignment of Responsibilities and Authorities . . . . . 5.1.3 Requirements for Review of Risk Management Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.1.4 Criteria for Risk Acceptability . . . . . . . . . . . . . . . . . . 5.1.5 Verification Activities . . . . . . . . . . . . . . . . . . . . . . . . . 5.1.6 Methods of Obtaining Relevant Post-Production Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.1.7 Example of Risk Management Plan Applied to Medication Guides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.2 Risk-Based CAPA System . . . . . . . . . . . . . . . . . . . . . . . . . . 5.3 Examples of Integration between Risk Management and other Quality Management Tools . . . . . . . . . . . . . . . . . . . . . 5.3.1 The Process Analytical Technology (PAT) Approach. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.3.2 Risk-Based Inspection Site Selection . . . . . . . . . . . . . 5.3.3 The Quality System Inspection Technique (QSIT). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.4 Pre- and Post-Market Risks . . . . . . . . . . . . . . . . . . . . . . . . . Drug and Biological Products . . . . . . . . . . . . . . . . . . . . . . . Medical Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 6 Methodologies and Tools . . . . . . . . . . . . . . . . . . . . . . 6.1 Selection and Types of Risk Assessment Techniques. . . . . . 6.1.1 Availability of Resources . . . . . . . . . . . . . . . . . . . . . . 6.1.2 The Nature and Degree of Uncertainty . . . . . . . . . . . 6.1.3 Complexity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

97

98 99 100 100

100 100

101

103 103 104 105

105 105 105

106

106 108

117

117 119

125 127 127 130

133 133 134 135 135

viiiof Contents Table

6.2 Application of Risk Assessment During Life Cycle Phases. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.3 Risk Assessment Techniques and Tools . . . . . . . . . . . . . . . . 6.3.1 Basic Risk Management Facilitation Methods . . . . . . 6.3.2 Failure Mode and Effects Analysis (FMEA) . . . . . . . 6.3.3 Fault Tree Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.3.4 Hazard Analysis and Critical Control Points (HACCP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.3.5 Hazard and Operability Analysis (HAZOP) . . . . . . . 6.3.6 Cause-and-Effect Analysis . . . . . . . . . . . . . . . . . . . . . 6.3.7 5 Whys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.3.8 Preliminary Hazard Analysis (PHA) . . . . . . . . . . . . . 6.3.9 Risk Ranking and Filtering . . . . . . . . . . . . . . . . . . . . 6.3.10 Supporting Statistical Tools . . . . . . . . . . . . . . . . . . . Chapter 7 Practical Applications of Quality Risk Management to the Life Science Manufacturing Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.1 Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.1.1 Internal Audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.1.2 Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.1.3 Error Risk Reduction . . . . . . . . . . . . . . . . . . . . . . . . . 7.1.4 Regulatory Actions: Recalls and Health Hazard Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.1.5 Benefit–Risk Determination . . . . . . . . . . . . . . . . . . . . 7.1.6 CAPA System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.1.7 Supplier Selection and Control . . . . . . . . . . . . . . . . . . 7.1.8 Outsourcing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.2 Documents and Records/Change Management . . . . . . . . . . 7.3 Data Integrity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.4 Facilities and Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.5 Design and Development . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.6 Production and Process Control . . . . . . . . . . . . . . . . . . . . . . 7.6.1 Trend Analysis and Statistical Process Control . . . . . 7.6.2 Aseptic Process in the Pharmaceutical Industry . . . . 7.6.3 Validations and Revalidations. . . . . . . . . . . . . . . . . . . 7.6.4 Laboratory Control . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.6.5 Packaging and Labeling . . . . . . . . . . . . . . . . . . . . . . . 7.6.6 Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.7 Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chapter 8 Risk Management Is More Than FMEA . . . . . . . . .

135 136 136 140 145

147 153 156 157 160 160 162

163 163 164 164 167

172 178 183 185 187 189 190 192 194 195 196 197 198 200 201 202 203 205

Table of Contentsix

Appendix A General Examples . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix B Case Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix C FailSafe FMEA. . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix D Quality Risk Management Certification. . . . . . . . Appendix E Useful Websites . . . . . . . . . . . . . . . . . . . . . . . . . . . . Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

209 219 299 311 319 321 325 331