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: 0
• EAN13: 9781953079329
• Langue: English

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
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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
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Development of FDA-Regulated Medical Products , Second Edition
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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
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.
Attention Bookstores, Wholesalers, Schools, and Corporations: ASQ Quality Press books, video, audio, and software are available at quantity discounts with bulk purchases for business, educational, or instructional use. For information, please contact ASQ Quality Press at 800-248-1946, or write to ASQ Quality Press, P.O. Box 3005, Milwaukee, WI 53201-3005.
To place orders or to request ASQ membership information, call 800-248-1946. Visit our website at http://www.asq.org/quality-press .



List of Figures and Tables
Figure 2.1 ISO 14971 risk management process.
Table 2.1 Relationship of ISO 14971:2007 with EU directives.
Table 2.2 Differences between ISO 14971:2007 and EU directives.
Table 2.3 FDA medical device classification.
Table 2.4 Canadian medical device inspection classification.
Table 2.5 Canadian medical device risk classification.
Table 2.6 Comparison of Canadian and European medical device classification.
Figure 2.2 ISO 22000 family of standards.
Table 2.7 Supply chain disasters.
Figure 4.1 Relationships between the components of the model for managing risk.
Table 4.1 Elements of the risk management framework.
Figure 4.2 Quality risk management model.
Table 4.2 Basic qualitative severity level.
Table 4.3 Severity categorization.
Table 4.4 Simplified example of quality probability level.
Table 4.5 Quantitative probability levels.
Figure 4.3 Risk estimation.
Table 4.6 Examples of risk control activities.
Table 4.7 Examples of hazards when using medical devices and risk reduction/mitigation measures.
Table 5.1 CAPA risk assessment criteria.
Table 5.2 Risk assessment score matrix.
Table 5.3 Example of risk assessment.
Figure 5.1 Risk prioritization of investigations.
Figure 5.2 Types of nonconformance investigations.
Table 5.4 Top-level components for the site selection matrix.
Figure 5.3 Site risk—potential elements.
Table 5.5 Product component factors.
Figure 6.1 FMEA process.
Figure 6.2 Example of FMEA for tablet packaging.
Figure 6.3 Fault tree analysis example.
Figure 6.4 HACCP principles.
Figure 6.5 HAZOP guide words.
Figure 6.6 Cause-and-effect (fishbone) diagram example.
Figure 6.7 Example of the use of the 5 whys.
Figure 6.8 Risk ranking.
Figure 6.9 Risk filtering.
Table 7.1 FDA recall classification.
Figure 7.1 FDA’s structured benefit–risk framework.
Table 7.2 Utilization of risk management in facilities and equipment.
Figure A.1 Elements of risk determination.
Table A.1 Examples of hazards.
Table A.2 Examples of initiating events.
Table A.3 Relationships between hazards, sequence of events, hazardous situation, and the harm that can be produced.
Table A.4 Risk management tools.
Table A.5 Example of qualitative risk component ranking.
Table A.6 Example of determination of risk priority ranking.
Figure B.1 Project charter.
Figure B.2 Process map.
Figure B.3 Cause-and-effect matrix.
Figure B.4 Sorted cause-and-effect matrix.
Figure B.5 FMEA table (partial).
Figure B.6 Final FMEA table.
Figure C.1 Partial process map for tablet packaging.
Figure C.2 Cause-and-effect matrix.
Figure C.3 Example of FMEA for tablet packaging.


Acronyms
API —active pharmaceutical ingredient
ART —assisted reproductive technology
BLA —Biologics License Application
CAPA —corrective and preventive action
CCP —critical control point
CDC —Centers for Disease Control and Prevention
CDER —Center for Drug Evaluation and Research
CDRH —Center for Devices and Radiological Health
CFR —Code of Federal Regulations
cGMP —current good manufacturing practice
CQA —critical quality attributes
EMA —European Medicines Agency
FDA —Food and Drug Administration
FDAAA —Food and Drug Administration Amendments Act
FD&CA —Food, Drug, and Cosmetic Act
FMEA —failure mode and effects analysis
FSMA —Food Safety Modernization Act
FTA —fault tree analysis
GHTF —Global Harmonization Task Force
HACCP —hazard analysis and critical control points
HAZOP —hazard and operability analysis
ICH —International Conference on Harmonization
IEC —International Electrotechnical Commission
IMDRF —International Medical Device Regulators Forum
ISO —International Organization for Standardization
NDA —New Drug Application
OOC —out of control
OOS —out of specification
OOT —out of trend
ORA —FDA’s Office of Regulatory Affairs
OTC —over the counter
PAT —process analytical technology
PDA —Parenteral Drug Association
PHA —preliminary hazard analysis
PPC —production and process control
QbD —quality by design
QMS —quality management system
QSIT —quality systems inspection technique
QSR —Quality System Regulation
QTPP —quality target product profile
RCA —root cause analysis
REMS —Risk Evaluation and Mitigation Strategy
RMP —risk management plan
SRP —site risk potential
USC —United States Code


Preface to the Second Edition
Since the publication of the first edition of this book (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, the fundamental international quality management system (QMS) standard, has been recently revised under the new version, ISO 9001:2015 (International Organization for Standardization 2015), and it now requires that top management promote the use of risk-based thinking.
Another example of the greater emphasis on risk management is the ISO standard 13485:2016, which specifies the requirements for a quality management system specific to the medical devices industry. It has recently been revised, with the new version published in March 2016 (International Organization for Standardization 2016) showing a greater emphasis on risk management and risk-based decision making.
A third example is the FDA Food Safety Modernization Act (FSMA), the most important reform of U.S. food safety laws in more than 70 years. It was signed into law by President Obama on January 4, 2011. It aims to ensure that the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. In other words, it is a risk-based food safety prevention system.
The purpose of this new edition is to offer an updated view of the risk ma