Statistical Process Control For The Fda Regulated Industry
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| Author | : Manuel E. Pena-Rodriguez |
| Publisher | : Quality Press |
| Total Pages | : 205 |
| Release | : 2013-04-11 |
| Genre | : Business & Economics |
| ISBN | : 0873898524 |
The focus of this book is to understand and apply the different SPC tools in a company regulated by the Food and Drug Administration (FDA): those that manufacture pharmaceutical products, biologics, medical devices, food, cosmetics, and so on. The book is not intended to provide an intensive course in statistics; instead, it is intended to provide a how-to guide about the application of the diverse array of statistical tools available to analyze and improve the processes in an organization regulated by FDA. This book is aimed at engineers, scientists, analysts, technicians, managers, supervisors, and all other professionals responsible to measure and improve the quality of their processes. Although the examples and case studies presented throughout the book are based on situations found in an organization regulated by FDA, the book can also be used to understand the application of those tools in any type of industry. Readers will obtain a better understanding of some of the statistical tools available to control their processes and be encouraged to study, with a greater level of detail, each of the statistical tools presented throughout the book. The content of this book is the result of the authors almost 20 years of experience in the application of statistics in various industries, and his combined educational background of engineering and law that he has used to provide consulting services to dozens of FDA-regulated organizations.
| Author | : José Rodríguez-Pérez |
| Publisher | : Quality Press |
| Total Pages | : 252 |
| Release | : 2017-02-21 |
| Genre | : Business & Economics |
| ISBN | : 1953079326 |
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.
| Author | : Jose (Pepe) Rodriguez-Perez |
| Publisher | : Quality Press |
| Total Pages | : 293 |
| Release | : 2024-04-18 |
| Genre | : Business & Economics |
| ISBN | : 1636941575 |
For quality professionals and manufacturers in the food safety and medical device industries, risk management is essential to ensuring organizations meet FDA regulations and requirements. Without these recognized standards, the lives of patients and consumers are placed in jeopardy. In this third edition of Quality Risk Management in the FDA-Regulated Industry, Jose Rodriguez-Perez provides an updated view of the risk management field as it applies to FDA-regulated products using risk-based thinking.
| Author | : José Rodríguez Pérez |
| Publisher | : Quality Press |
| Total Pages | : 289 |
| Release | : 2012-06-12 |
| Genre | : Business & Economics |
| ISBN | : 0873898346 |
Risk management principles are effectively utilized in many areas of business and government, including finance, insurance, occupational safety, and public health, and by agencies regulating these industries. The U.S. Food and Drug Administration (FDA) and its worldwide counterparts are responsible for protecting public health by ensuring the safety and effectiveness of the drugs and medical devices. Regulators must decide whether the benefits of a specific product for patients and users outweigh its risk, while recognizing that absolute safety (or zero risk) is not achievable. Every product and every process has an associated risk. Although there are some examples of the use of quality risk management in the FDA-regulated industry today, they are limited and do not represent the full contribution that risk management has to offer. The present FDA focus on risk-based determination is requiring that the regulated industries improve dramatically their understanding and capability of hazard control concepts. In addition, the importance of quality systems has been recognized in the life sciences industry, and it is becoming evident that quality risk management is a valuable component of an effective quality system. The purpose of this book is to offer a systematic and very 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 practices or good laboratory practices. The content of this book will provide FDA-regulated manufacturers with a framework within which experience, insight, and judgment are applied systematically to manage the risks associated with their products. Manufacturers in other industries may use it as an informative guidance in developing and maintaining a risk management system and process. The two appendices add even more insight: Appendix A contains general examples of risk management, while Appendix B includes 10 case studies illustrating real examples of the quality risk management process across the medical product arena.
| Author | : Robert James Oakland |
| Publisher | : Routledge |
| Total Pages | : 430 |
| Release | : 2018-10-08 |
| Genre | : Business & Economics |
| ISBN | : 1351662686 |
The business, commercial and public-sector world has changed dramatically since John Oakland wrote the first edition of Statistical Process Control – a practical guide in the mid-eighties. Then people were rediscovering statistical methods of ‘quality control’ and the book responded to an often desperate need to find out about the techniques and use them on data. Pressure over time from organizations supplying directly to the consumer, typically in the automotive and high technology sectors, forced those in charge of the supplying production and service operations to think more about preventing problems than how to find and fix them. Subsequent editions retained the ‘took kit’ approach of the first but included some of the ‘philosophy’ behind the techniques and their use. The theme which runs throughout the 7th edition is still processes - that require understanding, have variation, must be properly controlled, have a capability, and need improvement - the five sections of this new edition. SPC never has been and never will be simply a ‘took kit’ and in this book the authors provide, not only the instructional guide for the tools, but communicate the management practices which have become so vital to success in organizations throughout the world. The book is supported by the authors' extensive and latest consulting work within thousands of organisations worldwide. Fully updated to include real-life case studies, new research based on client work from an array of industries, and integration with the latest computer methods and Minitab software, the book also retains its valued textbook quality through clear learning objectives and end of chapter discussion questions. It can still serve as a textbook for both student and practicing engineers, scientists, technologists, managers and for anyone wishing to understand or implement modern statistical process control techniques.
| Author | : Leonard A. Doty |
| Publisher | : Industrial Press Inc. |
| Total Pages | : 396 |
| Release | : 1996 |
| Genre | : Business & Economics |
| ISBN | : 9780831130695 |
This in-depth introduction to SPC examines the technical aspects of the practices and procedures that are used to apply the quality management system in manufacturing. As in the successful first edition, the author provides a description and history of SPC along with an analysis of how it is applied to control quality costs, productivity, product improvement, and work efficiency. New to this edition are an explanation of seven basic tools, new charts, and an exploration of current trends.
| Author | : Merton R. Hubbard |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 347 |
| Release | : 2012-12-06 |
| Genre | : Technology & Engineering |
| ISBN | : 1461501490 |
Specifically targeted at the food industry, this state-of-the-art text/reference combines all the principal methods of statistical quality and process control into a single, up-to-date volume. In an easily understood and highly readable style, the author clearly explains underlying concepts and uses real world examples to illustrate statistical techniques. This Third Edition maintains the strengths of the first and second editions while adding new information on Total Quality Management, Computer Integrated Management, ISO 9001-2002, and The Malcolm Baldrige Quality Award. There are updates on FDA Regulations and Net Weight control limits, as well as additional HACCP applications. A new chapter has been added to explain concepts and implementation of the six-sigma quality control system.
| Author | : G. Barrie Wetherill |
| Publisher | : Springer |
| Total Pages | : 400 |
| Release | : 2013-08-02 |
| Genre | : Technology & Engineering |
| ISBN | : 9781489929501 |
Statistical process control (SPC) is now recognized as having a very important role to play in modern industry. Our aim in this book has been to present SPC techniques in a simple and clear way, and also to present some of the underlying theory and properties of the techniques. This volume arises partly out of a revision of Wetherill (1977), and partly out of experience in teaching and implementing SPC at industrial sites, especially with ICI. It would have been impossible to come to our present understanding of this field without the joint efforts of industry and university. A number of features of this book are new: (1) The special emphasis on process industry problems, including one at-a-time data. (2) The discussion of between and within-group variation, and the effects of this on charting and on process capability analysis. (3) The derivation of the properties of the techniques has not been gathered together before. (4) The presentation of sampling by variables contains many new features. The techniques themselves are presented in a very simple way by using 'method summaries', and these could be a basis for training when SPC is implemented.
| Author | : Sarina A. Lim |
| Publisher | : John Wiley & Sons |
| Total Pages | : 194 |
| Release | : 2019-02-25 |
| Genre | : Business & Economics |
| ISBN | : 1119152003 |
A comprehensive treatment for implementing Statistical Process Control (SPC) in the food industry This book provides managers, engineers, and practitioners with an overview of necessary and relevant tools of Statistical Process Control, a roadmap for their implementation, the importance of engagement and teamwork, SPC leadership, success factors of the readiness and implementation, and some of the key lessons learned from a number of food companies. Illustrated with numerous examples from global real-world case studies, this book demonstrates the power of various SPC tools in a comprehensive manner. The final part of the book highlights the critical challenges encountered while implementing SPC in the food industry globally. Statistical Process Control for the Food Industry: A Guide for Practitioners and Managers explores the opportunities to deliver customized SPC training programs for local food companies. It offers insightful chapter covering everything from the philosophy and fundamentals of quality control in the food industry all the way up to case studies of SPC application in the food industry on both the quality and safety aspect, making it an excellent "cookbook" for the managers in the food industry to assess and initiating the SPC application in their respective companies. Covers concise and clear guidelines for the application of SPC tools in any food companies' environment Provides appropriate guidelines showing the organizational readiness level before the food companies adopt SPC Explicitly comments on success factors, motivations, and challenges in the food industry Addresses quality and safety issues in the food industry Presents numerous, global, real-world case studies of SPC in the food industry Statistical Process Control for the Food Industry: A Guide for Practitioners and Managers can be used to train upper middle and senior managers in improving food quality and reducing food waste using SPC as one of the core techniques. It's also an excellent book for graduate students of food engineering, food quality management and/or food technology, and process management.
| Author | : Gordon Harnack |
| Publisher | : Quality Press |
| Total Pages | : 501 |
| Release | : 2014-07-18 |
| Genre | : Business & Economics |
| ISBN | : 1636940463 |
The number of FDA regulations and the agency’s increased expectations is staggering and their content tedious, creating a regulated industry need for compliance insight and appropriate detail. This book is the reference needed to successfully navigate through the FDA maze! The target audiences for this desk reference include: Regulatory professionals, who know their responsibility to keep their firm’s employees trained and competent on FDA device regulations and who need a preliminary desk reference that can be used throughout their enterprise to help train and ensure compliance Neophytes, who know nothing about FDA but need a resource that provides both broad and specific information in sufficient detail to be useful Beginners, who know a little about FDA, need to know more, and need a reference tool to help them be more effective and productive on the job Intermediates, who knows enough about FDA to know they need to know more and who need a reference tool that provides them with both more basics and executable detail Busy managers, who need to know regulatory requirements and FDA expectations in order to manage compliance in their specific activity Busy executives (CEOs, COOs, and operations managers, whom FDA holds responsible for all regulatory compliance), who also need a desk reference with specific information to quickly assess regulatory compliance, identify potential noncompliance, and review corrective, preventive, and compliance actions
