Author: Denise Robitaille
Publisher: Paton Professional
ISBN: 0971323151
Category : Business & Economics
Languages : en
Pages : 104
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Book Description
How do we harness the elusive concept of preventive action? People often think of preventive action as the extra thing you do after you've finished corrective action--like an extra coat of sealant. Actually, preventive actions are the initiatives you establish to minimize the number of corrective actions you conduct. The Preventive Action Handbook is a great guide for defining the process, writing the procedure, establishing criteria, developing plans, and reporting back to management. It will help you benefit from a fundamental management tool that has a direct relationship to your organization's bottom line. The Preventive Action Handbook will help you make your preventive action process more organized, more efficient, and more productive. The book's basic precepts hold true for any size organization. It can be used by quality managers, ISO 9000 management representatives, production supervisors, production group leaders, customer service managers, quality technicians, or anyone else involved in corrective action. The book includes sample forms that guide you through the corrective action process in a logical and straightforward manner. The forms may be photocopied. They include: Preventive Action Organizer Worksheet Matrix of Preventive Actions Preventive Action Initiative Preventive Action Plan
Author: Paul B. Stares
Publisher: Columbia University Press
ISBN: 0231544189
Category : Political Science
Languages : en
Pages : 287
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Book Description
The United States faces an increasingly turbulent world. The risk of violent conflict and other threats to international order presents a vexing dilemma: should the United States remain the principal guarantor of global peace and security with all its considerable commitments and potential pitfalls––not least new and costly military entanglements––that over time diminish its capacity and commitment to play this vital role or, alternatively, should it pull back from the world in the interests of conserving U.S. power, but at the possible cost of even greater threats emerging in the future? Paul B. Stares proposes an innovative and timely strategy—“preventive engagement”—to resolve America’s predicament. This approach entails pursuing three complementary courses of action: promoting policies known to lessen the risk of violent conflict over the long term; anticipating and averting those crises likely to lead to costly military commitments in the medium term; and managing ongoing conflicts in the short term before they escalate further and exert pressure on the United States to intervene. In each of these efforts, forging “preventive partnerships” with a variety of international actors, including the United Nations, regional organizations, nongovernmental organizations, and the business community, is essential. The need to think and act ahead that lies at the heart of a preventive engagement strategy requires the United States to become less shortsighted and reactive. Drawing on successful strategies in other areas, Preventive Engagement provides a detailed and comprehensive blueprint for the United States to shape the future and reduce the potential dangers ahead.
Author: Jose (Pepe) Rodriguez-Perez
Publisher: Quality Press
ISBN: 1636940129
Category : Business & Economics
Languages : en
Pages : 152
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Book Description
Worldwide regulatory agencies perform many inspections annually, and all too often investigation and CAPA system violations are at the top of the list of infractions. Life-sciences regulated companies (not only FDA-regulated ones) must ensure their investigation and CAPA systems look beyond the ‘usual suspects' to identify other quality issues in order to minimize risks (including safe ones) and reduce costs. Enhancements to this third edition include: A new section linking the investigation and CAPA programs with the overall quality culture of the company Fully updated, current versions of regulations including U.S. FDA, EU, ISO 9001, and ISO 13485 Updated inspectional observations from the U.S. FDA and U.K. MHRA A revised investigation and CAPA processes chapter, which has an improved barrier analysis section, including detailed flowcharts describing the barrier analysis process New charts and information related to the investigation of human errors; the human factor section includes information about training and competence A new chapter devoted to analytical laboratory investigations, including a section covering the invalidation of testing results Updated forms and examples of the different elements of the investigation and CAPA plan, including new case studies; a revised diagnostic tool used for investigating human error Jose(Pepe) Rodrguez-Perez, PhD, is president of Business Excellence Consulting, Inc., (BEC), a Puerto Rico-based, consulting, training, and remediation firm that focuses on the areas of regulatory compliance, FDA-regulatory training, and risk management. He is a biologist with a doctoral degree in biology from the University of Granada (Spain). Over his career, he has served as an educator, a technical services manager, and as a science advisor to the FDA.
Author: Denise Robitaille
Publisher: Paton Professional
ISBN: 1932828435
Category : Business & Economics
Languages : en
Pages : 59
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Book Description
They’re supposed to be useful tools, but whether they’re printouts, computer files, flowcharts, or forms, documents can often give more headaches than help. And yet without them, most organizations couldn’t function. ISO 9001 and other quality management systems place great emphasis on documents, and for good reason. Documents aren’t individual, stand-alone elements of the management process. They’re interrelated, formatted in different media, and controlled by various and distinct functions. Keeping critical information current and in the right hands requires more than just signing off on procedures. Document control is essential, but where should you begin? Inside you’ll find clear explanations about the document control process as well as practical solutions for creating, organizing, and maintaining documents, including: A discussion of different kinds of documents, including electronic media and QMS requirements Identifying and defining responsibility Understanding the relationship between documents and records Tips for document writers Managing and maintaining documents Issues of accessibility Handling revisions and deviations Writing document control procedures
Author: Heather A. Wade
Publisher: Quality Press
ISBN: 1636940218
Category : Mathematics
Languages : en
Pages : 553
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Book Description
The ever-changing fields of science and technology have made huge leaps, thanks in part to improvements in measurements. Without metrology, these areas may not have experienced exponential growth. Developed by experts in the field as a comprehensive and practical reference, The ASQ Metrology Handbook, Third Edition provides a foundation for understanding metrology as well as calibration principles and practices. This handbook is ideal for not only metrology professionals, but also calibration professionals including calibration technicians and technologists, quality professionals, workers in testing laboratories, consultants, and instructors. Whether you are entering a new phase of your career field, investing in your own continuous improvement journey, training your fellow calibration practitioners, or preparing for ASQ’s Certified Calibration Technician (CCT) exam, this handbook provides the information, guidance, and knowledge to help you achieve your goals. New to this Third Edition: • A thorough explanation of ISO/IEC 17025:2017 • The 2019 Redefinition of the International System of Units • Updated and expanded chapters, including information about training and competency, software validation, statistics, decision rules and risk, uncertainty in measurement, mass and weighing, force, and chemical and biological measurements and uncertainties
Author:
Publisher: BSI British Standards Institution
ISBN: 0580369439
Category : Computer programs
Languages : en
Pages : 223
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Book Description
Author: Mark Allen Durivage
Publisher: Quality Press
ISBN: 1636941516
Category : Technology & Engineering
Languages : en
Pages : 421
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Book Description
The ASQ Certified Pharmaceutical GMP Professional Handbook assists candidates preparing for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and serves as a handy reference guide for practitioners in the field. This handbook covers compliance with good manufacturing practices (GMPs) as regulated and guided by national and international agencies for the pharmaceutical industry.
Author: Chad Kymal
Publisher: Paton Professional
ISBN: 9781932828139
Category : Business & Economics
Languages : en
Pages : 330
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Book Description
Author: Anthony Manos
Publisher: Quality Press
ISBN: 0873898230
Category : Business & Economics
Languages : en
Pages : 357
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Book Description
This handbook’s intention is to gather into a single reference the information related to the joint lean certification program of SME, AME, The Shingo Prize, and ASQ. This book will enhance your understanding of the certification’s Body of Knowledge (BOK) as a whole and give you a more holistic look at lean. This comprehensive handbook covers all the topics included in the BOK: cultural enablers, continuous process improvement, consistent lean enterprise culture, and business results. Written by a team of lean experts with years of experience in the field, it will be indispensible to anyone interested in implementing and sustaining a lean initiative. The book is written, by design, at the Bronze Level for certification knowledge. This means that the weightings used in the Lean BOK for the Bronze Certification were considered for the depth and breadth of material considered for each rubric. By addressing the Lean BOK at the Bronze Level, this book provides a basic understanding of the lean principles, systems, and tools at a tactical level to drive improvements with measureable results. Material from several lean practitioners with differing backgrounds and experience has been gathered to create this handbook, which serves as an ideal starting point for practitioners who want both a holistic view of lean in general and also specifically the BOK of this groundbreaking joint certification program.
Author: Jurgen Pionteck
Publisher: ChemTec Publishing
ISBN: 1895198348
Category : Science
Languages : en
Pages : 297
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Book Description
This is the first comprehensive handbook written on the subject of antistatic additives for polymers. These are additives capable of modifying properties of materials in such a way they become antistatic, conductive, and/or EMI shielding. The book contains 22 chapters, each addressing a specific aspect of properties and applications of antistatic agents. The comprehensive analysis of performance of these materials forms a critical source of information for industry, research, academia, and legislature.
