The Preventive Action Handbook


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




The Corrective Action Handbook, Second Edition


Book Description

If the term "mangement review" conjures up visions of a wasteful and burdensome ordeal, The Management Review Handbook is just what you need to add value to your review process. The Management Review Handbook provides managers with a simple explanation of how to effectively document, implement, and maintain a management review process.Denise Robitaille's book is an excellent guide to management review for anyone involved in the process. The book's precepts hold true for any size company across a wide spectrum of industries and organizations. The tools found in the handbook can be used by top management, ISO 9001 coordinators, production supervisors, customer service managers, quality technicians, or anyone else involved in the management review process.Plus, the book includes sample forms that aid in the management review process. The forms may be photocopied. They include:* Management review agenda* Data analysis planning worksheet* Action item checklist* Customer contact form




How to Design a World-Class Corrective Action Preventive Action System for Fda-Regulated Industries


Book Description

"Diverse", is the book A Gift of a Child. This anthology of poetry talks about everything from love, to fame, to everyday life struggles. Geovens' point of view goes from a black woman's perspective like in "Momma I'm in Love with a White Man" to a man that gave up his love like in "When a Man Cries". "The strength of a man isn't on how hard he hits, but how tender he touches." (1). Words like these that touch your heart and your soul are found in every poem, words that do not allow you to put this book down. This beautifully written collection of poem makes the reader see what the author sees, feel what he feels, and go through what he goes through.




Root Cause Analysis


Book Description

Do you have recurring problems that are costing you time and money? Unresolved problems do more than aggravate. They can increase costs, lower quality, and drive customers away. Plus, quality management processes, such as ISO 9001, require organizations to have a corrective and preventive action process in place. Root cause analysis is integral to the success of any corrective action or problem-solving process. Unfortunately, root cause analysis is an often maligned, misunderstood, and misapplied process. Instead of viewing root cause analysis as an opportunity for improvement, many see it only as an admission that things have gone wrong. Root cause analysis should be seen as an opportunity, not a chore. This practical guide offers proven techniques for using root cause analysis in your organization. Inside you’ll find: What root cause analysis is When (and when not) to use root cause analysis Who should participate in the root cause analysis process How to construct a root cause analysis checklist Examples of how a well-run root cause analysis process works And much more!




Preventive Measures


Book Description

State failure, ethnopolitical war, genocide, famine, and refugee flows are variants of a type of complex political and humanitarian crisis, exemplified during the 1990s in places like Somalia, Bosnia, Liberia, and Afghanistan. The international consequences of such crises are profound, often threatening regional security and requiring major inputs of humanitarian assistance. They also may pose long-term and costly challenges of rebuilding shattered governments and societies. A vital policy question is whether failures can be diagnosed far enough in advance to facilitate effective international efforts at prevention or peaceful transformation. This volume of original essays examines crisis early warning factors at different levels, in different settings, and judges their effectiveness according to various models. Top contributors offer answers along with analyses as they move from early warning to early response in their policy recommendations.




Preventive Engagement


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.







Handbook of Investigation and Effective CAPA Systems


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.




CRC Handbook of Management of Radiation Protection Programs, Second Edition


Book Description

CRC Handbook of Management of Radiation Protection Programs, 2nd Edition, is unique in that it offers practical guidance for managing various aspects of radiation protection programs ranging from the daily operation of a health physics office to the preparation of radiation experts for court appearances as professional witnesses. The book also covers such topics as organization and management of nonionizing radiation safety programs (with special emphasis on laser safety programs) and management of radioactive waste, personnel monitoring programs, radiation accident victims, internal exposure, relative radiotoxicity and radiation therapy patients. Other chapters discuss handling radiation accidents and education and training requirements for radiation protection. Legal aspects covered in the book include the history of radiation court cases, legal implications of record keeping, and preparation for court appearances. CRC Handbook of Management of Radiation Protection Programs, 2nd Edition will be a valuable reference resource for medical and health physicists, industrial hygienists, physicians, nuclear engineers, radiation protection regulators, radiation emergency management agents, radiation safety committees, and managers of facilities using ionizing and nonionizing radiation sources.




Handbook of Antistatics


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.