Root Cause Analysis, Second Edition

Root Cause Analysis, Second Edition

Author: Duke Okes

Publisher: Quality Press

Published: 2019-02-06

Total Pages: 250

ISBN-13: 0873899822

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This best-seller can help anyone whose role is to try to find specific causes for failures. It provides detailed steps for solving problems, focusing more heavily on the analytical process involved in finding the actual causes of problems. It does this using figures, diagrams, and tools useful for helping to make our thinking visible. This increases our ability to see what is truly significant and to better identify errors in our thinking. In the sections on finding root causes, this second edition now includes: more examples on the use of multi-vari charts; how thought experiments can help guide data interpretation; how to enhance the value of the data collection process; cautions for analyzing data; and what to do if one can’t find the causes. In its guidance on solution identification, biomimicry and TRIZ have been added as potential solution identification techniques. In addition, the appendices have been revised to include: an expanded breakdown of the 7 M’s, which includes more than 50 specific possible causes; forms for tracking causes and solutions, which can help maintain alignment of actions; techniques for how to enhance the interview process; and example responses to problem situations that the reader can analyze for appropriateness.


The Corrective Action Handbook, Second Edition

The Corrective Action Handbook, Second Edition

Author: Denise E. Robitaille

Publisher: Paton Professional

Published: 2001-12

Total Pages: 81

ISBN-13: 0965044572

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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


Corrective Action for the Software Industry

Corrective Action for the Software Industry

Author: Denise E. Robitaille

Publisher: Paton Professional

Published: 2004

Total Pages: 80

ISBN-13: 0971323194

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Many people are confused about corrective action. They know it’s a requirement for compliance to standards such as ISO 9001. In some cases, the mandate is imposed by customers or regulatory agencies. Compounding this misunderstanding is that much of what has been written about the corrective action process is targeted toward manufacturing organizations, with the predictable references to tooling, production equipment, inspection of materials, storage issues, component design and the like. For software organizations, the product is intangible, and the processes may be electronically defined, derived, and controlled. Corrective action and the manner in which it is implemented needs to be explained specifically for software, both in language and supporting documentation. This practical handbook discusses the hows and whys of corrective action, with a particular focus on its application in software environments. It also illustrates how the process is integrated into the various other functions of the organization. Plus, Corrective Action for the Software Industry includes a CD-ROM with PDF forms you can use in your corrective action process. The forms are: Corrective action request form Root cause analysis form Action plan form Follow-up form


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

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

Author: David N. Muchemu

Publisher:

Published: 2006-08-01

Total Pages: 104

ISBN-13: 9781425950538

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"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.


Correct!, Prevent!, Improve!

Correct!, Prevent!, Improve!

Author: Jeanne Ketola

Publisher: Asq Press

Published: 2003-01

Total Pages: 113

ISBN-13: 9780873895750

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Correct! Prevent! Improve! Driving Improvement through Problem Solving and Corrective and Preventive Action is a concise, step-by-step guide that takes the reader through a basic problem-solving process, describing how the concepts of corrective and preventive action are incorporated into this process. an excellent reference for developing, implementing, and maintaining a Corrective and Preventive Action System, this book is designed to help organizations understand the key components that will help them achieve results for their organization. The book covers the philosophy of continual improvement by describing how to use data found within the organization to drive improvement and also provides a useful orientation to corrective and preventive action requirements found within ISO 9001:2000. Practice problems and case studies help the reader apply their knowledge inside their own organization and can be applied to any industry. Useful forms and flowcharts provide a basic toolkit for improvement. This book will be a helpful to anyone who needs to lead or facilitate problem-solving teams or those who need to implement and maintain corrective and preventive action systems whether you are a quality manager, quality technician, or an ISO coordinator. Examples included in this book can be applied to various industry segments including service, health care and education.


Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy

Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy

Author: Mahmoud Aljurf

Publisher: Springer Nature

Published: 2021-02-19

Total Pages: 181

ISBN-13: 3030644928

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This open access book provides a concise yet comprehensive overview on how to build a quality management program for hematopoietic stem cell transplantation (HSCT) and cellular therapy. The text reviews all the essential steps and elements necessary for establishing a quality management program and achieving accreditation in HSCT and cellular therapy. Specific areas of focus include document development and implementation, audits and validation, performance measurement, writing a quality management plan, the accreditation process, data management, and maintaining a quality management program. Written by experts in the field, Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: A Practical Guide is a valuable resource for physicians, healthcare professionals, and laboratory staff involved in the creation and maintenance of a state-of-the-art HSCT and cellular therapy program.


Code of Federal Regulations

Code of Federal Regulations

Author:

Publisher:

Published: 1987

Total Pages: 812

ISBN-13:

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Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries.


The ASQ Certified Quality Auditor Handbook

The ASQ Certified Quality Auditor Handbook

Author: Lance B. Coleman

Publisher: Quality Press

Published: 2020-02-01

Total Pages: 324

ISBN-13: 1951058119

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The value of the ASQ Certified Quality Auditor Handbook, Fifth Edition, is clear. It is designed to help new auditors gain an understanding of the field and prepare for the ASQ CQA exam. In addition, experienced auditors can refer to it as a helpful reference; audit managers and quality managers can rely on it for guiding their auditing programs; and trainers and educators can use it for teaching fundamentals. This in-depth overview of quality auditing represents auditing practices for internal and external applications. It provides practical guidance for both system and process auditors as well. Many current topics have been expanded to reflect changes in auditing practices since 2012, with guidance from the recent 2017 update of ISO 19011. In addition, readers will find example audit situations, stories, and review comments to enhance their understanding of the field. Topics covered include the common elements of all types of system and process audits (quality, environmental, safety, and health): Auditing fundamentals, including types of quality audits, purpose and scope of auditing, terms and definitions, roles and responsibilities of participants, and professional conduct The audit process, from preparation and planning, to performance and reporting, to follow-up and closure Auditor competencies, including resource management, conflict resolution, communication, interviewing, and team dynamics Audit program management and business applications, including staffing, training and development, program evaluation, organizational risk management, and best practices Quality tools and techniques, including problem-solving tools, process improvement techniques, basic statistics, verification, and validation "This book is an encyclopedia of all major bodies of information a new or experienced quality auditor would need. It covers both the qualitative and the quantitative, which is a strength. I can't think of a quality auditor that would not find this work helpful." Kim H. Pries, CRE, CQE, CSQE, CSSBB, CMQ/OE, CQA "This handbook will be helpful to those who are new to auditing or require more in-depth knowledge of the implementation of an audit program. Boxed examples or scenarios provide some of the practical challenges encountered during auditing." Govind Ramu, ASQ Fellow, Co-Author ASQ SSGB Handbook, Author ASQ CSSYB Handbook Lance B. Coleman, Sr. has over 25 years of leadership experience in the areas of quality engineering, Lean implementation, quality, and risk management in the Medical Device, Aerospace, and other regulated industries. He has presented, trained, and consulted throughout the United States and abroad. Lance is currently a Director of Quality for IDEX Health and Science, LLC, in Oak Harbor, Washington.