Every company considering or implementing the ISO or QS series of quality standards knows how important documentation and auditing are when it comes to certification. Documenting and Auditing for ISO 9000 and QS-9000 provides a comprehensive explanation of the documentation and audit process from both a practical and a theoretical point if view and leads readers through a detailed approach to preparing documentation and conducting an audit for a quality system in any organization. Each of the chapters and appendices are totally independent of each other and can be used as needed. Examples from a variety of industries illustrate the applicability of the standards and requirements. The need for sound documentation and auditing in the implementation process cannot be underestimated. Documenting and Auditing for ISO 9000 and QS-9000 will facilitate that process and help ensure a smooth registration or certification.

This book defines, develops, and examines the foundations of the APQP (Advanced Product Quality Planning) methodology. It explains in detail the five phases, and it relates its significance to national, international, and customer specific standards. It also includes additional information on the PPAP (Production Part Approval Process), Risk, Warranty, GD&T (Geometric Dimensioning and Tolerancing), and the role of leadership as they apply to the continual improvement process of any organization. Features Defines and explains the five stages of APQP in detail Identifies and zeroes in on the critical steps of the APQP methodology Covers the issue of risk as it is defined in the ISO 9001, IATF 16949, the pending VDA, and the OEM requirements Presents the role of leadership and management in the APQP methodology Summarizes all of the change requirements of the IATF standard

Although regularly introducing new products or services is the lifeblood of most industries, bringing them to market can be fraught with peril. Timing, cost, and quality all play important roles in a successful product launch and avoiding expensive - often in more than just dollars - recalls and redesigns. Quality Assurance: Applying Methodologies for Launching New Products, Services, and Customer Satisfaction details continual improvement (CI), a proven process for avoiding common problems and creating customer satisfaction. The book explores the three fundamental approaches required to create a truly CI culture in any organization: a) consistent philosophy of improvement by management, b) receptive organizational culture, and c) the entire culture of the organization must be willing to make decisions based on measurement and data. It outlines the seven principles: research/plan, assure, explain, prioritize, demonstrate, confirm, and show. However, as with CI itself, this attitude must be incorporated into the processes of any organization and create products or services for the market place that will delight customers rather than just satisfying them. Time and cost constraints are the biggest culprits here, not any one person's lack of due diligence. When this happens, organizations must look at the bigger picture internally and identify it as a system problem. Based on the author's 35 years of experience, this book covers the essential items for doing the right thing the first time especially during launching a good product and/or service to the customer. It identifies key indicators and methodologies that will help you attain excellent performance, delivery, and cost with both the customer and supplier. In other words, by following these methodologies and indicators, the job will get done right the first time.

This book addresses the essentials of an automotive audit which is required by all automotive suppliers world-wide. They are based on customer specific requirements, ISO standards, and Industry specifications. This book covers both the mandated documents and records that are necessary for compliance, with an extensive discussion on Layered Process Audits and distance auditing. The book addresses the six standards for certification in one volume. It explains "why" and "how" an effective audit should be carried out. It identifies the key indicators for a culture change with an audit, explains the "process audit" at length, discusses the rationale for Layered Process audits and summarizes all the mandatory documents and records for all standards and requirements. The book covers the issue of risk in auditing and emphasizes the role of a "checklist" in the preparation process. This book is for those that conduct audits, those that are interested in auditing, and those being audited. It specifically addresses automotive OEMs and their supplier base but is also of interest to anyone wanting information on auditing.

The essence of any root cause analysis in our modern quality thinking is to go beyond the actual problem. This means not only do we have to fix the problem at hand but we also have to identify why the failure occurred and what was the opportunity to apply the appropriate knowledge to avoid the problem in the future. Essential Statistical Concepts for the Quality Professional offers a new non-technical statistical approach to quality for effective improvement and productivity by focusing on very specific and fundamental methodologies and tools for the future. Written by an expert with more than 30 years of experience in management, quality training, and consulting, the book examines the fundamentals of statistical understanding, and by doing so demonstrates the importance of using statistics in the decision making process. The author points out pitfalls to keep in mind when undertaking an experiment for improvement and explains how to use statistics in improvement endeavors. He discusses data interpretation, common tests and confidence intervals, and how to plan experiments for improvement. The book expands the notion of experimentation by dealing with mathematical models such as regression to optimize the improvement and understand the relationship between several factors. It emphasizes the need for sampling and introduces specific techniques to make sure accuracy and precision of the data is appropriate and applicable for the study at hand. The author's approach is somewhat new and unique; however, he details tools and methodologies that can be used to evaluate the system for prevention. These tools and methodologies focus on structured, repeatable processes that can be instrumental in finding real, fixable causes of the human errors and equipment failures that lead to quality issues.

Offering a model, an implementing strategy, as well as traditional and nontraditional methods for the successful enhancement and maintenance of quality, this work establishes a rationale for the continuation of Total Quality Management (TQM) in all organizations. It considers leading quality-related topics, such as unusual charts, supplier-organization-customer relationships, customer needs and expectations, instructional design, adult learning, advanced quality planning, and reliability.

Total Quality Service rises to the business challenge of the 90s. It explains in the most concise terms possible the principles of TQS. The research stands-most unhappy customers do not complain. Instead, they never again buy from businesses that just once left them unsatisfied. What then is TQS? In the simplest terms, it is the true commitment to operationalizing the concept of customer focus, establishing service performance standards, measuring performance against benchmarks, recognizing and rewarding exemplary behavior, and maintaining enthusiasm for the customer at all times. Companies that do not provide quality service not only won't compete-they won't exist. Let Total Quality Service put you and your employees on the cutting edge of customer satisfaction.

This work examines the evolution and rationale of the ISO 9000 series of standards, their structure, interpretation and relationship to other quality systems. Theory and applications are provided, and the author explains how to put the standards into place and achieve quality. Specific methods and tools for the implementation of the ISO standards that lead to certification and certification maintenance are supplied.

Advanced Quality Planning: A Commonsense Guide to AQP and APQP is the first book dedicated to explaining with clarity and detail the total advanced quality planning (AQP) process and how to set quality planning in the framework of a business strategy. The book provides a close look at the basic and advanced concepts of AQP so that both the novice and experienced user will be able to apply AQP appropriately and effectively. In addition, you will learn the "Big Three" automotive companies' required use of Advanced Product Quality Planning (APQP), a specialized version of AQP that emphasized the product orientation of quality. A clear itemized list of Chrysler, GM, Ford, and Tier I suppliers requirements is included, illustrating what they would like to see implemented in their suppliers' processes. Written in a practical format, the book takes you step-by-step through the advanced quality planning methodology, providing you with an overview and discussion of the role of teams in AQP, and its key components including: scheduling, creating a product definition, prototype development, manufacturing preparedness, analytical techniques, documentation, reliability and maintainability, and their implementation. Also included are checklists to help plan the actions that will be appropriate for their respective projects, and appendixes containing a sample business plan and a case study of Chrysler's Process Sign-Off, which demonstrates the results of effective AQP implementation.

Although regularly introducing new products or services is the lifeblood of most industries, bringing them to market can be fraught with peril. Timing, cost, and quality all play important roles in a successful product launch and avoiding expensive - often in more than just dollars - recalls and redesigns. Quality Assurance: Applying Methodologies for Launching New Products, Services, and Customer Satisfaction details continual improvement (CI), a proven process for avoiding common problems and creating customer satisfaction. The book explores the three fundamental approaches required to create a truly CI culture in any organization: a) consistent philosophy of improvement by management, b) receptive organizational culture, and c) the entire culture of the organization must be willing to make decisions based on measurement and data. It outlines the seven principles: research/plan, assure, explain, prioritize, demonstrate, confirm, and show. However, as with CI itself, this attitude must be incorporated into the processes of any organization and create products or services for the market place that will delight customers rather than just satisfying them. Time and cost constraints are the biggest culprits here, not any one person's lack of due diligence. When this happens, organizations must look at the bigger picture internally and identify it as a system problem. Based on the author's 35 years of experience, this book covers the essential items for doing the right thing the first time especially during launching a good product and/or service to the customer. It identifies key indicators and methodologies that will help you attain excellent performance, delivery, and cost with both the customer and supplier. In other words, by following these methodologies and indicators, the job will get done right the first time.

Essentials for the Improvement of Healthcare Using Lean & Six Sigma is all about real and immediate quality improvement. Written by D.H. Stamatis, a renowned expert in organizational development and quality, the book addresses concerns that can be ameliorated with minimal government intervention. Detailing immediate paths for improvement fundamental to primary care, hospitals, and managed care, the book: Introduces much-needed mechanics of change, including transitioning from hierarchical groups to interactive inclusionary teams Focuses on customer satisfaction as a key indicator of quality Explains how Lean and Six Sigma tools can be readily applied to healthcare Spotlights primary care, including how to define and redesign its process and develop better metrics Presents IT applications that will improve billing, documentation, and patient care Examines Malcolm Baldrige National Quality Award criteria as it applies to healthcare Illustrates quality improvements and best practices through real world case studies Includes downloadable resources with Six Sigma forms and formulas, Lean improvement tools, and other quality tools and worksheets Whether you think advances in technology and medicine, coupled with freedom of choice, makes the U.S. healthcare system the best in the world, or whether you believe growing costs, regulatory morass, and a tort-obsessed culture drop it to the bottom; it is evident that the processes currently employed and the subsequent defensive medicine philosophy that has resulted will not be able to meet the future demands of our aging society. Through Six Sigma and Lean, this text moves the focus from reactive controls to the proactive efficiency required to implement real and sustainable quality improvements that will allow us to forge a system that is all about wellness.

A valuable tool for establishing and maintaining system reliability, overall equipment effectiveness (OEE) has proven to be very effective in reducing unscheduled downtime for companies around the world. So much so that OEE is quickly becoming a requirement for improving quality and substantiating capacity in leading organizations, as well as a required area of study for the ISO/TS 16949.

Breaking down the methodology from a historical perspective, The OEE Primer Understanding Overall Equipment Effectiveness, Reliability, and Maintainability explores the overall effectiveness of machines and unveils novel methods that focus on design improvement including hazard analysis, rate of change of failure (ROCOF) analysis, failure rate finite element analysis (FEA), and theory of inventive problem solving (TRIZ). It covers loss of effectiveness, new machinery, electrical maintenance issues, Weibull distribution, measurement techniques, and mechanical and electrical reliability. The book also:

• Discusses Reliability and Maintainability (R&M), not as tools to be used in specific tasks, rather as a discipline
• Covers the application of OEE as an overall improvement tool
• Assesses existing and new equipment from classical, reliability, and maintainability perspectives
• Includes a bonus CD with more than 100 pages of appendices and additional resources featuring statistical tables, outlines, case studies, guidelines, and standards

Introducing the classical approach to improvement, this book provides an understanding of exactly what OEE is and how it can be best applied to address capacity issues. Highlighting mechanical and electrical opportunities throughout, the text includes many tables, forms, and examples that clearly illustrate and enhance the material presented.

With a focus on both manufacturing as well as non-manufacturing organizations, "Six Sigma Fundamentals" demystifies the Six Sigma methodology and provides the reader with a solid understanding of what defines a Six Sigma initiative. Each chapter fully addresses the concepts of the Six Sigma philosophy and explains the methodologies for real-world applications.

"Six Sigma Fundamentals" gives a comprehensive overview to the entire process - from understanding the significance of "customer requirements," the variation-reducing tools, the necessary roles and responsibilities of all employees throughout the organization, all the way to "Designing for Six Sigma" and "implementation strategy."

Click here for Six Sigma Forms
Click here for definitions of Six Sigma terminology

I In this volume, the author demystifies the Design of Experiments (DOE). He begins with a clear explanation of the traditional experimentation process. He then covers the concept of variation and the importance of experimentation and follows through with applications. Stamatis also discusses full and fractional factorials. The strength of this volume lies in the fact that not only does it introduce the concept of robustness, it also addresses "Robust Designs" with discussions on the Taguchi methodology of experimentation. And throughout the author ties these concepts into the Six Sigma philosophy and shows readers how they use those concepts in their organizations.

Cost reduction…productivity improvement…customer retention…enhanced bottom line…these are the promises of six sigma quality management. But what is six sigma? What are the secrets to six sigma success? By implementing the six sigma philosophy you can save millions of dollars in annual cost savings and product quality improvements.

Six Sigma and Beyond: Foundations of Excellent Performance provides a roadmap to successful six sigma implementation that you can adapt to your organization. The book gives you a model of six sigma and explains frequently asked questions in a Q & A format for easy application. It outlines the seven steps to six sigma and how to use them to give your organization the competitive edge.

Understand the seven steps to the six sigma philosophy:
· Establish the Quality System, Management, and Cultural Environment
· Define Mission of Each Component of the Organization
· Set Performance Improvement Opportunities, Goals, and Priorities
· Establish Improvement Projects and Action Plans
· Implement Projects Using Improvement Methodologies
· Evaluate Improved Performance
· Review and Recycle

The goal of all this? You can uncover potential improvements in your organization and bring all your resources together to identify, measure, analyze, improve, and control the process. Six Sigma and Beyond: Foundations for Excellent Performance defines quality and the elements that both management and non-management personnel must understand to achieve quality success.

"Advanced Quality Planning: A Commonsense Guide to AQP and APQP" is the first book dedicated to explaining with clarity and detail the total advanced quality planning (AQP) process and how to set quality planning in the framework of a business strategy. The book provides a close look at the basic and advanced concepts of AQP so that both the novice and experienced user will be able to apply AQP appropriately and effectively. In addition, you will learn the "Big Three" automotive companies' required use of Advanced Product Quality Planning (APQP), a specialized version of AQP that emphasized the product orientation of quality. A clear itemized list of Chrysler, GM, Ford, and Tier I suppliers requirements is included, illustrating what they would like to see implemented in their suppliers' processes. Written in a practical format, the book takes you step-by-step through the advanced quality planning methodology, providing you with an overview and discussion of the role of teams in AQP, and its key components including: scheduling, creating a product definition, prototype development, manufacturing preparedness, analytical techniques, documentation, reliability and maintainability, and their implementation. Also included are checklists to help plan the actions that will be appropriate for their respective projects, and appendixes containing a sample business plan and a case study of Chrysler's Process Sign-Off, which demonstrates the results of effective AQP implementation.

The essence of any root cause analysis in our modern quality thinking is to go beyond the actual problem. This means not only do we have to fix the problem at hand but we also have to identify why the failure occurred and what was the opportunity to apply the appropriate knowledge to avoid the problem in the future. Essential Statistical Concepts for the Quality Professional offers a new non-technical statistical approach to quality for effective improvement and productivity by focusing on very specific and fundamental methodologies and tools for the future. Written by an expert with more than 30 years of experience in management, quality training, and consulting, the book examines the fundamentals of statistical understanding, and by doing so demonstrates the importance of using statistics in the decision making process. The author points out pitfalls to keep in mind when undertaking an experiment for improvement and explains how to use statistics in improvement endeavors. He discusses data interpretation, common tests and confidence intervals, and how to plan experiments for improvement. The book expands the notion of experimentation by dealing with mathematical models such as regression to optimize the improvement and understand the relationship between several factors. It emphasizes the need for sampling and introduces specific techniques to make sure accuracy and precision of the data is appropriate and applicable for the study at hand. The author's approach is somewhat new and unique; however, he details tools and methodologies that can be used to evaluate the system for prevention. These tools and methodologies focus on structured, repeatable processes that can be instrumental in finding real, fixable causes of the human errors and equipment failures that lead to quality issues.

A valuable tool for establishing and maintaining system reliability, overall equipment effectiveness (OEE) has proven to be very effective in reducing unscheduled downtime for companies around the world. So much so that OEE is quickly becoming a requirement for improving quality and substantiating capacity in leading organizations, as well as a required area of study for the ISO/TS 16949. Breaking down the methodology from a historical perspective, The OEE Primer: Understanding Overall Equipment Effectiveness, Reliability, and Maintainability explores the overall effectiveness of machines and unveils novel methods that focus on design improvement-including hazard analysis, rate of change of failure (ROCOF) analysis, failure rate finite element analysis (FEA), and theory of inventive problem solving (TRIZ). It covers loss of effectiveness, new machinery, electrical maintenance issues, Weibull distribution, measurement techniques, and mechanical and electrical reliability. The book also: Discusses Reliability and Maintainability (R&M), not as tools to be used in specific tasks, rather as a discipline Covers the application of OEE as an overall improvement tool Assesses existing and new equipment from classical, reliability, and maintainability perspectives Includes downloadable resources with more than 100 pages of appendices and additional resources featuring statistical tables, outlines, case studies, guidelines, and standards Introducing the classical approach to improvement, this book provides an understanding of exactly what OEE is and how it can be best applied to address capacity issues. Highlighting mechanical and electrical opportunities throughout, the text includes many tables, forms, and examples that clearly illustrate and enhance the material presented.

Risk is everywhere, in everything we do. Realizing this fact, we all must try to understand this "risk" and if possible to minimize it. This book expands the conversation beyond failure mode and effects analysis (FMEA) techniques. While FMEA is indeed a powerful tool to forecast failures for both design and processes, it is missing methods for considering safety issues, catastrophic events, and their consequences. Focusing on risk, safety, and HAZOP as they relate to major catastrophic events, Introduction to Risk and Failures: Tools and Methodologies addresses the process and implementation as well as understanding the fundamentals of using a risk methodology in a given organization for evaluating major safety and/or catastrophic problems. The book identifies and evaluates five perspectives through which risk and uncertainty can be viewed and analyzed: individual and societal concerns, complexity in government regulations, patterns of employment, and polarization of approaches between large and small organizations. In addition to explaining what risk is and exploring how it should be understood, the author makes a distinction between risk and uncertainty. He elucidates more than 20 specific methodologies and/or tools to evaluate risk in a manner that is practical and proactive but not heavy on theory. He also includes samples of checklists and demonstrates the flow of analysis for any type of hazard. Written by an expert with more than 30 years of experience, the book provides from-the-trenches examples that demonstrate the theory in action. It introduces methodologies such as ETA, FTA, and others which traditionally have been used specifically in reliability endeavors and details how they can be used in risk assessment. Highly practical, it shows you how to minimize or eliminate risks and failures for any given project or in any given work environment.

This book focuses on the basics of the six sigma methodology. It targets on both manufacturing as well as non-manufacturing organizations and demystifies the Six Sigma methodology. The book addresses the concepts of the Six Sigma philosophy and explains the methodologies involved in it.

Risk is everywhere, in everything we do. Realizing this fact, we all must try to understand this "risk" and if possible to minimize it. This book expands the conversation beyond failure mode and effects analysis (FMEA) techniques. While FMEA is indeed a powerful tool to forecast failures for both design and processes, it is missing methods for considering safety issues, catastrophic events, and their consequences. Focusing on risk, safety, and HAZOP as they relate to major catastrophic events, Introduction to Risk and Failures: Tools and Methodologies addresses the process and implementation as well as understanding the fundamentals of using a risk methodology in a given organization for evaluating major safety and/or catastrophic problems.

The book identifies and evaluates five perspectives through which risk and uncertainty can be viewed and analyzed: individual and societal concerns, complexity in government regulations, patterns of employment, and polarization of approaches between large and small organizations. In addition to explaining what risk is and exploring how it should be understood, the author makes a distinction between risk and uncertainty. He elucidates more than 20 specific methodologies and/or tools to evaluate risk in a manner that is practical and proactive but not heavy on theory. He also includes samples of checklists and demonstrates the flow of analysis for any type of hazard.

Written by an expert with more than 30 years of experience, the book provides from-the-trenches examples that demonstrate the theory in action. It introduces methodologies such as ETA, FTA, and others which traditionally have been used specifically in reliability endeavors and details how they can be used in risk assessment. Highly practical, it shows you how to minimize or eliminate risks and failures for any given project or in any given work environment.

This book defines, develops, and examines the foundations of the APQP (Advanced Product Quality Planning) methodology. It explains in detail the five phases, and it relates its significance to national, international, and customer specific standards. It also includes additional information on the PPAP (Production Part Approval Process), Risk, Warranty, GD&T (Geometric Dimensioning and Tolerancing), and the role of leadership as they apply to the continual improvement process of any organization. Features Defines and explains the five stages of APQP in detail Identifies and zeroes in on the critical steps of the APQP methodology Covers the issue of risk as it is defined in the ISO 9001, IATF 16949, the pending VDA, and the OEM requirements Presents the role of leadership and management in the APQP methodology Summarizes all of the change requirements of the IATF standard