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Secrets of Method Validation

Introduction to Risk Analysis and Analytical Quality Management
Introduction to Risk Analysis and Analytical Quality Management

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Six Sigma Quality Design and Control

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2006, 348 pages, 6" x 9" perfect bound
ISBN 1-886958-23-8

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Download a free chapter and the table of contents

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  • 20 Chapters
  • 6 appendices
  • Reference list
  • Glossary
  • Index
  • Six Sigma analysis of more than 40 example tests
  • Real-world metrics on thousands of laboratories
  • Updated data on desirable specifications for quality control from Ricos et al.
  • Financial worksheets

Six Sigma Quality is an advanced technique of improving processes and profitability that has revolutionized industries across America and around the world. The facts are plain: by improving quality with Six Sigma techniques, businesses have been able to save billions while gaining a competitive edge. In this book, Dr. Westgard shows you how to apply the Six Sigma techniques to laboratory testing processes.

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Six Sigma Quality Design and Control, Second Edition

Revised, Updated, Expanded. Essential.

A decade ago, Six Sigma was relatively unknown in healthcare. While widely embraced by other industries, Six Sigma was a latecomer to hospitals and diagnostic corporations.

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Today, Six Sigma is well-known in healthcare. Majors hospitals, reference laboratories, and diagnostic manufacturers have dramatically reduced waste, improved patient care - and saved millions in the process. For healthcare, Six Sigma is a win, win, win proposition.

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But even the most experienced black belts don't understand laboratory analytical processes. Generic Six Sigma applications may overlook the unique challenges and opportunities in the laboratory. Without a deep understanding of the core laboratory process, the QC practices in even advanced facilities may remain wasteful and antiquated, more emblematic of the 1950s than the 21st century.

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Dr James O. Westgard, PhD, the internationally recognized QC expert and originator of multirule QC procedures (popularly known as "Westgard Rules") has written a book that tackles the heart of laboratory performance. With over three decades of experience in laboratory quality, Dr. Westgard is the perfect guide to Six Sigma implementation in testing processes. With unique tools and insights, Dr. Westgard demonstrates how to assess laboratory processes and direct improvements.

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The book is divided into four sections and 20 chapters. The first section deals with Six Sigma methods and metrics - how to characterize a process in order to compare your performance with world class quality. The second section describes tools and technology for Six Sigma design and control. This includes specific illustrations of the use of the Westgard QC Validator® and EZ Rules® technology on real-world laboratory examples.

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The third section illustrates the application strategies for complicated laboratory services that involve multitest automated systems, cardiac markers in a POC setting, new-born screening, and patient data for laboratory QC. Of special importance are the illustrations showing how to define medical tolerance limits on the basis of medical cutoff points and test interpretation guidelines. Through the use of Six Sigma techniques, Dr. Westgard shows how world class quality can be achieved for any area of laboratory testing.

The last section discusses obstacles and opportunities in implementing Six Sigma Quality Management. There are frank discussions of the state of laboratory quality, leadership in the laboratory field, and the crisis in current quality control practices. A comparison of Six Sigma with other popular management fads is included, giving you the ability to compare the costs and benefits of ISO, Patient Safety, Lean, Risk Management, Quality Indicators and Six Sigma.

Finally, the book includes a series of financial worksheets to help you assess the current state of your laboratory testing processes and the cost savings that may be possible through Six Sigma improvements. Perhaps most importantly, it helps you identify the costs of your current laboratory performance.

The tools and techniques are completely described, using over 100 graphs and tables. Also included are a glossary, reference list, appendices with CLIA requirements, European biological goals, clinical requirements, and Six Sigma conversions.

Learning Objectives:

In twenty chapters, the Six Sigma Quality Design and Control manual teaches you how to:

  • Assess the sigma-capability of your laboratory processes.
  • Dramatically improve your laboratory processes.
  • Calculate sigma-metrics to select and design QC procedures.
  • Utilize advanced quality-planning techniques like Average of Normals patient data QC.
  • Design QC procedures with the aid of automated QC software.

Table of Contents

Metrics and Methods
1. Quality in the new millenium 1
2. Six Sigma Basics 11
3. Process Outcome Metric 29
4. Analytic Performance Capability 41
5. Quality Control Selection 55
6. Quality Design and Control Processes 69
Tools and Technology
7. Graphic attributes of the OPSpecs design tool 91
8. The Error Budget Framework 107
9. Quality Planning Models 117
10. Computer Technology 129
Application Strategies
11. Quality Design and Control Applications 157
12. Multi-Stage Quality Control 173
13. Medical Cutoffs as Tolerance Limits 185
14. Test Interpretation Guidelines as Tolerance Limits 197
15. Patient Data for Assessing Process Performance Stability 209
Obstacles and Opportunities
16. Quality Management Today 225
17.Analytical Quality Today 239
18. Quality Control Today 249
19. Quality Costs Today 259
20. Quality Leadership Today 279
References 285
Glossary 293
Six Sigma DPM (Defects Per Million) 307
CLIA'88 Analytical Quality Requirements 309
CLIA'88 Criteria and Six Sigma Goals 313
European Biologic Goals 315
Desirable Specifications for total error, imprecision, and bias 319
Clinical Quality Requirements 331
Index 333
Talking about Quality
"But we're different!" i
"But we're in compliance!" 27
"But manufacturers are responsible for Quality!" 28
"But we've always done it this way!" 68
"But Quality involves statistics!" 90
"But Quality costs too much!" 106
"But tests are already better than needed!" 116
"But we already use 'Westgard Rules'!" 184
"But QC requires computers!" 208
"But the doctors aren't complaining!" 238
"But it's time for new and different approaches for QC!" 248
"But we're we're already doing QC!" 292

Download a free chapter and the table of contents

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