LEARNING GUIDE
SIX SIGMA-
BASED QUALIT Y
CONTROL
COREL A BOR ATORY. A BBOT T
ACKNOWLEDGEMENTS
DR. JAMES O. WESTGARD
Dr. James O. Westgard is president of Westgard QC, Inc., a small business
providing education and training for laboratory quality management. He is an
emeritus professor in the Department of Pathology and Laboratory Medicine
at the University of Wisconsin Medical School. He spent many years as faculty
director of Quality Management Services for the Clinical Laboratories at the
University of Wisconsin Hospital and Clinics.
A native of North Dakota, Dr. Westgard obtained a bachelor’s degree in
chemistry from Concordia College in Moorhead, Minnesota, and master’s and
doctorate degrees in analytical chemistry from the University of Wisconsin,
Madison. He began his career at the University of Wisconsin as a clinical
chemist in 1968. His early interest was in the development of method evaluation
protocols, and he served as the first chairman of the Evaluation Protocols Area
Committee at the Clinical and Laboratory Standards Institute (CLSI). His
interest in quality control began in 1976 and 1977 when he was on sabbatical
leave at Uppsala University in Sweden working with Professor Carl-Henric
deVerdier and Drs. Torgny Groth and Torsten Aronsson. This work led to the
multirule control procedure, internationally known as “Westgard Rules.”
STEN WESTGARD, M.S.
Sten Westgard, M.S., is the Director of Client Services and Technology for
Westgard QC. For more than 20 years, Mr. Westgard has managed the Westgard
website, course portal and blog, creating and administering online training, as
well as editing and writing hundreds of reports, essays and applications on
quality control, method validation, Six Sigma risk management and other lab
management topics. He has edited and contributed to numerous books on
quality, including Basic QC Practices, Basic Method Validation, Six Sigma QC
Design and Control, Six Sigma Risk Analysis, CLIA Final Rules, Assuring the Right
Quality Right, The Poor Lab’s Guide to the Regulations and Nothing but the Truth
about Quality. Mr. Westgard is also an adjunct faculty member of the Mayo
Clinic School of Health Sciences in Rochester, Minnesota.
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HOW TO USE
THIS LEARNING GUIDE
This guide is organized into six chapters and a glossary. Each chapter includes a “What’s the Point”
summary and references for additional reading. The glossary includes an extensive list of key terms
found in each chapter, followed by a list of common abbreviations. Readers are encouraged to visit the
Westgard QC website ([Link]) for additional information.
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CONTENTS
FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
CHAPTER 1
Managing Analytical Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
CHAPTER 2
Determining Quality on the Sigma Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
CHAPTER 3
Selecting the Right SQC Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
CHAPTER 4
Implementing SQC Right . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
CHAPTER 5
Developing a QC Plan Including Risk Assessment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
CHAPTER 6
Monitoring Quality and Performance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
APPENDICES
Appendix A: Glossary of Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Appendix B: Control Rule Definitions (WQC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Appendix C: Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
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FOREWORD
It is standard practice in the clinical lab to test quality control (QC) samples (typically called “controls”)
at least daily and, preferably, multiple times per day. Controls are necessary to ensure analytical systems
are of sufficient quality and “fit for purpose” because the performance of even the best assays can
change over time. Statistical quality control (SQC) practices have long been established for this purpose.
However, once QC practices are established, there’s a tendency to accept them without question and to
continue to follow routine algorithms without periodic critical re-examination of their appropriateness.
A one-size-fits-all approach, such as testing two controls once a day, is common, but it’s a minimal
practice. Such a simple QC rule is easy to follow, but it ignores the fact that not all assays are of equal
analytical quality. An optimal QC program recognizes the need for customized QC rules for assays based
on their inherent variability and establishes practical rules to minimize false rejection of acceptable
patient test results and false acceptance of unacceptable results.
Dr. James Westgard has devoted his career to developing QC best practices and assessing analytical
quality through tools such as the Sigma-metric. This learning guide presents his concepts, based on
real working conditions in routine clinical labs. Clinical labs have used the Westgard Rules for years,
and labs routinely apply the Six Sigma metrics approach today. But, as Dr. Westgard himself notes, each
lab must assess its performance and apply the QC algorithms best suited to it. This requires a lab to set
quality targets for every analyte and measure each assay’s bias and imprecision. With these basic data,
the lab can calculate the Sigma-metric and select appropriate QC rules based on analytical quality. This
learning guide provides labs with sufficient basic information to create a practical, useable QC plan
specific for their facilities. It also describes current risk-based approaches to QC.
It’s important to note that SQC is necessary for optimal lab practice and patient care, but it is not
sufficient on its own. SQC addresses variability in the analytical phase, but errors can also occur in the
pre- and post-analytical phases, as well. In addition, external quality assessment/proficiency testing
(EQA/PT) programs are an essential and independent means to assess a QC program’s effectiveness.
Dave Armbruster, Ph.D., DABCC, FACB
Director, Clinical Chemistry, Abbott Diagnostics
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CHAPTER 1
MANAGING ANALYTICAL
QUALITY
INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
REGULATORY AND ACCREDITATION REQUIREMENTS. . . . . . . . . . . . . . . . . . . . . . . . . . 9
QUALITY GOALS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
QUALITY MANAGEMENT SYSTEM (QMS). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
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CHAPTER 2
DETERMINING QUALITY ON
THE SIGMA SCALE
INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
METHOD VALIDATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
DATA FOR RISK ASSESSMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
SIGMA AS AN INDICATOR OF RISK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
CALCULATION OF SIGMA METRIC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
GRAPHICAL DETERMINATION OF SIGMA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
DETERMINATION OF SIGMA-METRIC FROM RESULTS
OF METHOD VALIDATION STUDIES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
DETERMINING SIGMA-METRIC FROM PT AND SQC DATA. . . . . . . . . . . . . . . . . . . . . . 27
IMPORTANCE OF DETERMINING QUALITY ON
THE SIGMA SCALE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
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CHAPTER 3
SELECTING THE RIGHT
SQC PROCEDURE
INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
PERFORMANCE OF SQC PROCEDURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
SIZE OF A MEDICALLY IMPORTANT ERROR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
DEFINITIONS OF CONTROL RULES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
WESTGARD MULTIRULE SQC PROCEDURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
SIGMA SQC SELECTION TOOL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
CHARTS OF OPERATING SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
NORMALIZED OPSPECS CHART . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
WESTGARD SIGMA RULES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
SQC IN THE REAL WORLD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
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CHAPTER 4
IMPLEMENTING
SQC RIGHT
INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
SELECTION OF CONTROL MATERIALS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
DETERMINATION OF MEAN AND SD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
CALCULATING CONTROL LIMITS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
PREPARING A CONTROL CHART . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
REVIEWING CONTROL RULES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
ANALYZING CONTROLS IN EACH RUN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
INTERPRETING CONTROL RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
APPROPRIATE ACTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
DOCUMENTING RESULTS AND ACTIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
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CHAPTER 5
DEVELOPING A QC PLAN
INCLUDING RISK ASSESSMENT
INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
IDEA OF A QC PLAN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
CONTROLLING THE TOTAL TESTING PROCESS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
CMS/CDC GUIDANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
SELECTING CONTROL MECHANISMS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
PRE-ANALYTIC CONTROLS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
ANALYTIC CONTROLS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
POST-ANALYTIC CONTROLS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
PRIORITIZING ANALYTIC CONTROLS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
FREQUENCY OF CONTROLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
ASSEMBLING A TOTAL QC PLAN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
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CHAPTER 6
MONITORING QUALITY
AND PERFORMANCE
INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
QUALITY ASSESSMENT (QA). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
EXAMPLE QA PLAN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
ERROR OR DEFECT RATES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
EXTERNAL QUALITY ASSESSMENT/PROFICIENCY
TESTING (EQA/PT). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
MEASUREMENT UNCERTAINTY (MU). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
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GLOSSARY OF TERMS,
CONTROL RULES AND
ABBREVIATIONS
These definitions, some official and others unofficial, are referenced to the following sources:
International Standards Organization (ISO), Clinical and Laboratory Standards Institute
(CLSI), U.S. Centers for Medicare and Medicaid Services (CMS), U.S. Centers for Disease
Control and Prevention (CDC), and Westgard QC (WQC).
APPENDIX A: GLOSSARY OF TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
APPENDIX B: CONTROL RULE DEFINITIONS (WQC) . . . . . . . . . . . . . . . . . . . . . . . . . . 86
APPENDIX C: ABBREVIATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
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