40 Years of Westgard Rules

James O. Westgard
Westgard QC, Inc.
Madison, WI 53717 USA
www.westgard.com

Home ‐ North Dakota

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 Farmer, Successful Farmer
NY Times, Jan 1, 2008

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The Family Farm Today!

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 Home ‐ Wisconsin

University of Wisconsin‐Madison

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 1973 – Understanding Method
Validation

The Problem with Statistics!

Home – on the average, Minnesota

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 Inner, Hidden, Deeper, Secret
Meaning of Method Evaluation

• It’s all about errors

– Statistics useful to estimate size of the errors
– Different statistics tell about different errors
– “Statistics can provide estimates of errors upon
which judgments can be made, but are not a
substitute for judgments.”

1974 – Criteria for Acceptable

Performance in Validation Studies

Introduced concept of Total Analytical Error

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 Uppsala University, Sweden
1976‐1977 Sabbatical Leave

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1977 – Description of performance

characteristics of SQC procedures

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 Concept of Multi‐Rule QC
1977
1st recommendation for
use of combination of
rules, i.e., concept of
multi-rule QC

Suggested combination
of 13s for random error
and CuSum for
systematic error

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Combined Shewhart‐Cusum Control Chart

1977‐ 1st multi‐rule example application

Appeared in same issue as “Performance

characteristics” paper

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 1979 ‐ Power Function Graphs
1st QC Planning/Design Tool

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1981 – Computer program to

generate power function graphs
“Interactive” Program allows user to specify rules and
generate power function graphs

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 4 years later, at request of Gerald Cooper,
editor of “Selected Methods” volume 10,
prepared another very detailed multi-rule
example

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Multirule Quality Control

QC Data

• Concept 1977
• Example 1981
– “Westgard 13s 22s R4s 41s 10x
Rules”
Take Corrective Action

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 Recommendations for Rules vs
Number of Control Measurements

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“Westgard QC Rules”
Clin Chem 2018;64:874‐6

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 1986 ‐ Cost‐Effective Quality
Control
 Published by AACC
Press
 Authored with Patricia
Barry
 Direct application of
industrial QM principles
to analytical testing
processes in the
laboratory

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1990 – Example Application of QC

Design for Multi‐Test Analyzer

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 Critical‐Error Graph for Selecting
Control Rules and Total N
Sigma Scale
1.65 2.65 3 3.65 4 4.65 5 5.65 P P N R
1.0 fr ed
1 /2of3 /R /3 /6
3s 2s 4s 1s x
Probability for Rejection (P) 0.9
0.07 ----- 6 1
1 /2 /R /4 /8
0.8 3s 2s 4s 1s x
0.03 ----- 4 2
0.7 1 /2 /R /4
3s 2s 4s 1s
0.03 ----- 4 1
0.6 12.5s

0.5 0.04 ----- 4 1

12.5s
0.4 0.03 ----- 2 1
13s /22s /R4s
0.3
0.01 ----- 2 1
13s
0.2
0.00 ----- 2 1
0.1 13.5s
0.00 ----- 2 1
0.0
0.0 1.0 2.0 3.0 4.0
Systematic Error (SE, multiples of s)

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1990 – Prelude to Six Sigma

Relate QC to Process Capability Index (Cp)

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 1991 – New Design Tool
Chart of Operating Specifications

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OPSpecs QC Selection Tool

Chart of Operating Specifications
OPSpecs Chart TEa=10%
P N R
10.0 fr
1 /2of3 /R /3 /6
3s 2s 4s 1s x
9.0
Observed Inaccuracy, %Bias

0.07 6 1
1 /2 /R /4 /8
8.0 3s 2s 4s 1s x
0.03 4 2
7.0 13s /2 2s /R4s /4 1s
0.03 4 1
6.0 12.5s
3.
00

5.0 0.04 4 1
sig

12.5s
m
a

4.0 0.03 2 1
pe
rf o

13s /2 2s /R4s
rm

3.0
an

0.01 2 1
ce

13s
2.0
0.00 2 1
1.0 1
3.5s
0.00 2 1
0.0
0.0 1.0 2.0 3.0 4.0 5.0

ObservedImprecision,
Observed Imprecision,%CV
%CV

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 1994‐ Clinical and Analytical
Quality‐Planning Models

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1995 – A New Home

www.westgard.com

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 1st published as
Method Evaluation by
Am J Med Tech in
1978
Later published by
Westgard QC
1st ed. 1999
2nd ed. 2003
3rd ed. 2012
4th ed. 2020
Spanish ed. 2012

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Basic QC Practices
1st ed. 1998
2nd ed. 2002
3rd ed. 2010
Spanish ed. 2010
Chinese ed. 2015
English 4th ed. 2018

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 2001 – Convert Critical SE
to Six Sigma Metric
Critical Systematic Error (ΔSEcrit)
ΔSEcrit = [(TEa ‐ |Bias|)/SD] – 1.65
• Where 1.65 represents a one‐sided tail
equal to 5% of a gaussian distribution
• Medically important error occurs when
there is a 5% chance that the result
will exceed the defined TEa
TEa ‐ |Bias|)/SD = Sigma‐Metric
• Therefore, ΔSEcrit = Sigma‐Metric – 1.65
• Or, ΔSEcrit + 1.65 = Sigma‐Metric

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2005 – Retirement Party

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 2017 – New Graphical Tools for
Planning Risk‐Based SQC

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Run Size Nomograms

to Implement Parvin’s Risk Model

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 2018 – Multi‐stage Designs of Risk‐
Based SQC for Bracketed Operation

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2019 ‐ Westgard sigma Rules®

with Run sizes
Data
SQC Report Results

No No No No No
13s 22s R4s 41s 6X

Yes Yes Yes Yes Yes

N=2 N=2 N=4 N=6
Run Run Run Run
Size Size Size Size
1000 450 200 45

Take Corrective Action

6σ 5σ 4σ 3σ
Sigma Scale = (%TEa-%Bias)/%CV
Westgard JO, Westgard SA. Establishing Evidence-Based Statistical
Quality Control Practices. Am J Clin Pathol. April 2019;151:364-370.

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Many to thank!
Joan, Do you promise… to the ends of the earth?

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 English Professor Prausnitz
“Inner, hidden, deeper, secret meaning”
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My brother and sisters

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 My Madison CLS Students

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Lab scientists around the world!

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 Hard work, but worth it!

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