Practical Attribute and Variable Measurement Systems Analysis (MSA)
Also available from ASQ Quality Press:
Practical Engineering, Process, and Reliability Statistics Mark Allen Durivage
The Certified Pharmaceutical GMP Professional Handbook FDC Division and Mark Allen Durivage, editor
Reliability Data Analysis with Excel and Minitab Kenneth S. Stephens
Product Safety Excellence: The Seven Elements Essential for Product Liability Prevention Timothy A. Pine
The Metrology Handbook, Second Edition Jay L. Bucher, editor
The Certified Quality Engineer Handbook, Third Edition Connie M. Borror, editor
The Certified Six Sigma Green Belt Handbook, Second Edition Roderick A. Munro, Govindarajan Ramu, and Daniel J. Zrymiak
The Certified Six Sigma Black Belt Handbook, Second Edition
T. M. Kubiak and Donald W. Benbow
The Certified Reliability Engineer Handbook, Second Edition Donald W. Benbow and Hugh W. Broome
The Certified Quality Inspector Handbook, Second Edition
H. Fred Walker, Ahmad K. Elshennawy, Bhisham C. Gupta, and Mary McShane Vaughn
The Certified Quality Technician Handbook, Second Edition
H. Fred Walker, Donald W. Benbow, and Ahmad K. Elshennawy
HALT, HASS, and HASA Explained: Accelerated Reliability Techniques, Revised Edition Harry W. McLean
Failure Mode and Effect Analysis: FMEA from Theory to Execution, Second Edition
D. H. Stamatis
To request a complimentary catalog of ASQ Quality Press publications, call 8002481946, or visit our website at http://www.asq.org/qualitypress.
Practical Attribute and Variable Measurement Systems Analysis (MSA)
A Guide for Conducting Gage R&R Studies and Test Method Validations
Mark Allen Durivage
ASQ Quality Press Milwaukee, Wisconsin
American Society for Quality, Quality Press, Milwaukee 53203 © 2016 by ASQ All rights reserved. Published 2015 Printed in the United States of America
21 20 19 18 17 16 15
5
4
3
2
1
Library of Congress CataloginginPublication Data
Durivage, Mark Allen. Practical attribute and variable measurement systems analysis (MSA) : a guide for conducting gage R&R studies and test method validations / Mark Allen Durivage. pages cm Includes bibliographical references and index. ISBN 9780873899154 (hard cover : alk. paper) 1. Acceptance sampling. 2. Quality control—Statistical methods. 3. Measurement. I. Title.
TS156.4.D87 2015 

658.4'013—dc23 
2015021647 
ISBN: 9780873899154
No part of this book may be reproduced in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher.
Publisher: Lynelle Korte Acquisitions Editor: Matt T. Meinholz Project Editor: Paul Daniel O’Mara Production Administrator: Randall Benson
ASQ Mission: The American Society for Quality advances individual, organizational, and community excellence worldwide through learning, quality improvement, and knowledge exchange.
Attention Bookstores, Wholesalers, Schools, and Corporations: ASQ Quality Press books, video, audio, and software are available at quantity discounts with bulk purchases for business, educational, or instructional use. For information, please contact ASQ Quality Press at 8002481946, or write to ASQ Quality Press, P.O. Box 3005, Milwaukee, WI 532013005.
To place orders or to request ASQ membership information, call 8002481946. Visit our website at http://www.asq.org/qualitypress.
Printed on acidfree paper
Table of Contents
vi
Table of Contents
11.4
Chemicals
109
Table of Contents
vii
List of Figures and Tables
Figure 1.1 
Possible sources of process 
2 
Figure 1.2 
2 

Figure 1.3 
3 

Figure 1.4 
Repeatability, reproducibility, and 
4 
Figure 1.5 
Measurement system Pythagorean 
5 
Figure 2.1 
Gage R&R study life cycle 
7 
Figure 3.1 
Actual repeatability, withinsample variation, and observed 

15 

Table 4.1 
Forbidden 
18 
Figure 4.1 
Traditional gage R&R 
20 
Figure 4.2 
Completed traditional gage R&R 
22 
Figure 4.3 
Range 
23 
Table 4.2 
Gage acceptability 
24 
Figure 4.4 
Relationship between the number of distinct categories and the 

corresponding gage R&R 
25 

Table 5.1 
Forbidden 
28 
Figure 5.1 
TwoWay ANOVA data 
30 
Table 5.2 
Twoway ANOVA summary 
30 
Table 5.3 
Twoway ANOVA variance 
31 
Figure 5.2 
Completed twoway ANOVA data 
34 
Figure 5.3 
Range 
35 
Figure 5.4 
Decision limit 
37 
Table 5.4 
Completed twoway ANOVA summary 
37 
Table 5.5 
Completed twoway ANOVA variance 
37 
Figure 5.5 
Decision limit 
37 
Figure 5.6 
Decision limit interaction (appraisers and 
38 
Table 5.6 
Gage acceptability 
39 
Figure 5.7 
Decision limit 
40 
Table 5.7 
Completed twoway ANOVA summary table without 
40 
Table 5.8 
Completed twoway ANOVA variance table without 
40 
ix
x
List of Figures and Tables
Figure 5.8 
Decision limit 
40 
Figure 5.9 
Decision limit 
42 
Table 5.9 
Completed twoway ANOVA summary table without 
42 
Table 5.10 
Completed twoway ANOVA variance table without 
42 
Figure 6.1 
Relationship between the target value, accuracy, and 
45 
Figure 6.2 
Accuracy versus 
46 
Figure 6.3 
Bias and 
46 
Table 6.1 
Reference parts versus measured 
47 
Figure 6.4 
Linearity plot for the 
48 
Table 6.2 
Summary data table for the 
50 
Figure 6.5 
Relative degrees of 
51 
Figure 6.6 
Decision limit for linearity. 
53 
Figure 6.7 
Decision limit for 
55 
Figure 6.8 
Bias and linearity plot for the 
55 
Figure 6.9 
Stable and unstable 
56 
Figure 6.10 
Control chart interpretation 
58 
– 

Table 6.3 
Data for X and R 
59 
Figure 6.11 
Xbar and R chart example. 
60 
Table 6.4 
Data for XmR 
62 
Figure 6.12 
XmR chart example. 
63 
Figure 7.1 
Type A and B measurement uncertainties. 
65 
Figure 7.2 
Guard 
66 
Figure 7.3 
Consumer’s and producer’s risk. 
67 
Figure 7.4 
Traditional gage R&R guard banding 
68 
Figure 7.5 
ANOVA gage R&R guard banding 
69 
Figure 8.1 
Gage R&R as a proportion of process 
72 
Table 8.1 
Gage acceptability criteria for the MCI _{1} 
73 
Figure 8.2 
Gage R&R as a proportion of the 
74 
Figure 8.3 
Errors caused by gage 
74 
Table 8.2 
Gage acceptability criteria for the MCI _{2} 
75 
Figure 8.4 
Distortion of C _{p} for MCI _{1} . 
76 
Figure 8.5 
Distortion of C _{p} for MCI _{2} . 
76 
Figure 8.6 
Relationship of C _{p} and measurement capability 
77 
Figure 8.7 
C _{p} contours for MCI _{1} and MCI _{2} . 
78 
Figure 8.8 
Precision in estimating the standard deviation as a function of degrees 

of 
81 

Figure 9.1 
Shortform attribute R&R study 
84 
Figure 9.2 
Sample selection distribution. 
84 
List of Figures and Tables
xi
Figure 9.3 
Completed shortform attribute R&R 
86 
Figure 9.4 
Shortform attribute R&R study with standards 
87 
Table 9.1 
Gage acceptability 
87 
Figure 9.5 
Completed shortform attribute R&R study with 
88 
Table 9.2 
Attribute R&R study with standards acceptability 
89 
Figure 9.6 
Attribute R&R study with standards 
90 
Figure 9.7 
Attribute R&R study with standards results 
92 
Figure 9.8 
Attribute R&R study using Cohen’s kappa statistic 
94 
Figure 9.9 
Cohen’s kappa statistic contingency 
95 
Table 9.3 
Gage acceptability 
95 
Figure 9.10 
Completed attribute R&R study using Cohen’s kappa statistic 

96 

Figure 9.11 
Attribute R&R study using Fleiss’s kappa statistic 
98 
Table 9.4 
Interpreting the Fleiss’s kappa 
99 
Figure 9.12 
Completed attribute R&R study using Fleiss’s kappa 
101 
Table G.1 
Gage R&R 
135 
Table G.2 
Gage acceptability criteria (short 
136 
Table G.3 
Gage acceptability criteria with 
136 
Table G.4 
Gage acceptability criteria (Cohen’s kappa 
136 
Table G.5 
Gage acceptability criteria (Fleiss’s kappa 
137 
Preface
T his book—a result of 30 years of qualityrelated work experience—was written to aid quality technicians and engineers. To that end, the intent of this book is to provide the quality professional working in virtually any industry a quick, con
venient, and comprehensive guide to properly conducting measurement systems analy sis (MSA). The purpose of this book is to provide background and examples on the application of gage R&R methodology (test method validation) for variable and attribute data, help for those who work with devices that don’t fit the usual approach, and ideas for measure ment devices that require innovation to assess their performance under offline, static conditions. The ultimate objective is to ensure the measurement system is suitable for its intended purpose and capable of consistently providing valid measurements so that one may effectively control and ultimately improve the performance of a process. The reader is assumed to be familiar with basic control charting methodology since assessment of statistical control of the measurement process is important. One may wonder why performing a gage R&R is so important; the simple answers are profit, public health, and safety. Companies that are shipping product that is out of specification can be subjected to expensive litigation, especially in the aviation, pharma ceutical, and medical device industries. It is the author’s contention that decision making on and evaluation of measurement systems should be done in the context of a systems approach. The particular criterion used for measurement capability is less important than the full context of measurement and process variation. This book will be a useful reference when preparing for and taking many of the ASQ quality certification examinations, including the Certified Quality Technician (CQT), Certified Calibration Technician (CCT), Certified Quality Inspector (CQI), Certified Six Sigma Green Belt (CSSGB), Certified Quality Engineer (CQE), Certified Six Sigma Black Belt (CSSBB), and Certified Reliability Engineer (CRE).
xiii
Acknowledgments
I would like to acknowledge the previous work of Larry B. Barrentine in Concepts for R&R Studies. This book is an expansion of his efforts and an attempt to continue his style of presenting R&R studies in a simple, easytofollow style. I would like to
thank those who have inspired, taught, and trained me throughout my academic and pro fessional career. I also wish to recognize my friend, colleague, author of Implementing ISO/IEC 17024:2005, and fellow ASQ Fellow Bhavan “Bob” Mehta, principal consul tant at GMP & ISO Expert Services, for lending his expertise in reviewing this book for accuracy and content. ASQ’s reviewers T. Gourishankar and Autumn Farrell also pro vided invaluable insight and detailed feedback. A special thanks to my friend and col league Joshua Ball for lending his expertise and experience in developing the sample study procedure and sample audit checklist included in the appendixes. Additionally, I would like to thank ASQ Quality Press, especially Matt Meinholz, Acquisitions Editor, and Paul O’Mara, Managing Editor, for their expertise and technical competence, which made this project a reality. Lastly, I would like to acknowledge the patience of my wife Dawn and my sons Jack and Sam, who allowed me time to research and write Practical Attribute and Variable Measurement Systems Analysis (MSA): A Guide for Conducting Gage R&R Studies and Test Method Evaluations.
LiMiT oF LiAbiLiTy/DiSCLAiMer oF WArrAnTy
The author has put forth his best efforts in compiling the content of this book; however, no warranty with respect to the material’s accuracy or completeness is made. Addition ally, no warranty is made in regard to applying the recommendations made in this book to any business structure or environments. Businesses should consult regulatory, quality, and/or legal professionals prior to deciding on the appropriateness of advice and recom mendations made within this book. The author shall not be held liable for loss of profit or other commercial damages resulting from the employment of recommendations made within this book, including special, incidental, consequential, or other damages.
xv
1
Introduction
G age R&R—repeatability and reproducibility—studies analyze the variation of measurements of a gage (repeatability) and the variation of measurements by operators (reproducibility). Gage R&R studies are also referred to as test method
validation (TMV) in the Food and Drug Administration (FDA)–regulated industries. To understand why this is so important, recall that the goal of process control is reduction of variation in the process and, ultimately, the product. To address actual process variabil ity, the variation due to the measurement system must be identified and separated from that of the process. Studies of measurement variation are a waste of time and money unless they lead to action to reduce process variation and improve process control. Since you can not address something that can not be measured precisely, the assessment of the gage becomes an early priority during the design and development and transfer phases prior to commercial production. Before we can continue discussing gage R&R, we have to define “gage.” The term gage actually refers to any device used for making measurements. In this book, the terms gage and device are used interchangeably and refer to any device or equipment for making a measurement. Every observation of a process contains both actual process variation and measure ment variation (Figure 1.1). In the case of measurement systems, the sources are:
1. The gage/device.
a. Calibration—is the gage accurate?
b. Stability—does the gage change over time?
2. The operator—does the operator have the necessary skill and training?
3. Withinsample variation—variation within a sample is a part of process variation that is often mixed with measurement variation.
4. Repeatability—the variation observed when an operator measures the same sample using the same gage several times.
5. Reproducibility—the additional variation observed when several operators use the same gage to measure the same sample.
6. Linearity—is the gage more accurate at low values than at high values, or vice versa?
1
2
Chapter One
7. Bias—is there a shift of the average measurements from the reference value?
8. Discrimination—is the gage sensitive enough to measure the part?
Gage R&R studies assess reproducibility (operator variation) and repeatability (gage variation). Repeatability is the variation observed when an operator measures the same sample using the same gage several times (see Figure 1.2).
Figure 1.1
Measurements
Figure 1.2
Repeatability.
Introduction
3
Reproducibility is the additional variation observed when several operators use the same gage to measure the same sample (see Figure 1.3). The combination of both sources of variation is referred to as gage R&R (see Figure 1.4). Note that gage R&R does not address the total measurement system but is narrowly defined and is gage specific.
Appraiser averages
Repeatability 
Distribution of repeated measurements on the same part by one operator with the same gage 
+ 

Reproducibility 
Distribution of the averages of many operators using the same gage 
= 

R&R 
The combined effect of gage variation among operators 
Figure 1.4
Repeatability, reproducibility, and R&R.
4
Chapter One
The exclusion of the other potential sources of measurement variation does not imply that calibration, stability, or linearity are unimportant; it is just that those sources are ordinarily less significant in their impact. For that reason, gage R&R are often studied and quantified first. In order to improve them, you must address the key measurement process variables via procedures, standards, training, and appropriate studies. We plan and execute gage R&R studies in a fashion designed to avoid confusion with sources of variation other than repeatability (gage) and reproducibility (operator). While this man ual describes how to perform gage R&R studies, you can not ignore the other sources
of variation for long. In particular, the actual process variation is the ultimate subject to be addressed. Customers require both gage R&R studies and process capability. Process capability includes both process variation and measurement variation. Consequently, gage R&R studies should be accompanied or quickly followed by evaluations of calibra tion, variation within the sample, and any other relevant source of variability. Variation within the sample being measured is often difficult to exclude from the gage R&R study. While not attributable to measurement, this source is extremely important and should always be pursued with diligence. It not only has relevance to understanding gage R&Rs but also provides vital information on how to gain process capability improvements.
A specific example of variation within the sample is apparent in measurements of
surface texture by a profilometer. The test piece itself is sufficiently variable that if the measurement is made at a random position, the variation within the sample will inflate the estimate of repeatability. It is necessary to identify and measure this vari ability within the sample; but this alone is not identified by a gage R&R study. The key point is to make certain that process variability within the sample does not intrude on the gage R&R study if it can, or must, be avoided. Determination of an unsatisfactory gage R&R should always lead to an evaluation of whether variation within the sample is part of the problem. The impact of any environmental conditions also needs to be evaluated. This is more appropriately addressed by designed experiments. Prior to conducting gage R&R studies, an effort is made to block out such sources of variation during the devel opment phase.
It is necessary to introduce the mathematical version of Figure 1.4 since this
relationship is used repeatedly. To add distributions, one must add the variances, or σ ^{2} s, of the distributions being added. If the distributions, or spread, due to repeatabil ity and reproducibility can be characterized by their respective sigmas (σ _{R}_{e}_{p}_{e}_{a}_{t}_{a}_{b}_{i}_{l}_{i}_{t}_{y} and σ _{R}_{e}_{p}_{r}_{o}_{d}_{u}_{c}_{i}_{b}_{i}_{l}_{i}_{t}_{y} ), then combining these distributions as in Figure 1.2 results in the following distribution for gage R&R:
2
σ R&R
= σ
2
Repeatability
+ σ
2
Reproducibility
The sigma for gage R&R is the square root of this expression. This same Pythagorean relationship will be used to relate the process variation to the measurement system vari ation and the part variation (see Figure 1.5).
Introduction
5
^{σ} ^{2} GRR
^{σ} ^{2} Process ^{=} ^{σ} ^{2} Part ^{=} ^{σ} ^{2} GRR
where
σ 2 _{P}_{r}_{o}_{c}_{e}_{s}_{s} = Process variation σ 2 _{P}_{a}_{r}_{t} = Part variation σ 2 _{G}_{R}_{R} = Measurement system variation
Figure 1.5
Measurement system Pythagorean relationship.
Throughout this book there are several examples that are fully worked out using a simple scientific calculator. If the examples are worked using a spreadsheet or a com mercially available software package, the results can and will vary. The differences are attributed to rounding errors. Although there are differences, essentially the same results and conclusions will be obtained.
Index
A
accuracy, versus precision, 45 ANOVA gage R&R study, 27–43 example with interaction, 33–39
example without appraiser, 41–43 example without interaction, 39–41 guard banding using, 68
MCI 
in, example, 82 
steps 
in performing, 29–33 
appraiser variation (AV ), 17 appraisers in gage R&R study, 8, 17 results for, in ANOVA gage R&R with interaction, 36 without interaction, 39 attribute gage R&R study, performing, 83–103 shortform, 83–85 shortform with standards, 85–89 attribute measurements, in gage R&R study,
7–8
attribute R&R study using Cohen’s kappa statistic, 93–97 attribute R&R study using Fleiss’s kappa statistic, 98–103 attribute R&R study with standards, 89–93
B
balances, and scales, 113–14 bias, 2 definition, 45 and linearity, 46 analytical method, 47–49 graphical method, 47 relationships with linearity and stability,
45–61
bias test, 54 bore gage, 114–15
C
calibration, in gage R&R study, 8, 109, 113–14 chemical analysis, 109–10 Cohen’s kappa statistic, attribute R&R study using, 93–97 common cause variation, 56 confidence levels, in estimating standard deviations, 80–81 consumer’s risk, 67 control chart constants (Appendix A), 119 control charts, interpretation, 56–57 correlation analysis, 49–52 correlation coefficient, 49–52 critical values of (Appendix D), 127 C _{2} correction factors (Appendix B), 121
D
destructive tests, 111 device. See gage discrimination, measurement, 2 in gage R&R study, 10 distributions, in gage R&R, 4
E
electronic temperature equipment, 108–9 electronic width gage, 108 environmental conditions, in gage R&R study, 9 equipment variation (EV), 17–18
F
false alarms, 89–93 Fdistribution, selected percentages of (Appendix C), 123–25
149
150
Index
Fleiss’s kappa statistic, attribute R&R study using, 98–103 Food and Drug Administration (FDA), 1
G
gage definition, 1 number of, in gage R&R study, 11 as source of variation, 1 gage R&R (repeatability and reproducibility), 1–4 definition, 1, 19 effect on process capability, 79–80 and process capability, 75 gage R&R study attribute, performing, 83–103 attribute with standards, 89–93 audit checklist, example (Appendix H), 139 frequency of, 11 importance of performing, xiii life cycle, 7–11 performing ANOVA, 27–43 performing traditional, 17–25 procedure, example (Appendix G), 133–37 shortform attribute, 83–85 shortform attribute with standards, 85–89 special considerations in, 107–16 withinsample variation in, addressing, 13–16 guard banding, 65–67 and measurement uncertainty, 65–68 table (Appendix F), 131–32 using ANOVA gage R&R example, 68 using traditional gage R&R example, 67
I
interactions (appraisers and parts), results for, in ANOVA gage R&R, 38–39
L
leak rate, 89–93 linearity, 1 and bias, 46 analytical method, 47–49 graphical method, 47 definition, 45 relationships with bias and stability, 45–61 linearity test, 52–53 lower limit of detection (LLD), 110 lower limit of quantification (LLOQ), 110
M
McCune, Duncan C., 80
MCI _{1} (percentage of process variation), 10, 71–73
effect on process capability, 79
MCI _{2} (percentage of process specifications), 10,
73–75
effect on process capability, 79–80
measurement, considerations in gage R&R study,
10
measurement capability indices, 71–82 relationship between, and with C _{p} , 76–77,
77–78
measurement discrimination, in gage R&R study,
10
measurement systems, sources of variation in, 1–2 measurement systems analysis (MSA),
introduction to, 1–5 measurement uncertainty, and guard banding,
65–68
micrometers, 112–13 moisture gage, nuclear, 115–16
MR (moving range) chart, 61
N
nuclear moisture gage, 115–16 number of distinct categories (N _{D}_{C} ), 24–25
O
onesided tolerances, in gage R&R study, 10
operator
in gage R&R study, 8 as source of variation, 1
P
parts, results for, in ANOVA gage R&R with interaction, 36 without appraiser, 41 without interaction, 39 physical tests, 111 planning, in gage R&R study, 7–11 precision, versus accuracy, 45 process capability (C _{p} ) effect of gage R&R on, 79–80 and gage R&R, 75, 106 relationship to measurement capability indices, 76–77, 77–78 process capability indices, 71–82
Index
151
producer’s risk, 67 profilometers, 111–12
R
R chart, 27 range method, of gage R&R study, 17, 27 reference parts, 47 repeatability, 1, 2, 38, 105 reproducibility, 1, 2, 3, 105 results in gage R&R study, analyzing, 10 unacceptable, understanding, 105–6 root cause analysis (RCA), 28
S
sample selection strategy, in gage R&R study, 9 samples, in gage R&R study, 8 scales, and balances, 113–14 sheet flatness, 110–11 shortform attribute R&R study, 83–85 shortform attribute R&R study with standards,
85–89
special cause variation, 56 special causes, in gage R&R study, identifying, 11 stability, 55–56 definition, 45 relationships with bias and linearity, 45–61 standard deviations, confidence levels in estimating, 80–81 Student’s tdistribution (Appendix E), 129–30 Student’s ttest, 52–54
T
test method validation (TMV), 1 tolerances, onesided, in gage R&R study, 10 traditional gage R&R, guard banding using, 67
traditional variables R&R study, 17–25 example, 21–24
MCI 
in, example, 81–82 
steps 
in performing, 18–21 
trials, in gage R&R study, 9, 17 twoway ANOVA, in gage R&R study, 28
U
uncertainty
in measurement, and guard banding, 65–68
type A, 65 type B, 65
upper limit of detection (ULOD), 110 upper limit of quantification (ULOQ), 110
V
variable data, in gage R&R study, 7–8 variation in measurement systems, sources of, 1–2 in process, 1 See also withinsample variation
W
withinsample variation, 1, 4 addressing, in gage R&R study, 13–16 case A: no significant variation, 13–16 case B: significant variation present, 16 minimizing, in gage R&R study, 9
X
X chart, 61 Xbar and R charts, 57–60 XmR (moving range) charts, 61 Xray gage, 107–8
Гораздо больше, чем просто документы.
Откройте для себя все, что может предложить Scribd, включая книги и аудиокниги от крупных издательств.
Отменить можно в любой момент.