Index

Note: Page numbers followed by f or t refer to figures or tables, respectively.

A to tolerance ratio, 239

trade-offs with cost, 239
absolute instruments, 218–219 action plans, 16, 16f, 31f, 32f
acceptable quality level, 195, 197, 201t activity network diagram (AND), 27, 270,
acceptable quality limit (AQL), 198, 201t, 207. 271, 285. see also arrow diagrams
see also acceptance sampling actual cost, 99, 101
ANSI/ASQ Z1.4 and, 209 ADDIE model of training, 109, 111
ANSI/ASQ Z1.9 and, 211, 212, 212f, 213 addition rule, 365, 366, 368, 371, 372
in attribute sampling plans, 206 advanced product quality planning and
example, 210 control plan (APQP), 156, 158
OC curve useful for, 197 advanced quality planning (AQP), 15, 37, 45,
in producer’s risk, 195 183
in risk-based audit approach, 96t aerospace industry, 64
acceptance number, 196, 197. see also affective conflict, 57
sampling plans affinity diagrams, 270, 271, 272, 273f, 274,
critical defects and, 207 281. see also force field analysis
lot size, sample size, and, 198–199, 200t, affinity principle, 272, 283
201f Agresti, A., 405
in sampling plans, 195, 203, 210t aliasing, 505
acceptance quality limit (AQL), 195, 197, 198, AlMaian, R. Y., 64
206, 207, 209, 213 Alper, S. J., 259
for acceptance/rejection criteria, 212 alternative hypothesis, 406, 407, 408, 413
ANSI/ASQ Z1.9 and, 211, 212f ANOVA and, 436, 457
in sampling plans, 210 example, 410, 414, 421, 437, 458
acceptance sampling, 4, 5t, 181, 193–196, 198, in goodness-of-fit test, 443
202. see also acceptable quality limit rejecting null hypothesis for, 430, 431
(AQL); sampling plans rejection regions, 409t, 411t, 412t, 413t,
by attributes, 201 416t, 418t, 420t, 424t
in failure and root cause analysis, 336 type II errors and, 430
percentage of, 211t American National Standard, 66
in quality control/improvement, 80 American Society for Quality (ASQ), 8, 43,
in sampling inspection, 66 89, 204
accuracy, 290, 399, 560 Code of Ethics, 41, 42f, 44
of candidate instruments, 218 establishment of, 4, 6t
data, 343, 349–350 name change, 7t
of equipment, 237f professional ethics and, 1
of measurements, 238, 240, 242 quality control tools as defined by, 258
objectives, 238, 239, 240 webinars, 110
as service characteristic, 62t website, 310

643
644 Index

American Society for Quality Control approximations, 197, 199, 389, 389f, 390, 405,
(ASQC), 6t, 7t, 197. see also American 413, 423
Society for Quality (ASQ) APQP (advanced product quality planning
American Society for Testing and Materials and control plan), 156, 158
(ASTM), 197 AQL. see acceptable quality limit (AQL)
American Society of Mechanical Engineers, AQP (advanced quality planning), 15, 37, 45,
83 183
American Supplier Institute, 121 areas under standard normal distribution to
analysis of experiments, 343, 497–498. see also the left of Z-values, 576t–578t
design of experiments (DOE) ARIMA (autoregressive integrated moving
analysis of variance (ANOVA), 246–247, average), 462
431–432, 512, 514, 516, 522f ARL (average run length), 487
example, 437 arrow diagrams, 271, 285. see also activity
in gage R&R study, 249, 250t, 251t network diagram (AND)
method, 244, 250, 250t, 251, 251t, 252t, artifacts, 110, 233, 234, 236
253–255, 521 ASN (average sample number), 202, 204,
necessary quantities for, 248t 205–206
one-way, 432, 433, 436, 436t, 440 curve for double sampling plan, 206f
in significance of regression test, 457–458, ASQ. see American Society for Quality (ASQ)
458t, 459 ASQ Auditing Handbook, 90, 92
two-way, 246, 432, 438–441, 440t, 506 ASQ Code of Ethics, 1, 41, 42f, 44
in variance component estimates, 252 assembly instructions, 186
analysis of variance (ANOVA) table, 247, assignable causes, 463, 464, 477, 477t. see also
436, 439, 440, 458, 507, 515 special causes
for conversion rate data, 437t ASTM (American Society for Testing and
one-way, 436t Materials), 175
for testing significance of regression, 458t AT&T, 5t
for two-factor factorial experiment, 508t ATI (average total inspection), 209
two-way, 440t attribute data, 216, 255, 343, 465, 485, 485f,
for ventilation example, 516t 489, 493. see also discrete data; variables
analytical hierarchy process (AHP), 284, 285 data
analytical studies, 363 attribute sampling plans, 196, 202, 206–207,
AND (activity network diagram), 27, 270, 210–211
271, 285 attributes chart, 571
AND gates, 274, 275, 276. see also fault tree attributes control charts, 474–475
(FT) audit planning, 91, 93–94
Anderson-Cook, C. M., 311, 520 auditee, 91–94, 97
angle measurements, 218, 219, 219t, 234 autocorrelation, 348, 348f, 460, 461, 462
ANOVA. see analysis of variance (ANOVA) automatic gauging, 345
ANSI Y14.5M standard, 127 automotive industry, 7t, 64, 312
ANSI/ASQ S1-2012 standard, 66 Automotive Industry Action Group (AIAG),
ANSI/ASQ Z1 standards, 211 64, 158, 179, 218, 242, 246, 487, 553
ANSI/ASQ Z1.4 standard, 202, 204, 206, 207, autoregressive integrated moving average
208, 209, 210 (ARIMA), 462
ANSI/ASQ Z1.4-2003 (R2018) standard, 197, availability, 239, 273f, 326, 327t, 328, 329, 329f
198 equipment, 313
ANSI/ASQ Z1.9 standard, 212, 212f, 213, instructor, 273f
214 maintainability and, 145
ANSI/ASQ Z1.9-2003 (R2018) standard, 213 reliability and, 133
ANSI/ASQC Z1.4-1993 standard, 197 of resources, 78
ANSI/EIA-649 standard, 187 in strategic planning, 14
ANSI/ISO/ASQ 9001:2015 standard, 189 average moving range, 471
appraisal costs, 99, 100, 101, 102t–103t average run length (ARL), 487
 Index 645

average sample number (ASN), 202, 204, blocking, 503, 504, 505–506
205–206 body of knowledge (BoK), 121, 133, 263, 271,
curve for double sampling plan, 206f 488, 555
average total inspection (ATI), 209 BoK (body of knowledge), 121, 133, 263, 271,
averages charts, 488, 571 488, 555
Awbi, H., 509 Bond, T. P., 193
Bothe, D. R., 490
Box, George, 6t–7t, 11
B box plots, 437
balanced scorecard, 20, 21, 40, 351, 563 Box-Cox transformation, 349f
balancing point, 353 brainstorming, 197, 306, 335, 336, 337, 554
Baldrige, Malcolm, 89 as facilitation tool, 55
Baldrige criteria, 7 in quality training, 112
base units, 232, 233–234, 234t–235t breakdown, 21, 27, 28f, 39, 327t, 541
batches, 185t, 207, 208, 209, 313 machine, 326, 445t, 446t, 447t
example, 385, 421 value, 147
sample integrity and, 215 breakthrough thinking, 295, 296f
in sampling methods, 350 Breyfogle, F. W., 309
sizes, 322 bridge-type configuration, 227
batching, 350 Brumbaugh, Martin, 4
bathtub curve, 147, 147f, 148. see also infant Brumbaugh Award, 4
mortality phase budgets, 33, 40f, 64, 107, 109, 113, 290f, 323
behavioral theory of leadership, 45 in maintenance productivity, 20, 21
Bell Laboratories, 4, 5t–6t project, 28, 30
Bell System, 8 for risk management activities, 541
benchmarking, 16–17, 18, 27, 124f, 294–295, Building on Baldrige (Council on
296f, 297, 337 Competitiveness), 89
in process observation, 289 Burdick, R. K., 244
in production systems, 293f business processes, 17, 21, 294, 296, 302, 304
in quality management, 271 business risks, 546
in risk evaluation, 553
benefits/costs, 26, 553
best practices, 17–18, 168t–170t, 171t, 426, 553
C
Baldrige Quality Award responsible for, c charts, 475, 480–481, 482f, 485, 485f, 489,
89 571. see also u charts
in benchmarking, 294–295 c control charts, 474
communication skills and, 58 CADDIEM model, 109
Bhattacharya, S., 360 calibration, 97t, 101, 221, 234, 239–241, 242,
bias, 51, 57, 91, 92, 241 350, 534
in measurement system analysis, 242, initial, 79
243t, 256 labor, 103t
in point estimates, 395 measurement tool, 35
bilateral tolerance, 127 process, 65, 236
bimodal distribution, 357 standards, 216, 218, 232
binomial distribution, 196–197, 384–385, system, 28
387–389, 405, 591t–592t uniformity, 233
in classification of quality characteristics, calipers, 217, 219, 220, 230
116 Camgoz-Akdag, H., 121
in k-out-of-n systems, 142 Camp, R. C., 294
in large sample sizes, 413 “can,” 116
biomedical industry, 88–89 Canadian Standards Association (CSA), 322
Bisgaard, Søren, 506 cantilever configuration, 227, 228f
block diagram, 140, 141, 159, 160 capability studies, 76, 353f, 363, 490, 491
646 Index

categorical frequency distribution, 358, 359t coefficients, 452, 454, 455, 507, 517
Cauchy distribution, 392 correlation, 362, 448, 449, 450
causation, 392 of determination, 459
cause-and-effect, 266, 281 regression, 451
cause-and-effect diagram, 6, 6t, 11, 160, 261, thermal expansion, 218
336, 337. see also fishbone diagrams; cold standby redundancy, 144
Ishikawa diagram collaborative benchmarking, 17
cause-and-effect loop, 544 Collins, J. C., 60
cdf. see cumulative distribution functions column-type configuration, 227, 228f
(cdfs) common cause variation, 463
center line average (CLA), 221, 222 community, 19, 258
center line (CL), 221, 376, 465–470, 472–473, comparative instruments, 218
475–477, 479–482, 484, 487–489 comparators, 218, 219, 221
central limit theorem, 352, 389–390, 402 competitive benchmarking, 17, 124f, 294. see
certification, 42f, 64, 67, 103r, 536 also benchmarking
ISO, 84 complement, 364, 365
ISO 9001, 7t, 85, 86, 88, 534 completely randomized design, 505
operator, 339 computer-assisted coordinate measuring
process, 340t machines, 226, 228
supplier, 5t concept fans, 276
third party management system, 92 concept phase, 117
vendor, 194, 286t, 288t concurrent engineering, 121
certified quality engineers (CQEs), 121, 258, condition parameters, 147
263, 271, 343, 345, 487. see also quality conditional probability, 368–369, 370, 372
engineers (QEs) conditions, 107, 369
change agents, 73 maximum material, 127, 128f, 220, 221
change control, 65, 215, 216, 555 conferences, 11, 68, 112t
change management, 73 confidence intervals, 401, 402, 419, 425, 428,
check sheets, 182, 264, 271, 339, 345, 345f 456
creation, 265–266 constructing, 407
in data collection, 335 for decision making, 431
as quality control tool, 258 in gage repeatability and reproducibility,
as quality information, 336 244
rank ordering, 260 hypothesis test and, 406, 408
simple, 266f on population variance and standard
checklists, 68, 152, 153, 300, 301t, 339, 340t deviation, 403–405
in audits, 93 for process capability indices, 496
for communicating expectations, 15 in single population, 396–399
for recording survey results, 67 in transformation of data, 383
chi-square distribution, 403, 411, 412, 443, for two independent populations,
446, 593t–594t 414–417, 420, 422
chi-square goodness-of-fit test, 441, 442, 444 with yield and temperature data, 457
Cianfrani, C. A., 85 confidence level, 397, 399, 406, 573
CL (center line), 221, 376, 465–470, 472–473, configuration, 134, 221, 227, 230, 236, 525
475–477, 479–482, 484, 487–489 change data, 160
CLA (center line average), 221, 222 control, 215, 216
closed-loop failure reporting, 151 network, 140
closing conference, 68 systems, 143
CM (configuration management), 65, 187, configuration management (CM), 65, 187,
216 216
CMMs (coordinate measuring machines), conflict, 15, 42f, 48, 49, 53, 85
173t–174t, 219, 226, 228f communication and, 60
coefficient of determination (R2), 459 in national standards, 83
 Index 647

operating principles and, 98 process and performance capability and,

resolution, 55, 56–57, 58, 110, 298 491–496
confounding, 505 for process capability, 497
consistency, 10, 15, 34, 187, 218, 237f, 238, in process FMEA, 177f
252 in process monitoring, 35
constant failure rate, 139, 145, 147f, 148, 148f, in quality function deployment, 122
149f in quality system, 78
constant variance, 433, 438, 459, 518 revised, 477t
constants, 466, 469, 472 as run chart, 460–463
for control charts, 465, 572 Shewhart, 4, 8, 486, 487
constraints, theory of, 11 six sigma and, 309
consumer’s risk, 195 standardized, 489
containment, 182, 185t, 332, 334 in statistical process control, 11
contingency planning, 13, 22, 557, 558, for thermal performance, 253f
568–569, 569f in timeline of quality methods, 5t–6t
in process decision program chart, 278 for turnaround times, 468f
for product recall, 78 use of, 464–465
supplier purchases and, 71 variables, 465–466
contingency tables, 367, 367t, 370, 444–445, control factors, 499
445t control limit formulas, 486, 571
continuous data, 343, 485 control of revisions, 83
continuous distributions, 372, 374, 376, 384, control plans, 64, 156, 181, 182, 183, 557
384t on corporation dashboard, 352f
continuous flow manufacturing, 384t example, 184f, 185f
continuous uniform distribution, 382 coordinate measuring machines (CMMs),
contour plots, 518–519, 520f 173t–174t, 219, 226, 228f
control charts, 263, 363, 468–469, 476, 483, COQ (cost of quality), 98–100, 101, 105, 106
488 core processes, 79
5-why analysis and, 336 corrective action, 79, 87–88, 97–99, 100–101,
in acceptance sampling, 193 106–107, 257, 331–340
for attributes, 191 in audits, 94
attributes of, 474–475 in control plans, 184f, 185f
as basic tool, 271 in an FMEA, 165t
central limit theorem and, 389–390 in Gantt chart, 29f
choosing, 485, 485f in house of quality diagram for a
for complete blood count analysis paperwork process, 123f
turnaround times, 471f initiating, 76
constants for, 572t in inspection, 229
control limits for, 467t, 470t phases of, 331f
in control plans, 185f in plan-so-study-act cycle, 299f
for controlling in-process performance, process, 133
296 in product and process control, 182–183,
in data visualization techniques, 351 186, 192–193, 209, 240
flowcharts and, 258 in project planning and estimation, 28
in gage R&R, 245, 251–252 in quality cost elements by category,
for individual observations, 473t 103t
individuals, 471, 472 in quality training, 111
moving average, 484 in reliability and maintainability, 132, 151,
number nonconforming, 480 158, 160–161, 179
for package weights, 474f in risk-based audit approach, 96t–97t
in partial manufacturing cost in SIPOC diagram, 292f
improvement goal tree, 277f in supplier management, 67–69
in problem correction, 338–339 corrective maintenance, 115, 146
648 Index

correlation, 124f, 125, 190, 255, 348, 362, Cudney, E., 236
459. see also autocorrelation; positive cumulative distribution functions (cdfs), 134,
correlation 136, 139, 197, 372, 374, 375
linear, 447–448, 449, 450f continuous distributions and, 380, 381,
positive, 266, 267f 383
correlation coefficient, 362, 448–449, 450f, 459 in failure density versus time, 138f
cost of quality (COQ), 98–100, 101, 105, 106 in light bulb example, 137t
cost system, 75, 76, 99–100, 106 cumulative frequency distribution, 358
costs/benefits, 21, 22, 26, 107, 553 cumulative sum (CUSUM), 6t
Coull, B., 405 current processes, 165t, 177t, 290, 311, 497
Council on Competitiveness, 89 curriculum, 109, 110, 112t, 273f
countdown, 341–342 customer demands, 22, 117, 281, 282f, 293f,
coupled activities, 285 316, 324, 325
Cp process capability index, 308, 309, 310f, customer focus, 14, 63, 73, 84, 297, 302, 534
385, 494, 496, 497 customer needs, 61, 62, 72, 76
Cpk process capability index, 177f, 308, 309, in continuous improvement, 271, 281, 295,
310f, 494, 495, 496, 497 296, 302, 313, 324, 330
Cpm process capability index, 494, 495, 496 in enterprise-level process map, 290f
CQEs (certified quality engineers), 121, 258, ISO 9000 standards and, 84
263, 271, 343, 345, 487 parametric conformance and, 306f
Cr process capability index, 494, 496 in product, process, and service design,
Crawford slip, 55 118, 119
creativity, 21, 55, 276, 295, 322, 326, 337, 338 quality cost implementation and, 101
in customer-driven quality, 63 customer value analysis, 61, 62
lost, 319 customer-driven quality, 62–63
in quality training, 110 CUSUM (cumulative sum), 6t
statistical conclusions and, 363 cycle times, 2, 12, 296, 313, 323–325, 328, 338
critical control points, 181, 183, 186, 555 in control chart analysis, 487
critical defects, 192, 207, 366 deployment techniques and, 16
critical design review, 126 length of, 301t
critical failures, 151 in quality function deployment, 282f
critical path, 33, 286, 287, 289 quality improvement and, 72
critical values, 447, 455, 456, 458, 458t in value stream map, 315f
ANOVA and, 436, 439
in contingency tables, 444, 446
in goodness-of-fit tests, 443
D
in hypothesis testing, 407–410, 412, 420, Daniel, C., 521
421, 428, 429, 430 dashboard, 20, 351–352, 352f, 564
criticality, 33, 179, 180, 187, 284, 548 data coding, 345, 349
criticality, risk, 547, 548t, 549, 549t data collection, 335, 339, 343, 346, 351, 355,
criticality analysis, 151, 179, 180f 500
critical-to-qualities (CtQs), 118, 119, 120, 291 benchmarking and, 295
examples, 120t check sheets in, 265
measures, 78 in data accuracy and integrity, 349–350
tree, 119f as deployment technique, 17, 20
Crosby, Philip, 3, 11, 270 full-factorial, 500t, 501t
Crosby Medal, 8 methods, 344
Crosby Quality College, 11 in quality information system, 36
Crowtha, Samuel, 5t data sorting and filtering, 346
CSA (Canadian Standards Association), 322 data summarizing, 265, 269, 343, 373
C-shaped manufacturing cells, 321, 321f DeBono, E., 295
CtQs. see critical-to-qualities (CtQs) decision criteria, 283, 284–285
cube plots, 510t, 511f decision trees, 22, 23, 24f, 25
 Index 649

defects, 10, 359t, 366, 493, 562f Dell Corporation, 17

classification of, 181 Delphi method, 284
correction, 321 Deming, W. Edwards, 1, 2, 4, 8, 9, 11, 195, 270
critical, 192, 207, 366 14 points, 10f
losses, 327t on control charts, 363, 486
major, 192, 207, 366 in timeline of quality methods, 5t–6t
manufacturing, 134, 359t, 563 total quality management and, 297
in material classification, 191–193 Deming cycle, 299. see also plan-do-study-act
minor, 191, 192, 193, 207 (PDSA) cycle
per million opportunities (DPMO), 305, Deming Medal, 8
309, 310f, 493 Deming Prize, 6t, 9
per unit (DPU), 191, 309 density functions. see probability density
prevention of, 64, 164t, 167t–168t, 189 functions (pdfs)
process, 265, 327t, 329f Department of Defense (DoD), 126, 187, 216
product, 115 dependent variables, 498, 499. see also
production, 275f independent variables
rates, 305, 309, 314 ANOVA and, 433
rates versus sigma-quality level, 307f in design and analysis of experiments,
serious, 192 500, 501, 504, 512, 516, 517
surface, 230 as factors of interest, 439t
zero, 7t, 11 linear regression and, 451, 452
define, measure, analyze, improve, control simple linear correlations and, 449
(DMAIC) process, 50, 121, 291, 310–311 depth rulers, 219
define, measure, reduce, combine, select descriptive statistics, 59, 343, 352, 405
(DMRCS), 311 design failure modes and effects analysis
defining relations, 524, 526t, 527 (dFMEA), 132, 157, 164t, 182
definition phase, 117 action priority for, 550t–552t
degrees of freedom (df), 434, 435, 436, 439, analysis content and documentation of,
440, 447 165t
in ANOVA table for conversion rate data, blank form for, 162f
437t in dashboard, 352f
in ANOVA table for testing significance of detection criteria, 172t–173t
regression, 458t example, 176f
in ANOVA table for two-factor factorial occurrence criteria, 168t–170t
experiment, 508t and pFMEA, 161
in ANOVA table for ventilation example, relationship with UFMEA, 179
516t severity criteria, 165t–166t
in chi-square distribution, 593t–594t design FMEA. see design failure modes and
confidence intervals and, 401, 402, 403 effects analysis (dFMEA)
in contingency tables, 446 design for Six Sigma (DFSS), 121
in F distribution, 580t–582t, 584t–586t, design of experiments (DOE), 53, 78, 80, 160.
588t–590t see also confounding
in full-factorial experiments, 507, 515, 520, in design FMEA example, 176t
521 in process FMEA example, 177f
in gage R&R, 247 design reviews, 47, 76, 125–126, 132, 157, 335
in goodness-of-fit tests, 441, 443 in corporation dashboard, 352f
in hypothesis testing, 412, 417, 418, 419, process, 133
420, 421, 427 designed experiment, 131, 182, 247, 491,
linear regression and, 455, 458 497–498. see also causation; nuisance
in one-way ANOVA table, 436t factor
in sampling distributions, 392, 393 in analysis of results, 503
in t distribution, 603t–604t planning and organizing, 502
in two-way ANOVA table, 440t published work on, 5t–7t
650 Index

replicates for, 520 in risk assessment, 543

statistical control and, 506 in risk management processes, 538
destructive tests, 181, 194, 214, 229, 230, 471. in risk-based audit approach, 95t–97t
see also nondestructive tests of standard operating procedures, 298
detailed design phase, 117 in supplier management, 69, 71
detection, 101, 131, 161, 179, 319, 341, 553 DoD (Department of Defense), 126, 187, 216
in FMEA, 165t, 172t–173t, 173t–175t Dodge, H. F., 5t
in UFMEA process, 178f DOD-STD-480A standard, 216
df. see degrees of freedom (df) DOD-STD-481 standard, 216
dFMEA. see design failure modes and effects DOD-STD-973 standard, 216
analysis (dFMEA) DOE. see design of experiments (DOE)
DFSS, 121 dot plots, 356, 357f
Diaconis, P., 268 double sampling plans, 202, 203t, 204, 204f,
diagnosis, 108, 182, 185f, 330 205, 206f, 209, 210t
diagnostic testing process, 260, 260f DPMO (defects per million opportunities),
dial indicators, 219, 220, 221 305, 309, 493
dimensional inspection, 131 in Six Sigma metrics and implementation
direct computer-controlled coordinate strategy, 310f
measuring machines, 227, 229 DPU (defects per unit), 191, 309
discrete data, 115, 116, 343, 380, 465, 485 DR (discrimination ratio), 253, 254
discrimination ratio (DR), 253, 254 driving forces, 273, 274f, 294
disjoint events, 365, 371 Dudding, B. P., 5t
dispersions, 211 Duffy, G. L., 331
disposition, 79, 105, 182, 183, 186, 191–193, Duncan, A. J., 6t
229 Durivage, M. A., 340
in control plans, 185f
costs, 103t
in product life cycle, 77f
E
in QFD house of quality diagram, 123f earliest completion time (EC), 286, 287, 287f,
suspect material, 184f 288t, 289
distribution function, 135, 136. see also earliest start time (ES), 286, 287, 287f, 288t,
cumulative distribution functions 289
(cdfs) Ebeling, C. E., 132, 136, 141, 143
failure time, 134 EC (earliest completion time), 286, 287, 287f,
probability, 372 288t, 289
in reliability function versus time, 137f Economic Control of Quality of Manufactured
distribution phase, 117 Product (Shewhart), 5t, 8
DMAIC process, 50, 121, 291, 310–311 economics of quality, 98–99, 100
DMRCS process, 310–311 eddy current testing, 230
documentation, 84, 125, 215, 216, 554, 555, education, 10, 43, 46, 47, 89, 113, 337
556 in ASQ Code of Ethics, 42f
in acceptance sampling, 193 in audits, 95t
in audits, 91, 92 computer support and, 274f
in deployment techniques, 22, 32 of Japanese industrial managers, 6t
in design, 116 quality, 102t
flowcharts in, 258 Edwards, George, 1, 2, 4, 8
FMEA, 160, 161, 164f EEO (equal employment opportunity), 41,
in product and process control, 183 132
project, 33 effect estimate, 509
in quality information systems, 34 eight disciplines (8D) model, 331
quality system, 28f 8 Wastes, 313, 318
in quality system, 79, 80–83 elimination, 5t, 55, 101, 313, 316, 319, 341, 557
in reliability and maintainability, 158 Elsayed, E. A., 140
 Index 651

ELT (extract, load, transform), 346 external failure costs, 101, 104t, 105. see also
emergency changes, 215 cost of quality (COQ)
empowerment, 72, 297 external quality audits, 91
empty set, 364, 365 extract, load, transform (ELT), 346
enterprise resource planning (ERP), 317 extract, transform, load (ETL), 346, 347f
enterprise risk management, 530, 536 extrapolation, 454
environmental stress screening (ESS), 132
equal employment opportunity (EEO), 41,
132
F
equipment limitation, 236, 237f F distribution, 393, 420, 436
equipment manufacturers (OEMs), 89, 126 F0.01, 587f–590f, 587t–590t
ERP (enterprise resource planning), 317 F0.05, 583f–586f, 583t–586t
error proofing, 174t, 341, 342. see also F0.10, 579f–582f, 579t–582t
foolproofing facilitation, 1, 51–57, 109, 110, 341
error sum of squares. see sum of squares, facilitators, 45, 50, 51, 52–54, 55–57, 72
error fact, management by, 271, 343
error variance, 435, 455 factor level, 438, 500, 505, 512, 518
ES (earliest start time), 286, 287, 287f, 288t, coded, 508t
289 for ventilation experiment, 510t
estimates. see point estimates factorial design, 499. see also 2k factorial
estimator, 211, 362, 468 design; two-level factorial designs
point, 395, 415, 423, 454, 496 full, 499, 500, 507, 513, 523, 524, 527
unbiased, 395 ventilation, 513t
ethics, 1, 43. see also ASQ Code of Ethics factorial experiments, 438, 500, 506, 508t, 523
ETL (extract, transform, load), 346, 347f fail-safe devices, 341, 341t, 342
event trees, 276 failure analysis, 103t, 151
EWMA (exponentially weighted moving failure costs, 99, 100, 101, 103t, 104t, 106
average), 460, 461, 484, 571 failure density, 135, 136, 137t, 138f, 139
excess motion, 319 failure density function, 137
excess movement of material, 319, 320 failure mode, effects, and criticality analysis
excess processing, 319, 322 (FMECA), 151, 179, 180f
executives, 1, 18, 35, 89, 301, 305, 311 failure modes and effects analysis (FMEA),
dashboards for, 351 22, 78, 175, 178, 179, 276, 556. see also
in evaluation, 112t design failure modes and effects
management, 108, 302, 304, 312 analysis (DFMEA); process failure
expected frequencies, 442, 443t, 444, 445, 446, mode and effects analysis (pFMEA);
447, 447t. see also chi-square goodness- use failure mode and effects analysis
of-fit test (UFMEA)
expected values, 22, 23, 25, 202, 395, 415, blank design form, 162f
423. see also decision trees; random blank process form, 163f
variables communication skills and, 59
for a decision, 24f design detection criteria, 172t–173t
in linear regression, 454 design example, 176f
in probability distributions, 375–376, 384 design occurrence criteria, 168t–170t
in statistical decision-making, 394 design severity criteria, 166t
experimental error, 440, 499, 501, 505, 512, example dashboard, 352f
514. see also random error in hazard based risk management, 152f
experiments. see designed experiment heading and documentation information,
exponential distribution, 139, 380, 381, 164t–165t
595t–596t in identification and documentation, 555
exponentially weighted moving average in management and leadership, 51
(EWMA), 6t, 486 process detection criteria, 173t–175t
external benchmarking, 17 process example, 177f
652 Index

process occurrence criteria, 171t FMECA. see failure mode, effects, and
process severity criteria, 166t–168t criticality analysis (FMECA)
in product and process control, 182, 183 Food and Drug Administration (FDA), 189
in reliability and maintainability, 151, foolproofing, 340t, 341t. see also error
156–161 proofing; preventive action
in risk assessment, 553 force field analysis, 55, 160, 271, 272–274,
supplier management and, 64 274f. see also affinity diagrams
in verification and validation, 132 Ford, Henry, 2, 5t
failure rate, 115, 126, 179, 388. see also bathtub Ford Motor Company, 15
curve; exponential distribution fraction defective, 198, 200t, 201t, 202, 216. see
constant, 139, 145, 147f, 148, 148f, 149, also fraction nonconforming
149f fraction nonconforming, 116, 194–195, 197,
in reliability and maintainability, 134, 135, 204, 205, 216, 362. see also fraction
141, 143, 146, 147 defective
in standby system, 144f average sample number curve and, 206f
failure rate model, 145, 147f, 148, 149. see also control charts, 465, 474, 475
bathtub curve and effect of changing accept number,
failure reporting, 151 200f
failure time distribution function, 134, 148 and effect of changing lot size, 201f
Family Educational Rights and Privacy Act operating characteristic curve and, 196f,
(FERPA), 43 199f, 202f, 203t, 204f
fault tree analysis, 78 probability of acceptance for various
fault tree (FT), 78, 160, 274, 275, 275f, 276, levels of, 198t
554, 563 in statistical decision-making, 404
Fazel, F., 72 in statistical process control, 475, 476, 479
Federal Drug Administration (FDA), 35 fractional factorial experiments, 523–527
Feigenbaum, Armand V., 6t, 11, 270, 297 free slack (FS), 287, 288t
Feigenbaum Medal, 8 Freedman, D., 268
filters, 53, 346 frequency distribution, 336, 357, 358, 358t,
financial measures, 21 359t
fishbone diagrams, 261, 262, 274, 333. see also FS (free slack), 287, 288t
cause-and-effect diagram; Ishikawa functional benchmarking, 294
diagram functional block diagram, 159, 160. see
Fisher, R. A., 5t, 506 also block diagram; reliability block
fitness for use, 3, 10, 115, 191, 193 diagram
fitted regression line, 452, 453f, 454 functional objectives, 16
5S methodology, 313. see also visual control
5-why analysis, 335, 336–337. see also root
cause analysis
G
fixed bridge configuration, 227, 228f gage blocks, 219, 219t, 221, 236, 239, 240
fixed horizontal arm configuration, 228f gage repeatability and reproducibility (R&R),
fixed limit gages, 220 182, 241, 243–255
fixed significance level, 428 ANOVA for, 250t
flow diagrams, 160, 183, 335 estimates using tabular method, 249t
flowcharts, 65, 178, 257, 258–260, 271, 314. see example, 248
also process maps; quality control tools results using ANOVA method, 251t
for diagnostic testing process, 260f role of control chart in, 251–252
primary symbols, 259f studies, 254–255, 350
process, 159, 276, 277f, 289 typical data for, 248t
for risk response planning process., 569f variance component estimates and, 252t
traceability, 190 gage variability, 244, 247, 253
FMEA. see failure modes and effects analysis Gale, B. T., 61
(FMEA) gantry-type configuration, 227, 228f
 Index 653

Gantt, Henry, 5t in information systems strategy matrix,

Gantt charts, 1, 27, 29f, 30, 32, 285 37f
Garvin, D. A., 3 in quality information systems, 36, 37, 39
gates, 274, 275, 276 in V model for software development, 38f
gauge R&R. see gage repeatability and Hayes, B. E., 61
reproducibility (R&R) hazard analysis and critical control points
gauging, 66, 173t–174t, 211, 221, 226, 230, 345. (HACCP), 183, 186, 555
see also product conformance hazard analysis process, 154f
GD&T (geometric dimensioning and hazard and operability analysis (HAZOP),
tolerancing), 127–129 555
general addition rule, 366, 372 hazard rate function, 134, 135, 136, 139, 149,
general failure rate model, 147f, 148, 149. see 150f
also bathtub curve HAZOP (hazard and operability analysis),
general multiplication rule, 210t, 369, 370, 555
371, 372 Health Insurance Portability and
general system process, 498f Accountability Act (HIPAA), 43
generators, 524, 526, 527 healthcare industry, 187
generic risk syntax, 544 heijunka box, 320, 321f
geometric dimensioning and tolerancing heparin, 189
(GD&T), 127–129 Hibino, S., 295
geometric distribution, 196, 388–389 hierarchical relationships, 16, 274. see also
geometric symbols, 128f tree diagrams
Gilbreth, Frank, 5t hierarchy, 27, 30, 45, 111, 276. see also
given conditions, 269, 369 analytical hierarchy process (AHP)
global benchmarking, 294 documentation, 81, 81f
goal trees, 276, 277f organizational, 46
Goldratt, Eliyahu M., 11 process, 290
go/no-go control gages, 220, 220f, 221. see risk, 530
also limit gages Hill, H. M., 111
go/no-go control method, 182, 184f HIPPA, 43
go/no-go control outcomes, 384 histograms, 160, 194, 260, 265, 490, 491. see
go/no-go counts, 115 also quality control tools
go/no-go decision, 26 in continuous improvement, 268–270, 271,
goodness-of-fit tests, 360, 441–444. see also 336, 339
expected frequencies in descriptive statistics, 356, 357, 358
Gosavi, A., 236 horizontal-arm configuration, 227
Gosset, W. S., 5t hot standby redundancy, 143
Grant, Eugene, 6, 11 house of quality diagrams, 123f
Great Britain, 5t–7t Hunter, J. Stuart, 6t, 7t, 525
Gryna, F. M., 11, 38, 108, 109, 110, 111, 260 hypergeometric distribution, 196, 387, 389
Quality Control Handbook, 6t hypothesis tests, 195, 242, 397, 406–428, 438
on traceability, 189 graphical, 488
guide words, 153 possible decisions and errors in, 430f
p-value approach to, 428–431
rejection region for, 416t, 418t, 420t, 424t
H in simple linear regression, 454, 456
Ha. see alternative hypothesis single sample, 412t, 413t
HACCP (hazard analysis and critical control two-sample, 431
points), 183, 186, 555
Hallock, M. L., 259
hardware, 48, 65, 180, 188, 262, 276. see also
I
environmental stress screening (ESS) IATF (International Automotive Task Force),
in design FMEA example, 176f–177f 89
654 Index

IATF 16949:2016, 89 integrity, 37, 42f, 78, 181, 191, 193, 343, 349
identification phase of risk management, interaction plots, 438, 440, 514, 519, 520
543, 544, 545, 554 for partition length and gap underneath,
IEC (International Electrotechnical 515f
Commission), 118 for partition length and partition height,
IEC 60812, 179 514f
IEC 61160, 118 for temperature and catalyst, 441f
implementation, 28, 30, 32, 33, 48, 60, 75, 81 two-way ANOVA and, 438f
in action plan, 31f, 32f interactions, 30, 134, 246, 290. see also
of quality management system, 29f sparsity-of-effects principle
implementation schedule, 32, 32f AB, 525t
implementation strategies, 303, 310f in design and analysis of experiments,
incoming inspection, 66, 69, 76, 96t, 102t, 563 524, 525, 526
incremental improvement, 13, 16, 17, 271 in design principles, 505
independent events, 276, 370, 372, 387 full-factorial experiments and, 507,
independent variables, 499, 500, 504, 505, 512–514, 517, 517t, 521, 522
516, 517. see also dependent variables; higher-order, 521
predictors; regressors low-order, 521
ANOVA and, 432, 439 professional, 31f
catalyst as, 432t, 439t two-factor, 255, 441, 508t, 512, 514, 524,
in graphical methods for depicting 525, 526
distributions, 360 intercept, 451, 452, 455, 456, 457
linear regression and, 451, 452, 453, 454, internal benchmarking, 17, 294
459 internal failure costs, 101, 103t–104t
simple linear correlation and, 449 internal quality, 91, 158
individuals chart, 472, 571 internal rate of return (IRR), 23, 25, 26
individuals control charts, 465, 471, 472 International Automotive Task Force (IATF),
Industry 4.0, 36 89
infant mortality phase, 147 International Bureau of Weights and
inferential statistics, 363, 406 Measures, 232, 234, 235t
information systems, 1, 28, 36, 37, 37f, 39, 41. International Electrotechnical Commission
see also quality information systems (IEC), 118, 179
(QIS) International Electrotechnical Institute, 83
information systems strategy matrix, 37, 37f International Organization for
information technology (IT), 38 Standardization (ISO), 6t, 7t, 83. see also
infrastructure, 39, 300, 302, 303, 304 management standards
innovation, 15, 16, 63, 77, 169t, 337 International Statistical Institute, 8
in-process performance, 296 International System of Units, 232, 234, 235t
input variable, 293, 464, 500 Internet of Things (IoT), 346
input-output matrix, 122, 123f interpersonal conflict, 49, 57
in-service review, 126 interquartile range, 340t
inspection, 4, 10, 131, 229 interrelationship digraphs, 271, 281–283, 284f
100%, 66, 185t, 193, 194, 195, 211, 230, 462 intersection, 279, 364, 365
incoming, 66, 69, 76, 96t, 102t, 563 interval estimation, 396. see also confidence
normal, 207–209, 208f, 210, 213 intervals
reduced, 194, 207, 208, 208f, 209 interval scales, 344
tightened, 196, 207, 208f, 209, 211, 212, inventory control, 189, 316, 340t
212f IoT (Internet of Things), 346
installation qualification (IQ), 133, 340t IQ (installation qualification), 133, 340t
instantaneous failure rate function, 135 IRR (internal rate of return), 23, 25, 26
Institute for Healthcare Improvement (IHI), Ishikawa, Kaoru, 6t, 7t, 11, 258, 270, 271
158 Ishikawa diagram, 155, 261. see also cause-
Institute of Quality Assurance, 5t, 7t and-effect diagram; fishbone diagrams
 Index 655

Ishikawa Medal, 8 definition of quality of, 3

ISO (International Organization for invited to lecture in Japan, 6t
Standardization), 6t, 7t, 83. see also as leading quality expert, 1, 4
management standards as quality engineering movement pioneer,
ISO 4287:1997, 222 2
ISO 9000, 189, 532, 533 total quality management and, 297
in leading quality initiatives, 50 Juran Medal, 8
in product, process, and service design, Juran trilogy, 9
116, 156, 158 Juran’s Quality Handbook, 10
published, 7t–8t just-in-case philosophy, 319
in quality management system, 30 just-in-time (JIT), 6t, 11, 63, 298, 313, 316. see
quality management system also pull system
implementation, 29t
Quality management system
implementation project, 28t
K
in quality system, 77, 78, 83, 84–88, 89, 91 kaizen, 270–271, 297, 298–299, 302, 313, 319,
supplier management and, 64 329
ISO 9000:2015, 65, 80, 81, 84, 85, 88 blitz, 54, 324
in management and leadership, 3 events, 352f
in verification and validation, 131, 132 kanban, 316–317, 317f, 320
ISO 9001, 534–536, 536–537, 536t Kaplan, Robert, 21
ISO 9004:2009, 88 Karsh, B., 259
ISO 10013:2021, 82 Keeps, E. J., 110
ISO 14971:2019, 152 Kerns, D. T., 294
ISO 19011:2011, 91 Kilmann, R. H., 57
ISO 31000:2018, 531, 537, 538, 544, 546, 556, kilogram, 234, 234t, 235t
561 Kirkpatrick, D. L., 61, 111
risk fundamentals and, 529 Knowles, M. S., 110
risk management process per, 538f Kolarik, W. J., 271, 272, 276, 278, 281, 283,
ISO 31010:2019, 548, 556 289, 290
ISO/R 468, 222, 222f Kotz, S., 491, 496, 497
ISO/TS 16949, 156, 189 k-out-of-n systems, 140, 142–143
IT (information technology), 38 k-values, 573

J L
Japan, 11, 109, 271, 285, 298, 313, 326, 341. see Laford, R. J., 66, 67, 68
also 5S methodology; kaizen; poka-yoke Larsen, G., 244, 255
develop quality methods, 4 latest completion time (LC), 286, 287, 287f,
industry rebuilding, 6t 288t, 289
postwar recovery, 9 latest start time (LS), 286, 287, 287f, 288t, 289
quality control circle concept introduced layout, 279, 281, 313, 319, 321, 509
in, 7t layout devices, 220
Japan Institute of Plant Maintenance (JIPM), LC (latest completion time), 286, 287, 287f,
326 288t, 289
Japanese Union of Scientists and Engineers LCL. see lower control limit (LCL)
(JUSE), 6t lean manufacturing, 11, 16, 95t, 302, 316. see
JIT (just-in-time), 6t, 11, 63, 298, 313, 316. see also lean thinking
also pull system lean philosophy, 1, 11
Joint Commission, 158 Lean Six Sigma (LSS), 8t
Judge, T., 44, 45, 55, 58 lean thinking, 315, 322, 325. see also lean
Juran, Joseph M., 8, 9–10, 11, 15, 101, 260, manufacturing
270, 310 learning, 110, 111, 112, 302, 312, 322, 329, 346
656 Index

Code of Ethics and, 41 Lovelace, C., 491, 496, 497

in facilitation principles and techniques, lower control limit (LCL), 465–484, 571
51, 54 in c charts, 482f
as level of evaluation, 112t in I and MR control charts, 474f
in process approach, 532 in np control chart, 480f
in quality management systems, 12, 21 in p charts, 478f, 479f
in quality system, 77 in u chart, 484f
quality training in, 109 in –x and R control charts, 253f, 468f
least squares circle (LSC), 225, 225f in –x and s control charts, 471f
least squares estimates, 452 lower specification limit (LSL), 212–214, 248,
Lee, H., 509 253, 308, 309, 493, 494–496
left-skewed distribution, 357 in normal distribution curve, 306f
legal commitments, 564 in normal distribution shift, 307f
legal constraints, 1 LRM (linear responsibility matrix), 27
legal implications, 78 LS (latest start time), 286, 287, 287f, 288t, 289
legal issues, 41 LSC (least squares circle), 225, 225f
legal mandates, 22 L-shaped bridge configuration, 228f, 277
legal measurements, 232 LSL. see lower specification limit (LSL)
legal metrology, 232 LSS (Lean Six Sigma), 8t, 87
legal requirements, 43 LTPD (lot tolerance percent defective), 195,
legal system, 41 197
legality, 71 Lu, L., 311
length measurements, 218, 219t, 221, 235
level of significance. see significance level
levels of factors, 438, 444, 506–507, 511, 511f,
M
519f MA (moving average), 460, 461, 484, 571. see
life cycles, 30, 76, 77, 78, 117, 118, 126, 534. see also autoregressive integrated moving
also bathtub curve average (ARIMA); exponentially
in contingency planning, 568 weighted moving average (EWMA)
product, 77f magnetic particle testing, 230, 231
risk management, 536t magnification of senses, 341
in risk monitoring, 560 main effects, 517, 518, 519, 521, 522
in risk planning and assessment, 540, 549 ANOVA and, 439
limit gages, 220. see also bathtub curve; go/ in full-factorial experiments, 509, 511, 512,
no-go control outcomes 513, 514, 516
line support subprocess interrelationship and interactions, 525t
digraph., 284f plot for air quality example, 512f
linear correlations, 447–450 three-factor interactions and, 526t
linear measuring, 217, 218, 219 in two-level fractional factorial
linear regression, 447, 451–460, 461. see also experiments, 524, 525, 526
regression analysis for ventilation factorial design, 513t
linear responsibility matrix (LRM), 27 maintainability, 115, 132, 133, 335
linearity, 242 availability and, 145–147
liquid penetration, 230 maintainability indices, 140
listening, 53, 59, 60 major defects, 192, 207, 366
local control of error, 505–506 Makino, T., 149
locating devices, 220 Malcolm Baldrige National Quality Award
lognormal distribution, 383 (MBNQA), 7, 7t, 62, 63, 83, 89, 90
Long, C. S., 38 Malshe, A., 233
lost creativity, 319 management by fact, 271, 343
lot size, 196, 197, 198–200, 201f, 201t, 202f, management standards, 89
209, 475 manufacturing process, 315, 337, 358, 388,
lot tolerance percent defective (LTPD), 195, 197 398–399, 499, 561
 Index 657

histograms in, 269 mean time between failures (MTBF), 144,

in reliability and maintainability, 133 146, 380
in reliability models, 148 mean time to failure (MTTF), 20, 21, 144, 145
supplier management and, 64, 65, 69 mean time to repair (MTTR), 20, 146
value stream map for, 314f means model, 433
in verification and validation, 131 measurement, 232
MAPs (measurement assurance protocols), angle, 234
241 length and angle, 218, 219, 219t
margin of error, 399, 400 methods, 503
marginal conditions, 107 of roundness, 224, 224f
marketing functions, 75 surface texture, 218, 221
Maslow’s hierarchy of needs, 45 wall thickness, 418t
mass inspection, 4, 10 measurement and test, 181, 216, 217
material control, 67, 159, 181, 186, 187 measurement assurance protocols (MAPs),
material review board (MRB), 185f, 191, 241
192–193 measurement errors, 61, 236, 244, 247, 249,
matrix charts, 109 430
matrix diagrams, 271, 278–281, 282f, 284 measurement processes, 194, 216, 241. see also
maximum inscribed circle (MIC), 225, 225f measurement system analysis (MSA)
maximum material condition (MMC), 127, measurement scales, 269, 343, 344
128f, 129, 130, 220, 221 measurement system, 345, 488, 500, 503
“may,” 116 calibration and, 239
Mayo, Elton, 4 in data collection, 350
MBNQA (Malcolm Baldrige National destructive and nondestructive tests and,
Quality Award), 7, 7t, 62, 63, 83, 89, 90 229
MCC (minimum circumscribed circle), 225, in gage R&R, 253–255, 255–256
225f leadership principles and techniques and,
McClaskey, D. J., 111 45
mean, population, 402, 408–410, 414, measurement system analysis and, 241,
416–417, 426, 428 242, 243, 244
confidence intervals and, 396, 397, 398, standards of measurement and, 232
399, 401 measurement system analysis (MSA), 181,
in descriptive statistics, 353, 354, 356 182, 241–257. see also bias
linear regression and, 454 measurement tools, 1, 35, 181, 217–218, 339,
in probability distributions, 376, 377 352
in statistical decision-making, 394, 395 length, 218, 221, 235
testing, 411t measuring process, 18, 79, 236, 237, 237f, 238,
mean, single sample, 409t, 411t 490
mean squares (MS), 247, 248, 250, 435, 436, measuring systems, 79, 216–217, 226, 236,
439, 455, 507 239, 240
in ANOVA for gage R&R, 250t median, 336, 353, 354–355, 572t
ANOVA table for conversion rate data, ranks, 599t–600t
437t median chart, 572
ANOVA table for testing significance of median ranks, 599t–600t
regression, 458t meetings, 29f, 48, 50, 61, 301
in ANOVA table for two-factor factorial agenda, 52, 53
experiment, 508t closing, 94
in ANOVA table for ventilation example, FMEA, 159, 160
516t management skills, 53
necessary quantities for ANOVA and, opening, 93
248t pre-survey, 67
in one-way ANOVA table, 436t project, 57
in two-way ANOVA table, 440t quality management review, 95t
658 Index

review, 542 team, 301

steering committee, 28 worker, 4
work review, 32 Motorola, 7t, 109
mentoring, 109, 110, 111 moving average (MA), 460, 461, 484, 571. see
meter, 219, 234, 234t, 235, 235t, 236, 339t also autoregressive integrated moving
metrology, 181, 217, 218, 224, 231–241 average (ARIMA); exponentially
surface, 221 weighted moving average (EWMA)
MIC (maximum inscribed circle), 225, 225f moving bridge configuration, 228f
micrometers, 219–220, 230 moving horizontal arm configuration, 228f
milestone charts, 30. see also Gantt charts moving range chart, 473, 474, 571
milestones, 38, 151, 157, 333, 334 moving ranges (MR), 471–472, 473t, 474,
critical events as, 285 474f, 492
for FMEA, 158 charts, 491, 571
implementation, 338 MRB (material review board), 185f, 191,
major, 159 192–193
organizational, 35 MRS (minimum radial separation), 187f, 225,
program, 15 225f, 226
project, 33 MS. see mean squares (MS)
on time bar, 27 MSA (measurement system analysis), 181,
MIL-HDBK-61A(SE) standard, 187 182, 241–257. see also bias
MIL-STD 1629A standard, 157, 179, 180 MTBF (mean time between failures), 144,
minimum circumscribed circle (MCC), 225, 146, 380
225f MTTF (mean time to failure), 20, 21, 144, 145
minimum radial separation (MRS), 225, 225f, MTTR (mean time to repair), 20, 146
226 muda, 298, 313, 319
minimum zone circle (MZC), 225, 225f multinomial distribution, 388
Minitab, 245, 251, 348f, 349f, 487 multiple linear regression, 447
minor defects, 191, 192, 193, 207 multiple sampling plans, 202–204, 209, 210,
mission statements, 26, 27 210t
mitigation, 341 multivoting, 56, 56t
mitigation planning, 556, 564–569 mutually exclusive events, 365, 371
MMC (maximum material condition), 127, My Life and Work (Ford), 5t
128f, 129, 130, 220, 221 Myers-Briggs Type Indicator, 27, 48
model fitting, 458, 504, 514, 516, 518, 522t. see MZC (minimum zone circle), 225, 225f
also residual analysis
modes, 144, 144f. see also failure modes and
effects analysis (FMEA)
N
Mohanty, 458t Nadler, D. T., 294
monitoring, risk, 533, 538, 548t, 556, 559–561, Nadler, G., 295
562f, 564 naming conventions, 37, 38
Montgomery, Douglas C., 466 National Institute of Standards and
on dimensions of quality, 3 Technology (NIST), 89, 232, 234, 235t,
on effective management of quality, 80 239, 240, 241, 298
on gage R&R experiments, 244, 255 natural process limits, 495
on industry-specific standards, 83 natural tolerance limits, 493
on normality assumption, 390 natural variation, 463
on normally distributed data, 491 NAVAIR (Naval Air Systems Command),
on process performance indices, 497 118, 297
on significant factors, 520 Naval Air Systems Command (NAVAIR),
on workforce training, 297–298 118, 297
motivation, 1, 45, 73, 109, 297 Nazli, E. K., 121
employee, 78 NDT (nondestructive testing), 67, 181, 214,
task, 55 229–231
 Index 659

needs analysis, 109, 111 in developing, building, and organizing

negligible effects, 521 teams, 48
negotiation, 32, 46, 48, 53, 57 in gage R&R, 246–247
Nelson, Lloyd S., 7t hypothesis tests and, 406, 412, 420, 427
net present value (NPV), 22, 23, 25, 26 in point estimates, 395
networking, 37, 37f probability density function for, 377f,
networks, 36, 39, 286. see also activity 378f, 379f
network diagram (AND) in quantitative methods and tools, 359
CPM, 285, 287, 287f, 289 in reliability models, 149
IoT, 346 in reliability/safety/hazard assessment
local area and wide area, 41 tools, 151
telecommunications, 134, 140 in sampling distributions, 392, 393
NIST (National Institute of Standards and shifted, 307f
Technology), 89, 232, 234, 235t, 239, normal inspection, 207–209, 210, 213
240, 241, 298 normal probability plots, 359–360, 438, 459,
no correlation, 266, 267f. see also positive 460, 491, 518, 521. see also probability
correlation plots
noise factor, 499–500, 501, 505. see also of estimated effects for air quality
nuisance factor example, 522f
nominal group technique, 55–56, 56t, 284 of puncture force data, 360f
nominal scales, 344 of residuals for air quality example,
nonconforming products, 66, 96t, 185f, 189, 519f
191, 193, 229 normal scores, 601t–602t
goodness-of-fit test and, 443–444 normal use phase, 117
historical percentages of, 442t Norton, David, 21
nonconforming units, 78, 79, 343, 385, 387, not-mission capable equipment due to
424, 442, 475 maintenance (NMCM), 460, 461f
classification of, 194 np charts, 474–475, 479, 480, 482, 571
in containment, 185f NPV (net present value), 22, 23, 25, 26
as variable of interest, 384 NPV model, 22
nonconformity, 87, 116, 191, 332, 389, 442, 535 nuisance factor, 504, 505. see also blocking;
data, 443t noise factor
historical percentages of, 442t null hypothesis, 406–408
nondestructive testing (NDT), 67, 181, 214, number nonconforming control charts,
229–231 474–475, 479, 480, 482
nondestructive tests, 67, 181, 182, 214, 230. numeric studies, 363
see also destructive tests
non-value-added activities, 108, 298, 316,
319, 321, 322. see also value added/
O
non-value added observed frequencies, 442, 443t, 446
non-value-added components, 324 observed significance level, 429. see also
normal distribution, 360, 491. see also p-values
lognormal distribution; standard obsolescence and disposal phase, 117
normal distribution OC curve. see operating characteristic (OC)
ANOVA and, 433 curve
centered, 306f Occupational Safety and Health
central limit theorem and, 389, 390 Administration (OSHA), 144
confidence intervals and, 398, 400 OEE (overall equipment effectiveness),
in continuous distributions, 376–377, 379, 326–329, 327t, 329f
381, 383 OEMs (equipment manufacturers), 89, 126
control charts and, 465 Ohno, Taiichi, 6t
curve, 306f on-condition maintenance. see predictive
in deployment techniques, 22 maintenance
660 Index

100% inspections, 185f, 185t, 194, 195, 211, Palady, P., 159
230. see also screening; sorting paper standards, 233, 236
in acceptance sampling, 193 parallel systems, 140, 141, 142f, 143
in sampling inspection, 66 parameters, 198, 222, 294, 346, 353, 395, 426,
in statistical process control, 462 451
one-sided tolerance, 406, 573 design, 112
one-way ANOVA, 432, 433, 436, 436t, 440. see estimating, 452
also analysis of variance (ANOVA) manufacturing, 127
operating characteristic (OC) curve, 195, modulating, 532
196f, 197, 198, 199f, 202 of normal distribution, 376
calculations for double sampling plan, operating, 157
203t population correlation coefficient p, 448
for double sampling plan, 204f premeasured, 228
for sampling plans, 202f process, 488, 490
types A and B, 196 scale, 149, 150f
operational qualification (OQ), 133 shape, 149, 150f, 381
operator certification, 339 surface roughness, 222f, 223, 223f
operator fallibility, 236, 237f threshold, 381
opportunity, 493 Pareto, Vilfredo, 9, 260
opposing forces, 273, 274, 274f Pareto analysis, 106, 107, 271, 333
optical projectors, 221 Pareto charts, 106, 187, 258, 260–261, 261f,
OQ (operational qualification), 133 265
OR gates, 274, 275, 276. see also fault tree (FT) Pareto diagrams, 9, 160, 336, 339
ordinal scales, 344, 548 Pareto principle, 9, 56, 106
organizational goals, 16 Parsowith, B. S., 82
organizational hierarchy, 46 parts per million (ppm), 70, 305, 493,
organizational objectives, 16 574t–575t
organizational strategy, 16 part-to-part variation, 248
out of statistical control, 462, 473, 480, 484f, Pascal distribution, 388
486 payback period, 23, 26
outlier, 350, 356, 357, 477, 493 PC (peak count), 223
Outlier Test, 348 PCB (printed circuit board), 362, 489
plot test, 348f PCs (permanent corrections), 332
out-of-roundness, 218, 225, 225f, 226 pdf. see probability density functions (pdfs)
output variables, 500. see also dependent PDPC. see process decision program charts
variables (PDPC)
overadjustment, 182, 463, 486 peak count (PC), 223
overall equipment effectiveness (OEE), Pearlson, K. E., 37, 534
326–329, 327t, 329f percentiles, 359, 360
overcontrol, 463, 485 performance capability, 343, 490–496
overproduction, 298, 319 performance indices, 490, 497, 561, 563
oversight, 275f, 536t, 554 performance measures, 1, 248, 335, 352, 564
in deployment techniques, 17, 18, 19, 20,
21
P in quality management systems, 33
p charts, 474, 475–477, 477t, 479, 482, 485, 571. permanent corrections (PCs), 332
see also np charts Perry, B., 61
for errors in account activities, 478f personally identifiable information (PII), 43
in flow chart for control chart selection, PERT (program evaluation and review
485f technique), 285
for surgical site infection rate, 479f pFMEA. see process failure mode and effects
Page, E. S., 6t analysis (pFMEA)
paired observations, 426t Phillips, J. J., 111
 Index 661

philosophy, 319 Porras, J. I., 60

lean, 1, 11 positional tolerances, 129, 130f
quality, 2, 3, 11 positive control, 339
physical artifacts, 233, 234, 236 positive correlation, 266, 267f
PII (personally identifiable information), 43 positrol, 339, 339t
Pinar, I. H., 121 potential failure modes, 157, 161, 175, 179,
plan-do-check-act (PDCA), 297, 299, 342, 533, 182. see also fault tree (FT)
533f, 534. see also plan-do-study-act in analysis content and documentation of
(PDSA) cycle an FMEA, 164t–165t
plan-do-study-act (PDSA) cycle, 61, 297, 299, on blank design FMEA form, 162f, 163f
299f, 331, 331f, 342. see also Deming in design FMEA example, 176f
cycle; plan-do-check-act (PDCA) in process FMEA example, 177f
planned customer-driven quality, 62 power (statistical), 226, 300, 430–431, 512
planning tools, 30, 122, 257, 270–296 PowerPoint, 59
PLC (programmable logic controllers), 36–38 ppm (parts per million), 70, 305, 493,
pmf. see probability mass function (pmf) 574t–575t
point estimates, 394–396, 403, 404, 417, 452, PPQ (process performance qualification),
454, 456, 492 133
Poisson distribution, 116, 196, 197, 380, PQ (process qualification), 133
386–387, 389, 597t–598t practical interpretation, 397
poka-yoke, 182, 298, 329–330, 330f, 341 practical significance, 431. see also statistical
policy deployment, 22, 34 significance
policy statement, 81 precision, 231, 233, 236–237, 238, 241, 242. see
politics, 71, 72 also metrology
pooled standard deviation, 417, 418t in data collection methods, 345
pooled variance, 417, 418t definition, 243
population correlation coefficient, 448–449 in drawing statistical conclusions, 363
population mean, 401, 402, 408–409, 414, 416, measurement tools and, 218, 220, 221, 224,
417, 426, 428. see also pooled variance 226
confidence intervals for, 398 in measuring process, 237f
in continuous distributions, 376, 377 in process capability indices, 496
in descriptive statistics, 353, 354, 356 in statistical decision-making, 395, 399
in linear regression, 454 precision measurement. see metrology
in statistical decision-making, 394–397, precision-to-tolerance ratios (PTRs), 252–254,
399 494
testing, 410, 411t predictive maintenance, 115, 146–147, 327t
population median, 354 predictors, 451
population mode, 354 preliminary design review, 126, 157
population proportions, 396, 404, 405, 408, prevention costs, 99, 100–101, 102t, 106
413, 422, 423, 424 preventive action, 146, 257, 330, 331, 340,
population standard deviation, 356, 396, 404, 342, 533, 534. see also fail-safe devices;
409, 410 foolproofing
population variances, 419, 420, 421. see also process, 28f
pooled variance quality standards and, 86
ANOVA and, 436 in risk-based audit approach, 97t
confidence intervals and, 396, 398, 400, preventive maintenance, 96t, 115, 146, 340t.
402, 403–404 see also fail-safe devices
in continuous distributions, 376 preventive maintenance tools, 133–139
in descriptive statistics, 352, 356 printed circuit board (PCB), 362, 489
in hypothesis testing, 408, 410, 411, 415, prioritization matrices, 271, 283–285
417, 418 priority changes, 2
in point estimates, 395 proactive approaches, 539, 557
in sampling distributions, 393 probabilistic interpretation, 397
662 Index

probability density functions (pdfs), 149, process and performance capability, 343,
309, 372, 375, 384, 392. see also failure 352f, 490
density function process approach, 84, 532, 532f, 533, 533f, 534
for constant failure rate, 148f process audits, 65, 94, 101
in continuous distributions, 380, 381, 382, process behavior charts, 8. see also Shewhart
384t control charts
and cumulative density functions, 373 process capability, 253, 308, 309, 336, 352,
for exponentially distributed random 390, 493, 497
variable., 380f acceptance sampling and, 193
for normal distribution, 377f indices, 494
predictive and preventive maintenance inputs and, 118
tools and, 134, 135, 136, 139 ratios, 496, 496t
quality characteristics and, 115 in reliability and maintainability, 160
for a random variable X, 373f studies, 76, 490, 491
in reliability models, 148 process certification, 339, 340t
for standard normal distribution, 378f, process control, 8
379f process control chart, 4
for three t distributions, 392f process decision program charts (PDPC),
for Weibull model, 150f, 382f 160, 271, 276–280, 280t, 285, 290, 292
probability distributions, 151, 343, 364, enterprise-level process, 290t
372–393, 395, 441, 490. see also receiving/storage/stocking subprocesses,
cumulative distribution functions 279f
(cdfs); probability density functions visual alternative–improved subprocess,
(pdfs); probability mass function (pmf) 291f
approximations to, 389f process defects, 265, 327t
continuous uniform, 382f process design, 76, 117, 133, 156, 157, 159, 160
probability mass function (pmf), 197, 372, process environment, 236, 237f
374, 375, 385, 386, 389 process failure mode and effects analysis
for discrete distributions, 390t (pFMEA), 51, 157, 161, 175, 177f, 182,
line graph of, 374f 352f. see also failure modes and effects
probability of a type I error, 436 analysis (FMEA)
probability of acceptance, 195–198, 196f, 198t, blank form for, 163f
199t, 201t, 202. see also consumer’s risk detection criteria, 173t–175t
probability path, 155f occurrence criteria, 170t–171t
probability plots, 438, 459, 460, 490, 491, 518, process control, 165t
521 process function, 164f
normal, 519f, 522f severity criteria, 166t–168t
Weibull, 359–360, 361f process flowcharts, 159, 258, 276, 277f, 289
probability x impact, 548t process improvement team, 16, 26, 46, 48,
problem correction, 333, 337, 339 302
problem identification, 333–334 process logs, 486, 488
problem solving, 156, 257, 261, 297, 331, process mapping, 284f
340. see also failure modes and effects process maps, 27, 271, 289–290, 290f, 291f
analysis (FMEA) process performance, 46, 310, 340, 490
facilitator roles and responsibilities and, specifications vs., 491–494
53 process performance indices, 497
in leading quality initiatives, 50 process performance qualification (PPQ), 133
Pareto charts and, 258 process qualification (PQ), 133
in product, process, and service design, process reliability, 118
125 process stability, 490, 491. see also stable
problem statement, 248, 334, 336, 408, 409, processes
430, 443 process standard deviation, 468, 492, 494
procedural conflict, 53, 57 process surveys, 66
 Index 663

process value chain (PVC), 271, 292–294, Code of Ethics and, 41

293f, 325 and control, 462
diagrams, 292, 293f material review board and, 80, 192
maps, 325 personnel, 64, 66, 241
process variability, 455, 465, 468, 471, 498, 520 procedures, 269
producer’s risk, 195. see also probability of a program, 240
type I error in quality system, 75
product audits, 65 techniques, 41
product conformance, 229, 230 quality audits, 75, 90–93, 103t
product designs, 15, 67, 78, 121, 156–157, 187, quality control tools, 53, 257–258. see also
322, 560 statistical process control (SPC)
approval and release, 30f quality cost, 98–99, 335
in basic plan-so-study-act cycle, 299f categories, 100–101
and development, 77f collection, 105
inputs, 95t elements by category, 102t–104t
qualification test, 102t implementation, 101
product identification, 188–189 management of, 100
product recalls, 78, 101, 191 principles and lessons, 107–108
Production Part Approval Process Manual reporting, 106
(AIAG), 64 summary and analysis, 105
production phase, 117, 538 systems, 75, 76, 99, 106
production readiness review, 126 using, 106
profile limits, 127 quality cost implementation, 101
program evaluation and review technique quality council, 297, 333, 334, 338, 340
(PERT), 285 quality engineers (QEs), 75, 115, 258, 266,
programmable logic controllers (PLCs), 36–38 413, 531. see also certified quality
project charter, 26, 27 engineers (CQEs)
project justification, 26 communication skills and, 59
project management, 34, 38, 51, 289, 304, 541, customer relations and, 61, 63
559 FMEAs encountered by, 156
in deployment techniques, 16, 18, 22, 30 lead quality initiatives, 50–51
in strategic planning, 15 legal constraints, 1, 41, 44
project scope, 26, 27, 30f in product and process control, 182, 183,
prototype phase, 117 187, 193
protractors, 220 reliability and maintainability and, 157
PTRs (precision-to-tolerance ratios), 252–254, role of, 36–37, 108–110, 340–341
494 training of, 108
pull system, 312–313. see also push system use of 8D model, 331
push system, 312. see also pull system use of cause and effect analysis, 263
p-values, 251, 428–429, 429f, 436, 440, 507, use of control charts, 389
515, 517. see also significance level use of deployment techniques, 16, 22, 23
PVC. see process value chain (PVC) use of quality information system, 35, 38
use of statistical methods, 255
quality function deployment (QFD), 109,
Q 121–122, 123f, 125, 156, 281, 297
QE. see quality engineers (QEs) matrix diagram example, 282f
QFD. see quality function deployment (QFD) quality information systems (QIS), 12, 34–39,
QIS (quality information systems), 12, 34–39, 41, 64, 71
41, 64, 71 quality initiatives, 16, 50, 72, 115, 297, 310
qualitative factors, 499 communication skills and, 58
quality assurance, 226, 258. see also Institute in leadership principles and techniques,
of Quality Assurance; supplier quality 44
assurance (SQA) in quality system, 75, 79
664 Index

quality management system (QMS), 1, 12, 28, range method, 211, 211t, 212, 212f, 244, 246,
35, 81, 82. see also quality council 254, 255
implementation project, 29f ranges charts, 473, 474, 571
in quality audits, 94 rapid continuous improvement (RCI), 324
quality standards and, 84–85, 87, 88 ratio scales, 344
in risk management, 534–535 rational subgrouping, 462, 464
in risk-based audit approach, 95t–97t RCDQ (reactive customer-driven quality), 62
quality manual, 67, 79, 80, 81, 82, 95t RCI (rapid continuous improvement), 324
quality philosophy, 2, 3, 11 reactive customer-driven quality (RCDQ), 62
quality planning, 45, 62, 100, 121, 156, 183 readability, 238. see also sensitivity
in customer relations, 80 receiving/storage/stocking subprocesses
in management and leadership, 10, 15 PDPC, 279f
as quality cost element, 102t recurrence control, 333, 339
in quality information systems, 37 reduced inspection, 194, 207, 208, 208f, 209
quality policy, 28, 29f, 34, 81, 81f redundancy, 108, 143, 144, 341, 350
quality program, 1, 10, 67, 68, 73, 81, 89, 98 regression. see linear regression
as quality cost element, 102t, 106 regression analysis, 459, 516
in reliability and maintainability, 156, 158 regression coefficients, 451
six sigma and, 302, 303 regression line, 451, 452, 453, 453f, 454, 457,
total quality management and, 297 459
Quality Progress (magazine), 3, 7t regression models, 451, 457, 458, 517
quality records, 79, 81, 81f, 82 current, 459
quality standards, 64, 83–84, 88–89, 101, 194. fitted, 454
see also appraisal costs linear, 459, 461
quality system documentation, 28, 81 simple linear, 451, 454
quality system manual (QSM), 28, 29f temperature and yield, 458t
quality system procedures (QSP), 29f regression sum of squares, 457–458, 458t
quality systems, 35, 41, 66, 75, 106, 534 regressors, 451
standards, 7t rejection regions, 410, 412, 413, 415, 418, 420,
quantitative concepts, 343, 361–371 421, 423
quantitative measurement system, 255 goodness-of-fit tests and, 443
quantitative variable, 266 for a hypothesis test on means of two
questionnaires, 61, 112t, 152, 153, 339 independent samples, 416t, 418t
quick fix, 73 for a hypothesis test on two independent
proportions, 424t
for a hypothesis test on two independent
R variances, 420t
R charts. see –x and R charts p-value approach and, 428
R&D (research and development), 15, 16, for a single sample hypothesis test on
215 proportion, 413t
R&R (repeatability and reproducibility), 45, for a single sample hypothesis test on
215. see also gage repeatability and variance, 412t
reproducibility (R&R) for a single sample mean, 409t, 411t
RACI (responsible, accountable, consulted, in statistical decision-making, 407–408
and informed) matrix, 27, 28, 30f, 541 reliability allocation, 20
radio frequency identification (RFID), 187, reliability block diagram, 141. see also block
188, 346 diagram
radiographic techniques, 230 reliability engineering, 6t–7t, 20, 133
random error, 236, 242, 247, 433, 451. see also reliability function, 115, 134, 136, 137f, 145,
experimental error 148, 149, 149f. see also survival function
random experiments, 364 reliability models, 133, 147–151
random variables, 373f, 374f, 380f repeatability, 218, 237f, 243, 249t, 250t, 251t,
randomization, 254, 438, 504–506, 510 252t
 Index 665

repeatability and reproducibility (R&R), 45, risk identification, 86, 533, 534, 537, 540,
215. see also gage repeatability and 543–545, 554. see also risk assessment
reproducibility (R&R) risk management plan, 538, 539–543, 548, 555
repeated measures, 242, 254, 505 risk management process, 534, 536, 537, 538,
replacement costs, 103t, 167t, 190, 341, 371, 539, 541, 546. see also risk assessment
387, 389 overview, 537f
replication, 254, 501, 504, 505, 506, 512, 520, per ISO 31000:2018, 538f
523 in risk-based audit approach, 95t
reporting systems, 13, 15, 106 risk matrices, 155, 161, 179, 541, 547–549, 553,
research and development (R&D), 15, 16, 215 567
residual analysis, 459, 522 5x5, 547t
residuals, 438, 454, 459, 518, 519f, 520f coded for risk levels by acceptability
resistant measure, 355 decisions, 549t
resolution, conflict, 55, 56–57, 58, 110, 298 populated using probability x impact,
resolution III designs, 525, 526 548t
resolution IV designs, 525, 526, 526t risk mitigation, 533, 547, 556, 557, 560, 563
resolution V designs, 526 ISO 9000 and, 86
resource requirements matrix (RRM), 27, 30 in outcomes of risk evaluation process,
response surface methodology, 6t 553f
response variable, 293f, 503t in reliability and maintainability, 156, 161
responsible, accountable, consulted, and in risk management, 532, 541, 542, 553
informed (RACI) matrix, 27, 28, 30f, risk monitoring, 533, 538, 548t, 556, 559–561,
541 562f, 564
return on assets, 26 risk planning, 533, 539, 540, 568
return on investment (ROI), 1, 11, 21, 23, 26, risk priority number (RPN), 161, 165t, 178f,
98, 111, 292 179, 182, 547
ReVelle, J. B., 313 risk reduction, 531, 547, 550t–552t
RFDI (radio frequency identification), 187, risk response planning, 560, 564, 565f, 566,
188, 346 568, 569f
risk acceptance, 533 risk syntax, 543, 544, 545
risk analysis, 276, 533, 537, 538, 541, 544–545, risk tolerance, 546, 564
546, 569 risk treatment, 554, 569
consequence analysis and occurrence available, 564, 566
assignment, 545f in mitigation planning, 566, 567, 568
methods for, 539 options, 546, 558f, 564
results of, 554 in risk assessment, 553
in risk-based audit approach, 97t in risk management, 536, 540, 542
tools and techniques for, 543 in risk monitoring, 560, 561
risk appetite, 540, 546, 547, 553 strategies, 557, 558
risk assessment, 22, 161, 179, 536, 537, 538. risk-based process approach, 532, 532f
see also risk management process risk-based thinking, 533, 534, 536t, 538
in FMEA, 164t–165t Robbins, S. P., 44, 45, 55, 58
in identification and documentation, 554 Roberts, S. W., 6
in risk management process overview, robust design, 277f, 341, 342
537f robust systems, 11, 174t
in risk management system evaluation, robustness, 363, 419, 433, 459, 460
556 Rodriguez-Perez, J., 183, 186
in risk monitoring, 560 ROI (return on investment), 1, 11, 21, 23, 26
in risk planning and assessment, 539, 540, role-play, 110–111
543–544 rolled throughput yield (RTY), 309, 310f
risk attitudes, 557, 564 Romig, H. G., 5t
risk control, 154f, 155, 156, 543, 547, 553, 557 root cause analysis, 155, 160, 193, 333, 334
risk evaluation process, 538, 553, 553f root mean square (RMS), 221
666 Index

Rother, M., 315, 337 sampling distributions, 390, 391–395, 398. see
roundness, 128f, 226, 237 also standard error (s.e.)
measurement, 224, 224f sampling inspections, 66, 78, 194, 229. see also
RPN (risk priority number), 161, 165t, 178f, acceptance sampling
179, 182, 547 sampling methods, 5t, 212, 349, 350–351
RRM (resource requirements matrix), 27, 30 sampling plans, 66, 193, 197, 198, 199,
RTY (rolled throughput yield), 309, 310f 211–213, 491
Rule of Ten, 218 acceptance number, 195–196, 203
run charts, 160, 263–264, 264f, 336, 339, 460, attribute, 202, 206, 210
461f. see also descriptive statistics double, 203t, 204, 204f, 205, 206f, 209
Russell, J. P., 216, 488, 556 military, 6t
Sarbanes-Oxley (Sarbox) legislation, 41
Sarbox/SOX, 41
S Sauer Danfoss Company, 188
SAE (Society of Automotive Engineers), 64, Saunders, C. S., 37
157 SCADA (supervisory control and data
SAE J1739 standard, 157, 165t, 179 acquisition) systems, 36–37
Salegna, G., 72 scatter diagrams, 258, 266–267, 267f, 271,
sample homogeneity, 351 277f, 336. see also scatter plots
sample integrity, 214–215 scatter plots, 449f, 450f, 451, 453f. see also
sample mean, 353, 355, 362, 393–396. see also scatter diagrams
central limit theorem scientific framework, 271
in control charts, 253f, 468f, 471f Scientific Management (Taylor), 4, 5t
rejection regions for, 409t, 411t scientific method, 298, 331
sample mode, 354 scorecard, 106, 107, 352, 564
sample ranges, 245, 251, 253f, 255, 355, 468f balanced, 20, 21, 40, 351, 563
sample size, 362, 390, 400, 414, 591t–592t. see Scott, D., 268
also sampling plans screening, 193, 194, 230, 502, 503, 523, 524. see
in acceptance sampling, 211t also 100% inspections
changing, 199f, 200f SDWT (self-directed work team), 47
in control chart selection, 485f s.e. (standard error), 393–396, 455–457. see
in control plans, 184f also sampling distributions
in double sampling size, 203t self-directed work team (SDWT), 47
in indifference quality level, 200t sensitivity, 62t, 78, 218, 237f, 238, 431, 563. see
OC curves and, 202f also readability
in probability of acceptance, 199t sensitivity analysis, 25
in product and process control, 182, sequential activities, 285
198–200, 206, 209, 211, 213 series systems, 140–141, 140f
in risk-based audit approach, 96t serious defects, 192
in sampling plans, 210t service delivery, 17, 65, 117, 118, 120t,
unequal, 479f 156–160
sample spaces, 364–365, 373. see also setup instructions, 186
complement seven deadly diseases, 9
sample standard deviation, 395, 403, 410, severity, 155, 178f, 179, 541, 542, 555. see also
426, 468, 494, 497. see also dispersions; risk priority number (RPN)
sample variance in action priority rating levels, 550t–552t
in acceptance sampling, 211, 214 circumstances affecting, 153f
in control charts, 471f criteria, 165t, 166t–168t, 178t
in descriptive statistics, 356, 358 design, 166t
in turnaround time data, 469t–470t of harm, 155f
sample variance, 251, 355–356, 401, 403, 407, in hazard analysis process, 154f
412, 417, 420. see also sample standard level, 548t, 549t
deviation; variance component estimates “shall,” 116
 Index 667

Shewhart, Walter A., 1, 2, 8–9, 270, 271, 299, in Pareto analysis, 333
465 in reaction plans, 183
timeline, 5t source inspection, 364–365, 373
Shewhart control charts, 4, 8, 465, 485, 486, sparsity-of-effects principle, 521
487 special addition rule, 365, 366, 368, 371, 372
Shewhart control limits, 486 special causes, 9, 252, 462, 463, 487, 491. see
Shewhart cycle, 299. see also plan-do-study- also assignable causes
act (PDSA) cycle special checking, 341, 342
Shewhart Medal, 4, 8–9 special multiplication rule, 372
Shingo, Shigeo, 6, 270, 325 specification limits, 35, 193, 211–214, 212f,
Shook, J., 315 306f, 307f, 492, 493
short-run statistical process control, 488–489 specification phase, 117
“should,” 116 sponsors, 7t, 11, 32, 38, 39, 46, 48, 239
SI (Systems International), 232, 234, 235t SQA (supplier quality assurance), 70
signal-to-noise ratios (SNRs), 252, 254 SQM (supplier quality management), 64
significance level, 428, 429, 430. see also type SQP (strategic quality planning), 12, 13, 13f,
I errors 62
confidence intervals and, 396 SS. see sum of squares
contingency tables and, 446 stable processes, 363, 486, 491
in hypothesis testing, 407, 410, 418 stakeholders, 21, 27, 30, 85, 117, 531, 538, 555.
short-run statistical process control and, see also stockholders
488 analysis, 18–19, 542
simple linear correlations, 447–450 communication, 553
simple linear regression, 451, 452, 459 concerns, 547
hypothesis testing in, 454–457 consensus, 568
simple random sampling, 350 disagreement among, 554
Simpson, J. R., 506 feedback, 16
Simpson, O. J., 214 FMEA team leader responsibility to, 164t
sine bars, 220 indirect, 19
single minute exchange of dies (SMED), key, 13f, 18, 311, 539
325–326, 327t relevant, 539
single sampling plans, 195–198, 198–199, 204 requirements, 26
SIPOC diagrams, 271, 289–292, 292f. see also review, 566
current processes risk to, 546, 564
Six Sigma needs, 300, 301t roles and responsibilities, 540–541
skewed distribution, 357, 383 tolerances, 542
skip-lot inspections, 66, 96t value, 297
slope, 448, 451, 452, 455, 456, 457 standard deviation, 305, 376, 377, 409, 438,
SMART (specific, measurable, achievable, 469, 486
realistic, and time-based), 13, 14 standard deviation chart, 571
SMED (single minute exchange of dies), standard error (s.e.), 393–396, 455–457. see
325–326, 327t also sampling distributions
SNRs (signal-to-noise ratios), 252, 254 standard normal distribution, 377, 409, 413,
Society of Automotive Engineers (SAE), 64, 489, 492
157 areas under to left of Z-values, 576t–578t
sorting, 105, 167t, 168t, 184f, 330 probability density function for, 378f, 379f
in 5S, 313 for selected Z-values, 574t–575t
affinity principle used to, 272 in testing population mean, 411t
decision to, 193 standard normal random variables, 377, 392.
in histograms, 268 see also t distribution
inspections, 108 standard repair, 193
inventory, 320 standard work, 323, 323f
in kaizen improvement, 298 standardized control charts, 489
668 Index

standardized work, 313, 323 in ANOVA approach, 514

standards of measurement, 232–233 in ANOVA for gage R&R example, 250t
standby systems, 140, 143–145, 144f in ANOVA table for conversion rate data,
StarLink, 188 437t
statistical control, 473, 480, 486, 487, 491, 497, in ANOVA table for ventilation example,
506. see also stable processes 516t
in acceptance sampling, 195 due to treatments, 434, 435, 436t
in c chart for number of billing errors, regression, 457, 458, 458t
482f residual, 457
in quality system, 78, 79 total, 248t, 434, 436t, 439, 440t, 457, 458t, 508t
quantitative concepts and, 363 sum of squares, error, 434, 435, 439, 452, 455,
in statistical process control, 462 457, 458
in u chart for billing statement errors, 484f in ANOVA table for testing significance of
statistical decision making, 343, 363, 391, regression, 458t
394–395, 512 in ANOVA table for two-factor factorial
statistical process control (SPC), 1, 11, 28, 67, experiment, 508t
80, 343, 390, 460. see also average run in necessary quantities for an analysis of
length (ARL) variance, 248t
short run, 488 in one-way ANOVA table, 436t
in statistical process control, 462–488 in two-way ANOVA table, 440t
statistical quality control (SQC), 6t–7t, 9 Sumithra, B., 360
statistical significance, 431, 449. see also supervisory control and data acquisition
practical significance (SCADA) system, 36–37
statistical tests, 350, 359, 363 supplier quality assurance (SQA), 70
statistical tolerance factors for at least 99% of supplier quality management (SQM), 64
the population, 573 supply chain, 50, 86, 92, 117, 187, 561, 563
statistical tolerance intervals, 405 in quality methods, 8t
steel rulers, 219 in risk monitoring example, 562f
stem-and-leaf plots, 356, 490 surface metrology, 221
Stevenson, W., 261, 264 surface plates, 219, 220
stockholders, 18, 21. see also stakeholders surface texture measurement, 218, 221–222
Stolovitch, H. D., 110 survival function. see reliability function
strategic planning, 1, 34, 35, 38, 89 SWOT (strengths, weaknesses, opportunities,
basic design of, 75 and threats), 12, 13
formalized, 72 system audits, 65, 69, 90, 91, 102t
in leadership principles and techniques, system surveys, 66, 67
45 systematic errors, 236, 242
leading quality initiatives and, 50 systems change, 48
organizing teams in, 46 Systems Engineering Technical Review
process, 13, 62 Process, 118
in quality improvement, 73 Systems International (SI), 232, 234, 235t
in quality management systems, 12–16,
17, 18, 19, 21
in quality system, 79
T
strategic quality planning (SQP), 12, 13, 13f, t distribution. see Student’s t distribution
62 tabular method, 244–246, 249, 249t, 251, 252t,
strategic quality plans, 13f, 564–569 253, 254, 255. see also range method
stratified sampling, 350, 351 Taguchi, Genichi, 6t–7t, 11, 270
strong claim, 408, 410, 414, 416, 419 Tague, N., 156, 276, 283
Student’s t distribution, 392, 400, 401, 415 takt time, 313, 323–325. see also customer
Sturges’s rule, 268 demands
subgroup size, 480, 485, 485f, 572 tally sheets, 345. see also check sheets
sum of squares, 247, 436, 459, 507, 521. see Taylor, Frederick W, 4, 5. see also Scientific
also mean squares (MS) Management (Taylor)
 Index 669

teams, 46–50, 47f two-factor experiments, 439

technical drawings, 115, 127 two-factor factorial, 506
technical specifications, 38, 75, 279f two-factor interactions, 508t
telecommunications, 59, 88, 89, 134, 140 two-factor interaction model, 508t
Tennessee Eastman Company, 111 two-factor interactions, 441, 512, 514, 521,
test for significance of regression, 457, 458t 524–525, 526t
test statistic, 407–416, 411t, 443, 444, 447, 456 two-factor model, 246, 247, 508t
theoretical probability, 372 2k designs, 520–523. see also 2k factorial design
theory of constraints (TOC), 11 2k factorial design, 7t, 507, 515, 520, 521, 523
Thomas, K. W., 57 two-level factorial designs, 207, 523
threat, 12, 13, 300, 534, 544, 557. see also two-way ANOVA, 246, 432, 438, 440t, 441, 506
SWOT (strengths, weaknesses, two-way contingency table, 444
opportunities, and threats) type I errors, 407, 430, 430f, 436. see also
in ASQ Code of Ethics, 42f significance level
classification of, 544t type II errors, 195, 407, 430, 430f, 431
in risk response, 559f
tightened inspection, 196, 207, 209, 211, 212,
212f
U
time series analysis, 447, 462 u charts, 475, 482–483, 485, 571
time-dependent task diagrams, 27 for billing statement errors, 484f
tolerance intervals, 405–406 in flow chart for control chart selection,
tolerance limits, 78, 493, 495 485f. see also c charts
total productive maintenance (TPM), 319, u control charts, 474, 484f
326, 330–331 UCL. see upper control limit (UCL)
total quality control, 11 UFMEA (use failure mode and effects
Total Quality Control (Feigenbaum), 6 analysis), 175, 178, 178f, 179, 287
total quality cost, 101, 105, 106, 107 UFMEA process, 178f
total quality management (TQM), 11 ultrasonic testing, 230, 231
total slack (TS), 287, 288t unbiased estimator, 395
total sum of squares, 434, 439, 457 underadjustment, 463, 486
Townsend, A., 221 undercontrol, 463
Toyoda, Eiji, 6t ungrouped frequency distribution, 357
Toyota, 320 uniform distribution, 382, 383
Toyota Production System, 6t, 317f, 318f, unilateral tolerance, 127
321f, 323f, 325 union (of events), 364, 365
TPM (total productive maintenance), 319, union (worker organization), 322, 333
326, 330–331 universal set, 364
TQM (total quality management), 11 upper control limit (UCL), 465–470, 472–473,
traceability, 39, 121, 181, 187–191, 239 475, 477, 479–484, 571
trait theory of leadership:, 45 in c charts, 482f
treatment combinations, 499–500, 504, 505, in I and MR control charts, 474f
507, 509. see also replication in np control chart, 480f
tree diagrams, 160, 271, 274–276, 283. see also in p charts, 478f, 479f
fault tree (FT) in u charts, 484f
trend analysis, 35, 460, 461 in –x and R control charts, 253f, 468f
trust, 49, 55, 72, 73 in –x and s control charts, 471f
TS (total slack), 287, 288t upper specification limit (USL), 212–214, 248,
t-tests, 410, 449, 455, 507, 512, 517, 521. see 253, 308–309, 493–496
also Student’s t distribution in normal distribution curve, 306f
factors and interactions for, 517t in normal distribution shift, 397f
in hypothesis testing, 425, 426 use failure mode and effects analysis
results for air quality example, 522t (UFMEA), 175, 178, 178f, 179, 287
statistical software output of, 429f “useful many,” 9
two-factor design, 255 USL. see upper specification limit (USL)
670 Index

V WBS (work breakdown structure), 27, 28f, 30

weak claim, 408, 409, 413, 422, 425, 428, 444
V model, 37, 38f webinars, 110
validation, 132 Weibull distribution, 149, 282f, 359–361,
value added/non-value added, 108, 319, 324, 381–382
328. see also non-value-added activities Weibull hazard rate function, 149
defect correction and, 321 Weibull model, 150f
excess processing and, 322 Welch, Jack, 303
graph of, 316 West, J. E., 85
process sequences, 292 Westcott, R. T., 88
work activities, 298 Wheeler, D. J., 254, 497, 506
value chain diagrams, 271, 292, 293f, 315 Whitehouse, D., 218
value stream mapping (VSM), 314, 314f, 315, Whitney, Eli, 5t
315f, 316, 323 Wilson, K. B., 6t
values of t distribution, 603t–604t WIP (work in progress), 186, 313, 319, 325
Van Patten, J., 314 Wood, R. C., 61
variables charts, 465–466, 488, 571 work breakdown structure (WBS), 27, 28f, 30
variables control charts, 465, 474 work groups, 15, 45–47, 297, 333, 334, 337,
variables data, 115, 343, 465, 471, 485, 489, 340
493. see also attribute data; continuous work in process (WIP), 186, 313, 319, 325
data work instructions, 65, 76, 79, 81, 82, 181, 186
variables sampling plans, 210–211 8 Wastes and, 322
variance component estimates, 248, 251, 252, ISO 9001 quality management system, 29t
252t quality documentation hierarchy, 81f
verification, 79, 96t, 172t–173t, 174t, 183, 185f World War II, 4, 9, 11, 111
design, 165t
of effectiveness, 333, 340, 564
in product life cycle and quality system
X
elements, 77f –x and R charts, 465, 474, 485, 492, 497, 571
reliability, 71 in control charts, 251, 252
and validation, 76, 115, 130–133, 168t–169t in control plans, 182
vernier calipers, 219 in flow chart for control chart selection,
Vining, G., 351, 433, 441, 444, 454, 488, 506, 485f
520 by operator, 253f
visual communication, 59 turnaround time data for, 467t
visual control, 313, 318, 318f –x and s charts, 465, 469, 472, 488, 491, 492,
visual factories, 318 547
visual inspection, 131, 231 turnaround time data for, 469t–470t
“vital few,” 9, 20, 106, 260 Xerox, 17, 294
voice of the customer (VOC), 119, 121, 122, x-rays, 230
291, 300
VSM (value stream map), 314, 314f, 315, 315f,
316, 323
Y
yield regression model, 458t
W
waiting, 319
Z
Wal-Mart, 17 zero defects (ZD), 7t, 11
warm standby, 144 Z-values, 308, 376, 379, 391, 574t–575t,
Watson, G. H., 294, 295 576t–578t