Quality Engineering, 1 1 (3), 427-442 (1 999

Edgardo J. Escalante
ITESM, Departamento de Ingenieria Industrial
Sucursal de Correos J
64849 Monterrey NL, Mexico
Key Words
Variation; Defects; Variation reduction; Quality improve-
ment; Productivity improvement.
Since the development of quantitative techniques to
improve quality, like control charts, design of experiments,
evolutionary operation, response surfaces, Taguchi methods,
poka-yoke, and others, the measurement, reduction, and
control of variation and defects have been the driving force
to achieve a significant improvement in the quality of prod-
ucts and services.
The objective of this article is to gather and to contrast
opinions, propositions, and points of view regarding the
personal philosophy as well as applicable techniques lead-
ing to the improvement of quality, expressed by well-known
experts (theorists and some practitioners) in the field of
Definition of Variation
For Shewhart ( I) , sampling variation or fluctuations are
defined as differences between things, even if produced
under presumably the same conditions. Quality varies from
piece to piece. Juran and Gryna (2) agree with Shewhart's
definition of variation and observe that variation is part of
Copyright 0 1999 by Marcel Dekker, Inc.
life. Kane (3) defines variation in more statistical terms as
the spread or range of the process where most values occur.
For Taylor (4), statistical variation is defined as the differ-
ences among ideally identical units of product. For Barker
(9, variety is the spice of life, but variation is the nemesis
of quality.
Obviously, two products can be identical, depending on
the precision of the instrument used to measure them. In-
creasing precision will decrease the number of identical
products. How much precision is needed to evaluate a qual-
ity characteristic? It will depend on the type of product and
on the needs and resources of a particular firm. The effects
of variation are not the same for all products according to
their use. Some of them are more sensitive to variation than
others. Furthermore, reducing variation could be costly.
Types of Error and Defect
Mitra (6) defines "nonconformity" as a quality charac-
teristic that does not meet its stipulated specifications re-
quirement. A "nonconforming unit" is one that has one or
more nonconformities such that the unit is unable to meet
the intended standards and is unable to function as required.
"Defect" (7) is defined as a departure of a quality charac-
teristic from its intended level or state that occurs with a
severity sufficient to cause an associated product or service
not to satisfy intended normal, or reasonably foreseeable,
usage requirements. The modem term for "defect" is "non-
conformity," and a term for "defective" is "nonconforming
item." Banks (8) makes a distinction between nonconfor-
mity and defect by establishing that nonconforming is re-
lated to not meeting specifications and that defect is related
to not being useful, instead of not meeting requirements.
Juran and Gryna (2) also comment that in some cases, a
nonconforming unit will be fit for use. However, we will
assume that a product that does not meet specifications will
not be useful, and hence support Mitra's identification of
nonconformity and defect, and nonconforming unit and a
defective unit.
There are errors and there are defects. According to
Shingo (9), defects are the outcome of errors. As with varia-
tion, errors are also a part of life. Humans are prone to
commit errors, and it is perhaps impossible to eliminate
them completely. Nonetheless, it is possible to prevent them
from being transformed into defects. For Shingo, the major-
ity of mistakes are inadvertent.
A wider classification of different kinds of error are as
follows (1 0):
Forgetfulness: forgetting things due to lack of con-
Misunderstanding: wrong conclusion due to lack of
familiarity with the situation
Identification: misjudgment of a situation due to
quick viewing
Amateurs: mistakes due to lack of experience
Willful: errors due to ignoring the rules
Inadvertent: unnoticed mistakes due to absent-
Slowness: mistakes due to delays in judgment
Lack of standards: errors due to lack of suitable
instructions or work standards
Surprise: errors due to equipment malfunctions
Intentional: deliberate errors like crimes and sabo-
tages (in this case, the word "error" is considered
as a volition act rather than a mistake)
The following types of defect have been identified (10):
Omitted processing
Processing errors
Errors setting up workpieces
Missing parts
Wrong parts
Processing wrong workpiece
Adjustment error
Equipment not set up properly
Tools and jigs improperly prepared
Human errors are usually inadvertent. Juran and Gryna (2)
and Ishihara (1 1) propose a shorter list of errors. That list
is included in Shingo's classification. All of them include
inadvertent errors.
SourcedCauses of Variation
In a classical sense, Shewhart (1) classifies all causes of
variation into two systems of chance (or unknown) causes:
1. Constant (or controlled), in the sense that a certain
consistency is produced in the output of a process.
Its effects can be predicted, at least within limits, by
means of probability.
2. Variable. These causes are called assignable. Ex-
amples in manufacturing are differences in machines
and in sources of raw material.
It is possible to find and eliminate variable chance
causes, but not those of constant systems, in which there is
no predominating cause. There will always be sampling
fluctuations in the quality of a product. These sampling fluc-
tuations are controlled and can be predicted by probability
theory if they come from a constant system of causes. Juran
and Gryna (2) agree with Shewhart about the dual classifi-
cation of random (chance, common) causes, which produce
chronic problems, and assignable (special, specific) causes,
which produce sporadic problems.
Deming (12) follows the lead of Shewhart. Common
causes of variation are faults of the system and responsibil-
ity of management. Special causes of variation are specific
to a local condition. Its elimination is sometimes the respon-
sibility of people involved with the operation, but some
other times, it is management's responsibility (12,13). Con-
fusion between these two causes leads to greater variabil-
ity and to higher costs. The proportion of causes is 94%
common and 6% special. The three-sigma control limits
proposed by Shewhart are a rational and economic guide to
minimum economic loss from confounding between special
and common causes of variation. If a process is subject to
common causes of variation only, it is considered stable or
in statistical control. It does not mean that its variation is
small; it means it is predictable under certain limits. Its
improvement must come from the system. When a process
is out of control, it does not mean its variation is large; it
means it is unpredictable. The way of improving it is to
adjust the process immediately. Then, three-sigma control
limits are a way of knowing when to act on a process, by
identifying when to adjust it locally (if the process is out of
control) and when to let it run free from changes (if the pro-
cess is in control). Acting on a stable process increases
variation. This action is called "tampering."
The Western Electric Quality Control Handbook (14)
agrees with Shewhart, in that fluctuations in the data are
caused by a large number of minute variations or differ-
ences: differences in materials, equipment, the surrounding
atmospheric conditions, and the physical and mental reac-
tions of people. Most of these differences are extremely
Taguchi (1 5,16) (see also Ref. 17) defines error factors-
noise-as elements that cause variability in product func-
I .
External noise (environmental) (during use of the
Deterioration noise or internal noise (deterioration
during storage or during use so it can no longer
achieve its target functions)
Variational noise or unit-to-unit noise (differences
between individual units due to manufacturing im-
Sources of Variability [Unit-to-Unit Noise (17)J During
The sources of variability in production are all factors
that, because of their inherent variation, may affect the level
of specific quality characteristics: materials and purchased
components, process drift, tool wear, machine failure, vari-
ability in execution, and human error (15).
Bhote (18) is more specific by mainly describing com-
mon causes of variation (i.e., poor management, poor prod-
uct/process/component specifications, inadequate quality
system, poor supplier materials) and one special cause of
variation (i.e., "operator" errors). He also lists the causes of
these sources of variation and their remedies (1 8, Table 4-
1). Bhote is in agreement with Deming and Juran in that
management has the main responsibility for poor quality.
For Kane (3), sources of variation can be classified ac-
cording to the factors that compose a manufacturing pro-
cess: men, methods, machines, materials, measurement, and
environment. Variation is attributable to fluctuation in one
or more of the above factors and fluctuations in samples.
Harmful variation is uncontrolled variation, or controlled but
out of specifications.
Taylor (4), as well as Kane and Taguchi, has a more
pragmatic and specific classification of variation sources:
1. Manufacturing variation. This is the result of fluc-
tuation in materials and key process parameters, pro-
cess conditions, operator's variation, wearing and
changing in tooling, change in methods and manu-
facturing environment, storage, and transportation of
products (variation up to the time the product is de-
livered to the customer).
2. Usage variation. This comes from differences in
manners and conditions of use.
3. Variation because of deterioration. This is a result
of product aging.
Grant and Leavenworth (19) contribute with a very spe-
cific breakdown of source. Again, their main source of in-
formation is Shewhart: There is a certain amount of varia-
tion as a result of chance. Variation within a stable system
of chance causes is inevitable. Some variability is unavoid-
able; the amount of this basic variability will depend on
various characteristics of the production process, such as
machines, the material, and the operators.
Breakdown of Sources of Variability
Product spread is composed of variation between and
within lots. The variation within a lot could be the result of
variation between different streams of product and the varia-
tion within a particular stream. There is difference across
time for a particular stream, as well as at a particular instant.
For a particular instant of time, in the case of a machine with
multiple heads or positions, there are differences regarding
the location of a particular position as well as differences
between pieces produced in the same head because of pro-
cess variation and also due to human and equipment mea-
surement error. A summary of the above decomposition of
variability sources is shown in Figure 1.
On citing the Production and Engineering Bulletin (1 9a),
Grant and Leavenworth establish another source of variabil-
ity; that is, errors: "on a hand-operated job, errors will in-
crease variability of the product."
Hinckley and Barkan (20) add one cause not specifically
addressed by others: complexity related to the design of a
Sources/Causes of Defects
Shingo (9) is well known for his contributions in the
fields of quality and productivity. His development of the
"Zero Quality Control System" is a new way of thinking
about the possibility of reaching zero defects in manufac-
turing. Shingo made a clear separation between errors and
defects. Defects arise because errors are made. The two have
a cause-and-effect relationship.
In general, there are five situations in which defects
Product s o d :
-Lot-to-lot variation.
-Within lot variation:
-Stream-to-stream variation.
-Within stream variation:
-Time-to-time variation.
-Within time variation:
-Piece positional variation.
-Piece-to-piece variation:
-Inherent process variation.
-Error of measurement:
-Measurement Equipment error.
-Human error.
Figure 1. Breakdown of sources of variability. (From Ref. 19.)
1. Inappropriate standard work processes or inappro-
priate standard operating procedures
2. Excessive variation in actual operations
3. Damaged raw materials or excessive variation in
4. Tools with excessive play or worn out
5. Inadvertent errors by workers or machines
Nonetheless, errors are not the only cause of problems;
consider, for instance, lack of system optimization and prod-
uct complexity as sources of defects. The relationship be-
tween errors and defects is illustrated in Figure 2.
Juran and Gryna (2) established three sources of worker-
related defects:
1. Lack of attention.
2. Lack of technique.
3. Feelings of revenge, sometimes incited by manage-
Figure 2. Relationship between errors and defects.
(Adapted from Ref. 10.)
Adjustments errors, incorrect operation, incorrect piece or
equipment setup, wrong piece, others.
ment, when putting more emphasis on quantity
rather than quality. This is a consideration that is not
specifically included in Shinfo's work.
Processing omissions,
processing errors.
Kane (3) is in agreement with Shingo. For Kane, causes of
defects are lack of preventive maintenance, lack of training,
variability of work processes, and poor housekeeping.
Ishihara (1 1) adds two other causes: confusion and uncer-
Taylor (4) sheds light onto the problem of when defects
are due to errors and when they are due to excess of varia-
tion in the process. This is a key point in the method of
attacking defects. The two basic mechanisms causing de-
fects are errors and functional relationships. For instance,
in a bottling operation, a cap could be missing because the
operator failed to put one on (error). The cap could also
have fallen off due to poor tolerances resulting in a low
removal force. A functional relationship is one that relates
several inputs (e.g., dimensions of caps) and the output (e.g.,
removal force).
A new factor, proposed by Hinckley and Barkan (20) and
Hinckley (21) in addition to variation and mistakes, is com-
plexity. Complexity is related to the design of a product; see
Figure 3.
Figure4 shows an affinity diagram-a tool which ar-
ranges information that is in a disorganized state, by form-
ing groups based on common grounds (22,23)Ño all the
causes of variation and defects. It is obvious that manage-
Missing parts,
wrong items.
Figure 3. Relationship between complexity and
nonconformities. (Adapted from Ref. 20.)
t t
Defective products Defective subassemblies
ment has the main responsibility for poor quality, because,
as we see in Fig. 4, most causes of variation belong to them.
Common causes of variation could be eliminated through
the implementation of specific and permanent evaluation,
control, and improvement programs, and, as Deming said,
working less hard but more intelligently.
Again, it is possible to set up a frame for Figure 3 (see
Fig. 5) based on management's responsibility for poor qual-
i t y-common causes-as well as a connection between
mistakes and variation.
Relationship of Variation, Quality, and Nonconformities
There is a strong relationship among variation, quality,
and nonconformities. Several definitions of quality, from a
"manufacturing" perspective, are discussed in this section.
They exclude all the other aspects of quality considered in
a classic paper by Gamin (24).
Shewhart (1,25) defined quality as conformance to speci-
fied standards. Quality is controlled to attain uniformity, by
finding and removing causes of variability. Controlled qual-
ity will exhibit minimum variability and minimum fraction
defective; see Figure 6. Hence, to attain uniformity, it is
necessary to reduce variation, thus reducing the fraction
For Deming (12) and Box (26) (see also Ref. 27), high
quality is frequently associated with minimizing variation.
Taguchi (15) (see also Ref 28) defines quality as the loss
a product causes to society after being shipped, other than
-Poor light.
-Handling of materials.
-Heat or cold.
-Poor ventilation.
-Bad food.
-Poor housekeeping.
i -Etc.
-Deterioration with age.
-Wear outs durinc use.
-Human error.
1 -Deterioration due to transportation. 1
. -^
manner and conditions of use.
conditions during use.
-Variability of work processes.
-Procedures not suited.
-Management's emphasis on quantity rather than quality.
-Inadequate quality system, inadequate data.
-Uncertainty and confusion.
Figure 4. Causes of variation and defects.
-Inappropiate standard operating
-Imperfect standards.
-Change in methods.
-Inappropiate standard work processes.
-Deviation from standards.
-Poor specifications for product, processes,
and components.
-Poor instructions and supervision.
-To01 wear.
-Excessive play.
-Incorrect setups.
-Changing in tooling.
-Inadvertent errors.
-Lack of technique.
-Lack of attention.
-Lack of training.
-Lack of practice.
-Lack of preventive
rat^^ vh&ion/ variability e x d o n .
-Failure to measure the effect of common causes and to reduce
f ¥
Figure 5. Addition of management responsibility as well as
a connection between mistakes and variation.
by its intrinsic functions. To describe what intrinsic func-
tions mean, Taguchi gives the example of alcoholic bever-
ages. Because they contain alcohol, people who consume
them could suffer from health problems or accidents. There-
fore, loss considered in Taguchi's definition of quality is
restricted to two categories: (a) loss caused by variability of
function and (b) loss caused by harmful side effects. Harm-
ful side effects are the consequences of using a certain prod-
uct, like some kinds of medicine~although this last kind of
loss is related more to research and development than to
manufacturing. Another way of interpreting the above defi-
nition is "product uniformity around the target," rather than
conformance to specification limits.
For ~ha dke (29), ideal quality is that every product de-
livers the target performance each time the product is used,
under all intended operating conditions, and throughout the
product's intended life, with no harmful side effects. The
deviation of a product's performance from the target causes
loss to the user of the product, the manufacturer, and, in
varying degrees, to the rest of society as well. Nonetheless,
even when a small deviation produces a small loss, the ma-
jority of customers do not realize it because, in many cases,
it is very difficult to detect such deviations from target when
using a product.
For Bhote (1 S), quality is defined as the systematic iden-
tification, analysis, reduction, and eventual elimination of all
variation around a target value. The achievement of zero
defects is only a milestone on the long road to zero varia-
There is a direct relationship between variation and de-
fects, with opposite effects in quality. More variation will
Figure 6. Shewhart's view of variation, quality, and defects.
(assignable causes)
generate more defects and less uniformity around the target.
Less variation will do the contrary (i.e., more uniformity
around the target). Conformance quality, as stated by
Hinckley and Barkan (20), should be seen as mere formal-
ism (i.e., the classic way of defining quality). To improve
conformance quality, it is necessary to reduce nonconfor-
mity rates. The classic definition of quality, "conformance
to specification limits" (28,30), allows some degree of varia-
tion to occur and yet be acceptable. Nonetheless, a study
made by Ford showed that even inside specifications, there
are different levels of quality, the best value being the tar-
get value for that product (3 1). This conclusion agrees with
Taguchi's definition of quality (15). Thus, a more appropri-
ate definition of manufacturing quality should be "unifor-
mity around a target value" (15,28,31), for it includes the
never-ending process of reducing variation to obtain high
quality and lower the cost of products. According to Deming
(12), the difference between conforming to specifications
and statistical process control is that the aim of production
should be not just to get statistical control but to shrink
variation. Costs go down as variation is reduced. It is not
enough to meet specifications. There is no way to know that
one will continue to meet specifications unless the process
is in statistical control.
The term "six sigma quality" has been popularized by
Motorola, a worldwide manufacturer of electronic compo-
nents and systems. Motorola was one of the winners of the
Malcolm Baldrige (U.S.) National Quality Award in No-
vember 1988 (32). "Six sigma" (SS) means that the width
of a normally distributed process can be as large as 12 times
its standard deviation (sigma) and still be within specifica-
tions. Equivalently, a normal process having a width of six
times sigma will "use" half of the allowed tolerance (differ-
ence between upper and lower specification limits, USL and
LSL, respectively). Referring to Cp-the potential capabil-
ity index, defined as a comparison of widths: process ver-
sus tolerance-a SS process has a Cp = 2. The correspond-
ing Cpk-the real capability index, a comparison of widths
between process and tolerance as well as process location-
would be Cpk = 2 if the process is centered on the target
value for the characteristic being measured. The number of
defective items of the above process is less than one in a
million [0.00198 parts-per-million (ppm), or 1.98 parts-per-
billion (ppb)]. Nonetheless, considering a likely k1.5 times
sigma fluctuation in process mean, this figure increases to
3.4 ppm, which is the "standard" definition of SS quality.
In this case, Cp = 2, but Cpk = 1.5.
See Figure 7 for a summary of the above ideas in addi-
tion to Shewhart's.
-Minimum variation
-Minimum fraction defective
I Increase I
Removing or around target
reducing -Minimum variation. *
1 variation J
1 -Minimum fraction defective. 1 h- 1
Figure 7. Relationship among variation, quality, and defects.
Effects of Variation and Defects
The effects of variation and defects are many types of
loss (1-4,11,13,15,18,20,25,33); see Figure 8. The most
notorious of them are (a) nonconformities-when a quality
characteristic gets out of specification limits, according to
the classic definition of quality: conformance to require-
ments; or even though being inside tolerances, if it is off the
target, according to Taguchi's definition of quality; (b) poor
quality; and (c) economic loss. Variation is the principal
enemy of quality, for it produces differences between prod-
ucts that should perform on target with no deviations. Varia-
tion is to be controlled and reduced continuously, because
it is a fact of life and it will always be present in every day-
to-day event or activity. Reducing variation should be in-
cluded as an integral part of all strategic quality planning in
manufacturing and in service firms as well.
Measurement of Variation
There are several way of measuring variation during
production. All of them are based on probability and statis-
tics. Shewhart (1) proposed sampling limits (three-sigma
control limits and control charts). Juran and Gryna (2) rec-
^ ^<
-Economic loss. -Nonconformities/defects.
-Loss of customers -Nonconformances/defective units
-Inspection. (nonfulfillment of intended usage).
-Scrap. -Differences in quality between pieces.
-Rework. -Poor quality.
-Warranty costs. -Insufficient number of products.
-Increased cycle time -Accidents.
-Design changes. -Customer dissatisfaction.
-Tied-up capital. -Increased costs.
-Increased inventories. -Product recalls.
-Markdown to seconds.
Si ^
Figure 8. Effects of variation and defects.
ornrnend control charts, statistics, and statistical process
control (SPC). Bhote (18) and Schmidt and Launsby (33)
suggest process capability indices: C and C k (better). Kane
(3) proposes range and standard deviation, control charts,
process capability indices, and simple graphical techniques
like the seven basic tools.
Taguchi (1 5,33a) proposes his Quality Loss Function,
which relates a quality characteristic to its losses as a result
of not performing on target, and signal-to-noise ratios as a
measure of stability (robustness) (see also Ref. 34) and
quality (29). Quality can be measured as the degree of varia-
tion from the target functional value. The quality level of a
product is measured in terms of the total loss to society
resulting from functional variation and harmful side effects.
It is convenient to consider other types of loss that increase
product cost, like added operations not considered as rework
(e.g., touch up in wave soldering, and setting up product
tests caused by high field failure rates).
Taylor (4) gives specific recommendations for three
types of variation. Capability studies are used to measure
manufacturing variation. To measure usage variation, iden-
tify usage factors affecting product performance and deter-
mine the conditions resulting in the most extreme perfor-
mances. Variation because of deterioration is measured by
cycling the product quickly through a large number of us-
ages under relatively harsh conditions and calculating the
difference between initial and final conditions. In doing
these reliability tests, it is important not to create failure
modes that are not likely to occur during normal use of the
product. Figure 9 summarizes the proposed measures of
variation during manufacturing.
Measurement of Defects
The measurement of defects is based on a Pareto diagram
and check sheets (see Refs. 2 and 3 9 , on an attribute basis
to measure the effects of errors and omissions (see Ref. 4),
and finally, because inadvertent mistakes do not occur
fhrobability and Statistics.
-Sampling limits (control charts).
-Process capability indices
(to measure manufacturing variation).
-Range and standard deviation.
-Quality Loss Function.
, -Signal-to-noise ratios. 1
Figure 9. Measures of variation.
frequently and can hardly be detected by sampling,
Hinckley (21) suggests evaluating probabilities of defects
through his Decision Analysis-Based Quality Control Tree
Model of a process. A decision analysis tree is a graphical
approach which considers all possible events that can take
place as well as their associated probabilities of occurrence
in a way that depicts the different outcomes of the specific
situation or process being analyzed. Therefore, defects
can be measured based on probability and on counts; see
Fig. 10.
Remedies and Techniques to Reduce Variation and
Improve Processes
What we call classic techniques are proposed by
Shewhart (1,25) for the elimination of assignable causes of
-Pareto Diagram.
-Check sheets. 1
Figure 10. Measures of defects.
variability; Deming (12) specifically identifies the need of
understanding variation-special causes and common
causes. The necessity to reduce the variation from common
causes constantly is vital. To find the mistake is not enough.
It is necessary to find the cause behind the mistake and to
build a system that minimizes future mistakes. Warning: TO
improve a process (see Fig. 1 I), all the calculations and
statistical tests will not be useful if the data obtained do not
come from a stable system, in which the information con-
tained in the order of production is preserved. A stable pro-
cess, one with no indication of special causes of variation,
is said to be, following Shewhart, in statistical control, or
stable. It is a random process. Its behavior in the near fu-
ture is predictable. It has a definable identity and a defin-
able capability. The remaining variation must be left to
chance (common causes). Statistical control of the process
of measurement is vital for obtaining data that can be used
to improve a process. The measurement instrument should
also be capable (low bias compared to the "true" value, and
low variability compared to process variation) (for more
information, see Refs. 36-38). As Deming said, without
statistical methods, attempts to improve a process are hit or
miss, and it is not possible to know exactly if you are
improving or not.
Ott and Schilling (39) recommend data analysis and
troubleshooting, not only to correct problems but to prevent
them [graphical methods like run charts, tally sheets, con-
trol charts, and the great contribution of the late Ellis R. Ott,
analysis of means (ANOM), a control-chart-like procedure
to detect significant differences between means primarily
(but also to analyze attributes data, counts, variability, and
proportions) either as a result of a designed experiment or
as a comparison of different process conditions represented
by sets of data]. They also consider using design of experi-
ments (DOE) and evolutionary operation (EVOP). The great
impact of Ott and Schilling's work (39) is not the relatively
È- \
Deming (12,35a) distinguishes between two kinds of studies: (a) Enumerative (descriptive)
e.g. a census, used for counting purposes only, and (b) Analytic (comparative), used for
prediction, or planning for improvement of a process, e.g. comparison of machines.
Important aspect* olwalytic studies, see Moen et al. (35b).
Aim: Prediction.
Focus: Cause-and-effect system.
Method of access: Models of the product or process, such as flowcharts and cause-and-
effect diagrams.
Major and unquantifiable source of uncertainty: extrapolation to the future.
Environment of the study, dynamic.
Figure 11. Analytic studies.
common techniques shown in their book (except for
ANOM) but the mastery of how they are used to trouble-
shoot and to improve processes.
Juran and Gryna (2) propose continuous improvement:
(a) For chronic problems, this means achieving better lev-
els of performance each year (project-by-project approach);
(b) for sporadic problems, this means taking corrective
action on periodic problems (structured troubleshooting),
and continuous process regulation; (c) for processrefine-
ments, this means reducing variation around a target value.
Juran and Gryna 's Approaches to Process Improvement
1. Changing the average
Adjust settings on process equipment
Change selected product design parameters to
achieve robustness in manufacturing
Identify process variables and optimize
Employ automated process controls (measure,
analyze, and adjust variables that affect the
2. Reducing variability
Identify process variables that affect product re-
Change selected product design parameters to
achieve robustness in manufacturing
Identify and reduce causes of human variability
Reduce variability of inputs to processes through
an improvement program with internal and ex-
ternal suppliers
Employ automated process controls (measure,
analyze, and adjust variables that affect variabil-
For Box (26,41) (see also Refs. 40,42, and 43), the key is
corrective feedback, preemptive feedforward, and simplifi-
cation. The emphasis is on moving upstream and building
good quality into the products and processes, instead of
trying to inspect bad quality out.
Experiments can be used to bring the mean onto the
target and minimize variance at the same time (see also
Ref. 27). Experimental design has the potential to acceler-
ate research and the generation of improved products. Ex-
periments may also be used to find a robust design for a
product or a process that is insensitive to the following:
1. Variation transmitted by manufacturing variables
2. Environmental changes likely to be experienced in
Ishikawa's Seven Tools can be used to obtain informa-
tion from the process. Only by designing quality into the
products and processes can the levels of quality and produc-
tivity be improved. Product design (see Ref. 44) is usually
an incremental learning process based to a large degree on
experimentation, problem-solving, and detailed trouble-
Taguchi (15) (see also Ref. 29) proposes two "types" of
quality control:
1. Off-line Quality Control
(a) System design or primary design is focused on
the pertinent technology.
(b) Parameter design or secondary design means
reducing cost and improving quality by using
experimental design methods (i.e., finding the
optimum levels of the individual system pa-
rameters) and designing a product or process
with high stability and reliability under a wide
range of conditions.
Tolerance design or tertiary design. The goal
is to control causes by narrowing tolerances of
critical factors. This may increase cost and is
to be used as the last resort after the stage of
parameter design is correctly implemented. Ex-
perimental design methods and the loss func-
tion can be used to set tolerances and to mea-
sure the impact of critical factors.
2. On-line (Real-Time) Quality Control
(a) Production: (1) process diagnosis and adjust-
ment (process control), (2) prediction and cor-
rection (control), and (3) measurement and ac-
tion (inspection)
(b) Customer relations: to provide a satisfactory
after-sales service
Process Design
The results of system, parameter, and tolerance design
are passed to the production department in the form of
specifications. Then, process design is done in three steps:
(1) system design (i.e., selection of manufacturing process),
(2) parameter design, to improve process capability by re-
ducing the influence of harmful factors, and (3) tolerance
design, where tolerances of the process conditions and
sources of variability are set. Step 3 is a means of suppress-
ing quality variation by directly removing its cause. The use
of experimental design is recommended in Steps 2 and 3.
Design and production engineering departments use off-line
quality control methods. Production departments use on-line
quality control methods. One important characteristic of
Taguchi's system (29) (see also Ref 34) is to achieve ro-
bustness (characteristic of a product with a high signal-to-
noise ratio) (i.e., to make a product insensitive to all kinds
of variation to lower costs, reduce scrap and rework, and to
function as intended during its defined life). Taguchi's tools
are orthogonal arrays, linear graphs, the quality loss func-
tion, and signal-to-noise ratios (29,3 1).
Shainin and Shainin ( 49, Bhote (18), and Shainin (46)
recommend the use of all seven of Shainin's design of ex-
periments (DOE) tools plus Shainin's SPC tools: (a) define
the project, (b) establish an effective measuring system, (c)
list suspect variables, (d) DOE, (e) find important variables
and/or interactions, ( f) establish realistic tolerances, and (g)
if not an irreversible corrective action, use SPC and moni-
tor results. The main features of Shainin's system of statis-
tical engineering are as follows: there are never many
equally strong causes, and "talking to the parts" (i.e., ana-
lyzing the parts to track down real causes of a problem is
better than guessing). Using the system of statistical engi-
neering techniques would ensure customer enthusiasm and
encourage them to ignore competitors. "Customer enthusi-
asm" is what Shainin and Shainin (45) consider to be syn-
onymous to quality, according to the words of Motorola's
past chairman Bob Galvin. Shainin and Shainin also claim
that using their system for quality improvement will produce
high-quality products and, therefore, will generate "cus-
tomer enthusiasm."
Taylor (4) expresses a modem and practical point of
view, based on Taguchi and classic DOE:
(a) Design robust processes and products andlor tighten
up critical parameters (for manufacturing and usage
(b) Select higher-grade materials, tighten design speci-
fications, and design products robust to deteriora-
For Schmidt and Launsby (33), the method is classical
DOE: a thorough understanding of the relationships between
the output variables and the input variables. Finally, Shingo
(9) advocates the use of poka-yoke or mistake-proofing
devices for regulating a wide variation in quality.
Figure 12 shows the relationships between different tech-
niques and authors. Statistical quality control (SQC) and
continuous improvement are supported by Shewhart,
Deming, Juran, and Box. Box also proposes design of ex-
periments (see also Ref. 27). Taguchi created his own meth-
odology. Shainin recommends the use of statistical engi-
neering, and Shingo proposes poka-yoke.
Remedies and Techniques to Reduce Nonconformities
Shingo (9) proposes his revolutionary Zero Quality Con-
trol System, which is based on the following:
(a) Use of source inspections for preventing and elimi-
nating defects entirely. This means applying control
functions where defects originate. Source inspection
(I finckley and
Baikm, Bhote)
Figure 12. Relationships between techniques and authors.
malities occur, such as detection of a broken tool); (2)
warning (i.e., activation of a buzzer or light to alert work-
ers about abnormalities). An abnormality is considered as
either a defect about to occur or the detection of a defect.
Juran and Gryna's proposal (2) is similar to Shingo's,
adding a study of better working habits of workers:
Figure 13. An example of source inspection.
(Modified from Ref. 9.).
is not related to the supplier's quality improvement;
it means preventing a defect from occurring. For in-
stance, Shingo (9) mentions a case of carburetor as-
sembly (see Fig. 13), where a photoelectric device
activates a control to open a small door where the
caps are, but only when the operator has already
taken the inner element. This system will prevent
defective assemblies due to missing interior parts.
Because abnormalities appear irregularly and ran-
domly, always use 100% inspection (the proposed
100% inspection is by using inexpensive and 100%
effective poka-yoke devices rather than done by in-
spectors). An example is a height fixture that can be
incorporated into a machine to screen finished parts
that are higher than the upper specification limit
(rather than sampling inspection), to detect all spo-
radic inadvertent errors. The probability that statis-
tical sampling will find abnormalities at just the right
time is far lower than with this kind of 100% assess-
Minimize the time it takes to carry out corrective
action when abnormalities appear.
Human workers are not infallible. Hence, set up ef-
fective poka-yoke accordingly. Poka-yoke are mis-
take-proofing devices to prevent inadvertent mis-
The most effective strategies for reaching zero defects-or
60 performance-are using source inspection to move at the
level of causes, in combination with 100% inspections and
poka-yoke devices to speed up feedback and action. The
100% inspection through poka-yoke devices are trouble-free
and low-cost inspections. When it is possible to move at the
levels of causes, zero defects are achieved because errors do
not turn into defects and management cycles (feedback) are
extremely rapid.
There are two basic regulatory functions of poka-yoke
(9,lO): (1) control (i.e., shut down machines when abnor-
(a) Error-proof the process and reduce fatigue and mo-
notony (if possible, automate the process)
(b) Disclose worker-to-worker differences; analyze the
data for patterns of behavior; identify the consis-
tently best and worst performers, and study their
work methods; train, change technology, error-proof
the process
(c) Explain the impact of errors; provide a balance be-
tween productivity and quality; improve cornmuni-
cation; error-proof the operation
In many plants, the driving force is still production or
"quantity" instead of a compromise between quantity and
quality; thus, it is necessary to provide a balance between
these two apparently opposed terms by promoting the im-
portance of a work well done and the resulting pride it con-
veys. Communication between workers and management
can be improved by encouraging worker participation
through a rewarded suggestion system or by constituting
quality circles. To error-proof the operation can be done by
applying Shingo's ideas on incorporating poka-yoke devices
to prevent defects from occurring.
Juran and Gryna's methods of error-proofing are as fol-
lows (35): fail-safe devices (e.g., limiting mechanisms,
alarms, etc.); magnification of senses (e.g., pictures instead
of numbers, remote control viewing, etc.); redundancy (e.g.,
multiple-identity coding, etc.), countdowns (e.g., in a sur-
gical operation, check all material used). Their error-proof-
ing principles are as follows (2,35): elimination (i.e., elimi-
nate the possibility of error); replacement (i.e., substitute a
more reliable process); facilitation (i.e., make the work
easier to perform); detection (i.e., detect errors before fur-
ther processing); and mitigation (i.e., minimize the effect of
the error). Juran and Gryna (2) also propose the use of con-
trol charts.
Kane's (3) practical point of view combines classical
programs and techniques with the addition of two very
important factors: housekeeping (order) and preventive
maintenance. His recommendations are process control,
problem analysis, and continual improvement.
Vital systems: housekeeping, preventive maintenance,
training, and computers (to handle and process large
amounts of information otherwise very tedious to do
by hand, and to obtain relevant analysis that may lead
to support adequate decisions on how to improve a
Use of statistical problem-solving techniques [process
flow diagram, control chart, comparison plot,
scatterplot, histogram, cause-and-effect diagram,
check sheet, Pareto diagram, stratified graph, and
analysis of means (ANOM) plot (see Ref. 39)] and
statistical methods to evaluate and reduce variability.
For products to be within specifications, variation
must be controlled.
Ishihara (1 1) is in agreement with Shingo, in the use
of error-proofing. For Ishihara, error-proofing is the
foundation of quality control. He also includes a
checklist to find problems that can be handled with
error-proofing according to the following categories:
operator, tools, machinery and measurement instru-
ments, parts and materials, operating method, prod-
ucts, and layout and environment.
Taylor (4) gives a very useful recommendation of
when to use mistake-proofing and when to optimize
a process: Defects caused by errors should be elimi-
nated by mistake-proofing and low-cost automated
100% inspection. The effects of functional relation-
ships can always be measured as a variable. Defects
resulting from functional relationships should be
eliminated by methods of optimization and variation
For Hinckley and Barkan (20), the solution is a com-
bination of Shingo's poka-yoke with the control of
variation (SQC). SPC alone is ineffective in control-
ling mistakes. They also add a very important factor
(complexity) and stress the importance of reducing it
to lessen chances for errors and to lower the probabil-
ity of defects due to variation, although this may not
be always possible or easy to accomplish.
As we see, there are two main approaches for dealing
with nonconformities: the traditional and the mistake-
proofing one. Both are good, but we have to decide
when to use either one of them. In a continuous im-
provement model, both should be incorporated. See
Figure 14 for a summary of the techniques reviewed
in this section.
Based on the above proposals for improving a pro-
cess, Figure 15 presents a model for the reduction of
defects and the reduction and control of variation. It
shows what can be done during the stages of design,
manufacturing, inputs, and use of a product, and how
some of them are affected by noise; the design ele-
ment is the most important one. Quality and robust-
ness are to be "created" at this stage by means of de-
signing the system. Some elements are process,
technology, materials, testing for deterioration and
variation in usage, complexity, and so forth. Possible
suppliers are to be evaluated according to very strict
rules regarding quality, service, and cost. During
manufacturing, it is important that the measuring sys-
tem as well as production systems are stable and ca-
Benefits from Reducing Variation and Nonconformities
For Shewhart (l,25), the elimination of assignable causes
of variability, hence having a controlled process, will bring
the following benefits: a most efficient use of raw materi-
als, maximizing the assurance of the quality of the manu-
factured product (minimum variability, attainment of uni-
form quality, a reduction in tolerance limits), minimizing the
cost of inspection, and minimizing loss from rejections. As
a consequence, customers will be satisfied.
For Juran and Gryna (2,35), lower variability has become
an important tool of competition. It may result in improved
product performance, cost reduction, and less need for in-
spection; it may command a premium price on a product;
-Process control, problem analysis, and continuous improvement.
(the seven basic tools, process flow diagrams, control charts, and anom plots).
Figure 14. Remedies and techniques to reduce nonconformities.
-Off-line QC: robustness
(system design,
parameter design,
(~amifacturin~~racess \
-Off-line QC: robustness
(system design, parameter design,
tolerance design).
-On-line QC: adjustment
and correction.
-Automatic Process Control.
-statistical Quality Control.
-Measuring system (stable and
0 (^
Figure 15. A model for process improvement (adjusting the average and reducing variability).
and it may be a competitive factor in determining market
share (meeting specification limits is no longer sufficient).
Benefits from reducing nonconformities are a reduction in
scrap, rework, and complaints and improved productivity
and reduction in inventories. Increasing the quality of con-
formance (freedom from deficiencies) usually results in
lower costs and increased customer satisfaction.
Deming (1 2,13) established that reducing variation will
increase uniformity of output. It will reduce rework and
mistakes, waste of manpower, and machine time and mate-
rials. It will increase output with less effort and less cost.
Reduction of waste increases the capacity of production and
increases productivity [an increase in the number of units
produced (see also Ref. 9). Other benefits of improved
quality are lower costs, better competitive position, happier
people on the job, and more jobs. Other benefits from re-
ducing variation are economies in manufacturing (47) and
an improvement of the quality of the final product. Deming
mentioned the following advantages of stability in a process:
The process has an identity; its performance is
predictable. It has a measurable and communicable
Costs are predictable.
There is a regularity of output.
Productivity is at maximum (costs at a minimum un-
der the present system).
Costs diminish as quality improves.
The effects of changes in the system can be measured
with greater speed and reliability.
Deming (12) said that statistical control is not an end in
itself. A process may be in statistical control, yet produce
defective items. Once statistical control is established, se-
rious work to improve quality and economy of production
can commence.
For Box and Bisgaard (43), the enemy of mass produc-
tion is variability. Success in reducing variability will invari-
ably simplify processes, reduce scrap, and reduce costs.
Taguchi (15) again stated a more complete list of ben-
efits. They are obtaining products that perform their in-
tended functions without variability and cause little loss
through harmful side effects, including the cost of using it.
Controlling variation will reduce failure in the field, and "the
effort of reducing product failure in the field will simulta-
neously reduce the number of defectives in the factory" (34)
(italics added). Good functional quality means little func-
tional variation from any type of noi se-a product which
functions as intended under a wide range of conditions for
the duration of its design life (robustness).
Reducing variation will partially reduce nonconformities
(20). Motorola has sought two or three orders of magnitude
reduction in the nonconformity rate to achieve a six-sigma
production level. Reducing defects will improve confonn-
ance quality. Reducing variation and defects will maximize
customer satisfaction, reduce costs, and enhance competi-
tiveness in the marketplace (18). Reducing variation will
reduce the number of defects (3). Reducing defects will
produce high-quality products (see also Ref. 1 I), an increase
in productivity, and staying in business (3). Taylor (4) adds
some new benefits: broader product applicability, improved
reliability, and shortened total development time by prevent-
ing problems and delays.
Figure 16 is an affinity diagram which shows a summary
of the benefits of reducing variation and nonconformities.
Authors' Rationale, Goal, or Main Thesis
Shewhart (1) introduced a system to develop a scientific
basis for attaining economic control of quality of manufac-
tured product through the establishment of control limits.
These indicate when the quality of product is varying more
than is economically desirable at every stage in the produc-
tion process, from raw materials to finished products.
Derning (12) wanted to supply the direction for the trans-
formation of the American style of management and to
improve productivity.
Box (26:41,48) and Box and Bisgaard (43) stated that
every process generates information that can be used to
improve it. The crux of quality and productivity improve-
ment is detailed knowledge of the processes involved. Qual-
ity improvement is about finding out how to do things bet-
ter. The efficient way to do this is by using the scientific
method. Modem quality improvement extends the domain
of scientific method over users, over areas of human en-
deavor, over time, and over causative factors. The scientific
method ("a process for finding things out") is an iterative
induction-deduction (similar to the Shewhart-Deming cycle
process to obtain knowledge). It is accelerated by direct
experimentation. The inductive contribution from subject
matter is the only point at which truly new ideas are injected.
The continuous never-ending improvement is nothing else
but the logical description of the scientific method itself-
a lifelong education.
Taguchi (16) remarked on the importance of conducting
research for developing methods that increase the competi-
tiveness of new products by reducing their cost and increas-
ing their quality. The external customer will buy a product
that is desirable to own and meets intended purposes, and
is robust against environment, deterioration, and variation,
and better than competitive products (see also Ref. 3 1).
Shingo (9) proposed his "Zero Quality Control System"
(100% source inspection, poka-yoke devices, and irnrnedi-
ate feedback) for the attainment of zero defects.
Juran and Gryna (2) focused on the management of qual-
ity and customer satisfaction.
Ishihara's thoughts (1 1) are best described by Newcomb
and by himself:
How to manage our enterprises in order to be competitive, with a
high level of quality and low costs, in a new world economy
(Newcomb, in Ref. 1 1 ) .
I show how to manage work in the factory, how to improve it,
what role supervisory personnel should play in quality control and
much more ( 1 1).
Hinckley and Barkan (20) and Hinckley (21) proposed
a new model of conformance quality measured by the manu-
k ~ e s s inventories. )
-Product perfbnnance.
-Less defects.
-Improved reliability.
-Less failures in the field
-Less complaints.
-Reduced levels of inventory. j
-Happier customers.
-~appier workforce. I
-Better competition.
-Premium price.
Figure 16. Benefits from reducing variation and nonconformities.
facturing nonconformity rate: correlating nonconformities
and assembly complexity. Its premises are as follows: (1)
Complexity is a root cause of nonconformities. It increases
mistakes and variation. (2) Mistakes and variation increase
nonconformities. (3) SPC is ineffective in controlling mis-
takes. (4) Mistakes and variation are different sources of
Bhote (18) encouraged the use of Shainin's techniques
for problem-solving to obtain multiple benefits in quality,
productivity, and cost reduction.
Kane (3) suggests the development of a defect-preven-
tion system. He does not address the quality requirements
involved in the initial design of products or services, but
stresses its importance.
For Taylor (4), the goals are to improve quality, reduce
costs, and shorten development times, and an absolutely
perfect product, with every unit at the ideal [goal is not zero
defects (i.e., not only being within specifications)] by using
SPC, Taguchi techniques, DOE, and components swapping
(Shainin techniques) to simultaneously optimize average
and reduce variance-every unit performing at its ideal
Final Remarks
As was previously stated, this research tried to make a
compendium of the most important aspects of variation and
defects in manufacturing. Literature is rich, vast, and var-
ied, but dispersed. The approach in this article was to sum-
marize much of what has been said and written about varia-
tion and defects in manufacturing.
As was expressed throughout this research, variation is
the eternal and omnipresent ghost involved in everyday
processes or activities, not only in manufacturing but in
services as well. Nonetheless, as this study shows, there are
different and effective ways to deal with this problem: to
have a more "technical" or scientific mentality and to use
more statistical and nonstatistical approaches to measure,
control, and reduce variation successfully.
I am indebted to the I.T.E.S.M. authorities for their sup-
port and to Mr. Graham K. Rand from Lancaster University
(U.K.) for his valuable suggestions and guidance in prepar-
ing this article. I also would like to thank the Quality Engi-
neering reviewer Mr. Edwin S. Shecter for his very insight-
ful comments and ideas that improved this work.
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No. 123, Center for Quality and Productivity Improvement
University of Wisconsin, Madison (January 1995).
About the Author: Edgardo J . Escalante is a professor of
industrial engineering at the Institute Tecnologico y de
Estudios Superiores de Monterrey (I.T.E.S.M.) in
Monterrey, Mexico. He is a member of the American
Society for Quality.

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