Quality Engineering, 1 1(3), 427-442 (1999)

QUALITY AND PRODUCTIVITY IMPROVEMENT: A STUDY OF VARIATION AND DEFECTS IN MANUFACTURING

Edgardo J. Escalante
ITESM, Departamento de Ingenieria Industrial Sucursal de Correos J 64849 Monterrey NL, Mexico

Key Words
Variation; Defects; Variation reduction; Quality improvement; Productivity improvement.

Introduction
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 products 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 leading to the improvement of quality, expressed by well-known experts (theorists and some practitioners) in the field of quality.
Definition of Variation

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 differences 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. Increasing precision will decrease the number of identical products. How much precision is needed to evaluate a quality 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

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

Mitra (6) defines "nonconformity" as a quality characteristic that does not meet its stipulated specifications requirement. 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 characteristic 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 "nonconformity," and a term for "defective" is "nonconforming

Copyright 0 1999 by Marcel Dekker, Inc.

ESCALANTE

item." Banks (8) makes a distinction between nonconformity and defect by establishing that nonconforming is related 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 variation, 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 majority of mistakes are inadvertent. A wider classification of different kinds of error are as follows (10):
Forgetfulness: forgetting things due to lack of concentration 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 absentmindedness 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 sabotages (in this case, the word "error" is considered as a volition act rather than a mistake)

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. Examples 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 fluctuations 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 classification 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 responsibility of management. Special causes of variation are specific to a local condition. Its elimination is sometimes the responsibility of people involved with the operation, but some other times, it is management's responsibility (12,13). Confusion between these two causes leads to greater variability 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 process is in control). Acting on a stable process increases variation. This action is called "tampering."

The following types of defect have been identified (10): Omitted processing Processing errors Errors setting up workpieces Missing parts Wrong parts Processing wrong workpiece Misoperation Adjustment error Equipment not set up properly Tools and jigs improperly prepared

QUALITY AND PRODUCTIVITY IMPROVEMENT

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 differences: differences in materials, equipment, the surrounding atmospheric conditions, and the physical and mental reactions of people. Most of these differences are extremely small. Taguchi (15,16) (see also Ref. 17) defines error factorsnoise-as elements that cause variability in product functions:
I.

2.

3.

products (variation up to the time the product is delivered to the customer). Usage variation. This comes from differences in manners and conditions of use. Variation because o f deterioration. This is a result of product aging.

2.

3.

External noise (environmental) (during use of the product) 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 imperfections)

Grant and Leavenworth (19) contribute with a very specific breakdown of source. Again, their main source of information is Shewhart: There is a certain amount of variation as a result of chance. Variation within a stable system of chance causes is inevitable. Some variability is unavoidable; the amount of this basic variability will depend on various characteristics of the production process, such as machines, the material, and the operators. Breakdown o f Sources o f 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 variation 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 process variation and also due to human and equipment measurement 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 variability; that is, errors: "on a hand-operated job, errors will increase variability of the product." Hinckley and Barkan (20) add one cause not specifically addressed by others: complexity related to the design of a product.
Sources/Causes of Defects

Sources o f Variability [Unit-to-Unit Noise (17)J During Production 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, variability in execution, and human error (15). Bhote (18) is more specific by mainly describing common causes of variation (i.e., poor management, poor product/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 (18, Table 41). 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 according to the factors that compose a manufacturing process: 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 fluctuation in materials and key process parameters, process conditions, operator's variation, wearing and changing in tooling, change in methods and manufacturing environment, storage, and transportation of

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 manufacturing. 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 occur:

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Y Product s o d :
Y

-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.) ment, when putting more emphasis on quantity rather than quality. This is a consideration that is not specifically included in Shinfo's work. 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 uncertainty, Taylor (4) sheds light onto the problem of when defects are due to errors and when they are due to excess of variation in the process. This is a key point in the method of attacking defects. The two basic mechanisms causing defects 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 complexity. Complexity is related to the design of a product; see Figure 3. Figure4 shows an affinity diagram-a tool which arranges information that is in a disorganized state, by forming groups based on common grounds (22,23)o all the causes of variation and defects. It is obvious that manage-

1. Inappropriate standard work processes or inappropriate standard operating procedures 2. Excessive variation in actual operations 3. Damaged raw materials or excessive variation in them 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 product complexity as sources of defects. The relationship between errors and defects is illustrated in Figure 2. Juran and Gryna (2) established three sources of workerrelated defects: 1. Lack of attention. 2. Lack of technique. 3. Feelings of revenge, sometimes incited by manage-

I ERRORS 1
T

Adjustments errors, incorrect operation, incorrect piece or equipment setup,wrong piece, others.
r

Processing omissions, processing errors.

Missing parts, wrong items.

t
Defective subassemblies
Figure 3.

Defective products
Figure 2.

Relationship between errors and defects. (Adapted from Ref. 10.)

Relationship between complexity and nonconformities. (Adapted from Ref. 20.)

QUALITY AND PRODUCTIVITY IMPROVEMENT

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 quality-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 specified standards. Quality is controlled to attain uniformity, by finding and removing causes of variability. Controlled quality 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 defective. 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

COMMON (POOR MANAGEMENT) AND SPECIAL CAUSES

~NCOMFORTABLE WORKING CONDITIONS -Poor light. -Noise. -Confusion. -Dirt. -Handling of materials. -Heat or cold. -Poor ventilation. -Bad food. -Poor housekeeping. -Humidity. i-Etc.
^__________y
&~KINES

-Deterioration w i t h age. -Wear outs durinc use. -Deterioration due to transportation.

1.

-Human error.
-^

manner and conditions of use.

conditionsduring use.

"\ (WORKFORCE

-Failures. -To01 wear. -Excessive play. -Vibration. -0ut-of-order. -Incorrect setups. -Changing in tooling. -Lack of preventive maintenance.

-Inadvertent errors. -Lack of technique. -Lack of attention. -Lack of training. -Lack of practice. -Confusion. -Mistdies. rat^^ vh&ion/

f ^

variability

METHODS AND STANDARDS -Variability of work processes. -Proceduresnot suited. -Inappropiate standard operating procedures. -Imperfect standards. -Change in methods. o r k processes. -Inappropiate standard w -Deviation from standards. -Poor specifications for product, processes, and components. -Poor instructionsand supervision. exdon.

QUALITY POLICIES -Failure to measure the effect of common causes and to reduce -Management's emphasis on quantity rather than quality. -Inadequate quality system, inadequate data. -Uncertainty and confusion.
Figure 4. Causes of variation and defects.

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COMMON (POOR MANAGEMENT) AND SPECIAL CAUSES

MISTAKES NONCONFORMITIES VARIATION

Figure 5. Addition of management responsibility as well as

a connection between mistakes and variation.

by its intrinsic functions. To describe what intrinsic functions mean, Taguchi gives the example of alcoholic beverages. Because they contain alcohol, people who consume them could suffer from health problems or accidents. Therefore, 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. Harmful side effects are the consequences of using a certain product, 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 definition is "product uniformity around the target," rather than conformance to specification limits. For ~ h a d k e (29), ideal quality is that every product delivers 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 majority of customers do not realize it because, in many cases, it is very difficult to detect such deviations from target when using a product. ) , quality is defined as the systematic idenFor Bhote (1 S 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 variation. There is a direct relationship between variation and defects, with opposite effects in quality. More variation will

Removing variation
(assignable causes)

CONTROLLED QUALITY
-Minimum variation -Minimum fraction defective

Figure 6. Shewhart's view of variation, quality, and defects.

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 formalism (i.e., the classic way of defining quality). To improve conformance quality, it is necessary to reduce nonconformity rates. The classic definition of quality, "conformance to specification limits" (28,30), allows some degree of variation 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 target value for that product (3 1). This conclusion agrees with Taguchi's definition of quality (15). Thus, a more appropriate definition of manufacturing quality should be "uniformity 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 components and systems. Motorola was one of the winners of the Malcolm Baldrige (U.S.) National Quality Award in November 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 specifications. Equivalently, a normal process having a width of six times sigma will "use" half of the allowed tolerance (difference between upper and lower specification limits, USL and LSL, respectively). Referring to Cp-the potential capability index, defined as a comparison of widths: process versus tolerance-a SS process has a Cp = 2. The corresponding Cpk-the real capability index, a comparison of widths between process and tolerance as well as process locationwould 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-perbillion (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 addition to Shewhart's.

QUALITY AND PRODUCTIVITY IMPROVEMENT

I Increase
Removing or reducing variation J

CONTROLLED QUALITY

uniformity

-Minimum variation. -Minimum fraction defective.

1h 1 -

around target

conformance
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 requirements; 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 products that should perform on target with no deviations. Variation is to be controlled and reduced continuously, because it is a fact of life and it will always be present in every dayto-day event or activity. Reducing variation should be included 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 statistics. Shewhart (1) proposed sampling limits (three-sigma control limits and control charts). Juran and Gryna (2) recLOSS TO SOCIETY
^<

^
-Economic loss. -Lossof customers -Inspection. -Scrap.

-Nonconformities/defects.
-Nonconformances/defectiveunits (nonfulfillment of intended usage). -Differences in quality between pieces. -Poorquality. -Insufficientnumber of products. -Accidents. -Customer dissatisfaction. -Increased costs. -Product recalls. -Markdown to seconds.

-Rework.
-Warranty costs. -Increasedcycle time -Designchanges. -Tied-up capital. -Increased inventories.
Si

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 (15,33a) 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 variation 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, identify usage factors affecting product performance and determine the conditions resulting in the most extreme performances. Variation because of deterioration is measured by cycling the product quickly through a large number of usages 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

Figure 8. Effects of variation and 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

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QUANTITATIVE METHODS
fhrobability and Statistics. -Sampling limits (control charts). -Process capability indices
(to measure manufacturing variation).

-Range and standard deviation. -Quality Loss Function. -Signal-to-noiseratios.

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

QUANTITATIVE METHODS
-Probability. -Pareto Diagram. -Check sheets.

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. 1I), 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 contained in the order of production is preserved. A stable process, 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 future is predictable. It has a definable identity and a definable 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, control 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 experiments (DOE) and evolutionary operation (EVOP). The great impact of Ott and Schilling's work (39) is not the relatively
\

'

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-effectsystem. Method o f access: Models of the product or process, such as flowcharts and cause-andeffect diagrams. Major and unquantifiablesource o f uncertainty: extrapolation to the future. Environment o f the study, dynamic.
Figure 11. Analytic studies.

QUALITY AND PRODUCTIVITY IMPROVEMENT

common techniques shown in their book (except for ANOM) but the mastery of how they are used to troubleshoot and to improve processes. Juran and Gryna (2) propose continuous improvement: (a) For chronic problems, this means achieving better levels 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 processrefinements, this means reducing variation around a target value. Juran and Gryna 's Approaches to Process Improvement
1.

2.

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 average) Reducing variability Identify process variables that affect product results 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 external suppliers Employ automated process controls (measure, analyze, and adjust variables that affect variability)

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 troubleshooting. 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 parameters) and designing a product or process with high stability and reliability under a wide range of conditions. (c) 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. Experimental design methods and the loss function can be used to set tolerances and to measure the impact of critical factors. 2. On-line (Real-Time) Quality Control (a) Production: (1) process diagnosis and adjustment (process control), (2) prediction and correction (control), and (3) measurement and action (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 reducing 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 suppressing 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 robustness (characteristic of a product with a high signal-tonoise ratio) (i.e., to make a product insensitive to all kinds of variation to lower costs, reduce scrap and rework, and to

For Box (26,41) (see also Refs. 40,42, and 43), the key is corrective feedback, preemptive feedforward, and simplification. 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 accelerate research and the generation of improved products. Experiments 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 use Ishikawa's Seven Tools can be used to obtain information from the process. Only by designing quality into the products and processes can the levels of quality and produc-

ESCALANTE

function as intended during its defined life). Taguchi's tools are orthogonal arrays, linear graphs, the quality loss function, and signal-to-noise ratios (29,3 1). Shainin and Shainin ( 4 9 , Bhote (18), and Shainin (46) recommend the use of all seven of Shainin's design of experiments (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 monitor results. The main features of Shainin's system of statistical engineering are as follows: there are never many equally strong causes, and "talking to the parts" (i.e., analyzing the parts to track down real causes of a problem is better than guessing). Using the system of statistical engineering techniques would ensure customer enthusiasm and encourage them to ignore competitors. "Customer enthusiasm" is what Shainin and Shainin (45) consider to be synonymous 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 "customer 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 variation) (b) Select higher-grade materials, tighten design specifications, and design products robust to deterioration. 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 techniques and authors. Statistical quality control (SQC) and continuous improvement are supported by Shewhart, Deming, Juran, and Box. Box also proposes design of experiments (see also Ref. 27). Taguchi created his own methodology. Shainin recommends the use of statistical engineering, and Shingo proposes poka-yoke.

Remedies and Techniques to Reduce Nonconformities

Shingo (9) proposes his revolutionary Zero Quality Control System, which is based on the following: (a) Use of source inspections for preventing and eliminating defects entirely. This means applying control functions where defects originate. Source inspection

SQC & CONTINUOUS

IMPROVEMENT

DESIGN OF EXPERIMENTS

TAGUCHI

-Shainin
(Bhote)

-Shingo
(Ifinckley and

Baikm, Bhote)

STATISTICAL ENGINEERING

POKA-YOKE

Figure 12. Relationships between techniques and authors.

QUALITY AND PRODUCTIVITY IMPROVEMENT

437

malities occur, such as detection of a broken tool); (2) warning (i.e., activation of a buzzer or light to alert workers 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: (a) Error-proof the process and reduce fatigue and monotony (if possible, automate the process) (b) Disclose worker-to-worker differences; analyze the data for patterns of behavior; identify the consistently 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 between productivity and quality; improve cornmunication; 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 importance of a work well done and the resulting pride it conveys. 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 follows (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 surgical operation, check all material used). Their error-proofing principles are as follows (2,35): elimination (i.e., eliminate 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 further processing); and mitigation (i.e., minimize the effect of the error). Juran and Gryna (2) also propose the use of control 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

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 instance, Shingo (9) mentions a case of carburetor assembly (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 randomly, always use 100% inspection (the proposed 100% inspection is by using inexpensive and 100% effective poka-yoke devices rather than done by inspectors). 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 sporadic inadvertent errors. The probability that statistical sampling will find abnormalities at just the right time is far lower than with this kind of 100% assessment. Minimize the time it takes to carry out corrective action when abnormalities appear. Human workers are not infallible. Hence, set up effective poka-yoke accordingly. Poka-yoke are mistake-proofing devices to prevent inadvertent mistakes. 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-

ESCALANTE

by hand, and to obtain relevant analysis that may lead to support adequate decisions on how to improve a process) 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 instruments, parts and materials, operating method, products, 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 eliminated by mistake-proofing and low-cost automated 100% inspection. The effects of functional relationships can always be measured as a variable. Defects resulting from functional relationships should be eliminated by methods of optimization and variation reduction. For Hinckley and Barkan (20), the solution is a combination of Shingo's poka-yoke with the control of variation (SQC). SPC alone is ineffective in controlling 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 probability 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 mistakeproofing one. Both are good, but we have to decide when to use either one of them. In a continuous improvement 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 process, 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 element is the most important one. Quality and robustness are to be "created" at this stage by means of designing 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 system as well as production systems are stable and capable. 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 materials, maximizing the assurance of the quality of the manufactured product (minimum variability, attainment of uniform 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 inspection; it may command a premium price on a product;

NON-TRADITIONAL

' '

TRADITIONAL -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.

-\

QUALITY AND PRODUCTIVITY IMPROVEMENT

-Off-line QC: robustness (system design, parameter design,

-Suppliers (improvement program).

(~amifacturin~~racess -Off-line QC:robustness (system design,parameter design, tolerance design). -On-line QC: adjustment and correction. -Automatic Process Control. -Poka-yoke. -statistical Quality Control. -Measuring system (stable and

0(^
4
unit-to-unit
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 conformance (freedom from deficiencies) usually results in lower costs and increased customer satisfaction. Deming (12,13) established that reducing variation will increase uniformity of output. It will reduce rework and mistakes, waste of manpower, and machine time and materials. 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 reducing 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 capability. Costs are predictable. There is a regularity of output. Productivity is at maximum (costs at a minimum under 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, serious work to improve quality and economy of production can commence. For Box and Bisgaard (43), the enemy of mass production is variability. Success in reducing variability will invariably simplify processes, reduce scrap, and reduce costs. Taguchi (15) again stated a more complete list of benefits. They are obtaining products that perform their intended 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 simultaneously reduce the number of defectives in the factory" (34) (italics added). Good functional quality means little functional variation from any type of noise-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 confonnance quality. Reducing variation and defects will maximize customer satisfaction, reduce costs, and enhance competi-

ESCALANTE

tiveness in the marketplace (18). Reducing variation will reduce the number of defects (3). Reducing defects will produce high-quality products (see also Ref. 1I), 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 preventing 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 manufactured 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 production process, from raw materials to finished products. Derning (12) wanted to supply the direction for the transformation 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 improvement is detailed knowledge of the processes involved. Quality improvement is about finding out how to do things better. 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 endeavor, 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 itselfa lifelong education. Taguchi (16) remarked on the importance of conducting research for developing methods that increase the competitiveness of new products by reducing their cost and increasing 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 irnrnediate feedback) for the attainment of zero defects. Juran and Gryna (2) focused on the management of quality 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-

HIGHER QUALITY AND PROWL

L 1v 11 x

k ~ e s inventories. s

)
-Happier customers. -~appier workforce.

-Reduced levels of inventory.

-Uniformity. -Assurance. -Product perfbnnance. -Less defects. -Improved reliability. -Less failures in the field

SATISFACTION INCREASED

-Better competition. -Premium price.

-Less complaints.

Figure 16. Benefits from reducing variation and nonconformities.

QUALITY AND PRODUCTIVITY IMPROVEMENT

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 mistakes. (4) Mistakes and variation are different sources of nonconformities. 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-prevention 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 value.

References
Shewhart, W., Economic Control of Quality of Manufactured Product, D. Van Nostrand, New York, 1931; reprinted in 1989 by the American Society for Quality Control, Milwau122, 130-131, kee, WI, pp. 7, 12-14,25,28,30,32,40,47, 144, 146, 163-164, and 323. Juran, J. and Gryna, F., Quality Planning and Analysis, 3rd ed., McGraw-Hill, New York, 1993, pp. v, xvii, 4-5,40-41, 43,54,68-73, 109-1 12, 179,377,380,411412,414-416, and 418. Kane, V., Defect Prevention, Marcel Dekker, Inc., New York, 1989, pp. vii, 3,5, 8-10,35-36, and 38 (sponsored by the ASQC, Milwaukee, WI). Taylor, W. A., Optimization & Variation Reduction in Quality, McGraw-Hill, New York, 1991, pp. xi, 3, 13-14, 17, 19, 24, 27, 101, 136, 141, 143, 159, 174, 176, and 187-188 (sponsored by the ASQC, Milwaukee, WI). Barker, T., Can Variety and Variation Coexist? Qual. Prog., 23(12), 46-48 (1990). Mitra, A., Fundamentals of Quality Control and Zmprovement, MacMillan, New York, 1993, pp. 7-8. American National Standards InstituteIAmerican Society for Quality Control Standard A3 (1987). Banks, J., Principles of Quality Control, John Wiley & Sons, New York, 1989, pp. 3 4 . Shingo, S., Zero Quality Control: Source Inspection and the Poka-Yoke System, Productivity Press, Portland, OR, 1986, pp. x, 30, 33,45, 54, 65, 75, 82-85, and 93-94. Nikkan Kogyo Shimbun, Ltd./Factory Magazine, Poka-Yoke. Improving Product Quality by Preventing Defects, Productivity Press, Portland, OR, 1988, pp. x, 12, and 14-16. Ishihara, K., Implementing Quality on the Shop Floor, Quality Resources, White Plains, NY, 1992, pp. vii, ix, 58-59, 106, and 110. Deming, W. E., Out of the Crisis, M.I.T. Center for Advanced Engineering Study, Cambridge, MA, 1986, pp. ix, x, 3, 132, 136, 146147,225, 309-310, 312, 314-315, 318321,332-335,340-341, and 354. Deming, W. E., On Some Statistical Aids Toward Economic Production, Interfaces, 5(4), 1-5 (1975). Western Electric Co., Statistical Quality Control Handbook, Western Electric Co./AT&T Laboratories, Inc., Indianapolis, IN, 1956, p. 6. Taguchi, G., Introduction to Quality Engineering. Designing Quality into Products and Processes, Asian Productivity Organization, TokyoNnipub Kraus International Publications, White Plains, NYIThe American Supplier Institute, Dearborn, MI, 1986, pp. 1,2,7,73-79.83, and 93. Taguchi, G., Robust Technology Development, Mech. Eng., 115(3), 60-62 (1993). Fowlkes, W. and Creveling, C., Engineering Methods for Robust Product Design, Addison-Wesley, Reading, MA, 1995, pp. xxi and 3.

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 varied, but dispersed. The approach in this article was to summarize much of what has been said and written about variation 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.

Acknowledgments
I am indebted to the I.T.E.S.M. authorities for their support and to Mr. Graham K. Rand from Lancaster University (U.K.) for his valuable suggestions and guidance in preparing this article. I also would like to thank the Quality Engineering reviewer Mr. Edwin S. Shecter for his very insightful comments and ideas that improved this work.

ESCALANTE Bhote, K., World Class Quality, American Management Association, New York, 1991, pp. 4, 5, 30, 32-35, 41, 55, 169, and 206. 19. Grant, E. and Leavenworth, R., Statistical Quality Control, McGraw-Hill, New York, 1980, pp. 1,4, 101, and 156. 19a. British Ministry of Labour and National Service, and the Ministry of Production, Quality Control on Hand-operated Machines, Product. Eng. Bull., 3.25-31 (1944). 20. Hinckley, C. M. and Barkan, P., The Role of Variation, Mistakes, and Complexity in Producing Nonconforrnities, J. Qual. Technol.,27(3), 242-249 (1995). 21. Hinckley, C. M., A Global Conformance Quality Model: A New Strategic Tool for Minimizing Defects Caused by Variation, Error, and Complexity, Ph.D. dissertation. Stanford University, 1994; UMI Dissertation Services, Ann Arbor, MI, 1996, pp. 8, 11-12, 163-18 1, and 209. 22. Brassard, M., The Memory Jogger Plus+, GOALJQPC, Methuen, MA, 1989, p. 17. 23. Mizuno, S., Management for Quality Improvement, in The Seven New QC Tools, Productivity Press, Portland, OR, 1988, p. 115. 24. Gamin, D., What Does "Product Quality" Really Mean? Sloan Manag. Rev., 25(1), 25-43 (1984). 25. Shewhart, W., Statistical Method from the Viewpoint of Quality Control, Dover Publications, New York, 1939; reprinted 1986, pp. &-9, and 47. 26. Box, G. E. P., The R. A. Fisher Memorial Lecture, 1988, Phil. Trans. Roy. Soc. London Series A, 327, 617-630 ( 1989). 27. Box, G. E. P., Hunter, W., and Hunter, S., Statisticsfor Experimenters, John Wiley & Sons, New York, 1978. 28. Sullivan, L. P., Reducing Variability: A New Approach to Quality, Qual. Prog., 17(7), 15-21 (1984). 29. Phadke, M., Quality Engineering Using Robust Design, Prentice-Hall, Englewood Cliffs, NJ, 1989, pp. xv, 11 and 32-38. 30. Crosby, P., Quality is Free, McGraw-Hill, New York, 1979, p. 15. 31. Sullivan, L. P., The Seven Stages in Company-Wide Quality Control, Qual. Prog, 19(5), 77-83 (1986). 32. Penzer, E., Making the Quality Commitment, Incentive, 8894 (September 1989). 33. Schmidt, S. and Launsby, R., UnderstandingIndustrial Designed Experiments, 4th ed., Air Academy Press, Colorado Springs, CO, 1994, pp. 1-17-1-19. 33a. Taguchi, G., The Development of Quality Engineering, Am. Supplier Inst. J., l(1) (1988). 18. Taguchi, G. and Clausing, D., Robust Quality, Harvard Bus. Rev., 68(1), 65-75 (1990). 35. Juran, J. and Gryna, F., Juran 's Quality Control Handbook, 4th ed., McGraw-Hill, New York, 1988, pp. 16.36-16.37, 16.50, 22.3-22.34, and 22.35. 35a. Deming, W. E., On Probability as a Basis for Action, Am. Statistician, 29(4), 146-1 52 (1975). 35b. Moen, R., Nolan, T., and Provost, L., Improving Quality Through Planned Experimentation, McGraw-Hill, New York, 1991, p. 54. 36. Montgomery, D. and Runger, G., Gauge Capability and Designed Experiments (parts I and 11), Qual. Eng., 6(1) 115135,289-305 (1993). 37. Wheeler, D. and Lyday, R., Evaluating the Measurement Process, 2nd ed., SPC Press, Knoxville, TN, 1989. 38. Ford Motor Co., General Motors Corp., Chrysler Corp. Measurement Systems Analysis, Automotive Industry Action Group, Southfield, MI, 1995. 39. Ott, E. and Schilling, E., Process Quality Control, 2nd ed., McGraw-Hill, New York, 1990. 40. Montgomery, D., Design and Analysis of Experiments, 4th ed., John Wiley & Sons, New York, 1997. 41. Box, G. E. P., Statistics and Quality Improvement, J. Roy. Statist. Soc. Series A, 157(Part 2), 209-229 (1994). 42. Box, G. E. P. and Bisgaard, S., The Scientific Context of Quality Improvement, Qual. Prog., 20(6), 54-61 (1987). 43. Box, G. E. P. and Bisgaard, S., Statistical Tools for Improving Designs, Mech. Eng., 110(1), 32-40 (1988). 44. Bisgaard, S., Quality Improvement at the Design Stage. A Cyclic Incremental Approach, Report No. 69, Center for Quality and Productivity Improvement. University of Wisconsin, Madison (May 1991). 45. Shainin, D. and Shainin, P., OK Isn't Good Enough, Quality, 19-23 (1990). 46. Shainin, R., Strategies for Technical Problem Solving, Qual. Eng., 5(3), 433-448 (1993). 47. Scherkenbach, W., The Deming Route to Quality and Productivity. CEEPress Books, Washington, DC/ASQC, Milwauke, WI, 1992, p. 1. 48. Box, G. E. P., Total Quality: Its Origin and Its Future, Report No. 123, Center for Quality and Productivity Improvement University of Wisconsin, Madison (January 1995). 34. 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.