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Control chart
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| Control chart | |
|---|---|
| One of the Seven basic tools of quality | |
| First described by | Walter A. Shewhart |
| Purpose | To determine whether a process should undergo a formal examination for quality-related problems |
Control charts are graphical plots used in production control to determine whether quality and manufacturing processes are being controlled under stable conditions. (ISO 7870-1)[1] The hourly status is arranged on the graph, and the occurrence of abnormalities is judged based on the presence of data that differs from the conventional trend or deviates from the control limit line. Control charts are classified into Shewhart individuals control chart (ISO 7870-2)[2] and CUSUM(CUsUM)(or cumulative sum control chart)(ISO 7870-4).[3]
Control charts, also known as Shewhart charts (after Walter A. Shewhart) or process-behavior charts, are a statistical process control tool used to determine if a manufacturing or business process is in a state of control. It is more appropriate to say that the control charts are the graphical device for statistical process monitoring (SPM). Traditional control charts are mostly designed to monitor process parameters when the underlying form of the process distributions are known. However, more advanced techniques are available in the 21st century where incoming data streaming can-be monitored even without any knowledge of the underlying process distributions. Distribution-free control charts are becoming increasingly popular.[citation needed]
Overview
[edit]If analysis of the control chart indicates that the process is currently under control (i.e., is stable, with variation only coming from sources common to the process), then no corrections or changes to process control parameters are needed or desired. In addition, data from the process can be used to predict the future performance of the process. If the chart indicates that the monitored process is not in control, analysis of the chart can help determine the sources of variation, as this will result in degraded process performance.[4] A process that is stable but operating outside desired (specification) limits (e.g., scrap rates may be in statistical control but above desired limits) needs to be improved through a deliberate effort to understand the causes of current performance and fundamentally improve the process.[5]
The control chart is one of the seven basic tools of quality control.[6] Typically control charts are used for time-series data, also known as continuous data or variable data. Although they can also be used for data that has logical comparability (i.e. you want to compare samples that were taken all at the same time, or the performance of different individuals); however the type of chart used to do this requires consideration.[7]
History
[edit]The control chart was invented by Walter A. Shewhart working for Bell Labs in the 1920s.[8] The company's engineers had been seeking to improve the reliability of their telephony transmission systems. Because amplifiers and other equipment had to be buried underground, there was a stronger business need to reduce the frequency of failures and repairs. By 1920, the engineers had already realized the importance of reducing variation in a manufacturing process. Moreover, they had realized that continual process-adjustment in reaction to non-conformance actually increased variation and degraded quality. Shewhart framed the problem in terms of common- and special-causes of variation and, on May 16, 1924, wrote an internal memo introducing the control chart as a tool for distinguishing between the two. Shewhart's boss, George Edwards, recalled: "Dr. Shewhart prepared a little memorandum only about a page in length. About a third of that page was given over to a simple diagram which we would all recognize today as a schematic control chart. That diagram, and the short text which preceded and followed it set forth all of the essential principles and considerations which are involved in what we know today as process quality control."[9] Shewhart stressed that bringing a production process into a state of statistical control, where there is only common-cause variation, and keeping it in control, is necessary to predict future output and to manage a process economically.
Shewhart created the basis for the control chart and the concept of a state of statistical control by carefully designed experiments. While Shewhart drew from pure mathematical statistical theories, he understood that data from physical processes typically produce a "normal distribution curve" (a Gaussian distribution, also commonly referred to as a "bell curve"). He discovered that observed variation in manufacturing data did not always behave the same way as data in nature (Brownian motion of particles). Shewhart concluded that while every process displays variation, some processes display controlled variation that is natural to the process, while others display uncontrolled variation that is not present in the process causal system at all times.[10]
In 1924, or 1925, Shewhart's innovation came to the attention of W. Edwards Deming, then working at the Hawthorne facility. Deming later worked at the United States Department of Agriculture and became the mathematical advisor to the United States Census Bureau. Over the next half a century, Deming became the foremost champion and proponent of Shewhart's work. After the defeat of Japan at the close of World War II, Deming served as statistical consultant to the Supreme Commander for the Allied Powers. His ensuing involvement in Japanese life, and long career as an industrial consultant there, spread Shewhart's thinking, and the use of the control chart, widely in Japanese manufacturing industry throughout the 1950s and 1960s.
Bonnie Small worked in an Allentown plant in the 1950s after the transistor was made. Used Shewhart's methods to improve plant performance in quality control and made up to 5000 control charts. In 1958, The Western Electric Statistical Quality Control Handbook had appeared from her writings and led to use at AT&T.[11]
Chart details
[edit]A control chart consists of:
- Points representing a statistic (e.g., a mean, range, proportion) of measurements of a quality characteristic in samples taken from the process at different times (i.e., the data)
- The mean of this statistic using all the samples is calculated (e.g., the mean of the means, mean of the ranges, mean of the proportions) - or for a reference period against which change can be assessed. Similarly a median can be used instead.
- A centre line is drawn at the value of the mean or median of the statistic
- The standard deviation (e.g., sqrt(variance) of the mean) of the statistic is calculated using all the samples - or again for a reference period against which change can be assessed. in the case of XmR charts, strictly it is an approximation of standard deviation, the [clarification needed] does not make the assumption of homogeneity of process over time that the standard deviation makes.
- Upper and lower control limits (sometimes called "natural process limits") that indicate the threshold at which the process output is considered statistically 'unlikely' and are drawn typically at 3 standard deviations from the center line
The chart may have other optional features, including:
- More restrictive upper and lower warning or control limits, drawn as separate lines, typically two standard deviations above and below the center line. This is regularly used when a process needs tighter controls on variability.
- Division into zones, with the addition of rules governing frequencies of observations in each zone
- Annotation with events of interest, as determined by the Quality Engineer in charge of the process' quality
- Action on special causes
(n.b., there are several rule sets for detection of signal; this is just one set. The rule set should be clearly stated.)
- Any point outside the control limits
- A Run of 7 Points all above or all below the central line - Stop the production
- Quarantine and 100% check
- Adjust Process.
- Check 5 Consecutive samples
- Continue The Process.
- A Run of 7 Point Up or Down - Instruction as above
Chart usage
[edit]If the process is in control (and the process statistic is normal), 99.7300% of all the points will fall between the control limits. Any observations outside the limits, or systematic patterns within, suggest the introduction of a new (and likely unanticipated) source of variation, known as a special-cause variation. Since increased variation means increased quality costs, a control chart "signaling" the presence of a special-cause requires immediate investigation.
This makes the control limits very important decision aids. The control limits provide information about the process behavior and have no intrinsic relationship to any specification targets or engineering tolerance. In practice, the process mean (and hence the centre line) may not coincide with the specified value (or target) of the quality characteristic because the process design simply cannot deliver the process characteristic at the desired level.
Control charts limit specification limits or targets because of the tendency of those involved with the process (e.g., machine operators) to focus on performing to specification when in fact the least-cost course of action is to keep process variation as low as possible. Attempting to make a process whose natural centre is not the same as the target perform to target specification increases process variability and increases costs significantly and is the cause of much inefficiency in operations. Process capability studies do examine the relationship between the natural process limits (the control limits) and specifications, however.
The purpose of control charts is to allow simple detection of events that are indicative of an increase in process variability.[12] This simple decision can be difficult where the process characteristic is continuously varying; the control chart provides statistically objective criteria of change. When change is detected and considered good its cause should be identified and possibly become the new way of working, where the change is bad then its cause should be identified and eliminated.
The purpose in adding warning limits or subdividing the control chart into zones is to provide early notification if something is amiss. Instead of immediately launching a process improvement effort to determine whether special causes are present, the Quality Engineer may temporarily increase the rate at which samples are taken from the process output until it is clear that the process is truly in control. Note that with three-sigma limits, common-cause variations result in signals less than once out of every twenty-two points for skewed processes and about once out of every three hundred seventy (1/370.4) points for normally distributed processes.[13] The two-sigma warning levels will be reached about once for every twenty-two (1/21.98) plotted points in normally distributed data. (For example, the means of sufficiently large samples drawn from practically any underlying distribution whose variance exists are normally distributed, according to the Central Limit Theorem.)
Choice of limits
[edit]Shewhart set 3-sigma (3-standard deviation) limits on the following basis.
- The coarse result of Chebyshev's inequality that, for any probability distribution, the probability of an outcome greater than k standard deviations from the mean is at most 1/k2.
- The finer result of the Vysochanskii–Petunin inequality, that for any unimodal probability distribution, the probability of an outcome greater than k standard deviations from the mean is at most 4/(9k2).
- In the Normal distribution, a very common probability distribution, 99.7% of the observations occur within three standard deviations of the mean (see Normal distribution).
Shewhart summarized the conclusions by saying:
... the fact that the criterion which we happen to use has a fine ancestry in highbrow statistical theorems does not justify its use. Such justification must come from empirical evidence that it works. As the practical engineer might say, the proof of the pudding is in the eating.[14]
Although he initially experimented with limits based on probability distributions, Shewhart ultimately wrote:
Some of the earliest attempts to characterize a state of statistical control were inspired by the belief that there existed a special form of frequency function f and it was early argued that the normal law characterized such a state. When the normal law was found to be inadequate, then generalized functional forms were tried. Today, however, all hopes of finding a unique functional form f are blasted.[15]
The control chart is intended as a heuristic. Deming insisted that it is not a hypothesis test and is not motivated by the Neyman–Pearson lemma. He contended that the disjoint nature of population and sampling frame in most industrial situations compromised the use of conventional statistical techniques. Deming's intention was to seek insights into the cause system of a process ...under a wide range of unknowable circumstances, future and past....[citation needed] He claimed that, under such conditions, 3-sigma limits provided ... a rational and economic guide to minimum economic loss... from the two errors:[citation needed]
- Ascribe a variation or a mistake to a special cause (assignable cause) when in fact the cause belongs to the system (common cause). (Also known as a Type I error or False Positive)
- Ascribe a variation or a mistake to the system (common causes) when in fact the cause was a special cause (assignable cause). (Also known as a Type II error or False Negative)
Calculation of standard deviation
[edit]As for the calculation of control limits, the standard deviation (error) required is that of the common-cause variation in the process. Hence, the usual estimator, in terms of sample variance, is not used as this estimates the total squared-error loss from both common- and special-causes of variation.
An alternative method is to use the relationship between the range of a sample and its standard deviation derived by Leonard H. C. Tippett, as an estimator which tends to be less influenced by the extreme observations which typify special-causes.[citation needed]
Rules for detecting signals
[edit]The most common sets are:
- The Western Electric rules
- The Wheeler rules (equivalent to the Western Electric zone tests[16])
- The Nelson rules
There has been particular controversy as to how long a run of observations, all on the same side of the centre line, should count as a signal, with 6, 7, 8 and 9 all being advocated by various writers.
The most important principle for choosing a set of rules is that the choice be made before the data is inspected. Choosing rules once the data have been seen tends to increase the Type I error rate owing to testing effects suggested by the data.
Alternative bases
[edit]In 1935, the British Standards Institution, under the influence of Egon Pearson and against Shewhart's spirit, adopted control charts, replacing 3-sigma limits with limits based on percentiles of the normal distribution. This move continues to be represented by John Oakland and others but has been widely deprecated by writers in the Shewhart–Deming tradition.
Performance of control charts
[edit]When a point falls outside the limits established for a given control chart, those responsible for the underlying process are expected to determine whether a special cause has occurred. If one has, it is appropriate to determine if the results with the special cause are better than or worse than results from common causes alone. If worse, then that cause should be eliminated if possible. If better, it may be appropriate to intentionally retain the special cause within the system producing the results.[citation needed]
Even when a process is in control (that is, no special causes are present in the system), there is approximately a 0.27% probability of a point exceeding 3-sigma control limits. So, even an in control process plotted on a properly constructed control chart will eventually signal the possible presence of a special cause, even though one may not have actually occurred. For a Shewhart control chart using 3-sigma limits, this false alarm occurs on average once every 1/0.0027 or 370.4 observations. Therefore, the in-control average run length (or in-control ARL) of a Shewhart chart is 370.4.[citation needed]
Meanwhile, if a special cause does occur, it may not be of sufficient magnitude for the chart to produce an immediate alarm condition. If a special cause occurs, one can describe that cause by measuring the change in the mean and/or variance of the process in question. When those changes are quantified, it is possible to determine the out-of-control ARL for the chart.[citation needed]
It turns out that Shewhart charts are quite good at detecting large changes in the process mean or variance, as their out-of-control ARLs are fairly short in these cases. However, for smaller changes (such as a 1- or 2-sigma change in the mean), the Shewhart chart does not detect these changes efficiently. Other types of control charts have been developed, such as the EWMA chart, the CUSUM chart and the real-time contrasts chart, which detect smaller changes more efficiently by making use of information from observations collected prior to the most recent data point.[17]
Many control charts work best for numeric data with Gaussian assumptions. The real-time contrasts chart was proposed to monitor process with complex characteristics, e.g. high-dimensional, mix numerical and categorical, missing-valued, non-Gaussian, non-linear relationship.[17]
Criticisms
[edit]Several authors have criticised the control chart on the grounds that it violates the likelihood principle.[citation needed] However, the principle is itself controversial and supporters of control charts further argue that, in general, it is impossible to specify a likelihood function for a process not in statistical control, especially where knowledge about the cause system of the process is weak.[citation needed]
Some authors have criticised the use of average run lengths (ARLs) for comparing control chart performance, because that average usually follows a geometric distribution, which has high variability and difficulties.[citation needed]
Some authors have criticized that most control charts focus on numeric data. Nowadays, process data can be much more complex, e.g. non-Gaussian, mix numerical and categorical, or be missing-valued.[17]
Types of charts
[edit]| Chart | Process observation | Process observations relationships | Process observations type | Size of shift to detect |
|---|---|---|---|---|
| and R chart | Quality characteristic measurement within one subgroup | Independent | Variables | Large (≥ 1.5σ) |
| and s chart | Quality characteristic measurement within one subgroup | Independent | Variables | Large (≥ 1.5σ) |
| Shewhart individuals control chart (ImR chart or XmR chart) | Quality characteristic measurement for one observation | Independent | Variables† | Large (≥ 1.5σ) |
| Three-way chart | Quality characteristic measurement within one subgroup | Independent | Variables | Large (≥ 1.5σ) |
| p-chart | Fraction nonconforming within one subgroup | Independent | Attributes† | Large (≥ 1.5σ) |
| np-chart | Number nonconforming within one subgroup | Independent | Attributes† | Large (≥ 1.5σ) |
| c-chart | Number of nonconformances within one subgroup | Independent | Attributes† | Large (≥ 1.5σ) |
| u-chart | Nonconformances per unit within one subgroup | Independent | Attributes† | Large (≥ 1.5σ) |
| EWMA chart | Exponentially weighted moving average of quality characteristic measurement within one subgroup | Independent | Attributes or variables | Small (< 1.5σ) |
| CUSUM chart | Cumulative sum of quality characteristic measurement within one subgroup | Independent | Attributes or variables | Small (< 1.5σ) |
| Time series model | Quality characteristic measurement within one subgroup | Autocorrelated | Attributes or variables | N/A |
| Regression control chart | Quality characteristic measurement within one subgroup | Dependent of process control variables | Variables | Large (≥ 1.5σ) |
†Some practitioners also recommend the use of Individuals charts for attribute data, particularly when the assumptions of either binomially distributed data (p- and np-charts) or Poisson-distributed data (u- and c-charts) are violated.[18] Two primary justifications are given for this practice. First, normality is not necessary for statistical control, so the Individuals chart may be used with non-normal data.[19] Second, attribute charts derive the measure of dispersion directly from the mean proportion (by assuming a probability distribution), while Individuals charts derive the measure of dispersion from the data, independent of the mean, making Individuals charts more robust than attributes charts to violations of the assumptions about the distribution of the underlying population.[20] It is sometimes noted that the substitution of the Individuals chart works best for large counts, when the binomial and Poisson distributions approximate a normal distribution. i.e. when the number of trials n > 1000 for p- and np-charts or λ > 500 for u- and c-charts.
Critics of this approach argue that control charts should not be used when their underlying assumptions are violated, such as when process data is neither normally distributed nor binomially (or Poisson) distributed. Such processes are not in control and should be improved before the application of control charts. Additionally, application of the charts in the presence of such deviations increases the type I and type II error rates of the control charts, and may make the chart of little practical use.[citation needed]
See also
[edit]References
[edit]- ^ "Control charts — Part 1: General guidelines". iso.org. Retrieved 2022-12-11.
- ^ "Control charts — Part 2: Shewhart control charts". iso.org. Retrieved 2022-12-11.
- ^ "Control charts — Part 4: Cumulative sum charts". iso.org. Retrieved 2022-12-11.
- ^ McNeese, William (July 2006). "Over-controlling a Process: The Funnel Experiment". BPI Consulting, LLC. Retrieved 2010-03-17.
- ^ Wheeler, Donald J. (2000). Understanding Variation. Knoxville, Tennessee: SPC Press. ISBN 978-0-945320-53-1.
- ^ Nancy R. Tague (2004). "Seven Basic Quality Tools". The Quality Toolbox. Milwaukee, Wisconsin: American Society for Quality. p. 15. Retrieved 2010-02-05.
- ^ A Poots, T Woodcock (2012). "Statistical process control for data without inherent order". BMC Medical Informatics and Decision Making. 12: 86. doi:10.1186/1472-6947-12-86. PMC 3464151. PMID 22867269.
- ^ "Western Electric History". www.porticus.org. Archived from the original on 2011-01-27. Retrieved 2015-03-26.
- ^ "Western Electric – A Brief History". Archived from the original on 2008-05-11. Retrieved 2008-03-14.
- ^ "Why SPC?" British Deming Association SPC Press, Inc. 1992
- ^ Best, M; Neuhauser, D (1 April 2006). "Walter A Shewhart, 1924, and the Hawthorne factory". Quality and Safety in Health Care. 15 (2): 142–143. doi:10.1136/qshc.2006.018093. PMC 2464836. PMID 16585117.
- ^ Statistical Process Controls for Variable Data. Lean Six sigma. (n.d.). Retrieved from https://theengineeringarchive.com/sigma/page-variable-control-charts.html.
- ^ Wheeler, Donald J. (1 November 2010). "Are You Sure We Don't Need Normally Distributed Data?". Quality Digest. Retrieved 7 December 2010.
- ^ Shewhart, W A (1931). Economic Control of Quality of Manufactured Product. Van Nordstrom. p. 18.
- ^ Shewart, Walter Andrew; Deming, William Edwards (1939). Statistical Method from the Viewpoint of Quality Control. University of California: Graduate School, The Department of Agriculture. p. 12. ISBN 9780877710325.
{{cite book}}: ISBN / Date incompatibility (help) - ^ Wheeler, Donald J.; Chambers, David S. (1992). Understanding statistical process control (2 ed.). Knoxville, Tennessee: SPC Press. p. 96. ISBN 978-0-945320-13-5. OCLC 27187772.
- ^ a b c Deng, H.; Runger, G.; Tuv, E. (2012). "System monitoring with real-time contrasts". Journal of Quality Technology. 44 (1). pp. 9–27. doi:10.1080/00224065.2012.11917878. S2CID 119835984.
- ^ Wheeler, Donald J. (2000). Understanding Variation: the key to managing chaos. SPC Press. p. 140. ISBN 978-0-945320-53-1.
- ^ Staufer, Rip. "Some Problems with Attribute Charts". Quality Digest. Retrieved 2 Apr 2010.
- ^ Wheeler, Donald J. "What About Charts for Count Data?". Quality Digest. Retrieved 2010-03-23.
Bibliography
[edit]- Deming, W. E. (1975). "On probability as a basis for action". The American Statistician. 29 (4): 146–152. CiteSeerX 10.1.1.470.9636. doi:10.2307/2683482. JSTOR 2683482.
- Deming, W. E. (1982). Out of the Crisis: Quality, Productivity and Competitive Position. ISBN 978-0-521-30553-2.
- Deng, H.; Runger, G.; Tuv, Eugene (2012). "System monitoring with real-time contrasts". Journal of Quality Technology. 44 (1): 9–27. doi:10.1080/00224065.2012.11917878. S2CID 119835984.
- Mandel, B. J. (1969). "The Regression Control Chart". Journal of Quality Technology. 1 (1): 1–9. doi:10.1080/00224065.1969.11980341.
- Oakland, J. (2002). Statistical Process Control. ISBN 978-0-7506-5766-2.
- Shewhart, W. A. (1931). Economic Control of Quality of Manufactured Product. American Society for Quality Control. ISBN 978-0-87389-076-2.
{{cite book}}: ISBN / Date incompatibility (help) - Shewhart, W. A. (1939). Statistical Method from the Viewpoint of Quality Control. Courier Corporation. ISBN 978-0-486-65232-0.
{{cite book}}: ISBN / Date incompatibility (help) - Wheeler, D. J. (2000). Normality and the Process-Behaviour Chart. SPC Press. ISBN 978-0-945320-56-2.
- Wheeler, D. J.; Chambers, D. S. (1992). Understanding Statistical Process Control. SPC Press. ISBN 978-0-945320-13-5.
- Wheeler, Donald J. (1999). Understanding Variation: The Key to Managing Chaos (2nd ed.). SPC Press. ISBN 978-0-945320-53-1.
External links
[edit]Control chart
View on GrokipediaIntroduction
Definition and Purpose
A control chart is a graphical tool that displays a time-sequenced plot of data points from a process, accompanied by a centerline representing the process average and upper and lower control limits derived from statistical measures of variability, enabling the assessment of process performance over time.[1][9] This visualization allows practitioners to observe patterns in the data and determine whether the process remains stable or exhibits signals of change.[1] The primary purpose of a control chart is to detect shifts or trends in the process mean or variability, facilitating timely interventions to prevent defects and maintain consistent quality output.[10] Within the framework of statistical process control (SPC), which employs statistical methods to monitor, control, and improve process performance, control charts play a central role by distinguishing between common cause variation—random, inherent fluctuations expected in a stable process—and special cause variation arising from identifiable external factors.[10][11] This differentiation supports proactive decision-making to sustain process stability without overreacting to normal fluctuations.[12] For instance, in manufacturing, a control chart might track the dimensions of machined parts collected at regular intervals, alerting operators to potential issues like tool wear if points exceed the control limits, thereby ensuring product conformity and reducing waste.[1]Basic Components
A control chart is a graphical tool that displays data points representing measurements of a quality characteristic plotted sequentially over time or sample number. The x-axis typically denotes time or the order of observation, while the y-axis shows the measured values, providing a visual timeline of process performance.[9] At the core of the chart is the centerline, which represents the average value of the process when it is in a state of statistical control. This centerline is calculated as the arithmetic mean of the plotted data points, given by the formula where are the individual measurements and is the number of points.[9] Parallel to this centerline are two horizontal lines: the upper control limit (UCL) and the lower control limit (LCL), which define the boundaries within which process variation is expected under stable conditions.[9] The space between the UCL and LCL is often divided into zones to facilitate interpretation, with the region between the centerline and each limit further subdivided for assessing patterns in the data.[13] These components together enable the chart to monitor process stability by highlighting deviations from expected behavior.[9] In contrast to run charts, which simply plot data over time with a central line such as the median but lack statistically derived limits, control charts incorporate the UCL and LCL to differentiate between normal process variation and unusual shifts.[14]Historical Development
Origins with Shewhart
The origins of the control chart trace back to the work of Walter A. Shewhart at Bell Telephone Laboratories in the early 1920s, where he sought to apply statistical methods to monitor and improve manufacturing processes. On May 16, 1924, Shewhart issued an internal memorandum to his supervisor, George D. Edwards, proposing the use of charts to plot sample averages over time as a means to distinguish between common and special causes of variation in production.[15] This memo, often regarded as the first documented prototype of a control chart, emerged amid post-World War I challenges in the telephone industry, including increased demand for reliable equipment and persistent quality inconsistencies in manufacturing components like vacuum tubes and switches.[15][16] Shewhart's early concepts centered on the idea of statistical control, where process data would be plotted against dynamically calculated limits to detect deviations signaling assignable causes of variation. A pivotal innovation was the introduction of three-sigma control limits, derived from the assumption of a normal distribution for process measurements, which would encompass approximately 99.7% of observations from a stable process and flag outliers as potential issues requiring intervention.[17] These limits provided a rational, economically grounded criterion for quality control, balancing the costs of over-detection against the risks of undetected defects.[18] Shewhart continued refining these ideas through the late 1920s, collaborating with colleagues at Bell Labs to test them on real manufacturing data. His comprehensive theoretical framework was first published in 1931 with the book Economic Control of Quality of Manufactured Product, which formalized control charts as tools for achieving economic efficiency in quality management by integrating statistical theory with practical application.[19] This work laid the groundwork for statistical process control, emphasizing the distinction between inherent process variability and external disruptions.[15]Post-War Adoption and Evolution
Following World War II, W. Edwards Deming played a pivotal role in disseminating control chart methodologies internationally, particularly in Japan. Invited by the Union of Japanese Scientists and Engineers in 1950, Deming delivered lectures on statistical quality control, emphasizing Shewhart control charts to distinguish common from special causes of variation and foster continuous process improvement.[20] His efforts during the U.S. occupation contributed to Japan's post-war industrial revival, igniting a quality revolution that transformed manufacturing sectors like automotive and electronics by integrating control charts into everyday operations.[21] This influence culminated in the establishment of the Deming Prize in 1951, an annual award by the Japanese Union of Scientists and Engineers to recognize excellence in quality control practices, which further institutionalized the use of control charts nationwide.[22] In the United States, control charts gained formal traction through military and civilian standardization efforts. The U.S. Department of Defense issued MIL-STD-105A in 1950, incorporating attribute-based sampling procedures derived from statistical quality control principles, including elements aligned with control chart monitoring for process inspection during wartime production transitions to peacetime.[23] This standard facilitated the broader adoption of control charts in defense contracting and manufacturing, ensuring consistent quality oversight. Building on this, the American National Standards Institute and American Society for Quality developed ANSI/ASQ Z1.4 in 1971, providing civilian guidelines for attribute inspection sampling that complemented control chart applications in industry, promoting their use beyond military contexts for ongoing process monitoring.[24] The post-war period also saw refinements to attribute control charts, building on their initial development in the 1930s and 1940s at Bell Laboratories, where p-charts and np-charts were introduced for monitoring defect rates in production. During the 1950s and 1960s, these charts evolved through practical applications in diverse industries, with enhancements in limit calculations and sensitivity to small shifts, driven by wartime lessons and peacetime efficiency demands; for instance, adaptations for batch processes improved detection of non-conformities in high-volume manufacturing.[25] International standardization accelerated in the 1990s with the ISO 7870 series, offering comprehensive guidelines for control chart implementation. First published in 1993 as a general guide (ISO 7870:1993), the series provided unified procedures for establishing limits, selecting chart types, and interpreting signals, facilitating global adoption in quality management systems. Subsequent revisions, such as ISO 7870-1:2007, expanded on philosophical underpinnings and chart varieties, emphasizing their role in proactive process control, while ISO 7870-2:2013 specifically addressed Shewhart control charts. Recent milestones include the 2020 update to ISO 22514-3, which integrates control chart principles into machine performance studies for discrete parts, supporting modern applications like automated data collection in digital environments while referencing ISO 7870 for chart construction and validation.[26]Fundamental Principles
Statistical Foundations
Control charts are grounded in the principles of probability theory, particularly the normal distribution, which underpins the determination of control limits. Walter Shewhart developed the foundational approach in 1924,[27] establishing limits at three standard deviations (3σ) from the process mean, as this encompasses approximately 99.73% of data points in a stable process assuming normality. This empirical rule balances the risk of false alarms (Type I errors) against the detection of significant shifts, ensuring economic efficiency in process monitoring. The 3σ criterion was chosen not solely for probabilistic purity but for its practical effectiveness in distinguishing random fluctuations from assignable causes of variation.[28][29] The application of control charts parallels hypothesis testing in statistical inference, where the null hypothesis posits a stable process under common-cause variation, and out-of-control signals represent rejection of this hypothesis in favor of special-cause variation. Each plotted point or pattern triggers a test against the null, with control limits defining the critical region (e.g., beyond 3σ corresponding to a low probability, about 0.27%, of false rejection under normality). This framework allows sequential monitoring without predefined sample sizes, adapting to ongoing data collection while controlling overall error rates through the rarity of signals in stable conditions.[30][28] Rational subgrouping forms a critical sampling strategy to isolate within-subgroup variation, which primarily reflects common causes, while between-subgroup differences highlight potential special causes. Shewhart advocated forming subgroups from consecutive units produced under uniform conditions to minimize external influences and maximize sensitivity to process shifts. For instance, in variables charts, subgroups of size n (typically 4–5) are selected to estimate short-term variability accurately, ensuring control limits reflect true process capability rather than sampling artifacts.[28][31] While control charts traditionally assume normality for precise probabilistic interpretation, this requirement is often relaxed due to the central limit theorem (CLT), which states that the distribution of sample means (or subgroup statistics) approaches normality as subgroup size increases, even if individual observations are non-normal. For small subgroups (n ≥ 2), the CLT provides approximate normality, making 3σ limits robust for averages and ranges in many practical scenarios. However, severe skewness or outliers may still inflate false alarms, underscoring the need for data transformation or non-parametric alternatives when CLT approximations falter.[32][28]Types of Process Variation
In the framework of statistical process control, process variation is categorized into two primary types: common cause variation and special cause variation. This dichotomy, originally introduced by Walter A. Shewhart as "chance causes" and "assignable causes" of variation, forms the foundational principle for interpreting control charts.[33] Later refined by W. Edwards Deming into the terms "common" and "special," it distinguishes between predictable, inherent fluctuations and unpredictable, external disruptions in a manufacturing or production process.[34] Common cause variation refers to the random, inherent fluctuations that are an intrinsic part of any stable process, arising from numerous small, unavoidable factors within the system itself. These variations are predictable in aggregate, as they follow a consistent pattern over time and affect all outputs similarly, contributing to the natural "noise" in the process.[33] In a stable system, common cause variation alone indicates process control, where the output remains within expected limits without external intervention, though it may still lead to defects if the variation is too wide relative to specifications. For example, gradual machine wear that causes minor, consistent shifts in product dimensions exemplifies common cause variation, as it stems from the normal operation of the equipment.[34] Special cause variation, in contrast, involves non-random, assignable shifts due to specific, identifiable external factors that disrupt the process stability. These variations are unpredictable and irregular, often resulting in outliers or trends that signal an unstable system requiring immediate corrective action to restore control.[33] Unlike common causes, special causes are not inherent to the process and can be traced to particular events, making them amenable to targeted removal or mitigation. An illustration is tool breakage during operation, which suddenly alters output quality and introduces abrupt deviations beyond normal limits.[34] Shewhart's dichotomy underpins control chart signals, where points within limits reflect common cause variation (indicating stability and predictability), while excursions beyond limits or non-random patterns alert to special causes (demanding investigation and correction to prevent ongoing instability).[33] This classification enables practitioners to focus improvement efforts appropriately: reducing common cause variation requires systemic changes to narrow the process spread, whereas addressing special causes involves eliminating transient anomalies to achieve and maintain stability.[34]Construction of Control Charts
Establishing Control Limits
Control limits in a control chart define the boundaries within which process variation is expected to occur under stable conditions, typically set symmetrically around the centerline to encompass common cause variation while flagging potential special causes. These limits are statistically derived to minimize false alarms while ensuring timely detection of process shifts. The standard approach, pioneered by Walter A. Shewhart, uses three standard deviations (3-sigma) from the process mean, providing a balance between sensitivity and reliability.[9] For an individuals control chart, which monitors single measurements without subgroups, the upper control limit (UCL) and lower control limit (LCL) are calculated as follows: where is the average of the individual observations, and is the estimated process standard deviation. This formula assumes is known or reliably estimated from baseline data, ensuring the limits reflect the inherent process variability.[35] In subgroup-based charts, such as the X-bar and R chart for monitoring averages and ranges, control limits incorporate subgroup size to account for reduced variability in averages. The UCL and LCL for the X-bar chart are given by: where is the grand average of subgroup means, is the average subgroup range, and is a constant from standard tables that adjusts for subgroup size (e.g., for ), derived as with being the expected range factor for normal distributions. These factors ensure the limits equate to approximately 3-sigma equivalents for the subgroup means.[17] The 3-sigma criterion for control limits is grounded in the normal distribution, where approximately 99.73% of observations fall within of the mean, yielding a low false alarm rate of about 0.27% (or 0.0027 probability) for points exceeding the limits when the process is in control. Shewhart selected this threshold empirically to limit unnecessary interventions while capturing significant deviations, as points beyond these limits occur roughly once every 370 samples on average.[36][9] Establishing control limits often begins with trial limits computed from an initial set of baseline data, typically 20-25 subgroups, to assess process stability. If out-of-control signals are detected and assignable causes are addressed, the data points associated with those signals are removed, and revised limits are recalculated from the remaining in-control data to better represent the stable process state. Revised limits should only be updated with substantial new evidence, such as after 30 or more additional points or a major process change, to avoid instability in ongoing monitoring.[1][28]Estimating Process Variability
Estimating process variability is a critical step in constructing control charts, as it provides the measure of dispersion, typically the standard deviation , needed to set appropriate control limits that reflect common cause variation. This estimation relies on sample data from the process, assuming stability and normality unless otherwise addressed. Various methods are employed depending on the subgroup size and data type, ensuring the estimate is unbiased and representative of the underlying process sigma.[28] For data consisting of individual measurements (subgroup size ), where direct subgroup ranges or standard deviations cannot be computed, the sample standard deviation from a historical dataset of individual observations serves as an estimator for . This is calculated using the formula for the sample standard deviation: where are the individual observations, is the sample mean, and is the number of observations. This approach is particularly useful when a large historical dataset is available, allowing for a direct assessment of overall process dispersion without relying on paired differences.[37] When data are collected in subgroups of size greater than one, the range method offers a simple and efficient way to estimate , especially for smaller subgroup sizes (). The average subgroup range is first computed as the mean of the ranges within each subgroup, where the range for a subgroup is the difference between its maximum and minimum values. The process standard deviation is then estimated as , with being an unbiased constant derived from the expected value of the range for a normal distribution, tabulated based on subgroup size (for example, for ). This method leverages the range's sensitivity to variation while correcting for bias through the constant.[17][38] For larger subgroup sizes (), the standard deviation method using an s-chart provides a more precise estimate by incorporating all data points rather than just extremes. Here, the average subgroup standard deviation is calculated as the mean of the sample standard deviations from each subgroup, and , where is another unbiased constant from statistical tables (dependent on ). This approach reduces the influence of outliers compared to the range and is preferred when computational resources allow full variance calculation within subgroups.[17] In cases where process data deviate from normality, direct application of these estimators may lead to inaccurate control limits, as the constants and assume a normal distribution. To address this, one common strategy involves using a moving range of two consecutive observations to estimate variability for individual data, treating pairs as subgroups of size 2, or applying data transformations (such as Box-Cox) to approximate normality before estimation. These adjustments help maintain the chart's sensitivity to special causes without altering the core estimation framework.[35][39]Practical Setup Procedures
Implementing a control chart requires a systematic approach starting with the selection of the data type and subgroup size. For variables data, such as measurements, an X-bar and R chart is often appropriate, with subgroup sizes of 4 to 5 observations commonly used in initial studies to efficiently estimate process variability while maintaining chart sensitivity.[17] Larger subgroups, such as 10 or more, may be employed for standard deviation-based charts when higher precision is needed, but smaller sizes suffice for most range-based applications.[17] For attribute data, p or np charts are used for proportions or numbers of nonconforming units, while c or u charts are used for defect counts, with subgroup sizes based on sample availability (often 20 to 50 units for proportion-based charts to ensure reliable estimates).[1] Data collection follows, focusing on rational subgrouping to ensure the chart accurately distinguishes common from special cause variation. Rational subgroups are formed by sampling consecutive items produced under identical conditions, such as from the same machine shift, to minimize within-subgroup variation and maximize potential between-subgroup differences that could signal process shifts.[40] This contrasts with convenience sampling, which groups data for logistical ease and may inflate within-subgroup variation, leading to wider control limits and reduced detection power.[40] A baseline period of 20 to 30 subgroups, collected in time order over a period representing normal operations (e.g., several hours or days depending on process speed), is recommended to establish initial limits from stable process behavior.[1][41] Once collected, plot the provisional control chart using the subgroup averages (or proportions) and ranges (or counts) against time or subgroup number, with the centerline as the grand average and limits estimated from the data's variability.[1] If out-of-control signals appear during this initial plotting, investigate and eliminate assignable causes before revising the chart with the remaining in-control points to refine the limits.[1] Software tools facilitate automation of these steps, reducing manual calculation errors. Microsoft Excel offers basic templates for plotting and limit computation, suitable for simple implementations.[1] More advanced options like Minitab provide built-in functions for subgroup analysis, rational subgroup verification, and dynamic updating, enabling efficient handling of larger datasets and integration with variability estimation methods.[42] The baseline period's stability is crucial, as limits derived from non-stable data can mask true process issues; thus, confirm process steadiness through preliminary checks before finalizing the chart.[1]Interpretation and Signal Detection
Rules for Out-of-Control Signals
Control charts employ standardized rules to detect out-of-control signals, which indicate non-random patterns suggestive of special cause variation rather than common cause variation. These rules enhance the ability to identify process shifts, trends, or other anomalies beyond simple exceedance of control limits. The foundational Shewhart rules, introduced by Walter A. Shewhart in the early development of control charts, focus on basic indicators of instability. The primary rule signals an out-of-control condition if any point falls outside the upper or lower control limits, typically set at three standard deviations from the centerline. Later refinements identified runs of points as potential signals; for instance, seven or more consecutive points on one side of the centerline suggest a process shift. These rules prioritize simplicity to distinguish assignable causes from chance variation. In the 1950s, the Western Electric Company expanded upon Shewhart's approach with a set of eight sensitizing rules outlined in their Statistical Quality Control Handbook, aimed at detecting subtler non-random patterns while maintaining practical applicability in industrial settings. These include: one point beyond three standard deviations from the centerline (Zone A); two out of three consecutive points beyond two standard deviations (in Zone A or beyond) on the same side; four out of five consecutive points beyond one standard deviation (in Zone B or beyond) on the same side; eight consecutive points on the same side of the centerline; six consecutive points steadily increasing or decreasing; fifteen consecutive points within Zone C (the central third, ±1σ from centerline, indicating stratification); fourteen consecutive points alternating up and down; and any other unusual or non-random pattern. The expansions, such as trends of six points and shifts of eight points, were designed to flag gradual changes or level shifts that the basic rules might miss.[43] Lloyd S. Nelson further refined these concepts in 1984 by proposing eight sensitizing rules for Shewhart control charts, building on prior work to increase detection sensitivity across various pattern types. Notable among Nelson's rules are: one point beyond three standard deviations; nine points in a row on the same side of the centerline; six points in a row steadily increasing or decreasing; fourteen points in a row alternating up and down; two out of three points in an outer third of the chart (Zone A or beyond) on the same side; four out of five points in an outer third (Zone B or beyond) on the same side; fifteen points in a row in the central third (Zone C) far from the centerline; and a run of eight points on both sides of the centerline with none in the central third. These eight rules encompass and extend the Western Electric set, offering comprehensive coverage for diverse out-of-control scenarios.[44] In practice, these rules—Shewhart's foundational ones, Western Electric's expansions, and Nelson's detailed set—are applied sequentially to control charts, starting with the most straightforward signals and progressing to more complex patterns. This sequential evaluation boosts the chart's sensitivity to real process issues while minimizing false alarms from random variation, ensuring timely intervention without overreaction.[16]Assessing Run Length and Sensitivity
The average run length (ARL) serves as a primary probabilistic measure for evaluating the performance of control charts, defined as the expected number of samples required to detect an out-of-control condition.[17] It quantifies both the chart's stability under in-control conditions and its responsiveness to process shifts. The in-control ARL (ARL0), which indicates the average time between false alarms, is approximately 370 for a standard Shewhart chart using 3-sigma limits, reflecting a low false alarm rate of about 0.27%.[17][45] The ARL is computed using the formula ARL = 1 / p, where p represents the probability of generating a signal at any given sampling point under the specified conditions.[17] For out-of-control scenarios, the out-of-control ARL (ARL1) measures detection speed and diminishes as the magnitude of the process shift grows; for instance, a 1-sigma shift in the process mean on a Shewhart individuals chart results in an ARL1 of approximately 43, indicating faster signaling compared to larger shifts that can reduce it further to near 1.[45] This metric highlights how ARL1 provides a benchmark for comparing chart effectiveness across shift sizes. Assessing sensitivity involves analyzing trade-offs in chart design parameters to balance detection promptness against operational costs. Tighter control limits, such as 2-sigma rather than 3-sigma, decrease ARL0 to reduce time to false alarms but elevate the false alarm rate, potentially disrupting stable processes unnecessarily.[17] Conversely, incorporating combinations of sensitizing rules can lower ARL1 for small shifts while maintaining an acceptable ARL0, optimizing overall chart utility without excessive over-control.[17] To obtain exact ARL values, especially for charts employing multiple rules or non-standard setups, simulation methods like Markov chains are employed, modeling the process as a sequence of states based on recent observations to derive the run length distribution and its expectation.[46] This approach enables precise computation of ARL under complex conditions where analytical solutions are intractable, ensuring reliable performance evaluation.[46]Classification of Control Charts
Charts for Variables Data
Control charts for variables data are designed to monitor continuous measurements from a production process, such as dimensions, weights, or temperatures, by tracking both the process mean and variability over time. These charts assume the data follow a normal distribution and are particularly useful for detecting shifts in the central tendency or dispersion of the process. The primary types include paired charts for subgrouped data and charts for individual observations, with control limits typically set at three standard deviations from the centerline to achieve an average run length of approximately 370 for in-control processes under normality.[17] The X-bar and R chart pair is a foundational method for monitoring subgroup means and ranges, commonly applied when subgroup sizes are small (typically n ≤ 10). The X-bar chart plots the average of each subgroup, with its centerline at the grand mean , upper control limit (UCL) given by , and lower control limit (LCL) by , where is the average subgroup range and is a constant depending on subgroup size n. The accompanying R chart monitors variability by plotting subgroup ranges, with centerline , UCL , and LCL , using constants and . These factors, derived from the expected range distribution under normality, ensure unbiased estimates of process standard deviation , where is another tabulated constant. For example, with n=5, , , and . This combination effectively signals special cause variation when points exceed limits or exhibit non-random patterns.[17] For larger subgroups (n > 10), the X-bar and s chart provides a more efficient alternative by using sample standard deviations instead of ranges for variability estimation, as s offers better precision for bigger samples. The X-bar chart uses the same grand mean centerline, with UCL and LCL , where is the average sample standard deviation and is the size-dependent constant. The s chart plots sample standard deviations, with centerline , UCL , and LCL (noting for n ≤ 6). These constants are based on the chi-squared distribution for s under normality, yielding , with another bias-correction factor. For n=5, , , and .[17][47] This approach reduces sensitivity to outliers in range calculations and is preferred in modern applications with automated data collection.[17] When rational subgrouping is impractical, such as in low-volume production, the individuals (I) and moving range (MR) chart monitors single measurements and pairwise differences. The I chart plots individual values, with centerline at the overall average , UCL , and LCL , where is the average moving range (typically over n=2 consecutive points) and 2.66 = 3 / d_2 with d_2 = 1.128 for n=2. The MR chart tracks variability via these differences, with centerline , UCL 3.268 , and LCL at 0. This method estimates , though it is less sensitive to small shifts compared to subgroup charts due to the lack of within-subgroup averaging.[35]| Subgroup Size (n) | X-bar and R Factors | X-bar and s Factors |
|---|---|---|
| A₂ | D₃ | |
| 2 | 1.880 | 0 |
| 3 | 1.023 | 0 |
| 4 | 0.729 | 0 |
| 5 | 0.577 | 0 |