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Use of Statistical Process Control (SPC) Versus Traditional Statistical Methods in Personal Care Applications
Use of Statistical Process Control (SPC) Versus Traditional Statistical Methods in Personal Care Applications
Raymond W. Phillips
Dow Corning Corporation
Midland, MI 48686
USA
Presented at the 17th IFSCC International Congress Yokohama
October 13-16, 1992
Abstract
The basis for traditional statistical inference is the assumption of statistical stability. However, observations indicate that this assumption is often incorrect and has significant limitations for the study of skin and hair systems. This paper focuses on the use of analytic statistical
analysis versus enumerative statistical analysis for evaluating data from experiments and
product studies.
Traditional statistical analysis depends on the experimenter to classify random variation
(i.e., experimental noise) based on experience. This usually results in an inflated estimate of
noise level, which can obscure valuable signals from the study.
W. A. Shewhart developed control charts to evaluate data taken during analytic studies;
these charts represent a powerful tool for gaining an understanding of experimental variation and results when compared to methods of statistical inference. Analysis of experimental
data using the methods of statistical process control (SPC) allows the assumption of statistical stability to be tested. Further, the graphical techniques of SPC allow the experimenter to
see data, allowing insight into cause-and-effect relationships not readily apparent with
traditional statistical methods. SPC techniques allow discovery of sources of non-random
variation, resulting in a better understanding of the system being studied.
Introduction
According to W. Edwards Deming, the great contribution of control charts is to separate variation into two
sources: 1) the system itself (chance causes, as
Shewhart refers to them), which is the responsibility of
management, and 2) assignable causes, which Deming
calls special causes; those specific to some event that
can usually be discovered to the satisfaction of the expert on the job. Shewhart and Deming have pointed
out that measurement is itself a process, subject to both
sources of variation. Results obtained from two instruments, from a single instrument on different days, or
from an instrument operated by different operators,
cannot be usefully compared unless the process is in
statistical control and statistical control is ephemeral. Control charts are the most useful statistical
method for presenting data from laboratory studies.
Use of Statistical Process Control (SPC) Versus Traditional Statistical Methods in Personal Care Applications
1870
1910
1890
1930
Year
Figure 1.
Changes in the accepted values for certain universal constants between 1870 and 1940 suggest statistical
instability.
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R.N. Phillips
(C), the gravitational constant (G), and Plancks constant (h) did not appear as though they came from a
stable system.
Certainly these measurements are among the elite
of all measurements; yet it appears that sources of nonrandom variation existed at the time of their measurement, and that todays scientists are left to use their
own experience to determine the cause. To avoid problems of this nature, a Range chart or standard deviation chart is used in control charts to assess the stability
of variation and also to quantify the level of background
noise, which is then used to differentiate between levels of treatment.
60
Right-arm data
Sample
Figure 2.
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Use of Statistical Process Control (SPC) Versus Traditional Statistical Methods in Personal Care Applications
the researchers, and the source of variation was aggregated as background when T-tests were used to determine significance between treatments. Because the
cause remained undetermined, right arm data were
eliminated from the study, and future work is continuing on the left arm only. Focusing on the left arm has
greatly improved the ability to differentiate between
treatments.
A Range chart on blanks is now used to screen subjects, eliminating this source of variation from current
testing. This improves the precision of conductance tests
and enhances the ability of researchers to differentiate
between treatments. A full analysis of the
moisturization data from both transepidermal water
loss (TEWL) and conductance has been published [1]
and will not be described in detail here.
Figure 3 demonstrates how data can be rationally
subgrouped by combining all blanks from the left arm
by position as a means of seeking relationship, i.e., blank
TEWL measurements by position on the left arm. The
control limits signify the amount of variation that can
be explained by measurement precision. The graph
shows a linear increase of blank TEWL proportional to
the position on the forearm. This shows not only the
significance of the differences that are not explainable
by test-retest variation, but the relative magnitude of
TEWL upward along the arm.
Left-Arm Values
Figure 3.
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R.N. Phillips
treated, then evaluated by a panel for various qualities. The researchers then analyzed the results via a
user-friendly computer package with ANOVA capabilities.
ANOVA is a powerful statistical technique used to
detect signals in experimental data. However, the result is a significant F test, rather than results that
can be understood and used. The results of the significant F test show only that a signal exists in the data,
they do not indicate what the signal is. Further analysis is required to determine which treatments differ from
each other; the original researchers were not aware of
this and the computer failed to tell them. They assumed the cause of the signal based on their subject
knowledge, reinforced with a significant F, and concluded that C differed from A or B, which made sense
from a technical standpoint.
Another researcher analyzed the data using histograms of the original data, then questioned the conclusion. Clearly, C differed from A, but the bimodal nature
of B was lost in the ANOVA technique. In fact, B could
not be distinguished from C or A using statistical tests,
but the bimodal distribution of B was a signal of the
performance of treatment B, which led to further insight into the performance of all three hair treatments.
The histogram revealed to the second researcher the
evidence of a different system of causes contained in
the reduction in conductance measurements of petrolatum-treated skin over time. If only random variation
existed, measurements on untreated skin would result
in a distribution centered at zero and extending to
three standard deviations. However, Figure 4 depicts
not only the decrease in time in conductance measurements on treated skin, but also suggests the presence
of other assignable causes of variation contained in the
data by the spread of the histogram at 2, 4, and 6 hours
after treatment. Both the level of change and the variation of the treatment can easily be seen by the researcher, and the effect is not obscured by the language
of mathematics or other analysis.
Clearly, the true power of statistical analysis comes
from the partnership of the scientist and the statistician: The statistician brings knowledge of variation and
data presentation to the knowledge of the scientist, who
is an expert in the particular subject. Thus, the evolution of knowledge begins with the scientist and ends
with the statistician, and in between, the two must cooperate.
In many instances, the analysis of hair treatments
is subjective. Panels are asked to quantify the effects of
various treatments on samples of hair, typically rating
them from 0 to 10. In a recent study, researchers set
out to measure the effect of three hair treatments.
Samples of untreated hair were collected and randomly
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5 6
9 10 11 12 15 19 20 25 26 27 33
Three-dimensional histograms can help scientists see both the level of change and the variation in treatment
without complex analysis.
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the original data, which was obscured in the data summarized by the first group of researchers.
Conclusions
Statistical analysis is necessary when variation exists;
it is not necessary to tell researchers what they already
know. Caution should be exercised, however, with assumptions of stability, and when experts render opinions regarding essentially the same process. Simple
graphical presentation, including control charts, should
be used to supplement the experts view of experience.
As scientists, we generate data to acquire knowledge;
analytical studies are conducted with the aim of prediction. Shewhart pointed out that to every prediction
there corresponds a certain degree of rational belief;
that is the function of control limits. Deming warns
that the statisticians levels of significance furnish no
measure of belief in a prediction. Probability has use;
in analytic studies, tests of significance do not. The acquisition of knowledge is a continuing process, and control charts can give a picture of this process. They also
provide the necessary degree of rational belief in the
predictions.
References
1. Malczewski, R.M., and R.W. Phillips, ``The Use of
Statistical Process Control to Analyze Moisturization
Study Data, presented at the 16th International
Congress of the IFSCC, New York, NY, 1990.
1986.
Shewhart, W.A., Economic Control of Quality of
Manufactured Product, Van Nostrand, 1931.
Wheeler, D.J., Understanding Industrial Experimentation, Second edition, SPC Press, 1990.
Author
Raymond W. Phillips is a
consultant in statistical methods for Dow Corning and is the
companys primary internal
SPC consultant. He holds a B.S.
degree in chemical engineering,
has pursued graduate studies
in chemical engineering and
engineering management, and
is a registered professional engineer in Michigan, USA.