7/9/2017 Statistics in the Laboratory: Control Charts, Part 1 | American Laboratory

Statistics in the Laboratory: Control Charts, Part 1

Pos ted: Ja n u a r y 2 6 , 2 0 1 6 Share

Stanley N. Dem ing

Statistical process control (SPC) charts were introduced briefly in the prev ious colum n (October 2 01 5). This colum n will
look at the basic ideas behind control charts and how to construct the com m on X-bar and R chart, one of m any ty pes of
control charts. (Subsequent colum ns will cov er rules for detecting out-of-control situations and the difference between
being out of control and being out of specification.)

Figure 1 shows the relationship between an industrial process and a m easurem ent process (an analy tical m ethod). The
industrial process m akes m oney as long as the product quality (Q, perhaps a m easure of im purity ) m eets the custom ers
specifications. The m easurem ent process exam ines the output from the industrial process and reports the v alue of Q,
which can be plotted as a function of tim e or batch num ber. This inform ation about the industrial process is display ed in
the chart in the upper right of Figure 1 .

Measurem ent processes are fundam ental

they m ust be known to be valid for their
intended purposes and they m ust be fit for
use. This generally m eans they m ust hav e
sufficiently sm all bias and sufficiently
sm all im precision. Bias and im precision are
usually stated after a m easurem ent process
has been dev eloped, but those statem ents
are only one snapshot in tim e. (As a
consultant, I nev er trust these statem ents.)
Once im plem ented, a m easurem ent process
changesanaly sts change, reagent
suppliers change, instrum ents change, etc.
Requalification of the m easurem ent
process ev ery now and then isnt sufficient
requalification is just another snapshot
Figure in tim e. Instead, its im portant
1 Control charts for industrial and measurement processes. to continuously m onitor the perform ance of
the m easurem ent process. How does the
m easurem ent process perform from day to day outside the dev elopm ent laboratory ? Thats where control charts com e in.

Control charts were originally dev eloped in the 1 9 3 0s by Walter Shewhart 1 for m onitoring the output of industrial
processes. Analy tical chem ists soon realized that control charts could be used to m onitor m easurem ent processes as well.
For exam ple, in his classic 1 9 6 0 textbook, Laitinen 2 uses Wernim onts 1 9 4 6 application of control charts to com pare
different weighing m ethods. 3

Figure 2 depicts the start of a control chart for m onitoring (lets say ) the perform ance of a liquid chrom atographic m ethod
for m easuring trace am ounts of a toxic im purity . Well assum e that four tim es a day at 8:00 a.m ., 1 1 :00 a.m ., 2 :00
p.m . and 5:00 p.m .we put a reference m aterial through the chrom atograph and m easure the peak area of the
im purity , Q. The upper part of the control chart is known today as a spreadsheet. Each colum n represents a rational
subgroup4 of the data. Well use day as our rational subgroup and record the four peak areas obtained each day . On
day one, the peak areas are 4 9 .6 2 , 4 8.2 3 , 54 .83 and 4 9 .05 integrator counts. Their m ean (X-bar) is 50.4 3 , and their

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range (R, the difference between the largest and sm allest v alues) is 6 .6 0. Lets say I was the analy st on day one, and Iv e
put m y initials (SND) proudly in the spreadsheet.

Figure
2 An X-bar and R control chart.

Below the spreadsheet are two chartsthe upper chart for recording v alues of X-bar, and the lower chart for recording
v alues of R. These charts are usually not scaled until sev eral sets of data hav e been collected, but, because I know what
the full set of data will look like (y ou wont), Iv e gone ahead and scaled them so the future data will fit on them . The
v alue of 50.4 3 has been plotted in the X-bar chart, and the v alue of 6 .6 0 has been plotted in the R chart.

The next day , Stephen L. Morgan is the analy st. He obtains v alues of 4 8.85, 4 8.7 8, 4 9 .2 2 and 51 .1 0 integrator counts.
The av erage this second day is 4 9 .4 9 and the range is 2 .3 2 . Stev e dutifully plots these points in the X-bar and R charts
and initials his work (SLM). Its traditional to link the data points in these charts with straight lines.

Let m e interrupt our progress for a m om ent and m ake two points.

First, update these control charts on a tim ely basis. These charts are the only way the process can talk to y ou. You need
to listen (with y our ey es) continually . Although there are com puter program s that can do all the calculations and
plotting for y ou, I discourage their usetheres a tendency to wait until the end of the m onth to input all y our data and
then m ake the charts so that y ou can include them in y our m onthly report. If the m easurem ent process had gone out of
control earlier in the m onth, its far too late now to discov er the assignable causethe opportunity has been lost. You
need to listen each day . Making these charts m anually (y es, with old-fashioned paper and pencil) isnt a bad idea.

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Second, hide these control charts from m anagers, especially m icrom anagers. There are exceptions, of course, but m any
m anagers dont understand the nature of random v ariation. These m anagers think ev ery effect has a cause. For
exam ple, they m ight see that the m ean has decreased from 50.4 3 to 4 9 .4 9 and speculate about a reason for it: Wow!
That reference m aterial m ust be going bad! Replace it. Now! Whoa. May be, m ay be not. The difference m ight just be
random v ariation at work. Lets wait a while and see what happens. A m anager m ight see that the range has decreased
from 6 .6 0 to only 2 .3 2 . Som ewhere this m anager knows that a sm all range m eans sm all v ariation, and sm all v ariation
is good: Wow! That Stev e Morgan is a careful worker! Lets reward him with a steak dinner and lots of attaboy s for his
good hands. And old Stan? Looks like hes ov er the hill and we need to replace him . Whoa. Hold on. May be Stev e was just
lucky that day . Lets wait a while and see what happens.

Suppose now were at our ninth rational subgroup in Figure 2 . Statisticians would say that the data appear to be in
statistical controlthat is, the v ariation in the data is what would be expected from sm all random effects. With enough
data behind us, we can calculate control limits for both the X-bar and R charts. Details m ay be found in som e of the classic
texts. I like any of Don Wheelers writings4 and the classic text by Grant and Leav enworth. 5 (Go to an inexpensiv e used
book site like addall.com . You dont need m odern textsthis stuff hasnt changed in nearly a century , and therev e been
v ery , v ery few im prov em ents ov er the original.)

A com m on question is, How m any subgroups do I need before I calculate the control lim its? Most statisticians
recom m end 2 03 0 subgroups. Howev er, as Wheeler points out, 4 these lim its are v ery robustthey ev en work with
sm all am ounts of data. [W]hen lim ited am ounts of data are av ailable, go ahead and calculate control lim its, and then,
if and when additional data becom e av ailable, recalculate the lim its.

The lower (LCLX) and upper (UCLX) three-sigm a (3 ) control lim its for the X-bar chart (based on 2 0 sets of data, not all
shown here) are 4 2 .7 8 and 53 .57 , respectiv ely , as shown by the green horizontal lines in Figure 2 . The upper control
lim it for the R chart (UCLR) is 1 6 .89 and is shown by a blue line in Figure 2 . The lower control lim it for the R chart
(LCLR) is usually indistinguishable from the horizontal axis until the subgroup size gets up to about sev en and does not
appear in Figure 2 .

What do these control lim its m ean? If this process behav es in the future as it has in the past, the risk of obtaining a
subgroup m ean or a subgroup range outside these control lim its in either the X-bar chart or the R chart is approxim ately
equal to 0.002 7 0. That is, approxim ately 9 9 .7 % of the tim e the subgroup m eans and subgroup ranges will lie between
the control lim its. If they dont lie between the control lim itswell, thats the subject of the next colum n.

References
1 . Shewhart, W.A. Statistical Method from the Viewpoint of Quality Control; Dem ing, W. Edwards, Ed.; Graduate School,
U.S. Departm ent of Agriculture: Washington, D.C., 1 9 3 9 .
2 . Laitinen, H.A. Statistics in Quantitativ e Analy sis. In Chemical Analysis: An Advanced Text and Reference; McGraw-
Hill: New York, N.Y., 1 9 6 0; Chapter 2 6 .
3 . Wernim ont, G. Use of control charts in the analy tical laboratory . I nd. Eng. Chem. Anal. Ed. 1946, 18(1 0), 587 9 2
[doi: 1 0.1 02 1 /i56 01 58a001 ].
4 . Wheeler, D.J. Advanced Topics in Statistical Process Control: The Power of Shewharts Charts; SPC Press: Knoxv ille,
Tenn., 1 9 9 5.
5. Grant, E.L. and Leav enworth, R.S. Statistical Quality Control, 6 th ed.; McGraw-Hill: New York, N.Y., 1 9 88 [ISBN 0-
07 -02 4 1 1 7 -1 ].

Dr. Stanley N. Deming is an analytical chemist who can be found, as he says, masquerading as a statistician, at Statistical
Designs, 8423 Garden Parks Dr., Houston, Texas 77075-4731, U.S.A.; e-
mail: statisticaldesigns@gmail.com; www.statisticaldesigns.com

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