International Journal for Quality in Health Care 1998; Volume 10, Number I: pp.
69-73
Methodology matters — VIII
'Methodology Matters' is a series of intermittently appearing articles on methodology. Suggestions from readers of additional topics
they would like to see covered in the series are welcome.
Use and interpretation of statistical
quality control charts
JAMES C BENNEYAN
Department of Mechanical, Industrial and Manufacturing Engineering, 334 Snell Engineering Center, Northeastern University, Boston,
MA 02115, USA
Originally developed at Bell Laboratories by Dr Walter
Shewhart [1] in 1924 specifically to help detect statistical
changes in process quality, control charts have since become
one of several primary tools of quality control and process
improvement. Quality control charts are chronological graphs
of process data that, although based in statistical theory, are
easy for practitioners to use and interpret. These charts
also can help users to develop an understanding of the
performance of a process and to evaluate any benefits or
consequences of process interventions, complementing tra-
ditional methods by providing additional longitudinal in-
formation that otherwise might not be detected [2].
This article provides a brief introduction to the use of statistical
quality control charts for analyzing, monitoring, and improving
health care processes. After an overview of key concepts, several
examples illustrate control chart use and interpretation. The
article concludes with some common pitfalls to avoid and ref-
erences for further exploration. Readers unfamiliar with the topic
should also read introductory materials on the principles of
quality management and the philosophies of the late quality
pioneer, Dr W. E. Deming [3].
Key concepts: natural variability and
statistical control
Most processes exhibit some variability, all of which can be
classified into one of two categories: 'natural' or 'unnatural'.
The natural variability of a process is the systemic variation
inherent as a regular part of the process. Some examples of
'common causes' of natural variability might include the time
of day, hospital census and case-mix, weight and physical
condition of patients, other patient-to-patient differences,
and varying behaviors and demographics. Because they are
Address correspondence t o James C Benneyan. Tel: ( + 1 ) 617 373 2975; Fax: ( + 1 ) 617 373 2921; E-mail:
benneyan@coe.neu.edu
Downloaded from http://intqhc.oxfordjournals.org/ at Universidad Politécnica de Madrid on May 28, 2012
caused by regular sources within the process or its en-
vironment, data exhibiting natural variation occur in pre-
dictable and relatively common frequencies.
Conversely, outcomes or in-process observations that have
very small probabilities of occurrence, assuming only natural
variability, usually represent deviations from the regular pro-
cess. Such events suggest that the process fundamentally has
changed, for better or worse, due to atypical unnatural
variability that should be traced to root assignable causes for
management intervention. Examples of 'special causes' of
unnatural variability might include changes in clinical pro-
cedures, skill degradation, equipment failure, new staff, and
changes in population demographics, the rate of disease, or
a patient's physiology.
Finally, the term 'statistical control' refers to the stability
and predictability of a process over time and to the type of
variability that exists. A process that is completely stable over
time exhibits only natural variability, with its regular random
behavior remaining unchanged, and is referred to as being
in a state of statistical control. Conversely, a process that
changes from its norm will exhibit unnatural variability and
is referred to as being out of statistical control. Note that it
is usually quite difficult to determine intuitively, without the
aid of control charts, which type of variation exists and
therefore whether direct intervention ultimately would be
beneficial or harmful to process outcomes.
Control chart format, use and
interpretation
Figure 1 shows the general format of a statistical control
chart. Process data are collected at certain intervals over time
and formed into rational time-ordered subgroups (such as
69
Methodology Matters: J. C. Benneyan
Subgroup
Statistic
(e.g., average,
standard deviation,
rate, number,
proportion)
I •I•I•I•1•I•I •
2 4 6 8 10 12 14
Figure I General format of a quality control chart
by day or week). Some value of interest is calculated from each
subgroup soon after being collected, plotted in chronological
sequence on the chart, and then evaluated for typical versus
statistically irregular behavior. At least 25 subgroups are
recommended to start a control chart.
Along with these subgroup values, three horizontal lines
are also calculated and plotted on the chart. These are called
the centerline, the upper control limit, and the lower control
limit. The centerline and control limits help define the in-
control central tendency and natural variability of the process,
respectively. The centerline is almost always set equal to the
arithmetic mean or expected value of the plotted statistic, so
that approximately half of the subgroup values will fall on
each side. The control limits are then usually set equal to the
centerline plus and minus three theoretical standard deviations
of the plotted values.
A process is considered to be in statistical control if all of
the plotted subgroup values are between the control limits
over a sufficient span of time. There also should be no
evidence of unusual behavior between the limits, such as
trends, cycles, visibly evident changes, and other forms of
non-random variation such as those defined by the additional
rules listed in Table 1. Note that unequal subgroup sizes
(such as a differing number of medications filled each week)
result in varying control limits, although chart interpretation
is basically the same.
In this fashion, control charts are valuable for several
purposes throughout the process improvement cycle. These
uses are described and illustrated in greater detail elsewhere
[1,3-5] and include:
(1) testing for and establishing a state of statistical control;
(2) monitoring an in-control process for changes in process
and outcome quality;
(3) identifying, testing, and verifying process improvement
opportunities.
The long-term objectives are to tighten the control limits by
reducing process variation and to move the centerline so that
70
Upper Control Limit (UCL)
Center Line (CL)
Lower Control Limit (LCL)
• I •1 •I •I •I •I •I . 1 •
16 18 20 22 24 26 28 30 32 34 36 38 40 4 2 .
Downloaded from http://intqhc.oxfordjournals.org/ at Universidad Politécnica de Madrid on May 28, 2012
Subgroup Number
Table I Criteria for not being in a state of statistical control
Control chart out-of-control signals
Any single subgroup value outside either control limit
Eight consecutive subgroups on one particular side of the
centerline (CL)
Twelve of fourteen consecutive subgroups on one
particular side of the centerline
Three consecutive subgroups beyond 2 standard deviations
on a particular side of the CL
Five consecutive subgroups beyond 1 standard deviation
on a particular side of the CL
Thirteen consecutive subgroups within + 1 standard
deviation (on both sides) of the CL
Six consecutive subgroups with either an increasing or
decreasing trend
Cyclical or periodic behavior
the process is operating closer to some target value. Several
health care examples of these uses can be found in reference [5].
Common types of statistical control
charts
Several common types of control charts exist, each con-
structed using slightly different formulas and each being
appropriate for different types of data. The appropriate
equations for a given chart can be found in any good quality
control text [4,6,7]. Determining which specific type of control
chart should be used is based on identifying the type of
continuous or discrete data to be plotted. For example, three
of the most common statistical distributions are the normal,
binomial, and Poisson. While numerous other types are

?50I
£ 45 -•
- 4 0 -
< 35 -r
c 30 -
2 25 -
1 20--
Q
15-:
<5 10 -
H 1 1 11 -I 1 1 1 1 h—I 1-
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
100
90
80
70
60
50
40
30
20
10
H—I 1 1 1 1 1 1 1 H -I 1 1 1 1 1-
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
Subgroup Number
Figure 2 A'and S control charts of laboratory beta-sub turn-
around-time
possible, usually one of the following can be reasonably
appropriate for describing many processes.
For continuous values that are normally distributed (i.e.
'bell-shaped'), both an X (pronounced 'x bar3) and S control
chart should be used together. These two charts monitor the
process mean and standard deviation, respectively. Examples
of this type of data might include recovery duration, times
to complete various activities, patient weights, lung capacity,
and intake and output. For example, Figure 2 illustrates X
and S control charts for the laboratory time to complete
beta-sub pregnancy tests. The process is considered to be
out of control if either chart exhibits out-of-control signals.
In this case, note that both charts have out-of-control values
above the upper control limits. The root causes of these
outcomes should be identified and removed in order to
achieve a consistent and in-control process. Also note that
the chart later has a run of 10 consecutive values beneath
the centerline, signaling (via the second criterion in Table 1)
a now improved process.
For discrete data, the two most common pairs of control
charts are called np and p charts (for binomial distributions)
and c and u charts (for Poisson distributions). Unlike the
example given above, once the appropriate pair is identified
only one of the two charts should be used alone, rather than
both together (due to statistical reasons beyond the current
scope of this article). The choice within a pair is largely
preferential when all subgroups are the same size, whereas p
and u charts are preferred over np and c charts, respectively,
when dealing with unequal subgroup sizes. Each of these
four charts is appropriate in the following situations.
Given a certain number of dichotomous events, np and p
Use of quality control charts
charts are used for monitoring the number and fraction of
these, respectively, that have a particular characteristic of
interest (e.g. a billing error, a late patient arrival, or a Cesarean
section birth), where the probability of occurrence is reas-
onably the same for each event. For example, Figure 3
illustrates a p chart of the fraction of medication errors per
week (with non-constant control limits due to a varying
number of medications per week). Note that these data reveal
a gradually increasing trend in the error rate (criterion seven),
to the point where two subgroup values fall above the upper
control limit. Again, identifying and removing the root causes
of this unnatural variation is the first step in stabilizing and
improving this process.
Alternately, Poisson-based c and u charts often are ap-
propriate for count data for which no theoretical maximum
Downloaded from http://intqhc.oxfordjournals.org/ at Universidad Politécnica de Madrid on May 28, 2012
exists, such as the number of some particular type of oc-
currence per examined area, volume, or time period. Examples
can include the number of arrivals to an emergency room
per shift, telephone calls per hour, leukocytes per CBC, or
skin melanomas per patient. For example, Figure 4 illustrates
a u type of control chart for the number of patient falls per
month (with non-constant control limits now due to a varying
monthly census). Again, note the clear signals of atypical out-
of-control events (corresponding to the months 10/91,
1/93, and 8/93) in an otherwise stable and consistent process.
Further examples of each of the above types of control
charts can be found in the references cited. While these types
are the most commonly used, they are based on certain
assumptions that are usually but not always true. For example,
g and h control charts [8] are appropriate in situations where
the underlying count distribution is geometric, rather than
Poisson. These charts also are useful in situations involving
low rates by monitoring the number of dichotomous events
between outcomes, such as the number of surgeries between
postoperative infections [9]. As an example, Figure 5 illustrates
a g chart of die number of days between Clostridium difficile
nosocomial infections. As can be seen via multiple violations
of the second and third criteria, for statistical control an
increase in the infection rate appears to have occurred in the
vicinity of subgroup 34, with 18 of the next 22 subgroup
values — including a run of nine consecutive values — beneath
the centerline.
Some final cautions
While ease of use certainly is valuable, the effects of some
common oversimplifications and misunderstandings about
the use of control charts can be to decrease significandy
either specificity or the ability to detect true process changes.
For example, periodic statistical errors include basing control
limits on the overall standard deviation of the data instead
of on the recommended formulas, not using three standard
deviation limits in almost all cases, and not accounting for
significantly autocorrelated or multivariate processes. Other
pitfalls include not using at least 25—35 rational subgroups,
not taking sufficiendy large subgroups if process data are not
reasonably bell-shaped, and failing to design charts with
71
Methodology Matters: J. C. Benneyan

o
c 1
'• t.
&
2
Q.
F*^—» / \ / \ w-\ j \ i \ / \ I—H^—J—it—"T"
i V i V i i i V i 'i i i '» i i V i i • i i i V i i V i i \ i i i '• 1 i I i i \ \
10 15 Z0 25 30
Week Number

Downloaded from http://intqhc.oxfordjournals.org/ at Universidad Politécnica de Madrid on May 28, 2012

Figure 3 p control chart of fraction of medication errors per week

M > M I I I I t I I I I t I I I I I M I I I I I I I 1 I > I t I I I I I
1/91 4/91 7/91 10/91 1/92 4/92 7/92 10/92 1/93 4/93 7/93 10/93 1/94 4/94
Month

Figure 4 » control chart of patient falls per month

6-

i u
•i i l
15 30 45 75

Occurrence of Infection

Figure 5 £ control chart of nosocomial infection rate

desirable statistical properties (i.e. sensitivity and specificity). (especially in cases for which any of the above charts are
Common errors in control chart selection include failing more appropriate), and using standard control charts when
to identify an appropriate chart, using an X chart alone combining data from non-homogenous processes. Related
without an J" chart, overuse of the so-called 'individuals' chart implementation concerns include reacting to natural variability

72

J

('process tampering'), using control charts primarily to 'hold
the gains', and over-reliance on software. Although not the
current focus, additional information on these topics, related
quality control methods, and more advanced concepts can
be found in some of the listed references.
References
1. Shewhart W. A. The Economic Control of Quality of Manufactured
Product. New York: D. Van Nostand and Co., 1931.
2. BenneyanJ. C , Kaminsky F. C. Another view on how to measure
health care quality. Qual. Progress 1995; 28: 120-124.
3. Deming W. E. Quality, Productivity, and Competitive Position. Cam-
bridge, MA: Massachusetts Institute of Technology Center for
Advanced Engineering Studies, 1982.
Use of quality control charts
4. Montgomery D. C. Introduction to Statistical Quality Control, 3rd edn.
New York: Wiley, 1997.
5. Benneyan J. C. Statistical quality control methods in infection
control. Infect. Contr. Hosp. Epidemiol, (in press).
6. Gitlow H., Gitlow S., Oppenheim A., Oppenheim R. Tools and
Methods for the Improvement ofQuality. Homewood, IL: Irwin, 1989.
7. Banks J. Principles of Quality Control. New York: Wiley, 1981.
8. Benneyan J. C , Kaminsky F. C. Modeling discrete data in SPC:
the g and h control charts. Am. Soc. Qual. Contr. (Ann. Qual. Congr.
Trans.) 1994; 32-42.
9. BenneyanJ. C. Design of statistical^ control charts for nosocomial
infection and other alternatives. In International Applied Statistics
in Medicine Conference Proceedings (in press).
Downloaded from http://intqhc.oxfordjournals.org/ at Universidad Politécnica de Madrid on May 28, 2012
Received in revised form 25 July 1997
73