PHARMACEUTICAL STATISTICS

Pharmaceut. Statist. 2003; 2: 127132 (DOI:10.1002/pst.051)

Negative binomial control limits for

count data with extra-Poisson variation
David Homan*,y
Preclinical and Research Statistics, Sano-Synthelabo Research Division, Malvern, PA,
USA

Traditional techniques for calculating control limits for processes with discrete responses are based on
the Poisson distribution. However, for many processes, the assumption of a Poisson distribution is
violated. In such cases, use of traditional Poisson control limits may result in an inated risk of Type I
error. The negative binomial distribution is a natural extension of the Poisson distribution and allows
for over-dispersion relative to the Poisson distribution. A simple approach to calculating exact and
approximate control limits for count data based on the negative binomial distribution is described.
The approach is illustrated by application to water bacteria count data taken from a water
purication system. Copyright # 2003 John Wiley & Sons Ltd.

1. INTRODUCTION The negative binomial distribution is a natural

The Poisson is often the standard distribution
considered for modelling random counts. As such,
traditional techniques for calculating control limits
for processes with discrete responses are based on
the Poisson distribution [1]. The Poisson distribu-
tion has the well-known property that the mean of
the distribution is equal to the variance.
However, for many processes, the Poisson
distribution provides an inadequate model. Var-
ious types of processes can produce distributions
of counts which are not adequately modelled by
the Poisson distribution. Such processes include
situations where counts tend to occur in clusters,
or situations where the intensity rate of the counts
varies randomly over time [2].
*Correspondence to: D. Homan, Preclinical and Research
Statistics, Sano-Synthelabo Research Division, 9 Great Valley
Parkway, Malvern, PA 19355, USA
y
E-mail: david.homan@sano-synthelabo.com
and more exible extension of the Poisson
distribution and allows for over-dispersion relative
to the Poisson. The negative binomial distribution
can be derived from several models. Accordingly,
there are a variety of denitions in the literature.
Though typically derived as a generalization of the
geometric distribution, the negative binomial can
also be derived as a mixture of Poisson distribu-
tions.
Applications of the negative binomial distribu-
tion are wide-ranging. The negative binomial
distribution has been shown to have applicability
in accident statistics, birthdeath processes, mar-
ket research, econometrics, biometrics, and ecol-
ogy, among others [3]. However, there is little in
the literature to fully illustrate the use of the
negative binomial distribution for control chart
purposes, particularly with regard to the use of
modern statistical software for negative binomial
model-tting.

Copyright # 2003 John Wiley & Sons, Ltd.

128 D. Homan

This paper considers the negative binomial So

model as a simple and exible alternative to the Z 1
Poisson model for count data. A simple approach px pxjlf ldl
0
to constructing both exact and approximate Z 1
control limits for count data based on the negative x!Gaba
1 lxa1 el11=b dl
binomial distribution is described. The utility of 0
the negative binomial approach is illustrated by Gx abx

application to water bacteria count data taken x!Ga1 bxa
from a water purication system. !
x
a
xa1 b 1
:
a1 1b 1b
2. THE NEGATIVE BINOMIAL
DISTRIBUTION Note that this is simply a reparameterization of the
negative binomial distribution function given in
2.1. Probability function (1), with k 1=a and m b=k:
The negative binomial distribution is characterized
by two parameters: m and k, where k is typically
termed the negative binomial dispersion para- 3. CONSTRUCTION OF CONTROL
meter. The probability function for the negative LIMITS
binomial distribution with parameters (m, k) is
given by: 3.1. Parameter estimation
!

kmx Gx 1=k Several methods exist for estimating the para-
pxjm; k ;
1 kmx1=k x!G1=k meters of the negative binomial distribution [3].
The simplest method is the methods of moments.
x 0; 1; 2; . . . ; m; k > 0 1 The method-of-moments estimators of m and k are
The mean and variance of the negative binomial given by:
distribution are given by: s# 2  X%
m# X% ; k#
EX
m; varX
m km2 X%
2

It is clear that the negative binomial distribution where X% and s# 2 are the sample mean and variance,
may be particularly useful for over-dispersed data respectively.
where var[X]4E[X]. The maximum likelihood estimate of m is simply
the sample mean, while the estimate for k is the
2.2. A derivation of the negative binomial solution of a nonlinear equation and must be
solved iteratively. However, the maximum like-
Suppose that XPoisson(l) and that l itself is a lihood estimator for k is preferable, as it tends to
random variable with lgamma(a; b). Then the have smaller mean square error than the moment
unconditional distribution of X is negative bino- estimator [4]. Many statistical software packages,
mial, as follows. Let p(xjl) denote the conditional such as the SAS GENMOD procedure [5], are
distribution of X, given l. Likewise, let f l denote capable of obtaining the maximum likelihood
the distribution of l. Then estimates of m and k.
lx el
pxjl ; x 0; 1; 2; . . .
x! 3.2. Exact control limits
and
After obtaining estimates for m and k, these
f l Gaba
1 la1 el=b
; l>0 estimates can be used to obtain a tted negative

Copyright # 2003 John Wiley & Sons, Ltd. Pharmaceut. Statist. 2003; 2: 127132
 Negative binomial control limits 129

binomial distribution p#xjm# ; k#: Since the negative is a limit UCL such that:
binomial, like the Poisson, is an asymmetric

2 2UCL 1
distribution, probability limits are more appro- PX > UCL 1  P wn 4 a
1 mk
priate than typical 3s limits, such as those used for
control charts based on the normal distribution. Likewise, an approximate lower control limit for a
For a specied level a Type I error probability in nominal level a Type I error probability is a limit
one direction, an upper control limit (UCL) and LCL such that:
lower control limit (LCL) are limits such that

2LCL 1
P(X>UCL)4a and P(X5LCL)4a. Thus, an PX5LCL 1  P w2n 5 a
1 mk
exact level a upper control limit and exact level a
lower control limit are given by: Thus, an approximate level a upper control limit
(  ) and approximate level a lower control limit are
X n
 # given by:
UCL inf n p#xjm# ; k51  a  
 x0
w2n;1a 1 m# k#  1
(  ) UCL
X n 2

LCL inf n p#xjm# ; k# > a  
 x0
w2n;a 1 m# k#  1
LCL
These limits cannot be calculated directly, but can 2
be easily determined by iterative calculation. Also where w2n;1a w2n;a is the upper (lower) a percentile
note that these limits are truly exact only if the true  the  chi-square distribution with n 2m# =
of
distribution of the process response is indeed 1 m# k# degrees of freedom. Negative lower
negative binomial and the parameters m and k control limits can simply be set to zero.
are known. In most cases, the true distribution of
the process response will not be known well
enough to verify this.
4. AN EXAMPLE
4.1. Data
3.3. Approximate control limits
The use of exact and approximate negative
Approximate control limits can be obtained based binomial control limits will be illustrated with
on a chi-square approximation to the negative the following example. The data consist of water
binomial. Let X have a negative binomial distribu- bacteria counts (per millilitre) for water samples
tion with parameters (m,k). Then, from a result by taken from a water purication system. Eighteen
Guenther [6], sequential samples were taken and analysed for the

 number of bacterial colonies. The purication
2 2r 1
PX4r  P wn 4 system was assumed to be functioning normally
1 mk
and in control. It was desired to calculate an upper
where w2n is a chi-square variate with n 2m=1 control limit for the number of bacteria in future
mk degrees of freedom. Guenther shows the samples, based on these data. The data are listed in
approximation to be quite good over a range of Table I.
m and k values, particularly for r > 1:
Based on this approximation, approximate
4.2. Negative binomial model tting
upper and lower control limits can be determined.
For a nominal level a Type I error probability in Parameters of the negative binomial model were
one direction, an approximate upper control limit estimated using the SAS GENMOD procedure

Copyright # 2003 John Wiley & Sons, Ltd. Pharmaceut. Statist. 2003; 2: 127132
130 D. Homan

Table I. Water bacteria counts. deviance has an asymptotic chi-square distribution

Sample no. Count Sample no. Count with np degrees of freedom, where n is the
number of observations and p the number of
1 20 10 7
parameters. Thus, a scaled deviance value (de-
2 5 11 30
3 23 12 4 viance divided by degrees of freedom, denoted j)
4 19 13 16 close to 1 is indicative of model adequacy. From
5 13 14 2 the GENMOD procedure, the scaled deviance for
6 12 15 4 the negative binomial model is j 1:199; indicat-
7 14 16 1
ing adequate model t.
8 17 17 2
9 2 18 0

4.3. Control limits

(SAS version 8.2). The following SAS code
performs the model-tting:
PROC GENMOD;
MODEL COUNT = / DIST=NEGBIN LINK=LOG;
The GENMOD procedure yields the following
maximum likelihood estimates: m# 10:611; k#
0:7902:
Also note that the goodness of t for a general-
ized linear model can be roughly assessed by the
deviance criterion. If the model is correct, the
A one-sided a 0:001 upper control limit will be
constructed. The choice of a 0:001 is somewhat
arbitrary, but is chosen here to agree closely with
standard normal-theory 3s limits, which corre-
spond to a one-sided Type I error probability of
0.001 35.
Let p#x denote the tted negative binomial
model for the water bacteria data. An exact upper
control
Pnlimit is given by the smallest integer n such
that #x51  0:001: This yields PX467
x0 p
0:999 09: Thus, an exact one-sided a 0:000 91
upper control limit is given by UCL 67: Figure 1
gives the control chart with center line (c%) and

Figure 1. Control chart with exact UCL for water bacteria count.

Copyright # 2003 John Wiley & Sons, Ltd. Pharmaceut. Statist. 2003; 2: 127132

exact one-sided a 0:000 91 upper control limit
for the bacteria counts.
An approximate one-sided nominal a 0:001
upper control limit (UCL*) using the chi-square
approximation to the negative binomial can be
determined by:
w2n;10:001 1 10:611  0:7902  1
UCL
2 control limit is given by: UCLPoisson 22:
where w2n;10:001 is the upper a 0:001 percentile of
a chi-square distribution with n 2  10:611=1
10:611  0:7902 2:26 degrees of freedom. This
yields an approximate upper control limit of:
UCL 67:5:
Note that in this case, the approximate and
exact upper control limits yield an identical a level,
though this will not be true in general.
4.4. Comparison with Poisson model
As noted earlier, traditional control limits for
count data are based on the Poisson distribution.
For comparative purposes, the water bacteria
count data were also tted to a Poisson model
using the GENMOD procedure. The Poisson
Figure 2. Observed versus estimated cumulative distribution functions.
Copyright # 2003 John Wiley & Sons, Ltd.
Negative binomial control limits 131
model yields a scaled deviance value of j 8:052;
indicating very poor model t.
An upper control limit based on the Poisson
distribution can be obtained with exact or
approximate methods. An exact limit can be
obtained from the tted Poisson distribution with
l 10:611: We have PX422 0:999 35: Thus,
an exact one-sided a 0:000 65 Poisson upper
An approximate control limit can be found
using the chi-square approximation to the Poisson
[3]. An approximate upper control limit UCL is
found by setting:
 
1  P w22UCL1 52m# a
and solving for UCL, where w22UCL1 is a chi-
square variate with 2(UCL+1) degrees of free-
dom. This yields an approximate one-sided
a 0:001 Poisson upper control limit of:
UCLnPoisson 21:4:
Note that two (samples 3 and 11) of the eighteen
samples cross both Poisson upper control limits.
This illustrates the increased risk of a Type I error
associated with utilizing traditional Poisson con-
trol limits when the data exhibit extra-Poisson
Pharmaceut. Statist. 2003; 2: 127132
132 D. Homan
variation. Assuming the water bacteria counts
truly follow a negative binomial distribution with
parameters m 10:611 and k 0:7902; the exact
and approximate one-sided a 0:001 Poisson
upper control limits yield true Type I error risks
of a 0:114 and a 0:127; respectively.
A more illustrative comparison of the perfor-
mance of the negative binomial and Poisson
models for the water bacteria data can be seen
by visual inspection of the estimated cumulative
probability distributions. Figure 2 gives the
observed cumulative distribution function versus
the estimated negative binomial and Poisson
cumulative distribution functions. Figure 2 clearly
shows the superiority of the negative binomial
model. The Poisson model poorly characterizes the
water bacteria data.
5. CONCLUSIONS
Traditional techniques for calculating control
limits for processes with discrete responses are
based on the Poisson distribution. However, for
many processes, the Poisson distribution provides
an inadequate model. In such cases, use of
traditional Poisson control limits may result in
an increased risk of Type I error.
Copyright # 2003 John Wiley & Sons, Ltd.
The negative binomial distribution provides a
simple and exible alternative to the Poisson
distribution for modelling count data. Negative
binomial model-tting can be easily performed
with available statistical software, such as the SAS
GENMOD procedure. Exact control limits can be
obtained via iterative calculation. Approximate
control limits can be easily obtained based on a
chi-square approximation to the negative bino-
mial.
REFERENCES
1. Montgomery D. Introduction to statistical quality
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2. Rice J. Mathematical statistics and data analysis (2nd
edn). Duxbury: Belmont, CA, 1995.
3. Johnson N, Kotz S, Kemp A. Univariate discrete
distributions (2nd edn). Wiley: New York, 1992.
4. Wilson L, Folks J, Young J. Multistage estimation
compared with xed-sample-size estimation of the
negative binomial parameter k. Biometrics 1984;
40:109117.
5. SAS Institute, Inc. SAS/STAT1 users guide, Version 8.
SAS Institute: Cary, NC, 1999.
6. Guenther W. A simple approximation to the negative
binomial (and regular binomial). Technometrics 1972;
14:385389.
Pharmaceut. Statist. 2003; 2: 127132