Chapter 3

Fundamentals of Statistical
Studies
Definition of Statistics
Statistics is the study of variation, interactions
and, operational definitions.
Statistics is the study of data to provide a
basis for action on a population or process.
Types of Statistical Studies
Enumerative studies are statistical
investigations that lead to action on a static
population (that is, a group of items, people,
etc. that exist in a given time period and/or at
a given location).
Analytic studies are statistical investigations
that lead to action on a dynamic process.
Since this is a text on quality improvement,
the primary focus will be on analytic studies.
Enumerative Studies
Basic Concepts
A population (or universe) is the totality of units,
items, or people of interest that exist in a given time
period and/or given location Administration.
A frame is a list of the items in a population.
The gap is the difference between the frame and
the population.
A sample is a portion of the frame under
investigation, and is selected so that information
can be drawn from it about the frame.
Basic Concepts
Nonrandom samples are selected on the basis of
convenience (convenience sample), the opinion of
an expert (judgment sample), or a quota to ensure
proportional representation of certain classes of
items, units, or people in the sample (quota
sample).
 All nonrandom samples have the same shortcoming they're
subject to an unknown degree of bias in their results.
 This bias is caused by the absence of a frame.
 Nonrandom samples should be used only when better
information is too costly to obtain.
Random samples are selected so that every
element in the frame has a known probability of
selection. Types of random samples include simple,
stratified, and cluster.
 All random samples allow generalized statements to be
made about the frame from the sample.
 A random sample is selected by operationally defining a
procedure that utilizes random numbers in the selection of
the sampled items from the frame to eliminate bias and hold
uncertainty within known limits.
 Seven steps are involved in selecting a simple random
sample:
 Step 1. Count the number of elements in the frame, N.
 Step 2. Number the elements in the frame from 1 through N. If N
is 25, then the elements in the frame should be numbered from 01
through 25. All elements must receive an identification number
with the same number of digits.
 Step 3. Select a page in a table of random numbers. For
example, selecting a page and starting point yields.

19 30 40
09 28 78
31 13 98
67 60 69
61 13 39
04 34 62
05 28 56
73 59 90
54 87 09
42 29 34
27 62 12
49 38 69
29 40 93
Step 4. On the selected page of random numbers, select a
column of numbers, select a starting point in that column,
and use as many digits as there are digits in N (two digits
in the case of N = 25). For example, beginning with the
top of our column, selecting, and using the first two digits
of each number in that column, the first random number is
19.

Sample Number Identification Items

Number
1 19 S

2 09 I

3 04 D

4 05 E

5 13 M

6 12 L
 Step 5. Determine the necessary sample size.  
 Step 6. From the chosen column on the selected page,
select the first six two-digit numbers between 01 and 25,
inclusive. If a number is encountered that is smaller than 01
(e.g., 00) or larger than 25 (e.g., 31), ignore the number and
continue down the column. If an acceptable number
appears more than once, ignore every repetition and
continue moving down the column until six unique numbers
between 01 and 25 have been selected. If the bottom of the
page is reached before six unique random numbers are
obtained, go to the top of the page and move down the next
two-digit column.
 Step 7. Finally, analyze the information as a basis for
action.
 Two important points to remember are:
1. different methods of measurement will also yield
different results.
2. different samples of size six will yield different results,
and
 Random samples, however, don't have bias, and
the sampling error can be held to known limits
by increasing the sample size.
Conducting an Enumerative Study
The following 13 steps present a guide for
conducting an enumerative study.
The steps are the same whether the study is based
on a complete count of the population or a sample.
Step 1. Specify the reason(s) you want to
conduct the study (for example, to estimate the
average number of sick days per employee in the
XYZ Company in 2002). If this average is greater
than 8.0 days, then a new health care plan will be
instituted. If it is less than or equal to 8.0 days,
the current plan will be maintained.
Step 2. Specify the population to be studied. In our
example, the population would be all full-time
employees in the XYZ Company in 2002. An
employee is considered full-time in 2001 if he had
full-time status designation at any time during the
year.
Step 3. Construct the frame (a list of all full-time
employees). Everyone who will use the study's
results as a basis for action must agree that the
frame represents the population upon which they
want to take action.
Step 4. Perform secondary research (such as the
examination of pre-published data) to determine
how much information is already available about
the problem under investigation. For example,
check the Human Resources Department's
records.
Step 5. Determine the type of study to be
conducted (for example, mail survey, personal
interviews, analysis of units). In this example, we
would analyze employee absentee cards for
2002.
Step 6. Make it possible for respondents to
give clear, understandable information, and/or
for the researcher to elicit clear,
understandable information. For example, the
method for analyzing absentee cards should
be clear and straightforward. Consider the
problem of non-response. In this example, be
sure no absentee cards are missing, and
make sure the data gatherers know how to
interpret the absentee cards.
Step 7. Establish the sampling plan to be used,
determine the amount of allowable error in the
results, and calculate the cost of the sampling
plan. At this stage, Steps 1 and 2 may need
revisions due to cost considerations. For
example, we may decide to draw a simple
random sample of employee absentee cards
using random numbers, at a cost of $1 per card,
assuming an allowable error of one quarter of a
day in the estimate.
Step 7 requires a random sample. The result of a
nonrandom sample in an enumerative study is
worth no more than the reputation of the person
who signs the report.
Step 8. Establish procedures to deal with the non-
responses and differences between interviews,
testers, inspectors, and so on. For example, be
able to assess differences in collected data due
to differences in the data gatherers' abilities.
Step 9. Prepare unambiguous instructions for the
data gatherers that cover all phases of data
collection.
Step 10. Establish plans for data handling,
including format of tables, headings, and number
of classes.
Step 11. Pretest the data-gathering instrument and
data-gathering instructions.
Step 12. Conduct the study and the tabulations. It
is critical that the study be carried out according
to plans. From the gathered data, calculate the
sampling errors of interest. This is important so
that the study's users can understand the degree
of uncertainty present in the study results. In our
example, we would calculate the standard error
for the average number of days absent per
employee.
Step 13. Interpret and publish the results so that
decision makers can take appropriate action. For
example, if the average number of days absent per
employee is greater than eight, then establish the
new health care program.
Analytic Studies 
Basic Concepts
Analytic studies are statistical investigations that
lead to actions that will improve or innovate a
process over time.
The concept of a population does not exist for an
analytic study because future process output,
which does not yet exist, cannot be part of the
population.
A frame cannot exist without a population.
Lack of a population and frame makes it
impossible to draw a random sample to study a
process's behavior.
Models can be used to study these cause-and-
effect systems.
These models include flowcharts of a process,
simulations of the process, and cause-and-effect
diagrams.
In an analytic study (unlike an enumerative
study), there is no underlying statistical theory
that enables quantification of uncertainty.
Expert opinion is invaluable in understanding the
magnitude of the uncertainty caused by changes
to a process.
Generally, this uncertainty is best explained by an
expert who is involved with the process under
study.
Improvement or innovation of a process is
accomplished using the Plan-Do-Study-Act
(PDSA) cycle.
The PDSA cycle is used to narrow the difference
between process performance and customer
(either internal or external) needs and wants.
 The aim of the PLAN stage is to determine an improvement or
innovation to a process that will narrow the difference between
process performance and customer needs and wants. (i.e.
old flowchart to new flowchart)
 The DO stage of the PDSA cycle requires that planned
experiments be conducted to determine how best to
implement the PLAN established in the previous stage.
Experiments should be conducted on a small scale, using a
laboratory, an office or plant site, or, with his consent, even a
customer's location.
 The aim of the STUDY stage is to determine if the PLAN has
been effective in decreasing the difference between process
performance and customer needs and wants.
 In the ACT stage, the PLAN should be integrated into the
process.
Errors in Analytic Studies
A type one error occurs when action is taken on a
process when it should have been left alone.
A type two error occurs when we fail to take action
on a process when action is appropriate.
Design of Analytic Studies
We can increase our degree of belief in a prediction
from an analytic study by considering:
 Building of knowledge in a sequential fashion
 Testing over a wide range of conditions
 Selection of units for the study
Building of Knowledge in a Sequential Fashion
 Experiments performed in the iterations of the PDSA cycle,
in combination with theory about the process from subject
matter experts, may increase the degree of belief in
predictions about the future behavior of the process under
study.
 This degree of belief is increased as sequential predictions
about the process's future behavior come closer to the
actual performance of the process.
Testing over a Wide Range of Conditions
 The degree of belief in the predictive value of the
knowledge gained from an analytic study is increased if the
analytic study yields the same results over a wide range of
conditions.
 Only an expert in the subject matter under study can
answer questions such as how wide a range of conditions is
adequate to have a degree of belief sufficient to make a
prediction, or how close to actual conditions must the
experimental conditions be to have a degree of belief high
enough to make predictions.
Selection of the Units for the Study
 Since there is no frame in an analytic study, there can be no
random sample and quantifiable degree of uncertainty in a
prediction about the future.
 Judgment samples are used to conduct analytic studies.
Analysis of Data from Analytic Studies
 A Stable Process
 A stable process provides a forum for a subject matter
expert to conduct experiments to gain knowledge to predict
the future behavior of the process.
 Graphical Analysis
 The general approach for conducting analytic studies relies
on graphical techniques, such as control charts, which
utilize both statistical knowledge and subject matter
knowledge to learn about the process to predict its future
behavior.
Distinguishing Between Enumerative
and Analytic Studies

If a 100 percent sample of the frame answers the

question under investigation, the study is
enumerative; if not, the study is analytic.