Chapter 6 - Statistical Process Control - APIC Text Online

7/29/13 Chapter 6 – Statistical Process Control - | APIC Text Online
Chapter 6 – Statistical Process

Control
Timothy Wiemken, MPH, CIC

Database Analyst
University of Louisville School of Medicine
Division of Infectious Diseases
Louisville, Kentucky
APIC recognizes and appreciates the contributions made to this chapter by prior authors.
Copyright © 2013 by the Association for Professionals in Infection Control and Epidemiology, Inc. (APIC)
All rights reserved. Intended for personal use only. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form
or by any means, electronic, mechanical, photocopied, recorded or otherwise, without prior written permission of the publisher.
ABSTRACT
Statistical process control should have a central role in all infection prevention programs. Collecting
the correct data and creating the most appropriate graphics for the data can prove difficult unless
one has adequate training in the statistical methodology. Through adequate data collection and
critical analysis of control charts, the infection preventionist can detect aberrant data early, which
allows for prompt intervention and mitigation of any poor outcomes.
KEY CONCEPTS
Statistical process control is an essential component of quality assurance and performance

improvement.
The principles of statistical process control are used to monitor both processes and
outcomes in a systematic and statistically valid manner.
The elements of statistical process control enable the infection preventionist to create
control charts that include key statistical measurements.
Control charts can assist the infection preventionist in determining special-cause or
common-cause variations, which may be helpful for early detection of abnormal events.
BACKGROUND
text.apic.org/item-7/chapter-6-statistical-process-control/all 1/15
The development of statistical process control (SPC) is primarily credited to Dr. Walter Shewhart.
In 1924, Dr. Shewhart, a research physicist with Bell Laboratories, used rudimentary statistical
methods to develop what has become the control chart.1
Joseph Juran and W. Edwards Deming, two individuals now well known in the quality movement,
were protégés of Dr. Shewhart during his time at Bell Laboratories. In 1947, Dr. Deming traveled
to Japan to contribute to the post-World War II recovery efforts by assisting Japanese industry.
Deming brought SPC to the Japanese and taught them to incorporate the SPC methods into their
quality management programs within the manufacturing industries. Deming developed his
theories for total quality management in Japan during the years after the war. The results of this
effort and the success of Japanese industry are now legendary. One of Deming’s Japanese
students was Professor Kaoru Ishikawa, another pioneer in the quality movement.1,2
The methods and tools of Shewhart, Juran, Deming, and Ishikawa formed a nucleus for
continuous quality improvement (CQI). These methods were not considered for serious
application in the United States until the 1980s, when Deming and his methods were featured in
an NBC television special. Since then, application of total quality management has become a
common means for success and improved quality in U.S. industry. The concept of CQI, applying
the tools and methods as described by Deming and his colleagues, was introduced into healthcare
in the National Demonstration Project in 1987.3
With the proven success of SPC and CQI, The Joint Commission (JC) revised its approach to the
accreditation process beginning in 1989 through the Agenda for Change. This revised approach
required implementation and application of CQI methods, including SPC, by healthcare
organizations for performance measurement and improvement.4
BASIC PRINCIPLES
SPC may be applied to monitor outcomes (rates and frequency of healthcare-associated

infection [HAI]) or to monitor the process of care.
The occurrence of HAI is usually the result of random variation in the process of care that is
attributable to regular or common causes.
In general, efforts to decrease variation lead to improved quality and decreased costs.
Run charts are useful for identifying variations and trends, especially when assumptions for
construction of control charts are not met.
Infection preventionists who have a firm understanding of SPC can establish a quality and
performance monitoring process to quickly identify variations in practice or outcomes,
determine if and when interventions are necessary to address those variations, and
measure the impact of such interventions.
STATISTICAL PROCESS CONTROL
SPC in Infection Control

SPC was developed in industry in order to monitor production processes. The main objective of
SPC in industry was to ensure that each process was performed consistently and correctly within
predetermined parameters, thereby ensuring that the final product (outcome) is free of defects.
For example, SPC is applied to the manufacturing of parts for a motorcycle engine by measuring
specified dimensions of all the parts (or a sample of the parts) as they are manufactured. Parts
must be within certain specifications of the design to ensure that the engine will run properly
once the parts are assembled. If a part is defective (e.g., wrong diameter), it is replaced before the
entire motor is assembled and adversely affected by the bad part. This concurrent approach to
process control provides an enormous potential benefit for saving time and money by identifying
defects before the final product is assembled. By means of controlling the process (e.g., part
construction), the likelihood of the proper outcome (e.g., a running motorcycle) is increased.
SPC is a method of ensuring and improving quality based on valid statistical principles and
methods. It focuses on processes (as the term implies) and is based on the principle of random
variation. SPC is easily transferable to the healthcare environment; it is a tool that infection
preventionists can use to measure and improve healthcare quality.
An HAI is an adverse outcome that may occur as a result of an error (or defect, in SPC
terminology) in the process of care. Although some risk factors for HAIs cannot be controlled
(e.g., host factors), many of those relating to the process of care can be controlled (e.g., patient
care practices). By searching out and eliminating variations in the process of care, the risk of HAIs
can be decreased.
For example, perioperative antibiotics are used to reduce the risk of surgical site infection.
Research has determined that the optimal time to administer the first dose is within 2 hours of
incision. In a study by Classen et al,5 the authors examined the process of administration and
found that prophylactic antibiotics were not administered within the optimal period in 40% of the
elective surgical cases included in the study. Reducing this variation in administration of
perioperative antibiotics through process improvement was projected to result in a significant
decrease in the rate of the adverse outcome, surgical site infection.
SPC may be applied in infection prevention programs to monitor the process of care as well as
outcomes (frequency of HAIs). Process improvement efforts, such as those reported by Classen et
al,5 may contribute to an overall reduction in the risks of endemic HAI, which may in turn lead to
a reduction in incidence. In addition, monitoring of outcomes may lead to early detection of an
epidemic, which may then be mitigated by early intervention.
Process Variation
Variation within a process is a key concept in quality improvement and SPC. In general, efforts to
decrease variation can lead to improved outcomes and decreased costs.
As a quality management tool, SPC focuses on monitoring processes and outcomes to minimize or
decrease variation. SPC was developed using the basic principles of normal distribution and
random variation. A German mathematician, Carl Gauss, first described the concept of normal
distribution (i.e., bell curve) within a sample population. He also developed the calculation for
standard deviation (SD) in the study of random variation within the normal distribution. Although
the origins of SPC are within Gaussian statistics, it has since branched out to allow us to monitor
processes and outcomes within non-Gaussian distributions (e.g., Poisson, binomial, geometric,
etc.).
Quality theory teaches us that variation can have two sources: common cause and special cause.
Common Cause Variation
All processes have variation. This “normal” variation is part of the design of the process and is
attributable to regular or ordinary causes. A good demonstration of common cause variation is to
compare 10 signatures from the same person. Close examination of each signature will show
differences in size and shape of some letters, but on the grand scale, each looks very similar. This
variation is normal and expected for the process of a signature.
Common cause variation results in a stable process because the variation is predictable. Since it is
normal and expected, it is commonly known as “noise.” This type of variation explains why
infection rates in a facility have some variability from month to month. An example of common
cause variation in healthcare is the endemic level of urinary tract infections that may be
influenced by age, sex, duration or frequency of urinary catheterization, quality of perineal care,
and infection at another site. A process operating with only common cause variance is considered
in statistical control. It is important to note that although a process may be operating with only
common cause variance, it does not necessarily mean an intervention should not be initiated. For
example, if a facility has very high rates of methicillin-resistant Staphylococcus aureus (MRSA)
from month to month, they may have an in-control process (only common cause variance)
because the rates are similar each month. It would be unwise to forgo interventions, however,
because a high average MRSA rate is undesirable.
Special Cause Variation
Special cause variation occurs when a process or outcome is affected or influenced by a cause
outside of the process system. It results in an unstable process because it is not predictable. This
type of variation can be positive or negative (e.g., a decrease or an increase in infection rate). In
our signature example, special cause variance would be akin to having a muscle cramp in the
middle of writing. This would create an unexpected and unnatural signature, attributed to an
abnormal event. An example in healthcare of a special cause event would be a cluster or outbreak
of surgical site infections attributed to a breakdown in instrument processing. The source of
negative special cause variation should be identified and eliminated. The source of positive special
cause variance should be identified and noted for use in future interventions.
Based on Gaussian theory of normal distribution and standard deviation, common cause variation
results in a distribution that lies within 3 SDs above and below the mean (Fig. 6-1). This includes
99.73% of all probable events. Therefore, special cause variation should occur in less than 0.27%
of events sampled, if the process is in-control (e.g., operating with only common cause variance).
The occurrence of endemic HAI is usually the result of random variation based on common cause.
Data outside of the 3 SD marks can be considered special cause variance.
Analyzing Variation
Two common methods used to measure and plot variation include run charts and control charts.
Run charts are not typically considered part of SPC, but can be useful when the assumptions to
construct a control chart are not met.6
Run charts—
Can be used with any type of data (discrete, continuous,

etc.).
Do not use any statistical calculations aside from measures of central tendency.
Consider the median as the measure of central tendency (as opposed to the mean or mode).
Need at least 20 data points for reliability.7
Patterns are interpreted as follows6:
If <20 data point
7 or more points in a row on either side of the center line (median).

5–6 (or more) points in a row increasing or decreasing.
14 or more points alternating up and down.
If >20 data point
8 or more points in a row on either side of the center line (median).

7 or more points in a row increasing or decreasing.
14 or more points alternating up and down.
Figure 6-1. The Gaussian distribution and associated probabilities. (Adapted from Benneyan JC. Design, Use and Performance of Statistical Control Charts for Clinical Process
Improvement. Boston, MA: Northeastern University; 2001.)
SPC (Control) Charts—
Are more sensitive at detecting abnormalities.

Use the mean as the measure of central tendency.
Use the standard deviation (sigma, σ) as one way to detect special cause variance.
Need at least 25 data points for reliability and validity.8–11 A sufficient number of data
points provides adequate statistical power to detect a special cause.
Patterns (special causes) may be detected by many different methods. Some common rules
include6 (see Fig. 6-2 for zone descriptions):
Any points above UCL or below LCL
Zone A: 1 of 2 points above/below 2 SD
Zone B: 4 of 5 points above/below 1 SD
8 points in a row above or below center line
Trends of 6 points in a row increasing or decreasing
Zone C: 15 points in a row inside Zone C (hugging)
14 points in a row alternating up and down
Zone C: 8 points in a row outside Zone C
Selecting an SPC Chart
The type of data, distribution, frequency, measurement, and denominator all play a role in
selecting the most appropriate control chart for your data. Table 6-1 describes some of the
possible combinations of data and associated charts.
Although visual representation (e.g., histograms) and statistical tests, such as the Kolmogorov-
Smirnov test or the χ2 Goodness of Fit test, should be used to assess the distribution of your data
prior to selecting a chart, there are some general shortcuts that can aid in a quick chart selection.
These shortcuts do not always offer the most appropriate control chart for your data, but since
many control charts are fairly robust, the pitfalls of selecting the wrong chart (to an extent) may
be minimal. It is important to note that use of shortcut methods may decrease the sensitivity or
specificity of the chart, which must be taken under consideration when interpreting the results.
Figure 6-3 is a flowchart describing these shortcut methods for choosing a control chart.
Alternate and Non-Shewhart Charts: G and EWMA
Although the basic control charts are some of the most common types utilized in healthcare, there
are many other charts that can be very useful in certain situations. Two of these charts are the g
chart and exponentially-weighted moving averages (EWMA) chart.
Figure 6-2. Control chart zones for determination of within-limit special cause variation.
The g chart was developed by Dr. James Benneyan to observe the time between events (e.g.,
infections). For rare events, aggregated infection rates may be misleading or may be too
infrequent for timely intervention.10 For example, if a facility has very few device-related
bloodstream infections and commonly have months with no infections, rate-based charts are
difficult to interpret (Fig. 6-4). Here, the special cause variance is due to only one case of a device-
related bloodstream infection. In this example, plotting the time between each infection is much
more useful and powerful for determining special cause variance. It is important to mention that
with a g chart measuring the time between events, positive special cause variance is depicted by
data points above the upper control limit, as a larger time between events means that there are
fewer infections.
Table 6-1. Selecting a Control Chart
Data Type Distribution Appropriate

Data Type (Numerator)
(Denominator) Type Chart
Continuous (Single Point) N/A Normal XmR
Continuous (Average of 1–
N/A Normal Xbar and R
10 Data Points)
Continous (Average of >10

N/A Normal Xbar and S
Data Points)
Discrete Constant Binomial np

Discrete (e.g., rate) Variable Binomial p
Discrete Constant Poisson c
Discrete (e.g., rate) Variable Poisson u
Time to (or between) Geometric g
N/A
event Normal Individuals
Another benefit of the g chart is the ability to retain a more precise time-frame. When rates are
calculated, all data from the first to the last day of the month are combined, and monthly
aggregates are presented. Thus, an event on day 1 of the month is lumped together with an
infection on the last day of the month. Another infection on the first of the next month is then
combined with the next month’s aggregate data and so on. If there is a cluster of infections
towards the end of one month that continues into the beginning of the next month, one may not
detect this with standard rate-based control charts. Plotting the days between these infections
retains the precision of a shorter time period. As an example, Figure 6-5 indicates that if using a c
chart, this process appears to be operating with only common cause variance (it is important to
note that this chart should have more data points). To construct this type of chart, one must
aggregate the data into monthly blocks. The g chart, in comparison (using the same data, though
not aggregated), illustrates that there is a noticeable decline in days between infections towards
the end of the data collection period. Only the g chart would clue the infection preventionist that
an intervention may be needed. It is also possible to risk adjust a g chart. An example is to plot the
number of surgeries between surgical site infections. This method takes into account the
fluctuation in the number of surgeries as opposed to just looking at the time between the surgical
site infections.
Figure 6-3. Flowchart for shortcuts to control chart selection. (Adapted from Amin SG. Control charts 101: A guide to health care applications. Qual Manag Health Care
2001;9(3):1–27.)
Figure 6-4. U chart with rare events.
Traditional control charts (including the g chart) allow the user to detect sudden, abnormal data
points within the process (e.g., special cause variance). At times, it may be necessary to not only
identify large shifts in the process at specific time points, but to look at small changes in the
process mean over time. The EWMA chart allows for this.12 It is possible to have a process that
appears to be in statistical control with a Shewhart-type control chart (e.g., operating with only
common cause variance), while the moving average in an EWMA chart indicates special cause
variance (Fig. 6-6). What this shows is that over time, although no specific data point is out of
control in the Shewhart-type chart, the average rate is increasing abnormally. Utilizing the EWMA
chart will allow for detection of shifts in the average (e.g., average infection rate), which can
substantially increase the ability to detect abnormal processes. Special causes are indicated by a
data point above or below the three standard deviation upper and lower control limits. It is
important to note that EWMA charts are not appropriate for the detection of sudden shifts within
the process, and should thus be used in conjunction with Shewhart-type charts.12
Examples of SPC Charts
X and R chart (mean and range): These types of charts might be used to measure increased
complaints from the emergency department regarding turnaround times for laboratory
reports. Collect three complete blood counts (CBCs) per day for 23 consecutive weekdays
(each person has three samples).
X and s chart (mean and sample standard deviation): These charts are the same as X and R
but collect 15 CBCs per day for 23 consecutive weekdays (each person has 15 samples).
XmR (individual’s chart): An XmR chart shows daily blood pressure readings on one
individual patient for one month.
c chart: If a facility wants to reduce the number of patient falls, it might implement a new
program followed by 24 months of data collection. The facility has a stable census
(denominator).
u chart: If a facility wants to reduce the number of patient falls (each patient can fall more
than once per time period), it might implement a new program followed by 24 months of
data collection. The census (denominator) fluctuates in this facility.
p chart: A facility wants to use a control chart to plot the MRSA rate. Because this facility
only counts the first MRSA isolate per patient in their rate calculation, and the census
(denominator) fluctuates, a p chart can be used.
np chart: This chart can be used to follow 10 type and cross-match orders each week
(sample size stable) and monitor for appropriate checks and patient identification
procedures.
g chart: The facility wants to use a control chart to monitor the days between surgical site
infections (SSIs). SSIs are uncommon in this facility, so a g chart is appropriate.
EWMA chart: The facility wants to determine if their average rate of Clostridium difficile is
increasing over time, even though the p chart they normally construct does not indicate any
special causes.
Figure 6-5. Comparison of the sensitivity of a c chart and a g chart for detection of special causes.
Interpretation of Control Charts to Identify Special Cause
When an institution begins using SPC as a method for process improvement, there are typically
four objectives9:
1. Identify the current process performance—are we in our out of control?

2. Achieving a state of statistical control (only common cause variance).
3. Continued examination for special cause variance.
4. Reducing the mean and variance.
These four steps imply the creation of control charts based on historical data, applying specific
interventions to mitigate special causes, continued updating of the chart, and applying broad,
systems-wide interventions to lower the process mean and variation.
In the creation of the historical control chart, it is crucial for the infection preventionist to collect
an adequate amount of data. For an SPC chart, at least 25 data points, or subgroups, must be
collected prior to the construction of the chart. If 25 data points are not available, it is
recommended to construct a run chart and utilize the rules for those charts as described
previously until adequate numbers have been collected. As control charts utilize statistical
calculations to identify special cause variance, the sample size (e.g., number of data points or
subgroups) allows for sufficient statistical power to detect the abnormal data point.8–11 Without
enough data points, the risk of false negative results increases substantially.
Achieving a state of control that allows for identification of special causes can be difficult.
However, it is imperative that the process be in this state to be able to statistically detect special
causes or abnormal events. This is because one cannot predict future occurrences if the process
is not in control.9 This implies that an out-of-control process cannot be charted with expectations
to detect special cause variance (e.g., special causes must be removed prior to charting
subsequent data). The practical result of this is that any special cause that is found on a control
chart must be investigated, corrected, and removed from the chart, and the control limits must be
recalculated. For example, if a facility detects special cause variance on a p chart, the source of the
special cause variance must be found and intervened upon. Only then will the process be back to
its previous state of statistical control. To make sure of this, the point on the chart must be
omitted and the control limits must be recalculated. Harkening back to basic statistics, the mean
(the measure of central tendency used to calculate the SD) is very sensitive to outliers (e.g.,
special cause variance), so if the special cause point is left in the chart, the control limits will not
be accurate and future special causes may not be detected. Most computer software programs
allow for the removal of abnormal points from the control limit calculations.
Figure 6-7. The four quadrants of statistical control (adapted from Wheeler et al13).
As described earlier, data points are not only examined to determine whether they are within the
upper or lower control limits (±3 SD), but trends in data are considered as well. There are a
number of different “within limit” tests for special causes, as described earlier. Utilization of these
within limit rules may slightly increase the risk of false positive special cause detection, but in turn
will lessen false negative results.
It is also important to note that there is some debate as to whether to utilize 2 SD control limits, as
opposed to 3 SD limits in order to detect special causes earlier. This is typically not advised as the
use of 2 SD limits will only greatly increase the risk of false positive results. As Benneyan
describes, “It is critical to emphasize that a process either is or is not in a state of statistical
control, regardless of where the control limits arbitrarily or scientifically are placed.” He goes on
to say that, “changing the control limits or rules in no way changes a process from being in
statistical control to being out of statistical control, or vice versa, but only changes the power and
confidence (sensitivity and specificity) to detect each state.”9
At the end of the day, there are four situations where the process may be. Figure 6-7 illustrates
these quadrants as well as the necessary means to control.
<top>
CONCLUSIONS
The need to ensure that decisions are made using the best information available requires that the
infection preventionist have a firm understanding of the basics involved in statistical process
control. This means the ability to establish a quality and performance monitoring process that
enables the users to quickly identify variations in practice or outcomes and determine if and
when interventions need to be made as well as the impact of those interventions.
SUPPLEMENTARY RESOURCES
There are a number of supplementary materials on the APIC Web site: http://www.apic.org.
These materials will help you better understand how to create and interpret SPC charts and run
charts with your computer.
REFERENCES
1. Sloan MD. How to Lower Health Care Costs by Improving Health Care Quality. Milwaukee, WI:
American Society for Quality Control, Quality Press, 1994.
2. Ishikawa K. Guide to quality control. Asian Productivity Organization: 1971.
3. Berwick B, Godffey AB, Roessner J. Curing Healthcare. San Francisco: Jossey-Bass; 1990.
4. The Joint Commission. Framework for Improving Performance. Terrace IL: Oakbrook; 1994.
5. Classen DC, Evans RS, Pestotnik SL, et al. The timing of prophylactic administration of
antibiotics and the risk of surgical-wound infection. N Engl J Med 1992;326(5):281–286.
6. Amin SG. Control charts 101: A guide to health care applications. Qual Manag Health Care
2001;9(3):1–27.
7. Pande PS, Neuman RP, Cavanagh RR. The Six Sigma Way Team Fieldbook: An Implementation
Guide for Project Improvement Teams. New York: McGraw-Hill; 2002.
8. Benneyan JC. Statistical quality control methods in infection control and hospital
epidemiology, part I: Introduction and basic theory. Infect Control Hosp Epidemiol
1998;19(3):194–214.
9. Benneyan JC. Statistical quality control methods in infection control and hospital
epidemiology, part II: Chart use, statistical properties, and research issues. Infect Control
Hosp Epidemiol 1998;19(4):265–283.
10. Benneyan JC. Number-between g-type statistical quality control charts for monitoring
adverse events. Health Care Manag Sci 2001;4(4):305–318.
11. Benneyan JC. Design, Use and Performance of Statistical Control Charts for Clinical Process
Improvement. Boston: Northeastern University; 2001.
12. Morton AP, Whitby M, McLaws ML, et al. The application of statistical process control charts
to the detection and monitoring of hospital-acquired infections. J Qual Clin Pract
2001;21(4):112–117.
13. Wheeler DJ, Chambers DS. Understanding Statistical Process Control. 2nd ed. Knoxville, TN:
SPC Press; 1992.
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Last Revised: 1/23/11 1:50 PM

Copyright © 2013 by the Association for Professionals in Infection Control and Epidemiology, Inc. (APIC)
All rights reserved. Intended for personal use only. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form
or by any means, electronic, mechanical, photocopied, recorded or otherwise, without prior written permission of the publisher.

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7/29/13 Chapter 6 – Statistical Process Control - | APIC Text Online

Chapter 6 – Statistical Process

Timothy Wiemken, MPH, CIC

Statistical process control is an essential component of quality assurance and performance

SPC may be applied to monitor outcomes (rates and frequency of healthcare-associated

STATISTICAL PROCESS CONTROL

SPC in Infection Control

Common Cause Variation

Special Cause Variation

Can be used with any type of data (discrete, continuous,

If <20 data point

7 or more points in a row on either side of the center line (median).

If >20 data point

8 or more points in a row on either side of the center line (median).

Improvement. Boston, MA: Northeastern University; 2001.)

SPC (Control) Charts—

Are more sensitive at detecting abnormalities.

Selecting an SPC Chart

Alternate and Non-Shewhart Charts: G and EWMA

Table 6-1. Selecting a Control Chart

Data Type Distribution Appropriate

Continous (Average of >10

Discrete Constant Binomial np

Figure 6-4. U chart with rare events.

Examples of SPC Charts

Interpretation of Control Charts to Identify Special Cause

1. Identify the current process performance—are we in our out of control?

Last Revised: 1/23/11 1:50 PM

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