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Chapter 12.

Quality Control & Improvement

Chapter 12: Quality Control &


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OUTLINE
 Quality in Healthcare
 Quality Experts
 Quality Certification
 TQM & CQI
 Six-Sigma
 Monitoring Quality through Control Charts
 Control Charts for Attributes
 Control Charts for Variables
 Process improvement
 Methods for Generating New Ideas
 Tools for Investigation
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A BROAD DEFINITION. . .
 Quality refers to the ability of a product or service to
consistently meet or exceed customer expectations
 quality in healthcare is evaluated from differing perspectives of
providers, recipients and third-party payers.
 Most clinicians accept the Institute of Medicine (1990)
definition: “Quality is the extent to which health services for
individuals and populations increase the likelihood of desired
health outcomes and are consistent with current professional
knowledge.”

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WHAT IS QUALITY?
You are a world renowned surgeon that has just
completed a radical new surgical technique. There were
few complications, largely due to the excellence of the
hospital’s staff and technological capabilities.

QUALITY?

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WHAT IS QUALITY?
You are a patient who has just undergone radical new surgery.
Although the surgery went without technical difficulties, your
were upset at the doctor’s uncaring attitude. Furthermore, the
nursing staff often failed to respond to your calls, and twice you
were served meat despite the fact that you are a vegetarian.
Also, there was a used bedpan that sat next to your bed for
three days.

QUALITY?
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A QUESTION OF PERSPECTIVE
 Quality of care depends upon who is making the
assessment
 Clinician -- technical components, adequate skills, resources,
conditions
 Patients -- outcomes, interpersonal processes, amenities,
overall satisfaction
 Health Facility Managers -- appropriate and effective utilization
 Community -- availability, access, reputations, general health
status of community
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QUALITY MEASUREMENT
 Clinicians -- cure rates, mortality, morbidity
 Patients -- patient satisfaction surveys
 Health facility managers -- cure rates, mortality, morbidity,
intermediate process measures (patient falls, infection rates,
medication errors, appropriate staffing, etc.)
 Community -- area service distribution, insurance coverage,
incidence and prevalence rates, etc.

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Figure 12.1 Quality Measurement

Structure Process Outcome

Conversion Process
Inputs Outputs
(Throughput)
Treated
Patient, Various hospital Patient
Provider labor, and medical services
Equipment, transform poor health
Supplies, Etc. to wellness for patients
(diagnosis, procedures,
treatments)

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Quality Measurement
Quality Gaps
 Another way to look at the maintenance of quality is how mistakes
are to be avoided – design mistake-proof processes across the
whole spectrum of the care, to reduce undesired outcomes.
 Variance in diagnostic and therapeutic interventions and the
associated errors hamper the delivery of safe, effective patient care
and add to poor outcomes.
 To minimize the variation and the errors – sometimes
euphemistically called “quality gaps” – and work toward
completely eliminating them are major goals for healthcare systems.

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Quality Measurement
Quality Gaps
Chassin (1998) classifies the underlying causes of “quality gaps” into three categories:
1) Over-utilization. When the potential benefit of a therapy is less than its risk,
overuse of health services affects the quality of care. Pressures for overuse of
services may come from either providers or patients.
2) Under-utilization. A patient’s lack of insurance or insurance that has high co-
payments and deductibles can cause under-utilization of necessary health care.
3) Miss-utilization. Avoidable complications, negligent care, mistakes, and mishaps
create miss- utilization of services. Healthcare providers who generate such
conditions harm the quality of patient care and produce poor outcomes; they also
waste the organization’s resources and increase lengths of stay.

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Quality Measurement
 Healthcare providers do have an arsenal of methods to deal
effectively with the problems affecting quality of care.
 They include the programs called quality control (QC), total quality
management (TQM), continuous quality improvement (CQI),
reengineering, and Six-Sigma.
 All these programs include data gathering, analysis and statistical
monitoring to identify the problem and its cause.
 Nevertheless, the crux of the solution to quality problems lies in
changing human behavior, changing minds to perform care in new
ways.

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QUALITY EXPERTS
 Deming -- poor quality caused by the system, not employees; management’s
responsibility to correct system;” use 14 points to reduce variation caused
by special causes (correctable) and not common (random) causes of
variation.
 Juran -- 80% of defects are controllable; three elements: quality planning,
quality control, and continual quality improvement
 Crosby -- zero defects; quality is free
 Isikawa -- cause and effect diagrams, quality circles

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QUALITY CERTIFICATION
 Organizations can earn awards or achieve certification/accreditation by
international organizations or by their own trade organizations; for
instance, hospitals are evaluated periodically by the Joint Commission on
Accreditation of Healthcare Organizations (JCAHO).

 For the medical group practices, the Medical Group Management


Association (MGMA) is the principal voice. MGMA leads the profession
and assists members through information, education, networking and
advocacy” (MGMA, 2004).

 Quality is always a major concern in those advocacy and accreditation


bodies.

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QUALITY CERTIFICATION
ISO 9000
 Set of international standards on quality management and Quality assurance,
critical to international Business
 ISO 9000 series standards, briefly, require firms to document their quality-
control systems at every step (incoming raw materials, product design, in-
process monitoring and so forth) so that they’ll be able to identify those
areas that are causing quality problems and correct them.
 ISO 9000 requires companies to document everything they do that affects
the quality of goods and services.

 Hierarchical approach to documentation of the Quality Management


System
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TOTAL QUALITY MANAGEMENT
 A philosophy that involves everyone in an organization in the
quest for quality, with customer satisfaction as the driving force
 TQM involves:
 finding what customers want
 designing services to meet customer needs
 designing mistake proof delivery process “pokayoke”
 monitoring results and continuous improvement

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TQM, CONT.
 TQM requires:
 continual improvement
 competitive benchmarking
 employee empowerment
 team approaches
 knowledge of tools
 Quality at the source -- each worker responsible for his/her own work
 Quality function deployment -- involve customers in service design

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CONTROLLING QUALITY
 Quality control focuses on the conversion of inputs into
outputs, i.e., the processes
 Goal is to reduce the need for inspection of control efforts
 Quality assurance efforts occurring during production of
services are referred to as statistical process control

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Figure 12.2 The Deming Wheel/Shewhart Cycle

Plan

Act Do

Study

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CONTINUOUS QUALITY
IMPROVEMENT
 A philosophy seeking to make never-ending improvements to the
process of converting inputs into outputs
 Kaizen -- Japanese term referring to CI
 Environment must be conducive to CI
 appropriate vision statement, strategies, tactics
 management style encouraging trust, openness
 adherence to stated philosophy
 reward/incentive systems

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Continuous Quality Improvement
The CQI is a detailed version of a PDCA cycle that comprises:
1) selecting a process that needs an improvement
2) studying and documenting the current process seeking ways to
improve it
3) designing an improved process
4) implementing the new process
5) monitoring and evaluation
6) documenting the process if it worked successfully and publicizing it
through the healthcare organization
7) if it did not achieve its goals, re-starting from step 1.

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Six-Sigma
 Six Sigma is one of the latest quality improvement concepts
to have emerged during the 1990’s. Its name comes from the
measure of variation from the normal distribution (six
standard deviations).
 Adopting a Six Sigma strategy as a quality goal sets tolerance
levels for errors (defectives) to levels that occur only 3.4
times per million observations.
 The defect rates in healthcare can be defined in such distinct
areas as public health, inpatient care, ambulatory care, and so
on.

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Six-Sigma
 Healthcare organizations have reduced the deaths caused by
anesthesia from 25-50 per million cases to 5 per million cases
since the 1980s through improved monitoring techniques,
adaptation of practice guidelines, and other systematic
approaches to reduce errors.
 This is one area that comes very close to six sigma standards
(Chassin, 1998).

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Six-Sigma
 Deployment of six-sigma to improve the quality of healthcare and delivery
performance can be considered in the following areas:
 Clinical excellence
 Service delivery
 Service costs, and
 Patient satisfaction.
 The deployment can use either of these methodological sequences:
 DMAIC: Define, Measure, Analyze, Improve, and Control
 DMADV: Define, Measure, Analyze, Design, and Verify.
 DMAIC is generally used to improve existing systems that have fallen the below six-
sigma levels,
 DMADV is used to design and develop new processes or products at six-sigma levels
(Stahl, Shultz, and Pexton, 2003).
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Six Sigma
 The essence of Six Sigma methodologies is both
improvement of the knowledge and capability of
employees, and also changes behavior through
training. Thus Six Sigma employs a classification
system that identifies education and training for
employees, project managers and executives.
 Emulating karate honors, certification is granted at
Green Belt (GB), Black Belt (BB) and Master Black
Belts (MBB) levels.
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Six Sigma
 Green Belts (GBs) are the employees who have taken the training
courses on implementing the projects.
 Black Belts (BBs) are the project leaders, whose training may be more
intensive; they may complete several projects a year depending upon their
size and scope.
 Master Black Belts (MBBs) are generally assigned to an area that needs
improvement (for example, human resources), to ensure that objectives are
set, targets are identified, plans are made, and resources are secured to
implement the projects in their assigned area.
 MBBs may oversee many six-sigma projects at a time, working with various
BBs.

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Six Sigma
 Six Sigma projects require BBs and MBBs to have expertise in
basic statistical tools such as Pareto Diagrams, descriptive and
higher level statistics including regression, and statistical
modeling techniques as well as control processes.
 In addition to statistical concepts, they are expected
understand project management, finance, leadership,
measurement through socio-metric (survey) analysis, reliability
and validity.

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Six Sigma
Examples of successful six-sigma deployments in healthcare
include:
 reduction of emergency room diversions
 fewer errors in operating rooms’ cart materials
 reduced bloodstream infections in an ICU, and
 improved radiology turnaround time (Stahl, Shultz, and Pexton,
2003).

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QUALITY MEASUREMENT AND
CONTROL TECHNIQUES
Process Variability
 In the delivery of health care, there are many occasions when an error can
happen in the tasks performed by various clinical staff.
 Often the same task may not even be performed the same way for all
patients, though minor alterations within defined limits can be acceptable.
 When provider performance falls beyond acceptable limits, the errors that
occur require investigation and correction.
 In order to detect noteworthy variations in process, or tendencies that may
cause unacceptable levels of errors, healthcare managers must monitor the
processes for quality, using various charts.
 The intent of the monitoring is to distinguish between random and non-
random variation.
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QUALITY MEASUREMENT AND CONTROL
TECHNIQUES
Process Variability
 The common variations in process variability that are caused by
natural incidences are in general not repetitive, but various
minor factors due to chance and are called random variation.
 If the cause of variation is systematic, not natural, and the source
of the variation is identifiable, the process variation is called
non-random variation.
 In healthcare, non-random variation may occur by not following
procedures, using defective materials, fatigue, carelessness, or
not having appropriate training or orientation to the work
situation, among many reasons.
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QUALITY MEASUREMENT AND
CONTROL TECHNIQUES
Process Variability
 Process variation is the range of natural variability in a process
for which healthcare managers use control charts to monitor
the measurements. If the natural variability or the presence of
random variation exceeds tolerances set by control charts,
then the process is not meeting the design specifications.

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Figure 12.3 Process Capability

UCL
Process Variability

Process variability
Process variability meets Set design specifications
does not meet
and exceeds specifications for process capability
design specifications

LCL

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Figure 12.4 Control Charts Overview
Measurement Metrics

Continuous
Attributes
Variables

c-Chart p-Chart Mean Charts Range Charts

σ Method Range Method

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Figure 12.5 Control Limits, Random and Nonrandom Sample Observations
Non-random

α/2
Upper
Control
Limit
(UCL)

+2σ

95.5%
Process
Mean
-2σ
Lower
Control
Limit
(LCL)

α/2
1 2 3 4 5 6 7 8 9 10 11 12

Sample number

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Control Charts for Attributes
 When process characteristics can be counted, attribute-based
control charts are the appropriate way to display the
monitoring process.
 If the number of occurrences per unit of measure can be
counted, or there can be a count of the number of bad
occurrences but not of non-occurrences, then a c-chart is the
appropriate tool to display monitoring.
 Counting also can occur for a process with only two
outcomes, good or bad (defective); in such cases p-chart is the
appropriate control chart.

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Control Charts for Attributes: c-Chart

UCL  c  z c

LCL  c  z c

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Example 12.1
The number of infections from the Intensive Care Unit (ICU) at the ABC Medical Center
over a period of 24 months is obtained. These numbers are the counts of stool assay
positive for toxin, segregated by month. The patient population and other external
factors such as change in provider have been stable.
Months Infections in ICU
Year 1 Year 2
January 3 4
February 4 3
March 3 6
April 4 3
May 3 4
June 4 3
July 5 5
August 3 6
September 4 3
October 3 3
November 7 6
December 4 3

Total 47 49

The nurse manager who serves on the quality team wants to discover whether the
infections are in control within 95.5% confidence limits.
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Solution
If we consider each month as a sample of bad quality outcomes, for 24 samples we have a
total of 96 quality defects (infections), and the average would be:

c = 96/24 = 4.0.

Since the z-value for 95.5% confidence level is equal to 2, using formulas we obtain:

UCL  c  z c  4  2 4  4  2 * 2  8.

LCL  c  z c  4  2 4  4  2 * 2  0.

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Figure 12.6 ABC Medical Center Infection Control Monitoring

UCL= 8
Infections per month

c 4

LCL= 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

Sample Number

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Control Charts for Attributes: p-Chart
The proportion of defects in a process can be monitored using a p-chart that
has binomial distribution as its theoretical base. The center of the p-chart
represents the average for defects and LCL and UCL are calculated as:

p (1 p )
UCL  p  z n
p (1 p )
LCL  p  z n

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Example 12.2
The indicator Family Satisfaction, which is part of the National Hospice and Palliative Care
Organization’s survey, reflects the percentage of respondents who would not recommend the hospice
services to others.The following data are from Holistic Care Corporation’s completed surveys from 200
families each month during a year, showing the number of respondents each month who expressed
dissatisfaction with the organization’s services.
Months Dissatisfied Percent
Patient Dissatisfied
Families
January 12 0.060
February 14 0.070
March 16 0.080
April 14 0.070
May 25 0.125
June 14 0.070
July 15 0.075
August 16 0.080
September 14 0.070
October 14 0.070
November 24 0.120
December 14 0.070
Total 192 0.080

The manager in charge of quality wishes to construct a control chart for this data within 95.5%
confidence intervals.
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Solution:
First, we need to estimate the proportion mean,

Total number of quality infractions 192 192


p = -------------------------------------------- = ------------------- = --------- = .08
Total number of observations 12 (200) 2400

Since the z value for the 95.5% confidence level is equal to 2.0, using formulas we
obtain:

.08(1.08)
UCL  .08  2 200
 0.118.

.08(1.08)
LCL  .08  2 200
 0.042.

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Figure 12.7 Holistic Care Corporation’s Quality Monitoring

UCL = 0.128
Proportion of Families Dissatisfied

p  0.08

LCL = 0.042

1 2 3 4 5 6 7 8 9 10 11 12

Sample number

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Figure 12.8 Use of Mean and Range Charts

UCL

Process
Mean

LCL

Stable mean, increasing range process

UCL

LCL

Increasing mean, stable range process Mean indicator Range indicator

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(x )
CONTROL CHARTS FOR VARIABLES
Mean Charts - Standard Deviation Approach
In general the population standard is unknown, and so the average of sample
means and the standard deviation of sample distribution σ are used to construct
the confidence limits as:

.
UCL  x  z
LCL  x  z
x

where σ  s / n

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Example 12.3
With a time-motion study, the IV startup process has been examined in a medical
center nursing unit for five weekdays to determine whether in the future, additional
training of nurses is required. Each day 9 new patients’ IV startups were observed
and the measurements recorded in minutes, as shown below. Construct 99.7% (z = 3)
confidence limits for IV startup times.

Observation Day-1 Day-2 Day-3 Day-4 Day-5


1 5.1 4.9 5.5 6.1 6.0
2 5.4 5.7 5.6 5.8 5.2
3 5.5 6.3 5.3 5.9 6.3
4 5.8 7.5 4.9 6.0 5.0
5 5.6 5.8 5.2 6.2 5.5
6 5.8 5.9 5.4 5.7 5.1
7 5.3 5.5 6.4 4.8 5.9
8 4.9 5.8 7.5 6.3 5.3
9 6.2 5.5 5.8 5.9 4.8
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Solution:
Observation means for each day (sample) are calculated and are shown in the
last rows of the following table.

Sample Day-1 Day-2 Day-3 Day-4 Day-5

x
5.51 5.88 5.73 5.86 5.46
s 0.6

x = (5.51+5.88+5.73+5.86+5.46) ÷ 5 = 5.69.
with z = 3, n = 9 observations per sample (day), and s = 0.6, we obtain:

UCL  5.69  3(0.6 / 9 )  5.69  3(0.2)  6.29.

LCL  5.69  3(0.6 / 9 )  5.69  3(0.2)  5.09.


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CONTROL CHARTS FOR VARIABLES
Mean Charts - Range Approach
Another way to construct a mean chart is to use the average of sample
distribution ranges. This approach requires a factor to calculate the dispersion of
the control limits.

UCL  x  A2 R
.

UCL  x  A2 R
Where A2 is a factor from Table 12.1

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Table 12.1 Factors for Determining Control Limits for Mean and Range Charts
(for 3-sigma or 99.7% confidence level)

Factor for Mean Factors for Range Chart


Sample Size Chart, A2
n LCL, D3 UCL, D4

2 1.88 0 3.27

3 1.02 0 2.57

4 0.73 0 2.28

5 0.58 0 2.11

6 0.48 0 2.00

7 0.42 0.08 1.92

8 0.37 0.14 1.86

9 0.34 0.18 1.82

10 0.31 0.22 1.78

Source: p. 143, Operations Management by Rusell & Taylor, 1995.


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Example 12.4
During 5 weekdays, each day the number minutes spent for each of 10 patient
registration operations were observed in a time study as follows:

Observation Day-1 Day-2 Day-3 Day-4 Day-5

1 10.2 10.3 8.9 9.5 10.5

2 9.7 10.9 10.5 9.7 10.2

3 10.3 11.1 8.9 10.5 10.3

4 8.9 8.9 10.5 9.8 10.9

5 10.5 10.5 9.8 8.9 11.1

6 9.8 9.7 10.2 10.5 9.8

7 10.0 8.9 8.9 10.4 9.5

8 11.3 10.5 10.5 8.9 9.7

9 10.7 9.8 9.7 10.5 10.5

10 9.8 11.3 10.5 9.8 8.8

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Solution:
The overall mean for each sample and range is required to apply the
formulas, using the range approach. Here each day is considered as a
sample. The range is calculated by taking the difference between the
maximum and minimum of each sample (day). The, mean for each day also
is calculated and shown as follows:
Sample Day-1 Day-2 Day-3 Day-4 Day-5

Maximum 11.3 11.3 10.5 10.5 11.1


Minimum 8.9 8.9 8.9 8.9 8.8
Range 2.4 2.4 1.6 1.6 2.3

x 10.12 10.19 9.84 9.85 10.13

x = (10.12+10.19+9.84+9.85+10.13) ÷ 5 = 10.03.

R = (2.4+2.4+1.6+1.6+2.3) ÷ 5 = 2.06.

UCL = 10.03 + 0.31 (2.06) = 10.67.


LCL = 10.03 – 0.31 (2.06) = 9.39.
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CONTROL CHARTS FOR VARIABLES
Range Charts
Process dispersion is best monitored by range charts. The control limits for
range charts are constructed using factors. To calculate LCL, factor score D3 is
obtained from a factor chart (Table 12.1) based on the number of observations
in the sample distributions. Similarly, to calculate UCL, factor score D4 is
required. Control limits for range charts using these factor scores are then
. constructed as follows:
UCL  D4 R
LCL  D3 R

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Example 12.5:
Use the information provided in example 12.4 to construct a range chart.

Solution:
For n = 10, D3 and D4 from Table 12.1 are 0.22 and 1.78, respectively. Using
formulas we obtain:

UCL = 1.78 (2.06) = 3.67.

LCL = .22 (2.06) = 0.45.

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INVESTIGATION OF CONTROL CHART
PATTERNS
Run-Based Pattern Tests
A pattern in a control chart described by a sequence of observations that have
similar characteristics is called a “run.” A simple classification of sample
observations with respect to the center line that identify consecutive patterns is
called an Above/Below run, or A/B run.

.
Up (U) and down (D) runs is another way to classify and observe patterns. To
classify sample observations as U or D, the first observation is used as a
reference point.

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Figure 12.9 Identification of Runs

UCL

CL

LCL

1 2 3 4 5 6 7 8 9 10 11 12
Sample number
Observed runs

A B B A A A A B B A A B 6
1 2 3 4 5 6

* D U U U D D D D U D D 5

1 2 3 4 5
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INVESTIGATION OF CONTROL
CHART PATTERNS
Run-Based Pattern Tests
Control chart patterns identified by runs require statistical testing of whether
the runs are within expectations and hence the patterns are random, or beyond
expectations and hence non-randomness is present. It has been shown that runs
are distributed approximately normally (Stevenson, 2002, p.436) and using the z-
test the significance of too few or too many observed runs can be determined as
. follows:
Observed runs  Expected runs
z
S tan dard deviation of runs
A z-value within ±2, which provides 95.5% confidence level, would show that
the runs are random; however, beyond these values ≤ ±2 ≥, a non-random
presence would be shown.
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INVESTIGATION OF CONTROL
CHART PATTERNS
Run-Based Pattern Tests
It is necessary to calculate the expected runs and their standard deviations. The
formulas for expected A/B or U/D runs and their standard deviations are as
follows:
N
E (run) A / B   1 N 1
 (run) A / B 
2 4
.

2N  1 16 N  29
E (run) U / D   (run)U / D 
3 90

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Example 12.6:
Determine the presence/absence of non-randomness for the example
presented in Figure 12.8, with 95.5% confidence limits.

Solution:
The example has twelve observations, so N=12. Using the formulas we get:
12 12  1 11
E (run) A / B   1  7.0  (run) A / B    2.75  1.66
2 4 4
(2 * 12)  1 (16 * 12)  29 163
E (run) U / D   7.67  (run) U / D    1.81  1.35
3 90 90
67
zA/ B   0.60 conclude that the A/B runs exhibit randomness.
1.66
5  7.67
zU / D   1.98 conclude that U/D runs exhibit randomness.
1.35

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PROCESS IMPROVEMENT
Methods for Generating New Ideas:

 The 5W2H Approach


 Brainstorming
.  Nominal Group Technique
 Interviewing
 Focus Groups
 Quality Circles “Kaizen Teams”
 Benchmarking
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PROCESS IMPROVEMENT
Tools for Investigating the Presence of Quality Problems
and Their Causes:
 Check Sheet
 Histogram
.

 Scatter Diagram
 Flow Chart
 Cause-and-Effect Diagram
 Pareto Chart
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Figure 12.10. A Check Sheet and Corresponding Histogram for Emergency
Room Wait Times
A B C
Wait Time to Registration Wait Time for
Weeks register >10 Time > 5 MD > 15
Minutes Minutes Minutes

1 /// //////
2 //// / /
3 ////// /// //////
4 / // /////
5 ////// // /////
6

4
A
3
B
2 C
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1 Chapter 12: Quality Control &
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0
Week 1 Week 2 Week 3 Week 4 Week 5
Figure 12.11 Scatter Diagram

0.14
0.12
Morbidity Rate

0.1
0.08
0.06
0.04
0.02
0
0 5 10 15 20
Number of Infections per Month

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Figure 12.12 A Flow Chart for the X-Ray Order Process
in an Emergency Department
E.D. MD
Requests X-ray

NO Hand Write
Computer- Patient
Prepared Form Obtain Form Demographic
Available? Information

YES

Physician
Completes Form

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Figure 12.13 Cause and Effect Diagram
Methods/Processes Structure Functions

Tests Not Coordinated


Too Many Steps
Lab/Rad./ER
Depts. Report Delays in Ordering Tests
Hospital room to Different VPs
not available if
Test Errors
admitted
Patients
Wait Too
Long
Private MDs Boring Environment
Not on Site Lack of Feedback
Design is
Lack of Supplies Not Efficient
Lack of Lack of Incentives
Transporters Lack of Automated
System
Lack of ER Beds

People Rewards Equipment/Material


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Figure 12.14 Pareto Diagram

100%
80%
75%

50%

25%

0%
Lack of info. Too many Delays in Lack of Ineffective/
Other
to patient steps test orders automation voluminous
documentation

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CHAPTER SUPPLEMENT:
PARETO DIAGRAMS IN EXCEL

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The End

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