Special Report
Lean and Six Sigma: Not for Amateurs
Second in a 2-Part Series
James M. Jacobson, MD, MBA, CPE, FACP, FACPE,1 Mary E. Johnson, PhD2
( 1Six Sigma Black Belt and Net Education Design, Inc, Kennedale, TX, 2Lean Six Sigma Black Belt Instructor for the George Group Lean
Six Sigma Courses and Texas A&M University–Commerce, Commerce, TX)
The first article in this 2-part series discussed the challenge
of quality health care, the need for sophisticated problem solving
methods, the roles of process thinking and project prioritization,
and some of the problem-solving methods utilized with Lean.
This article describes Six Sigma and Lean Six Sigma.
Six Sigma
Six Sigma is a systematic data-driven improvement method
using cross-functional teams to reduce variation, improve qual-
ity, enhance bottom-line balance sheet performance, and
improve customer satisfaction.1 Six Sigma originated at
Motorola in 1986, and is a federally registered trademark of Mo-
torola. General Electric later modified Six Sigma, after which
many other manufacturing and service companies adopted it.
Six Sigma Philosophy: The philosophy of Six Sigma is that
process variation is a root cause for many quality problems such
as late shipments, incorrect services, or defective deliverables.2
Variation reduces quality and adds cost.
Why is it called Six Sigma? Every process has a mean and a
standard deviation. By comparing the process statistics to the spec-
ification limits, we estimate a sigma level. A ‘sigma level perform-
ance’ quantifies the relationship between customer specifications
and the natural distribution of the process results. As
improvements reduce process variation, more standard deviations
will fit between the process mean and the specification limit.
When Six Sigma performance occurs, 6 process standard devia-
tions will fit between the process mean and any specification limit,
and the product measure will fall within specification limits for
99.9997% of samples, resulting in only 3.4 failures (occurrences
outside the specification limit) per million opportunities. How-
ever, Six Sigma is much more than the calculation of sigma level.
People: Six Sigma has a defined structure of working rela-
tionships. It also specifies roles for Sponsors (Senior Executives),
Champions (Senior Managers), Black Belts (highly trained
process improvement experts and team leaders), Green Belts
(process improvement apprentices), and a Steering Committee.
There are numerous interpretations of these roles, but the overall
purposes are similar.1-5 Sponsors oversee the entire quality im-
provement initiative. Champions are the key decision makers for
individual projects and work closely with the Black Belts. Black
Belts have full-time responsibility to lead projects and can usu-
ally handle 2 or 3 concurrently. Green Belts may assist with se-
lected aspects of a project or lead a project that is not complex.
140 LABMEDICINE 䊏 Volume 37 Number 3 䊏 March 2006
DMAIC: To provide a systematic approach and ordering of
activities, Six Sigma uses a methodology known as DMAIC
(pronounced ‘duh-may-ik’). DMAIC is 5 phases of project man-
agement (Define, Measure, Analyze, Improve, and Control)
(Table 1), each punctuated with a formal gate review.1 The gate
review allows the team to present their project status and results
to company managers who make a go/no-go decision for the
next phase of the project. These reviews increase project visibil-
ity, promote buy-in by the company’s managers, provide for
timely and complete communication, reduce financial and im-
plementation risk, and force teams to rigorously apply the
DMAIC methodology.
Define Phase
Purpose: The purpose of the Define Phase is to define the
goals and scope of the project, create a similar vision for each
team member, and provide an estimate of potential benefits and
impact on the company and the customer. This involves select-
ing a project from among several potential projects, based on
potential performance and financial return, and setting realistic,
measurable goals. The influence and support of the Champion
helps to develop commitment and set the scope of the project.
The Black Belt provides tools, facilitates activities, and
documents the process. At this step, there is opportunity for the
Champion and Black Belt to make sure the right people are on
the team. There is also emphasis to determine customer needs
through an analysis of the “voice of the customer.”5
Deliverables: The single most important outcome of the
define phase is the project charter, which is a written definition
of the current state of the process and the desired state (goal).
The charter may also include potential benefits and impacts on
the customer and company, and a high level schedule with re-
source requirements.
Common Tools: Tools for the Define Phase tend to be
non-quantitative tools that engender discussion (brainstorming);
provide a broad perspective of the project process, such as high-
level process diagram, fishbone diagram (Figure 1) or Supplier-
Input-Process-Output-Customer (SIPOC) diagram (Figure 2);
and project scoping tools used to determine the breadth or scope
of the project.
Measure Phase
Purpose: The purpose of the Measure Phase is to refine the
project definition, identify inputs (X’s) and outcomes (Y’s), evaluate
the measurement system, and determine baseline process capability.
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Table 1_Activities and Tools Commonly Used in Six Sigma Projects

Activity Tools

Define

Identify the problem Charter

Complete a charter SIPOC diagram
Conduct SIPOC analysis (identify suppliers, inputs, process, outputs, and customers) Affinity diagram
Create a high level process map High level process map
Perform a Voice of the Customer analysis Brainstorming
Focus the project scope Non-value added analysis
Conduct gate review Customer analysis
Rolled throughput yield (RTY)
Measure

Identify key input, process and output variables Statistical sampling methodology
Develop data collection plan Data collection process
Complete gage R & R (repeatability and reproducibility) study Frequency plots
Collect baseline data; estimate sigma level and capability Time series plots
Prepare detailed process map Identification of constraints
Assess value of each process step Gage repeatability and reliability
Conduct gate review Pareto charts
Failure modes and effects analysis (FMEA)
Detailed process map
Identify VA, BVA, and NVA activities
Analyze

Select X variables for study Pareto chart

Prioritize X variables for study Cause and effect matrix
Complete root cause analysis Brainstorming
Select root causes with largest impact on Y variables Detailed process map
Conduct gate review Flow diagrams
Frequency plots, scatter plots
Correlations
Basic hypothesis testing
ANOVA
Linear regression
Discriminant analysis
Improve

Develop potential solutions Advanced hypothesis testing

Optimize solution Experimental plan
Develop improved process map Data collection plan
Develop high-level implementation plan Multiple linear regression
Estimate new sigma level and capability Full factorial design
Conduct gate review 2k factorial design
Logistic regression
Response surface design of experiments
Control

Clarify results from Improve phase Control charts

Design standard operating procedures, a training plan and a control system Standard operating procedures
Implement the new process and controls Communication plan
Monitor and stabilize the new process Training plan
Measure and calculate quality and financial benefits Implementation plan
Turn over to Process Owner Process control plan
Celebrate success! Control plan
Conduct gate review Transition plan

Deliverables: A detailed process diagram provides more in-
formation about the process and uncovers informal or “hidden”
steps in it. Each step in the process is assessed as value added,
non-value added, or business value added. Lead time, process
cycle efficiency, and sigma level are estimated for the baseline
process. Evaluation of the measurement system, often labeled a
gage study, allows assessment of the accuracy with which meas-
urements can be made. Similar to measuring analytes in the lab-
oratory, instrument repeatability, reproducibility, and lower limit
of detectability are critical parameters. In this phase, baseline
measurements are made of numerous X’s and Y’s.
Common Tools: A detailed process diagram, often sev-
eral pages in length, delineates the process. A cause and ef-
fect matrix (Figure 3) relates effects to potential causes of
the effect. A gage study (Figure 4) provides an assessment of
variation resulting from the process itself, the individual op-
erator, and the measurement device. Also, in this stage, one
would estimate the ability of the process to provide results
within acceptable limits. Typical estimates include potential
capability (Cp), short-term capability (Cpk), long-term ca-
pability (Ppk), defects per unit (DPU), and rolled through-
put yield (RTY).

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Figure 1_Example of a Fishbone

Diagram, so named because the
pattern of lines resembles the
skeleton of a fish. The diagram
lists causes, by category, for
inaccurate processing of labora-
tory samples. (From Jackson J.
DRL Labs Lean Six Sigma for
Service Processing Project, with
permission. Available from DRL
Labs, Tyler, Texas.)

Figure 2_Example of a SIPOC

Project: Processing Innovations Date: 8/5/2004 Diagram, so named because it
lists suppliers of necessary
materials, inputs to the process,
outputs from the process, and
Start Boundry: Courier delivers specimen End Boundry: Specimen is delivered to the tech customers. Note that there are
multiple suppliers, and multiple
customers. (From Jackson J.
DRL Labs Lean Six Sigma for
Suppliers Inputs Outputs Customers Service Processing Project, with
permission. Available from DRL
Couriers Requisitions Workable Coworkers Labs, Tyler, Texas.)
specimen

Client Services Specimens Test results Physician

Clients Add ons Bill Client

Patient

Other departments

Analyze Phase documents such as process diagrams, fishbone diagrams, or

Purpose: The purpose of this phase is to understand the
relationship between X’s and Y’s, determine which X’s are critical
to the process, reduce the number of X’s and Y’s for more formal
study, and detect and eliminate noise (variation).
Deliverables: The team initially analyzes baseline data for
relationships between X and Y variables (correlations), or
between X variables (interactions). The Black Belt or a statisti-
cian, may complete more sophisticated analyses such as Analysis
of Variance (ANOVA), multiple linear regression, discriminant
analysis, or other statistical analyses appropriate for the data and
the hypotheses.
Common Tools: The tools for this phase usually include
computer-based statistical packages such as SPSS (Chicago, IL),
or Minitab (State College, PA), among others. Each allows com-
putation of the most commonly required statistical analyses;
but they differ in utility to produce non-quantitative graphical
cause and effect matrices. Obviously, expertise in statistical
analysis is necessary in this phase, and is usually provided by the
Black Belt or a statistician.
Improve Phase
Purpose: The goal of this phase is to improve the process to
bring it to the performance goal. The team manipulates key X’s
to achieve a change in the Y variable of interest; that is, they
modify the process. While this phase involves experiments—
often several experiments—it allows discovery and testing of an
improved process.
Deliverables: The deliverable is an improved process and better
understanding of how to optimize the Y by manipulating the X’s.
Common Tools: After modifying X inputs for the experi-
ment, many of the same measurements and calculations from
previous phases are repeated. As an example, note the limited

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Figure 3_Example of a Cause and Effects Matrix used to prioritize steps in the process for evaluating cognitive function. Steps are listed verti-
cally. Outputs are listed horizontally. Value to the customer for the output (labeled “Customer Priority”) is used as a multiplier for the impact of
the step to obtain a total value for the step. Total value estimates indicate steps in a process that will likely have the greatest impact on the
customer. In this case, the cognitive testing result and interpretation of the cognitive testing result each received a score of 72, indicating that
they were more important to the client than other steps commonly used in evaluation of cognition. (From Jacobson JM. Improved Diagnostic
Process for Alzheimer’s Disease, with permission. Available from Net Education Design, Inc., Arlington, Texas.)

movement of technicians processing specimens after a work area
layout change was implemented to reduce transportation waste
(Figure 5) and compare it with the extensive movement of tech-
nicians in Figure 1 from the first article in the series. Because this
phase is an experiment, knowledge about experimental design is
important. If the experiment takes place during actual work,
rather than in a controlled environment, change management
techniques and communication skills play an important role.
changed process. Fortunately, proven improvements supported
by reliable data are difficult to resist. It is also important in this
phase for the Black Belt, who has organized and facilitated the
project, to back out of an everyday role and to return process
control to its rightful owners, the employees and managers who
are engaged in the process on a daily basis. The Champion sup-
ports this by approving a final report and assigning the Black
Belt to another project.

Control Phase
Purpose: The purpose of the control phase is to sustain the
gains; that is, to make the improvements last. Under stress or
deadlines, people have a tendency to revert to familiar old habits,
and thus backslide on improvements. There is also a tendency
for people to have difficulty letting go of a project. In this phase,
the Black Belt must completely return the process to the Process
Owner. A successful control phase achieves sustained improve-
ments even months after the process is completely returned to
the Process Owner.
Deliverables: Managers encourage control by developing
written policy and procedure, documenting new processes, train-
ing employees, and obtaining follow-up measurement of both
X’s and Y’s. A financial assessment substantiates cost reductions
and/or financial benefits.
Common Tools: Change management techniques and
communication skills are necessary to obtain buy-in for the
Lean Six Sigma
In some industries, Lean and Six Sigma have been viewed
as rivals fighting to become the recognized improvement
methodology. Unfortunately, the rivalry overlooks the real prize
of improving cost, quality, and speed while using the strengths
of both methodologies. Both Lean and Six Sigma have the po-
tential to improve quality and reduce waste; they differ in philos-
ophy, approach, and structure. Table 2 has a comparison of Lean
and Six Sigma.
Some consultants use selected aspects of both Lean and Six
Sigma, coining the description “Lean Six Sigma.”3 Lean Six
Sigma embraces the comprehensive DMAIC framework and
adds the Lean principles of speed, efficiency, and immediate ac-
tion. Lead time and process cycle efficiency are 2 fundamental
measures used in this method.

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Figure 4_Example of the graphical printout summarizing statistical analyses from a Gage Study completed to assess variation of test results for
a medical test administered to individuals. Variation may be attributed to the ColorFormTime test itself (the gage), the 3 individuals administer-
ing the test (the operators), or the individual being tested (labeled part-to-part variation). For a test to be good, one desires small variation
attributed to the test and operator, and most variation attributed to part-to-part variation. (From Jacobson JM. Improved Diagnostic Process for
Alzheimer’s Disease, with permission. Available from Net Education Design, Inc., Arlington, Texas.)

Figure 5_Example of a
“Spaghetti Chart.” The line
graphs represent the travel of
laboratory technicians as they
process specimens after the pro-
cessing steps were changed to
decrease transportation waste.
Compare this with Figure 1 from
Part 1 of this series. The total
line length is shorter and there is
much less repetition of move-
ment. (From Jackson J. DRL Labs
Lean Six Sigma for Service
Processing Project, with permis-
sion. Available from DRL Labs,
Tyler, Texas).

Lead time is important to understanding process velocity. Lead
time describes how long it takes to deliver a service or product once
a customer requests the order. Lead time is estimated by measuring
the number of items in the process and dividing it by the number
of items completed per unit of time, using Little’s Law.3,6
Lead Time = Number of items in process /average completion rate
For instance, if there are 20 specimens to interpret and each
interpretation requires an average of 1/2 hour to complete (com-
pletion rate of 2 items per hour), then an additional specimen
would need to wait 10 hours before processing. By controlling
the number of specimens in process, the lead time can be con-
trolled and predicted. Variation in lead time is known to dissat-
isfy customers because they cannot predict when results will be

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Table 2_Comparison of Lean and Six Sigma*
Lean Six Sigma
Maximizes process velocity Eliminates defects
Reduces delay, improves process Reduces variability to improve quality
velocity
Identifies and eliminates waste; Requires data-driven decisions made
identifies and eliminates using a comprehensive framework
non-value-added work (DMAIC)
Does not prescribe infrastructure Prescribes a proven infrastructure
*Adapted from George, ML. Lean Six Sigma for Service. New York: McGraw-Hill, 2003;
page 7.
available. Variation in lead time challenges laboratory managers
who must predict staffing levels and delivery times while main-
taining high quality.
Process cycle efficiency (PCE) is important to understand-
ing the amount and pervasiveness of waste. PCE is the propor-
tion of time spent on value-added work compared to the total
amount of time in the process.3 For instance, suppose it takes
24 hours from the time a urine specimen is picked up until the
report is delivered. If value-added activity required 1.2 hours,
then the PCE would be 1.2/24 or 0.05. A PCE below 0.10 is
common, and indicates a process ripe for improvement.3
Process Cycle Efficiency = Value-added time / Total lead time
Lean and Six Sigma for the Laboratory
Elements of both Lean and Six Sigma should seem very
familiar to laboratory professionals, who usually are knowledge-
able about process flow, measurement, research design, sophisti-
cated statistical analysis, and quality control. Each is a common
laboratory tool. Both Lean and Six Sigma provide structure and
methods that allow application of these tools to disciplines
where they are not traditionally in use. Hence, there is enthusi-
asm about applying them to manufacturing—or, for that matter,
to any other discipline. The methods may be applied with simi-
lar success to almost any discipline or organization that is com-
plex, fragmented, or characterized by interlinked processes.
Application in the laboratory will likely lead to improved quality
of service and care, faster results, and reduced cost.
Summary
Health care is very complex and composed of numerous
fragmented interlinked processes. Managing outcomes that em-
anate from this array of processes is challenging, and requires
powerful tools. Lean and Six Sigma represent systematic
methodologies that allow stakeholders in interlinked processes
and disciplines to work together to prioritize activities, analyze
inputs and outcomes, and implement changes to achieve quan-
tifiable beneficial results. Some of the tools, particularly the sta-
tistical tools, are sophisticated. Therefore, Lean and Six Sigma
are not for amateurs. These very powerful techniques require
sophisticated leadership, management, and analytical skills.
Laboratory professionals, because of their training and experi-
ence with process analysis, management, and statistical analysis,
are leading candidates to provide leadership for Six Sigma proj-
ect implementation.
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Special Report
Acknowledgements: The authors appreciate permission to
use selected data and information contributed by Ms. Jennifer
Jackson and DRL Laboratories of Tyler, TX. The data are de-
rived from a Lean Six Sigma quality improvement project.
1. Pande PS, Neuman RP, Cavanagh RR. The Six Sigma Way Team Fieldbook: An
Implementation Guide for Process Improvement Teams. New York: McGraw-Hill;
2002.
2. Pyzdek T. The Six Sigma Handbook: A Complete Guide for Greenbelts,
Blackbelts, & Managers at All Levels. New York: McGraw-Hill; 2001.
3. George, ML. Lean Six Sigma for Service. New York: McGraw-Hill; 2003.
4. Breyfogle FW. Implementing Six Sigma: Smarter Solutions Using Statistical
Methods. New York: John Wiley & Sons; 1999.
5. Gitlow HS, Levine DM. Six Sigma for Green Belts and Champions: Foundations,
DMAIC Tools, Cases, and Certification. Upper Saddle River, NJ: Pearson
Prentice Hall; 2005.
6. Hopp WJ, Spearman ML. Factory Physics. 2nd edition. Boston: McGraw-Hill;
2001:152-153.
Epilogue of the Good Samaritan Hospital
Scenario
Summary of Scenario (from first article in the 2-part
series) Good Samaritan Hospital received frequent complaints
from patients and staff about long waits before initial evalua-
tions and long turnaround times before discharge. Depart-
ment heads disagreed about the cause of the problems, and
about potential solutions. A solution was not in sight.
Epilogue: Fortunately, the Director of Facility Services
(the Champion) chose emergency room turnaround time as
a focus of process improvement. A Black Belt organized a
team of stakeholders to define the patient flow process, re-
flecting multiple process steps at which delay might occur.
Baseline measurement reflected a mean turn around time of
about 6 hours. Data analysis, aggregated by diagnosis and
procedure, showed inordinate waiting time for women, who
often needed a pregnancy test prior to undergoing a radio-
logical procedure. There was correlation between number of
pregnancy tests ordered and overall turnaround time. Inter-
estingly, the emergency room staff had not considered the
pregnancy test urgent, so specimen delivery to the labora-
tory was often delayed until an urgent specimen required
delivery. The laboratory, as well, did not consider the test
urgent, and relegated the task to a secondary priority. Influ-
enced by hard data about the problem, the laboratory agreed
to install a single-technician satellite laboratory in the emer-
gency room to perform just a few simple tests (hematocrit,
lytes, urinalysis, pregnancy test). There was as stunning de-
crease in overall emergency room patient turnaround time
by roughly 60%! When a visiting physician commented,
“There are so few patients in the waiting room; this must
not be a busy emergency room,” the Chief of the
Emergency Room retorted, “We spend our time caring for
patients, not for a flawed patient flow process.” This was a
lesson often learned by participants in Lean and Six Sigma
projects—that operating a busy, non-optimal health care
process steals time away from other value-add activities.
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