Int. J. Radiation Oncology Biol. Phys., Vol. 71, No. 1, Supplement, pp.

S187–S190, 2008
Copyright Ó 2008 Elsevier Inc.
Printed in the USA. All rights reserved
0360-3016/08/$–see front matter

doi:10.1016/j.ijrobp.2007.07.2385

QA FOR RT SUPPLEMENT

TOOLS FOR DEVELOPING A QUALITY MANAGEMENT PROGRAM: PROACTIVE

TOOLS (PROCESS MAPPING, VALUE STREAM MAPPING, FAULT TREE ANALYSIS,
AND FAILURE MODE AND EFFECTS ANALYSIS)

FRANK RATH, M.S.I.E.

Department of Engineering Professional Development, University of Wisconsin–Madison, Madison, WI

This article examines the concepts of quality management (QM) and quality assurance (QA), as well as the current
state of QM and QA practices in radiotherapy. A systematic approach incorporating a series of industrial engineer-
ing–based tools is proposed, which can be applied in health care organizations proactively to improve process
outcomes, reduce risk and/or improve patient safety, improve through-put, and reduce cost. This tool set includes
process mapping and process flowcharting, failure modes and effects analysis (FMEA), value stream mapping, and
fault tree analysis (FTA). Many health care organizations do not have experience in applying these tools and there-
fore do not understand how and when to use them. As a result there are many misconceptions about how to use
these tools, and they are often incorrectly applied. This article describes these industrial engineering–based tools
and also how to use them, when they should be used (and not used), and the intended purposes for their use. In
addition the strengths and weaknesses of each of these tools are described, and examples are given to demonstrate
the application of these tools in health care settings. Ó 2008 Elsevier Inc.

FMEA, Risk analysis, Quality assurance, Quality management.

INTRODUCTION Each of these reports prescribes a series of QA-related activ-

Although the terms ‘‘quality management’’ (QM) and ‘‘qual-
ity assurance’’ (QA) are used extensively, there is little com-
mon agreement on their exact meaning, and there are many
misconceptions about QM/QA systems, procedures, and
tools. The key to a successful QM/QA is a relentless focus
on processes and on giving people involved in organizations’
processes the tools necessary, and also the responsibility, to
improve quality. These tools include failure mode and effects
analysis (FMEA), fault tree analysis (FTA), flowcharting, and
process mapping. Unfortunately this approach to QM/QA has
not been widely adopted in the manufacturing or service in-
dustries or in the health care field. There are several reasons
for this lack of success, but the main reason is nonuse or mis-
use of the tools identified above. Both QM and QA strategies
in most organizations heavily depend upon inspection and
removal of defective products (or rework) in manufacturing,
or waiting until there is a failure and then trying to identify
the causes of those failures with the hope of preventing
them from occurring again in service organizations.
Over the past few decades, the American Association of
Physicists in Medicine (AAPM) has convened several task
groups to address the issue of QA in radiation therapy; these
include Task Group (TG) 40 (1), TG 45 (2), and TG 53 (3).
ities or approaches intended to verify the technical compo-
nents of various radiation therapy processes that are heavily
based upon testing, inspection, or verification of hardware
and software performance parameters.
Looking at one of these reports in more detail gives some
insight into the general QA strategy of these AAPM task
groups, as well as some potential problems with that ap-
proach. The report from AAPM TG 53 concentrates on QA
for the treatment planning process. It addresses most of the
technical components of radiation therapy planning (RTP).
The report calls for more than 170 tests or verifications to
be performed on several process components of RTP. Fol-
lowing these guidelines would be a Herculean task for
most radiation therapy departments. It would require a signif-
icant number of hours just to perform the tests or verifica-
tions, not to mention the QA management effort to plan
and control the QA process. It would also almost certainly
add cost and could tie up valuable equipment for testing
and verification.
The approach used by TG53 focuses on the treatment plan-
ning system, and how the system interacts with the RTP pro-
cess. This is an improvement over previous AAPM task
groups that looked primarily at the technical components of

Reprint requests to: Frank Rath, M.S.I.E., Department of
Engineering, Professional Development, University of Wisconsin–
Madison, Madison, WI 53706. Tel: (608) 263-5989; Fax: (608)
263-3160; E-mail: rath@engr.wisc.edu
S187
Conflict of interest: none.
Received April 16, 2007, and in revised form July 18, 2007.
Accepted for publication July 19, 2007.
S188 I. J. Radiation Oncology d Biology d Physics
radiation therapy such as the equipment and software. TG53
does not look at all of the components of the RTP process,
however. For example it does not look at the process steps in-
volving the evaluation of information and the resulting deci-
sions made when developing an RTP. An effective QA
system needs to address all of the components of a specific
process, not just the technical components or the operator–
equipment interfaces.
Currently AAPM TG 100 (4, 5) is reviewing reports from
previous task groups and from several professional organiza-
tions. This group is also reviewing ISO guidelines in an effort
develop a suitable general QA approach that ‘‘balances pa-
tient safety and quality versus resources commonly available
and strike[s] a good balance between prescriptiveness and
flexibility.’’ The TG 100 initiative identifies three industrial
engineering–based tools as potential components of a QA
management system in radiation therapy: namely, process
trees, FMEA, and FTA. In addition TG 100 recommends
that these tools be used to assess risks or hazards in radiation
treatment processes. There are a few potential problems with
these recommendations, however. The first is that the general
radiation therapy community is concerned that the use of
these tools to reduce the risks or hazards associated with ra-
diation therapy will require a considerable amount of addi-
tional resources. Although this should be a concern,
process mapping, flowcharting tools, and FMEA (5–10)
have been used for decades by the medical device and phar-
maceutical industries, among others, to reduce the level or
risks or hazards in products and processes with many positive
results. Also if the organizations are trained in the use of these
tools and if these tools are applied with the assistance of ex-
perienced facilitators, there are few if any additional re-
sources required, and the resulting process improvements
will increase the effectiveness and productivity of the organi-
zation. A second potential problem is TG 100’s recommen-
dation that these tools be used for risk and hazard analysis
versus overall process improvement. This might prevent
CT/MRI
Position Verify RTP-
patient phantom +
Check equip
Deliver output and
treatment other
parameters
Fig. 1. A system level, top-down process flow chart for radiation treatment planning and delivery. CT = computed tomog-
raphy; MRI = magnetic resonance imaging; PET = positron emission tomography; RTP = radiation therapy planning.
Volume 71, Number 1, Supplement, 2008
the realization of significant improvements in processes and
the resulting increase in quality and productivity.
Use of FMEA appears to have the highest potential for as-
sisting the radiation therapy community in improving overall
processes and in reducing and controlling the risk of injury
without overtaxing resources. The first step in using FMEA
to analyze a process is to define that process. Process maps,
process trees (5), and process flowcharts (7, 10) are all effec-
tive tools for defining a process. Process flowcharts offer the
most flexibility and are one of the easiest to use tools to use in
defining a process. When using any of these tools, a system-
level top–down or a bottom—up systematic approach can be
used. In a system-level top-down approach, the steps below
should be followed:
1. Flow chart the major steps in the process.
2. Perform an FMEA on those steps. The FMEA will identify
those steps with the highest likelihood of failure or injury.
3. For those process steps, develop a detailed process
flowchart.
4. Perform an FMEA on the detailed process steps, resulting
in the identification of only those detailed process steps
with the highest likelihood for failure or injury.
When using a bottom–up systematic approach, the steps
below should be followed:
1. Develop a flowchart for the major steps in the process and
all of the detailed process steps nested beneath them (this
can be difficult and time consuming).
2. Perform an FMEA on all of the detailed process steps and
the higher level process steps they flow into, resulting in
risk assessments for all detailed and higher-level pro-
cesses, both those with a low likelihood for failure or in-
jury and those with a high likelihood for failure or injury.
A system-level, top–down process flowchart for the radia-
tion treatment and delivery (RTPD) process is shown in
Fig. 1. This flowchart was developed with the assistance of
No
Is
Patient
tumor yes Physician
positioning
present evaluation
strategy
Initial RTP -
Dosimetry - How much PET/CT
develop RTP radiation and imaging
where
 Tools for developing a quality management program d F. RATH
Fig. 2. Standard process failure mode and effects analysis (FMEA) form.
the RTPD team at University of Wisconsin Hospitals. A
rough-cut FMEA of the process indicated that the step of
‘‘positioning the patient’’ had a high likelihood to fail, which
could result in injury the patient.
Figure 2 shows is the standard form used in completing ei-
ther a system-level top–down or a bottom–up, systematic
FMEA (5, 6). For the RTPD process step ‘‘position the pa-
tient,’’ the following steps should be adhered to when per-
forming an FMEA:
1. Identify the intended objective or purpose of each process
step: ‘‘Position the patient for optimal delivery of radia-
tion—both dose and delivery location.’’
2. Identify the potential failure modes for each process step:
‘‘Radiation treatment delivered to location outside of
specified location from the treatment plan’’ would be
one, and there would likely be several more.
3. Identify the causes of each potential failure mode: The
failure mode identified in the previous step will have sev-
eral causes. One cause might be, ‘‘Incomplete or incorrect
work instructions detailing the patient positioning pro-
cess, or inadequate training.’’ Causes of failure modes
come from the following general categories: hardware/
equipment, software, physicists/technicians, patient,
work instructions, and training. Each cause should specify
how it led to the patient being in the wrong position. Each
potential failure mode will have many potential causes.
4. Identify the local, downstream, and end effects of the fail-
ure mode. The local effect identifies what would happen
during the process step to the patient or the process
when the failure mode occurred. The downstream effect
identifies what would happen later if the failure mode oc-
curred. The end effect identifies what would ultimately
happen to the patient if the failure mode occurred. For
the failure mode ‘‘radiation treatment delivered to location
outside of specified location in the treatment plan’’:
a. There is likely no local or immediate effect on the patient.
b. There is no likely downstream effect on the RTPD
process, but there is a likely downstream effect on
the patient—the patient’s condition would worsen be-
cause of not treating the tumor and possibly destroying
unintended tissue.
c. The end effect on the patient ultimately could be death.
S189
The worst-case scenario should always be identified for
each level of effect, and any safety or injury effects always
take priority over all other effects. For the potential failure
mode, ‘‘radiation treatment delivered to location outside of
specified location in the treatment plan,’’ there are several po-
tential end effects including tissue or organ damage, the tu-
mor not being treated with the specified radiation dose, or
the patient experiencing irreparable damage and/or death. Ef-
fects should always be stated given the worst-case scenario.
5. Identify all of the process controls currently in place that
achieve the following:
a. Prevent the causes of failure modes from occurring.
b. Detect failure modes when they do occur.
c. Mitigate the severity of the effects resulting in failure
modes when they do occur.
Process controls are procedures, practices, policies and
methods put in place to improve the reliability, repeatability,
and quality outcomes of processes. They usually cover equip-
ment, technicians or operators, training, work instructions,
and so forth. The most effective process controls are those
that significantly reduce the likelihood of potential causes of
failure modes from ever occurring, or that result in the failure
mode being detected before the process fails or a patient is in-
jured. Technician or operator training, detailed work instruc-
tions, process visual aids, preventive maintenance, process
verification, and equipment calibration are effective controls
that can prevent the occurrence of potential causes or detect
a failure mode before there are any negative consequences.
In most process FMEAs it is difficult to moderate the severity
of the resulting effects when a failure mode occurs. For the
failure mode ‘‘radiation treatment delivered to location other
than specified in the treatment plan,’’ it would be virtually im-
possible to reduce the severity of the effects on the patient.
6. Judge the effectiveness of the current process controls, us-
ing three independent ranking scales (5, 6), with each
scale being from 1 to 10:
 The likelihood of an occurrence of a cause of a potential
failure mode (1 indicates that the cause will not occur,
and 10 that the cause is inevitable; known as the occur-
rence scale).
 The likelihood of detecting a failure mode if it occurs (1
indicates that the failure mode will always be detected,
S190 I. J. Radiation Oncology d Biology d Physics
and 10 that it will never be detected; known as the de-
tection scale).
 The severity of effects of a failure mode when it occurs
(1 indicates no effect, 10 that the effect is very serious;
known as the severity scale) on both the end user (the pa-
tient and/or hospital personnel) and the RTPD process.
The overall risk level for process failure or injury is deter-
mined by multiplying the occurrence score by the detection
score by local, downstream, and end effects severity scores.
Because there are three separate effects (local, downstream,
and end effects), there are three risky priority numbers
(RPNs) for each failure mode and cause combination. Never
reduce the severity score of an end effect because the team
performing the FMEA judges that the cause of a failure
mode resulting in that end effect almost never occurs. A se-
rious end effect score of 10 with a low occurrence score of
2 and a relatively moderate detection score of 4 would result
in an RPN of 80, which would indicate a low level of risk for
process failure or injury. However anytime a local, down-
stream, or end effect received a high severity score during
an FMEA, that process step would need to be closely evalu-
ated. Even though the occurrence score in the above example
is low, there is a distinct probability that the cause of the fail-
ure mode might occur. Also there is a high probability in the
above example that if the failure mode did occur, it would be
detected before something serious happend; however no de-
tection or inspection step is completely foolproof.
7. Completing the scoring–ranking and RPN calculation
phase of an FMEA can, and often does, lead to some spir-
ited discussions. It is highly recommended that a cross-
functional group familiar with the process being reviewed
performs the FMEA. This often results in divergent views
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