Quality and Safety Learning Corner

Define, Measure, Analyze, Improve, Control

(DMAIC) Methodology as a Roadmap in Quality
Improvement
Lea M. Monday1,2,3
1
Wayne State University School of Medicine, Detroit, MI, USA

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2
Detroit Receiving Hospital, Detroit, MI, USA
3
Henry Ford Hospital, Detroit, MI, USA

Address correspondence to Lea Monday ([email protected]).

Source of support: None. Conflict of interest: None.
Received: Mar 29, 2022; Revision Received: Apr 12, 2022; Accepted: Apr 23, 2022
Monday LM. Define, measure, analyze, improve, control (DMAIC) methodology as a roadmap in quality improvement. Glob J Qual
Saf Healthc. 2022; 5:44–46. DOI: 10.36401/JQSH-22-X2.
This work is published under a CC-BY-NC-ND 4.0 International License.

LEARNING OBJECTIVES by engineer Bill Smith in the 1980s to reduce process

variation at Motorola and were coined, ‘‘Six Sigma.’’ [2]
1. Know the history of Lean, Six Sigma, and DMAIC ‘‘Lean Six Sigma’’ combines the principles of both Lean
2. Describe the applicability of DMAIC methodology to and Six Sigma with the overarching goal to reduce both
healthcare waste and variation within a system using data and
3. Describe the steps and process tools used in DMAIC continuous quality improvement. To reduce variation in
a process, Six Sigma utilizes statistical analysis through a
5-step approach called the DMAIC method.
HISTORY OF LEAN, SIX SIGMA, AND DMAIC
METHODOLOGY
APPLICATION OF SIX SIGMA AND DMAIC IN
The term DMAIC, which stands for ‘‘define, measure, HEALTHCARE
analyze, improve, and control,’’ represents a method for
process analysis used in Lean Six Sigma. To understand Six Sigma and the DMAIC method originated in the
DMAIC methodology, one must first know the history of manufacturing industry; however, by the late 1990s
Lean and Six Sigma. ‘‘Lean’’ production originates from several healthcare organizations had adopted these
the Toyota Production System introduced in Japan by concepts to improve patient safety and healthcare
engineer Taiichi Ohno in the 1950s through 1980s. Lean delivery.[4] Challenges exist when implementing DMAIC
principles (aspects of which are shaped by Japanese methodology into a dynamic multifaceted health sys-
culture and Japanese Zen Buddhism) are designed to tem. Unlike the production line in a factory, a health
permeate every aspect of an organization from company system is not delivering a singular standardized product
culture and philosophy down to leadership, technology, and patients are not the only consumers. Healthcare
teamwork, and task standardization.[1] Ultimately, the professionals may bristle at the notion of standardiza-
goal of Lean is to improve efficiency of a process and tion, believing it will limit their autonomy to make
deliver the best product by eliminating waste.[1] Six decisions.[5] Gold-standards and medical recommenda-
Sigma is a Western concept that originated from tions may exist, but often with variation in strength of
statistical modeling of manufacturing processes them- evidence; these are meant not as hard rules but rather as
selves. In the 1920s, Walter Shewhart created the basis a guide in conjunction with clinical judgment. These
for statistical process control with the concept that qualities of patient care make removal of variation
observed variation in a manufacturing process leads to difficult; however, ample opportunities appropriate for
deviation which results in an unideal product.[2] Fur- standardization still exist. Lean Six Sigma concepts have
thermore, changing a manufacturing process without been applied successfully to improve these various
proper analysis can worsen variation and result in more aspects of patient care. In a recent systematic review
defects. Shewhart went on to work with physicist from 2020, Ninerola and colleagues identified 196
Edwards Deming to develop the ‘‘Plan Do Study Act’’ manuscripts outlining Six Sigma use in the healthcare
(PDSA) cycle in the 1930s.[3] These concepts were applied sector.[6] Most of these originated from the United States

Global Journal on Quality and Safety in Healthcare 2022 | Volume 5 | Issue 2 | 44

jqsh.org
 Quality and Safety Learning Corner 45

and were published case studies. Multiple specialties and

services have used these methods to standardize and
improve one or more processes. For example, Six Sigma
methodologies using DMAIC have been used to reduce
wait times for radiology results, improve the safe
administration of medications, and decrease unnecessary
antibiotic use.[7–9]

STEPS OF DMAIC

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Figure 1 is adapted from recent publications discussing
the use of DMAIC in healthcare and outlines the steps
and process tools involved.[9,10] One advantage to
DMAIC methodology compared to PDSA cycles (also
known as the Deming or Shewhart cycle) is that a more
robust preparation of measurement and analysis occurs
before any change or improvements are proposed.
Change is not proposed until step 4 of 5 (as opposed to
step 2 of the PDSA cycle). Additionally, process control is
required as a built-in final step, which may help impart
lasting change regardless of whether the cycle is Figure 1. Define, measure, analyze, improve, control (DMAIC)
methodology and process tools[9,10]
repeated.

Step 1: Define able brainstorming and using clear and regular

In the define phase, stakeholders must clearly define communication about potential solutions. Various stake-
the project objective, scope, and if possible, the time holders may disagree about who or what needs to change
frame. Stakeholders must agree on what the target of the to reach the targeted goal. National benchmarking and
project is, as well as its duration. This may include a discussion of established best practices may be needed.
process map or other analysis (Financial, Stakeholder, or Keep in mind that interventions relying on human
Kano analysis), to develop an aims statement. memory (education, pocket cards, policy changes, email
reminders) may be appropriate, but will be weaker than
Step 2: Measure those that are tied directly to process flow (hard stops in
Measurable data to serve as quality or safety indicators ordering, electronic alerts). The concept of Kaizen (a
are identified. This may require conducting data collec- Japanese term meaning, ‘‘change for the better’’) can
tion to establish baseline metrics. Data extracted from help ground the group in the idea that improved
aggregate databases should be analyzed for accuracy. operations should involve all employees and are contin-
Data should be able to be displayed visually for uous and methodical process.[11]
subsequent analysis. Box plots, pareto charts, control
charts, or histograms may be used which will subse- Step 5: Control
quently be used in further steps. An exemption from the The control phase is crucial to achieving sustainable
institutional review board can usually be obtained for change and requires tracking process performance. A
data being used for quality improvement. process control plan usually builds on the new ideal
process map indicating who is responsible for each
Step 3: Analyze aspect of the new process. The team must be aware of
This step merges what is known about the process as new potential problems that could arise because of work
well as the baseline data to identify and validate the arounds, design flaws, or resistance to process change.
causes of errors, deviation, delays, waste, or other Ongoing control charts can monitor variation. Team
etiologies of defects in the process. Analysis may include members must be aware of the metrics on a regular basis
pareto diagrams, histograms, pie charts, Ishikawa (fish- so that ‘‘out of control’’ performance can be corrected,
bone) diagrams, a 5-whys analysis, or other tools to and the control plan can be updated. How often team
explore cause and effect. members are updated (daily, weekly, annually, etcetera) is
dependent on the metric being tracked and the amount
Step 4: Improve of time required to gather and/or verify the data.
In this phase, the team works to address the root cause
and make changes to eliminate the issues leading to CONCLUSION
variability and waste in the process. Communication
with team members and team involvement and com- DMAIC can serve as a roadmap to apply the Lean Six
mitment is parament. Stakeholders should be comfort- Sigma philosophy and improve a process even in a
46 Monday: DMAIC as a roadmap for QI

complex field such as healthcare. Involving the relevant Accessed Mar 20, 2022. www.ihi.org/communities/blogs/
stakeholders and building in long-term plans for process does-standardization-mean-the-end-of-autonomy.
control are crucial to its applicability and sustainability. 6. Niñerola A, Sánchez-Rebull MV, Hernández-Lara AB.
Quality improvement in healthcare: six sigma systematic
review. Health Policy. 2020;124:438–445.
References 7. Cavagna E, Berletti R, Schiavon F, Scarsi B, Barbato G.
Optimized delivery radiological reports: applying Six
1. Chiarini A, Baccarani C, Vittorio M. Lean production, Sigma methodology to a radiology department. Radiol Med
Toyota Production System and Kaizen philosophy: A (Torino). 2003;105:205–214.
conceptual analysis from the perspective of Zen Bud- 8. Castle L, Franzblau-Isaac E, Paulsen J. Using six sigma to
dhism. TQM J. 2018;30:425–438. reduce medication errors in a home-delivery pharmacy

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sigma quality, TQM and company culture. The TQM 9. Monday LM, Yazdanpaneh O, Sokolowski C, et al. A
Magazine 2006;18:263–281 physician-driven quality improvement stewardship inter-
3. Harolds J. Quality and safety in health care, part I: Five vention using lean six sigma improves patient care for
pioneers in quality. Clin Nucl Med. 2015;40:660–662. community-acquired pneumonia. Glob J Qual Saf Healthc.
4. Chassin MR. Is health care ready for Six Sigma quality? 2021;4:109–116.
Milbank Q. 1998;76(4):565–591, 510. 10. Ahmed S. Integrating DMAIC approach of lean six sigma
5. Llody R. Does standardization mean the end of autono- and theory of constraints toward quality improvement in
my? Why it matters standardization for health care healthcare. Rev Environ Health. 2019;34:427–434.
improvement does not mean practicing ‘‘cookbook med- 11. Yamada S. Are you ready for kaizen in your clinical
icine.’’ Institute for Healthcare Improvement. Nov 8, 2018. practice? Circ J. 2020;84:546–548.