Improvements in the Manufacturing Industry Versus Health Care Industry
EDITORIAL
Introducing quality improvement
In 1950, a New York University professor received an
unusual letter. It came from Japanese industrial leaders
requesting help to improve manufacturing quality in
their country. The professor taught statistics and had
used it to improve farm crops and military equipment.
At the time, Japanese products were considered ‘cheap’,
and the leadership wanted to change that reputation.
The professor agreed to help. He spent the next 20 years
working with Japanese industries and founded quality
improvement (QI) Science along the way. The rest is his-
tory: Japanese products became known for superior
quality in the likes of Toyota and Sony. The professor’s
name was Dr. Edward Demings.
Some 60 years later, Pediatric Anesthesia launches a
themed issue and a section in subsequent issues dedi-
cated to QI, following the journal Pediatrics in this
regard (1). Why now? All over the world, health care
faces a critical economic crossroad: How do we deliver
better and more care at lower cost? Deming’s message to
Japan’s leadership many years ago: improving quality
will reduce expenses while increasing productivity. This
has been proven time and again in every industry. Now
is the time for us to learn and apply QI and model the
way for others in our institutions. The QI section of the
journal aims to teach QI and illustrate its application
through original articles. To begin this journey, I will
describe the basic elements of QI, differentiate it from
QA (quality assurance), and describe the format for
publication of QI articles.
Quality assurance contains two types of knowledge:
subject matter knowledge and profound knowledge (2).
The former is the knowledge basic to the field. If the
field is pediatric anesthesiology, it is medical knowledge
(e.g., developmental physiology, pharmacology, anes-
thesia equipment, pediatric diseases). As pediatric anes-
thesiologists, we possess subject matter knowledge in
our field. Profound knowledge consists of four elements:
appreciation of a system, understanding variation,
action learning, and change management (2). Profound
knowledge is common to all industries, whereas subject
matter knowledge is industry specific. For pediatric
anesthesiologists to conduct QI, it is necessary to learn
and apply profound knowledge in our work. Let us dive
into the four elements of profound knowledge.
Appreciation of a system: a system is an interdepen-
dent group working together toward a common pur-
pose. The purpose of the system must be clear to
everyone in the system. The vast majority of product
defects originate from system failures and not individual
failures. Thus, understanding the system and getting every-
one in the system to work together is key to successful QI.
In health care, three broad systems exist: microsystems,
mesosystems, and macrosystems. For pediatric anesthe-
siology, generally speaking, the microsystem is the
operating room, the mesosystem is the hospital, and the
macrosystem is the government. The product defect can
arise from one or more failures in these systems. All too
often, the leaders in these systems point fingers at each
other. Improving quality requires the QI team to iden-
tify the role of each system in the defect and to get the
parties to work together.
Understanding variation: high quality is all about
reducing variation in the product. An entire field of sta-
tistics evolved for QI that is distinct from medical statis-
tics (3). All manufacturing industries utilize QI statistics;
hospitals are increasingly using it. In the 1920s, Demings
studied under Walter Shewhart of Bell Laboratories, the
founder of QI statistics, which included statistical pro-
cess control, common and special causes of variation,
and the control chart. Statistical process control views
products as resulting from defined work processes,
which contain variation. Common cause variation is the
variation that is inherent to the process (the ‘noise’).
Special cause variation is not part of the process but
arises from a special situation. A control chart plots the
product specification over time; QI statistics are applied
to determine the variation and significant change. The
QI team aims to favorably shift the average (significant
change) and to reduce common and unintended special
cause variation.
Action learning: QI follows the scientific method:
hypothesis, inductive and deductive reasoning, study
design, and experimentation. Inductive reasoning
generates a hypothesis about the system that predicts a
response in which an experiment can be designed to test
the hypothesis. Deductive reasoning analyzes the experi-
mental data to validate or refute the hypothesis. In QI
science, this methodology appears in the roadmap and
plan-do-study-act (PDSA) cycle. The roadmap
begins with a smart aim (purpose) followed by key driv-
ers (hypotheses) about the system and designing
interventions (experiments) to test the key drivers. The
experiments are known as PDSA cycles. In the PDSA
cycle, the first step is to plan the test of the new process.
Second is to do the test; third is to study the results of
the test. And fourth is to act on the results: if the test
yields positive results, additional PDSA cycles are
performed to evaluate the sustainability over time and
© 2013 John Wiley & Sons Ltd Pediatric Anesthesia 23 (2013) 569–570
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generalizability to other parts of the system. For exam-
ple, if a process change yields positive results in one
operating room on one day, additional PDSA cycles are
conducted on other days (sustainability) and in other
operating rooms (generalizability) before the process is
permanently adopted.
Change management: Of the profound knowledge
elements, change management is perhaps the most
important. Systems and people inherently resist change,
whether from fear of the unknown, inertia, distrust, or
lack of motivation or time. Excellent communication
skills by the QI project leader along with overt support
by the leadership of the system remain absolutely
essential to overcome resistance and drive process
improvement. QI and leadership have to go hand in
hand.
QI vs QA: There are many differences between QI
and QA despite clinicians referring to the two inter-
changeably. QA involves systematic measurement and
comparison with a standard. QA is goal directed to meet
the standard and is widely used in benchmarking. It is
retrospective and says nothing about how to improve
the product if it is substandard. QI involves a formal
approach to the analysis of performance and the system-
atic efforts to increase it. The approach applies the
elements of profound knowledge as well as systematic
measurement. QI is process directed and is both pro-
spective and retrospective. In essence, QI encompasses
QA along with the methodology to improve the product
if it is substandard.
Format of QI articles: Although QI utilizes the scien-
tific method, it requires a different format for writing an
article than a research article. QI focuses on making care
better at local sites, rather than on generating new, gen-
eralizable scientific knowledge. QI contains a strong
‘local context’, whereas research is not supposed to be
dependent on the site of the study. However, systems in
health care around the world share similar features, and
thus, many aspects of QI at one institution are generaliz-
able. Given the local context, special statistics, action
learning, and change management issues, the research
format was not suitable to QI articles. In 2005, an
author group drafted a standardized format for QI arti-
cles, which was refined through a systematic vetting pro-
cess with input from an expert panel and public
feedback and approved as the Standards for Quality
Improvement Reporting Excellence (SQUIRE) (4). QI
submissions to Pediatric Anesthesia are expected to use
the SQUIRE format, exemplified by the articles in this
issue, and detailed on the website (5).
Now that we have a legitimate format and the journal
Pediatric Anesthesia to communicate QI for our spe-
cialty, we hope you will get started in this journey to
learn, conduct projects, and share the trials and tribula-
tions that go with it. We eagerly look forward to receiv-
ing original QI articles and scholarly reviews.
Conflict of interest
No conflicts of interest declared.
C. Dean Kurth Cincinnati Children’s Hospital Medical Center, University of Cincin-
nati College of Medicine, Cincinnati, OH, USA Email: [email protected]
doi:10.1111/pan.12167
References
1 Kemper AR, Moyer VA, First LR. Introduc-
ing Quality Reports. Pediatrics 2001; 127:
187–188.
2 Langley GJ, Moen RD, Nolan KM et al. The
Improvement Guide, 2nd edn. San Francisco,
CA: Jossey-Bass, 2009: 13–72.
3 Wheeler DJ. Understanding variation. The
Key to Managing Chaos. 2nd edn. Knoxville,
TN: SPC Press, 2000: 1–111.
4 Davidoff F, Batalden P, Stevens D et al.
SQUIRE Development Group. Introducing
Quality Reports, 2008; 17: i3–i9.
5 http://squire-statement.org/guidelines/.
© 2013 John Wiley & Sons Ltd Pediatric Anesthesia 23 (2013) 569–570
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Editorial
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