34 ISE Magazine | www.iise.org/ISEmagazine
Quality management has evolved as a discipline over
time and has been aligned with both organizational
and customer needs of today and tomorrow. Today,
quality management is considered an inextricably
interwoven aspect of every organization that strives
for sustainability and a circular economy.
Quality” is a quite subjective term and carries different
connotations to different people in different industrial settings.
According to Joseph Juran, one of the quality gurus from the
United States, quality means “fitness for use.” Philip Crosby, a
quality specialist from the U.S., views quality as “conformance
to requirements.” According to the American Society for
Quality, quality can have two meanings: “The characteristics
of a product or service that bear on its ability to satisfy stated or
implied needs” and “A product or service free of deficiencies.
This article discusses the four phases of the evolution of
quality management in terms of approach, features, pros and
cons. By understanding these phases you will deepen your
knowledge of quality management and how its characteristics
have evolved over the last 100 years; better understand where
your quality management system is in its evolution; and iden-
tify actions you can take to improve and strengthen the impact
of your quality management system over time. This evaluation
will develop a baseline for your current system on which you
can improve in the future.
An overview of the four phases
After the first Industrial Revolution, inspection was in-
troduced to identify defects found in production lines. We
evolved into a more focused approach to quality control since
World War II.
Quality control is the set of measures and procedures to
ensure the quality of a product is maintained and improved
against a set of benchmarks, and that errors are eliminated
The genealogy of Quality 4.0
From inspection to automation, the quest to meet standards evolves
By Jiju Antony, Shreeranga Bhat, Raja Jayaraman, Olivia McDermott, Michael Sony and Ronald Snee
April 2022 | ISE Magazine 35
or reduced. Quality control (QC) was achieved by training
personnel, creating standards for product quality, and testing
products to check for statistically significant variations. This
combination of inspection and QC can be described as Qual-
ity 1.0. Both inspection and quality control operate in reactive
modes, which means defects are already made by the process
and companies generally develop a “blame” culture; this im-
plies no one is responsible or accountable for defects.
The next stage of this quality evolution was the advent of
quality assurance (QA) or Quality 2.0. This approach focuses
on preventing defects rather than simply detecting them and
adhering to standards that set minimum quality levels. ISO
9000 quality management system standard is a part of quality
assurance. It was first published in 1987 by the International
Organization for Standardization, a specialized agency for
standardization composed of the national standards bodies of
more than 160 countries. The standards were revised in 1994,
2000 and 2008. The most recent versions, ISO 9001:2015,
were published in September 2015.
However, there are some major limitations associated with
ISO 9001 standards, according to various quality manage-
ment and engineering experts. For instance, ISO 9001 does
not guarantee the final product or service quality. Moreover,
it creates a sense of complacency for achieving quality; this
implies many senior managers view ISO as the pinnacle of
quality achievement. In a quality assurance phase, it was felt
that not everyone was responsible for quality and there was
very little emphasis on continuous improvement until 2008.
These issues are very well addressed in the next stage or
phase of the quality evolution called Quality 3.0. This phase is
referred to as the total quality management (TQM), which is
centered around three core principles: customer focus, contin-
uous improvement and total employee participation for quality
However, with increasing digital transformation, we have
witnessed a new evolution of quality over the past three years
called Quality 4.0, dened as the “digital transformation of
quality and increased use of data to drive decision-making,
root causing corrective action and prediction of quality.
Enhanced process optimization can enable machine learn-
ing and enhanced decision-making can aid quality. Quality
decisions will be based less on human interaction and instead
on the enabling machine and process technology. In a nutshell,
it can be dened as the “digital empowerment of all the stake-
holders of the process for dynamic quality enhancement and
sustainment.” Figure 1 portrays the evolution of quality from
Quality 1.0 to Quality 4.0 with their basic tenets.
Quality 1.0: Inspection and quality control
The first stage in the evolution of quality, or Q1.0, was the ad-
vent of inspection and quality control (QC). Starting with the
Industrial Revolution in the late 1800s and early 19th century,
the factory system emphasized productivity and started to in-
clude inspections to find defects. However, an overfocus on
productivity negatively affected quality, so QC departments
became the norm. During World War II, the U.S. enacted
legislation to help steer civilian industries toward military
production. Quality became a critical component of the war
Evolution of quality
How the application of quality has progressed from Quality 1.0 to Quality 4.0 with their basic tenets.
36 ISE Magazine | www.iise.org/ISEmagazine
The genealogy of Quality 4.0
effort and an important safety issue. The U.S. armed
forces inspected virtually every unit produced to en-
sure safety. To overcome this delay in productivity
while still ensuring quality, they moved to statistical
quality control (SQC) and sampling inspection. This
method of inspection and QC was the first stage in the
evolution of quality management. It is important to
note that many organizations today are still using these
procedures to achieve quality.
Approach: Inspection involves various activities
such as tests, measurements and gauges applied to a
business process to check product quality. In this con-
text, an inspector checks quality of the product from
the process. If the product quality is “bad,” the inspec-
tor either scraps or reworks it based on its quality level.
The inspector ships good quality products directly to
customers. In comparison, QC is a procedure with
predefined standards executed and implemented by the
organization to ensure products or services are regulat-
ed by specic quality standards, limits, thresholds and
guidelines. ISO defines quality control as “the opera-
tional techniques and activities used to fulll require-
ments for quality.
The seven basic seven tools of QC, developed by Dr. Kaoru
Ishikawa, are a set of graphical techniques identified as be-
ing most helpful in troubleshooting issues related to quality.
Ishikawa further reiterated in What is Quality Control? in 1985
that “95% of problems in processes can be accomplished by the
use of the seven QC tools,” and that in very complicated pro-
cesses, advanced techniques and computers are a requirement.
Features: The primary purpose of the inspection is to
check whether the specification of the product or service has
met the standard or not (Norman L. Johnson, et al., CRC
Press, 2020). The QC process aims to test the quality of units
and determine if specifications are within the limit for the fi-
nal product. Quality testing involves several steps performed
at the manufacturing stage, such as testing raw materials, pull-
ing samples (e.g., acceptance sampling plans) from the manu-
facturing or assembly line to test finished products. Testing
at various manufacturing stages helps to detect the problem
occurring during different processes and provide remedial so-
lutions to prevent for the near future (Chung-Ho Chen and
Chao-Yu Chou, Quality Technology & Quantitative Management,
2020). Figure 2 represents the approach, features and compo-
nents of Quality 1.0.
Pros: Inspection and QC avoids unnecessary reengineer-
ing works on the products later. Further, inspection checks
packaging integrity, which avoids damage during transition.
Moreover, it reduces overall quality-related risk and cost. Also,
implementing QC procedures ensures that organizations sell
the best product to their customers. QC protocols may help
to use resources effectively and inspire employees to produce
high-quality products.
Cons: Inspection adds to the cost of the product but does
not add much value to the product from customers’ perspec-
tives. Similarly, inspection merely separates only good or bad
items with no focus on continuous improvement. In addi-
tion, this process is partially subjective, as the inspector judges
whether a product passes from quality check. It is a reactive
approach as defects are already made from the process and it
costs money to fix them. W. Edwards Deming referred to this
as “burning the toast and then scraping it.
There is always a probability that bad products will be
shipped to customers, even though stringent inspection pro-
cedures are executed by the quality inspector, or that good
units will be rejected by the same inspector because of poor
judgement in the inspection.
Quality 2.0: Quality assurance
The second stage in the evolution of quality relates to qual-
ity assurance (QA), or Quality 2.0. Many organizations had
adopted this proactive approach to reduce defects in products
and reduce inspection costs. QA can be dened as “a positive
declaration intended to give confidence or a promise.” It of-
fers the opportunity to avoid defects or mistakes in products
and service delivery and includes systematic measurements,
administrative and procedural processes. The ISO 9000 stan-
dards dene QA as, “a part of the quality management system
that focuses on providing confidence that quality requirements
will be fullled” (Clara Martínez Fuentes, et al., International
Journal of Quality & Reliability Management, 2003).
Approach: The QA assists the products and services in
Inspection and QC
The components of Quality 1.0.
April 2022 | ISE Magazine 37
meeting the requirements as per internal and external custom-
er specifications. A QA system can be established and sustained
through personal assessment or reliance on independent au-
dits. Different certifications provide a platform for such audits
and ensure a robust QA system for stakeholders. Consequent-
ly, a quality audit system will ensure continual improvement
culture within the organization (Stanislav Karapetrovic and
Walter Willborn, International Journal of Quality & Reliability
Management, 2000). However, the QA deployment process
must be from a continual improvement perspective rather than
a task of merely achieving a certificate of achievement.
Features: QA demands the involvement of all stakeholders
of the organization, not just managers, technicians and con-
sultants. These unied efforts will help to quantify the cost of
quality. Thus, it will reduce the business cost by determining
how and where quality costs are incurred (Low Sui Pheng
and Henson K.C. Yeo, Structural Survey, 1997). Nevertheless,
the objectives of QA can be achieved only through organiza-
tional-level training with an emphasis on the practical usage
of nonstatistical and statistical tools and techniques. This will
strengthen the continuous improvement through a structured
bottom-up process.
Gaining a certification or quality accreditation does
not necessarily indicate the organization is committed
to quality. Quality 2.0 ensures enhanced product or
service quality when QA and quality certification are
viewed as a foundation for quality and not the pin-
nacle (Sonny Nwankwo, International Journal of Quality
& Reliability Management, 2000). The key components
and characteristics of Q 2.0 are shown in Figure 3.
Pros: It will ensure customer satisfaction as it is
more proactive than a pure inspection-based approach.
Further, it reduces the inspection cost, rejection and
reworks. Moreover, it ensures higher quality products
or services by establishing and complying with stan-
dards. Further, it improves employee morale due to
the involvement of people in fixing quality problems
at the team level within the organization.
Cons: However, Quality 2.0 demands substantial
investment in human resources and finance to adhere
to quality assurance standards. ISO 9001 standards
create a sense of complacency for many organizations
that treat it as the highest achievement of quality. Im-
plementation of ISO 9001 is rather a time-consuming
exercise for many companies and there is evidence
from many companies, especially small and medium-
sized enterprises, that the costs associated with imple-
mentation of ISO 9001 outweighs the benefits gained.
Quality 3.0: Total quality management
The third stage of quality, Q 3.0, took a holistic per-
spective and established the total quality management
(TQM) philosophy, aimed at the organizational improvement
to quality. During this phase, computers acted as an aid for
workers due to advances in computational power, memory
and knowledge sharing (Sung Hyun Park, et al., Total Qual-
ity Management and Business Excellence, 2017). This was an era
of quality management wherein quality was seen as a must
for every business and everyone should be responsible for it.
Though meeting the customer needs was the priority, it ca-
tered to all the stakeholders’ voices in quality improvement.
This era was marked by productivity, efficiency and effec-
tiveness in the system. We have seen an extension of TQM in
the form of operational excellence (OPEX) or continuous im-
provement methodologies such as Lean, Six Sigma and Lean
Six Sigma. The focus of these methods is on waste reduction
(nonvalue-added activities or tasks) and variability reduction
(i.e., to improve performance consistency for customers).
Approach: Quality 3.0 emphasized designing world-class
and efficient processes, identifying different forms of wastes,
involvement of everybody for quality initiatives, standardiza-
tion and sustainment (Greg Watson, Quality Progress, 2019).
This era saw a proliferation of standardization activities and
Inspection and QC
The components of Quality 1.0.
Following the path toward quality
The emphasis on quality in industrial and systems engineering is the
focus of the IISE Quality Control and Reliability Engineering Division;
learn more at iise.org/qcre. A related track of presentations is planned
for the IISE Annual Conference & Expo 2022 May 21-24 in Seattle,
Washington. Look for program updates at iise.org/Annual.
Quality assurance
The components of Quality 2.0.
38 ISE Magazine | www.iise.org/ISEmagazine
The genealogy of Quality 4.0
operational excellence initiatives such as Lean, Six
Sigma and Lean Six Sigma. Further, this era was also
marked by organizationwide assessment models such
as Malcolm Baldridge criteria for performance excel-
lence, European Foundation for Quality Management
(EFQM) model and the Deming Prize. The emer-
gence of quality management models has been touted
as a signicant development in management practice.
Features: Quality 3.0 targets quality improvement
systematically by matching product and service speci-
fications to customer needs. This phase emphasizes the
importance of continuous improvement across the or-
ganization. TQM is one of the prominent models of
the Quality 3.0 era, which was deployed by a continu-
ously evolving management system consisting of val-
ues, methodologies and tools. TQM has been widely
recognized as a means of sustainable competitive ad-
vantage (James W. Dean Jr. and David E. Bowen, The
Academy of Management Review, 1994).
Besides, OPEX methodologies such as Lean Six Sig-
ma, an extension of TQM, also resulted in a sustainable
organizational performance in terms of operational, fi-
nancial, environmental and social performance. Quality 3.0
incorporated elements such as management leadership and
commitment, employee involvement, supplier partnership and
continuous improvement for effective deployment of quality
management practices across the organization.
Pros: This phase substantially improved productivity and
performance with an emphasis on the sustainment of improved
results. Moreover, it has contributed to enhancing a companys
image, profitability, customer satisfaction and service quality,
customer focus and understanding, employee morale, share-
holder and stakeholder value and innovative processes.
Cons: Quality 3.0 implementation is seen as one of the
complex endeavors a company undertakes, and it impacts the
organizational structures, employees, processes, systems and
culture. Quality 3.0 deployment also takes time to realize the
results and sustain outcomes. Moreover, many organizations
failed to align the corporate strategic objectives with the strat-
egy of Q 3.0 and its counterparts. The authors also observed
that there are just a handful frameworks or road maps available
in the current literature to assist with implementation. More
research needs to be done for the development of strategic and
practical road maps for different organizational settings and
Quality 4.0: Digitalization
of quality management
The dynamic market conditions, development of disrup-
tive technologies, changing customer preferences and expo-
nential expectations of stakeholders forced organizations to
adopt intelligent, robust and dynamic continual quality im-
provement approaches. These factors pave the way to adopt
technology as an integral part of the organization from a
system-thinking perspective.
Moreover, dynamic product/service innovation, in addi-
tion to continual improvement, has emerged as the norm
for new quality adventure. Quality 4.0 can be thought of as
combining new technologies and standard quality tools and
methods to achieve superior performance, higher operation-
al excellence and optimal innovation. “Quality 4.0: Taking
quality to its next level,” June 2020 issue of ISE (link.iise.
org/isejune20_antony) provides an alternative denition for
Quality 4.0, as follows: Quality 4.0 is “the use of advanced
technologies such as Internet of Things, cyber-physical sys-
tems and cloud computing to design, operate and maintain
adaptive, predictive, self-corrective, automated quality sys-
tems along with improved human interaction through qual-
ity planning, assurance, control and improvement to achieve
new optimums in performance, operational excellence and
innovation to meet the vision, mission and goals of an orga-
Approach: Quality 4.0 is built on both the managerial
and statistical foundation of previous approaches or method-
ologies by leveraging Inspection 4.0 tools and techniques to
dynamically ensure the quality of the process and enhance
a businesss efficiency, performance, innovation and bottom
line. This can be achieved by dynamic learning, knowledge
discovery, data generation, collection and analysis to make
smart and informed decisions (C.A. Escobar, et al., Journal of
Intelligent Manufacturing, 2021).
Key features: Quality 4.0 utilizes Inspection 4.0 tech-
Total quality management
The components of Quality 3.0.
April 2022 | ISE Magazine 39
nologies such as articial intelligence, Internet of Things
(IoT), big data, blockchain, deep learning, machine learn-
ing and data science to achieve defect-free processes, smart
and speedy decision-making. Figure 5 illustrates these criti-
cal components, a fusion of people, process and technology.
Further, digital empowerment, digitalization and dynamic
quality enhancement are essential to ensure Quality 4.0 de-
Pros: Quality 4.0 enhances the quality of decisions by re-
inforcing human intelligence, robust and dynamic decision-
making, enhanced transparency and trackability. Further, it
assists in robust prediction, unearthing the bias and dynami-
cally providing feedback with potential solutions.
Cons: The new philosophy demands a systems-thinking
approach, reliable data, learning organization, dynamic
improvement ecosystem, sociocultural and sociotechnical
Critical learnings from the evolution
The evolution of quality management leaves a lot of in-
formation to digest. As we review Figures 2-5, we see the
critical elements of quality management include people,
testing, product, process, audit and technology. After intro-
duction, these elements continue to be part of quality man-
agement over time and evolve to take into account new
learnings and developments. As change pioneer Thomas
Kuhn pointed out in The Structure of Scientic Revolutions
(1962), change happens when the current way of doing
things no longer works in todays environment.
While quality and quality management have been around
for a long time, our focus begins around the turn
of the 20th century. The focus of Quality 1 was on
people, testing including measurement and product.
Testing enabled inspection and control charting until
the early 1950s.
The advent of Quality 2 focused on quality assur-
ance and the introduction of audits of processes and
systems. Later, with the focus on process, the statisti-
cal process control was emphasized to monitor and
control the “voice of the process.
Quality 3 saw the advent of total quality man-
agement, bringing the focus on quality to all as-
pects of the organization. Paying attention to the
“voice of the customer” is highlighted and the idea
of quality management systems becomes an im-
portant focus.
Quality 4 in the early 21st century is when tech-
nology becomes important. Measurement systems
produce large amount of data, automation increases
and systems thinking becomes useful. As we are in
this phase today, we are only beginning to see how
it will play out increasing the impact of quality man-
agement and, as Kuhn pointed out, identifying needed en-
hancements for the quality management system.
The story of quality management is “to be continued.
Quality management will continue to evolve. We live in a
dynamic world. The only constant is change. As limitations
to the current approach are identified, enhancements will be
created and implemented. The evolution continues.
Jiju Antony, Ph.D., is a professor of industrial and systems engineer-
ing at Khalifa University in Abu Dhabi, UAE.
Shreeranga Bhat, Ph.D., is a professor in the Department of Me-
chanical Engineering at St. Joseph Engineering College in Banga-
lore, India.
Raja Jayaraman, Ph.D., is a professor of industrial and systems en-
gineering at Khalifa University in Abu Dhabi, UAE. He is an
IISE member.
Olivia McDermott, Ph.D., is a faculty member at the National
University of Ireland in Galway, Republic of Ireland.
Michael Sony, Ph.D., is a faculty member with the Wits Business
School in Johannesburg, South Africa.
Ronald Snee, Ph.D., is president of Snee Associates, LLC, in
Newark, New Jersey.
Note: For a complete list of source references for this article,
visit iise.org/isemagazine/references.
The components of Quality 4.0.