Hear from guest columnist Onega Ulanova on AI and quality management systems in manufacturing. Photo via Getty Images

The concept of quality management is so intrinsic to modern manufacturing — and yet so little understood by the general public — and has literally revolutionized our world over the past hundred years.

Yet, in the present day, quality management and the related systems that guide its implementation are far from static. They are continuously-evolving, shifting to ever-changing global conditions and new means of application unleashed by technological innovation.

Now, more than ever, they are essential for addressing and eliminating not only traditional sources of waste in business, such as lost time and money, but also the physical and pollutant waste that threatens the world we all inhabit.

But what are quality management systems, or QMS, exactly? Who created them, and how have they evolved over time? Perhaps most pressingly, where can they be of greatest help in the present world, and when can they be implemented by businesses in need of change and improvement?

In this article, we will explore the history of QMS, explain their essential role in today’s manufacturing practices, and examine how these systems will take us into the future of productivity.

Quality Management Systems: A Definition

In the United States and globally, the gold standard of quality management standards and practices is the American Society for Quality. This preeminent organization, with over 4,000 members in 130 countries, was established in 1946 and has guided practices and implementation of quality management systems worldwide.

The Society defines a quality management system as “a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives,” and further states that “a QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.”

From this definition, it can be understood that a good quality management system’s purpose is to establish the conditions for consistent and ever-increasing improvement through the use of standardized business culture practices.

Which QMS Standards are Most Widely Used?

The results of quality management’s remarkable growth since the 1940s has led to the rise of a number of widely-used standards, which can serve as the basis for companies and organizations to design and implement their own practices. Most of these modern quality management standards are globally recognized, and are specifically tailored to ensure that a company’s newly-developed practices include essential elements that can increase the likelihood of success.

The most widely-known entity which has designed such guidance is the International Organization for Standardization (ISO), a global organization which develops and publishes technical standards. Since the 1980s, the ISO has provided the 9000 series of standards (the most famous of which is 9001:2015) which outline how organizations can satisfy the checklists of quality management requirements and create their own best practices.

In 2020, over 1.2 million organizations worldwide were officially certified by the ISO for their quality management implementation practices.

However, it should be understood that the ISO 9000 standards are merely guidelines for the design and implementation of a quality management system; they are not systems in and of themselves.

Furthermore, the ISO is far from the only relevant player in this field. Many industry-specific standards, such as the American Petroleum Institute’s API Q1 standard, have been developed to target the highly specialized needs of particular business practices of oil and gas industry. These industry-specific standards are generally aligned with the ISO 9000 standards, and serve as complimentary additional guidance, rather than a replacement. It is entirely possible, and in many cases desirable, for a company to receive both ISO certification and certification from an industry-specific standards body, as doing so can help ensure the company’s newly-developed QMS procedures are consistent with both broad and specialized best practices.

A History of Quality Management

The concept of quality management is intrinsically tied to the development of industrial production. Previous to the industrial revolution, the concept of ‘quality’ was inherently linked to the skill and effort of craftspeople, or in other words, individual laborers trained in specialized fields who, either individually or in small groups, produced goods for use in society.

Whether they were weaving baskets or building castles, these craftspeople were primarily defined by a skill that centered them in a specific production methodology, and it was the mastery of this skill which determined the quality. Guilds of craftspeople would sign their works, placing a personal or group seal on the resulting product and thereby accepting accountability for its quality.

Such signatures and marks are found dating back at least 4,500 years to the construction of Egypt’s Great Pyramid of Giza, and came into widespread practice in medieval Europe with the rise of craft guilds.

In these early confederations of workers, a person’s mastery of a skill or craft could become a defining part of their identity and life, to the extent that many craftspeople of 13th Century Europe lived together in communal settings, while the Egyptian pyramid workers may have belonged to life-long ‘fraternities’ who returned, year after year, to fulfill their roles in ‘work gangs’.

However, in the Industrial Revolution, craft and guild organizations were supplanted by factories. Though ancient and medieval projects at times reached monumental scale, the rise of thousands of factories, each requiring human and machine contributions to generate masses of identical products, required a completely different scale of quality management.

The emphasis on mass production necessitated the use of workers who were no longer crafts masters, and thus resulted in a decrease in the quality of products. This in turn necessitated the rise of the product inspection system, which was steadily refined from the start of the Industrial Revolution in 1760 into the early 20th century.

However, inspection was merely a system of quality control, rather than quality management; in other words, simply discarding defective products did not in and of itself increase total product quality or reduce waste.

As influential American engineer Joseph M. Juran explained, in 1920s-era America, it was common to throw away substantial portions of produced inventory due to defects, and when Juran prompted inspectors at his employer’s company to do something, they refused, saying it was the responsibility of the production line to improve. Quality control, in and of itself, would not yield quality management.

As is often the case in human history, war was the driver of change. In World War II, the mobilization of millions of American workers into wartime roles coincided with the need to produce greater quantities of high-quality products than ever before.

To counteract the loss of skilled factory labor, the United States government implemented the Training Within Industry program, which utilized 10-hour courses to educate newly-recruited workers in how to conduct their work, evaluate their efficiency, and suggest improvements. Similar training programs for the trainers themselves were also developed. By the end of the war, more than 1.6 million workers had been certified under the Training Within Industry program.

Training Within Industry represented one of the first successful implementations of quality management systems, and its impact was widely felt after the end of the war. In the ashes of conflict, the United States and the other Allied Powers were tasked with helping to rebuild the economies of the other wartime combatants. Nowhere was this a more pressing matter than Japan, which had seen widespread economic devastation and had lost 40 percent of all its factories. Further complicating the situation was the reality that, then as now, Japan lacked sufficient natural resources to serve its economic scale.

And yet, within just 10 years of the war’s end, Japan’s economy war growing twice as fast per year than it had been before the fighting started. The driver of this miraculous turnaround was American-derived quality management practices, reinterpreted and implemented with Japanese ingenuity.

In modern business management, few concepts are as renowned, and oft-cited for success, as kaizen. This Japanese word, which simply means “improvement,” is the essential lesson and driver of Japan’s postwar economic success.

Numerous books written outside Japan have attempted to explain kaizen’s quality management principles, often by citing them as being ‘distinctly Japanese.’ Yet, the basis for kaizen is actually universal and applicable in any culture or context; it is, simply put, an emphasis on remaining quality-focused and open to evolution. The development of kaizen began in the post-war period when American statistician William Edwards Deming was brought to Japan as part of the US government’s rebuilding efforts.

A student of earlier quality management thought leaders, Deming instructed hundreds of Japanese engineers, executives, and scholars, urging them to place statistical analysis and human relationships at the center of their management practices. Deming used statistics to track the number and origin of product defects, as well to analyze the effectiveness of remedies. He also reinstated a key idea of the craftsperson creed: that the individual worker is not just a set of hands performing a task, but a person who can, with time, improve both the self and the whole of the company.

Deming was not alone in these efforts; the aforementioned Joseph M. Juran, who came to Japan as part of the rebuilding program several years later, also gave numerous lectures expounding similar principles.

Like Deming, Juran had previously tried to impart these approaches to American industry, but the lessons often fell on deaf ears. Japanese managers, however, took the lessons to heart and soon began crafting their own quality management systems.

Kaoru Ishikawa, who began by translating the works of Deming and Juran into Japanese, was one of the crucial players who helped to create the ideas now known as kaizen. He introduced a bottom-up approach where workers from every part of the product life cycle could initiate change, and popularized Deming’s concept of quality circles, where small groups of workers would meet regularly to analyze results and discuss improvements.

By 1975, Japanese product quality, which had once been regarded as poor, had transformed into world-class thanks to the teachings of Deming, Juran, and kaizen.

By the 1980s, American industry had lost market share and quality prestige to Japan. It was now time for US businesses to learn from Deming and Juran, both of whom at last found a receptive audience in their home country. Deming in particular achieved recognition for his role in the influential 1980 television documentary If Japan Can, Why Can’t We?, in which he emphasized the universal applicability of quality management.

So too did kaizen, which influenced a new generation of global thought leaders. Arising out of this rapid expansion of QMS were new systems in the 1970s and ‘80s, including the Six Sigma approach pioneered by Bill Smith and Motorola in 1987. Ishikawa, who saw his reputation and life transformed as his ideas spread worldwide, eventually summed up the explanation as the universality of human nature and its desire to improve. As Ishikawa said, “wherever they are, human beings are human beings”.

In no small part due to the influence of the thought leaders mentioned, quality management systems are today a cornerstone of global business practice. So influential are the innovators of these systems that they are often called ‘gurus.’ But what are the specific benefits of these systems, and how best can they be implemented?

How QMS Benefits Organizations, and the World

The oft-cited benefits of quality management systems are operational efficiency, employee retention, and reduction of waste. From all of these come improvements to the company’s bottom line and reputation. But far from being dry talking points, each benefit not only serves its obvious purpose, but also can dramatically help benefit the planet itself.

Operational efficiency is the measurement, analysis, and improvement of processes which occur within an organization, with the purpose of utilizing data and consideration to eliminate or mediate any areas where current practices are not effective.

Quality management systems can increase operational efficiency by utilizing employee analysis and feedback to quickly identify areas where improvements are possible, and then to guide their implementation.

In a joint study conducted in 2017 by Forbes and the American Society for Quality, 56 percent of companies stated that improving operational efficiency was a top concern; in the same survey, 59 percent of companies received direct benefit to operations by utilizing quality management system practices, making it the single largest area of improvement across all business types.

Because operational improvements inherently reduce both waste and cost, conducting business in a fully-optimized manner can simultaneously save unnecessary resource expenditure, decrease pollutants and discarded materials, and retain more money which the company can invest into further sustainable practices. Efficiency is itself a kind of ‘stealth sustainability’ that turns a profit-focused mindset into a generator of greater good. It is this very point that the

United States government’s Environmental Protection Agency (EPA) has emphasized in their guidance for Environmental Management Systems (EMS). These quality management system guidelines, tailored specifically to benefit operational efficiency in a business setting, are also designed to benefit the global environment by utilizing quality management practices.

Examples in the EPA’s studies in preparing these guidelines showcased areas where small companies could reduce environmental waste, while simultaneously reducing cost, in numerous areas. These added to substantial reductions and savings, such as a 15 percent waste water reduction which saved a small metal finishing company $15,000 per year.

Similarly, a 2020 study by McKinsey & Company identified ways that optimizing operations could dramatically aid a company’s sustainability with only small outlays of capital, thereby making environmental benefit a by-product of improved profitability.

Employee retention, and more broadly the satisfaction of employees, is another major consideration of QMS. Defined simply, retention is not only the maintenance of a stable workforce without turnover, but the improvement of that workforce with time as they gain skill, confidence, and ability for continued self and organizational improvement. We may be in the post-Industrial Revolution, but thanks to the ideas of QMS, some of the concept of the craftsperson has returned to modern thinking; the individual, once more, has great value.

Quality management systems aid employee retention by allowing the people of an organization to have a direct hand in its improvement. In a study published in 2023 by the journal Quality Innovation Prosperity, 40 percent of organizations which implemented ISO 9001 guidance for the creation of a QMS reported that the process yielded greater employee retention.

A crucial success factor for employee satisfaction is how empowered the employee feels to apply judgment. According to a 2014 study by the Harvard Business Review, companies which set clear guidelines, protect and celebrate employee proposals for quality improvement, and clearly communicate the organization’s quality message while allowing the employees to help shape and implement it, have by far the highest engagement and retention rates. The greatest successes come from cultures where peer-driven approaches increase employee engagement, thereby eliminating preventable employee mistakes. Yet the same study also pointed out that nearly half of all employees feel their company’s leadership lacks a clear emphasis on quality, and only 10 percent felt their company’s existing quality statements were truthful and viable.

Then as now, the need to establish a clear quality culture, to manage and nurture that culture, and to empower the participants is critical to earning the trust of the employee participants and thereby retaining workers who in time can become the invaluable craftspeople of today.

Finally, there is the reduction of waste. Waste can be defined in many ways: waste of time, waste of money, waste of resources. The unifying factor in all definitions is the loss of something valuable, and irretrievable. All inevitably also lead to the increase of another kind of waste: pollution and discarded detritus which steadily ruin our shared planet.

Reducing waste with quality management can take many forms, but ultimately, all center on the realization of strategies which use only what is truly needed. This can mean both operational efficiencies and employee quality, as noted above. The Harvard Business Review survey identified that in 2014, the average large company (having 26,000 employees or more) loses a staggering $350 million each year due to preventable employee errors, many of which could be reduced, mitigated, or eliminated entirely with better implementation of quality management.

This is waste on an almost unimaginable financial scale. Waste eliminated through practices which emphasize efficiency and sustainability, as noted in the McKinsey & Company study, can also yield tremendous savings. In one example, a company which purchased asphalt and previously prioritized only the per-ton price found that, when examining the logistical costs of transporting the asphalt from distant suppliers, they were actually paying more than if they purchased it locally. The quality management analysis they performed yielded them a cost savings, and eliminated 40 percent of the carbon emissions associated with the asphalt’s procurement. In this case, not only was wasteful spending eliminated, but literal waste (pollution) was prevented.

In taking these steps, companies can meaningfully improve their bottom lines, while at the same time doing something worthwhile and beneficial for the planet. That, in turn, helps burnish their reputations. A remarkable plurality of consumers, 88 percent of Americans surveyed in a 2017 study to be exact, said they would be more loyal to a company that supports social or environmental issues.

It is therefore clear that any steps a company can take which save money, improve worker satisfaction, and yield increased positivity in the marketplace are well worth pursuing.

What is the Future of QMS?

Until the 2000s, quality management systems were just that: systems of desirable practices, outlined by individuals and implemented individually. That was the age of the gurus: the visionaries who outlined the systems. But what that age lacked was a practical and easy means for companies, sometimes located far away from direct guidance by the gurus, to implement their teachings.

In the intervening years, technology has radically changed that dynamic. Today, QMS software fills the marketplace, allowing businesses small and large to design and guide their quality management plans. But even these software solutions have not yet solved the last great challenge: personalized assistance in putting standards into practice.

That is why the latest innovations, particularly in artificial intelligence, have the potential to upend the equation. Already, major companies have started to use artificial intelligence in connection with QMS datasets managed by software, utilizing the programs for statistical analysis, suggested improvements, and even prediction of potential faults before they occur.

These are immensely valuable opportunities, hence why huge players such as Honeywell are spending billions of dollars to bring innovative AI technology companies into their platforms to refine existing QMS systems.

But while AI has already begun to significantly affect the biggest players, small and mid-sized companies remain eager, but not yet able, to take full advantage. It is thus the next great revolution for a new evolution of QMS, one which will bring these emerging technologies to all companies, regardless of size or scale. The future of QMS, and therefore the future of efficiency in business, rests upon this shift from companies being the recipients of ‘guru knowledge,’ to themselves being the designers of their own quality-minded futures.

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Onega Ulanova is the CEO of QMS2GO, a provider of quality management systems leveraging AI in manufacturing.

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Autonomous truck company rolls out driverless Houston-Dallas route

up and running

Houston is helping drive the evolution of self-driving freight trucks.

In October, Aurora opened a more than 90,000-square-foot terminal at a Fallbrook Drive logistics hub in northwest Houston to support the launch of its first “lane” for driverless trucks—a Houston-to-Dallas route on the Interstate 45 corridor. Aurora opened its Dallas-area terminal in April and the company began regular driverless customer deliveries between the two Texas cities on April 27.

Close to half of all truck freight in Texas moves along I-45 between Houston and Dallas.

“Now, we are the first company to successfully and safely operate a commercial driverless trucking service on public roads. Riding in the back seat for our inaugural trip was an honor of a lifetime – the Aurora Driver performed perfectly and it’s a moment I’ll never forget,” Chris Urmson, CEO and co-founder of Pittsburgh-based Aurora, said in a news release.

Aurora produces software that controls autonomous vehicles and is known for its flagship product, the Aurora Driver. The software is installed in Volvo and Paccar trucks, the latter of which includes brands like Kenworth and Peterbilt.

Aurora previously hauled more than 75 loads per week under the supervision of vehicle operators from Houston to Dallas and Fort Worth to El Paso for customers in its pilot project, including FedEx, Uber Freight and Werner. To date, it has completed over 1,200 miles without a driver.

The company launched its new Houston to Dallas route with customers Uber Freight and Hirschbach Motor Lines, which ran supervised commercial pilots with Aurora.

“Transforming an old school industry like trucking is never easy, but we can’t ignore the safety and efficiency benefits this technology can deliver. Autonomous trucks aren’t just going to help grow our business – they’re also going to give our drivers better lives by handling the lengthier and less desirable routes,” Richard Stocking, CEO of Hirschbach Motor Lines, added in the statement.

The company plans to expand its service to El Paso and Phoenix by the end of 2025.

“These new, autonomous semis on the I-45 corridor will efficiently move products, create jobs, and help make our roadways safer,” Gov. Greg Abbott added in the release. “Texas offers businesses the freedom to succeed, and the Aurora Driver will further spur economic growth and job creation in Texas. Together through innovation, we will build a stronger, more prosperous Texas for generations.”

In July, Aurora said it raised $820 million in capital to fuel its growth—growth that’s being accompanied by scrutiny.

In light of recent controversies surrounding self-driving vehicles, the International Brotherhood of Teamsters, whose union members include over-the-road truckers, recently sent a letter to Lt. Gov. Dan Patrick calling for a ban on autonomous vehicles in Texas.

“The Teamsters believe that a human operator is needed in every vehicle—and that goes beyond partisan politics,” the letter states. “State legislators have a solemn duty in this matter to keep dangerous autonomous vehicles off our streets and keep Texans safe. Autonomous vehicles are not ready for prime time, and we urge you to act before someone in our community gets killed.”

Houston cell therapy company launches second-phase clinical trial

fighting cancer

A Houston cell therapy company has dosed its first patient in a Phase 2 clinical trial. March Biosciences is testing the efficacy of MB-105, a CD5-targeted CAR-T cell therapy for patients with relapsed or refractory CD5-positive T-cell lymphoma.

Last year, InnovationMap reported that March Biosciences had closed its series A with a $28.4 million raise. Now, the company, co-founded by Sarah Hein, Max Mamonkin and Malcolm Brenner, is ready to enroll a total of 46 patients in its study of people with difficult-to-treat cancer.

The trial will be conducted at cancer centers around the United States, but the first dose took place locally, at The University of Texas MD Anderson Cancer Center. Dr. Swaminathan P. Iyer, a professor in the department of lymphoma/myeloma at MD Anderson, is leading the trial.

“This represents a significant milestone in advancing MB-105 as a potential treatment option for patients with T-cell lymphoma who currently face extremely limited therapeutic choices,” Hein, who serves as CEO, says. “CAR-T therapies have revolutionized the treatment of B-cell lymphomas and leukemias but have not successfully addressed the rarer T-cell lymphomas and leukemias. We are optimistic that this larger trial will further validate MB-105's potential to address the critical unmet needs of these patients and look forward to reporting our first clinical readouts.”

The Phase 1 trial showed promise for MB-105 in terms of both safety and efficacy. That means that potentially concerning side effects, including neurological events and cytokine release above grade 3, were not observed. Those results were published last year, noting lasting remissions.

In January 2025, MB-105 won an orphan drug designation from the FDA. That results in seven years of market exclusivity if the drug is approved, as well as development incentives along the way.

The trial is enrolling its single-arm, two-stage study on ClinicalTrials.gov. For patients with stubborn blood cancers, the drug is providing new hope.

Elon Musk's SpaceX site officially becomes the city of Starbase, Texas

Starbase, Texas

The South Texas home of Elon Musk’s SpaceX rocket company is now an official city with a galactic name: Starbase.

A vote Saturday, May 3, to formally organize Starbase as a city was approved by a lopsided margin among the small group of voters who live there and are mostly Musk’s employees at SpaceX. With all the votes in, the tally was 212 in favor to 6 against, according to results published online by the Cameron County Elections Department.

Musk celebrated in a post on his social platform, X, saying it is “now a real city!”

Starbase is the facility and launch site for the SpaceX rocket program that is under contract with the Department of Defense and NASA that hopes to send astronauts back to the moon and someday to Mars.

Musk first floated the idea of Starbase in 2021 and approval of the new city was all but certain. Of the 283 eligible voters in the area, most are believed to be Starbase workers.

The election victory was personal for Musk. The billionaire’s popularity has diminished since he became the chain-saw-wielding public face of President Donald Trump’s federal job and spending cuts, and profits at his Tesla car company have plummeted.

SpaceX has generally drawn widespread support from local officials for its jobs and investment in the area.

But the creation of an official company town has also drawn critics who worry it will expand Musk’s personal control over the area, with potential authority to close a popular beach and state park for launches.

Companion efforts to the city vote include bills in the state Legislature to shift that authority from the county to the new town’s mayor and city council.

All these measures come as SpaceX is asking federal authorities for permission to increase the number of South Texas launches from five to 25 a year.

The city at the southern tip of Texas near the Mexico border is only about 1.5 square miles (3.9 square kilometers), crisscrossed by a few roads and dappled with airstream trailers and modest midcentury homes.

SpaceX officials have said little about exactly why they want a company town and did not respond to emailed requests for comment.

“We need the ability to grow Starbase as a community,” Starbase General Manager Kathryn Lueders wrote to local officials in 2024 with the request to get the city issue on the ballot.

The letter said the company already manages roads and utilities, as well as “the provisions of schooling and medical care” for those living on the property.

SpaceX officials have told lawmakers that granting the city authority to close the beach would streamline launch operations. SpaceX rocket launches and engine tests, and even just moving certain equipment around the launch base, requires the closure of a local highway and access to Boca Chica State Park and Boca Chica Beach.

Critics say beach closure authority should stay with the county government, which represents a broader population that uses the beach and park. Cameron County Judge Eddie Trevino, Jr. has said the county has worked well with SpaceX and there is no need for change.

Another proposed bill would make it a Class B misdemeanor with up to 180 days in jail if someone doesn’t comply with an order to evacuate the beach.

The South Texas Environmental Justice Network, which has organized protests against the city vote and the beach access issue, held another demonstration Saturday that attracted dozens of people.

Josette Hinojosa, whose young daughter was building a sandcastle nearby, said she was taking part to try to ensure continued access to a beach her family has enjoyed for generations.

With SpaceX, Hinojosa said, “Some days it’s closed, and some days you get turned away."

Organizer Christopher Basaldú, a member of the Carrizo/Comecrudo Nation of Texas tribe, said his ancestors have long been in the area, where the Rio Grande meets the Gulf.

“It’s not just important,” he said, “it’s sacred.”