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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Houston edtech company closes oversubscribed $3M seed round

fresh funding

Houston-based edtech company TrueLeap Inc. closed an oversubscribed seed round last month.

The $3.3 million round was led by Joe Swinbank Family Limited Partnership, a venture capital firm based in Houston. Gamper Ventures, another Houston firm, also participated with additional strategic partners.

TrueLeap reports that the funding will support the large-scale rollout of its "edge AI, integrated learning systems and last-mile broadband across underserved communities."

“The last mile is where most digital transformation efforts break down,” Sandip Bordoloi, CEO and president of TrueLeap, said in a news release. “TrueLeap was built to operate where bandwidth is limited, power is unreliable, and institutions need real systems—not pilots. This round allows us to scale infrastructure that actually works on the ground.”

True Leap works to address the digital divide in education through its AI-powered education, workforce systems and digital services that are designed for underserved and low-connectivity communities.

The company has created infrastructure in Africa, India and rural America. Just this week, it announced an agreement with the City of Kinshasa in the Democratic Republic of Congo to deploy a digital twin platform for its public education system that will allow provincial leaders to manage enrollment, staffing, infrastructure and performance with live data.

“What sets TrueLeap apart is their infrastructure mindset,” Joe Swinbank, General Partner at Joe Swinbank Family Limited Partnership, added in the news release. “They are building the physical and digital rails that allow entire ecosystems to function. The convergence of edge compute, connectivity, and services makes this a compelling global infrastructure opportunity.”

TrueLeap was founded by Bordoloi and Sunny Zhang and developed out of Born Global Ventures, a Houston venture studio focused on advancing immigrant-founded technology. It closed an oversubscribed pre-seed in 2024.

Texas space co. takes giant step toward lunar excavator deployment

Out of this world

Lunar exploration and development are currently hampered by the fact that the moon is largely devoid of necessary infrastructure, like spaceports. Such amenities need to be constructed remotely by autonomous vehicles, and making effective devices that can survive the harsh lunar surface long enough to complete construction projects is daunting.

Enter San Antonio-based Astroport Space Technologies. Founded in San Antonio in 2020, the company has become a major part of building plans beyond Earth, via its prototype excavator, and in early February, it completed an important field test of its new lunar excavator.

The new excavator is designed to function with California-based Astrolab's Flexible Logistics and Exploration (FLEX) rover, a highly modular vehicle that will perform a variety of functions on the surface of the moon.

In a recent demo, the Astroport prototype excavator successfully integrated with FLEX and proceeded to dig in a simulated lunar surface. The excavator collected an average of 207 lbs (94kg) of regolith (lunar surface dust) in just 3.5 minutes. It will need that speed to move the estimated 3,723 tons (3,378 tonnes) of regolith needed for a lunar spaceport.

After the successful test, both Astroport and Astrolab expressed confidence that the excavator was ready for deployment. "Leading with this successful excavator demo proves that our technology is no longer theoretical—it is operational," said Sam Ximenes, CEO of Astroport.

"This is the first of many implements in development that will turn Astrolab's FLEX rover into the 'Swiss Army Knife' of lunar construction. To meet the infrastructure needs of the emerging lunar economy, we must build the 'Port' before the 'Ship' arrives. By leveraging the FLEX platform, we are providing the Space Force, NASA, and commercial partners with a 'Shovel-Ready' construction capability to secure the lunar high ground."

"We are excited to provide the mobility backbone for Astroport's groundbreaking construction technology," said Jaret Matthews, CEO of Astrolab, in a release. "Astrolab is dedicated to establishing a viable lunar ecosystem. By combining our FLEX rover's versatility with Astroport's civil engineering expertise, we are delivering the essential capabilities required for a sustainable lunar economy."

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This article originally appeared on CultureMap.com.

Houston biotech co. raises $11M to advance ALS drug development

drug money

Houston-based clinical-stage biotechnology company Coya Therapeutics (NASDAQ: COYA) has raised $11.1 million in a private investment round.

India-based pharmaceuticals company Dr. Reddy’s Laboratories Inc. led the round with a $10 million investment, according to a news release. New York-based investment firm Greenlight Capital, Coya’s largest institutional shareholder, contributed $1.1 million.

The funding was raised through a definitive securities purchase agreement for the purchase and sale of more than 2.5 million shares of Coya's common stock in a private placement at $4.40 per share.

Coya reports that it plans to use the proceeds to scale up manufacturing of low-dose interleukin-2 (IL-2), which is a component of its COYA 302 and will support the commercial readiness of the drug. COYA 302 enhances anti-inflammatory T cell function and suppresses harmful immune activity for treatment of Amyotrophic Lateral Sclerosis (ALS), Frontotemporal Dementia (FTD), Parkinson’s disease and Alzheimer’s disease.

The company received FDA acceptance for its investigational new drug application for COYA 302 for treating ALS and FTD this summer. Its ALSTARS Phase 2 clinical trial for ALS treatment launched this fall in the U.S. and Canada and has begun enrolling and dosing patients. Coya CEO Arun Swaminathan said in a letter to investors that the company also plans to advance its clinical programs for the drug for FTD therapy in 2026.

Coya was founded in 2021. The company merged with Nicoya Health Inc. in 2020 and raised $10 million in its series A the same year. It closed its IPO in January 2023 for more than $15 million. Its therapeutics uses innovative work from Houston Methodist's Dr. Stanley H. Appel.