Quality. Few words mean as many different things to as many different people. But no matter how it is articulated, there is general consensus that quality is good, it is important, and it has the power to change lives for the better. On World Quality Day, Nov. 14, MasterControl’s GxP Lifeline recognizes the significant contributions made by quality professionals worldwide who devote their energy and expertise to this subjectively defined, universally prized, and uniquely human concept.
Ask the average person to define quality and each response is sure to differ from the next. Ask a quality professional what quality means to him or her, like we did in this video from the 2019 Masters Summit user conference, and the same will be true – though with several common themes, among them: ensuring safety, adhering to standards, meeting customer needs and expectations, achieving continuous improvement, and enhancing quality of life.
When asked what quality means to him, Jon Beckstrand, CEO of MasterControl, a provider of cloud-based quality and compliance software for life sciences and other regulated industries, described it quite succinctly.
“Quality means we can trust the products we use – we can use them knowing they will work and not cause harm,” Beckstrand said. “The fact that millions of patients are treated with the help of any number of different medical products every single day is a testament to quality. And that’s truly an amazing thing.”
How we define, practice and talk about quality have changed a lot in the course of its relatively short history. And as we navigate the current technology revolution, it can be difficult to imagine what quality might look like in the future. As is so often the case, making sense of where we are and looking ahead to where we’re going requires some reflection on where we’ve come from.
In the spirit of this year’s World Quality Day theme – “100 Years of Quality” – let’s take a short tour of the history of quality. As you revisit some of quality’s key figures and moments, we encourage you to consider what quality means to you. The following might provide you some context and inspiration. And if nothing else, it will help to remind you of just how far the quality discipline has come.
Like any good story, we’ll start at the beginning.
Pre-1900s: Medieval Guilds and the Industrial Revolution
The origins of quality management date back to medieval Europe. Around the late 13th century, craftsmen started organizing into specialized trade unions known as guilds(1). These groups developed formal product and service quality requirements, and products of particularly high quality as determined by inspection committees were marked with a special symbol. Individual master craftsmen would also mark their goods with a unique symbol which served as a proof of quality, but could also be used to track products to their source if health and safety issues occurred.
Enjoying this article? You may also like this video:
"Quality Changes Everything"Watch Video Now
This craftsmanship approach to quality continued until the Industrial Revolution of the late 18th century, when modern manufacturing was born. In the absence of governing bodies to oversee and enforce quality standards and practices, some (but far from all) factories employed a single person who inspected each product as it came off the line and removed those that were defective. The standards of acceptable quality were subjective to each inspector, meaning they varied considerably and were not formalized in any way.
Over the next century, industry boomed and companies grew, leading to a more acute need for formal quality inspection and control. The single inspector became a group of inspectors, and eventually an entire department dedicated to product quality inspection. As a result, consistent and formalized quality inspection training, standards, systems and processes became necessary. And so was born the quality control function, which was responsible for all aspects of a company’s overall product quality.
Early 1900s: The Age of Inspection
Around the turn of the 20th century, U.S. manufacturers diverged from the factory inspection model and implemented a new, slightly more proactive approach to quality developed by Frederick Taylor. Simply put, Taylor’s method aimed to increase productivity with fewer workers. But while productivity improved significantly, it came at the cost of quality.
In the 1920s, statistician Walter Shewhart was the first to take a highly methodical, quantitative approach to quality. His tools, charts and inspection activities systematized quality control and made it more reliable. Shewhart’s method for statistical quality control (SQC) laid the foundation for control charts, a quality tool still used today.
No history of quality would be complete without mention of Toyota and the Just in Time system introduced by Taiichi Ohno in 1938. The system, also still in use today, introduced and developed the concepts of eliminating waste, Takt time, standardized work charts and inventory reduction.
Image Source: Chartered Quality Institute (CQI)(2). Click here to download
a full-size version of the World Quality Day 2019 poster and other materials.
Mid 1900s: Focus on Customer Satisfaction
World War II was instrumental in the evolution of quality management. Safe and effective military equipment was critical to the U.S. war effort, and legislation was enacted to ensure its reliable production. Due to the high demands of unit inspection on personnel, the armed forces implemented sampling inspection and leveraged Shewhart’s SQC techniques, at the recommendation of W. Edwards Deming.
Following the war, Japan experienced a quality revolution as a means of reviving its economy and manufacturing trade. Japanese businesses embraced the teachings of Deming and Joseph Juran, two American quality visionaries who helped conceive the total quality approach. The two are widely regarded as the fathers of modern quality management, which focused on improving organizational processes by way of the people who performed them. The method worked, and Japan began exporting higher-quality products at lower prices much to the delight of customers. In response to Japan’s success, the U.S. eventually adopted, adapted and formalized the process into what we know it as today, Total Quality Management (TQM).
Late 1900s: ISO 9000, Lean Manufacturing and Digital Quality
Quality management came into its own in the last half of the 20th century, with a flurry of prominent activity and developments occurring in each decade that would forever change the practice of quality management.
In the early 1960s, the U.S. Food and Drug Administration (FDA) began placing a higher burden of proof on drug manufacturers regarding the safety and efficacy of their products, thanks largely to Frances O. Kelsey(3). Her pioneering work and ultimate rejection of the new drug application (NDA) for thalidomide was responsible for averting a medical crisis in the U.S. and instrumental in passing the Kefauver-Harris Drug Amendments.
By the 1970s, worldwide consumer markets and manufacturing processes alike had reached a level of maturity that not only facilitated, but necessitated higher product quality. Fierce global competition for consumer dollars ensued, initially putting the U.S. at a distinct disadvantage to countries like Japan that had been prioritizing and optimizing quality for decades, but ultimately laying the groundwork for some of the most influential quality movements.
The Toyota Production System, with its focus on minimizing inventory and waste, is considered one of the earliest quality management systems. Familiar lean concepts such as Kanban, 5S, visual management and standardized work became prominent in the 1970s. Published in 1987, the quintessential ISO 9000 series of quality management standards formalized and universalized quality management practices for the first time. Lean manufacturing took hold in early the early 1990s, and has gained momentum ever since.
Throughout the 1990s, technology also began to fundamentally change quality, forcing both companies and regulatory bodies to adapt and react, a shift that Beckstrand remembers well.
“Before 21 CFR Part 11 was passed in 1997, all quality records had to be paper,” Beckstrand explained. “From that point on, as quality data moved to digital, quality processes have grown significantly more efficient. This has paved the way for quality to become a strategic objective.”
While many of the above-mentioned quality principles and practices still hold true, quality is currently experiencing a period of transformational change enabled by groundbreaking new technology and solutions, many of which have yet to demonstrate their full potential.
Advanced technologies like smart manufacturing, cloud computing, big data, natural language processing, Internet of Things (IoT), artificial intelligence (AI) and machine learning (ML), and predictive analytics, collectively known as Industry 4.0, are rewriting the script of quality management, not only when it comes to improving product safety, but also when it comes to speeding the pace of innovation and reducing costs.
Companies are still maturing into this new tech. But as far as MasterControl’s Beckstrand is concerned, the future – one where companies can overcome longstanding obstacles and be connected by quality rather than divided by it – is already here.
“Proper documentation and record keeping is the bedrock of quality and GxP compliance,” Beckstrand said. “But as we move from paper documents and forms to digital records, we can enable the entire organization to use this critical quality information in their processes and decision-making. And by leveraging this data throughout the product life cycle, we can – for the first time in history – fully realize the gains that underpin the philosophy of quality as a core business principle.”
Indeed, digital transformation across the enterprise is helping quality move beyond document-centricity to data-centricity, where expertise can be applied to improving the quality of products instead of the quality of documents. As this happens, quality becomes a competitive differentiator.
It’s not possible to predict just how the future of quality will unfold. But surely, it will look more and more like the very personal, and very human story shared by Oscar-nominated documentarian Irene Taylor Brodsky in her keynote at the recent Masters Summit. Taylor Brodsky’s mother, father and son are deaf, but each of their lives have been transformed thanks to the technology of cochlear implants, as chronicled in her latest film Moonlight Sonata: Deafness in Three Movements.
By giving them the “superpower” of getting to know their own voice, and allowing them to choose when they want to tune in to their audible surroundings or lean in to silence, these medical devices have not only changed their lives, but in many ways, they’ve saved them.
Directly addressing the audience, which was largely made up of quality, compliance and manufacturing professionals, Taylor Brodsky gratefully acknowledged the enormous effort it takes to create safe and effective medical products – including testing, documentation, training and ultimately, getting them to market.
“You know what it takes to develop the basic science behind a product and to bring it to market,” Taylor Brodsky spoke to the audience. “Everything you do in that whole prequel part of the story […] is staggering to me in its complexity. And make no mistake, it is staggering in its human impact.”
Today, more efficiently and impactfully than ever, quality and the professionals who practice it enable countless innovations that safely and effectively improve lives and often save them. And while it may seem like a thankless job at times, the importance of this work is not lost on anyone who experiences the human impact it has. And really, that means all of us.
That quality means something different to everyone is maybe not that surprising after all, and it’s certainly not a bad thing. Quality wasn’t invented or conceived of by just one person, nor can it be achieved by one person acting alone.
It simply means that, like the quality pioneers of the past, today’s quality professionals can use their differing views of quality to approach it from different angles and in so doing, collectively discover new solutions, methods and frameworks to help shape the next 100 years of quality. As the adage goes, it takes a village to raise a child – and the same applies to delivering quality. In more ways than one, quality is a uniquely human concept that unites more than it divides.
In conclusion, we hope that this article has given you some food for thought – or maybe inspired you to start a dialogue in your organization – on the meaning of quality, how far the discipline has come over the past century, and where it just might go in the next.
To quality professionals everywhere: we applaud you. And we look forward to our continued partnership in bringing life-changing innovations to more people sooner.
(1) The History of Quality. American Society for Quality (ASQ). https://asq.org/quality-resources/history-of-quality.
(2) World Quality Day 2019 Toolkit. Chartered Quality Institute (CQI). https://www.quality.org/article/world-quality-day-2019-toolkit.
(3) How Frances O. Kelsey Blazed a Trail for Women in Regulatory Compliance. GxP Lifeline. https://www.mastercontrol.com/gxp-lifeline/how-frances-o-kelsey-blazed-a-trail-for-women-in-regulatory-compliance/.