Fabrizio Maniglio, Director of Industry and Business Development, Sparta Systems, a Honeywell company07.20.23
Quality and compliance can often be conflated, but they have distinct meanings. Quality refers to a way of measuring customer satisfaction, while compliance refers to a method of measuring regulatory satisfaction. In other words, quality aims to satisfy customers and patients with what we manufacture and do, while compliance ensures that regulators are happy with our work. Understanding these terms is crucial for maintaining high standards in our industry.
Considering these definitions, is it possible to ascertain a product's compliance level or quality merely through observation?
Contemplate a fluffy white pillow or a robust orange brick: which exhibits superior compliance or higher quality? It's not a straightforward answer; neither is an inherent property of the product or service. Instead, it depends on customer satisfaction. This perspective challenges the traditional notions of quality and compliance and brings to light the importance of understanding and meeting the consumer’s needs and expectations.
How can we then measure satisfaction, if it's so important?
Yet, expectations shift. They alter based on what customers or clients have become accustomed to. Expectations transform in response to competitors' actions. The shift in expectations typically hinges on previous experiences.
For example, mobile phones were initially expected to enable voice calls on the go. As text messaging emerged, expectations shifted to include efficient texting capabilities. The advent of smartphones further expanded expectations, encompassing internet access, multimedia features, and apps. Today, customers compare different models to assess quality based on performance, usability, and overall smartphone experience. The evolution of mobile phones and changing expectations have transformed the satisfaction equation.
Furthermore, quality doesn't exist independently. When discussing a singular entity, its existence is only meaningful compared to others, so it’s correlated to created expectations. Therefore, if there's an assortment of products available, or if I have a myriad of diverse products being produced continuously and I can begin comparing them, this comparison allows me to discern whether the quality is superior or inferior.
The advent of Industry 2.0 was characterized by the introduction of electricity, which ushered in a shift toward process-oriented thinking and task rearrangement. Furthermore, this era also witnessed machinery mass production, amplifying productivity. As a result, quality started being perceived as a crucial business aspect, primarily because as processes became intricate, scrutinizing and controlling every element was no longer feasible.
This revolution faced challenges, notably the productivity paradox. Despite the introduction of electricity and technological advancements, initial productivity gains fell short of expectations. This highlighted the need for a thoughtful approach to adapting processes with the new technology. It was not merely about adding electricity to existing systems, but rather reimagining and restructuring workflows to fully harness the power of this innovation. Recognizing that power sources were not confined to steam lines and motor sizes could be adjusted without efficiency loss unlocked the true potential of electricity. This era emphasized the importance of aligning technology with process redesign, which is critical for driving productivity and quality control improvements. This valuable lesson paved the way for subsequent industrial evolutions' technological transitions.
Transitioning into Industry 3.0, the scene was dominated by computers and logic controllers, fostering greater automation and speedy throughput. Quality was elevated to a higher level of importance, as accelerating processes necessitated continuous improvements. The spotlight was on meeting customer requirements, and ISO 9001 appeared, emphasizing customer expectations.
We are in Industry 4.0, an era of advanced tools and technology like AI (artificial intelligence) and IoT (Internet of Things). As a result, the focus on quality has shifted toward process design and "quality by design."
This is driven by the complexity of modern industrial systems and the need for a holistic approach to ensure quality throughout the product lifecycle. Data-driven insights enable proactive quality management while designing processes with quality in mind, optimizing workflows, and reducing variability.
Once again, technology supplants humans, liberating them to concentrate on tasks of greater significance.
A recurring theme throughout this historical narrative is the human constraint in process efficiency and how introducing innovative tools and technologies has perpetually fueled advancement and progress.
Altering the process and using a swirling technique creates a vortex, and the time required could be halved to eight seconds. Introducing a cutting-edge tool—a simple straw, in this case—can further slash the time to approximately four seconds. This experiment illustrates how process optimization can increase efficiency, but only introducing innovative tools can radically transform a controlling paradigm, enabling us to leap-frog to the next stage of evolution.
While we’re still on the topic of tools, it is essential to recognize their dual role in overcoming human limitations and instilling operational efficiency. However, the utility of these tools hinges on the level of trust we place in them. For instance, consider a laser distance-measuring device. It can swiftly measure the dimensions of a room. Still, if there's any doubt about its precision or reliability, there might be an inclination to resort to a tape measure for verification.
Unfortunately, such double-checking slows down processes and undermines the intended potential of innovative tools.
A noteworthy reflection on the importance of trust in systems comes from David Allen's seminal work "Getting Things Done": "If you don't trust your systems, you can't let go of operational details, and you limit your ability to create at a higher level." This underscores the crucial role of tools in promoting productivity and delivering the quality our end-users deserve, provided we place unwavering trust in them. Ultimately, this trust enables us to fully exploit the potential of these tools, rather than dwelling on skepticism and hampering our productivity.
In this ever-changing landscape, numerous trends seem to accelerate change. If you're unfamiliar with VUCA, let me define it. VUCA—an acronym for Volatile, Uncertain, Complex, and Ambiguous—has been around for a while. However, I've added a 'D' for Digital, transforming VUCA to VUCAD, representing our current world. We exist in a reality rife with recurring disruptions, making it almost impossible to predict and plan for the future perfectly.
To offer a bit of perspective, a recent study by McKinsey surveyed around 75 CEOs about the challenges anticipated for 2023. The top three concerns they highlighted included the rise of disruptive digital technologies, the risk of prolonged inflation and economic downturn, and the escalation of geopolitical risks. We may need to prepare for these three potential disruptions in the years ahead, emphasizing the imperative need for adaptability in an increasingly VUCAD world.
Part 2 of this series will look deeper into this evolution of quality. Join me as we consider how to navigate the future’s uncertainties with holistic risk management and learn how to undergo an effective digital transformation journey.
Fabrizio Maniglio is an industry thought leader and the director of Industry and Business Development for Sparta Systems. He leverages vast subject matter expertise to drive innovation for the industry and within Sparta Systems, where he continuously monitors the evolution of the ever-changing healthcare and life-sciences sectors. He fosters contacts with other industry thought leaders and regulators to collaborate and influence the future of our industry.
Considering these definitions, is it possible to ascertain a product's compliance level or quality merely through observation?
Contemplate a fluffy white pillow or a robust orange brick: which exhibits superior compliance or higher quality? It's not a straightforward answer; neither is an inherent property of the product or service. Instead, it depends on customer satisfaction. This perspective challenges the traditional notions of quality and compliance and brings to light the importance of understanding and meeting the consumer’s needs and expectations.
How can we then measure satisfaction, if it's so important?
The Satisfaction Equation
Satisfaction is the perception of the product or service delivered, divided by the expectation for that type or category of product or service. When you talk about a specific product, perception is often fixed based on the intended use and the appearance and properties of the product at hand. During discussions about a particular product, perception is frequently anchored on the product's intended use, aesthetic, and attributes. Naturally, a product's perception may evolve as we progressively refine and enhance it to match more closely with customer anticipations. Nevertheless, the perception is unchanging for a product at its point of use. The product is as it exists—the intended use is what it is.Yet, expectations shift. They alter based on what customers or clients have become accustomed to. Expectations transform in response to competitors' actions. The shift in expectations typically hinges on previous experiences.
For example, mobile phones were initially expected to enable voice calls on the go. As text messaging emerged, expectations shifted to include efficient texting capabilities. The advent of smartphones further expanded expectations, encompassing internet access, multimedia features, and apps. Today, customers compare different models to assess quality based on performance, usability, and overall smartphone experience. The evolution of mobile phones and changing expectations have transformed the satisfaction equation.
Furthermore, quality doesn't exist independently. When discussing a singular entity, its existence is only meaningful compared to others, so it’s correlated to created expectations. Therefore, if there's an assortment of products available, or if I have a myriad of diverse products being produced continuously and I can begin comparing them, this comparison allows me to discern whether the quality is superior or inferior.
Quality and Industry Evolution
Embarking on a journey into the past, let's explore a brief history of the industrial evolution and its significant implications for quality. The narrative begins with human beings crafting items manually. Soon, however, they realized their limitations were impeding the manufacturing process. The emergence of Industry 1.0 marked a significant breakthrough, with tools and technology like steam and water acting as catalysts to ramp up productivity, enabling humans to shift their attention to other pursuits. At this juncture, quality was predominantly gauged through inspection and measurements.The advent of Industry 2.0 was characterized by the introduction of electricity, which ushered in a shift toward process-oriented thinking and task rearrangement. Furthermore, this era also witnessed machinery mass production, amplifying productivity. As a result, quality started being perceived as a crucial business aspect, primarily because as processes became intricate, scrutinizing and controlling every element was no longer feasible.
This revolution faced challenges, notably the productivity paradox. Despite the introduction of electricity and technological advancements, initial productivity gains fell short of expectations. This highlighted the need for a thoughtful approach to adapting processes with the new technology. It was not merely about adding electricity to existing systems, but rather reimagining and restructuring workflows to fully harness the power of this innovation. Recognizing that power sources were not confined to steam lines and motor sizes could be adjusted without efficiency loss unlocked the true potential of electricity. This era emphasized the importance of aligning technology with process redesign, which is critical for driving productivity and quality control improvements. This valuable lesson paved the way for subsequent industrial evolutions' technological transitions.
Transitioning into Industry 3.0, the scene was dominated by computers and logic controllers, fostering greater automation and speedy throughput. Quality was elevated to a higher level of importance, as accelerating processes necessitated continuous improvements. The spotlight was on meeting customer requirements, and ISO 9001 appeared, emphasizing customer expectations.
We are in Industry 4.0, an era of advanced tools and technology like AI (artificial intelligence) and IoT (Internet of Things). As a result, the focus on quality has shifted toward process design and "quality by design."
This is driven by the complexity of modern industrial systems and the need for a holistic approach to ensure quality throughout the product lifecycle. Data-driven insights enable proactive quality management while designing processes with quality in mind, optimizing workflows, and reducing variability.
Once again, technology supplants humans, liberating them to concentrate on tasks of greater significance.
A recurring theme throughout this historical narrative is the human constraint in process efficiency and how introducing innovative tools and technologies has perpetually fueled advancement and progress.
Process Enhancement Versus Technological Advancements
Consider this scenario: an endeavor to empty a bottle. Two approaches are available—improving the process or employing new technology. The conventional method of upturning the bottle might take about 16 seconds.Altering the process and using a swirling technique creates a vortex, and the time required could be halved to eight seconds. Introducing a cutting-edge tool—a simple straw, in this case—can further slash the time to approximately four seconds. This experiment illustrates how process optimization can increase efficiency, but only introducing innovative tools can radically transform a controlling paradigm, enabling us to leap-frog to the next stage of evolution.
While we’re still on the topic of tools, it is essential to recognize their dual role in overcoming human limitations and instilling operational efficiency. However, the utility of these tools hinges on the level of trust we place in them. For instance, consider a laser distance-measuring device. It can swiftly measure the dimensions of a room. Still, if there's any doubt about its precision or reliability, there might be an inclination to resort to a tape measure for verification.
Unfortunately, such double-checking slows down processes and undermines the intended potential of innovative tools.
A noteworthy reflection on the importance of trust in systems comes from David Allen's seminal work "Getting Things Done": "If you don't trust your systems, you can't let go of operational details, and you limit your ability to create at a higher level." This underscores the crucial role of tools in promoting productivity and delivering the quality our end-users deserve, provided we place unwavering trust in them. Ultimately, this trust enables us to fully exploit the potential of these tools, rather than dwelling on skepticism and hampering our productivity.
Survival of the Fittest
Let's revisit the concept of survival of the fittest from a Darwinian perspective. It posits that survival does not necessarily favor the strongest or the most intelligent species but rather those most responsive to change. Keeping this principle in mind, one might have a choice: to embody the indomitable T-Rex or the adaptable possum. With hindsight, the choice seems obvious—choose the possum. However, in real-time decision-making, it's challenging to make such predictions. Indeed, the question of what change looks like and what changes are on the horizon is difficult to answer, given our world's rapid and continuous evolution.In this ever-changing landscape, numerous trends seem to accelerate change. If you're unfamiliar with VUCA, let me define it. VUCA—an acronym for Volatile, Uncertain, Complex, and Ambiguous—has been around for a while. However, I've added a 'D' for Digital, transforming VUCA to VUCAD, representing our current world. We exist in a reality rife with recurring disruptions, making it almost impossible to predict and plan for the future perfectly.
To offer a bit of perspective, a recent study by McKinsey surveyed around 75 CEOs about the challenges anticipated for 2023. The top three concerns they highlighted included the rise of disruptive digital technologies, the risk of prolonged inflation and economic downturn, and the escalation of geopolitical risks. We may need to prepare for these three potential disruptions in the years ahead, emphasizing the imperative need for adaptability in an increasingly VUCAD world.
Part 2 of this series will look deeper into this evolution of quality. Join me as we consider how to navigate the future’s uncertainties with holistic risk management and learn how to undergo an effective digital transformation journey.
Fabrizio Maniglio is an industry thought leader and the director of Industry and Business Development for Sparta Systems. He leverages vast subject matter expertise to drive innovation for the industry and within Sparta Systems, where he continuously monitors the evolution of the ever-changing healthcare and life-sciences sectors. He fosters contacts with other industry thought leaders and regulators to collaborate and influence the future of our industry.