All Features
Prerna Sudera
Ensuring that automotive components meet the highest quality standards is critical to vehicle safety and performance. Metals and protective coatings used in automotive manufacturing must withstand extreme conditions such as mechanical stresses, corrosion, and wear during a vehicle’s lifespan. Here…
CIH Equipment
Industrial hygiene equipment plays a critical role in ensuring workplace safety by monitoring airborne contaminants, noise levels, and other hazardous conditions. However, accurate readings depend on regular industrial hygiene equipment calibration to maintain precision and compliance with…
John O'Kelly
Warehouses are the backbone of supply chains, ensuring that goods move efficiently from suppliers to consumers. However, the physical demands of warehouse work—heavy lifting, repetitive motions, and prolonged standing—can take a toll on employees, leading to fatigue, injuries, and long-term strain…
Bryan Christiansen
Failure analysis helps uncover the root cause of equipment issues so you can fix problems and prevent them from happening again. This guide outlines a clear, six-step process to conduct effective failure analysis and write a report that adds long-term value.
Failure analysis techniques vary widely…
Kelley Jacobsen
As global trade uncertainty intensifies, health systems should take steps to minimize the effect of this volatility on their medical equipment inventory. The evolving policies of the United States and its trading partners could strain global supply chains and make acquiring or maintaining medical…
Etienne Nichols
What’s your favorite regulatory pitfall? I know that’s a strange question, but if you’ve spent much time in the medical device industry, there are likely a few that come to mind. People reach out to me all the time asking how to break into the medical device industry—and I love those conversations…
ISO
How do health and safety incidents affect your business? If a worker is injured or becomes ill, what kind of disruption does it cause? Is your productivity affected? What’s the effect on other workers in terms of workload or psychological health and well-being?
People are the foundation of every…
Michael Mills
Risk-based thinking—it sounds easy. How hard can it be to think about risk? But did you know that the phrase “risk-based thinking” was only invented in 2015?
Did you know that the ISO says “risk-based thinking” is one of the foundations of quality management, but never defines it? Or that it…
Felipe Monteiro
Global risks are rising, and many companies are struggling to adapt. The World Economic Forum’s 2025 Global Risks Report makes it clear that challenges like escalating global tensions and conflicts, climate change, economic instability, and supply chain disruptions are interconnected and build on…
Jonathan R. Todd
Geopolitical risk is emerging as one of the greatest challenges facing domestic and international business today. It has risen from a boardroom issue to one drawing the awareness and attention of both personnel and the general public. These days everyone knows the word “supply chain” and has some…
Maria DiBari
This current job market is plagued by fake job postings that have been misleading American job seekers, wasting their time and distorting employment data. These deceptive listings—often created to collect résumés, inflate company growth metrics, or manipulate job market statistics—erode trust in…
Etienne Nichols
Have you ever wondered what your medtech company looks like from the point of view of a U.S. Food and Drug Administration investigator? Well, this is your chance to find out.
Greenlight Guru invited Vincent Cafiso, a former FDA investigator, to the Global Medical Device Podcast to share his…
Stephanie Ojeda
Quality risk management (QRM) has become a crucial tool for ensuring regulatory compliance worldwide. It plays a central role in ISO management system standards and regulations, as well as the EU Medical Device Regulation (MDR/IVDR), FDA 21 CFR 820, and ICH Q10 in the pharmaceutical and biotech…
Nick Haase
After spending years working alongside frontline manufacturing teams, I’ve come to see one thing clearly: Preventing incidents isn’t just a legal requirement. It’s the heartbeat of a healthy operation. With workplace safety making headlines daily—often with tragic details—it’s time to highlight how…
Saurabh Joshi Shripad
Established pharmaceutical facilities play a pivotal role in public health by ensuring the safety and efficacy of the medications they produce. This critical responsibility demands strict adherence to the Code of Federal Regulations, including 21 CFR 211.67—“Equipment cleaning and maintenance,”1,2…
Sergey Sukhovey
The collapse of Baltimore’s Francis Scott Key Bridge in March 2024 was the consequence of a long-standing problem: the fragility of aging infrastructure. As reconstruction gets underway on an estimated four-year timeline, the disaster reflects the urgent need for better bridge inspection nationwide…
Megan King
When first responders need to rescue people from an earthquake-ravaged home, they need real-time information. If law enforcement officers are looking for a shooter in a crowded building, they must learn everything they can about the scene.
Emergency responders need to know where people are and…
Eric Linxwiler
Quality management has evolved far beyond traditional checklists and periodic inspections. For complex supply chains, quality is no longer a static endpoint. It’s a dynamic real-time process deeply interwoven with collaboration, transparency, and data-driven decision-making. As supply chains grow…
Saili Sonawane
In a growing business milieu, ISO quality management system compliance ensures that organizations meet global standards for quality, safety, and efficiency. However, maintaining compliance with ISO frameworks such as ISO 9001 (quality management), ISO 45001 (occupational health and safety), and ISO…
John Tschohl
What are the elements of a successful team? In a nutshell—whether it’s an athletic team, a dance team, or a business team—the critical elements are people who are knowledgeable, dedicated, productive, work well with others, and constantly seek to improve their skills.
But hiring and firing are…
Harish Jose
Today I’m looking at the free energy principle (FEP) by the British neuroscientist Karl Friston. The FEP basically states that to resist the natural tendency to disorder, adaptive agents must minimize surprise. This has implications for the gemba, as you’ll see.
A good example to explain this is…
Angie Basiouny
Wharton management professor Peter Cappelli is routinely asked to predict the future of work. His expert answer is always the same: “The future looks like the past.”
He’s not trying to be cryptic. It’s just that the big changes ushered in by the pandemic five years ago are still unfolding—remote…
Stephanie Ojeda
In April 2018, the U.S. Food and Drug Administration (FDA) approved the first artificial intelligence-powered diagnostic system, a software program used to detect diabetes-related vision loss.
Since then, the industry has seen explosive growth of AI in medical device manufacturing, which is…
Ayush Soni
Audits and inspections are critical components of industrial safety management. These processes help organizations ensure compliance with legal requirements, identify risks, and improve workplace safety and operational efficiencies. Conducting regular audits and inspections is not just a regulatory…
Malcolm Chisholm
Data are the fuel of the Information Age, and all organizations acknowledge the value of well-managed corporate data assets. The problems start when we begin to ask just exactly how the data assets are to be well managed.
In response, many organizations have put data governance departments in…
Angie Basiouny
Hospital patients rate their pain on a scale of 1–10. Teachers grade on a curve. Sports fans spend hours debating stats on their favorite teams. Even the most ardent language lover can’t deny the power of numbers to convey information, especially when choices need to be made.
A new study from…
Prashant Kondle
Unplanned equipment downtime costs manufacturers an estimated $50 billion annually, according to a study by Deloitte. It is estimated that unplanned downtime costs more than $100,000 per hour. Traditional maintenance approaches—whether reactive or scheduled—are not sufficient to address these…
4C Consulting
ISO 27001 is a globally recognized standard for establishing, implementing, maintaining, and improving an information security management system (ISMS). Successfully implementing ISO 27001 can provide tremendous benefits, such as ensuring data security, building trust with customers, and meeting…
Horacio Falcão
Wouldn’t it be wonderful if we could outsource to technology the complex, laborious, and often emotionally intense process of negotiating? Until recently, the idea of merging negotiation and AI was only a dream. However, the launch of more sophisticated AI systems has changed how we approach the…
Megan Wallin-Kerth
It’s 2024, and the age of automation has largely taken over our phones, computers, and businesses. This isn’t entirely a bad thing, you understand. It gives us the ability to spend time and money elsewhere—from investing in staff to spending more time on innovating technology rather than whittling…
Erin Vogen
For many maintenance teams, the story is all too familiar: Limited resources make it difficult to anticipate equipment failures, which leads to frequent, costly breakdowns. During these moments of crisis, miscommunication and disorganization only amplify the problem. This perpetuates the perception…
Etienne Nichols
Compliance with industry regulations and standards is a fundamental part of medtech. Without proper medical device compliance, companies risk patient harm, litigation, and reputational damage.
Fortunately, compliance with medical device regulations and standards is not an impossible task. A…
Jennifer King
A study by Upwork has revealed that about 22% of the American workforce will be working from home by 2025. Remote work is here to stay, bringing many benefits along with it—including significant cost savings for businesses and the promise of a better work-life balance for employees. However, the…
Marian Merritt
Cybersecurity is a fast-growing field with a constant need for skilled professionals. But unlike other professions—like medicine or aviation—there’s no clear-cut pathway to qualifying for cybersecurity positions. For employers and job seekers alike, this can make the journey to building a team (or…
Rachel Byfleet
In an eco-friendly plot twist that would make Captain Planet proud, the European Union has rolled out the Corporate Sustainability Reporting Directive (CSRD), a blueprint that’s got big companies talking about more than just profits. Imagine a world where every major company’s reports don’t just…
Victoria Alestra
In regulated industries like pharmaceuticals, medical devices, and food manufacturing, compliance is crucial for operational excellence. A validated quality management system (QMS) is key to maintaining this compliance. Let’s explore how QMS software streamlines validation and ensures regulatory…
Gleb Tsipursky
As organizations increasingly integrate generative AI (gen AI) to boost productivity, innovation, and competitive advantage, they encounter a host of challenges. Many face resistance to change, fears of job displacement, and concerns about data privacy.
Understanding and overcoming these…
ISO
A customer calls asking for details about how they are registered in your company’s database so they can make sure their information is updated. You get a phone call from a business partner who needs to contact your colleague and asks you to check her calendar to see when she’s free. Although in…
Chris Rush
The U.S. Food and Drug Administration (FDA) recently published new guidance on conducting clinical trials with decentralized elements. It offers recommendations for sponsors, investigators, CROs, and other parties that are interested in implementing decentralized clinical trials.
By issuing this…
ISO
From small family-run companies to tech giants, the business world is changing at an unrelenting pace. Amid a constantly evolving economic landscape and sometimes dizzying technological advances, one thing remains constant: the need to maintain the highest level of quality.
Whether manufacturing a…
James Chan
Construction is an asset-intensive industry. Companies depend on building equipment, power tools, construction vehicles, and all heavy machinery for essential functions like excavation, construction, and demolition. This equipment must always be kept in safe, proper, and optimal working order so…
George Thuo
Data breaches and cyberattacks are things that small to medium-size manufacturers think won’t happen to them. Yet, according to the Verizon 2023 Data Breach Investigations Report, 43% of all cyberattacks are conducted against small businesses.
If that doesn’t grab your attention, consider this…
Chris Rush
While clinical trials are the gold standard for generating clinical data to use as evidence of your medical device’s safety and effectiveness, they are by no means the only way to gather clinical evidence.
Real-world data (RWD), which typically come from routine healthcare delivery or…
Stephanie Ojeda
In the highly regulated world of life sciences, data integrity isn’t optional; it’s essential. The ALCOA principles—attributable, legible, contemporaneous, original, and accurate—provide a foundational framework for ensuring data are reliable and trustworthy.
With the rise of digital…
Adam Zewe
In the 1960s cartoon series The Jetsons, Rosie the robotic maid seamlessly switches from vacuuming the house to cooking dinner to taking out the trash. But in real life, training a general-purpose robot remains a major challenge.
Typically, engineers collect data that are specific to a certain…
Adam Zewe
Despite their impressive capabilities, large language models (LLMs) are far from perfect. These artificial intelligence models sometimes “hallucinate” by generating incorrect or unsupported information in response to a query.
Due to this hallucination problem, an LLM’s responses are often verified…
Jones Loflin
Recently, while driving through North Dakota on a crisp fall evening, I found myself surrounded by the sights and sounds of harvest. Combines and trucks moved through golden cornfields, reaping the season’s bounty. I imagined the farmers, exhausted but satisfied, reflecting on the season’s…
James Chan
Facility and equipment maintenance is most effective when performed proactively and regularly. This kind of routine maintenance can take many forms, ranging from the most basic approaches to complicated strategies using sensors and data to trigger maintenance. Time-based maintenance (TBM) is a…
Gleb Tsipursky
The recent $22.1 million verdict in the case of Billesdon vs. Wells Fargo Securities has cast a spotlight on the increasing legal risks companies face when they ignore work-from-home (WFH) requests under the Americans with Disabilities Act (ADA). This landmark case underscores the critical need for…
Mohammad Mahdi Zare
Remote work is now an essential part of the modern workplace, offering flexibility and convenience to millions of employees worldwide. However, with this shift to home offices and flexible workspaces comes a new set of security challenges. Remote workers face a unique set of risks, and businesses…
Mei Lee Ngan
I once transformed my face to look like Ron Swanson—for science.
I never thought disguising myself with wigs and makeup would be part of my job, but as a NIST facial recognition researcher I sometimes do just that. To make myself look like the gruff character from the show Parks and Recreation, I…
Zach Winn
Most doctors go into medicine because they want to help patients. But today’s healthcare system requires that they spend hours each day on other work—searching through electronic health records (EHRs), documenting, coding and billing, gaining prior authorization, and evaluating services—that often…
Michael Mills
You’ve finally gotten ISO 9001 certification. Congratulations! You’ve built your quality management system, written your procedures, trained your staff, sweated through internal and external audits, and your registrar sent you a certificate suitable for framing. Now, at long last, all of your…
Scott Crow
W ithin the utility industry, regional entities increasingly focus on internal controls as a measuring stick for overall compliance performance.
Developing and executing rock-solid internal controls with an automated compliance management software solution can help maintain compliance, not only…
Rob Moorey
Biomedical equipment technicians (BMETs) are facing increased workloads and staffing shortages that are expected to get worse as the current workforce retires.
About one-third of healthcare technology management (HTM) professionals are older than 55, putting pressure on health systems to attract…
ISO
Modern-day security breaches, such as the SolarWinds or T-Mobile attacks, aren’t one-off events; they are prime examples of how someone can steal your organization’s credentials and use them to gain illegitimate privileged access to sensitive assets. Data breaches happen daily, and in too many…
Harish Jose
In this article, I’m looking at Weber’s Law. It’s named after Ernst Heinrich Weber (1795–1878), a German physician who was one of the pioneers of experimental psychology. I highly recommend the Numberphile YouTube video that explains this in detail.
A simple explanation of Weber’s Law is that we…
Steve Ilmrud
As we approach 2025, one of the most pressing challenges manufacturers face is a growing labor shortage. Research anticipates that 1.9 million jobs will go unfilled during the next decade. This issue, compounded by the retirement of experienced workers and the lack of interest from younger…
James Chan
Asset maintenance isn’t just about fixing things when they break. It’s a complex mix of strategies, both proactive and reactive. Finding the most cost-effective blend makes all the difference in the success of your maintenance program and your business as a whole.
Whether your team is scrambling…
ISO
Cybersecurity has become increasingly critical in the digital age as organizations across all sectors face growing threats from cybercriminals.
Imagine that hackers breached a small healthcare practice through “phishing”—sending a scam email and gaining access to sensitive patient data, including…
Julie Gowthorpe
Management goals commonly include maintaining harmonious work environments that make employees happy and motivated. But how do you achieve this when people don’t get along? “Sort it out on your own” is no longer an option when employees are in conflict. As teams grow and experience turnover, a…
ISO
ISO and the United Nations Development Program (UNDP) have unveiled the world’s first international guidelines to help businesses and organizations expedite their contributions to the U.N.’s sustainable development goals (SDGs).
New guidelines for urgent action
The ISO/UNDP guidelines for…
Thierry Mantel
Metal cold-rolling is a critical process in manufacturing various steel and aluminum products. As manufacturers look for ways to modernize and streamline their manufacturing and quality control processes, digital technologies are poised to transform the metal cold-rolling industry by offering…
Stephanie Ojeda
How can a quality manager secure stakeholder engagement and hold individuals accountable for the quality of their work throughout the corrective and preventive action (CAPA) cycle?
With the burden of quality and compliance on their shoulders, it can be tempting for a quality manager to gather…
Seb Murray
Last year, the corporate world adopted a new term: flattening. This refers to how tech companies, which rapidly hired droves of middle managers during the pandemic boom, are now eliminating this layer through widespread job cuts.
Recent research by Mustafa Dogan, Alexandre Jacquillat, and Wharton’…
James Chan
The U.S. Food and Drug Administration (FDA) is the country’s chief agency for regulating the manufacture, marketing, and distribution of critical consumer goods including food, cosmetics, medical devices, biological products, and pharmaceuticals. The FDA provides direct oversight of the businesses…
Nadav Klein
When conflicts in a team, no matter how minor, are left unresolved, they can eventually breed resentment. If unaddressed, this could lead to cynicism and distrust, as well as harm to individual and team performance. How should leaders deal with this?
The intuitive answer might involve…
Jennifer King
Many people don’t realize just how long AI has been around in the healthcare industry—and are surprised to find out that it’s something that’s been relied on for 50 years already.
MYCIN, a computer-based model with machine learning capabilities, was developed by a team of researchers at Stanford…
Michael Platt, Vera Ludwig
Four years after the Covid-19 pandemic accelerated remote work, its advantages and drawbacks have been well documented. For leaders, the biggest hurdles have remained constant: building employee engagement, trust, and communication.
Nano Tool
Scientists from the Wharton Neuroscience Initiative …
Robyn Coward, Brian Brooks
This year, the Medical Device Innovation Consortium held an Excellence in Quality Summit where it was promised that participants would receive a “unique opportunity to learn adoptable cutting-edge practices to maximize the impact of investing in quality across [their] total product life cycle.”…
John Tschohl
Are your employees empowered to make decisions on the spot in favor of the customer? Your single goal should be to have overly happy customers. Too many things go wrong each day. You want your employees to understand they are in customer service, and their No. 1 responsibility is to take care of…
Touradj Ebrahimi
For the last 30 years, the JPEG image format has been a staple for the internet’s billions of users. While the technologies used to display images have evolved tremendously during the past few decades, the JPEG format is still used everywhere. This is a great example of what can happen when a new…
John Hilgendorf
Whether you’re an executive with limited energy or an hourly employee trying to minimize work, the bottleneck in your productivity isn’t time or money but mental effort. And in a digital age where all data can be stored electronically, the most valuable functions of software—especially those in…
Mike Figliuolo
Reading the news (or even your email) can be distressing to the point of despondency. It can also be fun. It’s especially fun when people say or write silly stuff, and the reporter or editor has to write [sic] after a misspelling or a stupid comment in the original transcript. Sic, usually placed…
Etienne Nichols
On Jan. 31, 2024, the U.S. Food and Drug Administration (FDA) released its final rule for the new Quality Management System Regulation (QMSR).
The new QMSR is the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s quality system regulation (QSR) with the…
Stephanie Ojeda
There’s no question about it: Should an auditor or inspector visit your facility, one thing that will certainly be under the microscope is your corrective and preventive action (CAPA) system.
CAPA management is a recurring theme in U.S. Food and Drug Administration (FDA) warning letters, a fact…
George Schuetz
In this job, I get a lot of questions. In fact, I did some figuring the other day and estimated, conservatively, that we have probably answered at least 50,000 gauging questions over the past 35 years or so.
Some of these questions have been challenging. They’ve pushed me to learn more about my…
Chris Rush
Ensuring the accuracy and security of clinical data, as well as compliance with good clinical practice (GCP), will in large part determine the success of your study and regulatory submission to the U.S. Food and Drug Administration (FDA). Data management and reporting are essential practices when…
ISO
Global awareness of climate change and sustainability has grown exponentially during the past decade, making terms like corporate responsibility, carbon footprint, and transparency the new buzzwords of our time.
The drive toward a more sustainable future has propelled environmental, social, and…
Chip Bell
The cost of acquiring a new customer can be five to 10 times the cost of keeping an existing customer, depending on the industry. You already knew that. But while most organizations know why their customers opened the exit door, they devote little effort to understanding what prompted customers to…
Patty Davidson
For the U.S. Department of Labor’s Wage and Hour Division, protecting children in the workplace is the top priority. The division is responsible for enforcing foundational labor standards, including the child labor provisions of the Fair Labor Standards Act (FLSA). The FLSA establishes minimum wage…
James Chan
Maintenance teams operate in challenging environments that can often produce workplace mishaps, near misses, and other potential hazards. That’s where maintenance incident reports come in. Not only do these reports help team members isolate and problem-solve safety concerns, leading to a safer…
Luk Van Wassenhove
In today’s business environment, where the insatiable desire to grow profits overshadows environmental and social interests, it’s easy to overlook how the actions of economic actors can shape corporate—and environmental—outcomes.
In the accounting profession, practitioners exercise skepticism…
Stephanie Ojeda
Customer complaints are a fact of life in any industry. Even though manufacturers would prefer not to receive complaints, they do come with a silver lining. Managed effectively, they play an important role in improving your products and processes over time—that is, for companies that take a…
Andreas Janz, Horacio Falcão
Failing to identify faults seems to be a prevalent issue nowadays, considering recent reports of quality control problems at Boeing and numerous recalls by car manufacturers, to name a few. Yet, excessive fault-finding occurs when the ability to pinpoint faults—a beneficial behavior—is taken too…
Creaform
When it comes to aircraft, poorly documented dents can lead to more significant problems, potentially compromising structural integrity or performance. Dents can trap moisture and lead to corrosion. The stress they generate can initiate fatigue cracks. Their effects on the structure can also affect…
James Chan
Thoughtful planning is the cornerstone of an effective preventive maintenance program. Your maintenance plan is the framework for everything from building a maintenance schedule and automating inventory management to streamlining work order management and improving interdepartmental communication…
Jones Loflin
I love gardening and growing fresh vegetables. Recently I had checked in on my Brussels sprouts seedlings and, well, they looked awful! The reason quickly became obvious to me: I had overwatered them.
I was so excited about growing Brussels sprouts this year, I didn’t want anything to happen to…
Matt Fieldman
If you look around your plant floor, I’m sure the layout, equipment, and technologies are different today from what they were 10—or even five—years ago. You’ve put time, effort, and money into improving every aspect of your operations. You’ve cut costs and made investments where they were necessary…
Etienne Nichols
If you’re a medtech professional who’s been working with the quality system regulation (QSR) in the United States, then you’re probably familiar with the three terms the U.S. Food and Drug Administration uses for record-keeping requirements: 1) device master record (DMR), a compilation of records…
David Isaacson
For any manufacturer, ensuring well-run, successful processes and protocols is the backbone of a successful and profitable operation. Yet, despite the most well-laid plans, circumstances can change and manufacturers may sidestep best practices in the race to meet demand. Still, ensuring quality,…
William A. Levinson
The International Accreditation Forum (IAF) and ISO have published a joint communiqué to require organizations to “consider” climate change in the context of risks and opportunities relevant to the management system.
Although this is pursuant to the London Declaration, which has goals for…
Stephanie Ojeda
Look through even a few FDA warning letters and you’re likely to find violations related to change management.
For instance, a recent warning letter from the U.S. Food and Drug Administration cited a pharmaceutical manager for changing drug components without justification. Another noted a lack of…
Stefano Puntoni, Bart De Langhe
Most businesses rightly see data as a source for making better decisions. But the conventional data-driven approach often falls short because of common errors made by the decision-makers. Many leaders rely excessively on existing data that might not always address the issue at hand, or they pass…
Veronica Muzquiz Edwards
Health connects each one of us to one another. No matter where we are in the world, who we are, or what we do, the state of our health is a key determinant in our quality of life. Simply put, it’s our most valuable asset.
Individual health crises can be disastrously grim, and if not addressed…
NIST
To combat global warming, companies are building direct air capture (DAC) facilities worldwide to remove carbon from the atmosphere. The National Institute of Standards and Technology (NIST) has developed a new method for testing the materials used in these plants to capture carbon. The agency…
James Chan
The plan-do-check-act (PDCA) cycle plays a central role in fostering improvement by facilitating a structured and ongoing approach to problem-solving. Because the PDCA cycle is ongoing, it also plays a central role in helping organizations navigate shifts in the economic climate, align with new…
Gleb Tsipursky
In the evolving landscape of workplace dynamics, the trend toward revoking employee flexibility and mandating a return to the office (RTO) is gaining traction among corporations, as evidenced by significant players like Boeing enforcing near-full-week office attendance. Leaders often cite the…
Andy J. Yap, Winnie Jiang, Mark Mortensen, Spencer Harrison
Imagine a world where your boss could be fined for contacting you after hours. California is considering a law to make this a reality.
The “right to disconnect” movement is gaining traction globally, with Australia joining France, Italy, Slovakia, Luxembourg, Portugal, and the Canadian province…
Daniel Marzullo
When was the last time you asked your clients for genuine feedback on working together, beyond just revisions on projects and deliverables?
Over the years, I’ve found it incredibly beneficial to do quarterly check-ins with every client to get a sense of how things are going.
Not only does this…
Knowledge at Wharton
Nano Tools for Leaders, a collaboration between Wharton Executive Education and Wharton’s Center for Leadership and Change Management, are fast, effective tools that you can learn and start using in less than 15 minutes, with the potential to significantly affect your success and the engagement and…
Gabriel Popkin
They’re called per- and polyfluoroalkyl substances, or PFAS, a group of thousands of compounds that contain a chemical bond between fluorine and carbon. That bond has proved to be one of the most stable and unbreakable known to chemistry—a fact baked into the common nickname “forever chemicals,”…
James Chan
Preventive maintenance (PM) is an approach to asset and facilities management that relies heavily on planning, coordination, and collaboration. These features are essential to performing preventive maintenance activities such as routine inspections, preemptive equipment maintenance, and parts…
Luk Van Wassenhove, Akhil Bhardwaj, Henk Akkermans
Disasters can act as brutal audits of organizations to which even venerable institutions like Boeing are subject. In the wake of two fatal crashes, as well as a midflight door blowout, Boeing has shaken up its C-suite and pledged to prioritize safety over profit.
Will these measures solve its…
James Chan
Preventive maintenance (PM) is a proactive maintenance strategy built on calendar-based maintenance tasks, regular inspection, and preemptive repair of physical assets. Physical assets may refer to equipment, production machinery, and operational facilities. Preventive maintenance tasks are…
Katie Gilbert
Researchers at Stanford Graduate School of Business have pushed past the limitations of A/B testing into another area of experimentation focused on “multi-armed bandits.” Mohsen Bayati, a professor of operations, information, and technology who has been exploring these problems for the past 15…
Pierre-Nicolas Disser, Megan Wallin-Kerth
QIMA, previously called AsiaInspection, is known for not only making inspection and certifications easier, but also increasing accessibility via a convenient digital platform and strong focus on compliance. Both SMEs and e-commerce businesses have benefited from this increase in affordability and…
Rob Moorey
Equipment failures in healthcare can have serious consequences, including delays in diagnosis or treatment, scheduling disruptions, and patient safety risks. Health systems should empower clinical engineering teams with technology that helps identify potential failures. This will allow health…
ISO
From small family-run companies to tech giants, the business world is changing at an unrelenting pace. Amid a constantly evolving economic landscape and sometimes dizzying technological advances, one thing remains constant: the need to maintain the highest level of quality that endures over time.…
Henry A. Zumbrun
We’ve been asked by customers how many decimal places are enough. It’s either because they want to maximize the resolution of their purchase or they expect far more resolution from the equipment than is reasonable.
We’ve seen a lot, even a meter being set to read 100,000.001. That’s 100 million…
Jennifer King
As the modern work environment continues its march toward remote settings, managers are increasingly turning to agile metrics to keep their teams trackable and transparent. But what’s all the fuss about? Why are these tools not just beneficial but essential?
Measurement for remote teams
By…
Harish Jose
In this article, I’m looking at the relationship between capability index (Cpk or Ppk) and tolerance intervals. The capability index is tied to the specification limits, and tying this to the tolerance interval enables us to use the confidence/reliability statement allowed by the tolerance interval…
William A. Levinson
The current alleged quality problems with the Boeing 737 underscore the importance of zero tolerance for poor quality. No manufacturing or quality professional should ever compromise on this issue. Most importantly, the potential consequences to customers but also to the organization are simply not…
Peter Cappelli
A recent report showed that 59% of managers said they had received no training on how to be a manager before becoming one. Management professor and director of Wharton’s Center for Human Resources Peter Cappelli says that stunning statistic is compounded by the fact that most of those managers are…
Etienne Nichols
In the United States, the Food and Drug Administration (FDA) is the federal agency tasked with regulating the medical device market and ensuring the safety and effectiveness of all devices for patients.
The FDA classifies medical devices by risk into three categories: Class I, Class II, and Class…
Stephanie Ojeda
An analysis of U.S. Food and Drug Administration (FDA) warning letters by the Food and Drug Law Institute reveals a perhaps not-so-surprising link between training gaps and FDA violations.
It’s one of several factors motivating companies to switch to automated training management software. The…
Kelly Nault, Ko Kuwabara, Yejin Park
Giving and receiving help are essential aspects of organizational life, whether that’s providing career advice or soliciting a colleague’s input on a tricky technical problem that you just can’t solve. Through help exchange, individuals gain access to ideas, resources, and relationships that help…
Pawel Korzynski
Amid seemingly never-ending layoffs and a laser focus on efficiency, companies expect their employees to make productive and focused use of their time on the clock. Yet, research has shown that they often spend a significant amount of time cyberloafing—using the internet for personal purposes…
Morehouse Instrument Co.
In the healthcare sector, precision isn’t just a requirement. It’s a necessity where the margins for error are perilously thin, and the consequences of inaccuracy can be grave. At the heart of this precision lies the unassuming yet critical load cell, a device whose reliability is foundational to…
James Chan
Management of change (MOC) is a defined process that organizations establish and follow to ensure health, safety, and reduction of risk during periods of change. MOC systems and policies are essential for companies that undergo significant updates to their facilities, personnel, equipment, or…
Gleb Tsipursky
Generative AI, when harnessed correctly, has the potential to revolutionize the way companies operate, innovate, and compete. But the question that arises is how businesses can effectively tap into this potential. The answer lies in setting up an AI center of excellence that combines IT with…
ISO
Trust makes the world go ’round. Without it, democracies crumble and relationships suffer. The same goes for organizations and businesses: Without the trust of their customer base, they simply can’t succeed.
Trust, however, is never a given. Like respect, it must be won. In an ever-evolving…
Saurabh Joshi Shripad
Risk assessment and continual process verification (CPV) are fundamental regulatory requirements for pharmaceutical companies to ensure drug safety, efficacy, and quality. While risk assessment involves analyzing, mitigating, communicating, and monitoring risks that could ultimately affect patients…
Ferdinando Fioretto
Artificial intelligence’s capacity to process and analyze vast amounts of data has revolutionized decision-making processes, making operations in healthcare, finance, criminal justice, and other sectors of society more efficient and often more effective.
However, with this transformative power…
Stephanie Ojeda
Companies today implementing automated compliance management systems are motivated by a wide variety of factors.
For many, it’s about reducing manual labor hours required to execute quality processes—and achieving greater efficiency and effectiveness in their operations. For others, the priority…
Patrick Gale
Medical equipment is a necessary yet substantial investment for any health system. Making strategic decisions about these assets can be daunting in the face of shifting patient demand, financial uncertainty, and fast-changing cybersecurity risks.
Because clinical assets account for an average of…
Denise Robitaille
The buzz has begun. ISO 9001 is being revised. There hasn’t been a revision in about 10 years, so it’s due—if not overdue. Still, there are individuals who don’t understand the justification or the purpose of the revision. After all, it’s a perfectly good standard. So, what’s up?
It’s worth…
Jennifer King
The cost of poor quality can be devastating to business: Failed quality control costs manufacturers anywhere between 15–20% of their total profits on average, and as much as 40% for some, the ASQ reveals. Businesses with successful quality programs, on the other hand, can benefit from increased…
William A. Levinson
What do quality and productivity have to do with World War III, which we all hope will never happen? The answer is everything. A massive loss of American manufacturing capability between 1945 and 2024 has conceded enormous advantages to aggressor nations that might be inclined to break the peace.…
Alonso Diaz, Maria DiBari
The U.S. Food and Drug Administration (FDA) emphasizes the importance of being prepared for device recalls.
FDA product recalls are on the rise in the post-pandemic era. There has been a clear upward trend from 2021 through 2023, and medical devices ranked the highest of all product types. (See…
Stephanie Ojeda
Implementing an automated compliance management solution is a mammoth undertaking with high stakes and potentially high returns for those who navigate the process successfully.
Get it right and you could save thousands of labor hours, avoid millions of dollars in compliance issues, and free up…
Stephanie Ojeda
As U.S. Supreme Court Justice Louis D. Brandeis famously wrote, “Sunlight is said to be the best of disinfectants.”
In the field of quality, internal audits are the equivalent of sunlight. Like spring cleaning, internal audits provide the opportunity to bring process issues into the open before…
Jamie Bihary
An internal audit can be an overwhelming prospect, especially if you’re new to a company or internal auditing in general.
The MedTech space is huge, and even the standards that are meant to help, like ISO 13485:2016, cover a lot of ground.
So, if you’re part of the audit team in your company, and…
James Chan
Reactive maintenance is a form of physical asset management in which maintenance is only performed on equipment or machinery when it malfunctions or fails entirely. Sometimes referred to as run-to-failure maintenance or breakdown maintenance, reactive maintenance strategies provide the most basic…
Stephanie Ojeda
Formal complaint management is a requirement in regulated industries such as medical device and pharmaceuticals under U.S. Food and Drug Administration (FDA) and other international regulations.
The FDA mandates that medical device companies, for example, designate a formal unit for managing…
Denise Robitaille
ISO 9001 has begun its revision process. In the next few months, all eyes will be riveted on that arena as everyone seeks to anticipate the changes and what they’ll augur for their own quality management systems. The attention is not undeserved.
Equally important but with considerably less…
Jamie Fernandes-ETQ
Generative AI took the world by storm in 2023, from the classroom to the film studio, and the writer’s bench to the White House. Enterprises and creative industries worked to figure out how to leverage it in their operations, while classrooms and government entities struggled to govern its use.
In…
James Chan
In manufacturing industries, calculating overall equipment effectiveness (OEE) offers deep insights into the performance of production processes and enables data-driven improvements.
Determining OEE is a standard method for assessing the productivity of production lines compared to their…
Erin Vogen
Utility companies play an essential role in our communities, supporting our well-being and quality of life. But providing always-on services that rely heavily on machinery, technology, and other assets can pose a challenge. In the dynamic and demanding world of utilities, mastering the art of asset…
Matthew Barsalou
The FMEA (failure modes and effects analysis) turned 75 years old in 2024. However, a look at the literature may paint a different picture. Both the origin year of FMEAs and the name of the organization that developed FMEAs seem to vary among authors. Much of the literature on FMEAs is inconsistent…
Meg Sinclair
At Qualio, our mission is to help life science companies embed robust digitized quality to get their critical products to market at rapid speed and keep them there. And because the Qualio+ team combines over a century of collective quality and regulatory experience from within the life science…
Pierre-Nicolas Disser
With concerns for an economic downturn constantly looming, the global manufacturing industry finds itself navigating through a sensitive time. Once bustling factories, go-to for the world’s largest brands, are experiencing an unexpected lull attributed to multiple factors, including inflation and…
Jennifer King
In the hustling world of manufacturing, where machines hum and productivity is king, there’s a human element that’s sometimes overlooked: the well-being of the workers themselves. That’s where employee wellness programs come in, adding a jolt of energy and care into the mix. These programs aren’t…
Michael Mills
Superficially, ISO 9001 and climate change sound different: ISO 9001 is about how to do things well so your organization satisfies its customers; climate change is about physical and chemical interactions in the atmosphere, and the consequences for our lives in the future.
But ISO is adding…
Del Williams
An experienced conveyor supplier can advise food processors on the ideal options for resolving common challenges associated with conveying powdered food products, such as caking, packing, and hazardous dust emissions.
Almost every industry has a powdered version of products or ingredients that…
Alonso Diaz, Maria DiBari
Inspections by the U.S. Food and Drug Administration (FDA) are on the rise after the nation has recovered from the Covid-19 pandemic. Domestic inspections showed a drop in 2020 due to state health guidelines around quarantine.
The rise has more than doubled within three years of post-pandemic…
Anjana Susarla, Casey Fiesler, Kentaro Toyama
The year 2023 was one of AI hype. Regardless of whether the narrative was that AI was going to save the world or destroy it, it often felt as if visions of what AI might be someday overwhelmed the current reality. And though anticipating future harms is a critical component of overcoming ethical…
Alonso Diaz, Maria DiBari
Quality consistently ranks among organizations’ foremost competitive priorities; it’s a prerequisite for success in the global marketplace. Firms that want a competitive edge do it by delivering products that meet customer needs and function as intended.
Despite the long-standing emphasis on the…
ComplianceQuest
Today’s quality leaders in the life sciences industry have nearly impossible charters. Long-term trends and sudden black swan events in combination can hinder an organization’s ability to exert control over product quality. Globalization, labor shortages and strikes, outsourcing, just-in-time…
Matthew Zajechowski
Stress is an inevitable part of life, shaping and influencing our every decision, emotion, and action, including the way we communicate. It may induce the silent treatment or cause an emotional outburst, both of which can cause future regret.
Preply, a language learning service, surveyed Americans…
The MEP National Network
The personalized nature of coaching makes it a powerful force for manufacturers. You can employ coaching to improve leadership, enhance performance and teamwork, or address personal and organizational development.
With as many as five generations in the workplace at the same time, and constant…
Mark Hembree
Without raising false alarms, it’s fair to say that password insecurity is a problem that lives near you and is worthy of your attention.
In its article, “139 password statistics to help you stay safe in 2023,” digital security firm Norton cites a report by password manager LastPass that more than…
Kari Miller
Traditionally, quality management in the pharmaceutical industry has strayed away from artificial intelligence (AI) for fear of setting it loose with such sensitive information. They have been cautious of implementing an additional element of intelligence into their process. But will organizations…
Gleb Tsipursky
Are employers walking into a legal storm by enforcing rigid return-to-office (RTO) mandates? The post-pandemic era presents a unique challenge as employers grapple with shifting workforce dynamics. The insistence on a full return to the office without considering individual circumstances could lead…
Stephanie Ojeda
There’s an old saying in regulated industries: If it isn’t documented, it didn’t happen.
In the past, maintaining fully compliant documentation meant handling a mountain of paper, which created extra work—and hidden risks—from a quality perspective.
Today, document management has become the…
Brad Jobe
Artificial intelligence (AI) has the potential to reshape the healthcare industry. There is a massive amount of healthcare data available for AI to process. Nearly one-third of the world’s data volume is generated by the healthcare industry, and the volume of big data is projected to increase…
Erin Vogen
One large concern when maintaining a business’ facilities and assets is cost. Managing the costs of repairs, new parts, and personnel can present a challenge.
Although maintenance can be costly, it’s important to see it as an investment that prolongs equipment life span, enhances productivity, and…
Master Gage and Tool Co.
Calibration is essential in almost every facet of industrial processes. The calibration process verifies test instrument accuracy by comparison with recognized standards, and measurement validity hinges on one crucial concept: traceability.
Traceability adherence ensures a continuous link between…
Jón Bergsteinsson
Clinical investigations play an important role in your journey of bringing a medical device to market. While the relevant standards are often perceived as difficult and complex, having a good grasp of them makes the process less confusing.
Understanding ISO 14155:2020 is essential. It’s a guide to…
Megan Wallin-Kerth
We all make mistakes. Despite a vigorous editing process, there may even be one in this article! Although everyone makes mistakes, not everyone owns up to them, and thus they miss an opportunity to grow, learn, and—if they appreciate and apply what they’ve learned—consistently improve the quality…
Shaneé Dawkins
A scene from the movie Ocean’s 8 provides a surprisingly useful lesson on cybersecurity. The character played by Rihanna needs to hack into a security person’s computer. She looks up his social media to find he loves corgis. The Rihanna character sends him a phishing email featuring corgis, and he…
Gleb Tsipursky
In an era when flexibility and autonomy are requirements, financial services leaders are ready to break the chains of traditional office norms. The results of a recent Deloitte and Workplace Intelligence survey make it clear: The future of the financial services sector is hanging in the balance,…
Scott A. Hindle, Douglas C. Fair
We are one year away from the 100th anniversary of the creation of the control chart: Walter Shewhart created the control chart in 1924 as an aid to Western Electric’s manufacturing operations. Since it’s almost prehistoric, is it now time to leave the control chart technique—that started out using…
Rob Moorey
Growing medical equipment inventories and increasing technical complexity are demanding more than ever from the clinical engineering teams responsible for maintaining clinical assets. Simultaneously, a shrinking talent pool of biomedical equipment technicians (BMETs) could lead to large staffing…
Stephanie Ojeda
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue its long-awaited overhaul of its Quality System Regulation (QSR). The biggest change is that the new Quality Management System Regulation (QMSR) will harmonize with ISO 13485 for medical device quality management. With…
Aymen Saidane
As the manufacturing world pushes toward the goal of zero-defect production, part inspection is critical. Sheet metal’s thinness, coupled with its susceptibility to warping, demands precision inspection—even the most minor deviations have significant implications down the line. This underscores the…
Steve Thompson
If you’ve ever enjoyed the experience of an audit or inspection, then you know it’s about as much fun as having your wisdom teeth extracted. As painful as audits and inspections may be, they are necessary to bring needed medical products to market and monitor them to protect consumers and patients…
Bryan Christiansen
Deciding whether to repair or replace an asset can be difficult. That’s why maintenance and reliability managers perform an analysis to determine whether it’s more economical to repair a failing asset or replace it with a new one. This process helps minimize total costs while ensuring that your…
Douglas C. Fair, Scott A. Hindle
Today’s manufacturing systems have become more automated, data-driven, and sophisticated than ever before. Visit any modern shop floor and you’ll find a plethora of IT systems, HMIs, PLC data streams, machine controllers, engineering support, and other digital initiatives, all vying to improve…
Melissa Stewart
Companies are always looking for ways to bring in fresh ideas and new perspectives. And in an ever-evolving digital world, you can’t blame them. Young talents possess the latest technological skills and insights, which can be incredibly useful in adapting to the times. However, there’s one thing…
Stephanie Hinton
If you’re conducting a clinical investigation of a medical device in a European Union member state, you will be required to submit a clinical investigation report (CIR) along with a summary of the CIR to that member state.
The European Union Medical Device Regulation (EU MDR) lists this as one of…
Stephanie Ojeda
The number of ISO 45001 certificates is growing fast, jumping 54% from 2020 to 2021, according to the ISO Survey.
This occupational health and safety standard is especially prevalent in manufacturing, where managing safety incidents is a core concern from the perspective of protecting workers,…
William A. Levinson
The difference between common (or random) cause and special (or assignable) cause variation is the foundation of statistical process control (SPC). An SPC chart prevents tampering or overadjustment by assuming that the process is in control, i.e., special or assignable causes are absent unless a…
Peter Nathanial, David Zuluaga Martínez, Theodoros Evgeniou, Francois Candelon
Last month, the heads of seven major American AI companies emerged from the White House with an agreement on “self-regulation.” On the other side of the Atlantic, Europeans debate the long-awaited EU AI Act, the next major digital regulation following the EU’s Digital Services Act (DSA). The DSA is…
William A. Levinson
Inflation is a serious national issue. Credit agency Fitch Ratings just downgraded the U.S. credit rating—as in the “full faith and credit of the United States”—from AAA to AA+.1 This doubtlessly reflects the fact that our national debt exceeds $31 trillion, or almost $100,000 for every American,…
Stephanie Ojeda
Untitled Document
Workplace safety incidents are a key driver of risk in manufacturing organizations. There are the obvious risks to workers, whose ability to make a living directly depends on their employer’s approach to safety.
There are also huge risks to companies themselves, which face…
Mark Graban
I can’t count how many times during the past 20 years I’ve heard executives complain that their people aren’t enthusiastically participating in their lean program. Leaders lament that while the company has spent a small fortune to put everybody through continuous improvement training, hardly…
Andrey Koptelov
In this age of rapid technological innovation, the introduction of sophisticated technologies in various industries has raised complex ethical dilemmas. As businesses strive to achieve financial goals and keep stakeholders happy, they also have to mitigate the adverse effects of technology…
Matthew M. Lowe
Let’s start with a definition of Industry 4.0, keeping in mind that we’re rapidly approaching Industry 5.0. Industry 4.0 is an era marked by enhanced digitization and the increased connectivity of smart technologies. Where Industry 5.0 is more values-driven, it will require the technology of…
Jeffrey Lewis
I’ve observed that ISO management system audits have remained largely unchanged, even after the advent of ISO 19011:2018, the auditing standard that superseded ISO 19011:2011. Auditors are still using clause-based auditing, despite ISO 19011:2018’s direction to take a risk-based approach.…
Kurt Kleiner, Knowable Magazine
When a Manhattan parking garage collapsed in April 2023, rescuers were reluctant to stay in the damaged building, fearing further danger. So they used a combination of flying drones and a doglike walking robot to inspect the damage, look for survivors, and make sure the site was safe for human…
Emily Newton
Solving problems goes beyond noticing the symptoms and wanting to resolve them. It’s also necessary to perform a root cause analysis, pinpointing the factors likely to have made an issue occur. It’s only then that leaders can create concrete solutions for lasting changes. However, root cause…
Lindsey Walker
In the quickly changing industrial landscape, firms continue to place a high premium on safety. Innovative approaches to improving industrial safety have been made possible by technological advancements. One particularly revolutionary option is computerized maintenance management system (CMMS)…
Ujjwal Parwal
Risk analytics is a vital component of risk management that uses statistical models, data analysis, and predictive modeling techniques to assess, quantify, and mitigate risks in various domains. This article will delve into the definition of risk analytics, discuss its importance, and explore its…
Etienne Nichols
On Feb. 23, 2022, the U.S. Food and Drug Administration (FDA) released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (QSR…
Michael Jarrett
History is filled with tales of courageous and decisive heroes. Individuals like Julius Caesar and Winston Churchill, for example, have led from the front to guide people through adversity and achieve ultimate success. This myth building is especially prominent in business, with stories of…
Kari Miller
Since 2010, citations for insufficient corrective action and preventive action (CAPA) procedures have been at the top of the list of the most common issues within the U.S. Food and Drug Administration (FDA) inspections, particularly for the medical device industry. Issues can occur while…
Etienne Nichols
Amedical device company is expected to deliver innovative, life-changing devices while ensuring compliance and achieving true quality. This task bears loads of responsibility—all of which must be kept and documented within your quality management system (QMS).
A QMS contains everything that…
Hank C. Andersen
Not many years ago, there was a CEO so exceedingly fond of finding the right strategy that he spent all of his money on consultants to tell him what the strategy should be. One day there came two consultants, and they said they could craft the most magnificent strategy imaginable. Not only would it…
Aaron Smith
A successful company can’t run without happy and motivated employees. One way you can achieve that is by improving your employees’ uptime. Uptime refers to your employees’ freedom to pursue personal and occupational growth without the burden of preventable injuries. Here is everything you need to…
Stephanie Ojeda
Design controls are a frequent citation in 483 observations and warning letters from the U.S. Food and Drug Administration (FDA). In fact, the agency has noted a large proportion of past recalls that could have been prevented with design controls.
FDA guidance also makes an explicit link between…
ISO
Net zero is our strongest tool yet against the climate crisis. The transition to net-zero emissions presents a compelling solution that offers not only environmental benefits but also economic, social, and health advantages. Failing to act swiftly and decisively risks catastrophic climate change,…
Sébastien Breteau
Supply chain quality control is a demanding job. Ensuring that products meet specific standards and expectations for safety and customer satisfaction by monitoring and managing the entire supply chain, from raw materials to finished products, must be accomplished consistently and reliably.
At any…
Etienne Nichols
The goal of your MedTech company’s supplier management process should be to ensure a consistent supply of high-quality parts and components that conform to your specifications.
But achieving that goal is easier said than done, and it depends heavily on whether you take a risk-based approach to…
Michael King
Medical companies work in an environment of ever-increasing challenge and complexity. Global regulations continue to evolve with advancements in technology and variations in requirements from country to country. This brings unavoidable technical complexity to daily tasks of quality and regulatory…
Melissa Phillips
The levels of contaminants in our food supply are, generally, decreasing. That’s the good news.
But we still need to measure those contaminants and make sure our food is safe. And measuring tiny things (and big things) is what we do best here at NIST.
In our food safety program, we’re studying all…
Etienne Nichols
Medical device companies must have established risk management processes that comply with ISO 14971. It doesn’t matter whether you’re developing medical devices in the U.S., EU, Canada, or elsewhere. Every international regulatory agency you’ve ever heard of accepts ISO 14971.
ISO 14971 is a good…
Jake Mazulewicz
Wildland firefighters. Air traffic controllers. Flight deck crews of aircraft carriers. Operators of nuclear power plants and the national bulk electric grid. These are among the safest and most reliable work teams in the world. And they don’t try to eliminate all errors and surprises.
Decades of…
Harish Jose
I’m looking at a topic in statistics. I’ve had a lot of feedback on one of my earlier posts on OC curves and how one can use them to generate a reliability/confidence statement based on sample size (n), and rejects (c). I provided an Excel spreadsheet that calculates the reliability/confidence…
Martin Cottam
It’s tempting to attribute the increased profile now given to occupational health and safety (OH&S) to the Covid-19 pandemic. But while in many organizations the pandemic shone a spotlight on OH&S management, there are other issues that will keep OH&S at the fore throughout the next…
Ken Chapman, Tony Orlowski
‘Turning to the men around him, Dodge shouted, ‘Up this way!’ but the men ignored him. Dodge later stated that someone responded, ‘To hell with that, I’m getting out of here.’ The team raced past Dodge up the slope toward the ridge. Four men reached the crest, but only two, Bob Sallee and Walter…
Bryan Christiansen
With so many assets and projects to think about, facilities management is a huge and complex field. It’s easy to lose focus.
Luckily, there’s a simple and easy fix for this problem—facility management KPIs (key performance indicators). Outlining and tracking the most important ones will help you…
Kari Miller
Life science organizations depend on quality management systems (QMS) to improve products, minimize risks, ensure patient safety, and support regulatory compliance. When companies use a horizontal QMS that is not purpose-built for the life science industry, they must execute additional steps to…
Gleb Tsipursky
A ccording to a recent Monmouth University poll, 55 percent of Americans are worried by the threat of artificial intelligence (AI) to the future of humanity. In an era where technological advancements are accelerating at breakneck speed, it’s crucial to ensure that AI development is appropriately…
Stephanie Ojeda
Quality management and environmental health and safety (EHS) have traditionally existed as siloed processes and roles in most organizations. It’s easy to see why, given the forces that have shaped quality and safety during their history.
Modern quality management was born from the post-World War…
Bryan Christiansen
Functional failures are a problem in every industry. They’re a silent way to lose money, waste time, and squander precious manpower. You need to understand them—so you can prevent them. We’ll show you what functional failure is, explain the difference between functional and partial failures, and…
NIST
Here’s a pop quiz for cybersecurity pros: Does your security team consider your organization’s employees to be your allies or your enemies? Do they think employees are the weakest link in the security chain? Let’s put that last one more broadly and bluntly: Does your team assume users are clueless…
Oak Ridge National Laboratory
The Autonomous Systems group at the U.S. Department of Energy’s Oak Ridge National Laboratory is in high demand as it incorporates remote sensing into projects needing a bird’s-eye perspective. When it comes to collecting data for environmental and national security research, the team sends its…
Bryan Christiansen
People often use the terms maintenance and reliability interchangeably. However, they are two separate concepts. Although there is some overlap, their scope and focus are quite different.
Understanding those differences, as well as how each concept affects the other, is a necessary step for…
Megan Wallin-Kerth
“The best is the enemy of good,” wrote French historian and philosopher Voltaire. Today that quote seems more appropriate than ever. A longitudinal meta-analysis study from 1989 to 2016 looking at data from more than 41,000 students across the U.S., U.K., and Canada revealed that perfectionism has…
Shawn Wasserman
MathWorks, creators of MATLAB and Simulink, and the embedded software safety and security company Green Hills Software have announced new features in Simulink that help engineers produce safety-related applications for Infineon’s AURIX TC4x family of automotive microcontrollers. Specifically,…
Akhilesh Gulati
Efrain entered his office on a bright, sunny morning, a smile on his face. He poured a cup of coffee and took his seat behind his desk. From his vantage point, he could see his staff walking in and settling down to the day’s work.
His executive placement firm had risen from a downswing and was…
ISO
Economic practices need to change. The environmental and social consequences of unsustainable growth strategies are becoming increasingly obvious. A circular economy offers a way to counteract the climate crisis, strengthen our adaptive capacity, and make society more sustainable and resilient.…
Rupa Mahanti
Data decay, or the aging of data, is data degradation over time—which results in bad data quality (Mahanti 2019).
There are some data, such as date of birth and place of birth, which are evergreen and not subject to decay; that is, if you have captured the data values correctly in the first place…
Gleb Tsipursky
One of the biggest challenges for companies in transitioning to remote work is their handling of layoffs. Having helped 21 companies transition to hybrid and remote work, I can attest that planning for the whole worker’s life cycle, from onboarding to offboarding, is critical as part of effective…
Todd Hawkins
Most companies face the challenge of managing the documentation they generate—those that are developed to control their business and processes (e.g., standard operating procedures—SOPs) and the associated records as evidence of compliance with those procedures. This may go a step further if the…
Etienne Nichols
On Dec. 9, 2022, the U.S. Food and Drug Administration (FDA) issued a new draft guidance, “Content of Human Factors Information in Medical Device Marketing Submissions,” that provides recommendations for the inclusion of human-factors information in marketing submissions.
The drafted guidance is…
Tom Taormina
The quality profession has been evolving since the Industrial Revolution. I’ve lived part of this journey since the 1970s and have experienced its effect. ASQ and other organizations have continually pushed the envelope in creating training and certifications in the skill sets we’ve developed over…
William A. Levinson
Environmental, social, and governance (ESG) is growing in popularity as a metric to guide investment decisions. What does ESG have to do with productivity, quality, or stakeholders, aka relevant interested parties? The answer is—with the exception of generally accepted practices for workplace…
Alonso Diaz, Maria DiBari
A company’s quality management system should have a formal, effective, and efficient corrective action and preventive action (CAPA) program so management can stay informed and correct existing business problems. The data output and corrective actions from a CAPA program can help prevent recurring…
Liza Dzhezhora
Having appeared in the early 2000s, connected health technologies have gradually become a game changer in the healthcare industry. Healthcare providers that have embraced smart medical IoT solutions reduce costs, improve patient experience, and ensure preventive care.
The trend is not fading away…
Rupa Mahanti
Data are an organization’s most valuable asset. However, too much data are inaccurate, incomplete, irrelevant, obsolete, not well defined, or otherwise not fit for use. Bad quality data can lead to operational inefficiencies, poor decision making, non-compliance issues, and lost revenue.
According…
Gorur N. Sridhar
Obsessive-compulsive disorder (OCD) is an anxiety condition characterized by intrusive thoughts that produce uneasiness, apprehension, fear, or worry (collectively termed obsessions), along with repetitive behaviors (or compulsions) aimed at reducing the associated anxiety.
For team members in…
Jake Mazulewicz
Do you lead your team to learn primarily from successes, or from failures? Many leaders argue that their teams are just too busy to spend time discussing why a successful project went well. They just wrap up fast, then dive into the next project. So, the unspoken insights and unwritten lessons…
Shabnam Azimi
Consumers who have a personality that scores high in terms of openness—such as being open to new adventures and intellectually curious—have better success at spotting fake reviews than other personality types, according to our recently published research. Extroverted people, on the other hand, tend…
Del Williams
For owners and operators in the agricultural and food-processing industries, Jan. 1, 2022, was the deadline for completing a dust hazard analysis (DHA) for existing facilities in accordance with Chapter 7 of the National Fire Protection Association’s Standard 61 (2020) for the Prevention of Fires…
Scott Trevino
Nearly a quarter of surveyed healthcare cyberattack victims experienced increased mortality rates following a data breach, and more than half reported poorer patient outcomes due to longer hospital stays and delayed procedures. Healthcare has faced the highest average data breach cost—more than $10…
Gleb Tsipursky
One of the key stakeholders in stakeholder capitalism is the employee. You could argue that the employee is the key stakeholder, because without employees you’d have no stakeholders at all. This is why employers need to stay aware of today’s health environment and its effect on their employees.…
Matthew Barsalou
A root case analysis is performed to identify “what, how, and why something happened, thus preventing reoccurrence” (“Root Cause Analysis for Beginners.” Rooney, J. J. and Vanden Heuvel, L. N. Quality Progress 37, 2004, p. 45). This can be difficult when the problem being investigated is both…
Sue Via
Research shows that during times of economic uncertainty, companies that find a balance between reducing the resources they need to survive and investing in key areas for growth will fare better through a recession and beyond. It’s a nuanced approach that involves playing offense and defense at the…
Harry Hertz
Yes, I have a wicked dream. No, not that definition of wicked—I mean wicked in the sense meant by scientists when they discuss “wicked problems.” Wicked problems are those that typically involve a combination of technical, social, and economic challenges. Wicked problems are daunting. They’re…
Brian Brooks
Manufacturers spend too much on quality issues. Some issues they are blind to, some are due to poor detection, and some are the costs incurred when issues escape to a customer.
It seems like in recent years the challenges have been great in both magnitude and quantity—supply chain turmoil, global…
William A. Levinson
Corrective action and preventive action (CAPA) is probably the most important process in any quality management system because so much else depends on it. This includes not only its traditional role as a response to defects, nonconformances, customer complaints, and audit findings, but also outputs…
Ann Brady
Few of us today are unaware of the significance of cybersecurity and the threat of cyberattacks on our computers, smartphones, and other devices. We’re constantly reminded never to disclose passwords and to be on the lookout for spam and phishing emails that attempt to manipulate us into divulging…
Gleb Tsipursky
What’s your decision-making philosophy? Do you toss a coin, or do you consider all the risks of your decisions? As a quality professional, you've probably developed a well-thought-out approach to decision making and risk management. But have you considered how other people’s decision-making…
Joshua Sadlock
Yup, that’s me in the photo. You’re probably wondering how I ended up hanging under a bridge over the Mississippi River. I’m a certified bridge safety inspector.
If you have questions after seeing people hanging under a bridge, in a basket suspended from the long arm of a truck, or have seen…
Stephanie Ojeda
Corrective and preventive action (CAPA) is a core function in any quality management system (QMS), and a critical piece in the plan-do-check-act process approach. Like any quality process, tracking CAPA key performance indicators (KPIs) is crucial to continuous improvement.
It’s also a focus of…
Bryan Christiansen
Every day, manufacturers rely on a large number of tools, machinery, and infrastructure to produce their goods. And while all of those assets help you generate profit, they are a significant expenditure—both in terms of the purchase cost and ongoing maintenance costs.
When deciding which…
Doug Folsom
Unpatched vulnerabilities remain a target of cyberattacks, and an ever-present risk for healthcare organizations. Medical devices pose an additional burden because patches are frequently unavailable for medical devices. So, dealing with the potential threat isn’t usually straightforward. The stakes…
Gleb Tsipursky
Why do companies bury their heads in the sand instead of facing dangerous facts, whether about quality problems or other issues? It happens more often than you might think—most recently with Adidas. It usually boils down to companies falling for three cognitive biases.
“Adidas does not tolerate…
Del Williams
With the threat of contamination from harmful pathogens such as salmonella, listeria, and e. coli a continual concern, food processors are seeking to protect not only the public but also their companies’ bottom lines from the massive costs, reputational damage, and greater regulatory scrutiny…
Anton Ovchinnikov
In the age of mass production, the demand for customization is increasing. Customers prefer products catered to their individual needs and preferences over standard items—albeit at a cost.
Fortunately, recent advances in information technology, logistics, and advanced manufacturing processes such…
Christopher Dancy
Despite the important and ever-increasing role of artificial intelligence in many parts of modern society, there is very little policy or regulation governing the development and use of AI systems in the United States. Tech companies have largely been left to regulate themselves in this arena,…
Jake Mazulewicz
A technician spills a toxic chemical. She isn’t injured but easily could have been. The hazmat cleanup costs more than $10,000 and shuts down a critical building for a week.
An electrical engineer flips the wrong switch in a substation control room. He isn’t injured. But within seconds, a $50,000…
Bryan Christiansen
Assets are resources owned and used by a company to generate a positive economic benefit. Assets can be physical items, like equipment or furniture, or they can be intangibles like software, patents, or documents.
As a business owner, it’s important to know which assets you own, their location,…
Gleb Tsipursky
BlackRock CEO Larry Fink claimed in a recent interview with Fox that “we have to get our employees back in the office.” According to him, doing so would result in “rising productivity that will offset some of the inflationary pressures.”
Fink didn’t provide any data in the form of statistics,…
Quy Huy
In September 2022, Boeing agreed to pay $200 million for charges that it misled investors about two crashes of its 737 Max aircraft that killed 346 people. The penalty imposed by the U.S. Securities and Exchange Commission is small change compared to the $2.5 billion shelled out by the plane maker…
Jon Speer
Medical device product development and risk management are often treated as entirely separate processes. Sure, there is usually acknowledgement and understanding that these two processes are related. But it is important to realize that product development and risk management share more than that.…
Tom Taormina
It’s a conundrum that faces everyone who operates a manufacturing or service business: Most are unaware of the dire consequences of a defect reaching a customer until a process server hands them a lawsuit. By then it’s too late. Regardless of the outcome, the people and businesses will be…
Pat Toth
In an earlier article in this series, “Cybersecurity and Industry 4.0: What You Need to Know,” we discussed the four aspects of Industry 4.0: cyber-physical systems (CPS)/cobots, internet of things (IoT), cloud manufacturing, and automation, as well as how they are interconnected. Strong…
Patrick Hardy
Responding to disasters is one of the most important activities that employees can be asked to grapple with. From natural disasters like hurricanes and earthquakes to technological situations such as power outages, chemical spills, and transportation accidents, as well as security emergencies like…
Dirk Dusharme @ Quality Digest
Every company wants to succeed, but not all can say they meet the current requirements to do that. More than a focus on capital, business plans, or staff, a successful business in 2022 must operate digitally. Yet for the 45 percent of small and medium-sized businesses (SMBs) that still rely on…
David Isaacson
In 1982, when asked about the state of the company’s Xenix operating system, a Microsoft engineer reportedly called it “vaporware“ to indicate that the operating system had really not yet materialized. Unfortunately, the term stuck for this and many other premature software launches.
It’s not only…
John Logan
Labor Day 2022 came smack-bang in the middle of what is increasingly looking like a pivotal year in the history of American unions.
The summer saw a steady stream of workforce mobilizations. Employees at Trader Joe’s locations in Massachusetts and Minneapolis both voted to unionize. Meanwhile,…
Gleb Tsipursky
Recently, JPMorgan CEO Jamie Dimon claimed that returning to the office will help improve diversity. If he’s right, that’s an important argument for office-centric work. After all, extensive research shows that improving diversity boosts both decision-making and financial performance.
Yet does…
Abdul Salam
Water is the most essential resource for life, for both humans and the crops we consume. Around the world, agriculture accounts for 70 percent of all freshwater use.
I study computers and information technology in the Purdue Polytechnic Institute, and direct Purdue’s Environmental Networking…
Gene Kaschak
Many manufacturers that adopted lean principles by applying a “just-in-time” (JIT) mindset to inventory of materials and parts have been burned, sometimes badly, by cascading supply chain disruptions. Broken links in the supply chain have created havoc, especially for smaller manufacturers.
Some…
Dwayne Duncum
The workplace has changed forever, having gone through a revolution similar to the Industrial Revolution. Our workplaces are diverse, complex, and frequently changing. If we take any lesson from the Covid pandemic, it’s that the way we work, where we work, and how we work have fundamentally shifted…
Etienne Nichols
I know what you’re thinking. You’ve got a medical device prototype that the FDA has categorized as Class I. You’re ready to push forward to manufacturing or marketing the device, since there are no formal requirements for design controls. “So why would I waste time on design controls?”
The fact is…
Sam Hunter, Gina Ligon
There’s a well-known aphorism that generals are always fighting the last war. It’s a natural human tendency to focus on the kinds of threats you’re used to while playing down the likelihood or importance of some new sort of attack.
Of course, novel threats can crop up anytime and anywhere. An…
Bryan Christiansen
CNC (for computer numerical control) machines have made manufacturing easier, faster, and more precise. Supported by the development of IoT technology, the CNC machine market is set to experience significant growth. With that in mind, this seems like a great time to discuss the intricacies of CNC…
Katie Rapp
The Covid-19 pandemic brought to light a stark reality about current supply chains. As Nissan Motor’s chief operating officer Ashwani Gupta points out, “The just-in-time model is designed for supply-chain efficiencies and economies of scale. The repercussions of an unprecedented crisis like Covid…
William A. Levinson
Inflation has skyrocketed during the first half of 2022, which also saw a sharp downturn in the stock market in response to the Federal Reserve’s increase in interest rates to reduce demand. This resulted in a bear stock market and raised the prospect of an economic recession. The nonpartisan…
Grant Ramaley
The FDA Quality System Regulation (QSR) 21 CFR Part 820 was written in 1997 to harmonize with ISO 13485:1996. The goal was to relieve some of the burden of manufacturers having to meet two different criteria, the FDA’s and ISO 13485.
But by 2003, ISO 13485 had changed so significantly that the FDA…
Claudine Mangen
Work has become an around-the-clock activity, courtesy of the pandemic and technology that makes us reachable anytime, anywhere. Throw in expectations to deliver fast and create faster, and it becomes hard to take a step back.
Not surprising, many of us are feeling burned out. Burnout—which often…
Jill Roberts
Florida’s outbreak of listeria has so far led to at least one death, 22 hospitalizations, and an ice cream recall since January 2022. Humans get sick with listeria infections, called listeriosis, from eating soil-contaminated food, undercooked meat, or dairy products that are raw or unpasteurized.…
Huw Thomas
In what has been called the “biggest moment for workers’ rights in a quarter of a century,” the International Labour Organization (ILO) adopted a safe and healthy work environment as one of its five fundamental principles and rights at work for all at its June 2022 international conference. This is…
Gleb Tsipursky
Imagine you’re driving along the highway and you see an electric sign that reads, “79 traffic deaths this year.” Would this make you less likely to crash your car shortly after seeing the sign? Perhaps you think it would have no effect?
Neither are true. According to a recent peer-reviewed study…
Patricia Santos-Serrao
The pharmaceutical industry has seen significant upheaval and disruption during the past several years. These changes are due in part to the impacts of Covid—for example, interruptions in the supply chain and overwhelming market demand for shortened production times.
They are also being driven by…
Kath Lockett
‘Firefighters are heroes.” We hear it all the time, from children, the media, and young people looking for a rewarding career. It’s probably something you’ve said or thought yourself at one time or another. These brave men and women put their own safety on the line every day to protect their…
Becky Ham
In February 2020, MIT professor David Simchi-Levi predicted the future. In an article in Harvard Business Review, he and his colleague Pierre Haren warned that the new coronavirus outbreak would throttle supply chains and shutter tens of thousands of businesses across North America and Europe by…
Ann Brady
Safer food, better health: This was the theme of World Food Safety Day (June 7, 2022), and it’s obvious, is it not, that access to safe food is vital for life and health? The challenge in today’s world is how to achieve this. Global food systems, already under pressure before the pandemic, are now…
Ruth Castel-Branco, Hannah Dawson
Narrative frames are fundamental to unifying ideologies. They frame what is possible and impossible, which ideas can be accepted, and which must be rejected. In her book, Digital Democracy, Analogue Politics (Zed Books, 2018), storyteller and political analyst Nanjala Nyabola examines the framing…
Hayder Radha
It’s hard to miss the flashing lights of fire engines, ambulances, and police cars ahead of you when you’re driving down the road. But in at least 11 cases from January 2018 to July 2021, Tesla’s Autopilot advanced driver-assistance system did just that. This led to 11 accidents in which Teslas…
David Stevens
The United States has more than 6,000 hospitals, and each one has thousands, if not tens of thousands, of clinical assets, such as imaging machines, ventilators, and IV pumps. Managing this equipment becomes a mighty task when hospital staff must handle the monitoring, repair, and maintenance of…
Richard Harpster
On Dec. 7, 2021, Ford Motor Co. updated its IATF 16949—“Customer specific requirements” (CSR), which require the use of reverse FMEAs (RFMEA) on new equipment (“tooling”). The first sentence of the reverse FMEA requirement reads: “Organizations are required to have a process in place that ensures…
Adam Zewe
Malicious agents can use machine learning to launch powerful attacks that steal information in ways that are tough to prevent and often even more difficult to study.
Attackers can capture data that “leak” between software programs running on the same computer. They then use machine-learning…
Naresh Pandit
Rather than rebounding in 2022, economic conditions in the United Kingdom have deteriorated. Forecasts for growth in 2022 and the year after have been cut dramatically.
The reasons for this are well documented. Take your pick from soaring energy costs, supply chain disruptions, the effect of Covid…
Kari Miller
Quality management is essential to the growth and performance of any organization. It’s a valuable resource in the effort to ensure that products and services satisfy the highest quality requirements and deliver positive customer results.
Pharmaceutical manufacturers must ensure that the…
William A. Levinson
Quality-related data collection is useful, but statistics can also deliver misleading and even dysfunctional results when incomplete. This is often the case when information is collected only from surviving people or products, extremely satisfied or dissatisfied customers, or propagators of bad…
Nathan Parde
For years, organizations have taken a defensive “castle-and-moat” approach to cybersecurity, seeking to secure the perimeters of their networks to block out any malicious actors. Individuals with the right credentials were assumed to be trustworthy and allowed access to a network’s systems and data…
Greg Fiumura
After wading through airport security and a turbulent trans-Atlantic flight, the last thing I wanted was more friction arriving back in the USA. However, I was looking forward to using Global Entry, a voluntary Department of Homeland Security program that, after a thorough background check, allows…
Pat Toth
This morning my favorite local morning news program had an interesting segment on new slang words and what they mean. While the definitions were probably not necessary for millennials or generation Z, but for baby boomers like me, it was an eye-opening vocabulary lesson. I must admit I didn’t know…
NIST
A vulnerable spot in global commerce is the supply chain: It enables technology developers and vendors to create and deliver innovative products but can leave businesses, their finished wares, and ultimately their consumers open to cyberattacks. A new update to the National Institute of Standards…
Gleb Tsipursky
Covid-19 has disrupted many areas of our lives, including our careers. Fortunately, there are steps you can take to strengthen and secure your career during these uncertain times.
Due to the devastating effect of the pandemic on the restaurant industry, one of my coaching clients, Alex, who served…
Brandon Cornuke
Manufacturers work hard to minimize disruptions to their operations and invest significant resources to minimize production risk. They also are under constant pressure to find new ways to deliver more value to their customers. Sustainable business growth is critical to delivering this value. Many…
Cybercrime is on the rise. And as we move deeper into the digital age, the era of the so-called Fourth Industrial Revolution, it’s also growing more sophisticated and severe, with serious consequences. As cyber criminals become more adroit, cybercrime has touched all our lives in one way or another…
Oliver Binz, Elia Ferracuti, Peter Joos
In early 2021, people had already started commenting that inflation might be coming back. But few people could predict just how high it would go. In January 2022, year-on-year inflation in the OECD area rose to 7.2 percent. Consumer price inflation in the United States hit a 40-year high of 7.5…
Steven I. Azizi
It has been more than five decades since Title VII of the Civil Rights Act of 1964 was enacted to outlaw harassment and discrimination against workers in American workplaces. Unfortunately, workplace harassment is still a serious problem for millions of workers in the country.
Different forms of…
Oliver Laasch
It’s been a tough few years for people who own or manage a business. Lockdowns shut down whole industrial sectors worldwide, turning profitable businesses into loss-making ones, while a lot of smaller businesses went under.
Many companies will now be hoping for a return to some type of normality…
Gleb Tsipursky
The biggest falsehood in business leadership and career advice may also be the most repeated: “Go with your gut.” Surely you’ve heard this advice often as a decision-maker, as well as some variations of that phrase, such as, “Trust your instincts,” “Be authentic,” “Listen to your heart,” or “Follow…
NIST
To combat Covid-19 amid supply shortages in 2020, healthcare facilities across the United States resorted to disinfecting personal protective equipment (PPE), such as N95 masks, for reuse with methods such as ultraviolet (UV) light. But questions lingered about the safety and efficacy of these…
Eric Pauley
Organizations’ failure to properly manage the servers they lease from cloud service providers can allow attackers to receive private data, as research my colleagues and I conducted has shown.
Cloud computing allows businesses to lease servers the same way they lease office space. It’s easier for…
Mark Hembree
As a late Boomer, I can say my particular age group is better positioned than any to marvel at and bemoan what’s become of journalism and publishing in the last 40 years.
Not that I’m a Luddite. The advent of word processors was a boon to ham-fisted typists like me. A word processor that actually…
Anthony Tarantino
In 2007, Nassim Taleb described black swans as highly improbable events that had dramatic or even catastrophic effects on markets and economies. Until recently, it seemed that such events were indeed rare.1 There’s now a major rethinking with the world entering the third year of the Covid-19…
Del Williams
From design to prototyping to manufacturing and scaling up, manufacturing is fraught with risk. Machining of critical parts may not be on the front burner until well into a product’s development. This isn’t in stakeholders’ best interests.
Take products with semiconductors as a component, for…
Wade Schroeder
On May 12, 2021, President Biden signed the Executive Order on Improving the Nation’s Cybersecurity. Among other items in the order was a requirement that every vendor that supplies the federal government with software must provide a software bill of materials (SBOM) with their product.
Given that…
Jonathan Gilpin
The world of procurement is often tricky. It involves choosing one appropriate candidate, ultimately benefiting them while rejecting and disadvantaging others.
That said, it isn’t just the businesses picked that will profit from winning the contracts; it’s also their supply chain, their local…
Tinglong Dai
Francis Fukuyama, the U.S. political scientist who once described the collapse of the Soviet Union as the “end of history,” suggested that Russia’s invasion of Ukraine might be called “the end of the end of history.” He meant that Vladimir Putin’s aggression signals a rollback of the ideals of a…
Dennis Fridrich
As the number of networked medical devices grows, so too will online threats and vulnerabilities. In this era of interconnectivity, healthcare systems must prioritize medical device security and patient safety.
The heightened risk is drawing the attention of federal regulators, who warn that “it…
Danielle Underferth
As municipalities clamor for a slice of President Biden’s $1.2 trillion infrastructure spending bill, one Johns Hopkins scientist is re-examining one of the basic elements of road-building: Determining the width of road lanes. But determining the width that provides the highest level of safety,…
Aliyah Kovner
To combat a pandemic, science needs to move quickly. With safe and effective vaccines now widely available, and a handful of promising Covid-19 treatments coming soon, there’s no doubt that many aspects of biological research have been successfully accelerated during the past two years.
Now,…
Adam Zewe
Multiple programs running on the same computer may not be able to directly access each other’s hidden information. But because they share the same memory hardware, their secrets could be stolen by a malicious program through a “memory timing side-channel attack.”
This malicious program notices…
Duxin Sun
It takes 10 to 15 years and around $1 billion to develop one successful drug. Despite these significant investments in time and money, 90 percent of drug candidates in clinical trials fail. Whether because they don’t adequately treat the condition they’re meant to target or the side effects are too…
Violetta Njunina
According to the CDC, approximately one out of six Americans are diagnosed with foodborne diseases each year. Out of this, about 128,000 are hospitalized, and as many as 3,000 lose their lives.
These sorry statistics show why food safety is paramount and why more effort should be put into reducing…
Andrew Moreo, Imran Rahman, Lisa Cain, Trishna Mistry
About 3.5 million people have at least temporarily left the U.S. workforce since March 2020. More than one-third of them—1.2 million—are in the leisure and hospitality industry.
This has created huge problems for restaurants, hotels, and other leisure and hospitality businesses that have struggled…
Anthony Murphy
Kendrick Plastics is an IATF/TS 16949-certified, tier one and tier two supplier of interior decorative trim components and assemblies to the automotive industry. Located in Grand Rapids, Michigan, its 300,000 sq ft engineering and manufacturing facility has more than 50 presses serving fully…
The Un-Comfort Zone With Robert Wilson
When I was a kid, I was enamored of cigarette-smoking movie stars. When I was a teenager, some of my friends began to smoke; I wanted to smoke too, but my parents forbade it. I was also intimidated by the ubiquitous anti-smoking commercials I saw on television warning me that smoking causes cancer…
Grant Ramaley
The IAF Medical Device Working Group has updated one of the most important documents that supports the medical device quality system ISO 13485. IAF MD9:2022—“Application of ISO/IEC 17021-1 in the field of medical device quality management systems (ISO 13485)” provides the mandatory requirements for…
Rodney Rohde
Medical laboratory professionals form the backbone of healthcare and the public health system. They conduct some 13 billion laboratory medicine tests annually in the United States. As of February 2022, these individuals had also performed more than 900 million Covid-19 tests and counting during the…
Ryan E. Day
ISO 9001:2015, Clause 6.1 introduces the term “actions to address risks and opportunities,” as a replacement for the standard’s previous term, “preventive actions.” The juxtaposition of “risks” and “opportunities” seems to imply a relational nature between the two concepts. But is it still…
Georgia Institute of Technology
This country’s semiconductor chip shortage is likely to continue well into 2022. Now, a Georgia Tech expert predicts that the United States will need to make major changes to the manufacturing and supply chain of these all-important chips to stave off further effects. That includes making more of…
Jennifer Helgeson, Maria Dillard
In September 2018, a North Carolina city’s long road to recovery from Hurricane Matthew two years earlier became even longer. Lumberton, a small but diverse city of 21,000 people, 96 km (60 miles) inland from the coast, unfortunately found itself in Hurricane Florence’s sights. The Lumber River,…
Theodoros Evgeniou, Caroline Zimmerman
This isn’t a new story: A novel technology disrupts society, bringing with it many benefits but also major risks and costs. We saw it during the Industrial Revolution, which vastly improved the average living standard but also led to poor labor conditions and environmental degradation, all within a…
Derek Hills
The importance of medical device cybersecurity is growing exponentially. As more devices become connected to the internet, threats to public safety mount. Cybercriminals, formerly interested in stealing financial or medical records, have begun to essentially hold healthcare providers hostage by…
Tahira Reid, James Gibert
People interact with machines in countless ways every day. In some cases, they actively control a device, like driving a car or using an app on a smartphone. Sometimes people passively interact with a device, like being imaged by an MRI machine. And sometimes they interact with machines without…
Rebecca Saenz
There are three key things cobot developers and employers using cobots must remember when considering implementation: 1) human life takes precedence, 2) human life takes precedence, and 3) human life takes precedence.
Dictionary.com defines cobot as “a computer-controlled robotic apparatus that…
Josh Wilson
Paraphrasing Winston Churchill, Rahm Emanuel, a former White House chief of staff and Chicago mayor, famously quipped that you never want a serious crisis to go to waste. Few of us will face the number of crises that a big-city mayor or a presidential aide may deal with in a day, but we still need…
Megan Wallin Kerth
In the wake of manufacturing and chip shortages, some may think that Covid-19 slowed down production on the whole as supply chain issues and remote work presented significant obstacles for manufacturers. However, there were both struggles and some unexpected benefits that arose as professionals…
William A. Levinson
The U.S. Military Academy’s Honor Code says that “A Cadet will not lie, cheat, steal, or tolerate those who do.” Lt. Gen. Darryl A. Williams, the USMA’s superintendent, elaborated, “The tenets of honorable living remain immutable, and the outcomes of our leader development system remain the same,…
Prasad Akella
We are a full two years into post-pandemic manufacturing life, with the omicron variant the latest cause for concern. It might sound hyperbolic, but I’m pretty sure manufacturing will never be the same as it was in 2019. In some ways, that’s a good thing.
One silver lining of the novel coronavirus…
Winnie Jiang
In what has become the most watched commencement speech ever, Steve Jobs had this advice for the class of 2005 at Stanford University: “The only way to be truly satisfied is to do what you believe is great work, and the only way to do great work is to love what you do.”
Inspiring words from the…
Sybil Derrible, Juyeong Choi, Nazli Yesiller
Communities across the U.S. Southeast and Midwest are assessing damage from the deadly and widespread tornado outbreak on Dec. 10–11, 2021. It’s clear that the cleanups will take months and possibly years.
Dealing with enormous quantities of debris and waste materials is one of the most…
Kate Zabriskie
They’re with me, I just know it, at least I think they’re with me... OK, maybe not. Oh no! They’re gone. Well, thank goodness that’s over!
Has that happened to you? How about the following:
• I addressed this issue 30 minutes ago. How did they forget so soon? They have minds like sieves—easy in…
Bryce Austin
There were seven people seated around the table: The CEO, the VP, the CFO, the special agent from the FBI, the owner, the forensics technician, and the company’s CISO (chief information security officer).
“Don’t pay,” was the CEO’s vote. Same for the VP.
“Pay it,” was the owner’s response. The CFO…
Prashant Yadav, Antoine Désir
The pandemic has seen an unprecedented global effort to accelerate the development of safe and effective vaccines as well as a rapid expansion of vaccine manufacturing capacity. However, challenges in further scaling up vaccine manufacturing capacity to meet higher-than-expected demand, and the…
Roxanne Oclarino
Artificial intelligence (AI) promises that organizations will be 40-percent more efficient by 2035, unlocking an estimated $14 trillion in new economic value to global GDP by 2030, according to PwC. This makes it the biggest commercial opportunity in today’s fast-changing business climate, all…
Emily Newton
Risks are inherent in the construction industry, and they come in various types. The National Institute for Occupational Safety and Health (NIOSH) reports that more than one in three deaths happen in this sector because of falls. The data also show that companies with fewer than 20 workers had more…
Chip Bell
One of my favorite Halloween memories was decorating the annual giant pumpkin with my son when he was young. As a toddler, he was primarily an observer as he watched me sculpt the face of the pumpkin with a scrimp knife. However, his commitment to the pumpkin-carving process ramped up dramatically…
Ian Williamson
Finding good employees has always been a challenge, but these days it’s harder than ever. And it’s unlikely to improve anytime soon.
The so-called quit rate—the share of workers who voluntarily leave their jobs—hit a new record of 3 percent in September 2021, according to the latest data available…
David Gillum, Kathleen Vogel, Rebecca Moritz
The origin of SARS-CoV-2 remains a mystery. One theory is that the coronavirus that causes Covid-19 was transmitted from animals to humans—a fairly common occurrence. Another is that it came from a laboratory accident—a more infrequent circumstance.
Around the world, scientists conduct many kinds…
Angus Robertson, Ahmet Abaci, Beth Somplatsky-Martori
Often, there’s a razor-thin margin between success and failure. Not long ago, Gillette—which dominated the $3.5 billion market for razors and accessories for longer than a century—was challenged by a little upstart called Dollar Shave Club, which had just starred in its first commercial for a…
Gregg Profozich
If your food manufacturing plant has to issue a product recall, many people might take to social media to vent their frustrations, resulting in a public backlash that can damage your brand’s reputation. Other consumers might opt to switch brands, resulting in further revenue loss. How can you…
Christine Schaefer
When the City of Germantown, Tennessee, was named a Baldrige Award recipient in 2019, the small suburb of Memphis (just 20 square miles in size) became only the fourth city to earn the prestigious, presidential award for organizational excellence.
During the Baldrige program’s 32nd Quest for…
Gleb Tsipursky
It’s too bad that so many rely on their intuition for their decision-making process. From former President Donald Trump, to Steve Jobs, and even allegedly Mark Twain, gut reactions are viewed as something almost magical, acquired either by hard-earned experience or possessed by a select few young…
Ryan E. Day
‘By the authority vested in me as President by the Constitution and the laws of the United States of America, including sections 3301, 3302, and 7301 of title 5, United States Code, it is hereby ordered as follows....”
Why do these words make me cringe? Well, because when presidential ink hits…
David Isaacson
Within every organization, problems or incidents arise that can affect the quality of your operations. Take for example, food recalls due to improper food labeling that not only could cause sickness in humans, but also result in a hit to a company’s reputation. Or, automotive product recalls due to…
Raz Godelnik
In his 2021 letter to CEOs, Larry Fink, the CEO and chairman of BlackRock, the world’s largest investment manager, wrote: “No issue ranks higher than climate change on our clients’ lists of priorities.”
His comment reflected a growing unease with how the climate crisis is already disrupting…
Karla Jo Helms
Disruptors are defined by several characteristics. They see beyond the existing status quo and challenge it by visualizing improvement and the outcome of that solution. Innovators do not provoke anger for its own sake, but they are not afraid to upset the competition or even potential allies. They…
Sachin Waiker
Know who invented the first digital camera? It was Kodak—or more accurately, an engineer at the historic camera company who conceived the technology and built a prototype in 1975. But corporate leadership had no interest in pursuing the idea, given the company’s dominant position in the market for…
Gleb Tsipursky
How should organizations—including their quality departments—reshape office space to maximize productivity in the future of work? What will the new workspace—from the office to homes—look like in the future? We know it will be different. But to survive and thrive in the post-Covid world, you need…
Emily Newton
Electric vehicles (EVs) are becoming more popular. The consumers interested in buying them generally want to know answers to questions such as: Is the car’s battery an explosion or fire risk? Will its useful life match or exceed the vehicle’s? Will the battery charge as fast as promised? Can it…
Amrou Awaysheh
You’ll probably hear the term “net-zero emissions” a lot over the coming weeks as government leaders and CEOs under pressure talk about how they’ll reduce their countries’ or businesses’ impact on climate change. Amazon, for example, just announced that more than 200 companies have now joined The…
Leo Simonovich
The digital revolution is the key to unlocking a more innovative, sustainable, and connected global economy. This future hinges on transforming the decades-old analogue machines that run the world’s energy and industrial sectors into a hyperconnected network of physical and digital assets—an…
Knowledge at Wharton
After more than a year of being pummeled by pandemic-related supply chain shortages, computer maker HP had some good news to report during its third-quarter earnings call last month. Revenue is up 7 percent over the prior-year period, even though it fell short of projections.
The problem isn’t…
Stavros Karamperidis
Ningbo-Zhousan may not exactly be a household name, but find something in your house made in China, and it’s quite likely it was delivered from there. Ningbo-Zhousan, which overlooks the East China Sea some 200 km south of Shanghai, is China’s second-busiest port, handling the equivalent of some 29…
Andrew Maynard
Elon Musk announced a humanoid robot designed to help with those repetitive, boring tasks people hate doing. Musk suggested it could run to the grocery store for you, but presumably it would handle any number of tasks involving manual labor.
Predictably, social media immediately filled with…
Christopher Allan Smith
This series, a chronicle of one man’s experience before, during, and after a megafire that destroyed the Northern California town of Paradise, provides a series of lessons that others can apply to help them if they face a major disaster. The following links refer to the articles in which the…
Taran March @ Quality Digest
You may work in a state-of-the-art lab, but do your ergonomic practices still linger in the 19th century? If you spend more than five hours a day at a microscope, leave work with blurred vision and a persistent downward tilt to your neck, then the answer is, sadly, yes. In that case it’s time you…
Taran March @ Quality Digest
In regulated industries, every step of the production process must be verified to some sort of guidance or standard. What this comes down to, practically speaking, is an enormous amount of time and effort spent on actions outside the sphere of production. Every day of production seems to create a…
Rajesh Talpade
In April 2018, the U.S. Food and Drug Administration (FDA) permitted the marketing of the first medical device to use artificial intelligence (AI). The device, called IDx-DR, is a software program that uses an AI algorithm to analyze images of the eye taken with a retinal camera called the Topcon…
Ann Brady
Better buying power, greater efficiencies, and more innovative ideas are not just for big businesses. The publication of ISO 44003 is helping smaller players flex their collective muscle by making the most of strategic partnerships.
How many of us cooped up at home during the lockdowns and travel…
Ravi Anupindi
Inoculating the planet from Covid-19 presents an unprecedented logistical challenge like none we’ve seen before. Mobilizing for a world war may be the closest comparison, but in this case, the enemy is invisible and everywhere.
Some of the vaccines require super-cold storage at virtually all…
Sara Adams
Designing, developing, and getting your medical device approved and onto the market is a huge accomplishment—but it isn’t the end of your responsibilities.
For the European Union (EU) market, the European Commission (EC) requires manufacturers to perform ongoing postmarket surveillance (PMS)…
Rick Gould
Ever since people could tie logs together to form rafts and use them to transport goods by water, seaborne trade has flourished and grown. Historians believe that the first international trade routes were developed 5,000 years ago between the Arabian Peninsula and Pakistan, while by the 18th…
Gleb Tsipursky
Recent surveys show, and many managers are learning, that their employees are often not interested in working from the office full time.
It’s easy to assume we know what they want due to a bias known as the false consensus effect, which causes us to perceive others whom we feel to be in our team…
Wade Schroeder
As more medical devices using network-connection technology are developed, cybersecurity will continue to grow in importance and focus among regulators and manufacturers.
Many connected devices store or transmit patient data for which there is an expectation of both privacy and accuracy. Any sort…
Ann Brady
Innovation is the fuel that drives a successful business. Organizations that give their managers and employees the tools to respond to and make the most of opportunities, both internal and external, are well placed to grow profits, improve the health and well-being of their employees, and thereby,…
Mayank Kejriwal
Imagine you’re having friends over for lunch and plan to order a pepperoni pizza. You recall Amy mentioning that Susie had stopped eating meat. You try calling Susie, but when she doesn’t pick up, you decide to play it safe and just order a margherita pizza instead.
People take for granted the…
Boris Babic, Sara Gerke, Theodoros Evgeniou, I. Glenn Cohen
For many of us, our electronic device can be a communications lifeline, entertainment system, and professional networking hub. If trends continue, it may become our health advisor as well.
Direct-to-consumer (DTC) medical apps are a growing segment of the $10 billion market for healthcare…
Dileep Thatte
In 2018, the United Nations General Assembly proclaimed that, every year, June 7 would be celebrated as World Food Safety Day. In 2020, the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) of the United Nations decided to jointly facilitate the observance.
The…
Saligrama Agnihothri
Health-tracking devices and apps are becoming part of everyday life. More than 300,000 mobile phone applications claim to help with managing diverse personal health issues, from monitoring blood glucose levels to conceiving a child.
But so far the potential for health-tracking apps to improve…
Gleb Tsipursky
Due to strong employee resistance and turnover, Google recently backtracked from its plan to force all employees to return to the office and allowed many to work remotely. Amazon also backtracked on its plans to have a fully office-centric culture and allowed employees to have a hybrid schedule.…
Dawn Bailey
The spirit of service—for a small clinic started in 1913 to provide free care to Los Angeles (LA)—lives today in the servant-leader aspirations of 2019 Baldrige Award recipient Adventist Health White Memorial (AHWM), a 353-bed, safety-net hospital.
The community of two million people that AHWM…
Clare Naden
Travel and tourism took a beating during the Covid-19 pandemic, with borders closed, airlines grounded, and many establishments shut for months. Now as the industry attempts to recover in this new context, constantly changing rules and regulations are making it a far-from-simple task. What’s more,…
John Preston
‘This government is obsessed with skilling up our population,” said Boris Johnson in his recent speech on “leveling up.” There’s still a fair amount of uncertainty about exactly what the United Kingdom prime minister’s plan to level up the regions will involve, but manufacturing and skills seem…
Gleb Tsipursky
When a threat seems clear to you, it’s hard to believe others will deny it. Yet smart people deny serious risks surprisingly often.
A case-in-point example comes from my experience helping a midsize regional insurance company conduct a strategic pivot to thrive in the post-Covid world in January…
Silke von Gemmingen
Due to digitalization in Industry 4.0, internal logistics is subject to constant change. Internal traceability—i.e., tracking goods in the warehouse or production facility—increasingly plays a key role. Manufacturers and consumers are placing more emphasis on the safety and quality of products.…
Lawrence Livermore National Laboratory
A Lawrence Livermore National Laboratory (LLNL) scientist and collaborators have demonstrated the first-ever “defect microscope” that can track how populations of defects deep inside macroscopic materials move collectively.
The research, which appeared last month in Science Advances, shows a…
Adrian Hernandez, C. Michael White
T
he U.S. Food and Drug Administration (FDA) regularly inspects manufacturing facilities to ensure that drugs meet rigorous quality standards. These standards are vital to protect patients from drugs that are incorrectly dosed, contaminated, or ineffective.
But over the past few years, tens of…
Phanish Puranam
As businesses increasingly adopt AI-driven decision making, experts agree that the most interesting questions are not about whether humans can beat machines or vice versa, but how the two forms of intelligence can most fruitfully collaborate—and how organizations can best facilitate those…
Steven Severt
When it comes to ongoing certification of your quality management system (QMS), whether it’s certified to ISO 9001, ISO 13485, IATF 16949, or AS9100, how many times have you found yourself “preparing for an external audit?”
Picture the scene: You’ve got the dates set on the calendar months in…
Steven Stein
Supply chain management (SCM) has been defined as “the design, planning, execution, control, and monitoring of supply chain activities with the objective of creating net value, building a competitive infrastructure, leveraging worldwide logistics, synchronizing supply with demand, and measuring…
Terry Onica, Cathy Fisher
With recent disruptions critically impacting the automotive supply chain and costing manufacturers millions in lost production and sales, it is clear that supply delivery issues now need the same level of attention as vehicle safety and quality. What is really at the root of ongoing delivery…
Christopher Allan Smith
This series is about getting you through a catastrophe. The first three articles (see “All articles in this series”) were about preparing and responding to the world around you when it’s consumed by calamity. As our world here was. In this article, we deal with how to handle all the information,…
Christopher Allan Smith
I was a strange kid. Who knows where our fears come from? What I do know is Godzilla is somewhere near the core of one of my weirder fascinations. When I was four, I watched Godzilla vs. King Kong on TV with my father. It made a mark.
One part megalophobia, one part awesome nature, one part primal…
Duke University
Price discounts and other promotions on consumer goods can boost a product’s sales in the short term, but that same strategy may destroy a brand’s equity, according to research from Carl Mela, a marketing professor at Duke University’s Fuqua School of Business.
Brands often focus on the short-term…
Kimberly Merriman, David Greenway, Tamara Montag-Smit
As vaccinations and relaxed health guidelines make returning to the office a reality for more companies, there seems to be a disconnect between managers and their workers about remote work.
A good example of this is a recent op-ed written by the CEO of a Washington, D.C., magazine that suggested…
Joseph Near, David Darais
In previous articles we have explored what differential privacy is, how it works, and how to answer questions about data in ways that protect privacy. All of the algorithms we’ve discussed have been demonstrated via mathematical proof to be effective for protecting privacy. However, when…
Gleb Tsipursky
Quality professionals are often told that “failing to plan is planning to fail.” You might be surprised to learn that this phrase is a misleading myth at best and actively dangerous at worst. Making plans is important, but our gut reaction is to plan for the best-case outcomes, ignoring the high…
Ryan McKenna
To date, this series focused on relatively simple data analyses, such as learning one summary statistic about our data at a time. In reality, we’re often interested in a slightly more sophisticated analysis, so we can learn multiple trends and takeaways at once and paint a richer picture of our…
Arron Angle
Iwas talking to a friend recently, and the subject of organizational health came up. With my quality background my ears perked up, and I asked him to explain what he thought organizational health meant.
The friend went on for several minutes explaining that organizational health was all about six…
Christopher Allan Smith
This series is about planning for the worst that can face us.
It’s jumping-off point is the National Institute of Standards and Technology publication, “A Case Study of the Camp Fire—Fire Progression Timeline,” an epic and thorough study about the wildfire that changed the lives of my family,…
James Wells
I was talking recently with a friend who runs an academic program at a major U.S. university. She was telling me about solving a problem in her department and how the solution was obvious so she just did it. She then related how one of her colleagues protested that she should have used some Six…
Christopher Allan Smith
By 6:25 a.m., my fate was sealed.
That morning, 10 miles from my front door in Paradise, California, a poorly maintained power line owned by Pacific Gas & Electric arced, dropping molten metal into the brush at its base and starting a fire.
At the time, I was rousing myself and my high-school-…
Don Cox
Despite the high ratio of intelligent work-from-home (WFH) business professionals, the current cybersecurity landscape for that work model could best be described as disorganized and dysfunctional. Hackers have been busy exploiting these cyber risks, as evidenced from the reported 300-percent…
Barbara Cuthill
The internet of things (IoT) offers many attractions for small and medium-sized manufacturers (SMMs) that may want to integrate IoT into their facilities and operations, or who seek to enter the IoT market with innovative products. However, when venturing into the IoT waters, it’s helpful to be…
David Darais, Joseph Near
In our last article, we discussed how to determine how many people drink pumpkin spice lattes in a given time period without learning their identifying information. But say, for example, you would like to know the total amount spent on pumpkin spice lattes this year, or the average price of a…
Jon Speer
The medical device technical file is a must-have document for devices to be sold in the European Union (EU) marketplace. The file contains detailed information about your medical device, its design, intended use claims, composition, and clinical evaluations. It’s essentially an “everything you must…
Chip Bell
Iam often asked by customer service leaders how to get the CEO to care about customers. They are convinced there is a missed tactic that, if implemented, would have the C-suite camping out in the contact center and inviting customers to board meetings. When I outline a number of possible approaches…
David Darais, Joseph Near
How many people drink pumpkin spice lattes in October, and how would you calculate this without learning specifically who is drinking them, and who is not?
Although they seem simple or trivial, counting queries are used extremely often. Counting queries such as histograms can express many useful…
Graham Freeman
Here’s an unfortunate truth: The story of the Covid-19 pandemic is one of epic quality failures in almost every area imaginable. Although there have been some admirable successes, such as the food and beverage organizations that have ensured the continued safe delivery of food supplies to most…
Bob Holmes, Knowable Magazine
This story was originally published by Knowable Magazine.
Most of us won’t soon forget that disconcerting moment last spring when grocery store shelves were suddenly bare where the flour, pasta, and other staples should have been. The news told of farmers dumping milk—nearly four million gallons a…
Rita Men
Ending the pandemic depends on achieving herd immunity, estimated at 70 percent or even 80 percent to 90 percent of a population. With some 30 percent of Americans telling pollsters they have no interest in getting vaccinated, that’s cutting it a bit close. The numbers are even worse in many other…
Del Williams
On conveyor systems in the food processing industry, some powdered and bulk solid materials such as grains, sugar, and creamer are ignition-sensitive in specific concentrations, particularly when exposed to static electricity discharge. Key concerns are conveyor-system connection points such as…
Dirk Dusharme @ Quality Digest
Quality professionals no longer focus solely on product or service quality. Today, the quality function is involved in almost every aspect of a company, from customer interactions and compliance management to environmental health and safety, supply chain management, risk management, and more.
A…
Joseph Near, David Darais
It’s not so simple to deploy a practical system that satisfies differential privacy. Our example in the last post was a simple Python program that adds Laplace noise to a function computed over the sensitive data. For this to work in practice, we’d need to collect all the sensitive data on one…
Michael Mallen
The concept of cost of quality (COQ) has been around for decades, but applying it to business is difficult. The adage “quality is free” (coined by Philip B. Cosby in his book by the same title) does not simply mean that you don’t have to pay for it. It means that you are likely already paying to…
Sharona Hoffman
Artificial intelligence holds great promise for improving human health by helping doctors make accurate diagnoses and treatment decisions. It can also lead to discrimination that can harm minorities, women, and economically disadvantaged people.
The question is, when healthcare algorithms…
Michael P. Powell
The promise of advanced manufacturing technologies—also known as smart factories or Industry 4.0—is that by networking our machines, computers, sensors, and systems, we will (among other things) enable automation, improve safety, and ultimately become more productive and efficient. And there is no…
Manfred Kets de Vries
Serge faced a conundrum. One of his business partners was in a legal dispute with Serge’s father, Charlie, and asked for his help. Serge knew that his father was prone to suing everyone who crossed his path—including family members. The business partner had repeatedly tried to end this legal fight…
Tinglong Dai, Christopher Tang, Ho-Yin Mak
More than 50 million Americans have received at least one dose of either the Pfizer or Moderna Covid-19 vaccine. So far, Americans have been largely brand-agnostic, but that’s about to change as the Johnson & Johnson vaccine rolls out.
The vaccine has been hailed as a game changer. It requires…
Joseph Near, David Darais, Kaitlin Boeckl
Does your organization want to aggregate and analyze data to learn trends, but in a way that protects privacy? Or perhaps you are already using differential privacy tools, but want to expand (or share) your knowledge? In either case, NIST’s blog series on differential privacy is for you.
Why are…
Theodore Kinni
There is no shortage of advice regarding the art and craft of business strategy. Yet, in 2019, when the consulting firm Strategy& surveyed 6,000 executives, only 37 percent said their companies had well-defined strategies, and only 35 percent believed that their strategies would lead to success…
Sébastien Breteau
It’s been about one year since the Covid-19 impact intensified from a seemingly isolated health scare to a worldwide, ubiquitous tragedy that has upended daily life as we know it. Ever since consumers first faced widespread product shortages of essential items during the early days of the pandemic…
Nate Burke
Undeniably, the power of data is unmatched. With an abundance of data collection opportunities available online, and with an increasing number of businesses taking them, the potential and value of such information is richer than ever before. And businesses are benefiting.
Particularly where data…
Mark Schmit
During the Sept. 18, 2020, session of the “National Conversation with Manufacturers,” our three West Coast manufacturing leaders on the panel kept coming back to their critical need for skilled workers.
The conversation was one in a series of 11 virtual listening sessions hosted by the National…
Lucca Henrion, Duo Zhang, Victor Li, Volker Sick
One of the big contributors to climate change is right beneath your feet, and transforming it could be a powerful solution for keeping greenhouse gases out of the atmosphere.
The production of cement, the binding element in concrete, accounted for 7 percent of total global carbon dioxide emissions…
James Wells
When is a product “good enough” to accept? This is the classic challenge of quality. High customer expectations demand that suspect products be thoroughly scrutinized and a high standard set for their release. Customers expect this, and quality staff strive to achieve it.
The other side of the tug…
Yoav Kutner
Like business-to-consumer (B2C) e-commerce, business-to-business (B2B) e-commerce allows customers to purchase parts and supplies via an online portal. The difference is that in B2B e-commerce, both the customers and suppliers are businesses, and the customers may or may not be the end users of the…
Jose Luis Alvarez
Alexander Hamilton, one of the United States’ founding fathers, famously called energy the most important characteristic of the executive branch of government. “A feeble Executive implies a feeble execution of the government,” he said in the Federalist Papers. “A feeble execution is but another…
Gleb Tsipursky
Negotiators, even professional ones, make surprisingly many wrong decisions that doom negotiations that should have succeeded. Many of these mistakes relate to overestimating how well they can read the feelings and thoughts of other parties in the negotiation, as well as the extent to which the…
Aarti Gumaledar, Sameer Hasija, V. Paddy Padmanabhan
Globalization of trade and decades-long innovation in supply chain networks have resulted in significant benefits for all stakeholders—greater efficiencies, lower costs, and greater access to markets, to name just a few. Yet Covid-19 has exposed vulnerabilities in global supply chains. Dispersed…
Ashley Y. Metcalf
Lean supply chains are designed based on several key principles. First, the general philosophy of lean is to reduce or eliminate nonvalue-added waste. The concept of reducing waste is always beneficial to organizations. We should continuously strive to reduce things like wasted time, wasted effort…
Jill Neimark
If you’ve ever stayed in a relationship too long or stuck with a project that was going nowhere, you’re not alone. Humans are generally reluctant to give up on something they’ve already committed time and effort to. It’s called the “sunk costs” phenomenon, where the more resources we sink into an…
Steven Ouellette
What is the most important thing for your business to be working on right now? Would everyone else working there agree? Is everyone working toward the business’s goals? How do you know?
Most businesses in my experience cannot answer these questions. There may be metrics, but they are not…
Sheronda Jeffries
Since the beginning of the coronavirus outbreak, UK officials have seized millions of substandard face masks at Heathrow Airport. These masks could have put millions at risk for contracting or spreading the Covid-19 virus.
Industry and governmental organizations including the Therapeutic Goods…
Philippe Aghion
Imagine a ship at sea, at risk of sinking in a tempest. Is it better to empower the crew to do whatever it takes to save the ship, or should every decision be made by the captain and top officers? Similarly, what should the optimal form of firm organization be during a severe downturn? The need to…
Corey Brown
Lockout/tagout (LOTO) procedures are common in industrial and manufacturing environments. Despite this, failure to adequately train employees on LOTO procedures continues to be one of the U.S. Occupational Health and Safety Administration’s (OSHA) top 10 most frequently cited violations during…
Matthew Bundy
Untitled Document
Burning plastic cart carrying a fax machine, a laptop computer, and a three-ring binder. Click here for larger image. Credit: FCD/NIST
Several centuries ago, scientists discovered oxygen while experimenting with combustion and flames. One scientist called it “fire air.” Today,…
Zach Winn
This story was originally published by MIT News.
These days businesses have enough to worry about without thinking about their insurance. Unfortunately, tasks like managing insurance claims and completing annual renewals require a lot of thinking.
The startup Newfront Insurance is seeking to…
Gleb Tsipursky
Should quality professionals be worried about the new Covid strains originating in the United Kingdom, South Africa, and elsewhere, and recently identified in the United States?
Authorities have focused on downplaying concerns about vaccine effectiveness against these new variants. While some…
James J. Kline
Ever since the International Organization for Standardization (ISO) included risk-based thinking in ISO 9001:2015, an idea has arisen among some in the quality profession that quality managers can move into the risk management arena without any competition from other professions. This article looks…
NordVPN Teams
According to Gartner, 99 percent of the vulnerabilities exploited in 2020 have been ones known about by security and IT professionals at the time of the incident. However, taking care of them is tiresome, as it takes 38 days to implement a patch and in the past year alone 12,174 new common…
Bryan Christiansen
A manufacturing facility can’t operate without a maintenance team. Frankly, most businesses can’t. In one way or another, we all rely on different machines and infrastructure to deliver our products and services.
To avoid expensive, unexpected breakdowns and keep assets in good operating condition…
Richard Harpster
As someone who has helped companies in a wide variety of industries for the last 30 years solve many problems using risk-based thinking, I cannot think of an issue that I have worked on that is more important than preventing the spread of Covid-19. With three high-risk people in my home, I have…
Annette Franz
Over the years, I’ve written a lot of posts about change and change management. In an article I wrote earlier this year about change and some of the learnings and takeaways from the pandemic and the business crisis that it created, I noted that we had (and still have) a lot to learn. Here’s one of…
Bahar Aliakbarian
The two major U.S. developers of the early Covid-19 vaccines are Pfizer/BioNTech and Moderna. They both developed mRNA vaccines, a relatively new type of vaccine. A major supply-chain issue is the temperature requirement for these vaccines.
The Pfizer vaccine needs to be stored at between –112° F…
Thomas Malnight, Ivy Buche
The Covid-19 pandemic has prompted different responses from company CEOs seeking to ensure their businesses survive. Keeping their employees safe has been the first priority, but beyond that, their task has involved understanding the situation, launching countermeasures, and trying to evolve ways…
Gleb Tsipursky
Have you changed your views about Covid-19 months into this pandemic? Or are you anchoring to the same views you held last spring?
For example, many people still believe the false claim spread by many prominent leaders in March 2020 that Covid is no worse than the common flu. They protest against…
Tim Waldo
If you are like many small and medium-sized manufacturers, finding good help has been a pain point for many years, and it has become even more difficult during the Covid-19 pandemic. The market forces driving that dynamic are not likely to change soon.
Your shop has had to become more adaptive and…
Jeffrey Phillips
First, a slight diatribe. Why is it that company leaders think their people can do successful innovation when they don’t share a common language? In this article’s title I’ve used the word “disruptive,” and by this I mean innovation in the “third horizon”—incremental, breakthrough, and disruptive.…
Ryan E. Day
If you are a quality engineer or maybe even the quality manager of a manufacturing company, investing in quality improvements may be a no-brainer. Defects are inherently undesirable, right? Well, yes, but at the level of plant manager, president, or CEO, decisions about where to allocate assets…
Ken Voytek
During the past few years, I have written more than a few blogs and papers looking at manufacturing productivity across the 50 states. I wanted to update some of these analyses to reflect more recent data, see what they tell us, and examine how states were performing when looking at the change in…
Natalie Weber
Unlike Covid-19, remote audits aren’t unprecedented. Remote audits didn’t start with the pandemic, although it has forced more companies to use them than previously. At MasterControl, we’ve been doing remote audits for years for our international customers. It saves time and expense, and it’s every…
Steven Stein
Recently there have been a number of articles whose authors discuss conducting assessments remotely because of the pandemic. This article will discuss my experience with an actual assessment conducted remotely, how the plan changed in response to the pandemic, lessons learned, and some of my…
Sanjay Mishra
As the weather cools, the number of infections of the Covid-19 pandemic are rising sharply. Hamstrung by pandemic fatigue, economic constraints, and political discord, public health officials have struggled to control the surging pandemic. But now, a rush of interim analyses from pharmaceutical…
Nader Moayeri
I am part of a grassroots effort at the National Institute of Standards and Technology (NIST) that is developing an exposure notification system for pandemics in general, though we hope it could be used in at least a limited fashion during the current Covid-19 pandemic. We are fortunate at NIST to…
Alper Kerman
Huh? What? At least that was my response the first time I heard the words "zero trust" when I started working at the National Institute of Standards and Technology (NIST) National Cybersecurity Center of Excellence (NCCoE) in the fall of 2018. Mind you, I was also making a fresh start with an…
Gleb Tsipursky
Does the phrase “garbage in—garbage out” (GIGO) ring a bell? That’s the idea that if you use flawed, low-quality information to inform your decisions and actions, you’ll end up with a rubbish outcome. Yet despite the popularity of the phrase, we see such bad outcomes informed by poor data all the…
Hamza Mudassir
Disney has announced a significant restructuring of its media and entertainment business, boldly placing most of its growth ambitions and investments into its recently launched streaming service, Disney+. The 97-year-old media conglomerate is now more like Netflix than ever before.
What this means…
Victor Piedrafita
During the last decade, we’ve witnessed the emergence of sustainability issues among the most important business concerns in a firm’s supply chain. An increasing number of firms have reexamined their relations with suppliers and moved forward to build a more sustainable supply network, by not only…
Erik Fogelman, Jeff Orszak
With the increasing power of digital technology, the idea of a connected manufacturing system that can sense, analyze, and respond will soon be a reality. This idea—called “intelligent edge”—combines computing power, data analytics, and advanced connectivity to allow responses to be made much…
John Keogh
Almost all businesses involved in the food supply chain have experienced effects ranging from a mild shock to severe disruptions during the Covid-19 pandemic, and further disruptions may be ahead this winter.
Yet not all organizations have learned critical lessons, and history shows us some…
Grant Ramaley
IEC 60601-1: “Medical electrical equipment,” edition 3.1, is the base medical-device standard to ensure “basic safety and essential performance” of medical electrical equipment. It is used by medical device regulators but also recognized by some other regulatory authorities as a regulatory…
Zane Patalive
Meet Humphrey. Humphrey is a gray squirrel that a friend of mine rescued as an abandoned baby squirrel. For weeks, my friend and his family nursed the young creature by hand. While Humphrey was growing, he became very friendly with the family members, often perching on their shoulders and snuggling…
Celia Paulsen
October happens to be (among other things) Breast Cancer Awareness Month, Dental Hygiene Month, National Bullying Prevention Month, and my personal favorite, National Pizza Month. Plus, it’s Halloween! But I digress. We’re here to talk about cybersecurity.
Every manufacturer should hold…
Gleb Tsipursky
‘It’s not going away, and we have to face that reality.” That’s what the CEO and founder of a quality-centered high-tech manufacturing startup with 180 employees told the leadership team in early July 2020 to convince them of the need to do a strategic pivot to address Covid-19.
Previously, the…
Eric Stoop
Data can transform manufacturing. It’s also a term that continues to prompt discussions within the industry. People have been saying it for years now, and there is plenty of empirical evidence: Data are the way forward in business generally and manufacturing in particular.
But right now, when…
Mark Williams
One of the favorite aspects of my career in the insurance industry is delivering a positive outcome to someone in the midst of a personally challenging situation. Whether it’s giving someone the means to provide for care when health starts to fail, or a cushion to ease financial burdens after the…
NordVPN Teams
The FBI reported earlier this year that complaints of cyber attacks received by its cyber division had risen to almost 4,000 a day—a 400-percent increase over pre-coronavirus numbers. In one four-month period (January to April), 907,000 spam messages, 737 incidents related to malware, and 48,000…
Merilee Kern
As Covid-19 rages on, warning sirens have sounded of late amid a flurry of headlines surrounding ultraviolet C (UVC) light device-safety issues. Rightfully so, as the current pandemic has ushered in a veritable wild west of UVC gadget deployments with subpar consumer safeguards, instructions, or…
Tinglong Dai, Guihua Wang, Ronghuo Zheng
The Covid-19 pandemic has crippled the airline industry. Passenger numbers are down more than two-thirds from last year, and airlines have been canceling flights and shutting down routes.
It’s frustrating for travelers, but for patients on organ transplant waiting lists, the loss of flights can…
Ayman Jawhar
As a business leader, you probably think similarly to McKinsey about what makes a great product manager (PM): a perfect combination of skills like business acumen, market orientation, and technical skill as well as soft ones... the usual suspects.
Unfortunately (or fortunately, depending on your…
Gleb Tsipursky
Although deeply fulfilling, establishing and growing a quality-oriented startup poses serious dangers for the mental health of quality leaders. During the expansion stage, a founder will often face brutally long work weeks, pressure from different sources to manage the startup while raising funding…
Ryan E. Day, Dirk Dusharme @ Quality Digest, Taran March @ Quality Digest
In order to best illustrate how enterprisewide SPC software can help address shop-floor problems and then funnel the captured data to the corporate level where strategic issues can be analyzed, here is a case study of a hypothetical manufacturing facility. In it, the company makes effective use of…
Jon Speer
Risk can mean many different things depending on the situation. Flying on an airplane, biking on a busy road, driving in a car—all of these involve some level of risk.
Although risk is a variable we encounter in everyday life, it means something uniquely different to the medical device industry.…
Tom Taormina
After more than 50 years as a quality control engineer and having worked with more than 700 companies, it is my observation that the vast majority of quality professionals hold their prime directive to be reducing defects to the lowest acceptable level by minimizing process variability. Most of us…
Amitrajeet Batabyal
Arguing against globalization is like arguing against the laws of gravity, said former United Nations Secretary General Kofi Annan. Globalization, the international trade in goods and services with minimal barriers between countries, may seem inevitable as the world’s economies become more…
Manfred Kets de Vries
Effective organizations rely on teamwork, not least because it facilitates problem solving. Many leaders, however, are ambivalent about teams. They fear overt and covert conflict, uneven participation, tunnel vision, lack of accountability, and indifference to the interests of the organization as a…
Thomas R. Cutler
About one in two U.S. adults has a musculoskeletal disorder, costing an estimated $213 billion each year in treatment and lost wages, according to a report from the United States Bone and Joint Initiative. Musculoskeletal disorders (MSD) are injuries and conditions to the bones, muscles, and joints…
The Un-Comfort Zone With Robert Wilson
When I was a kid, I hated Burger King. I hated it because they put sweet pickle relish on their regular hamburgers, and I hated sweet pickle relish. And, they put mayonnaise on The Whopper, and I hated mayonnaise. I know what you’re thinking: “Why didn’t you get the fish sandwich?” Well, they put…
Shobhendu Prabhakar
The “mantra” for continuous improvement is to learn from our mistakes. Not only learn but also take necessary actions and come up with strategies to prevent the recurrence of the same or similar mistakes. It is true for humans as well as for businesses. In business, especially in the oil and gas…
Stewart Black, Patrick van Esch
Millions of Americans are unemployed and looking for work. Hiring continues, but there’s far more demand for jobs than supply.
As scholars of human resources and management, we believe artificial intelligence (AI) could be a boon for job seekers who need an edge in a tight labor market like today’…
Donald J. Wheeler
In past articles I have used graphs to provide perspective on how the Covid-19 pandemic is progressing around the world. In this article I shall update some of those graphs and use these historical data to make projections on what may be expected in the United States in the fall.
The worldwide…
Tom Taormina
Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall…
William A. Levinson
Face masks and respirators may well offer the only way to return to an even remotely normal living and working style in the second half of 2020, which means they will play a vital role in any kind of economic recovery. This article’s purpose is to discuss what we know about respiratory protection,…
James Anderton
Injection mold making used to be a relatively simple business: machine the cavities and runners, polish, cross-drill for cooling, then shoot resin. Today, however, relentless pressure for lower part cost and higher productivity have led to bigger, faster machines with molds to match.
Multilayer…
Benjamin Kessler
The full economic impact of the pandemic has yet to be felt. However, it seems beyond dispute that Covid-19 and globalization don’t mix well. Of course, all economic activity is suffering in this worldwide recession—but the global breadth of business may experience an especially acute shrinking…
Jason Chester
For manufacturers—as for all of us—the past few months have been a blur of fast adaptations and long periods of waiting. At the start of the pandemic, many manufacturers did what they have always done in the face of disruption: adapt and find the fastest workaround for the challenge at hand.…
Kate Zabriskie
‘It was one thing to see her entire family during meetings when everyone first went into lockdown, but we’re months into this. Shouldn’t she have come up with some kind of work-at-home plan by now? I did. The situation is maddening! Her kids, dog, and husband do not mix well with work.”
“At first…
Bob Holmes, Knowable Magazine
This story was originally published by Knowable Magazine.
Infectious disease expert Anthony Fauci. Coronavirus response coordinator Deborah Birx. County health officials across the United States. The Covid-19 pandemic has led to the emergence of a new set of household names: those in the media…
Jacob Horne
Cybersecurity is a complex topic no matter what industry vertical it is applied to. In order to reduce that complexity, it helps to frame cybersecurity in the context of the business. For manufacturers, there is a familiar concept that can be used: Begin with the end in mind.
So what does the end…
Joerg Niessing
Since Covid-19’s arrival, digital resilience increasingly refers to the strategic use of digital technologies in delivering customer value and business growth despite adversities. Indeed, some industries—such as hospitality, higher education, or traditional retail—were hit more than others because…
Greg Hutchins
My recent epiphany was that the lens for all work and even for everyday living during the next few years will be risk-based. Why do I make this case?
In January 2020, my company was selected to participate in the largest pitch fest in the Northwest, TechfestNW, which was originally scheduled for…
Tom Taormina
Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall…
Elizabeth Tippett
If you’re among the tens of millions of people returning to work or preparing to do so after months sheltering in place, you may be worried it will put you and your family at increased risk of exposure to Covid-19.
The dilemma may be especially stark for the millions of Americans who can expect…
Douglas S. Thomas
The cyber world is relatively new, and unlike other types of assets, cyber-assets are potentially accessible to criminals in far-off locations. This distance provides the criminal with significant protections from getting caught; thus, the risks are low, and with cyber-assets and activities being…
Ted Theyerl
‘Forward!” It’s the state motto of Wisconsin, where I work to help manufacturing companies improve their operations and processes. It’s one simple word that holds a lot of meaning and relevance. It’s what I want companies I work with to embrace, practice, and execute. Forward is a word that helps…
Bruce Hamilton
For the last four months, GBMP has, of necessity, pivoted to predominantly virtual consulting, training, and coaching. Now, as the economy begins to reopen, I’d like to share with you two lessons that we have learned.
Office space adds limited value to our work
We have discovered that physical…
Farhana Ahmad
When Intelex developed its return-to-work program, we decided the best approach would be a phased one. Similar to the concept of continuous deployment, breaking down the plan to allow individuals to quickly process, adapt, and execute practices and procedures makes it more manageable for employers…
Celia Paulsen
Artificial intelligence (AI)-powered robots, 3D printing, the internet of things (IoT)... there’s a whole world of advanced manufacturing technology and innovation just waiting for small and medium-sized manufacturers (SMMs) that want to step up their digital game. Unfortunately, manufacturing…
Knowledge at Wharton
While sales of products like toilet paper, hand sanitizer, and even home appliances have skyrocketed during the coronavirus pandemic, auto sales have experienced the opposite. Through March, April, and May 2020, total vehicle sales in the United States fell to levels not seen since the Great…
Gleb Tsipursky
As a vast number of companies rush to reopen, they’re falling into the trap of “getting back to normal.” They don’t realize that we’re heading into a period of waves of restrictions, due to many states reopening too soon. Indeed, some of the states that opened early have already reimposed some…
Michael Weinold
After nearly 130 years in business and a series of breakthrough innovations that shaped the way we light up our homes, General Electric has sold its lighting division to the U.S.-based market leader in smart homes, Savant, for a reported $250 million (£198 million). Although a licensing agreement…
Jeffrey Phillips
Throughout human history we’ve constantly sought out tools and capital to make us more productive. From the formation of basic tools to assist in farming to real cultivation and shaping of the land for greater yields, humankind learned to grow food. Further research into genetics, fertilizers, and…
Gleb Tsipursky
How can quality professionals defeat unconscious bias? First, you need to know what unconscious bias is.
Unconscious bias (also known as implicit bias) refers to unconscious forms of discrimination and stereotyping based on race, gender, sexuality, ethnicity, ability, age, and so on. It differs…
Adam Bahret
‘What’s the MTBF of a human?” A bit of a strange question I ask in my Reliability 101 course. Why ask such a weird question? I’ll tell you why. Because MTBF is the worst, most confusing, crappy metric used in the reliability discipline.
OK, maybe that statement is a smidge harsh, but it does have…
Martin J. Smith
Robert Siegel has peered into the post-Covid-19 future and concluded that anyone hoping for a quick recovery is likely to be disappointed. Which means a great many businesses will fail.
“We can say that with 1,000-percent certainty, and there are many reasons why,” says Siegel, a lecturer in…
Katherine Harmon Courage, Knowable Magazine
This story was originally published by Knowable Magazine.
From mask wearing to physical distancing, individuals wield a lot of power in how the coronavirus outbreak plays out. Behavioral experts reveal what might be prompting people to act—or not.
With many states and towns lifting strict stay-at…
Matthew Staymates
As a fluid dynamicist and mechanical engineer at the National Institute of Standards and Technology (NIST), I’ve devoted much of my career to helping others see things that are often difficult to detect. I’ve shown the complex flow of air that occurs when a dog sniffs. I’ve helped develop ways to…
Donald J. Wheeler
The daily Covid-19 pandemic values tell us how things have changed from yesterday, and give us the current totals, but they are difficult to understand simply because they are only a small piece of the puzzle. This article will present a global perspective on the pandemic and show where the United…
Eric Buatois
As the coronavirus wreaks economic turmoil around the world, our modern supply chains are facing unprecedented stress. For months prior to the Covid-19 crisis, trade tensions had been mounting due to the escalating tariff war between Washington and Beijing. A rise in protectionism, coupled with…
William A. Levinson
The U.S. House of Representatives has passed the HEROES Act (Health and Economic Recovery Omnibus Emergency Solutions Act)1 which will, if approved by the Senate and president, require OSHA to develop a standard for workplace protection against Covid-19.
Under section 120302 the legislation says…
Denrie Caila Perez
A new report from Trend Micro Research illustrates how advanced hackers are using unconventional attack vectors against smart manufacturing environments. Smart manufacturing technology generally operates through proprietary systems, which use their own proprietary language. However, these systems…
Leigh Turner
Given the death, suffering, social disruption and economic devastation caused by Covid-19, there is an urgent need to quickly develop therapies to treat this disease and prevent the spread of the virus.
But the U.S. Food and Drug Administration (FDA), charged with the task of evaluating and…
Tom Taormina
Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall…
Vanessa Bates Ramirez
Long before coronavirus appeared and shattered our preexisting “normal,” the future of work was a widely discussed and debated topic. We’ve watched automation slowly but surely expand its capabilities and take over more jobs, and we’ve wondered what artificial intelligence will eventually be…
Taran March @ Quality Digest
What is quality intelligence, exactly? It’s more than marketing spin. More, even, than the sum of its many control charts. It’s not collecting data simply to further go/no-go actions. And it doesn’t mean turning the cognitive wheel entirely over to artificial intelligence, either—far from it.
We…
Ryan E. Day
An organization can achieve great results when everyone is working together, looking at the same information generated from the same data, and using the same rules. Changes can be made that affect a company’s bottom line through operational improvements, product quality, and process optimization.…
Dirk Dusharme @ Quality Digest
Blame it on Moore’s law. We live in a digital Pangaea, a world of borderless data driven by technology, and the speed and density with which data can be transmitted and handled. It’s a world in which data-driven decisions cause daily fluctuations in markets and supply chains. Data come at us so…
Ryan E. Day
It’s no secret that manufacturing companies operate in an inherently unstable environment. Every operational weakness poses a risk to efficiency, quality, and ultimately, to profitability. All too often, it takes a crisis—like Covid-19 shutdowns—to reveal operational weaknesses that have been…
Mary Rowzee
During the first six months after the publication of its first edition in June 2019, the AIAG & VDA FMEA Handbook gained popularity in the global automotive industry. Both U.S. and European OEMs have started to require the AIAG VDA approach to failure mode and effects analysis (FMEA) in their…
M. Tina Dacin, Laura Rees
A small business has been given the green light to reopen amid the Covid-19 pandemic. What does it need to consider for employees and customers?
Small-business owners are reorganizing physical space to account for continued distancing requirements, and rethinking supply chains to deliver products…
Ken Levine
Lean Six Sigma (LSS) professionals have an enormous opportunity to add value to organizations and to our communities during this coronavirus pandemic. We have the objective orientation, methods, and tools to help. Process improvement is currently more important than ever in this “new normal”…
Jessica Reiner
For more than 20 years, a class of man-made, potentially cancer-causing chemicals called per- and polyfluoroalkyl substances (PFAS) has commonly been found in humans and the environment. These chemicals are used in a variety of industries and can be found in many consumer products, such as food…
Maria Watson
The U.S. government has committed hundreds of billions of dollars to help small businesses weather the coronavirus pandemic. But early reports suggested larger companies were gobbling up much of the aid, while many of the neediest ones—particularly those with only a few dozen employees—weren’t…
Anne Trafton
When MIT announced in March 2020 that most research labs on campus would need to ramp down to help prevent the spread of Covid-19, Canan Dagdeviren’s lab was ready.
For the past two years, Dagdeviren and her lab manager, David Sadat, have run the Conformable Decoders Group using “lean lab”…
Steve McKee
The Philippine Department of Transportation got into a bit of a fix recently for publicly thanking the coronavirus. In an attempt to “provide an enlightening and awakening narrative” that might cause people to see a silver lining in the viral cloud over their heads, the DOT instead found itself…
Dirk Dusharme @ Quality Digest
Around the world, local agencies and institutions have scrambled to find personal protective equipment (PPE) to protect their essential employees from Covid-19. Not just healthcare workers, but also the men and women who to work to keep our cities and counties up and running, from emergency…
Stanley Chao
‘Can you help me source PPEs from China?” asks a caller on the phone. I have received dozens of these inquiries since March from local governments, medical clinics, and mom-and-pop shops after hospitals and first responders began reporting massive shortages of N95 masks, latex gloves, and surgical…
Quality Digest
It’s easy to assume that something as simple as a mask wouldn’t pose much of a risk. Essentially, it’s just a covering that goes over your nose and mouth.
But masks are more than just stitched-together cloth. Medical-grade masks use multiple layers of nonwoven material, usually polypropylene,…
Grant Ramaley
The International Accreditation Forum (IAF), the association of conformity assessment accreditation bodies worldwide, held an emergency meeting after confirming what appears to be an outbreak in the use of fake ISO 13485 certificates. ISO 13485 is a quality management system standard particular to…
Hari Abburi
If there’s one thing the global business community is learning from the Covid-19 pandemic, it’s the outright imperative for companies to be agile “from top to bottom.” This lesson continues to ebb, flow, and unfold daily, wreaking having on bottom lines in every corner of the world.
In fact,…
Corey Brown
Many industrial businesses have heard of the dangers of relying on tribal knowledge. But what exactly does tribal knowledge mean? How does tribal knowledge impact an organization? How do you capture tribal knowledge?
Organizations spend substantial time and resources developing the knowledge and…
Gleb Tsipursky
So many companies are shifting their employees to working from home to address the Covid-19 coronavirus pandemic. Yet they’re not considering the potential quality disasters that can occur as a result of this transition.
An example of this is what one of my coaching clients experienced more than a…
Tom Taormina
Each article in this series presents new tools for increasing return on investment, enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system. They will help implementers evolve quality management to overall business…
Jon Speer
Historically, risk management has been a complex and polarizing subject, with various stakeholders assigning different values on the probability and severity of harm. In the medical device industry, risk management’s high importance has led to the publication of standards such as ISO 14971,…
Greg Hoeting
Nuclear power has long been a clean, dependable source of energy throughout the world. However, as power plants age, concerns grow about their continued reliability. Many components make up the infrastructure of a nuclear power plant with the design intent to reduce radiation and contamination…
Ryan E. Day
As shelter-in-place orders make work-from-home (WFH) the new normal, some organizations are struggling with the transition to working as a remote team. But there are companies that have been doing so for quite some time, and we can benefit from their experience.
Covid-19 is forcing thousands of…
Knowledge at Wharton
Long stretches of empty supermarket shelves and shortages of essential supplies are only the visible impacts to consumers of the global supply-chain disruption caused by the Covid-19 pandemic. Unseen are the production stoppages in locations across China and other countries and the shortages of raw…
Alan Rudolph, Raymond Goodrich
We [Alan Rudolph and Raymond Goodrich] are both biotechnology researchers and are currently seeking to repurpose an existing medical manufacturing platform to quickly develop a vaccine candidate for Covid-19.
This process is used for the treatment of blood products such as plasma, platelets, and…
Jason Chester
Even in the midst of the pandemic, product safety and quality remain critical. For many manufacturers, complex quality management systems and procedures stand in the way of agile responses and effective operational optimization. Cloud technology provides the means to dramatically simplify quality…
Cheryl Carleton
The labor market is changing rapidly with the onset of the coronavirus pandemic.
Many organizations are laying off almost all of their workers, while others are considering which workers to lay off, which to furlough, and which to keep. Alternatively, some are expanding their labor forces.
When…
Michael Dehoyos
The amount of risk that one is exposed to when running a business is vast. Some risks may result in severe legal or financial trouble or cause the business to shut down. Mitigating these risks is a major aspect of successfully running a business.
Every aspect of a business has certain risk factors…
Julius DeSilva
ISO 9001 certifications have seen a decline during the past two years, per data from ISO. Some say the standard has gotten too complicated with the introduction of organizational context, risk-based thinking, and the removal of mandatory documented procedures. Even a few of QMII’s clients have…
Bruce Hamilton
Most lean folks use 5 Whys daily to problem solve, but relatively few are familiar with a clever problem-solving device developed 30 years ago by Deming Prize winner Ryuji Fukuda, called the why-not diagram.
Because objection is a natural human response to new ideas, Fukuda created the why-not…
Kathleen Wybourn
Business continuity is a relatively simple idea. Plan ahead so you can keep your business successful during times of difficulty. Key management transitions, loss of a major customer, the impact of a lawsuit, perhaps a fire or an earthquake. But what if that “difficulty” is a global public health…
Donald J. Wheeler, Al Pfadt
Each day we receive data that seek to quantify the Covid-19 pandemic. These daily values tell us how things have changed from yesterday, and give us the current totals, but they are difficult to understand simply because they are only a small piece of the puzzle. And like pieces of a puzzle, data…
Stanislav Shekshnia
Corporate boards across Europe are reacting to the coronavirus pandemic in three ways. For some, it’s business as usual. “Crisis is the business of the CEO; the board does not need to adjust its workings,” the chair of one such board told me. Other boards are going in the opposite direction,…
William A. Levinson
The phrase “flatten the curve” means to slow the transmission of the coronavirus (Covid-19) in order to spread the total number of cases out over a longer period of time. This will avoid overwhelming the healthcare system.1 The model is accurate as presented throughout the internet, but it also…
David Dubois, Joanna Teoh
From AI-enabled chatbots to ads based on individuals’ search or social media activities, digital data offer novel ways to connect with customers. These connections can develop into intimate customer relationships that boost satisfaction, engagement, and ultimately, loyalty. Consider Netflix’s…
Knowledge at Wharton
When the Mosaic browser, with its consumer-friendly interface, was released to the world in 1993, most had no idea how radically this first foray into the internet era would transform our lives, both personally and professionally. As humans, we are generally poor at detecting and acting on early…
Norm Friesen
As the Covid-19 pandemic forces many U.S. colleges and universities to move their courses online, connecting online via video is now having its moment.
Family, friends, neighbors, and even TV talk-show hosts are now meeting and broadcasting from home. Meanwhile, Microsoft, Google, and Zoom are…
Eric Stoop
According to the National Safety Council, the rate of preventable workplace fatalities per 100,000 workers has flattened or risen slightly since 2009 after decades of steady improvement in occupational safety.
Companies conducting layered process audits (LPAs) can help get the United States get…
Jason Chester
The Covid-19 pandemic has hit every industry with a barrage of challenges. The impacts on the manufacturing sector are already extending far beyond factory walls. And for now, the depth of those impacts and the expectation for recovery are unknown.
Fortunately, manufacturers are a highly adaptable…
Lee Seok Hwai
In the trenches of the battle against Covid-19, critical defensive gear and medical equipment are in short supply. Doctors and nurses fighting the nonstop onslaught of the highly contagious coronavirus desperately need more ventilators, test kits, surgical masks, shields, and gowns.
In Spain,…
Tom Taormina
Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall…
James Anderton
While healthcare professionals globally struggle to contain the Covid-19 pandemic, acute care patients are taxing ICU units worldwide. Critical to the care needed for the most serious cases is breathing support through mechanical ventilators. In Italy, the worst-hit nation in Europe, the lack of…
Jason Chester
Manufacturers routinely face uncertainty, risk, and volatility in everyday operations. It’s understood that organizations must be ready for anything, from supply chain interruptions, supplier quality issues and process variations, to volatility in market demand, competitor activities, and political…
Oscar Combs
With the emergence of the coronavirus (Covid-19), many organizations are doing their part to prevent the spread of infection by practicing social distancing. Some organizations have implemented no-visitor policies, which helps prevent the spread of the disease, but is not so good when it comes to…
Paula Caligiuri, Helen De Cieri
The coronavirus pandemic has forced tens of millions of employees across the United States to work from home. While this will save lives by limiting the transmission of Covid-19, it also poses significant challenges for employees’ well-being.
How can companies support the health of their employees…
Rebecca Spang
Arnold Schwarzenegger tweeted a video of himself on March 15, 2020, saying: “No more restaurants.” Seated in his palatial kitchen with two miniature horses, Whiskey and Lulu, beside him, the former California governor pronounced: “We don’t go out; we don’t go to restaurants. We don’t do anything…
NIST
Unlike diamonds, solar panels are not forever. Ultraviolet rays, gusts of wind, and heavy rain wear away at them over their lifetime.
Manufacturers typically guarantee that panels will endure the elements for at least 25 years before experiencing significant drop-offs in power generation, but…
Lee Seok Hwai
Hong Kong scientists teaching a panicked populace to make their own surgical masks with paper towels and metallic wire must surely rank as one of the most Kafkaesque moments of the new coronavirus disease outbreak. But the worst is yet to be if global medical supply chains, already stretched in…
Anjalika Singh
The toughest part of being in a relationship is finding a perfect gift for your loved one. Gifting is an essential part of any relationship. You gift your better half for every reason and every season. Gift as a form of bribery in love is a time-tried tool.
Being a system believer, I use the…
Ken Maynard
When educational and public sectors consider applying a proven method like lean Six Sigma, the perception persists that this “manufacturing program” will not work in a nonmanufacturing environment. Along with that limiting assumption, there is an underlying expectation within the service industry…
Sophia Finn
Effective and efficient supplier management is possible, but not when we’re still using old tools and expecting different outcomes.
Emailing suppliers to communicate product specs, corrective action requests, or audit reports may be “the way it’s always been done,” but that doesn’t mean it isn’t…
Gleb Tsipursky
The Covid-19 coronavirus has developed into a widespread pandemic. With growing outbreaks of diagnosed cases in all 50 states, and vastly larger numbers of undiagnosed cases, there’s serious cause for concern. Yet quality professionals who follow the official advice on Covid-19 coronavirus prep…
Jennifer Grant
With Covid-19 continuing to impact many businesses, lead time as well as sourcing new suppliers is increasingly difficult. If you currently outsource manufacturing overseas, it is likely you have encountered some turbulence to your supply chain.
Rapid prototypes and large-quantity production of…
This is supposed to be trade-show season. The time when companies send their employees to industry tech shows and user-group meetings to see and experience the latest offerings in their field. A time when companies expend a good portion of their budget on booth space, shipping costs, and hotel and…
David Pride
‘That escalated quickly!” is a common trope used in popular culture to describe when a situation gets out of hand before you’ve even had a chance to think about it. We don’t often use this trope in medicine, but I can think of nothing better to describe what has been going on in the United States…
Sean Spence
The outbreak of the Covid-19 virus in China and the railway disruptions across Canada represent two different yet similar classic case studies. They remind us that nations and global economies are becoming increasingly interconnected. Incidents thousands of kilometers away are being felt locally.…
William A. Levinson
The Chinese character for “crisis” means danger and opportunity. The coronavirus, aka Covid-19, outbreak has already wreaked havoc in the global economy, curtailed international and even domestic travel, and caused roughly 7,146 fatalities to date around the world.1 The reaction to this outbreak,…
Tom Taormina
Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall…
Nico Thomas
Each new year brings about a period of reflection, where one can think back on the path that the previous year took us on. 2020 represents an even larger opportunity for reflection as the world enters a new decade. Reflection provides an opportunity to learn and improve, and extends beyond just an…
Jack Dunigan
When the definition of power includes the “ability to exert influence,” then you’re also describing an element of leadership: knowledge. Take, for example, Ann Landers.
Ann Landers is a pen name invented by Chicago Times columnist Ruth Crowley in 1943 and taken over by Eppie Lederer in 1955. For…
Jon Speer
If you’re a medical device company manufacturing Class II or Class III devices, you can expect to have the U.S. Food and Drug Administration (FDA) turning up for an inspection. It’s what happens after that inspection that we’re concerned with in this article.
The unfortunate truth of the matter is…
Rupa Mahanti
We are currently living in the digital age and are drowning in an ocean of data. Organizations have a large number of data entities and data elements, and a large volume of data corresponding to the same, and they continue to amass more and more data with each passing day. With the large amount of…
Manfred Kets de Vries
Recently, I spoke to a CEO who had commissioned a survey on his organization’s health. To his great surprise—and that of his executive team—more than 80 percent of the respondents said that they were reluctant to speak their mind. They felt unsafe to express their opinions, doubts, or frustrations…
Gleb Tsipursky
Perhaps the worst quality failure of modern times is Boeing’s 737 Max disaster.
Due to the grounding of its 737 Max airplane following two deadly crashes that killed 346 people, Boeing lost $5 billion in direct revenue by summer 2019. The overall losses—ranging from damage to the brand to losing…
Ian Hesketh, Cary Cooper
Most people are familiar with presenteeism, where employees spend many more hours at the workplace than necessary—out of a sense of duty or to impress the boss or whatever. Presenteeism damages productivity, ultimately weakening the economy, and many companies now prioritize stamping it out.
A few…
Ken Voytek
I find that every so often it is good to step back and think about the current state of manufacturing in the broadest sense. We all see bits and pieces as part of our daily work with manufacturers across the country and from reading the news, but sometimes it can be difficult to fit those puzzle…
Randall Goodden
The manufacturing industry, stock market, and new product development have really taken off in the past four years, and there’s a lot of focus now on moving offshore manufacturing back into the United States. With all of this growth, it is also apparent that many manufacturing corporations are…
Matthew Hora
When her college started requiring students to complete an internship in order to graduate, it created a serious dilemma for Janelle.
“I wouldn’t be able to do classes, do the internship, and work to make money—which is kind of important because I’m basically just paying for school as I can,”…
NIST
Artificial intelligence (AI) promises to grow the economy and improve our lives, but along with these benefits, it also brings new risks that society is grappling with. How can we be sure this new technology is not just innovative and helpful, but also trustworthy, unbiased, and resilient in the…
Jon Speer
Believe it or not, paper is very expensive. Although the going rate for a ream of standard copy paper is only about 10 bucks, the expense of relying on paper for your medical device quality management system is downright outrageous.
Some medical device manufacturers have recognized how expensive…
Anne Trafton
After a patient has a heart attack or stroke, doctors often use risk models to help guide their treatment. These models can calculate a patient’s risk of dying based on factors such as the patient’s age, symptoms, and other characteristics.
While these models are useful in most cases, they do not…
Tom Taormina
In part one of this series, I said that I want to help my colleagues use their ISO 9001 implementation as a profit center and to turn risk-based thinking into risk avoidance. To do this I will share a set of tools that help evolve quality management into business management.
These tools include…
Kelvin Lee
Biopharmaceutical manufacturing uses living cells to produce therapies that treat diseases like cancer, diabetes, and autoimmune disorders. Manufacturing medicine using biology presents different challenges from the traditional chemical manufacturing processes that stamp out identical pressed pills…
Gleb Tsipursky
In the context of our increasingly disrupted, globalizing, and multicultural world, quality leaders greatly appreciate the security and comfort of clear-cut strategic plans for the future. After all, following our in-the-moment intuitions frequently leads to business disasters, and strategic plans…
William A. Levinson
The Automotive Industry Action Group’s (AIAG’s) and German Association of the Automotive Industry’s (VDA’s) new Failure Mode and Effects Analysis Handbook (AIAG, 2019) offers significant advances over FMEA as practiced 15 or 20 years ago.1 The publication is definitely worth buying because the new…
Michael Lueck
After the first crash, of Lion Air in Indonesia in October 2018, people blamed poor maintenance and insufficient pilot training. When a second airliner, an Ethiopian Air aircraft, crashed in March 2019, similarities quickly transpired. There was no apparent external influence such as poor weather.…
Anton Ovchinnikov
Left to their own devices, humans tend to fall prey to biases that make them poor decision makers. For instance, among other foibles, most purchasing managers routinely under-order. In fact, past research has shown that managers are typically 10 to 20 percent off the mark when it comes to ordering…
Miriam Boudreaux
If you are wondering whether your organization could benefit from formal root cause analysis (RCA) and corrective action training, read on to see if any of these issues are present in your day-to-day operations. RCA and corrective actions are some of the most useful tools for continual improvement…
Penelope B. Prime
The United States and China have reportedly reached a so-called phase one deal in their ongoing trade war.
While few details have been disclosed, the agreement principally seems to involve the United States calling off a new round of tariffs that were slated to take effect on Dec. 15, 2019, and…
Nathan Furr
Few companies and CEOs have attracted as much praise, derision, skepticism, and enthusiasm as Telsa Motors and its founder Elon Musk. Having interviewed Musk and the Tesla leadership as part of my research, one of the questions I’m asked most frequently is: How can you make sense of Tesla’s wild…
Dirk Dusharme @ Quality Digest
What a year.
No matter your job, your industry, or your political beliefs, this year has been a heck of a ride. The (still ongoing) trade war with China, manufacturing gains (and losses), the 737 MAX, Hong Kong riots, North Korea, Brexit, impeachment. What a mixed bag of ups and downs that has…
As usual with Quality Digest’s diverse audience, this year’s top stories covered a wide range of topics applicable to quality professionals. From hardware to software, from standards to risk management, from China trade to FDA regulations. It’s always fun to see what readers gravitate to, and this…
Anat Amit-Eyal
Eric, a 40-something married father of three, runs a successful startup. Given his demanding career, he and his wife decided she would be a stay-at-home mum. Eric believed the attention he devoted to his family was adequate, and that he had fully harmonized his work as CEO and life as a family man…
Michael Millenson
In late November 1999, a TV producer called me about an alarming report that 44,000 to 98,000 Americans were being killed each year by preventable errors in hospitals, and another 1 million were being injured. Could that be true? Based on my research, I replied, the estimate seemed low.
The “To…
Davis Balestracci
During the late 1970s, quality began to evolve from its historically Neanderthal, passive inspection approach to its current Cro-Magnon state, where its more proactive, project-based approach is bolted on to the operational status quo. Joseph Juran was a pioneer in such efforts. Various subsequent…
Clifton B. Parker
An underlying theme emerged from the Stanford Institute for Human-Centered Artificial Intelligence’s fall conference: Artificial intelligence (AI) must be truly beneficial for humanity and not undermine people in a cold calculus of efficiency.
Titled “AI Ethics, Policy, and Governance,” the event…
Gleb Tsipursky
When was the last time you as a quality professional saw a major failure in implementing decisions? What about in project or process management? Such disasters can have devastating consequences for high-flying careers and successful companies. Yet they happen all too often, with little effort taken…
David Hart
Climate plans are the order of the day in the presidential primary campaign because carbon pollution is a global threat of unique proportions. But it’s worth asking whether candidates’ plans are based in the reality of the climate, the economy, and the election.
All three dimensions must come…
Heather Thompson
Software as a medical device (SaMD) is a growing sector in medical device technology. Through the use of artificial intelligence and machine learning, SaMD has the power to influence health on a global scale as well as allow for personalization in medicine and life-saving therapies.
Medical device…
Matt Kunkel
Third-party vendors are increasingly working with their own third parties (fourth and fifth parties), spreading your data across many different vendors. This can make your company an easy target for cybersecurity threats, especially if your organization is a hospital or part of the healthcare…
ISO
As artificial intelligence (AI) becomes increasingly ubiquitous in various industry sectors, establishing a common terminology for AI and examining its various applications is more important than ever. In the international standardization arena, much work is being undertaken by ISO/IEC’s joint…
Chad Kymal
With the advent of the internet, cloud, and electronic workflows, what is the future of documented management systems? Do we continue with a structure of quality manual, processes, work instructions, and forms and checklists? How do we imagine the future of documented management systems?
For…
Dileep Thatte
According to information from the Centers for Disease Control and Prevention (CDC), every year 48 million people in the United States get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases. That means one in six people in the United States get sick from contaminated food every 12…
Boris Liedtke
In May 2019, a California jury found Monsanto’s weed killer, Roundup, to be a “substantial factor” in the cancer suffered by a couple and ordered the U.S. agrochemical company to pay them $2 billion in damages. This was the third and largest verdict against Monsanto, now owned by German…
Kartik Hosanagar
Much has been written about the challenges associated with AI-based decisions. Some documented failures include gender and race biases in recruiting and credit approval software; chatbots that turned racist, and driverless cars that fail to recognize stop signs due to adversarial attacks;…
Taran March @ Quality Digest
So it seems the contentious wall along our southern border, variously known as the Trump wall or the Mexico-United States barrier, isn’t meeting requirements. Walls keep people in; walls keep people out. They serve as backdrops for graffiti. But aside from fulfilling the last item, this wall might…
Theodoros Evgeniou
It seems that every week, AI technology has learned to do something humans do, but faster and better. From detecting cancers and eye conditions to predicting floods; or analyzing the language, tone, and facial expressions of candidates during recruitment processes, AI is now at the stage where it…
Frances Brunelle
Just as baby boomers on the manufacturing plant floor are getting ready to retire, so are the owners. More than 5,000 small manufacturing operations (with annual revenues between $2 and $20 million) will either close their doors or find new owners during the next five years.
Some of these owners…
Michael Fagan
Technology is supposed to help us, but sometimes it feels like for every step forward, we take two steps back. Like many people (and despite my resistance), my family has accumulated a few internet of things (IoT) devices in our home. Our motivation for acquiring them has been to streamline our…
Derek Benson
As a quality professional, you’ve probably heard the famous quote from W. Edwards Deming, “In God we trust; all others bring data.” Thanks to technological advancements in our industry, data exist more abundantly than ever. This presents a new challenge for those tasked with extracting and…
Pavel Kireyev
Good salespersonship is a species of street smarts. It’s about quickly sizing up your customers and pitching your wares in terms that reverberate with their unspoken needs and desires. As artificial intelligence (AI) and machine learning increasingly intersect with e-commerce, these priceless human…
Paige Needling
Amidst a sea of alarming cybersecurity statistics, there’s one that perfectly captures today’s reality. It’s from a 2019 Trend Micro survey, which says: “80 percent of all businesses expect to be hacked this year.” Not “perhaps” or even “likely.” But will be hacked.
And perhaps worse, only 39…
Suman Sarkar
Most people attribute business disruption to technology, thinking of the iPhone, 3D printing, robotics, and artificial intelligence. However, technology alone does not cause disruption. The iPhone didn’t succeed because of its technology; it succeeded because it met customer needs better than any…
Himanshu Singh
The most noteworthy and significant change in data privacy regulation in more than 20 years recently came by way of the General Data Protection Regulation (GDPR) in the European Union (EU). Being GDPR-compliant has become an important consideration in the way data are stored, handled, and processed…
Jesse Lyn Stoner
Have you created a vision? You might be excited about it, but are others? Does your vision inspire, motivate, and guide decision making?
It’s better to test your vision now than to find out later that it’s simply a wall decoration.
And if you already created a vision a while ago, it’s still…
J. Stewart Black
For growth-starved Western entrepreneurs, the Chinese market is appealing. Think about it: Since 1995, China’s economy has grown by a factor of 18.5, from $735 billion to $13.6 trillion (excluding Hong Kong). In terms of purchasing power parity, it is now the No. 1 economy in the world.…
Inderjit Arora
Every company uses a system to understand the requirements and inputs of its customers, and then plans to deliver outputs meeting those requirements as a conforming product or service. The International Organization for Standardization (ISO) publishes management system standards that, when…
Dylan Walsh
In principle, the mountaineer’s work is simple: “To win the game he has first to reach the mountain’s summit,” said George Mallory, who took part in Britain’s first three attempts on Everest during the 1920s. “But, further, he has to descend in safety.”
The tension between these two goals—…
Jeffrey Hirsch
Science fiction has long imagined a future in which humans constantly interact with robots and intelligent machines. This future is already happening in warehouses and manufacturing businesses. Other workers use virtual or augmented reality as part of their employment training, to assist them in…
Chad Kymal
Organizations in the automotive and related industries such as steel, plastics, and semiconductors have been heavily influenced by automotive industry standards and practices like IATF 16949, advanced product quality planning (APQP), failure mode and effects analysis (FMEA), and production parts…
Rachel Ehrenberg, Knowable Magazine
This story was originally published by Knowable Magazine.
If you’re lucky, you’ve tasted a perfectly ripe fruit—a sublime peach, perhaps, or a buttery avocado. But odds are most of the fruit you’ve eaten tastes more like wet cardboard. Although plant breeders have mastered growing large, perfect-…
Daniel Hess
We all expect hospitals to be open and operating when we need them, but extreme weather events like hurricanes are a strain on resources and pose significant challenges for hospitals.
Closing a hospital is an extreme action, but several hospitals in Florida, Georgia, and South Carolina did just…
DNV GL
Workplace safety is a complex issue, addressing everything from rules for operating heavy machinery to guidelines for respecting your fellow employees. For many of these issues we, as a business community, have developed and applied a variety of best practices and global standards—such as ISO 45001…
Sébastien Breteau
Whether it be a move forced by the U.S.-China tariff turmoil, or a sourcing strategy long in the works, the exodus from China is a reality for a host of businesses, from small to medium-sized enterprises to multinationals.
While the departure is widespread, it isn’t universal—some major players,…
Krystle Morrison
From carrying food in from the field, to shipping processed products, to assembling a supermarket display, packaging matters. As a follow-up to our exploration of emerging trends in food packaging, we’re taking a look at several innovative technologies that could change the future of packaging.…
Britta Voss
When you email friends, you don’t have to worry about whether they use Gmail, Outlook, Yahoo, or some other email provider. You just enter their email address, write your message, and hit send. The reason this works is because there are layers of standardized protocols that all the email clients…
Sharona Hoffman
A career as a physician has traditionally been considered to be among the best vocations that talented students can pursue. That may no longer be the case. All too many doctors report that they are unhappy, frustrated, and even prepared to leave the profession.
That should worry all of us. The…
Jill Barshay, Sasha Aslanian
When Keenan Robinson started college in 2017, he knew the career he wanted. He’d gone to high school in a small town outside Atlanta. His parents had never finished college, and they always encouraged Robinson and his two older siblings to earn degrees. Robinson’s older brother was the first in the…
Ekim Saribardak
Transporting cargo over long distances has always been a logistical nightmare, but when the goods are of a delicate nature, the whole operation becomes significantly more challenging. Perishable foods, chemicals, pharmaceutical products, and other delicate goods all need special treatment during…
Peter Rose
On May 26, 2020, the new European Union Medical Device Regulation (MDR) will finally take effect. By that date, all Class I manufacturers wishing to continue their trading activities within the EU market must have effectively completed the transition from the previous medical device directive and…
Knowledge at Wharton
From a lone statistician toiling over narrowly defined problems for the marketing department, to a C-level executive overseeing a mission-critical area impacting every function of the company, the meaning of “data and analytics professional” has changed a lot in recent years. A. Charles Thomas’s…
Natasha Gilbert, Knowable Magazine
This story was originally published by Knowable Magazine.
Alfalfa, oats, and red clover are soaking up the sunlight in long narrow plots, breaking up the sea of maize and soybeans that dominates this landscape in the heart of the U.S. farm belt. The 18 by 85 meter sections are part of an…
The Un-Comfort Zone With Robert Wilson
When I was 7 years old, I went into the woods behind my house, built a fire, then fried an egg over it in an old pie tin. When the egg was done, I ate it. I didn’t even like eggs, but because I had cooked it on my own, it was delicious.
I was so proud of my achievement that I ran inside and told…
David Blustein
On the surface, the well-being of the American worker seems rosy. Unemployment in the United States hovers near a 50-year low, and employers describe growing shortages of workers in a wide array of fields. But looking beyond the numbers tells a different story.
My new book, The Importance of Work…
Ziv Carmon
Counterfeiting is widespread and rapidly expanding. In 2015, the value of fake and pirated products globally was estimated at $1.7 trillion, equivalent to the GDP of Canada. The scope of this phenomenon is vast. In both developing and developed countries, counterfeiting affects many sectors,…
Stephen McCarthy
In our constantly evolving, data-rich universe, collecting, interpreting, and understanding process data can be tricky. But it is increasingly important if we want to maintain sustainable quality across product development and manufacturing processes. This challenge is particularly evident in the…
Jim Benson
Responsibility. It’s a hard word to come to grips with. What is the responsible thing to do right now? What is my personal responsibility? What is my responsibility as a team, family, company, state, or country member? What do I expect from others?
The world now is in transition, from being…
Ben Brumfield
For decades, Krishan Ahuja tamed jet noise, for which the National Academy of Engineering elected him as a new member this year. Today, Ahuja is an esteemed researcher at the Georgia Institute of Technology, but he got his start more than 50 years ago as an engineering apprentice in Rolls Royce’s…
Michael D. Williams
As I spoke recently with colleagues at a conference in Florence, Italy, about healthcare innovation, a fundamental truth resurfaced in my mind: the U.S. healthcare industry is just that. An industry, an economic force, Big Business. It is a vehicle for returns on investment first and the success of…
Gabriel Hawawini
Given the recent, renewed intensification of the shareholder vs. stakeholder debate, the concept of value creation has become more ambiguous. On whose behalf should organizations generate value? For owners, employees, upstream and downstream partners, or local communities immediately affected by…
Barnaby Lewis
Put in the terms of this article’s title, most of us would run a mile, whatever the proposition. But the popularity of online reviews, and the trust we place in persons unknown when making major decisions about where to stay, what to eat, and how to get the most from a trip, tells a different story…
Rob Matheson
In the Iron Man movies, Tony Stark uses a holographic computer to project 3D data into thin air, manipulate them with his hands, and find fixes to his superhero troubles. In the same vein, researchers from MIT and Brown University have now developed a system for interactive data analytics that runs…
The FDA has announced an end to the alternative summary reporting (ASR) program for medical device manufacturers and will make the data publicly accessible.
The ASR program originally launched in 2000 when device manufacturers sought an “alternative summary” reporting exemption. ASR permitted…
Manfred Kets de Vries
David was extremely gratified when he was named businessman of the year. He felt he deserved the recognition. Many articles had portrayed him as an entrepreneur who had reframed his industry, which gave him the courage to make his boldest move yet: taking over his largest competitor.
Some analysts…
Knowledge at Wharton
For decades, relatively easy access to space and the big profits to go with it have dangled elusively just over the horizon. With a little more R&D money and a few more advances in the technology, the thinking went, space would be ours.
Are we there yet? More than a few signs are pointing in…
Stephen Rice, Scott Winter
As driverless cars become more capable and common, they will change people’s travel habits not only around their own communities but across much larger distances. Our research has revealed just how much people’s travel preferences could shift, and found a new potential challenge to the airline…
Romesh Saigal, Abdullah AlShelahi
Soon after the Great Recession, the U.S. stock markets plunged—and rebounded within 36 minutes. The Dow Jones Industrial Average dropped more than 9 percent, losing more than 1,000 points before suddenly recovering.
This May 6, 2010, event was the first recorded “flash crash.” Although it didn’t…
Sameer Hasija, Vivek Choudhary
One fine morning in 1909, Henry Ford made a surprise announcement during a company meeting. In the future, Ford Motor would stick to a single car model, the Model T, in black only. No other choices, or as he said, “Any customer can have a car painted any color that he wants so long as it is black…
Knowledge at Wharton
CEOs are stepping forward to confront public policy issues that often extend beyond their core business, in part at the urging of their employees, write Caroline Kaeb and David Scheffer in this opinion piece. Kaeb is co-chair of the Business and Human Rights Pillar and a senior fellow of the…
Boris Liedtke
‘Any customer can have a car painted any color that he wants,” said Henry Ford in 1909, “so long as it’s black.” Ford’s strategy of standardization and efficiency made a runaway success of the Model T car and built Ford Motor Co. into one of the world’s biggest automakers. But 110 years on,…
Matthew M. Lowe
While most business sectors have welcomed the efficiencies and benefits that cloud technologies and software-as-a-service (SaaS) offerings bring, the life sciences industry has been slow to embrace external cloud networks. Merely a decade ago, in fact, an International Data Corp. survey showed that…
James J. Kline
The term “risk-based thinking” (RBT) is familiar to those in the quality profession. This familiarity comes in part from its inclusion in ISO 9001:2015, the International Organization for Standardization (ISO) quality management system standard. Although numerous articles and several books have…
Kevin Price
In the world of risk management, maintenance of mission-critical equipment drives priorities and budgets. It is the ultimate test of proactive maintenance and smart decision making. Managing assets that “cannot be allowed to fail” is more than an emotionally charged mandate that forces managers…
Venkat Viswanathan, Shashank Sripad, William Fredericks
As electric cars and trucks appear increasingly on U.S. highways, it raises the question: When will commercially viable electric vehicles take to the skies? There are a number of ambitious efforts to build electric-powered airplanes, including regional jets and planes that can cover longer…
Shobhendu Prabhakar
Someone recently asked me why quality failures and safety incidents continue to occur despite organizations communicating their quality and safety visions to the workforce, developing and implementing quality and safety management systems, and campaigning day in and day out about quality and safety…
Ronda Culbertson
The AS9100 family of standards has completed very important updates, raising the business management quality bar again for aerospace and defense suppliers and OEMs. The transition to the new standards caught quite a few organizations somewhat flat-footed; particularly with the emphases on risk…
AssurX
Last month an investigative report revealed that the U.S. Food and Drug Administration (FDA) has millions of “hidden” serious injury and malfunctions reports on medical devices. According to the report from Kaiser Health News, “Since 2016, at least 1.1 million incidents have flowed into the…
Ryan E. Day
More and more, manufacturers are becoming the target of hackers, but what can they do about it, if anything? It seems every month, maybe even every week, we hear about some sort of data breach or cyberattack. Think Facebook, Google, and Marriott. As consumers we’ve almost become inured to the idea…
Beth Humberd, Scott Latham
Walmart recently announced it plans to deploy robots to scan shelves, scrub floors, and perform other mundane tasks in its stores as the retail giant seeks to lower labor costs.
Although the retail giant did not say which jobs, if any, might be lost as a result, the announcement—and the many more…
Paul Foster
When you look at standards like IATF 16949 or ISO 9001, the requirements boil down to two essential elements: improving customer satisfaction and reducing risk.
They go hand in hand because effective risk management means safer products and happier customers—and fewer problems for their suppliers…
Jeffrey Phillips
One of my favorite quotes comes from George Bernard Shaw, who said that all change in life originates from unreasonable people. Reasonable people, he said, will accept the status quo and change their lives to adapt to the status quo. Unreasonable people won’t. Unreasonable people force change…
Robyn Metcalf
In an outbreak that has now run for more than 28 months, at least 279 people across 41 states have fallen ill with multidrug-resistant Salmonella infections linked to raw turkey products. Federal investigators are still trying to determine the cause. In response to food company recalls, more than …
Morgan Sliff
Boeing has been rife with issues lately. While the recent Ethiopian Airlines crash has dominated headlines and elicited an FBI investigation into the company, another federal body has stated it will be keeping a closer eye on Boeing’s safety shortfalls.
Boeing is now in hot water with the U.S. Air…
Matthew M. Lowe
It’s human nature to resist change, and the life sciences industry is not exempt from a change-averse mindset. The proof: Life science organizations (LSOs) lag far behind counterparts in other sectors in implementing digital technologies that are designed to streamline business and manufacturing…
Theodoros Evgeniou
History indicates that major technological changes can take about half a century to go from the first lab drawings to society. Alan Turing first proposed the Turing machine, laying the foundations of computation, in 1936; the first general-purpose “Turing-complete” system was built in 1945, and “…
Sylvain Charlebois
Your own voice will likely become the most significant focus for food retailers and restaurants in the immediate future. Voice searches are increasingly becoming the norm. A recent study suggests that more than 50 percent of all online searches will be voice-activated by 2020.
To a lesser extent,…
Ryan E. Day
According to the International Labor Organization, around the world every day 7,600 people die from work-related accidents or diseases—that’s more than 2.78 million people every year. To address the issue, the International Organization for Standardization (ISO) has developed a standard, ISO 45001…
Stephen Rice, Scott Winter
In the wake of the Lion Air and Ethiopian Airlines crashes of Boeing 737 Max planes, people are thinking about how much of their air travel is handled by software and automated systems—as opposed to the friendly pilots sitting in the cockpit.
Older commercial airliners, such as the Beechcraft 1900…
Rachel Mann
With medical cannabis being legal in Canada since 2002, and recreational use becoming legal in 2018, Prime Minister Justin Trudeau’s promise to his country has caused a storm.
This legal framework has given Canadian companies the leverage to lead the cannabis industry to new heights. Not only…
Kelli Matthews
In a crisis, time is not on your side. A crisis creates a vacuum, an informational void that gets filled one way or another. The longer a company or other organization at the center of the crisis waits to communicate, the more likely that void will be filled by critics.
That’s exactly what’s…
Ismael Belmarez
Given the number of meetings most organizations have, you’d think everyone couldn’t help but be on the same page. Sort of a natural, automatic byproduct of spending so much time together. Nice idea, but not really true.
In fact, organizing is one of the most difficult things for an organization to…
Tom Taormina
Outsourcing is historically one of the most misunderstood concepts in quality management system (QMS) implementation and operation. Prior to ISO 9001:2015, the requirement for outsourced processes was limited to a few sentences in the standard’s clause 4.1. This article will present, through a case…
Shobhendu Prabhakar
Historically, conventional wisdom among business managers was that the higher the quality, the higher the cost. This perception still holds true today among a few business managers. Common sense also tells us the same thing, i.e., to create higher quality products or services, organizations will…
Chad Kymal
When we think about IT security, we typically think about the large hacks that were reported in the press. When viewed as a whole, we can understand the magnitude of lost data. It’s no surprise that these hacks are what come to mind when we think about information security.
The table below shows…
Oihab Allal-Chérif
In just five short months, two Boeing 737 Max 8 airliners crashed, killing a total of 346 passengers and crew members. Both crashes occurred shortly after takeoff, and the similarities between the two catastrophes raised fundamental questions about the aircraft’s safety. It was grounded by nation…
Claire Harbour, Antoine Tirard
Born to a Dalit family, Megha was raised in Southwest India and learned English at her convent school. As a child, she aspired to be a fashion designer or a cardiologist, but her parents insisted that she become an IT engineer. After four years of higher education, Megha found a job in the booming…
Taran March @ Quality Digest
Life science companies are no strangers to data, so it would be easy to assume they are adept at making innovative use of huge amounts. Not necessarily. A tradition of rigorous scientific method and clinical trial hasn’t prepared them for the shifting inundation of big data or all its baffling…
Knowledge at Wharton
Many people work on their goals by engaging in positive actions—hitting the gym, planning a trip, or taking guitar lessons. But they may be overlooking one of the most important tools for effecting change: the power of thought.
Harvard Business School professor emeritus Gerald Zaltman recommends…
Ryan E. Day
I love standards, and whether you know it, you love standards, too. For example, let’s say a bulb in your lamp goes bad. You drive down to the local hardware store, buy a bulb, come back home, change out the bulb, plug the lamp back in, and... it lights up. You just benefited from at least seven U.…
Nicole Radziwill, Graham Freeman
In 2013, thousands of consumers in the United Kingdom (UK) and Ireland bought, prepared—and ate—beef lasagna, hamburgers, and frozen dinners. What they didn’t know is what they were actually putting in their mouths.
Although a burger is only required by law in that region to contain 47-percent…
Kelly Kuchinski
Imagine building a brand over decades. Hundreds of millions of dollars invested in design and development. Sponsorships with celebrity athletes and professional and college teams. Leading-edge marketing making your company one of the top 20 brands in the world. It only takes one incident to unravel…
NIST
Engineers at the National Institute of Standards and Technology (NIST) needed a way to secure smart manufacturing systems using the digital thread, so they turned to the new kid on the block... blockchain, that is.
According to a new NIST report, the security system better known for underpinning…
Knowledge at Wharton
In the 1999 film Office Space, a dark comedy about the mundane conventionality of work, disgruntled software engineer Peter Gibbons tells his new love interest, Joanna, that he hates his job and doesn’t want to go anymore.
When Joanna, played by actress Jennifer Aniston, asks Peter whether he is…
William A. Levinson
The Pareto principle calls for focus on the vital few rather than the trivial many. While none of ISO 9001’s clauses are trivial—a nonconformance for any of them requires corrective action—ISO 9001 users can avoid most nonconformances by focusing on the clauses that are the most frequent trouble…
Mike Richman
Great quality is pretty much the same everywhere, but the cost of poor quality is not equivalent from industry to industry. For example, it’s conceivable (but I hope not probable) that this article may turn out to be a real bomb, or worse, a complete snoozer. What’s the cost of that poor quality?…
Quality Digest
Within the life science industry, federal and industry regulations have prompted the need for compliance, and that trend has only increased in magnitude and complexity. Along with that has come technological solutions to enable both compliance and efficiency, without which life science…
Laurel Thoennes @ Quality Digest
Compliance to U.S. Food and Drug Administration (FDA) regulations has come a long way in the past 30 years. Here are the main changes. Have they affected your business?
1988: Food and Drug Administration ActOfficially establishes the FDA as an agency of the Department of Health and Human Services…
Dirk Dusharme @ Quality Digest
As the United States struggles with rising healthcare costs, reducing the amount of money pharmaceutical companies spend dealing with regulation, while at the same time meeting drug safety requirements, would seem to be competing interests.
The goal of any honest pharmaceutical company is to make…
Taran March @ Quality Digest
It’s been a year and a month since Stephen McCarthy switched C suites, moving from Johnson & Johnson, where he served as vice president of quality system shared services, to Sparta Systems, where he’s now vice president of digital innovation. His focus has switched as well.
At J&J, he…
Graham Freeman
Many industries have no clear boundary between safety and quality culture. In fact, they are often closely integrated. Quality failures and nonconformances that require rework have been correlated with increased accidents and recordable injury rates in manufacturing organizations. These injuries…
Chip Bell
Visioning beyond the customer is the responsibility of every person interested in a competitive advantage.
What do Bill Marriott, Ray Kroc, and Al Hopkins have in common?
No, they are not all people of wealth and fame. In fact, Hopkins is a small-town accountant and part-time preacher. They all…
Zac Cooper
The role of quality starts with product design and moves rapidly across the supply chain to the selling and buying experience, which includes the bidding process. When operating a formal continuous process improvement program, nearly all manufacturing engineers are tasked with some level of quality…
Dirk Dusharme @ Quality Digest
We interview Stanley Chao, author of Selling to China: A Guide for Small and Medium-Sized Businesses (iUniverse, 2018), about the impact of the current U.S.-China trade war. Does China really care, and where do U.S. multinationals go from here? Also, a quick look at Conformance Manager, a web-based…
Brian Strzempkowski, Shawn Pruchnicki
When Amelia Earhart took off in 1937 to fly around the world, people had been flying airplanes for only about 35 years. When she tried to fly across the Pacific, she—and the world—knew it was risky. She didn’t make it and was declared dead in January 1939.
In the 80 years since then, many other…
Wolfgang Ulaga
Offering free services may seem like a good way to keep customers happy, but how much money is your business leaving on the table? By redefining freebies as paid opportunities, B2B firms can generate new sources of income and secure long-term growth.
This not to say that companies should stop…
Stanley Chao
This past year has created havoc for Western companies purchasing raw materials, furniture, high-tech components, auto parts, and power tools from China. And the rocky relationship continues into 2019 as both countries continue to negotiate while kicking the can down the road toward a new March 1,…
Stephen Fankhauser, Matt Ebbatson
The world is running out of experienced pilots. Supply is not keeping up with the growing demand for air travel. In Australia, the effects are already starting to bite. Even flagship carrier Qantas is having problems. In recent months it has had to perform a very nimble tap dance to crew its vast…
Richard Harpster
On Oct. 13, 2018, the Automotive Industry Action Group (AIAG) sponsored a webinar on the status of the AIAG Core Tools Software (AIAG CTS). John Cachat, AIAG project manager for the AIAG CTS project, was the presenter for the webinar. The presentation provided information on why the AIAG was…
Dirk Dusharme @ Quality Digest
We tied up last year in a neat little bow, talking about how stories define ourselves and our work; waste is waste, no matter your political leanings; and putting numbers from the news in context.
“The Gift of Being Small” This article by Quality Digest’s Taran March wonderfully illustrates how we…
William A. Levinson
The U.S. government’s Fourth National Climate Assessment warns that climate change “creates new risks and exacerbates existing vulnerabilities in communities across the United States, presenting growing challenges to human health and safety, quality of life, and the rate of economic growth.” The…
Wudan Yan, Knowable Magazine
Nearly every month, it seems, comes a new report. In March 2018, there was news of contaminated romaine lettuce, which eventually led to five deaths and sickened more than 200 people across the United States and Canada. In May 2018, about 100 people in California got sick after eating raw oysters…
Mike Richman
This Thursday, for the first Thanksgiving in decades, I won’t be watching football, drinking beer, and stuffing myself into oblivion. Instead, I’ll be serving the homeless, giving clothes, and making myself useful.
Thanksgiving is always a time to give thanks—I mean, it’s right there in the holiday…
Paul Foster
Next to defining a problem accurately, root cause analysis is one of the most important elements of problem-solving in quality management. That’s because if you’re not aiming at the right target, you’ll never be able to eliminate the real problem that’s hurting quality.
So which type of root cause…
Amy Mahn
The NIST Cybersecurity Framework consists of standards, guidelines, and best practices to manage cybersecurity-related risk. The framework’s prioritized, flexible, and cost-effective approach helps to promote the protection and resilience of critical infrastructure and other sectors important to…
Ryan E. Day
BioBridge Global (BBG) is a parent organization for four subsidiary organizations, three of which are involved in production activities, and they’re all around regenerative medicine, including blood components, clinical laboratory testing, and cell and tissue therapies. Organizations in the life…
Dirk Dusharme @ Quality Digest
The Dec. 31, 2018 deadline looms for medical device companies that sell their devices in Canada. On that day, any company that sells medical devices to Canada will either need to hold an MDSAP certificate or show proof that they are on track to be MDSAP certified, or they won’t be able to sell…
Ryan E. Day
One of the unique aspects of Finch Therapeutics is that although its product does not fall easily into any regulated category and thus is not FDA-approved, the company has been working closely with the agency for at least five years. The FDA has broad jurisdiction to regulate all health products,…
Matthew M. Lowe
Life science companies play a major role in the global economy, with revenues expected to reach a staggering $1.5 trillion by 2020.1 Such a rosy forecast is likely to attract innovators and encourage current industry players to blaze new trails. Whether new or established, life science companies…
William A. Levinson
Chad Kymal1 gave an excellent overview of the ISO 45001 occupational health and safety (OHS) standard that was released in March 2018. I purchased a copy of the standard, and it provides an excellent framework, modeled on Annex SL, which defines the structure of all the new ISO standards, for an…
The Un-Comfort Zone With Robert Wilson
Last year I was invited to give a lecture on critical thinking to the U.S. Navy. I opened my presentation with a story I’d read in Reader’s Digest magazine as a child. It’s an old story you may have heard before, but it’s a perfect introduction to the importance of critical thinking. Here’s how it…
Mike Richman
Our industry embodies many aspects, but “Big Q” quality generally involves issues affecting management, measurement, and methodologies. This week on QDL, we covered all of them, and more. Let’s look closer:
“Ripped from the Headlines: Tariff Fallout” U.S. manufacturers are currently dealing with…
Mike Richman
For manufacturers in diverse sectors such as automotive, aerospace, electronics, and medical device, there’s little question that ensuring great quality would be impossible without the proper testing of materials. And proper material testing applications begin with reliable and repeatable…
Andreas Engelhardt
An international standard that specifies requirements for an occupational health and safety (OH&S) management system, ISO 45001:2018—“Occupational health and safety management systems–requirements” replaces OHSAS 18001 as the primary OH&S standard used internationally. It follows other…
Anthony Chirico
In my first article, the merits and cautions of AS9138 c=0 sampling plans were discussed and a simple formula was provided to determine the required sample size to detect nonconforming units. In the second article, the process control properties of MIL-STD-105 c>0 sampling plans were…
Anthony Chirico
In my previous article, I discussed the merits and cautions of the “acceptance number” equal zero (c=0) sampling plans contained within AS9138. A simple formula was provided to determine appropriate sample size, and it was illustrated that twice the inspection does not provide twice the consumer…
Dan Jacob
LNS Research published its research, “Driving Operational Performance With Digital Innovation: Connecting Risk, Quality, and Safety for Superior Results” to address fundamental challenges quality and safety leaders face today.
If quality and safety are separate functions in your organization (…
Anthony Chirico
Aerospace standard AS9138—“Quality management systems statistical product acceptance requirements” was issued this year (2018), a few years after its accompanying guidance materials in section 3.7 of the International Aerospace Quality Group’s (IAQG) Supply Chain Management Handbook. The new…
Gary Marchionini
As millions of people came online iduring the late 1990s, they needed help figuring out what each web page was about, and how to find what they were looking for. Web indexes and search engines sprang up. When Google was founded in September 1998, it had to compete with the information retrieval…
Bita Kash, Stephen L. Jones
Can you imagine a future where the question, “Did you bring a copy of your test results?” becomes entirely unnecessary? That could happen, but the methods that most healthcare providers use to exchange healthcare information are little different than they were 5,000 years ago, when physicians…
Mike Richman
This week’s show contained a range of fun and interesting content from some of our favorite corners of the world of quality. Here’s what we covered:
“More Unidentified Museum Objects”
The National Institute of Standards and Technology has a wealth of crazy old artifacts from measurement days of…
Eryn Brown, Knowable Magazine
Alan Colquitt is a student of the ways people act in the workplace. In a corporate career that spanned more than 30 years, the industrial-organizational psychologist advised senior managers and human resources departments about how to manage talent—always striving to “fight the good fight,” he says…
Nicole Radziwill
ISO 31000 defines risk as “the effect of uncertainty on outcomes.” Identifying risks and determining ways to respond to them help you learn about your processes, your organization, and the environment you’re operating within. It also raises your awareness of how any of these things might change in…
Manfred Kets de Vries
A certain amount of stress is needed for us to function effectively. Stress is very much a part of the human condition. We all face disappointments, setbacks, losses and pain. But to live a rich and meaningful life, we must learn to deal in a constructive way with life’s challenges.
Stress evolved…
Oscar Combs
ISO 9001:2015, clause 6.1 requires an organization to identify its risks and take actions to address identified risks. It is very tempting to start with a huge list of potential risks for the organization, but is the organization focusing on the actual risks that have an effect on its operations?…
Richard Wilkinson
Whether it’s the effort to redefine the kilogram or researching the Harry Potter realm of quantum mechanics where things can somehow be in two or more places at one time, quite a bit of the science carried out at the National Institute of Standards and Technology (NIST) can be hard for the average…
Michael Jarrett
Transformational leaders are the exception, not the rule.
A consistent picture emerges from lists of top CEOs. In Harvard Business Review’s Best-Performing CEOs ranking, Pablo Isla of Inditex, the parent company of Zara; Ajay Banga of Mastercard; and Bernard Arnault of LVMH stand out for both…
NIST
Organizations worldwide stand to lose an estimated $9 billion in 2018 to employees clicking on phishing emails. We hear about new phishing attacks regularly from the news and from our friends. So why do so many people still click? NIST research has uncovered one reason, and the findings could help…
Mike Richman
‘Culture” is one of those business-speak words that’s used a lot, but for a good reason—having the right one is the key to unlocking your company’s quality potential. On the other hand, nothing will overcome a poor culture. Do you know which you have? We explored these issues during the Aug. 10,…
Morgan Ryan Frank, Iyad Rahwan
How do workers move up the corporate ladder, and how can they maximize their career mobility? Increased wealth disparity, increased job polarization, and decreases in absolute income mobility (i.e., the fraction of children who earn more than their parents) all suggest that upward mobility is…
Scott Gottlieb
There’s new technology that can improve drug quality, address shortages of medicines, lower drug costs, and bring pharmaceutical manufacturing back to the United States. At the U.S. Food and Drug Administration (FDA), we’re focused on propelling these innovations, collectively referred to as…
Mike Figliuolo
Legislative and regulatory changes can cause massive upheaval for your strategic plan. Elections happen all the time. New rules and regulations are proposed, implemented, or repealed on a daily basis. Court cases can change an entire industry landscape.
To stay on top of all these changes and to…
Mark Miller, Lucas Conley
Recently, General Electric—the last remaining member of the Dow Jones Industrial Average’s original 1896 index—was removed from the world’s most prestigious equity benchmark. News of the venerable brand’s dismissal from the Dow, the index of 30 large, publicly traded U.S. brands reflecting the…
AssurX
Proposed in 2012 and now in effect, the general data protection regulation (GDPR) is the newest landmark of data protection legislation. GDPR compliance legislation is designed to better protect personal data of individuals in the European Union (EU) by making companies more accountable for how…
Vanessa Burrows, Suzanne Junod, John Swann
During the early 20th century, Americans were inundated with ineffective and dangerous drugs, as well as adulterated and deceptively packaged foods.
A cosmetic eyelash and eyebrow dye called Lash Lure, for example, which promised women that it would help them “radiate personality,” in fact…
Dirk Dusharme @ Quality Digest
If asked whether you guard your company’s secrets, most of us would say, “Well, of course I do.” But I’m guessing that if you are a remote worker, or do any work while on the road, you are blithely handing out company secrets and don’t even know it. If nothing bad has happened yet, it’s only…
Thomas R. Cutler
Although automation has been successful in replacing repetitive, simple tasks, the human workforce still plays a critical role in manufacturing. Even the most sophisticated and automated manufacturing operations rely on human operators to configure, run, and properly maintain production equipment…
Fred Schenkelberg
Reliability activities serve one purpose: to support better decision making. That is all they do. Reliability work may reveal design weaknesses, which we can decide to address. Reliability work may estimate the longevity of a device, allowing decisions when compared to objectives for reliability.…
Aiman Sakr
Does your organization benefit from lessons learned? Does it learn from previous quality issues? A vast amount of learning takes place every day in every manufacturing facility. Do global manufacturing companies share experiences gained from resolving quality issues between overseas plants? And…
Rick Barker
Return on investment (ROI) is the subject of many discussions about ergonomics, and rightfully so. Musculoskeletal disorders are an expensive and preventable workplace injury, with total costs averaging nearly $30,000 per case, according to data from the Occupational Safety and Health…
Richard Wilson
According to the Verdantix global survey of 382 EHS decision-makers, 57 percent expect to use mobile apps in 2018 either widely across all their facilities, at multiple facilities, or as a pilot project at one facility. Mobile has become a game changer for modern quality management systems (QMS).…
Qi Alfred Chen, Z. Morely Mao
The day when cars can talk to each other—and to traffic lights, stop signs, guardrails, and even pavement markings—is rapidly approaching. Driven by the promise of reducing traffic congestion and avoiding crashes, these systems are already rolling out on roads around the United States.
For…
Sharona Hoffman
On June 12, 2018, the American Medical Association announced that drug shortages pose an urgent public health crisis. This crisis should be of concern to all Americans.
The Food and Drug Administration (FDA) defines a drug shortage as a “period of time when the demand or projected demand for a…
Matthew M. Lowe
The medical marijuana industry is being heralded as the new frontier in the life sciences, thanks to the potential of cannabis-derived products in treating ailments that range from chemotherapy-induced nausea to epilepsy and neuropathic pain. If you’re a startup in the industry, what does this mean…
Steven Brand
Many consider 2017 the “worst year ever” for data breaches and cyber attacks, largely due to the rise in ransomware, and IT experts predict it’s only going to get worse. According to the Online Trust Alliance (OTA), a nonprofit that works to develop tools and best practices that enhance internet…
Dirk Dusharme @ Quality Digest
In our June 15, 2018, episode of QDL, we get a field report from the HxGN LIVE user conference, examine the “story of quality,” and consider the importance of experience.
HxGN Live recap
Mike Richman went to HxGN LIVE... but I didn’t. I relive it vicariously through Mike’s field report.
“A…
Tim Lozier
Quality management systems (QMS) have become strategic components that touch more and more of the business today. With new versions of QMS standards, and the enrollment of all people in the quality management effort, the need for cohesion from one system to the next is becoming critical.
Let’s…
NIST
Augmenting its efforts to protect the nation’s critical assets from cybersecurity threats as well as protect individuals’ privacy, the National Institute of Standards and Technology (NIST) has issued a draft update to its Risk Management Framework (RMF) to help organizations more easily meet these…
Ryan E. Day
With the threat of a trade war between China and the United States looming, business relations between Asia and the West have not been this hot a topic since the Japanese Economic Miracle that was birthed shortly after WW II. Today, it is China’s turn on center stage as its soaring economic growth…
Dirk Dusharme @ Quality Digest
In part one we saw that China has made great strides in terms of product quality, notably in the tech sector. But it still has a long way to go in other products. Driven by the growing middle class, who like all middle class buyers want value for their money, and by the Chinese government’s desire…
Dirk Dusharme @ Quality Digest
Back in the 1950s and 1960s, Japanese products were synonymous with cheaply made. Anyone over the age of 50 probably remembers cheap Japanese transistor radios when they were a kid. We all believed, in the day, that the more transistors a radio had, the better. That wasn’t necessarily true, but try…
William A. Levinson
A job safety analysis (JSA) worksheet is almost identical in organization to a job breakdown sheet and standard work, all of which assess a job (or process) on a step-by-step basis. This suggests combining standard work with job safety analysis to support ISO 45001.
The concept can be carried even…
Mohammad Jalali
Like any large company, a modern hospital has hundreds, even thousands, of workers using countless computers, smartphones, and other electronic devices that are vulnerable to security breaches, data thefts, and ransomware attacks. But hospitals are unlike other companies in two important ways. They…
Matthew E. May
Process improvers the world over rally around root cause analysis as if it were the holy grail of all things organizational. But is it?
Understanding the root cause of a problem certainly makes sense in the context of a present day situation carrying the potential for a correct answer or solution…
Ryan E. Day
Unily is a leading digital workplace platform designed by BrightStarr to improve engagement, productivity, and efficiency for global enterprises. Unily is also a SaaS solution. That is, it’s served up via the cloud. Meaning that—with more than a million users, including the likes of Shell, Hershey’…
Terry Onica
The new automotive quality management system (QMS), IATF 16949:2016, was released in October 2016, and it officially went into effect on Jan. 1, 2017, along with revisions to IATF Rules for Achieving and Maintaining IATF Recognition, Fifth Edition. Starting Oct. 1, 2017, all automotive QMS audits…
Fred Schenkelberg
Mean time between failures (MTBF) is a symptom of a bigger problem. It’s possibly a lack of interest in reliability (which I doubt is the case). Or it’s a bit of fear of reliability.
Many shy away from the statistics involved. Some simply don’t want to know the currently unknown. It could be the…
BSI
Organizations worldwide recognize the need to provide a safe and healthy working environment, reduce the likelihood of accidents, and demonstrate they are actively managing risks. ISO 45001 will provide an internationally accepted framework that will help protect employees as well as protect the…
Ryan E. Day
So, the Quality Digest team is considering a transition to working remotely for the most part. I and two other associates already do. In part one of this series, I outlined my ad-hoc attempt at creating a computer work space at home. The result was not very pretty.
As I said in part one, my home…
Jay Zagorsky
The world is an uncertain and risky place. The news constantly bombards us with scary situations from school shootings to gruesome murders.
Risk is everywhere and associated with everything. For example, the Centers for Disease Control and Prevention a decade ago estimated 234,000 people a year…
Larry Emond
The number of publicly listed U.S. companies traded on U.S. exchanges has been cut almost in half during the past 20 years—from about 7,300 to 3,700—which goes to show that mergers and acquisitions are still a primary growth strategy.
In fact, 2018 looks to be another banner year for mergers and…
Sal Lucido
Policies and procedures tell your employees, partners, vendors, and customers how your system operates. With changing regulations and expectations, a static library is not enough. Policies are dynamic and require a system to manage their creation, documentation, distribution, and management. Here’s…
Marin Hedin
Limiting first-year medical residents to 16-hour work shifts, compared to “flexing” them to allow for some longer shifts, generally makes residents more satisfied with their training and work-life balance. It also makes their training directors more dissatisfied with curtailed educational…
Knowledge at Wharton
America’s healthcare system has been on the examining table lately: from the tortuous battle over the Affordable Care Act, to Senator Bernie Sanders’ bill to allow low-cost prescription drugs in from Canada, to the intriguing announcement in January that Amazon, Berkshire Hathaway, and JPMorgan…
Dirk Dusharme @ Quality Digest
On April 10, 2018, Facebook co-founder and CEO Mark Zuckerberg testified before Congress regarding the unauthorized sharing of 87 million Facebook users’ personal data, vacuumed up by data research company Cambridge Analytica. There were pointed questions regarding Facebook’s lack of transparency…
Martin Gordon
On March 15, 2018, a 950-ton partially assembled pedestrian bridge at Florida International University (FIU) in Miami suddenly collapsed onto the busy highway below, killing six people and seriously injuring nine. Forensic engineers are taking center stage in the ongoing investigation to find out…
Richard Harpster
The AIAG-VDA FMEA Handbook committee and everyone who responded to the request for comment on the proposed AIAG-VDA failure mode and effects analysis (FMEA) manual must be applauded for their efforts. Harmonizing the VDA and AIAG FMEA methods is not an easy task. According to industry sources,…
Mike Richman
During this past Friday’s episode of QDL, we presented two great interviews, both revolving around standards and certification, plus a piece about analytics, and a lively off-script about the responsibilities of media companies like Facebook when it comes to protecting user data. Here’s a closer…
Georgia Tech News Center
It’s small enough to fit inside a shoebox, yet this robot on four wheels has a big mission: keeping factories and other large facilities safe from hackers.
Meet the HoneyBot. Developed by a team of researchers at the Georgia Institute of Technology, the diminutive device is designed to lure in…
Mike Richman
During this past Friday’s episode of Quality Digest Live, our weekly web TV show, QD editor in chief Dirk Dusharme and I covered stories about the gig economy and the skills gap and workforce shortages within manufacturing, especially as it relates to metrology, which is the science of measurement…
Chad Kymal
ISO 45001 is the much-anticipated, first ISO-based international occupational health and safety (OH&S) standard. The International Organization for Standardization (ISO) has tried twice and failed in the past to create an international OH&S management system standard. Although there are a…
Kyle Rose
As I’m sure many of you know, the ISO 13485 standard for medical devices was updated in 2016, which means the time to transition your quality management system (QMS) is now. Most auditing organizations have either cut off ISO 13485:2003 recertifications or will be doing so very soon.
I was…
Mike Richman
QDL always strives to bring you a look at the people and stories making the news in the world of quality. We succeeded admirably on the “people” side of things this week and threw in a fun story about the physics of the basketball to boot. Let’s take a closer look:
“Clarity First Book Review and…
James Tehrani
People get overly tired. People get distracted; they get stressed and make poor decisions. People multitask when they shouldn’t. People lack training at times.
Our brains and bodies are machines, but they are imperfect ones. Even the most thorough and careful person will become an “err apparent”…
Tim Lozier
The concepts and frameworks behind quality management are evolving. As more companies adopt new technologies, and standards like ISO 9001:2015 begin to shift in focus, there is a concept that is arising out of Industry 4.0, the factory of the future, and the industrial internet of things (IIoT).…
Jeff Dewar
On Feb. 25, 2018, an asteroid 30 ft in diameter flew past the Earth, closer than the moon is to us. The newly discovered asteroid, named “2018 DU,” is the 17th known asteroid to fly past Earth within one lunar distance (the distance between the Earth and the Moon, approximately 250,000 miles)…
Laurel Thoennes @ Quality Digest
Employers can’t find people with the skills needed for the today’s workplace, because high schools and universities fail to teach students useful job skills. The skills gap is a decades-old and well-known problem that will remain unsolved unless we flip priorities not only in our school systems…
Ian Setliff, Amyn Murji
The current 2017–2018 flu season is a bad one. Hospitalization rates are now higher than in recent years at the same point, and infection rates are still rising. The best line of defense is the seasonal influenza vaccine. But H3N2 viruses, like the one that’s infecting many people this year, are…
Scott Shackelford
While some countries struggle with air safety, U.S. airplane travel has lately had a remarkable safety record. In fact, from 2014 through 2017, there were no fatal commercial airline crashes in the United States.
But those years were fraught with other kinds of trouble: security breaches and…
John Toon
Can companies rely on the results of one or two scientific studies to design a new industrial process or launch a new product? In at least one area of materials chemistry, the answer may be yes—but only 80 percent of the time.
The replicability of results from scientific studies has become a…
Knowledge at Wharton
When Tide and other detergent manufacturers developed colorful, convenient pods designed to be tossed into washing machines and dishwashers, they never expected teenagers would try to eat them. But what was dubbed the “Tide pod challenge” quickly went viral, with teens posting videos of themselves…
AssurX
Recent FDA warning letters indicate that many drug manufacturers do not have their manufacturing in a state of current good manufacturing practices (CGMPs) control. During the first half of 2017, the FDA cited adulterated products and insanitary conditions as the two most common violations in drug…
Dirk Dusharme @ Quality Digest
Our Feb. 9, 2018, episode of QDL looked at electronic notes, electronic privacy, smart electronic device, and... wow... have we taken technology too far?
“Study Shows Doctors Record Better Notes After Using Best-Practices Program”
Shortcuts to electronic note taking, such as autofill and copy…
Wendy Wood
Employers have a stake in their staff’s health. It’s not just a matter of keeping health insurance premiums in check which is a consideration in countries without universal healthcare. It’s also about maximizing employee engagement and productivity, and even happiness.
Promoting health habits is…
Fred Schenkelberg
MTBF use and thinking is still rampant. It affects how our peers and colleagues approach solving problems, and there is a full range of problems that come from using the “mean time between failure” (MTBF) metric.
So, how do you spot the signs of MTBF thinking even when MTBF is not mentioned? Let’…
Richard Harpster
Richard Harpster's op-ed is in response to a recent Quality Digest article and webinar discussing the benefits of the draft AIAG-VDA FMEA Handbook. As he points out at the end of this article, the AIAG has provided a means to solicit comments, pro or con, on the handbook. We encourage interested…
Michael Lynn
Some journalists and other social commentators have in recent years called for the abolition of restaurant tipping, primarily because they argue that it hurts workers. Several restaurateurs have even replaced tipping at their restaurants with automatic service charges or inclusive pricing.…
Annet Aris
After an initial phase of euphoria about how the digital world improves our daily life with virtual assistants, among other gadgets and services, slowly but surely, we're coming firmly back to earth. Post-honeymoon, the breakneck speed of digital development has created an increasing number of…
Jack Barkenbus
Every day about 100 people die in car crashes on U.S. roads. That death toll is a major reason why both Congress and the Trump administration are backing automotive efforts to develop and deploy self-driving cars as quickly as possible.
However, officials’ eagerness far exceeds the degree to…
Stanislav Shekshnia, Veronika Zagieva, Alexey Ulanovsky
During the last decade, we studied CEOs of companies that thrive within some of the most challenging business environments on the planet. Though very different in many respects, these CEOs share leadership behaviors and attitudes that strongly parallel those of top athletes. We further theorize…
Dirk Dusharme @ Quality Digest
Our Jan. 12, 2018, episode of QDL looked at smart manufacturing, remanufacturing, pants-on-fire bosses, and five things your QMS needs.
“Impatient With Colleges, Employers Design Their Own Courses”
Microsoft, Amazon, and others are teaming up with third-party online courseware providers to…
Abdesalam Soudi
Recently, while on my way to the University of Pittsburgh’s campus, I made a quick “Pittsburgh left”—taking a left turn just as the light turns green—while facing a driverless car.
Instead of jolting forward or honking as some human drivers would be tempted to do, the car allowed me to go. In…
Jenna Gallegos, Jean Peccoud
Biology is becoming increasingly digitized. Researchers use computers to analyze DNA, operate lab equipment and store genetic information. But new capabilities also mean new risks, and biologists remain largely unaware of the potential vulnerabilities that come with digitizing biotechnology.
The…
Richard Harpster
The concept of risk-based thinking has been implicit in previous editions of ISO 9001 through requirements planning, review, and improvement. But ISO 9001:2015 requires companies to use risk-based thinking to manage their business.
If you want to implement an ISO 9001:2015-compliant quality…
Bhargav Mitra, Robert McCausland
Google might be in trouble for collecting the personal data of its users, but many companies have a growing incentive to rid their hands of the data that users entrust them with. This is because of growing costs of holding onto it.
A major cause is the rising number of cyber attacks where hackers…
Scott Berkun
On Tuesdays I write about the top-voted question on “Ask Berkun.” This week’s question came from J.R., who wrote: “What is a favorite theory that you wish more people understood?”
A favorite theory that I wish was more well-known is the Satir Change Model. It’s popular in some circles, but often…
William A. Levinson
ISO 9001:2015, Clause 6.1—“Actions to address risks and opportunities,” relates to Clause 4.1—“Understanding the organization and its context.” The external context includes the social environment, which in turn includes social networking, a potentially devastating vehicle for the delivery of “…
Peter J. Strauss
The recent spate of natural disasters that devastated parts of North America included a violent variety of events. There were three major hurricanes—Harvey, Irma, and Maria—wildfires in California, an earthquake in Mexico, and tornadoes in Oklahoma.
One thing these calamities have in common: They…
Rob Magee
I have a friend who owns a hardware store. One morning during the 1980s, he strolled into his back-room office to start his day. He was shocked to discover his safe was missing—along with a lot of cash inside.
The thing is, when he’d arrived a few moments earlier, all the doors had been locked,…
Tab Wilkins
There’s no question the digital manufacturing revolution is racing at us. As a small or medium-sized manufacturer, how close are you to already being “smart?” Here are five steps in the journey to becoming a smarter digital enterprise.
First and foremost, be cybersecure. Cybersecurity is an…
Dirk Dusharme @ Quality Digest
Our Dec. 8, 2017, episode of QDL looked at smart manufacturing, remanufacturing, pants-on-fire bosses, and five things your QMS needs.
“Smart Manufacturing Trends in 2017”
The digital manufacturing environment, or smart manufacturing, is growing by leaps and bounds, and is spurred on by…
William A. Levinson
The recent revelation that a major steel maker falsified test data,1 and similar scandals at other companies,2 underscores the menace of counterfeit parts, or what a 1987 Senate hearing called COME UPS: COunterfeit MatErials and Unauthorized Product Substitutions. The history of COME UPS shows the…
Jay Desai
The presidential symposium at this year’s annual meeting of the Child Neurology Society of America in early October in Kansas City raised many eyebrows: The first presentation focused on burnout rates among neurologists around the country.
Many of my colleagues felt that this was an inappropriate…
ISO
A new version of ISO 31000:2009—“Risk management” is due to be unveiled early next year. As the threat of risks grows for governments, organizations, and the public alike, how can the new, streamlined standard help to make our future more secure?
Ten years ago, the boardrooms of banks and…
Jon Speer
What exactly is a risk-based quality management system (QMS)? This is a timely topic to get into. In 2016, ISO 13485—“Medical devices”—“Quality management systems” was updated, and one of the key concepts presented is the idea of a risk-based QMS.
Historically, regulations have almost exclusively…
Scott Shackelford
Hackers around the world are attacking targets as diverse as North Dakota’s state government, the Ukrainian postal service, and a hospital in Jakarta, Indonesia. Unfortunately, many governments—in the developing world, and even cash-strapped states and local communities in the United States—lack…
Jason Furness
You have defined what you want as an outcome of the change program; you have looked at how to understand your financial statements and how to use them to assess options. You have looked at the obstacles that lay in your path. Now we are going to start to look at your business, specifically.
Why…
Fred Schenkelberg
The term “Weibull” in some ways has become a synonym for reliability. Weibull analysis = life data (or reliability) analysis. The Weibull distribution has the capability to describe a changing failure rate, which is lacking when using just mean time between failures (MTBF). Yet, is it suitable to…
Jeremy Straub
Some people are afraid that heavily armed artificially intelligent robots might take over the world, enslaving humanity—or perhaps exterminating us. These people, including tech-industry billionaire Elon Musk and eminent physicist Stephen Hawking, say artificial intelligence technology needs to be…
Olympus
Sponsored Content
High-volume manufacturers need fast, nondestructive testing methods to help avoid material mix-ups and to meet customer quality requirements. Quality assurance (QA) inspectors are responsible for evaluating incoming raw materials by determining their elemental makeup and…
Kemper Lewis
President Trump has long talked about reinvigorating U.S. manufacturing, which has suffered heavy job losses as a result of automation, trade deals, and other factors. In July, the Trump administration even celebrated “made in America” week by showcasing things built in the United States and…
Christopher Martin
Nearly two decades ago, rising from the ashes of the once-giant video game hardware manufacturer Sega, Microsoft debuted the Xbox and entered into the video game market with the intent of competing directly with Sony’s PlayStation brand. By 2006, Microsoft’s launch of the second-generation of Xbox…
Lily Elefteriadou
What self-driving cars want, and what people want from them, varies widely. Often these desires are at odds with each other. For instance, carmakers—and the designers of the software that will run autonomous vehicles—know that it’s safest if cars stay far away from each other. But traffic…
Dane Warren
Sponsored Content
As businesses become increasingly dependent on an effective supplier network, more data must be shared with these suppliers to support business goals and delivery business value. This gives rise to the need for a more robust, next-generation approach to supplier assurance and…
Ken Kingery
The first in-car measurements of exposure to pollutants that cause oxidative stress during rush-hour commutes has turned up potentially alarming results. The levels of some forms of harmful particulate matter inside car cabins was found to be twice as high as previously believed.
Most traffic…
Timothy Zimmerman
Cybersecurity, at this point in the technological age, has become a household word. Every week, almost like clockwork, it seems there is a story in the news about a newly discovered hack or data breach, often made possible by poor cybersecurity practices. Many of these incidents are focused around…
Chad Kymal
When Philip Crosby announced zero defects as a philosophy during the 1970s, it was met with incredulity. There were already many articles written on the fallacy of such a strategy and the enormous costs of moving toward zero defects. Fast forward 40+ years, and zero defects has become a reality.…
Therese Graff
Medical device companies use ISO 14971 to identify and manage user risks with their devices. However, we often find these same companies do not manage their project risks well.
What is project risk management?
The Guide to the Project Management Body of Knowledge (Project Management Institute,…
Ben Snedeker
Storms like Hurricanes Irma and Maria as well as other natural disasters bring with them lots of uncertainty: Where will they go? How much damage will they cause? What is certain is that no matter where they strike, natural disasters knock out power.
And no power means no internet for thousands…
Knowledge at Wharton
NASA Chief Astronaut Chris Cassidy has lived for months on the International Space Station and has performed six spacewalks. “Imagine hanging out with a glass bubble on your head, one hand on a hunk of metal, Earth going beneath your feet at five miles a second, and the whole world listening to…
Ann Cleland
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If your hospital or clinic uses a Windows 7-based version of a Siemens PET/CT or SPECT system, it could be vulnerable to attack by a relatively low-skill hacker, according to a July 26, 2017, security advisory from the company.
The Industrial Control System Cyber…
Mike Richman
Our most recent episode of QDL from Friday, Sept. 29, 2017. featured news, technology, and two great interviews. Let’s have a closer look:
“Domestic Cars Fail to Keep Up With International Competition”
The most recent American Customer Satisfaction Index (ASCI) survey took a look at people’s…
Jack Phillips, Patti Phillips
According to W. Edwards Deming, “Every system is perfectly designed to achieve exactly the results it gets.” This applies to any quality initiative and any other activity, including learning and development. Yet, according to an ATD/ROI Institute study, only 8 percent of CEOs see the results most…
Anna Abram
We’re at a moment of extraordinary opportunity to improve public health. New innovations are giving us fundamentally better ways to address disease. Some of the same technology is providing consumers with a broader selection of foods that can improve peoples’ diets and products that can expand…
Arun Hariharan
In my October 2013 column, “Standardize to Improve,” I dealt with business process mapping in detail. Business process management systems (BPMS) comprise the entire gamut of documenting process steps, assigning ownership to process owners, and often, process-compliance audits to check whether you…
Mary McAtee
True to my profession as an engineer, I am a total geek at heart and proud of it. Spending time in automobile museums always fascinates me. It excites me to see a prescient innovator from the past come up with an idea like headlights. The first ones were Limelight carbide models that had a nasty…
Thomas Kochan, Lee Dyer
The technologies driving artificial intelligence (AI) are expanding exponentially, leading many technology experts and futurists to predict that machines will soon be doing many of the jobs that humans do today. Some even predict humans could lose control over their future.
While we agree about…
Jacqueline Calhoun
Which cybersecurity-related activities are most important to your business strategy and critical service delivery? How do you assess the effectiveness and efficiency of your use of cybersecurity standards, guidelines, and practices? To answer these questions and build excellence in your…
Joshua Fairfield
Internet-enabled devices are so common, and so vulnerable, that hackers recently broke into a casino through its fish tank. The tank had internet-connected sensors measuring its temperature and cleanliness. The hackers got into the fish tank’s sensors and then to the computer used to control them…
Peter Merrill
ISO 9001:2015 has significant structural changes that differentiate it from the previous standard. The new high-level structure is common to all ISO management system standards (i.e., quality, environmental, IT security) and enables us to start looking at integration of these systems. There is a…
Mary Drotar
A recent article in MIT Sloan Management Review, “Using Scenario Planning to Reshape Strategy,” indicated a resurgence of scenario planning that initially gained recognition during the 1960s and ’70s. Royal Dutch/Shell has been the “poster child” of success ever since it used scenario planning to…
Dirk Dusharme @ Quality Digest
Our Sept. 8, 2017, episode of QDL examined a different way to conduct clinical trials, discussed fixing problems before they occur, and in the aftermath of Hurricane Harvey looked at resources for building a more resilient and sustainable infrastructure.
“A Better Way to Design Clinical Trials”
A…
Laurel Thoennes @ Quality Digest
There’s nothing like a splash of cold water to wake you up. Imagine what a 33-trillion-gallon splash would do. Maybe 24 hours of wind at 185 miles per hour would sweep you onto your feet. Hurricanes Harvey and Irma said, “Wakey wakey,” and we can’t afford to nod off.
How do you recover from…
Arun Hariharan
In the last week of August 2017, two extreme weather events occurred on opposite sides of the world. Hurricane Harvey brought record-breaking rain and catastrophic flooding to Houston, Texas, causing loss of life, mass evacuation of people, and damage estimated to be in billions of dollars. Around…
Greg Hutchins
I live in the Northwest of the United States. We are now the small business and startup mecca of the country. Why? San Francisco and Silicon Valley are too expensive. So, folks are moving in droves to Portland and Seattle; one-third of the license plates in my hood are out of state.
But there are…
DNV GL
Sponsored Content
A new report by Jupiter Research says $8 trillion will be the price tag—within the next five years—of cyber attacks against businesses around the world. Hacks and other forms of digital theft are accelerating despite what would seem to be nonstop efforts by corporations to harden…
Stephen Chick
Value has found a place at the heart of healthcare innovation. For money-conscious governments and other actors in the system, it’s not enough that a new treatment be beneficial and safe. It also needs to be cost effective.
This emphasis on value is even changing the profile of the pharmaceutical…
Mike Richman
On Friday, Sept. 1, 2017, QDL included news about the disaster in Texas and no apocalypse in retail, an interview covering a different approach to failure modes and effects analyses, a feature article on consumer views about for-profit social-benefit enterprises, and a great new Tech Corner demo.…
Mike Richman
Last week, my friend and colleague, QD editor in chief Dirk Dusharme, wrote an uplifting and important column in this space. Titled “The Day We All Looked for the Same Thing,” Dirk’s article used last week’s solar eclipse, seen in its totality in so many places around the United States, as a motif…
Saerom Lee, Karen Winterich, Lisa E. Bolton
Have you ever wondered who collects the clothes you stuff into that donation drop box in your neighborhood? Chances are, you assumed it was a nonprofit, but that box actually may instead belong to a for-profit social venture. If you don’t know what that means, you’re not alone.
Years ago, just…
Automated Precision Inc.
Sponsored Content
Scientists at the Fermi National Accelerator Laboratory (Fermilab) are working on research projects that aim to answer fundamental physics questions. How did the universe begin? What are dark matter and dark energy? What is the mass hierarchy of neutrinos? Are there other…
Michelle LaBrosse
It’s summertime. You’ve saved up your time off and planned a great vacation for yourself and your family. How, as a project manager, do you make sure your vacation just has those fun “risks,” that everything runs smoothly while you’re away, and you’re able to enjoy your vacation uninterrupted?…
Ryan E. Day
What do cocoa, socks, and smartphones have in common? If you guessed risk of slavery in the manufacturing supply chain, you are correct. Does your organization have an international supply chain? Then it’s at risk. What are you doing to address the risks associated with modern slavery in your…
Dirk Dusharme @ Quality Digest
Our August 11, 2017, episode of QDL looked at the role of technology in after-market service, stairs that help you up, Fidget Cubes, and more.
“Climbing Stairs Just Got Easier With Energy-Recycling Steps”
These stairs actually help you go up.
“The Curious Case of the Fidget Cube”
How a product…
Phil Klotzbach, Michael M. Bell
June 1 marked the official start of the Atlantic hurricane season, which runs through the end of November. It’s a busy time for us at the Tropical Meteorology Project in Colorado State University’s (CSU) Department of Atmospheric Science, where we are issuing our 34th annual Atlantic basin…
Mike Richman
The dog days of summer are here, but the Aug. 4, 2017, episode of QDL offered lots of cool content. Let’s take a closer look:
“What Went Wrong With the F-35?” One expert calls the Lockheed Martin’s F-35 fighter jet an “inherently terrible airplane.” So why does the Air Force consider it warfighter…
Bruce Weinberg
Science funding is intended to support the production of new knowledge and ideas that develop new technologies, improve medical treatments, and strengthen the economy. The idea goes back to influential engineer Vannevar Bush, who headed the U.S. Office of Scientific Research and Development during…
Michael Hughes
The F-35 was billed as a fighter jet that could do almost everything the U.S. military desired, serving the Air Force, Marine Corps, and Navy—and even Britain’s Royal Air Force and Royal Navy—all in one aircraft design. It’s supposed to replace and improve upon several current—and aging—aircraft…
AssurX
Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical-device inspection investigative focus. CAPA noncompliance is a top concern.
Inadequate corrective actions
An FDA investigation was conducted from January to February 2017 at…
Loic Sadoulet, Giovanni Tassini
Making the most of its position as an important seaport, Venice’s remarkable economic development during the Middle Ages relied on network effects, contractual innovation, and coordination among the players involved in long-distance trade. Companies today still exploit these mechanisms to succeed…
Katina Sawyer, Christian Thoroughgood
In times of organizational crisis, some companies are able to right the ship, while others sink under the pressure.
Recently, Uber has been under fire for a bad corporate culture, which promoted, among other things, sexism and other forms of toxic behavior. This led to a four-month investigation…
Pam Bethune
Every company is in business to take risks.
Every action or failure to take action by that company naturally has some form of risk inherent in the process. To survive, a company needs to identify opportunities and take them when beneficial, but the amount of risk must be understood. Whether it’s…
Mike Richman
The July 17, 2017, episode of QDL focused on some of the nitty-gritty of quality improvement, from the value of personal certifications to the opportunities of disruptive innovation, and to the fundamentals of risk management to the challenges of customer service. In case you missed it, here’s a…
Rick Barker
Operations and safety don’t always speak the same language, not because operations isn’t committed to keeping people safe at work or safety isn’t concerned with meeting operational goals, but rather because each area has its own methods, processes, and measures. This communication gap can increase…
Pat Toth
Recently a segment on my favorite morning news program stopped me in my tracks. The young and attractive hosts (why are they always so young and attractive?) were demonstrating new appliances, among them a smart refrigerator. The fridge was equipped with all kinds of high-tech features including…
Amie Whittington
Is your governmental hospital exempt under Section 501(c)3? If you have a 403(b) plan, the answer is yes, but even if you don’t, you need to check.
The Internal Revenue Service (IRS) is ramping up compliance audits of governmental hospitals that are exempt under 501(c)3 (dual status). The…
Tim Lozier
The dynamic of risk management and compliance seems to be experiencing a shift toward risk management in operations, and learning to pay attention to detail in order to leverage it.
The biggest question often asked is, “I’m aware my company needs to pay great attention to the detail of risk, but…
Erin Connelly
For a long time, medieval medicine has been dismissed as irrelevant. This time period is popularly referred to as the “Dark Ages,” which erroneously suggests that it was unenlightened by science or reason. However, some medievalists and scientists are now looking back to history for clues to…
Roger Lehman, Julius Koh
Lucy felt hollow and dissatisfied. She was a star performer and had just helped her team clinch a large government deal that they had been working on for months. At the celebration that evening, Lucy was forced to put on a smile and a dynamic front. She had good relationships with her team members…
William A. Levinson
‘We’ve always done it that way” explains why many suboptimal and even obsolete methods are taken for granted. The range chart for statistical process control (SPC) is, for example, somewhat inferior to the sample standard deviation chart, and it is almost certainly a holdover from when all…
Cassandra Burke Robertson, Irina Manta
Recent reports suggest that terrorists can now create bombs so thin that they cannot be detected by the current X-ray screening that our carry-on bags undergo.
In an effort to protect against such threats, the United States is considering banning laptops and other large electronic devices in the…
Wesley McGrew
Last month, the WannaCry ransomware attack hit more than150 countries and infected tens of thousands of systems worldwide. Among those victimized were England’s National Health Service, automobile manufacturers, and government systems. The worm’s ominous red ransom screen, informing the user that…
Iffet Turken
The world faces a new crisis situation more or less every day—be it political, economic, or humanitarian. Wherever a crisis is experienced, echoes are felt around the globe. In the digital age, social media conveys crises in real time, resulting in rich portfolios of pictures, videos, written…
Ryan E. Day
I remember my first trip to Michigan in 2012. I was covering the Ford Motor Co.’s annual Trend Conference and had the opportunity to meet Alan Mulally, who gave a compelling presentation explaining the vision, strategy, and implementation of the One Ford plan. I was impressed more with the man…
AssurX
The FDA’s Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives pertaining to medical device manufacturers.
The CDRH continues to put a premium on quality when it assesses a…
Ryan E. Day
Sponsored Content
Founded in 1927 to produce aluminum splints—cutting edge at the time—Zimmer Biomet is a medical device company commanding second place in the entire world’s overall orthopedic market share. The organization’s stated purpose is to “Restore mobility, alleviate pain, and improve the…
UC Davis
Three transportation revolutions are in sight, and together they could help reduce traffic, improve livability, eventually save trillions of dollars each year, and reduce urban transportation carbon dioxide (CO2) emissions by 80 percent or more worldwide by 2050. That’s according to a report…
Winnie Ip
You may have heard that it takes 21 days to form a new habit. Well, it turns out that’s just a myth. Researchers found that, on average, it takes people more than two months before a new behavior becomes automatic. So what does that have to do with your office ergonomics process? A lot, especially…
AssurX
A common pitfall in quality management system (QMS) process automation occurs with a poorly planned process automation strategy. Too often, the temptation is to automate all quality processes at once and streamline the entire eQMS process in one giant undertaking. However, real-world experience…
DNV GL
The internet of things (IoT), robotics, augmented reality, 3D printing... look at megatrends, and despite their unique attributes and myriad differences, you’ll find that they all have one thing in common: time—or more precisely, the fact that there’s always less of it.
No matter how long your…
Mark Bartholomew
Ethics lawyers and historians have argued that Donald Trump has blurred the line between his public office and private business interests in an unprecedented fashion. In another sense, it’s part of a much larger social trend.
Commercial entreaties, whether in the form of magazine ads, radio…
William A. Levinson
Among other requirements ISO 9001:2015, clause 4.4.1 requires an organization to identify the inputs and outputs of the processes of the quality management system; identify the sequence and interaction of these processes, noting that handoffs between processes often create risks; and identify the…
Ryan E. Day
I like my job in journalism. I get some interesting invitations from some interesting people. Last Friday my inbox greeted me with “The American Homebrewers Association (AHA) is throwing a rally in Chico! Let us know if you’d be interested in a press pass or an interview with an AHA representative…
Volodymyr Bilotkach
On April 9, 2017, a passenger was forcibly removed from a United Airlines flight from Chicago O’Hare to Louisville after the carrier was unable to find volunteers to accommodate four of its employees on standby. Many articles have reported that airlines routinely overbook their flights, and…
Knowledge at Wharton
The mismanagement of bet-the-company business crises has become pandemic. Consider just the most recent examples.
In December 2016, Yahoo disclosed that three years earlier hackers had stolen confidential information from more than 1 billion accounts, including users’ names, birthdates, phone…
Fred Schenkelberg
A conversation the other day involved how or why someone would use the mean of a set of data described by a Weibull distribution.
The Weibull distribution is great at describing a dataset that has a decreasing or increasing hazard rate over time. Using the distribution we also do not need to…
Gleb Tsipursky
Let’s say you’re interviewing a new applicant for a job, and you feel something is off. You can’t quite put your finger on it, but you’re a bit uncomfortable with this person. She says all the right things, her resume is great, she’d be a perfect hire for this job—except your gut tells you…
Michael Causey
The FDA has made it abundantly clear that it expects medical device manufacturers and other life sciences firms to have strong cybersecurity management programs. Since the FDA hasn’t always been clear on what it expects on a granular level, the Common Vulnerability Scoring System can provide much-…
Taran March @ Quality Digest
As manufacturing becomes increasingly oblivious of where one country stops and another begins, the responsibilities of quality managers have extended beyond the safely measurable and into the loosely regulated wilds of global competition. Quality control now requires a sense of how different…
Chad Kymal
What is enterprise quality? Simply put, it is a system where there is one quality manual, and a core of common processes, work instructions, and forms and checklists for a multisite environment. Why is this a good idea? Because it saves money.
Figure 1 illustrates how enterprise quality takes…
Michael Jovanis
Sponsored Content
Particles of metal in children’s medicine. Adulterated baby formula. Spontaneously combusting smartphones. When scandal is only a tweet away, companies can’t hide from quality failures.
High-profile quality problems like these can not only harm consumers, but also lead to huge…
Ryan E. Day
Sponsored Content
My wife and I purchased a new car this year. The employee handling the closing paperwork gave a compelling presentation concerning the extended warranty, which we also purchased. His presentation included a litany of high-tech components and even higher-tech systems that could…
Inderjit Arora
Risk-based thinking can be considered the fundamental change in ISO 9001:2015. Compared to ISO 9001:2008, where preventive action (PA) held a spot in the “act” phase of the plan, do, check, act (PDCA) cycle, risk now appears in the “plan” phase and at each stage thereafter. This change formalizes…
Timothy Lozier
Compliance is a common term that is very broad, and many companies interpret compliance as a host of different items. It can be related to quality, safety, or operations, but it encompasses a long list of areas within the organization, including financial, risk, governance, sustainability, and…
Greg Anderson
The most astute executives in health systems are rightfully concerned about compliance risks in physician contracting. Among these risks are that a transaction or an arrangement between a hospital and a physician are consistent with fair market value (FMV) and are commercially reasonable (CR) as…
Jeffrey Phillips
The attempt to eliminate noise from an operating system or a business process is an interesting and perhaps worthwhile challenge, until one considers the question: What is the real signal? What is creating the noise?
In many businesses today, there are several signals, what we might call noise…
Jon Speer
If you’re in the business of developing medical devices, then risk and risk management become terms synonymous with your daily operations. Your overall task is to bring a device to market that not only provides a needed function to a patient, but is also proven to be safe to use—maybe even used by…
Mark Whitworth
Layered process auditing (LPA) is a quality management approach increasingly used by manufacturing and service companies alike to address a gap in traditional product-oriented approaches. When properly implemented, layered auditing is the most effective way to ensure that processes consistently…
Stefan Geib
While the fallout of the United Kingdom’s decision to exit the European Union has sent shockwaves throughout the political and economic world, Brexit is merely a footnote in the global supply chain risk story. According to the latest risk index from the Chartered Institute of Procurement &…
Daniel Blake, Caterina Moschieri
Pulling out of a country is an expensive proposition for a multinational firm, but it is sometimes required for the corporate bottom line. If the host country changes laws or even expropriates a subsidiary, it is often time to leave or divest.
Divestiture—pulling out assets or closing down part…
Thomas R. Cutler
Two words no manufacturing organization wants to hear: product recalls. By their very nature, product recalls are unpredictable events.
The cost to a company transcends potentially expensive litigation and settlements. Product recalls and the effects that product failures have on companies that…
Katherine Watts
While at the National MACRA MIPS/APM Summit in Washington, D.C., I heard much discussion centered on how to create and implement strategies that pay physicians fairly, while controlling spending in the Medicare program. It’s a question we’ve wrestled with for almost 20 years and a challenge we…
Jessica Gabel Cino
Forensic science has become a mainstay of many a TV drama, and it’s just as important in real-life criminal trials. Drawing on biology, chemistry, genetics, medicine, and psychology, forensic evidence helps answer questions in the legal system. Often, forensics provides the “smoking gun” that…
Mike Richman
Before I dive into this column, a quick programming note: You may have noticed some formatting changes in today’s issue of Quality Digest. Starting today, on each Thursday we will present a special edition of our newsletter, with a pair of particularly thought-provoking articles from our library…
Fred Schenkelberg
If you have been a reliability engineer for a week or more, or worked with a reliability engineer for a day or more, someone has asked about testing planning. The questions often include, “How many samples?” and, “How long will the test take?” No doubt you’ve heard the sample-size question.
What…
Pat Toth
They say opposites attract. Although my husband and I have many important things in common, we are complete opposites in one area. He’s a “risk taker,” and I’m... well, not so much. Rather than being labeled as “risk averse,” I prefer the term “caution giver.”
I’m a federal employee. I come from…
Penelope B. Prime
Chinese goods seem to be everywhere these days. Consider this: At the Olympics in Rio this summer, Chinese companies supplied the mascot dolls; much of the sports equipment; the security surveillance system; and the uniforms for the volunteers, technical personnel, and even the torch-bearers.
Do…
Tannaz Mirchi
With airfares at their lowest point in seven years and airlines adding capacity, this year’s holiday air travel is slated to be 2.5 percent busier than last year. The system we use to coordinate all those flights, however, is decades old, and mostly depends on highly trained air traffic…
Greg Fox
It’s that time of year again. The time when eggs get nogged, pudding gets figgy, and it becomes socially acceptable to speak in rhyme. So on that note, and with apologies to Clement Clarke Moore, I bring you this timely and heartfelt public service announcement. Enjoy.
’Twas the week before…
Michael A. Witt
Editor’s note: This is part two of a two-part series. Read part one here.
While globalization has benefited humanity in many ways, its continued progress is in serious doubt. As I wrote previously, the two leading political science theories, liberalism and realism, both predict that globalization…
Kara Baskin
Care.com co-founder Donna Levin played a key part in that company’s growth, and the passion was personal. Levin’s work plans were curtailed when her son was 11 weeks old and had a seizure following a difficult pregnancy. Tests were inconclusive. Her daycare situation evaporated; she and her…
Sponsored Content
Manufacturers often hold suppliers to a rigid quality process that dictates tight controls on all raw materials. Nonconforming material can potentially halt the production line, wasting time and money. Unfortunately, material mix-ups are a reality in critical manufacturing…
AssurX
Life sciences companies around the world should make sure their corrective and preventive action (CAPA) plans are in good shape before a Food and Drug Administration (FDA) inspector comes calling. Looking at a deep pool of letters issued this year domestically and internationally, it’s clear the…
Knowledge at Wharton
There were no Olympic medals up for grabs when Sim Yi Hui and Jane Lee, the co-founders of the Singapore Women’s Everest Team, set out to recruit team members to climb the world’s tallest mountain in 2004. “When we first formed the team my goal was just to climb the mountain,” Sim Yi Hui told me…
ASQ
Sponsored Content
When flood waters ravaged portions of Colorado in September 2013—killing crops, inundating homes, and buckling many miles of roadways—countless federal, state, and municipal government workers sprang into action helping citizens. State and federal government agencies spent…
The United State Occupational Safety and Health Administration (OSHA) estimates that $60 billion is lost annually from workplace injuries and illness. Using the administration’s $afety Pays Program calculator, 20 carpal tunnel syndrome injuries will cost a company $1,260,000 in direct and indirect…
Sudeep Pasricha
American mining production increased earlier this decade as industry sought to reduce its reliance on other countries for key minerals, such as coal for energy and rare-earth metals for use in consumer electronics. But mining is dangerous—working underground carries risks of explosions, fires,…
Michael Causey
It’s time to get your compliance programs in order to meet some looming international regulatory compliance demands, experts including former Food and Drug Administration officials say. Having a firm grip on quality management processes—especially document management and change control—will be…
Ryan E. Day
Handheld X-ray fluorescence (XRF) analyzers are proven analytical tools commonly used for the fast, easy, accurate, and nondestructive identification and analysis of metals and alloys. Common applications include metal alloy identification for quality control, scrap sorting and positive material…
Rodney Petersen
Acronyms. The world, and especially the government, is overflowing with them. You’d be hard-pressed to pick a favorite. People might even look at you funny if you suggested that you had one. I’m lucky enough to have my favorite one on my business card: NICE—the National Initiative for…
Brooke Pierce
When Congress passed the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), “risk” moved front and center as a feature of provider reimbursement models. These days, terms such as “at risk” and “risk-based” are used more and more, but what do they really mean? And why should healthcare…
The business environment is fraught with more threats and opportunities than three years ago, due to disruptive technologies, the internet of things, more demanding customers, and increasing regulations. Organizations, which must keep pace with these developments, are concerned with their ability…
Dawn Bailey
Should an organization embrace risk or spend millions of dollars a year to avoid it? How do you know when a particular strategy is best?
Considerations for such thinking are covered in the Baldrige Excellence Framework, and the topic was recently explored by Brennan McEachran in an Innovation…
Marci Crane
Of the myriad ways in which the Earth’s inhabitants could potentially be destroyed, a zombie apocalypse is undoubtedly one of the least impressive. Though a zombie apocalypse is decidedly scary, unpleasant, and would “get the job done” as the unromantic expression goes, it tends to lack the…
Industrial companies are facing critical challenges rooted in slow growth, globalization, the effect of disruptive technologies, and unforeseen competitive threats. A new report from global management consulting firm, L.E.K. Consulting, reveals how those companies are responding—and what the…
Andrew Maynard
In 2014, more than 32,000 people were killed in car crashes in the United States. In 2012, more than 2 million Americans visited the emergency room as a result of car crashes. An estimated 94 percent of the crashes that caused these injuries and fatalities are attributable to human choice or error…
Peter Bussey
Operational risk management (ORM) centers on environmental, health, and safety (EHS) risks that can cause accidents or incidents anywhere that work takes place, whether it’s a manufacturing plant, an offshore drilling platform, a mine, or a marine terminal. This article will discuss why and how…
Festo Didactic
Manufacturing in the United States and Canada is marked by negative stereotypes left behind from 1955. Repetitive and simplistic duties in grimy workplaces, without a chance to change or advance a career, are the images most people see when they imagine what it means to work in a factory. But, a…
Taran March @ Quality Digest
I hate banks. I’ve hated them since I was a drifty teenager who had a volatile relationship with math and trouble coming up with the required documents proving my adultness. My first checking account had less to do with the paltry sum I owned than it did with running head-on into the vast and…
Fred Schenkelberg
We establish reliability goals and measure reliability performance. Goals and measures can be related; however, they’re not the same, and neither do they serve the same purpose.
Recently, I’ve seen a few statements that seem to confuse the role of statistical confidence when establishing a goal.…
Chad Kymal
Deadlines for ISO 9001:2015 and ISO 14001:2015 registration have appeared on the horizon. Although we have 24 months to get registered to these new standards, some related timelines are looming even closer, notably scheduling a recertification or surveillance audit.
Some organizations have…
Kate Remley
If you’ve ever used a device that picks up signals over the air, you know that sometimes you just can’t get the signal to come in clearly. You point the device every which way, move it all around the room, do a little dance, but nothing seems to work. There doesn’t seem to be any explanation.…
Gabriele Suder
The costs of global terrorism on business go beyond the destruction caused in the attacks and actually impact the value of brands and supply chains for products, new research shows. It can give a competitive edge to some companies while destroying others.
During the 15 years since the Sept. 11,…
Nir Kshetri
It’s looking increasingly likely that computer hackers have in fact successfully attacked what had been the pinnacle of cybersecurity—the U.S. National Security Agency (NSA). Reports have emerged of claims by a hacking group called the Shadow Brokers that it had breached the network of, and…
William A. Levinson
Clause 6.1 of ISO 9001:2015 requires “Actions to address risks and opportunities” first with regard to section 4.1, “Understanding the organization and its context” and second in section 4.2, “Understanding the needs and expectations of interested parties.” As 4.2 goes on to say, the latter are…
It’s no surprise to many consumers that some retailers and brands think that packaging—although necessary—isn’t really something to invest a lot of time, money, or effort in.
Consider the box. Many would look at it as an inconsequential container. It’s the thing you must rip, cut, tear, or…
Brooke Pierce
Think back to your last car, truck, or SUV purchase. What did you want to know before spending so much money?
More than likely, you first wanted to know the price range of the type of car you were considering. You might have also wanted to know what features were standard on the various makes and…
Swapnil Srivastav
Mandatory reporting requirements for regulations such as Europe’s REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) and RoHS (Restriction of Hazardous Substances) legislation have increased the focus on environmental compliance and ethical sourcing across the globe.…
InfinityQS
What do you feel when you imagine your next regulatory audit? Stress? Anxiety? Overwhelming dread? The average recall can cost a manufacturer as much as $10 million, making compliance important to your brand as well as your bottom line.
As you manage the daily ins and outs of your quality…
British Assessment Bureau BAB
There are hundreds of security breaches that happen every day but in the end, they fall into three main groups: malicious, intentional, or criminal; system glitches; and human error.
The IBM “2015 Cost of Security Breach Survey” conducted by Ponemon Research, catalogs 49 percent of the breaches…
Peter J. Sherman
As organizations become successful and grow, uncertainty is generally the enemy. Thriving organizations seek to eliminate variation and increase efficiency. They identify best practices and policies, and design standard operating procedures. Such efforts can make a business wildly efficient at…
Jennifer Huergo
As I peer into the cardboard box NIST researcher Amanda Forster holds out for me, I can’t help thinking that this mild-mannered materials scientist has an impressive collection of shivs.
Forster’s collection of handmade prison weapons include a ballpoint pen with a razor embedded in the shaft and…
Gilles Hilary, Sivakumar Viswanathan
It all started as a normal day for traders David and John (not their real names). Out of the blue, their company’s audit and compliance team called them, seeking clarifications about some of their recent trades. Shortly afterward, David and John realized they had just become victims of the rise of…
Andrew Maynard
Elon Musk, CEO of Tesla Motors, recently revealed the second part of his master plan for the company, and it’s a doozy. Not content with producing sleek electric cars (which to be fair, were only a stepping stone to greater things), Musk wants to fundamentally change how we live our lives. But the…
Jesseca Lyons
This may be stating the obvious, but engineers are generally very analytical. One of the areas where this trait comes to the fore is in evaluating all the ways things can go wrong. This includes exposure and using tools like failure mode and effects analysis (FMEA).
As an engineer, there’s a good…
John Elliott
In 1978, REO Speedwagon released the single “Roll with the Changes,” a song that never fails to give me an adrenaline rush, especially as I run or bike. I think it’s pertinent to what healthcare professionals are experiencing since health reform became law in 2010 and the Centers for Medicare…
Heinz Schandl
The world is using its natural resources at an ever-increasing rate. Worldwide, annual extraction of primary materials—biomass, fossil fuels, metal ores, and minerals—tripled between 1970 and 2010. People in the richest countries now consume up to 10 times more resources than those in the poorest…
Manfred Kets de Vries
Thrill-seeking employees’ addiction to risk can create havoc in the workplace. Managed correctly, however, their fearlessness can be a great advantage to any organization.
People who knew Lawrence Devon, a VP of sales in a large retail group, viewed him as the quintessential sensation seeker—a…
Robert Fangmeyer
In August 1987, Congress created the Baldrige Performance Excellence Program, a public-private partnership that spawned a global movement. This small program was given a great big purpose: to improve the quality and performance of U.S. businesses so as to improve our national competitiveness. As a…
Mark Whitworth
Quality is, for every organization and across all industries, a key competitive differentiator. This is especially true in the highly competitive automotive industry, where cost pressures have pushed automakers and their suppliers toward global sourcing and distributed supply-chain operations.…
Right now, scientists all over the world are trying to understand how we get injured when our bodies are subjected to strong, dynamic loads—a hard body-check on the hockey rink, a tackle on the football field, a car crash, or even a bomb blast. Fortunately, I haven’t had any experience with bomb…
Davis Balestracci
Today I want to concentrate on the foundation of what is most commonly taught as design of experiments (DOE)—factorial designs.
Elsewhere I’ve mentioned three of C.M. Hendrix’s “ways to mess up an experiment.” After 35 years of teaching DOE, I’ve concluded that he pretty much captures the…
Jonathan Jacobi
When I first entered the safety profession, older, more experienced professionals recommended that I consider OSHA as a potential employer. The innuendo I sensed in this advice was that if I worked for the Occupational Safety and Health Administration (OSHA), got to know influential people, and…
Day in, day out, business leaders are reminded that digital disruption is coming for their customers, for their talent, and for their bottom lines. CEOs of traditional companies consistently rate digital upstarts disrupting their business models as their No. 1 concern.
And it’s no wonder. We’re…
ISO
The global food industry has never faced more challenges. From tainted dairy products to contaminated beef, high-profile cases crop up regularly to dent consumer confidence, while leading companies work hard to reclaim lost faith. So how trustworthy is your food?
Food safety is something we tend…
Loic Sadoulet, Thomas Hinterseer
It’s a tragic irony that the day before the 2010 Deepwater Horizon oil well disaster, executives from BP and the rig’s operators, Transocean, visited the platform on a “management tour” that included a number of specific safety-related purposes.
During the tour, there were already signs that all…
Knowledge at Wharton
I t wasn’t that long ago that GM ran commercials advertising that its Oldsmobile division didn’t just produce cars for your grandfather, but also for everyone else. It was an attempt to reinvent the brand’s staid image—and it didn’t work.
Now, the Oldsmobile division and its iconic vehicles are…
Jon Speer
Design controls and risk management processes should be tools to ensure that medical devices are designed, developed, and manufactured to be safe and effective, and to address indications for use, too.
All too often, however, design controls and risk management are viewed as a pile of “stuff”…
Fred Schenkelberg
A fault tree analysis (FTA) is a logical, graphical diagram that starts with an unwanted, undesirable, or anomalous state of a system. The diagram then lays out the many possible faults, and combinations of faults, within the subsystems, components, assemblies, software, and parts comprising the…
More than 313 million global work-related accidents occur each year, according to the International Labour Organization, with a high percentage of those accidents resulting in significant time away from work. Each accident bears a personal and financial cost for the worker and the employer. Yet,…
Sam Sharter
The tragic shooting in Orlando brought dozens of victims to emergency rooms. Even now, several of those people are still clinging to life. Many across the nation are praying for them and the other victims. Without quick response and high-quality emergency medical care, many more than the 49 already…
Howard Sklamberg
Globalization is posing challenges for public health. For the U.S. Food and Drug Administration (FDA), part of that challenge is the ever-increasing volume and complexity of FDA-regulated products coming to America’s shores.
In fiscal year 2015, there were more than 34 million shipments of FDA-…
Cuong Nguyen
When I go home after work, my wife and I are typically focused on the present moment, and especially on our young son. As new parents, we benefit from many innovative products and services—from improved car seats and creative toys to safer cribs and video baby monitors. One of the first products…
Gilles Hilary
President Obama has been injured in a terrorist attack on the White House. A tweet released by the Associated Press (AP) attests to this. It carries the company’s “verified” stamp of authenticity. The S&P 500 just lost more than $130 billion. Well, not quite.
The AP’s tweet was the byproduct…
The QA Pharm
Aquality management review of data with responsible company leadership is a current good manufacturing practices requirement. Quality management review procedures vary, but there seems to be a struggle with presenting data from across the quality management system in a meaningful and consistent…
Mike Figliuolo
Work is a convenient excuse for not taking care of yourself. Not exercising, poor diet, and stress are a bad combination. You’ve got to make time for you. Work will always be there when you get back.
Just over a year ago, I had a heart attack. My second heart attack. Yep. Two. The first one…
Jeffrey Phillips
The tone of this article is a bit tongue in cheek, but the point is quite serious. Innovators go through a number of phases as they accept the reality of innovation based on what executives and corporate culture allow. Growing as an innovator is something like experiencing the seven stages of…
Rachel Tracy
Two things are true when it comes to making important decisions that affect your company: You need a way to quantify risk to make the best choice, and you need to be able to explain that choice. A risk matrix helps you do both.
Calculating risk across various outcomes can give you clear…
Stephan Manning, Marcus M. Larsen
One of the big themes in the current presidential race is how decades of free trade have dealt a heavy blow to the U.S. worker as millions of jobs were shipped overseas to take advantage of cheap labor.
That’s even turned some pro free-trade Republicans into protectionists. As a result, the…
Rachel E. Sherman, Robert M. Califf
In an earlier article, we discussed a pair of concepts—interoperability and connectivity—that are essential prerequisites for creating a successful national system for evidence generation (or “EvGen”). Here, we take a look at how we would apply these constructs as we go about building such a…
Taran March @ Quality Digest
They sound like words and have a mysterious dignity rolling off the tongue. Their meanings seem both apparent and elusive. If an alien delegation landed on Earth, words like these might feature in their formal greetings. They are the most expensively researched neologisms in use around the globe.…
Jeffrey Eves
Sponsored Content
There are many paths for organizations to become good, sustainable, low-footprint citizens of the business world. Production processes can be redesigned to be more efficient, corporate campuses can be located so as to reduce employees’ dependence on fossil fuels, and buildings…
NIST
Recently on the Taking Measure blog, we asked Tara Lovestead, a recipient of the 2016 Presidential Early Career Award for Scientists and Engineers (PECASE), a few questions about her life and work. She was recognized for her extensive application of new methods to rapidly and inexpensively detect…
Rachel E. Sherman, Robert M. Califf
Across the clinical research enterprise, there is a growing awareness of serious shortfalls in the current model for generating the scientific evidence that supports medical product evaluation and clinical care decisions. As a result the FDA seeks to modernize methods and satisfy expectations…
Paul Voss
Not long ago, most Americans could safely ignore congressional deliberations about Federal Aviation Administration (FAA) authority, leaving the details to industry experts and lobbyists. But this time, we may need to fasten our seatbelts and actually read the card in the seat pocket.
A bill under…
Tim Lozier
When we look at business dynamics, regardless of industry, we see an increasing rate of change in products, processes, and regulations. One process affects the next, and with a growing focus on regulations and standards, complexity becomes an ever-expanding theme, whether related to quality…
Jon Speer
If you’re still using failure mode and effects analysis (FMEA) as your methodology to capture medical-device risk management activities, then your risk management process is out of date. Let me tell you why.
Here’s the definition of “risk management” as defined in ISO 14971:2007—“Medical devices—…
Ken Miller
Please pardon me, but I feel a little like a modern-day Paul Revere alerting you to the start of the second wave of Health Insurance Portability and Accountability (HIPAA) compliance audits.
Last week, Jocelyn Samuels, director of the Health and Human Services’ Office of Civil Rights (OCR),…
Bruno Scibilia
Sponsored Content
Suppose that on your way to a summer holiday resort (a very distant place), your car breaks down. You might just call roadside assistance and wait for your car to be towed to a repair shop. But suppose that you think you’re smarter than that, and you would like to solve the issue…
Jill Hartzler Warner, Thinh Nguyen
Combination products represent an important and growing category of therapeutic and diagnostic products under the U.S. Food and Drug Administration’s (FDA) regulatory authority. These products, which combine a drug, device, and/or biological product (referred to as “constituent parts”) with one…
FDA
One of the vivid images that sticks with me from my tenure at the Food and Drug Administration (FDA) is of the port of entry at Nogales, Arizona. There, I saw large trucks from Mexico lined up as far as the eye could see, awaiting entry into the United States, many loaded full with fresh produce…
MIT News
In March 2011, Leonardo Bonanni was preparing to defend his Ph.D. thesis about Sourcemap, software that lets consumers map every connection of a product supply chain on a digital map, when tragedy struck in Japan. Although the deadly earthquake and tsunami occurred half a world away, the events…
Gilles Hilary
Phil used to be a very senior financial executive. When asked for a number, he would typically provide with a rough ballpark answer, such as, “It’s about 5 percent.” He’d then be peppered with questions about how he had arrived at that figure.
After a while, he got tired of this questioning and…
Dan Jacob
Airbags, ignition switches, and even emissions software; although large recalls make the news at a regular pace, these are surrounded by scandal. News reports include claims of illegal or unethical activity executed by individuals or larger groups of people. Unfortunately, as new reports expose…
Mike Micklewright
When considering any effort toward performance improvement, you should always start by looking at the organization’s principles and culture, and making sure these are aligned so they not only permit positive changes to occur, but also ensure that the changes will be sustained over the long run. By…
Manufacturing Extension Partnership MEP
Whether it’s for performance management or for risk, it’s important to know who your suppliers are and have a close business relationship with them.
It’s a given you should already have a strong relationship with your key suppliers, but how often does your supplier request the following items? •…
Timothy Lozier
There’s been a shift in how companies view quality and compliance, and as a result, businesses are looking for a more comprehensive method for measuring operational efficiency. Risk management processes are proving to be an effective option for this. ISO 9001:2015 now promotes risk-based thinking…
William A. Levinson
ISO 9001:2015 has created a new focus on risk with regard to context of the organization and the needs and expectations of interested parties.
The Army Techniques Publication ATP 5-19 Risk Management, by the United States Government, U.S. Army (CreateSpace Independent Publishing Platform, 2014)…
Chris Howells
Reputation is fast becoming one of the most important risks to manage. Build quantifiable arguments to get boards on board.
Corporate reputation, the close cousin of a firm’s brand, is one of the most intangible assets a company has. If a brand is the inside-out perception of a firm, reputation…
These days, even a cursory scan of the headlines brings fresh reminders of risk, from the ramifications of climate change to shocking terror events such as the recent attacks on Paris by the Islamic State. Now more than ever, companies need risk managers.
Paradoxically, however, the new ubiquity…
Gilles Hilary, Arnaud Lagarde
Eric (not his real name) was under pressure from his sales department. He was hesitant to close a large financing deal with a Chinese corporation but had little beyond his intuition to back up his position.
The company’s stock price had gained a whopping 600 percent in one year. Nevertheless,…
Dawn Bailey
I heard the example that best helped me understand work systems and supply chains at a Baldrige training event right after the very sad 2011 earthquake and tsunami in Japan. A colleague was talking about automakers in the United States and elsewhere whose suppliers were located in the devastated…
Timothy Lozier
Compliance is a broad term. It can mean compliance to financial obligations, quality and safety, or general compliance to any regulation that is driving the organization. When you look at the current state of quality management and safety management with respect to compliance, most of the…
Sonal Sinha
In a recent poll, employees (22.9%) were identified as the top source of supply chain fraud risk, followed by vendors (17.4%) and other third parties (20.1%), including subcontractors and their vendors. In calling new attention to the old cliché of “an inside job,” the statistics may prove to be…
Fred Schenkelberg
Why do so many avoid confronting the reality of failure? In plant asset management, we are surrounded by people who steadfastly don’t want to know about nor talk about failures. Yet failure does happen; let’s not ignore this simple fact.
The blame game
Unlike a murder mystery, failure analysis (…
Quality Digest
Born in Bulawayo, Zimbabwe, and raised in Cape Town, South Africa, Wayne Visser, Ph.D. is, as CSRWire USA says, “. . . one of the most prolific, creative, and original thought leaders on corporate social responsibility.” That begs a question, however—should we use the term “social” or “sustainable…
Akhilesh Gulati
The big data revolution is requiring a seismic shift inside organizations, both in the way we build relationships and the way we make decisions. Each is now driven by data rather than intuition.
In general, decision making is accomplished via a thought process of selecting a logical choice from…
Mary McAtee
Technology is evolving more rapidly than at any point in history. We tend to think of seminal moments in history, such as the inventions of the steam engine or powered flight, as literal moments in time.
The reality is that the invention of the steamboat by Robert Fulton was only possible…
William A. Levinson
The requirement for risk-based thinking is among the most significant changes in ISO 9001:2015. Army Techniques Publication (ATP) 5-19, Risk Management is a public domain reference that supports this requirement.
ATP 5-19 includes a risk assessment approach that is similar to failure mode and…
Yo Delmar
In June 2015, it was initially reported that the U.S. Office of Personnel Management (OPM) experienced a massive data breach, potentially affecting as many as 4 million current and former federal employees. Updated reports indicate that the actual number of people compromised is more than five…
Randall Goodden
E
very year in the United States, an estimated 80,000 product liability lawsuits are filed, and thousands of products recalled—and that’s happening to companies with certified quality programs in place.
In 2014 alone, some of the highest fines were imposed by government agencies because…
Jesse Lyn Stoner
Delegating is often one of the hardest things for a manager to do. You give away your authority to make decisions but are still responsible for the outcome if something goes wrong.
Often managers don’t delegate because they hold one or more of these beliefs. Do any sound familiar?
“If you want…
Marc Dominus, Douglas Montgomery
The key challenge for risk professionals is no longer how to establish an enterprise risk management (ERM) program, but how to sustain its effectiveness. Often, ERM programs get off to a great start but soon lose their momentum because of certain missteps that occur.
Misstep 1: Assuming that the…
Chad Kymal
The final draft international standard (FDIS) of ISO 9001:2015 will be released in July, and the revised standard is slated for publication in September. Per Annex SL of the “Consolidated ISO Supplement,” some elements of the standard will be restructured to allow for easier integration of…
William A. Levinson
Management of change is a safety-related phrase from the chemical process industry that is adaptable to risk-based thinking. The basic premise is that anything new, different, or nonroutine (such as repairs or replacement of equipment, and process startups) creates a safety risk.
This principle…
Benjamin Mack
Suppliers play a major role in bringing products to market. This means that the product received from suppliers must be safe and of the highest possible quality, which is a must because stakeholders not only rely on their suppliers to help bring products to market—they also rely on them to help…
Jim Benson
Risk mitigation, risk assessment, risk management: We insure ourselves against risk, put buffers in our estimates to compensate for risk, and we make decisions based on risk. Or do we?
We think risk is a thing. It’s rarely a thing. Risk is part of the system we’re creating. It’s the variation,…
Phil Wiseman
All the technical journals are abuzz with the changes to ISO 9001:2015. One significant paradigm shift is to a risk-based management approach. Most companies already apply risk-based thinking in their planning process for organizational management. This article will take a narrowly focused…
Paula Oddy, Jeffrey Eves
In the years since ISO 9001 and ISO 14001 were first published, many organizations have followed the models of these standards in designing their own management systems. However, many of those systems haven’t been utilized to effectively manage risk. Many have been minimally developed to meet…
Glen Fraser
No matter what industry you’re in, you’re probably hearing about risk management. It’s in compliance, governance, quality management—it’s everywhere. It’s also a broad-reaching topic. In quality and compliance management, we see risk as a function of operations. We’re being told to manage our…
Hermann Ries
In the world of quality management systems (QMS), the nature of the relationship between risk management and preventive actions is often confused and misunderstood. Indeed, some believe that a thorough risk assessment process replaces the need for preventive action.
In fact, risk management and…
Jim Benson
Sometimes work is terrifying. We’re asked to do something that we know, or at least strongly suspect, won’t work. Maybe we’re asked to do several things, some of which are are simple, but one or two make us uncomfortable. We might even place a hard estimate on a task (“It’ll take six hours!”), but…
James Lamprecht
Anyone who has done an online search using the terms “risk analysis,” “managing risk,” “risk management,” or any other variation will have discovered that the subject has been around for a long time and been covered by numerous authors. Still, the daunting challenge remains: How can one conduct…
Quality Digest
Some of the [ISO 9001: 2015] requirements are relatively clear; others are more “euphemisms,” and you don’t know how to react… —James Lamprecht, author of ISO 9000: Preparing for Certification (CRC Press, 1992) and former member of ISO/TC 176
During an Aug, 16, 2013, interview on Quality Digest’s…
Tim Lozier
Editor’s note: Tim Lozier will be a guest on Quality Digest Live this Friday, Oct. 18, 2013, at 11 a.m. Pacific
During the past few years, risk management continues to be a topic of interest. There are plenty of benchmarking trends that point to risk. We see it in enterprise strategic initiatives…
Greg Hutchins
In Against the Gods: The Remarkable Story of Risk (Wiley, 1998), Peter Bernstein says the mastery of risk is the foundation of modern life and is what divides modern from ancient times. By consciously or unconsciously calculating probabilities, quality professionals make intelligent decisions…
Morgan Palmer
Editor’s note: Quality Digest hosted Morgan Palmer’s webinar, “Defining and Building a Risk Management Strategy for Quality and Compliance Management Systems” on Tuesday, April 30, at 2 p.m. Eastern/11 a.m. Pacific.
When we look at the dynamics of commerce, from any industry, we see an increasing…
Ed Perkins
Much has been written and discussed about “risk” being the future of “quality.” But what does this really mean, and how does it work?
Definitions of quality
Let’s us look at common working definitions of quality: zero defects, customer satisfaction, control of process variance, reliability,…
Jim Colton
Story update 12/13/2011: Additional information was added to the first paragraph pointing out the connection between FDA requirements and statistical tools.
According to a September 2010 interview of Rick Friedman, director of the manufacturing and product quality division at the Food and Drug…
Laurel Thoennes @ Quality Digest
“What makes a personal kanban any better than a to-do list?” asked Julie, crossing out a completed task on her “ta da!” list with exaggerated strokes.
“With personal kanban you visualize your work, it becomes tangible, you get kinesthetic feedback, it’s flexible, contextual, and it promotes…
Greg Hutchins
“I think we now live in an era when many of the concerns in running organizations are being reframed in terms of risk, which suggests that risk professionals are likely to rise to the top.”
(Source: “Managing Risk in the New World,” Harvard Business Review, October 2009)
My basic message is…
Stephen J. Marshall
Printed circuite board (PCB) manufacturing is moving rapidly up the technology ladder. Keeping internal processes current (and compliant) with new requirements, without disrupting existing customer demands, presents ongoing risks. To minimize potential failures, it is necessary to identify and…
Stewart Anderson
The 5 Whys is a well-known root cause analysis technique that originated at Toyota and has been adopted by many other organizations that have implemented lean manufacturing principles. Unlike more sophisticated problem-solving techniques, the 5 Whys doesn’t involve data segmentation, hypothesis…
Greg Hutchins
This is the first of a new QualityInsider column that will discuss new practices, processes, tools, and lessons learned in what I think is the future of quality—risk management. I’ll feature quality and other professionals who use quality and risk in supply management, auditing, health care,…
