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A Quick Guide to Functional Failures
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…
How to Rapidly Test New Organization Designs
Phanish Puranam
It’s no secret that there are no universally applicable organization designs. What works in one context may not work in another because each organization has a different history, culture, and cast of characters. And yet there is a thriving segment of the management consulting business that…
Is Your Cybersecurity Strategy Falling Victim to These Six Common Pitfalls?
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…
Drones Give Bird’s-Eye View for Collecting Environmental and Security Data
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…
Silicon Valley Bank: Another ESG Failure
William A. Levinson
I wrote previously1 that environmental, social, and governance (ESG) metrics are often dysfunctional because they prioritize the wrong things and thus deliver the wrong results. The recent failure of Silicon Valley Bank (SVB) despite SVB Financial Group’s “medium” (at the time) ESG risk rating…
The Relationship Between Maintenance and Reliability
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…
Is There Really a Link Between Perfectionism and Procrastination?
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…
Design Automotive Safety Applications in Simulink
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,…
IAF CertSearch Team Identifies 20,000 Fake or Fraudulent ISO QMS Certs
Grant Ramaley
As of 2023, more than 27,000 medical device QMS certificates have been issued worldwide, providing confidence in medical devices. From cardiac stents to simple dental tools used to correct teeth, the healthcare systems of the world have come to rely on ISO 13485 to provide critical support to world…
Stay In Your Lane: How to Compete In a Saturated Market
Megan Wallin-Kerth
At last year’s Masters Summit, MasterControl’s chief strategy officer, Matt Lowe, chatted with Quality Digest’s CEO, Jeff Dewar, about the challenges and rewards of his work and the many titles he’s held over the years. Lowe, who has worked at MasterControl for more than 15 years, has a lot to say…
Do You Think Inside the Box, Outside the Box, or at the Edge of the Box?
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…
The Circular Economy: Building Trust Through Conformity Assessment
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.…
Data Must Be Kept Fresh!
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…
Four Challenges in Navigating Remote Work Layoffs
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…
Document Management: Risks, Controls, and a Sample SOP Template
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…
The Need for Data Governance
Rupa Mahanti
Data are an enterprise asset, and data governance (DG) is about establishing policies, processes, rules, standards, and controls around data to improve the quality of data and ensure data security and privacy.1 However, organizations struggle to implement data governance and, as a result, face a…
Understanding the FDA’s Human Factors Guidance Draft
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…
Ten Ways to Improve Safety at Your Facility
Bryan Christiansen
According to “The 2022 State of Employee Safety Report,” 79 percent of employees say they’re concerned about their health and safety at work. Workplace safety policies along with various technologies can be effective tools for preventing injuries and increasing employee productivity. Overlooking or…
Do You Know Where Your Quality Career Is Heading?
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…
Labor Challenges Drive Packaging Automation
Chip Reavley
The business challenges of the past few years—labor shortages, supply chain disruptions, and inflation—have accelerated the long-term trend toward automated packaging operations.  All types of manufacturers and distributors, including food and beverage, pharmaceuticals, automotive, and e-commerce…
ESG: A Dysfunctional Metric
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…
Using CAPA to Improve the Health of Your Business
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…
Top Five Challenges for Medical Device Integration
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…
NIST Improves Flagship Device for Measuring Mass
Jennifer Lauren Lee
In a brightly lit subterranean lab at the National Institute of Standards and Technology (NIST) sits a room-sized electromechanical machine called the NIST-4 Kibble balance. The instrument can already measure the mass of objects of roughly 1 kilogram, about as heavy as a quart of milk, as…
Data Profiling: The First Step in Climbing the Data Quality Ladder
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…

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