All Features

BIM Increases Efficiencies and Optimizes ROI in Healthcare Construction
Bhushan Avsatthi
The very nature of healthcare construction and its specific infrastructural and functional needs pose significant challenges to the architectural, engineering, and construction (AEC) sector. Crucial hospital spaces such as operation theaters and critical care centers need fail-proof connections to…
CAPA, FMEA, and the Process Approach
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…
Incorporate Cyber Resilience in Your Business
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…
FTX: The Harmful Consequence of No Oversight and Poor Risk Management
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…
Hanging by a Thread: The Life of a Bridge Inspector
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…
European Commission Proposes Extending MDR Deadlines
Dirk Dusharme @ Quality Digest
Updated 12/12/22 At a meeting of EU health ministers in Brussels on Dec. 9, 2022, the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council announced it will be proposing an extension to the transition date for Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). On…
Promoting Quality at the Administrative Level
Megan Wallin-Kerth
Founded in 2012, GoFormz is a uniquely flexible documentation platform for professionals in all industries—and a long-awaited solution for those chasing lean efficiency without sacrificing quality. What does that mean? Well, unlike using a fillable PDF or Adobe document, GoFormz is an online…
Eight CAPA KPIs You Should Be Measuring Now
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…
How to Conduct Level of Repair Analysis (LORA)
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…
Seven Mistakes to Avoid in Hiring and Firing During Uncertain Economic Times
Gleb Tsipursky
After firing half its workforce, Twitter is already asking many to come back. Indeed, research from McKinsey finds that even as recession fears grow, 40 percent of workers plan to quit their jobs. And a survey from Greenhouse, a New York-based hiring software provider, finds that 57 percent of 1,…
How to Prioritize Cybersecurity Risks in Medical Devices
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…
Why Did Adidas Wait So Long to Drop Kanye West?
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…
Equipment Calibration: The What’s, Why’s, and How’s
Bryan Christiansen
An important part of production is to carefully monitor and control temperature, speed, volume, weight, or mass. To ensure these measurements are always accurate, manufacturers need to calibrate their equipment and instruments regularly. Devising a proper equipment calibration schedule can be a…
Protect Against Food Recalls With the Right Conveyor System
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…
Should Companies Allow Returns of Customized Goods?
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…
The Rising Importance of Soft Skills in Driving Productivity
Maria Guadalupe, Bryan Ng
Soft skills, the behavioral and social traits that enable individuals to work harmoniously with one another, aren’t just nice to have. They’re essential for the growth of a nation. In France, 60 percent of employers consider soft skills, such as the ability to organize, adapt, and work in teams,…
‘AI Bill of Rights': Five Principles to Make Artificial Intelligence Safer, Less Discriminatory
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,…
Seven Practical Steps to Build a Culture of Safety and Human Reliability
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…
To Break New Ground With Frequency Combs, NIST Plays With the Beat
NIST
An improvement to a Nobel Prize-winning technology called a frequency comb enables it to measure light pulse arrival times with greater sensitivity than previously possible—potentially improving measurements of distance along with applications such as precision timing and atmospheric sensing. The…
What Is an Asset Management Policy?
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,…
ESG and Cybersecurity Compliance Are Every Employee’s Concern
Leeza Garber, Allison Jegla
In late spring 2022, the U.S. Securities and Exchange Commission (SEC) charged an elite investment adviser for “misstatements and omissions” about environmental, social, and governance (ESG) considerations related to its managed mutual funds. This same financial firm has also faced myriad…
Many See, Few Observe
William A. Levinson
‘You see, but you do not observe,” Sherlock Holmes told Dr. Watson in Sir Arthur Conan Doyle’s (1891) A Scandal in Bohemia. Taiichi Ohno, who developed Henry Ford’s lean production system into the Toyota Production System, told managers to stand in a circle on the shop floor and observe everything…
Does Remote Work Contribute to Inflation?
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,…
ASQE’s Board of Directors Talk the Walk
Jeff Dewar
This is the fourth installment of a five-part series. As detailed in our third installment, ASQE is a new legal entity connected to the ASQ we all know and love. It’s a trade organization to which organizations, rather than individuals, can belong. Current membership is about 180 organizations,…
The Cumulative Sum Technique
Donald J. Wheeler
The cumulative sum (or Cusum) technique is occasionally offered as an alternative to process behavior charts, even though they have completely different objectives. Process behavior charts characterize whether a process has been operated predictably. Cusums assume that the process is already being…