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Top 10 Things You Need to Know About Reverse FMEAs
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…
Keeping Web-Browsing Data Safe From Hackers
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…
What Struggling Businesses Can Do to Weather the Economic Storm
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…
The Value of Risk-Based Supplier Inspections in Pharma Quality Management
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…
Beware of These Common Types of Bias
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…
A New Approach to Securing Cyber Systems
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…
A Tale of Two Errors: Measuring Biometric Algorithms
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…
Cybersecurity and Industry 4.0: What You Need to Know
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 Updates Cybersecurity Guidance for Supply Chain Risk Management
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…
Five Steps to Making Wise Career Decisions
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…
Innovate Your Way to Growth While Minimizing Risks
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…
Countering Attacks on Cybersecurity
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…
Sales Numbers Are Up? It May Only Be Inflation.
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…
How to Deal With Workplace Harassment Effectively
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…
Three Ways Businesses Can Adapt Their Models to Working in an Age of Crises
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…
How to Be a Wise Decision-Maker
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…
Ultraviolet Light Can Clean N95 Masks for Reuse Without Hindering Performance
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…
Mismanaged Cloud Services Put User Data at Risk
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…
Editorial Quality Assurance the Old-Time Way
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…
Using Smart Technologies to Improve Quality and Reliability
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…
Managing Product Development Risk With DFM and Quality Partnerships
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…
Software Bill of Materials for Medical Devices
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…
Why Sometimes You Need to Source Locally
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…
Sanctions on Top of Covid: Trouble Ahead for Global Supply Chains
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…
Managing Medical Device Vulnerabilities With Compensating Controls
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…

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