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How Pharma Quality Leaders Navigate Shifts and Instigate Change
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…
Small Businesses: Keeping Up With Today’s Economy
ISO
Standards are not for just the minority of businesses with thousands of employees. According to the World Bank, micro, small, and medium-sized enterprises (MSMEs) make up more than 90 percent of all companies and account for up to 70 percent of total employment. In developing countries, small…
From Wax Light to Moonlight
Steven Brown
One of the unexpected rewards of working at NIST has been the opportunity to see other disciplines through the NIST prism of measurement science and standards. By working with NASA scientists, astronomers, oceanographers and geologists, I’ve had the opportunity to witness the lives of scientists in…
Standards Help Keep Firefighters Safe
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…
Companies Use MIT Research to Identify and Respond to Supply Chain Risks
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…
Safer Food, Better Health, and a Brighter Future
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…
The Fourth Industrial Revolution: A Seductive Idea Requiring Critical Engagement
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…
Why Tesla’s Autopilot Crashes Spurred the Feds to Investigate Driver-Assist Technologies
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…
ASME Provides Fundamental 3D-Printing Design Guidance
Jonathan Griffin
Since the 1940s, engineers have used a common design language—a set of definitions, symbols, and practices—to draft engineering drawings that can serve as clear manufacturing blueprints or inspection checklists. Although this system still works well for many traditional manufacturing methods, it…
Four Reasons Why Healthcare Facilities Struggle With Clinical Asset Management
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…
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…
Cryptographic Standards: A Look at Their 50-Year Evolution
Lily Chen, Matthew Scholl
In our connected, digital world, cryptographic algorithms are implemented in every device and applied to every link to protect information in transmission and in storage. During the past 50 years, the use of cryptographic tools has expanded dramatically, from limited environments like ATM…
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…
Baldrige Award Process Suspended for 2022, Pending Review
In an open letter, Bob Fangmeyer, director of the Baldrige Performance Excellence Program, wrote that the Baldridge Award process would be suspended this year. The reasons and future plans are outlined in the letter shown below. Dear Friend of Baldrige, I am writing today to provide an important…
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…

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