All Features
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…
NIST
You need to measure length accurately to do things like make a dress, build a house, survey a plot of land, or determine if the home team made a first down on the football field. These length measurements and many others are often made with the help of a measuring tape. The major companies that…
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…
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…
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…
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…
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…
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…
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…
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…
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…