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Daniel Desilets
Sponsored content
Y our product or service is only as good as the management system that supports it. Certification by an independent third-party certification body, such as Intertek, confirms that your management system complies with the respective international standards for quality,…
NIST
NIST scientists have devised and modeled a unique optical method of sorting microscopic and nanoscopic particles by size, with a resolution as fine as 1 nm for particles of similar composition.
A stream of particles of various sizes enters the system at a single point, but the particles exit the…
Swapnil Srivastav
Mandatory reporting requirements for regulations such as Europe’s REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) and RoHS (Restriction of Hazardous Substances) legislation have increased the focus on environmental compliance and ethical sourcing across the globe.…
InfinityQS
What do you feel when you imagine your next regulatory audit? Stress? Anxiety? Overwhelming dread? The average recall can cost a manufacturer as much as $10 million, making compliance important to your brand as well as your bottom line.
As you manage the daily ins and outs of your quality…
James Warren
Creating a new material has long been either an accident or a matter of trial and error. Steel, for instance, was developed over hundreds of years by people who didn’t know why what they were doing worked (or didn’t work). Generations of blacksmiths observed that iron forged in charcoal was…
British Assessment Bureau BAB
There are hundreds of security breaches that happen every day but in the end, they fall into three main groups: malicious, intentional, or criminal; system glitches; and human error.
The IBM “2015 Cost of Security Breach Survey” conducted by Ponemon Research, catalogs 49 percent of the breaches…
Thinh Nguyen, Rachel E. Sherman
One question that product sponsors often ask the U.S. Food and Drug Administration (FDA) is whether their medical product will be regulated as a drug, a device, a biologic, or as a combination product—and in the case of the latter, which FDA component will regulate it.
One way sponsors may…
Jon Speer
Did you know that during the first six months of 2015, 69 percent of 510(k) submissions were rejected the first time? And that up to 75 percent of first-time 510(k) submissions are regularly sent back? I heard this and thought it was a crazy statistic. Is it really that high?
Then I spoke with a…
NIST
A new publication from the National Institute of Standards and Technology (NIST) provides a basic model aimed at helping researchers better understand the internet of things (IoT) and its security challenges.
Examples of IoT systems include a smart electric grid, a home controlled by sensors,…
Jennifer Huergo
As I peer into the cardboard box NIST researcher Amanda Forster holds out for me, I can’t help thinking that this mild-mannered materials scientist has an impressive collection of shivs.
Forster’s collection of handmade prison weapons include a ballpoint pen with a razor embedded in the shaft and…
Jesseca Lyons
This may be stating the obvious, but engineers are generally very analytical. One of the areas where this trait comes to the fore is in evaluating all the ways things can go wrong. This includes exposure and using tools like failure mode and effects analysis (FMEA).
As an engineer, there’s a good…
Dan Sawyer
Whether they’re made of leather or metal, tape measures have been used by people for a long time. The first spring-loaded metal tape measure was invented and patented in England in 1829. Alvin Fellows of New Haven, Connecticut, made improvements to that design, including the locking mechanism that…
Chad Kymal
In 2014, the International Automotive Task Force (IATF) reported that the automotive industry wouldn’t upgrade the ISO/TS 16949 standard to ISO 9001:2015, much to the dismay of Tier One suppliers. In a survey that same year, Tier One suppliers related their desire to update their management…
Erwin Miller
The Federal Drug Administration’s (FDA) mission to protect consumers from unsafe food follows different paths. The seven rules that have been finalized since the fall in 2015 to implement the 2011 FDA Food Safety Modernization Act (FSMA) will require food producers, importers, and transporters to…
Jonathan Jacobi
When I first entered the safety profession, older, more experienced professionals recommended that I consider OSHA as a potential employer. The innuendo I sensed in this advice was that if I worked for the Occupational Safety and Health Administration (OSHA), got to know influential people, and…
ISO
The global food industry has never faced more challenges. From tainted dairy products to contaminated beef, high-profile cases crop up regularly to dent consumer confidence, while leading companies work hard to reclaim lost faith. So how trustworthy is your food?
Food safety is something we tend…
NIST
A high-tech version of an old-fashioned balance scale at the National Institute of Standards and Technology (NIST) has just brought scientists a critical step closer toward a new and improved definition of the kilogram. The scale, called the NIST-4 watt balance, has conducted its first measurement…
Sam Manzello
I’m a dragon wrangler. Although that might sound like something straight out of Harry Potter or Game of Thrones, this isn’t fantasy—it’s serious science.
As a fire researcher, or more colloquially, a dragon wrangler, my job is to help protect people and property from fire’s devastating effects.…
Jon Speer
Design controls and risk management processes should be tools to ensure that medical devices are designed, developed, and manufactured to be safe and effective, and to address indications for use, too.
All too often, however, design controls and risk management are viewed as a pile of “stuff”…
Howard Sklamberg
Globalization is posing challenges for public health. For the U.S. Food and Drug Administration (FDA), part of that challenge is the ever-increasing volume and complexity of FDA-regulated products coming to America’s shores.
In fiscal year 2015, there were more than 34 million shipments of FDA-…
Cuong Nguyen
When I go home after work, my wife and I are typically focused on the present moment, and especially on our young son. As new parents, we benefit from many innovative products and services—from improved car seats and creative toys to safer cribs and video baby monitors. One of the first products…
James Olthoff
I’m a physicist, and as anyone who watches the popular TV series The Big Bang Theory knows, it’s a commonly held conception that there is a strong connection between being a scientist and being enthralled with all things science fiction, fantasy, and superheroes. Anyone who walks into my office at…
NIST
Anyone who has ever covered a wall with sticky notes to clearly map all of the steps in a process knows how valuable that exercise can be. It can streamline workflow, increase efficiency, and improve the overall quality of the end result. Now, a public-private team led by the National Institute of…
Brian Stanton
Doors that are obviously meant to be pushed not pulled, footprints painted on the floor telling you where to stand at the airport—these are examples of good design and usability. You don’t have to think too hard about what to do because someone else put a lot of thought into how to get across the…
Chad Kymal
The aerospace standard AS9100 Revision D was originally planned to be released in April 2014. Many of us close to the standard expected it to be released in May 2016 after the April International Aerospace Quality Group (IAQG) meeting in Singapore. However, this was not the case; the IAQG decided…
