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Timothy Lozier
Current management regulations and standards stress the importance of making quality management a higher priority throughout all areas of operation. At Verse Solutions, we wanted to find out how quality managers are adjusting to that new mindset, and how they are using quality-based technology to…
William A. Levinson
Clause 6.1 of ISO 9001:2015 requires “Actions to address risks and opportunities” first with regard to section 4.1, “Understanding the organization and its context” and second in section 4.2, “Understanding the needs and expectations of interested parties.” As 4.2 goes on to say, the latter are…
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…
It’s no surprise to many consumers that some retailers and brands think that packaging—although necessary—isn’t really something to invest a lot of time, money, or effort in.
Consider the box. Many would look at it as an inconsequential container. It’s the thing you must rip, cut, tear, or…
Brooke Pierce
Think back to your last car, truck, or SUV purchase. What did you want to know before spending so much money?
More than likely, you first wanted to know the price range of the type of car you were considering. You might have also wanted to know what features were standard on the various makes and…
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,…
Peter J. Sherman
As organizations become successful and grow, uncertainty is generally the enemy. Thriving organizations seek to eliminate variation and increase efficiency. They identify best practices and policies, and design standard operating procedures. Such efforts can make a business wildly efficient at…
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…
Gilles Hilary, Sivakumar Viswanathan
It all started as a normal day for traders David and John (not their real names). Out of the blue, their company’s audit and compliance team called them, seeking clarifications about some of their recent trades. Shortly afterward, David and John realized they had just become victims of the rise of…
Andrew Maynard
Elon Musk, CEO of Tesla Motors, recently revealed the second part of his master plan for the company, and it’s a doozy. Not content with producing sleek electric cars (which to be fair, were only a stepping stone to greater things), Musk wants to fundamentally change how we live our lives. But the…
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…
John Elliott
In 1978, REO Speedwagon released the single “Roll with the Changes,” a song that never fails to give me an adrenaline rush, especially as I run or bike. I think it’s pertinent to what healthcare professionals are experiencing since health reform became law in 2010 and the Centers for Medicare…
Heinz Schandl
The world is using its natural resources at an ever-increasing rate. Worldwide, annual extraction of primary materials—biomass, fossil fuels, metal ores, and minerals—tripled between 1970 and 2010. People in the richest countries now consume up to 10 times more resources than those in the poorest…
Manfred Kets de Vries
Thrill-seeking employees’ addiction to risk can create havoc in the workplace. Managed correctly, however, their fearlessness can be a great advantage to any organization.
People who knew Lawrence Devon, a VP of sales in a large retail group, viewed him as the quintessential sensation seeker—a…
Robert Fangmeyer
In August 1987, Congress created the Baldrige Performance Excellence Program, a public-private partnership that spawned a global movement. This small program was given a great big purpose: to improve the quality and performance of U.S. businesses so as to improve our national competitiveness. As a…
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…
Mark Whitworth
Quality is, for every organization and across all industries, a key competitive differentiator. This is especially true in the highly competitive automotive industry, where cost pressures have pushed automakers and their suppliers toward global sourcing and distributed supply-chain operations.…