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Consumerism Is Coming to Healthcare
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…
Managing Compliance in the Supply Chain
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.…
Four Food Safety Audit Mistakes You’re Making...
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…
Three Causes of Security Breaches
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…
What You Can Learn From Startups
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…
Staying Ahead of the Curves
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…
Machine Learning for Risk Management
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…
First the Innovation, Then the Persuasion
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…
ISO 14971 or FMEA: Which Should You Use?
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…
Moving From Volume to Value
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…
How Do We Uncouple Global Development From Resource Use?
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…
Managing Thrill Seekers
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…
Organizational Excellence in the Cyber-Risky Age
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…
From Automotive to Aerospace
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.…
If I Had a Hammer...
Right now, scientists all over the world are trying to understand how we get injured when our bodies are subjected to strong, dynamic loads—a hard body-check on the hockey rink, a tackle on the football field, a car crash, or even a bomb blast. Fortunately, I haven’t had any experience with bomb…
Despite 35+ Years of Evidence to the Contrary...
Davis Balestracci
Today I want to concentrate on the foundation of what is most commonly taught as design of experiments (DOE)—factorial designs. Elsewhere I’ve mentioned three of C.M. Hendrix’s “ways to mess up an experiment.” After 35 years of teaching DOE, I’ve concluded that he pretty much captures the…
‘OSHA-Proofing’ Your Business
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…
Four Signs That Your Industry Is Ripe for Digital Disruption
Day in, day out, business leaders are reminded that digital disruption is coming for their customers, for their talent, and for their bottom lines. CEOs of traditional companies consistently rate digital upstarts disrupting their business models as their No. 1 concern. And it’s no wonder. We’re…
Do You Trust the Food You Eat?
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…
Is the Time Ever Right to Flout Procedure?
Loic Sadoulet, Thomas Hinterseer
It’s a tragic irony that the day before the 2010 Deepwater Horizon oil well disaster, executives from BP and the rig’s operators, Transocean, visited the platform on a “management tour” that included a number of specific safety-related purposes. During the tour, there were already signs that all…
How Automakers Can Think Like a Disruptor
Knowledge at Wharton
I t wasn’t that long ago that GM ran commercials advertising that its Oldsmobile division didn’t just produce cars for your grandfather, but also for everyone else. It was an attempt to reinvent the brand’s staid image—and it didn’t work. Now, the Oldsmobile division and its iconic vehicles are…
Eight Reasons Why Your Design Controls and Risk Management Processes Fail
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”…
Fault Tree Analysis and Its Common Symbols
Fred Schenkelberg
A fault tree analysis (FTA) is a logical, graphical diagram that starts with an unwanted, undesirable, or anomalous state of a system. The diagram then lays out the many possible faults, and combinations of faults, within the subsystems, components, assemblies, software, and parts comprising the…
Building a Culture of Prevention, Part 1
More than 313 million global work-related accidents occur each year, according to the International Labour Organization, with a high percentage of those accidents resulting in significant time away from work. Each accident bears a personal and financial cost for the worker and the employer. Yet,…
How Can Hospitals Possibly Prepare for Disasters?
Sam Sharter
The tragic shooting in Orlando brought dozens of victims to emergency rooms. Even now, several of those people are still clinging to life. Many across the nation are praying for them and the other victims. Without quick response and high-quality emergency medical care, many more than the 49 already…

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