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AssurX
Life sciences companies around the world should make sure their corrective and preventive action (CAPA) plans are in good shape before a Food and Drug Administration (FDA) inspector comes calling. Looking at a deep pool of letters issued this year domestically and internationally, it’s clear the…
Knowledge at Wharton
There were no Olympic medals up for grabs when Sim Yi Hui and Jane Lee, the co-founders of the Singapore Women’s Everest Team, set out to recruit team members to climb the world’s tallest mountain in 2004. “When we first formed the team my goal was just to climb the mountain,” Sim Yi Hui told me…
ASQ
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When flood waters ravaged portions of Colorado in September 2013—killing crops, inundating homes, and buckling many miles of roadways—countless federal, state, and municipal government workers sprang into action helping citizens. State and federal government agencies spent…
The United State Occupational Safety and Health Administration (OSHA) estimates that $60 billion is lost annually from workplace injuries and illness. Using the administration’s $afety Pays Program calculator, 20 carpal tunnel syndrome injuries will cost a company $1,260,000 in direct and indirect…
Sudeep Pasricha
American mining production increased earlier this decade as industry sought to reduce its reliance on other countries for key minerals, such as coal for energy and rare-earth metals for use in consumer electronics. But mining is dangerous—working underground carries risks of explosions, fires,…
Michael Causey
It’s time to get your compliance programs in order to meet some looming international regulatory compliance demands, experts including former Food and Drug Administration officials say. Having a firm grip on quality management processes—especially document management and change control—will be…
Ryan E. Day
Handheld X-ray fluorescence (XRF) analyzers are proven analytical tools commonly used for the fast, easy, accurate, and nondestructive identification and analysis of metals and alloys. Common applications include metal alloy identification for quality control, scrap sorting and positive material…
Rodney Petersen
Acronyms. The world, and especially the government, is overflowing with them. You’d be hard-pressed to pick a favorite. People might even look at you funny if you suggested that you had one. I’m lucky enough to have my favorite one on my business card: NICE—the National Initiative for…
Brooke Pierce
When Congress passed the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), “risk” moved front and center as a feature of provider reimbursement models. These days, terms such as “at risk” and “risk-based” are used more and more, but what do they really mean? And why should healthcare…
The business environment is fraught with more threats and opportunities than three years ago, due to disruptive technologies, the internet of things, more demanding customers, and increasing regulations. Organizations, which must keep pace with these developments, are concerned with their ability…
Dawn Bailey
Should an organization embrace risk or spend millions of dollars a year to avoid it? How do you know when a particular strategy is best?
Considerations for such thinking are covered in the Baldrige Excellence Framework, and the topic was recently explored by Brennan McEachran in an Innovation…
Marci Crane
Of the myriad ways in which the Earth’s inhabitants could potentially be destroyed, a zombie apocalypse is undoubtedly one of the least impressive. Though a zombie apocalypse is decidedly scary, unpleasant, and would “get the job done” as the unromantic expression goes, it tends to lack the…
Industrial companies are facing critical challenges rooted in slow growth, globalization, the effect of disruptive technologies, and unforeseen competitive threats. A new report from global management consulting firm, L.E.K. Consulting, reveals how those companies are responding—and what the…
Andrew Maynard
In 2014, more than 32,000 people were killed in car crashes in the United States. In 2012, more than 2 million Americans visited the emergency room as a result of car crashes. An estimated 94 percent of the crashes that caused these injuries and fatalities are attributable to human choice or error…
Peter Bussey
Operational risk management (ORM) centers on environmental, health, and safety (EHS) risks that can cause accidents or incidents anywhere that work takes place, whether it’s a manufacturing plant, an offshore drilling platform, a mine, or a marine terminal. This article will discuss why and how…
Festo Didactic
Manufacturing in the United States and Canada is marked by negative stereotypes left behind from 1955. Repetitive and simplistic duties in grimy workplaces, without a chance to change or advance a career, are the images most people see when they imagine what it means to work in a factory. But, a…
Taran March @ Quality Digest
I hate banks. I’ve hated them since I was a drifty teenager who had a volatile relationship with math and trouble coming up with the required documents proving my adultness. My first checking account had less to do with the paltry sum I owned than it did with running head-on into the vast and…
Fred Schenkelberg
We establish reliability goals and measure reliability performance. Goals and measures can be related; however, they’re not the same, and neither do they serve the same purpose.
Recently, I’ve seen a few statements that seem to confuse the role of statistical confidence when establishing a goal.…
Chad Kymal
Deadlines for ISO 9001:2015 and ISO 14001:2015 registration have appeared on the horizon. Although we have 24 months to get registered to these new standards, some related timelines are looming even closer, notably scheduling a recertification or surveillance audit.
Some organizations have…
Kate Remley
If you’ve ever used a device that picks up signals over the air, you know that sometimes you just can’t get the signal to come in clearly. You point the device every which way, move it all around the room, do a little dance, but nothing seems to work. There doesn’t seem to be any explanation.…
Gabriele Suder
The costs of global terrorism on business go beyond the destruction caused in the attacks and actually impact the value of brands and supply chains for products, new research shows. It can give a competitive edge to some companies while destroying others.
During the 15 years since the Sept. 11,…
Nir Kshetri
It’s looking increasingly likely that computer hackers have in fact successfully attacked what had been the pinnacle of cybersecurity—the U.S. National Security Agency (NSA). Reports have emerged of claims by a hacking group called the Shadow Brokers that it had breached the network of, and…
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…
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…
