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AssurX
Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical-device inspection investigative focus. CAPA noncompliance is a top concern.
Inadequate corrective actions
An FDA investigation was conducted from January to February 2017 at…
Dirk Dusharme @ Quality Digest
Our July 28, 2017, episode of QDL we looked at science, technology, engineering, art, and math (STEAM) education for the deaf and hard of hearing; Quality 4.0; and cloud computing.
“Teaching STEAM Skills to Deaf Kids Using Drones and 3-D Printing”
The deaf and hard of hearing are underreprented in…
Coleman Flanagan
Sponsored Content
Your life as a nondestructive testing (NDT) inspector is not always easy. And if you’re engaged in rope access inspections, you face additional challenges. Whether you’re dangling from a rope 30 feet in the air or hanging over the ocean from a platform rig, you have to be choosy…
Ken Levine, Satish Nargundkar
Completing the define phase of a lean Six Sigma (LSS) project is a critical part of any project, although it’s often underestimated in practice. The define phase of the define, measure, analyze, improve, control (DMAIC) process typically includes three elements. The first is selecting a specific,…
Mark Whitworth
For decades, audit management has centered on paper checklists, with tracking moving to Excel spreadsheets in more recent years. Despite growing adoption of cloud-based manufacturing software, many auto suppliers still rely on paper checklists and spreadsheets to manage audit programs.
There’s a…
John Guaspari
‘You want me to pull the kids out of school for what?”
I could tell that my wife didn’t like my idea because she had used the tone she uses when I say something that is, to employ the pet phrase she employs in such instances, “really stupid.”
“For Guaspari Family Quality Day,” I replied. “We take…
The Un-Comfort Zone With Robert Wilson
I recall, back in 1995, trying to decide whether to get an internet account. I only knew two or three people who had them. Email sounded like a cool idea, but you still needed to pick up the phone to get in touch with someone. (Remember when the question was, “Do you have an email address?”…
Jeffrey Phillips
I have just returned from a trip to Dubai to speak at an innovation conference there. This is my third trip to Dubai, and I always come away consistently amazed at what the people and the government are doing. When I return to the States, people ask me what Dubai is like. I joking tell them that I…
Jesse Lyn Stoner
Jerome said his biggest problem was time management. He was overloaded, deadlines were getting missed, and he was stressed.
Managing his team was his biggest time drain.
“When they ask me questions, I get stuck spending time with them instead of doing my own work. And when I don’t hear from them…
Loic Sadoulet, Giovanni Tassini
Making the most of its position as an important seaport, Venice’s remarkable economic development during the Middle Ages relied on network effects, contractual innovation, and coordination among the players involved in long-distance trade. Companies today still exploit these mechanisms to succeed…
Shaun Wissner
Sponsored Content
Connectivity has changed the world we live in. While today it is a trend, the true potential of connectivity lies in the future. As manufacturers begin to investigate how they can integrate this developing technology, they rely on solutions from organizations, like Hexagon…
Kelly Graves
The following is an excerpt from Kelly Graves’ book, The Management and Employee Development Review (CRC Press, 2016).
When Darwin first made famous the term “survival of the fittest,” I don’t believe he was talking about the strongest species, or the fastest, but rather those species most able to…
Sophia Finn
Sponsored Content
The quality sector hasn’t seen real software innovation for nearly two decades. Even with an overabundance of options, the available quality software is fragmented, and its dated technology leaves a lot to be desired.
Ineffective quality management systems (QMS) can lead to…
Elizabeth Gasiorowski Denis
Change is nothing new. Nobel laureate Bob Dylan sang that “the times they are a-changin’” back in 1964. The difference today is the pace of change. In his book, Thank You for Being Late: An Optimist’s Guide to Thriving in the Age of Accelerations (Farrar Straus & Giroux, 2016), Thomas Friedman…
Mike Richman
The July 21, 2017, episode of QDL came to you from the 8,000-ft grandeur of Cliff Lodge in Snowbird, Utah—site of the 2017 Coordinate Metrology Society Conference. During this special episode, we toured the show floor, looked at some great portable 3D measurement solutions, and chatted with…
Dan Jacob
The most recent decade has seen rapid advances in connectivity, mobility, analytics, scalability, and data, spawning what has been called the fourth industrial revolution, or Industry 4.0. This fourth industrial revolution has digitalized operations and resulted in transformations in manufacturing…
Chip Bell
‘How ya gonna keep ’em down on the farm after they’ve seen Paree? How ya gonna keep ’em away from Broadway, jazzin’ around and paintin’ the town?” This 1914 song by Andrew Bird was a hit as soldiers returned home from World War I. The song captured the concern of farmers whose sons left their…
Jim Benson
The other day I was driving down Point Brown Road in Ocean Shores, Washington. Ocean Shores is a small town with almost no economic base. If you live there, you are likely a retiree or work in one of the restaurants or hotels that serve the tourists. The internet in Ocean Shores is anemic, but it…
Laurel Thoennes @ Quality Digest
There is no shortage of weirdness in quantum mechanics, and the phenomenon known as entanglement is weird with a capital “W.” When two particles are entangled, they share a connection no matter how far the distance between them.
Measuring one particle can tell you what measuring the other…
Fran Webber
Right now, the National Institute of Standards and Technology (NIST) museum in Gaithersburg, Maryland, is displaying a glass globe the size of a large beach ball. When visitors first come upon it, they’re not sure what to make of it. Is it a giant light bulb? A highly impractical fishbowl?…
Steven Brand
Labor costs are likely the largest line item on your company balance sheet. Therefore, a successful cost-reduction strategy must adequately balance resourcing and cost controls.
Although laying off part of the workforce may seem like the quickest and easiest solution to reducing labor costs in…
Scott Gottlieb
It is incumbent upon the U.S. Food and Drug Administration (FDA) to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory approaches to enable the efficient development of these technologies. By…
Bruce Hamilton
On May 5, 1961, Alan Shepard became the first U.S. astronaut to journey to the “final frontier.” Atop a Mercury rocket, Shepard launched into a 15-minute suborbital journey reaching an altitude of about 100 miles before returning to Earth. His space capsule, Freedom 7, was a wonder of science,…
InfinityQS
On Jan. 1, 2017, Philadelphia became one of the first U.S. cities to pass a tax ($0.15 per oz) on sugary drinks, including artificially sweetened beverages, such as diet soda. In California, San Francisco, Albany, Berkeley, and Oakland have joined Philadelphia in this initiative, as well as…
Katina Sawyer, Christian Thoroughgood
In times of organizational crisis, some companies are able to right the ship, while others sink under the pressure.
Recently, Uber has been under fire for a bad corporate culture, which promoted, among other things, sexism and other forms of toxic behavior. This led to a four-month investigation…
