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About a year ago, we shared with you our combination product review, Intercenter Consult Process Study Report, developed by the U.S. Food and Drug Administration’s (FDA) Office of Planning. The report findings were derived from focus group studies with reviewers from the FDA’s different centers…
In spite of the overwhelming odds against me, every new year I firmly resolve to reignite my relentless passion about creating a critical mass of colleagues committed to practicing improvement as “built-in” to cultural DNA using data sanity.
Will this be the year you join me?
Here is a …
Most of us who have been in leadership roles for awhile understand the importance of delegating. It’s simply a matter of leverage: The more we delegate, the more gets done. But sometimes we get confused. We think we are delegating, when in fact, we are abdicating. What’s the difference?
Delegate…
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The year 2017 is finally upon us, so Happy New Year one and all! For many, it will take a little while to get used to this turn of the calendar. Others however, particularly in the quality space, may already have their eyes on 2018.
That’s because next year is the deadline for…
I’m pinch-hitting for my co-host Mike Richman in the wrap-up of this past Friday’s episode of Quality Digest Live. Mike was off on vacation last week, so I presented the show myself.
On Friday’s show, we covered:
The FDA Mutual Reliance Initiative In order to lower their inspection costs, avoid…
There’s a lot of power and even nobility in the word “resolution.” But when it shows up accompanied by the trickster phrase “new year’s,” it's like a solemn king preceded by a capering jester. With every step we and our resolutions take into the year, it becomes harder to ignore the widening…
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Everything, it seems, has a vulnerability. For werewolves, it’s silver bullets. For Superman, it’s Kryptonite. For manufacturing—it’s rework. Rework means loss of throughput, which means loss of profit, which can mean death by a thousand rewelds. But, just as silver bullets can…
A member of Minitab’s LinkedIn group asked how to create a chart to monitor change by month, specifically comparing last year’s data to this year’s data. My last post showed how to do this using an Individuals chart of the differences between this year’s and last year’s data. Here’s another…
For FDA professionals focused on drug quality and safety, the rapid increase in imported drugs from nations where we devote limited inspection resources is of great concern. One way to address this concern would be to create an expanded inspectorate, one where investigators and inspectors from the…
Forensic science has become a mainstay of many a TV drama, and it’s just as important in real-life criminal trials. Drawing on biology, chemistry, genetics, medicine, and psychology, forensic evidence helps answer questions in the legal system. Often, forensics provides the “smoking gun” that…
A part of every leader’s job is to provide the coaching necessary to each of the individuals on the team. The challenge is that sometimes we end up coaching about something that happened recently, or that most stands out, rather than on what would most affect the future results of the person. At…
A U.S. Air National Guard veteran, a high school dropout, a person with a background in sales, and a family man who hadn’t been in a classroom for 20 years; four men on very different paths that ultimately led to one destination: the Massachusetts Manufacturing Extension Partnership’s (MassMEP)…
(Frost & Sullican: London) -- Self-learning artificial intelligence (AI) in cars is the key to unlocking the capabilities of autonomous cars and enhancing value to end users through virtual assistance. It offers original equipment manufacturers (OEMs) fresh revenue streams through licensing,…
What can be done when a test is destructive? How do we characterize measurement error? How can we determine if a test method is adequate for a given product or application? How can we check for bias?
All of the techniques for assessing the quality of a measurement system require us to make…
If compliance with the North American Electric Reliability Corp. (NERC) Reliability Standards wasn’t complex enough, registered utilities must also factor in the regulatory nuances of the bulk power system’s (BPS) eight regional entities (RE), even as NERC emerges with new risk management…
For most of human history, people have been terrified by lightning. Frightening bolts from above, lightning was considered a tool of the gods to smite mortals for their hubris (or their unfortunate penchant for seeking shelter from storms under trees). The discovery and implementation of Benjamin…
Happy New Year one and all!
In case you missed it, our first 2017 episode of Quality Digest Live contained some great articles and discussion between myself and my co-host, Quality Digest editor in chief Dirk Dusharme. In the show, we covered:
“Drop in LED Prices Drives Manufacturers Away”
LED…
Before I dive into this column, a quick programming note: You may have noticed some formatting changes in today’s issue of Quality Digest. Starting today, on each Thursday we will present a special edition of our newsletter, with a pair of particularly thought-provoking articles from our library…
Often we become so focused on fixing problems and resolving issues that our entire sense of reality shifts. We begin to live in a bubble that encompasses the negative and blocks the positive. Because they demand our attention, the negative aspects of work and life consume a disproportionate amount…
(Quality Digest: Chico, CA) – On Jan. 3, 2017, Ford Motor Co. announced plans to invest $700 million to expand its Flat Rock Assembly Plant in Michigan into a factory that will build high-tech autonomous and electric vehicles. The expansion will create 700 direct new jobs. The announcement was…
If you have ever used Maslow’s hierarchy of needs out of context, and especially as they relate to motivation in the workplace, I will track you down and tape you to a lamppost with a sign around your neck explaining your major error. Maslow’s theory dates back to ideas from the 1940s, and…
First of all, what does it mean to be orphaned by your customer relationship management (CRM) vendor? In short, it means that your CRM vendor sold you on a CRM product and for one reason or another forgot about you. Are you feeling left behind?
Of course, it’s no secret that choosing the right…
The process of alloy grade verification has advanced significantly with the development of portable and handheld devices that bring analytical capabilities traditionally found in the laboratory to anywhere rapid metals identification is needed. For years, handheld analysis technology has provided…
In the not so distant future, first responders to a disaster zone may include four-legged, dog-like robots that can bound through a fire or pick their way through a minefield, rising up on their hind legs to turn a hot door handle or punch through a wall.
Such robo-rescuers may be ready to deploy…
The barracuda is an ambush fish, capable of speeds of 25 mph and feared by all but killer whales and sharks. If confronted by one of those enemies and there is no place to hide, the barracuda simply attacks. Whether hunting or escaping, the barracuda is a formidable predator.
I find myself…
