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Editor's note: This is the first in a five-part series exploring issues that affect management’s ability to detect the warning signals of current good manufacturing practice (cGMP) compliance problems in the pharmaceutical industry.
Compliance to current good manufacturing practice (cGMP)…
It’s time to clear out some thoughts on an eclectic mix of articles I've been reading, so please pardon the potential mental whiplash. What does your company do to keep an eye on competitors? Perhaps it’s an informal process handled by the sales department, or perhaps there’s a database of some…
(NIST: Gaithersburg, MD) -- National Institute of Standards and Technology (NIST) authors and CRC Press have arranged to give all attendees at the 2013 North American Coordinate Metrology Association (NACMA) conference a 20-percent discount on the definitive coordinate metrology book, Coordinate…
New products and new processes do not appear full-grown. They are founded on new principles, which in turn are painstakingly developed by research in the realms of science.
—Vannevar Bush
In 1945, Vannevar Bush, the head of the Office of Scientific Research and Development, laid out his vision for…
There’s no such a thing as a linear decision-making process. Some so-called quality gurus will pretend there is a one-to-one relationship between a decision and the time needed to make it. I mean no criticism to them, although I think they pay scant attention to the reality of human cognitive…
How often do we see Health Insurance Portability and Accountability (HIPAA) violations issued because a regulated entity did not secure the electronic records at the hospital and small clinics? Large-scale security breaches and, sometimes, reports of illegal sales of electronic medical records by…
W
hy do so many businesses fail after surviving a disaster? Because the true costs of the disaster are misunderstood.
After the 1994 earthquake in the Northridge neighborhood of Los Angeles, many businesses that had survived relatively unscathed found their revenues declining. Prior to the quake…
A bright future beckons for a University of Huddersfield metrology instrumentation designer who has recently completed his doctorate, won a national award, and will now embark on a project to bring a patented product to the market.
It was a master of science in control systems and instrumentation…
Only 30 percent of U.S. employees are engaged in their jobs—a figure that hasn’t moved much in more than a decade. Given the proven links between employee engagement and financial outcomes, this low level of engagement is a drag on an already sluggish U.S. economy. Imagine the positive, even…
Gone are the days of carts carrying reams of paper documentation and checklists from station to station on the shop floor. Fortunately, with enterprise content management, document management, collaboration tools, and other digital services, paper is on its way out of the office. But that doesn’t…
The fifth edition of A Guide to the Project Management Body of Knowledge (Project Management Institute, 2013) is out, and I’m here to welcome it with a huge bear hug. Call me nerdy, but I think this is the best edition yet. Why? Because stakeholder management has been put in a corner for far too…
The U.S. LHC Accelerator Program (LARP) has successfully tested a powerful superconducting quadrupole magnet that will play a key role in developing a new beam focusing system for CERN’s Large Hadron Collider (LHC). This advanced system, together with other major upgrades to be implemented during…
Disagreements are inevitable in science, medicine—and even life. As part of a regulatory agency committed to public health, the Food and Drug Administration’s (FDA) medical devices center occasionally confronts scientific and policy disagreements among its staff and with the various stakeholders…
Disagreements are inevitable in science, medicine—and even life. As part of a regulatory agency committed to public health, the Food and Drug Administration’s (FDA) medical devices center occasionally confronts scientific and policy disagreements among its staff and with the various stakeholders…
When we think about limiting work in process (WIP), we have to realize that there are many types of work. Simply limiting work is not enough; we must know what we are limiting. We have to see what we’re really completing.
A real danger is that we tend to limit our WIP and then say, “What’s the…
Doctors have a new way of thinking about how to treat heart and skeletal muscle diseases. Body builders have a new way of thinking about how they maximize their power. Both owe their new insight to high-energy X-rays, cloud computing, and a moth.
The understanding of how muscles get their power…
Familiarity breeds contempt. Or neglect. We see this all the time. We grow tired of things often in our lives. In relationships. In politics. With music. With food. With jobs. It’s important that we mix things up from time to time. Or in many cases, to reenergize or recommit.
Maybe—just maybe—we…
We’ve all heard the clichés: “If you’re going to do something, do it right,” and “If you want something done right, do it yourself.” Change one word—“right” to “artfully”—and the view of work as art is not the far reach it may appear to be. But allow me to state my case more, er, artfully.
Like…
Boxers or briefs. Republican or Democrat. Yin or yang. Why is it that life often seems to boil down to two choices?
Heck, it even happens when you open the Basic Stats menu in Minitab. You’ll see a choice between a two-sample t-test and a paired t-test:
Which test should you choose? And what’s…
Approximately half of the 704 employers participating in a survey by The Chronicle of Higher Education and American Public Media’s Marketplace said they have trouble finding qualified college graduates to fill their companies’ positions. Yet, 68 percent of the survey’s manufacturers said colleges…
Editor’s note: This continues Jack Dunigan’s series about unsung heroes in the workplace, and the 16 traits they all share.
One stormy night many years ago, a man and his wife entered the lobby of a small hotel in Philadelphia. Trying to get out of the rain, the couple approached the front desk…
Pitch is a representation of takt image—a visual and often audible management time frame that lean practitioners use to pace and monitor value stream performance. It’s typically driven by, and linked to, a value stream or line’s pacemaker process.
Pitch performance is routinely tracked and…
Few quality professionals would want to hear somebody call their quality policies propaganda, but they are exactly that by definition. “Propaganda consists of the planned use of any form of communication designed to affect the minds, emotions, and action of a given group for a specific purpose,”…
(SICK: Minneapolis) -- SICK, one of the world’s leading manufacturers of sensors, safety systems, machine vision, encoders, and automatic identification products for factory and logistics automation, has launched the Dx35 line of laser distance measurement sensors.
These mid-range distance…
I live and work in Germany, and I recently learned a useful German phrase: “Service Wüste.” Well, half-German; the service part is actually English. Translated into English it would mean “service wasteland” or “service desert.” That’s how many Germans describe Germany.
In general, I’ve found the…
