All Features
Gene Rider
Approximately three-fourths of product safety recalls in the United States are the result of some design flaw in the product rather than a manufacturing or other defect. Most violations of the U.S. Consumer Product Safety Commission (CPSC) “small parts” standard, for example, are the result of…
Sal Lucido
The compliance department’s primary function is to ensure that the company complies with all applicable regulations, rules, and laws. Regardless of the industry—life science, energy and utilities, or financial services—this is a universal mandate.
As someone who serves customers across many…
National Association for Healthcare Quality
The Toyota Production System and U.S. health care improvement share a long history. What lessons can health care leaders learn from Toyota’s recent production troubles? A few experts recently discussed this on WIHI, an audio program sponsored by the Institute for Healthcare Improvement (IHI). Here…
Michele DeMeo
A surgical technician prepares her back table for the next laparoscopic surgery. Instruments are removed from their containers and packages, and placed neatly on the back table. Chemical indicators show that sets and instruments are sterilized; the patient is prepped. The surgeon begins the…
(Academy Leadership Publishing: King of Prussia, PA) -- When news headlines trumpet story after story about fiscal mismanagement, unchecked greed, massive bankruptcies, and rampant downsizing, it’s hard to believe there’s any good news about the business world. Indeed, it’s almost impossible not…
In the classic Aesop fable, “The Fox and the Grapes,” a fox desires some grapes hanging high overhead. When he is unable to come up with a way to reach them, he convinces himself that the grapes are probably sour and therefore not desirable anyway. “Sour grapes” has become an idiomatic expression…
Tony Shaw
A woman in Southern California’s Inland Empire, age 53, is suffering from an unidentified neurological disorder. It started as an odd numbness in her left arm, and now she feels an uncomfortable, persistent tingling and prickling pain from the bottom of her feet to the top of her eyebrows. She…
Leaders of quality assurance programs must be able to generate interest and commitment without burdening clinical and administrative staff with an activity they neither understand nor believe in.
Hospital accreditation has been defined as “A self-assessment and external peer assessment process…
Environmental Quality Corner with Ken Appel
At the time of this writing, inspectors from the Food and Drug Administration (FDA) are at work monitoring seafood safety in areas affected by the oil spill in the Gulf of Mexico. Finger-pointing continues and there is now talk on the news of criminal prosecutions. The full economic effect of the…
The Un-Comfort Zone With Robert Wilson
With the morning mist still on the Hudson River and the sun just kissing the cliff tops of the New Jersey Palisade, Aaron Burr, vice president of the United States, shot and killed former Secretary of the Treasury Alexander Hamilton. Political opponents for years, the duelists faced each other…
Oriel STAT A MATRIX
In recent years, there have been published reports of an increase in Food and Drug Administration (FDA) inspectional observations associated with training deficiencies. Specifically, these inspectional observations have focused on training related to the quality system requirement that…
Environmental Quality Corner with Ken Appel
Having exhibited at INTERPHEX for many years, Veriteq, a provider of environmental monitoring and validation solutions, has made many connections with leading pharmaceutical and biotech companies. The Veriteq team attending INTERPHEX 2010, on April 20–22, was struck by two trends in the…
NIST
The U.S. Department of Veterans Affairs Cooperative Studies Program (VACSP) Clinical Research Pharmacy Coordinating Center (the Center) is a federal government organization that supports multicenter clinical trials targeting current health issues for America’s veterans. Located in Albuquerque, New…
Where does the U.S. Food and Drug Administration (FDA) stand on good manufacturing practices (GMP), the set of regulations that govern manufacture and testing of medical devices and other medical products like pharmaceuticals, diagnostics, and food? And what of the universal device identification…
(TWI Institute: Liverpool, NY) -- Training within industry is needed more now, in this down economy, than ever before. It was in a time of crisis that the Training Within Industry (TWI) Service proved its worth more than 60 years ago. Today, leading organizations are turning to training within…
Oriel STAT A MATRIX
After years of focusing on the pharmaceutical industry and establishing better controls for reviewing the safety and efficacy of pharmaceutical products prior to approval, the Food and Drug Administration (FDA) is now directing its attention to the medical device industry.
On Feb. 18, the FDA…
Georgia Institute of Technology
The cross-functional team at Piedmont Newnan was made up of employees that deal with the process daily. For this process improvement project, they focused on case carts, which are used for pulling together all supplies needed for surgical procedures.
Pam Murphy, a…
Knowledge at Wharton
Toyota’s legendary lean processes didn’t come out of nowhere. They were forged by the fire of urgency in post-World War II Japan when resources were scarce. Toyota innovated—and continued to innovate. Today, the Toyota Production System is the most respected manufacturing and inventory control…
redOrbit
With a silicone rubber “stick on” sheet containing dozens of miniature, powerful lenses, engineers at Harvard are one step closer to putting the capacity of a large laboratory into a microsized package.
The marriage of high-performance optics with microfluidics could prove the perfect match for…
Mark Graban
When I was in Sweden recently, we had a lot of good discussion about the lean concept of “standardized work.”
There was much agreement from different presenters at the lean laboratories conference, and from the hospital people we visited, concerning standardized work—that it isn’t a robotic…
The Un-Comfort Zone With Robert Wilson
On a summer weekend in 1977, my friend Tony and I made plans to go water-skiing. When he picked me up there were two people in the car that I did not know. He introduced his new girlfriend, Sue, and her brother, Bubba.
Bubba was the quintessential redneck. Within minutes of getting on the boat…
Raissa Carey
As in any good relationship, open communication is vital and Toyota Motor Corp., which recently suspended production and sales of eight models suspected of having sticky accelerator pedal problems, now has the perfect chance to show the world how healthy a relationship it has with its customers…
Jane Martinsons
With or without health care reform, health care quality professionals know that change is already a new reality for U.S. health care, transforming the industry, their own organizations, and their professional roles on what seems a daily basis.
“With all the changes that we’re facing in health…
Jennifer Sprance
The molecular diagnostics industry is a relatively new territory that offers much promise for early disease detection and personalized patient care. When analyzing samples at the molecular level, there are serious consequences for errors, and tests must be highly accurate and precise. For example…
The Un-Comfort Zone With Robert Wilson
In the early 1970s I was a young teenager who was completely caught up in the Zeitgeist. I admired the long-haired rebels and radicals who were engaged in protesting the establishment and developing the counter-culture. I didn’t really know what any of that meant, but to me it was all about…