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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

The world is changing so fast today that it is almost impossible to keep up with the latest trends in your own profession. If you are not spending at least two hours per day updating yourself in your chosen profession, you probably are behind the current state of the art. It has been estimated that…

Can you imagine producing products with a tremendous amount of variation? I’m sure many of you know this all too well. I mean, here you’re trying to produce the same products, trying to ensure consistency, and many of the products you produce have different shades of color, many function…

To improve customer satisfaction, enhance the quality of services and reduce costs, Peach Regional Medical Center has worked with the Georgia Institute of Technology to adopt process improvement techniques traditionally used by the manufacturing industry. Already, Peach Regional Medical Center’s…

Outstanding means being superior, striking, exceptional, clearly noticeable—essentially, to stand out. People are attracted to outstanding organizations. They want to buy from them, sell to them, invest in them, volunteer at them, and work for them. And as we close out the first decade of the 21st…

The rapid pace of technological advancement in the last decade has introduced both significant benefits as well as significant challenges to medical device makers. Companies these days are faced with demands of bringing products to market faster and faster, not only to meet sales and market…

I’ve spent most of the past two years living in China where I have learned much on how enterprise is managed over there. Many people have said that this century belongs to Asia. That may be, but they have a lot to learn and change before that happens. They cannot depend on cheap rote labor to…