All Features
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…
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…
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…
Benny Shaviv
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…
Malcolm Chisholm
I have just finished rereading Walter A. Shewhart's 1939 book Statistical Method from the Viewpoint of Quality Control (Dover Publications, 1986). Mine is the 1986 edition, which has a foreword by W. Edwards Deming. Shewhart, a Bell Labs man, pioneered quality control and was a major inspiration…
Mike Richman
Here at Quality Digest, we get a lot of mail: Some of it’s critical, some of it’s praiseworthy, some of it’s cantankerous, and some of it’s challenging. All of it is insightful. And then, every once in awhile, something comes along that simply... well...
The following was sent to us from a…
Joby George
The FDA’s Center for Devices and Radiological Health (CDRH) posted a notice of draft guidance that will require all medical device adverse-event reports to be submitted electronically. While the process of electronic submission of data is a more efficient and traceable means for reporting, it…
Steve Arbogast
A quality management system is a framework of processes and procedures that are used to ensure that an organization can fulfill all tasks required to achieve its goals, strategies, and objectives.
The majority of businesses around the world have some sort of well-defined quality management…
GKS Global Services
In this case study of reverse engineering and rapid prototyping we will look at a company that developed an initial prototype of an anti-snoring device based on many years of research in the field of dentistry. The company’s main dental advisor is a pioneering dentist in the research and…
Georgia Institute of Technology
Radio frequency identification (RFID) systems are widely used for applications that include inventory management, package tracking, toll collection, passport identification, and airport luggage security. More recently, these systems have found their way into medical environments to track patients…
John Stiller
Story update 9/23/09: Reference to 9.5.2.f was changed to 8.5.2.f in second paragraph.
As more suppliers are required by their regulators and customers to achieve ISO 9001 certification, and because certification symbolizes a point of competitive differentiation in a tight economy, emphasis on…
Matthew J. Savage
As companies downsize, they cut down on the number of employees, or move, or close, and thousands find themselves without jobs in a highly competitive job market that they never anticipated. A 55-year-old former NCR systems engineer is in line for jobs along with whiz-bang new college graduates,…
Resistance to the National Animal Identification Scheme (NAIS) has been strong. This six-year-old USDA policy initiative to reduce the catastrophic effects to the livestock and meat industry from a major animal disease outbreak has received so much negative reaction from so many and now seems…
Bill Kalmar
The band “Chicago” sang those words about "time" decades ago. The second line “Does anybody really care?” seems to sum up what is still in vogue today, especially in the workplace. Just as with vacations where workers are reluctant to leave for fear that someone will discover that their job is…
David C. Crosby
When I say quality manager, of course I’m talking about the department he or she manages as well.
I’ve been in the “quality business” for fifty years now. That’s right, fifty years. Much of my career—from source inspector to quality engineer, to corporate director of quality—was spent in other…
Richard A. Vincins
Through the 1990s, the application of a quality system relied primarily upon the Food and Drug Administrations’ (FDA) good manufacturing practice requirements or the FDA 21 CFR Part 820 Quality System Regulation. At that time, the international standards for quality management systems (QMS) were…
H. James Harrington
I often get assignments at organizations where I am required to take aside a group of people, either within the building facility or off campus, to focus on issues or problems. Typically these groups spend a considerable amount of time to summarize and present a well-defined problem. The next step…
David C. Crosby
The most important element in producing a quality product or service is the attitude of the people doing the work—not only the worker—but the attitude of all levels of management. Employee attitude about the product, about the work, about the boss, and about the company will pretty well determine…
Minitab LLC
A $1 billion annual budget may sound ample, but a few years ago, the costs of services ranging from law enforcement to cleaning county buildings had squeezed the government of Erie County, New York, to its limit. Residents faced a painful choice: raise taxes or slash services. But Chris Collins,…
Dale Hershfield
Twitter is the latest new thing. Want to follow John McCain or Al Gore throughout their day? Easy. Just sign up to receive their tweets. While their tweets may provide insights, or just entertainment (Ashton Kutcher and 50 Cent also tweet), does Twitter have value for business management?
The…
Craig Cochran
When I first got into quality, I really hated verifying the effectiveness of actions taken to correct a problem. After all, I was young and inexperienced. All of the people whose actions I was verifying were older, wiser, and more experienced than I was. Who was I to say that their actions were…
