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Identifying Nanomaterials in Food
As You Sow
A first-of-its-kind framework released Dec. 6, 2011, offers recommendations to food and food packaging companies on how to identify and evaluate nanomaterials in products. Not only is this technology unregulated and untested for its implications on public health but companies may not even be…
Quality Pro Salaries Keep Pace with Inflation
ASQ
(ASQ: Milwaukee, WI) -- The results of ASQ’s 25th annual Salary Survey show strong average salaries for quality professionals in 2011 and fewer lay-offs as companies continue to see the value of quality and its positive impact on an organization. The survey results also show that experience…
Hat Trick for One Baldrige Winner CEO?
Bill Kalmar
The 2011 Malcolm Baldrige National Quality Award winners were announced last week, and for the first time, three recipients are in the health care category. The recipients of the 2011 Baldrige Award are: • Concordia Publishing House, St. Louis (nonprofit) • Henry Ford Health System, Detroit (…
‘Drinking from a Fire Hose’: Has Consumer Data Mining Run Amok?
Knowledge at Wharton
In a world of endless information sharing, consumers have become the product. Platforms such as Google, Facebook, Foursquare, and Twitter are the new factory floor, and online users who leave digital crumbs as they browse the web and tap into social networks generate data that can be bought and…
FDA Reorganization Signals More Inspections for Drug, Device Firms
Michael Causey
Under pressure from all sides, the beleaguered Food and Drug Administration (FDA) keeps announcing new reorganization initiatives, name changes, and all sorts of stuff that would be funny if it was scripted by the same team handling Steve Carell’s departure from The Office and the ushering in…
Foreign Exporters Study U.S. Food Safety Law
FDA
The Food and Drug Administration’s (FDA) international program has logged nearly 75,000 hits to its web pages on the new food safety law, as foreign companies that export food to the United States scramble to learn how the law affects them. “A lot of our foreign offices are being deluged with…
Fingertip-Size Microscope Has Potential for Studying Brain Diseases
Stanford News Service
A readily portable miniature microscope weighing less than 2 grams and tiny enough to balance on your fingertip has been developed by Stanford University researchers. The scope is designed to see fluorescent markers, such as dyes, commonly used by medical and biological researchers studying the…
Quality by Design Pilot Presents Industry with New Challenges
Patrick Stone
What products will be affected by the Food and Drug Administration’s (FDA) quality by design (QbD) stipulation, as outlined in its report, “Pharmaceutical Quality for the 21st Century: A Risk-Based Approach”? It will apply to new marketing authorization applications, new drug applications, Type…
Clinical Integration: A New Model for Cost-Effective Health Care
The Advisory Board Co.
In our current health care environment, hospitals face increasing urgency to strengthen relationships with physicians. Among the concerns are an aging population driving increased demand for health care (as well as a growing Medicare population), reimbursement reductions and changes, and…
Quality Problems More Likely in Offshore Drug Plants
The Ohio State University
Drugs produced in offshore manufacturing plants—even those run by U.S. manufacturers—pose a greater quality risk than those prepared in the mainland United States, a new study suggests. Researchers found that drugs produced at plants located in Puerto Rico that are owned and operated by U.S…
The Food Safety Modernization Act: A Public Health Imperative
Les Schnoll
According to recent data from the Centers for Disease Control and Prevention, every year about 48 million people get sick, 128,000 are hospitalized, and 3,000 die from food-borne diseases. Hardly a day goes by where there isn’t another recall of food contaminated with a variety of microorganisms…
When ‘Reason to Believe’ Halts Food Production
Cathy Crawford
As of July 3, 2011, the Food and Drug Administration (FDA) has increased authority to use administrative detention as an enforcement tool. For this reason, companies that manufacture, prepare, pack, or hold food should ensure strong record-keeping practices. Under the current criteria of the…
Customer Advocacy Behavior Measurement: Part 2
Michael Lowenstein
There is a strong recognition that customer service is especially important in the branded experience. Service is one of the few times that companies will personally interact with their customers. This interaction helps the company understand customers’ needs while, at the same time, it shapes…
Customer Advocacy Behavior Measurement, Part 1
Michael Lowenstein
The word “advocate” has French and Latin origins. It has multiple applications, including legal, political, social care, and marketplace. It is the marketplace applications where the business, academic marketing, and management consulting communities have focused. Essentially, advocacy can be…
FDA Protects Us from Terror of Unpasteurized Milk
Patrick Stone
I don’t know about you, but I sleep easier now knowing that our Food and Drug Administration (FDA) has declared war on unpasteurized milk in the United States [Editors note: also see Fox News, NaturalNews.com]. It’s not enough that the U.S. government is fighting the war on terror (an oxymoron)…
Putting the ‘Continuous’ Back into Health Care Improvement
When the Japanese word kaizen entered the language of quality improvement via Masaaki Imai’s seminal book, Kaizen: The Key to Japan’s Competitive Success, (McGraw-Hill/Irwin, 1986), the author defined kaizen as “ongoing improvement involving everyone.” In a 2011 video posted on YouTube, Imai…
Undercover Hospital Sensei’s Diagnosis
Mark R. Hamel
First, the introduction. This post was earnestly written by my friend, Jeff Fuchs. He’s the director of the Maryland World Class Consortia, a lean nonprofit assistance organization in the mid-Atlantic. He’s also president of Neovista Consulting, which works with large and small organizations on…
A New Conversation for Quality Management
Davis Balestracci
Finally, the medical industry is putting aside its “We’re medicine; we’re different” mindset and taking a more practical look at quality improvement. Bravo! Although an element of physician culture remains convinced that improvement is all about outcomes and double-blind clinical trials, the…
Should Commitments Made to the FDA Be Taken Seriously?
The QA Pharm
Responses to the Food and Drug Administration’s (FDA) Warning Letters and the FD483—a written notice of deficiencies found during inspections—are usually full of commitments. They involve what will be done to correct compliance problems, and when it will be done. The FDA has even started to ask…
American College of Surgeons Goal: Enlist 1,000 Hospitals in Quality Improvement Program
American College of Surgeons
The American College of Surgeons (ACS) has set a goal to enlist at least 1,000 hospitals into its respected National Surgical Quality Improvement Program (ACS NSQIP). The commitment is part of the ACS Inspiring Quality initiative, an effort to raise awareness of proven models of quality…
Medical Tragedy Can Be Easily Prevented by Error Proofing
William A. Levinson
Dr. Gary Brandeland’s article, “The Day Joy Died,” which appeared in the Oct. 20, 2006, edition of Modern Medicine, underscores the primitive nature of quality thinking—and more specifically, safety thinking—in hospitals. Although I’m not going to give formal engineering advice about medical…
Please Pass the Apple Fries?
Bill Kalmar
Sseems the Diet Police are once again running rampant in our nation. It has been said that close to 30 percent of Michigan residents are overweight, and thus there is a movement afoot to curtail our eating habits, not only in that state but also nationally. Believe it or not, there is some…
The Road to Health Care Reform Is Paved with Missed Opportunities
Davis Balestracci
After reading Joe De Feo’s July 8, 2011, Quality Digest Daily article, “A Positive Prognosis: Transforming Health Care in America,” I took another look at the wonderful book, Escape Fire (Jossey-Bass, 2003), a compendium of Dr. Donald Berwick’s inspiring plenary speeches at the Institute for…
FDA to Set Production Standards for Safer Fruit and Vegetables
FDA
As headlines from Europe implicate tainted vegetable sprouts in more than 4,000 illnesses and dozens of deaths, American consumers may wonder, “Could that happen here?” The United States has had its own headline-grabbing outbreaks from contaminated vegetables—such as lettuce in 2010, peppers in…
A Positive Prognosis: Transforming Health Care in America
Joseph A. DeFeo
In the U.S. health care system, quality and safety have developed into strategically important issues. Progress is being made at the local level, even if it is slow and doesn’t get much of the public’s attention. Health care improvement has certainly come a long way since the early 1990s, when an…

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