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Mike Richman
A recent article appearing in the Quality Digest Daily e-newsletter (“Why Lean? Why Now?” by Dean Bliss http://www.qualitydigest.com/inside/health-care-news/why-lean-why-now.html) discusses the value of lean in a health care setting. In his editorial, Bliss writes about the manufacturing origins…
It is no secret that the health care industry is undergoing revolutionary changes. Are you responding by re-evaluating your approach to process improvement? In a world where doing more work with fewer resources is the norm rather than the exception, now is the right time to update your own work…
The QA Pharm
We hear much about the importance of listening to customers and meeting their needs. Lean Six Sigma devotees say that metrics from the customer’s vantage point are at the center of their philosophy.
Many pharmaceutical companies embed their high view of the professional community and patients…
Sal Lucido
Figure 1: Closed-loop process for managing regulatory compliance
In Part I, Part II, and Part III of this compliance series, I have described the benefits of using a closed-loop process for managing regulatory compliance (illustrated in figure 1).
Readers of this series…
Mark Graban
Lean thinkers see the waste in health care when they are at the hospital gemba. I think this is true whether you are a lean person who is new to health care or if you’re a long-time hospital person who has learned lean. Experts (doctors) ranging from John Toussaint to Patricia Gabow to Don Berwick…
Melanoma is one of the less common types of skin cancer, but it accounts for the majority of skin cancer deaths (about 75%). The five-year survival rate for early-stage melanoma is high (98%), but the rate drops precipitously if the cancer is detected late or there is recurrence.
So a great…
The QA Pharm
One of the regulatory responsibilities of the quality control department is the release decision for drug batches into the market. When I was first given that responsibility early in my quality assurance (QA) career, it was impressed upon me to not count the cost of the batch when making that…
Environmental Quality Corner with Ken Appel
On July 8, the Food and Drug Administration (FDA) announced an initiative “… to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003 Guidance for Industry Part 11, Electronic Records; Electronic Signatures—Scope and…
Sal Lucido
In Part I and Part II of this series we discussed the benefits of using a closed-loop process for managing regulatory compliance called the “circle of compliance,” pictured in figure 1. I also showed how setting up key performance indicators (KPIs) that monitor performance to goals is a good way…
Oriel STAT A MATRIX
Medical device manufacturers may gain a one-year exemption from Food and Drug Administration (FDA) inspections if their establishment has been audited under one of the regulatory systems implemented by the Global Harmonization Task Force (GHTF) founding members using ISO 13485. Manufacturers must…
Environmental Quality Corner with Ken Appel
For quite some time, polls have indicated that public approval for Congress remains at an all-time low. Congressional gridlock is difficult to watch for U.S. citizens who care about any issue and how our legislative process resolves the problems of our time—no matter what their party affiliation…
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…