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Norman A. Paradis
The last few months have witnessed the unraveling of the remarkable life sciences company Theranos, culminating in the news that federal regulators may ban Theranos founder Elizabeth Holmes from the blood-testing industry for at least two years. The company is also facing a federal criminal…
Kevin Meyer
During the past few years I’ve been working hard on cultivating positive habits. New habits can be powerful. But habits can also create barriers that limit our perspective, which can hinder kaizen, creativity, and even our knowledge of ourselves. We’ve all found ourselves in the proverbial “rut”…
Fred Schenkelberg
What if all failures occurred truly randomly? Well, for one thing the math would be easier.
The exponential distribution would be the only time to failure distribution—we wouldn’t need Weibull or other complex multi-parameter models. Knowing the failure rate for an hour would be all we would need…
William A. Levinson
All process activities can be broken down into one of five categories: waiting, handling and setup, inspection, transportation, and transformation. Of these, only transformation of the product adds value.
A figure in Frederick Winslow Taylor’s 1911 book, Shop Management makes it clear that, while…
Bruce Hamilton
Today’s article is inspired by the politically-charged gobbledygook we call presidential primaries. This battle of principles turned battle of wills reminds me that the role of the change agent can be as much theater as science. In a public forum, at least, the positions of the opponents are…
Rachel E. Sherman, Robert M. Califf
Across the clinical research enterprise, there is a growing awareness of serious shortfalls in the current model for generating the scientific evidence that supports medical product evaluation and clinical care decisions. As a result the FDA seeks to modernize methods and satisfy expectations…
Paul Voss
Not long ago, most Americans could safely ignore congressional deliberations about Federal Aviation Administration (FAA) authority, leaving the details to industry experts and lobbyists. But this time, we may need to fasten our seatbelts and actually read the card in the seat pocket.
A bill under…
Bruno Scibilia
In yesterday’s column, I discussed how a DOE was chosen to optimize a chemical-mechanical polishing process in the microelectronics industry. This important process improved the plant’s final manufacturing yields. We selected an experimental design that let us study the effects of six process…
Bruno Scibilia
Ionce worked in the manufacturing industry. Some processes were so complex that even a very experienced and competent engineer would not necessarily know how to identify the best settings for the manufacturing equipment.
You could make a guess using a general idea of what should be done regarding…
Tim Lozier
When we look at business dynamics, regardless of industry, we see an increasing rate of change in products, processes, and regulations. One process affects the next, and with a growing focus on regulations and standards, complexity becomes an ever-expanding theme, whether related to quality…
NIST
They activate airbags. Keep aircraft correctly positioned in flight. Detect earthquakes or sudden vibrations in failing machinery. Guide military hardware. Monitor falls in elderly individuals and initiate calls for help. They rotate the display on a smartphone from vertical to horizontal, and…
Jon Speer
If you’re still using failure mode and effects analysis (FMEA) as your methodology to capture medical-device risk management activities, then your risk management process is out of date. Let me tell you why.
Here’s the definition of “risk management” as defined in ISO 14971:2007—“Medical devices—…
Ken Miller
Please pardon me, but I feel a little like a modern-day Paul Revere alerting you to the start of the second wave of Health Insurance Portability and Accountability (HIPAA) compliance audits.
Last week, Jocelyn Samuels, director of the Health and Human Services’ Office of Civil Rights (OCR),…
Ken Levine
One poorly understood concept in lean Six Sigma is how much to “stretch” when setting S.M.A.R.T. goals. These letters are defined as S—specific; M—measureable; A—assignable, attainable, or achievable; R—realistic, reasonable, or relevant; and T—time-based or time-bound. Regardless of the different…
Bruno Scibilia
Sponsored Content
Suppose that on your way to a summer holiday resort (a very distant place), your car breaks down. You might just call roadside assistance and wait for your car to be towed to a repair shop. But suppose that you think you’re smarter than that, and you would like to solve the issue…
Kimberly Watson-Hemphill, Kristine Nissen Bradley
Editor’s note: This is an excerpt from the new book, Innovating Lean Six Sigma, by Kimberly Watson-Hemphill and Kristine Nissen Bradley.
Like every company, healthcare businesses do their work through processes, and any process can be studied and improved using basic lean Six Sigma methods. Figure…
NIST
Researchers at the National Institute of Standards and Technology (NIST) have developed the first widely useful standard for magnetic resonance imaging (MRI) of the breast, a method used to identify and monitor breast cancer.
The NIST instrument—a “phantom”—will help standardize MRIs of breast…
Jill Hartzler Warner, Thinh Nguyen
Combination products represent an important and growing category of therapeutic and diagnostic products under the U.S. Food and Drug Administration’s (FDA) regulatory authority. These products, which combine a drug, device, and/or biological product (referred to as “constituent parts”) with one…
Lillian Erickson
The updated version of ISO 9001, published in September 2015, generated much anxiety among companies fearing a bumpy transition to the updated and significantly changed international standard. Admittedly, we at MasterControl were not immune to those worries.
Despite having quality experts…
FDA
One of the vivid images that sticks with me from my tenure at the Food and Drug Administration (FDA) is of the port of entry at Nogales, Arizona. There, I saw large trucks from Mexico lined up as far as the eye could see, awaiting entry into the United States, many loaded full with fresh produce…
Tonianne DeMaria
I recognize that the title of this column might stir up some controversy, especially among fellow coffee enthusiasts. Not to mention it puts me at risk of getting exiled from my beloved adopted home, Seattle. And yes, perhaps “Clarity > Coffee” even seems a tad hypocritical, considering that I’…
MIT News
In March 2011, Leonardo Bonanni was preparing to defend his Ph.D. thesis about Sourcemap, software that lets consumers map every connection of a product supply chain on a digital map, when tragedy struck in Japan. Although the deadly earthquake and tsunami occurred half a world away, the events…
NIST
I
n the age-old struggle between humans and microbes, bacteria seem to be regaining the offensive. Only about a dozen classes of chemicals protect us from the myriad pathogens that populate our environment. Numerous agencies have warned that evolved resistance could soon render common antibiotics…
John Nolan
The ultimate aim of ISO 9001:2015 is to enable businesses to satisfy their customers effectively. You could say that all the standard’s clauses help to provide your customer with a consistent and rewarding experience from your goods or services, but ISO 9001:2015 actually deals with “customer…
Gilles Hilary
Phil used to be a very senior financial executive. When asked for a number, he would typically provide with a rough ballpark answer, such as, “It’s about 5 percent.” He’d then be peppered with questions about how he had arrived at that figure.
After a while, he got tired of this questioning and…