All Features
James Olthoff
I’m a physicist, and as anyone who watches the popular TV series The Big Bang Theory knows, it’s a commonly held conception that there is a strong connection between being a scientist and being enthralled with all things science fiction, fantasy, and superheroes. Anyone who walks into my office at…
NIST
Anyone who has ever covered a wall with sticky notes to clearly map all of the steps in a process knows how valuable that exercise can be. It can streamline workflow, increase efficiency, and improve the overall quality of the end result. Now, a public-private team led by the National Institute of…
Brian Stanton
Doors that are obviously meant to be pushed not pulled, footprints painted on the floor telling you where to stand at the airport—these are examples of good design and usability. You don’t have to think too hard about what to do because someone else put a lot of thought into how to get across the…
Chad Kymal
The aerospace standard AS9100 Revision D was originally planned to be released in April 2014. Many of us close to the standard expected it to be released in May 2016 after the April International Aerospace Quality Group (IAQG) meeting in Singapore. However, this was not the case; the IAQG decided…
Harry Hertz
I recently read an HBR blog by Sunnie Giles that reported the results of a study of 195 leaders representing 30 global organizations. The leaders were asked to identify the most important competencies for leadership. The study reminded me of a complementary article in Forbes, written by Glen…
Jennifer Marshall
For as long as we have had automobiles, we have had traffic accidents. Even the vehicles that we depend on to take care of us in the event of an accident—ambulances—get into accidents nearly every day. Because ambulances are basically a small emergency room on wheels, the occupants in the back are…
Mark Esser
Depending on whom you ask, May (or August or April—it would be great if someone were to standardize this, but we’re going with May) is National Inventor’s Month. Lots of people have dreams of being a famous inventor. Even I’ve had “ideas” for inventions before.
For instance, during the 1990s,…
Grant Ramaley
The Quality System Regulation (QSR) 21 CFR Part 820, aka FDA current Good Manufacturing Practices (cGMP) for Medical Devices, is what regulatory professionals should be referencing in their quality system procedures. Part 820 embodies all the major parts of the FDA quality system that are shared…
Richard Gates
Put your hands together. Now move them back and forth to rub them against each other. Feel that heat? That’s from friction. No matter if it’s between siblings or the gears of an engine, we usually think of friction as a bad thing, and often it is. Friction can cause things to heat up, wear down,…
Jennifer Lauren Lee
When a team of researchers at the National Institute of Standards and Technology (NIST) Physical Measurement Laboratory (PML) first tested a new kind of pressure sensor two years ago, initial results showed it was faster and had higher resolution than the centuries-old mercury-based method for…
Jeffrey Eves
Sponsored Content
There are many paths for organizations to become good, sustainable, low-footprint citizens of the business world. Production processes can be redesigned to be more efficient, corporate campuses can be located so as to reduce employees’ dependence on fossil fuels, and buildings…
NIST
Recently on the Taking Measure blog, we asked Tara Lovestead, a recipient of the 2016 Presidential Early Career Award for Scientists and Engineers (PECASE), a few questions about her life and work. She was recognized for her extensive application of new methods to rapidly and inexpensively detect…
Eric Gasper
An upcoming audit can be one of the more stressful times of the year for a quality team. Whether you are pursuing a new certification or retaining your current one, audit preparation can be a daunting challenge to even the most diligent organization. Although standards such as ISO/IEC 17025, ISO/…
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…
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),…
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…
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…
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…
NIST
Medical implants and spacecraft can suddenly go dead, often for the same reason: cracks in ceramic capacitors, which are devices that store electric charge in electronic circuits. These cracks, at first harmless and often hidden, can start conducting electricity, depleting batteries or shorting…
ISO
With medical devices ranging from simple needles to life-saving high-tech implants, ensuring the highest possible level of safety is one of the industry’s greatest priorities. Here, as the chair of the ISO technical committee for quality management and related general aspects for medical devices,…
Stephen Mundwiller
One of the more enjoyable discussions I’ve seen on the Internet recently has to be about what to do with the quality manual. A common question is, “So what do I call this thing I put all the procedures in, now that we can’t have a quality manual?” It’s part of the panic brewing among quality…
Donald J. Wheeler
Here we look at a simple example to discover the commonalties of various data analysis techniques widely used in industry today. Careful consideration of the following may result in insights that were not part of your introductory class in statistics.
Our example uses the gate oxide thicknesses…
