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ISO 14971 or FMEA: Which Should You Use?
Jesseca Lyons
This may be stating the obvious, but engineers are generally very analytical. One of the areas where this trait comes to the fore is in evaluating all the ways things can go wrong. This includes exposure and using tools like failure mode and effects analysis (FMEA). As an engineer, there’s a good…
Going the Distance on National Tape Measure Day
Dan Sawyer
Whether they’re made of leather or metal, tape measures have been used by people for a long time. The first spring-loaded metal tape measure was invented and patented in England in 1829. Alvin Fellows of New Haven, Connecticut, made improvements to that design, including the locking mechanism that…
ISO/TS 16949 Piles on the Requirements This Year
Chad Kymal
In 2014, the International Automotive Task Force (IATF) reported that the automotive industry wouldn’t upgrade the ISO/TS 16949 standard to ISO 9001:2015, much to the dismay of Tier One suppliers. In a survey that same year, Tier One suppliers related their desire to update their management…
Registration of Food Facilities
Erwin Miller
The Federal Drug Administration’s (FDA) mission to protect consumers from unsafe food follows different paths. The seven rules that have been finalized since the fall in 2015 to implement the 2011 FDA Food Safety Modernization Act (FSMA) will require food producers, importers, and transporters to…
‘OSHA-Proofing’ Your Business
Jonathan Jacobi
When I first entered the safety profession, older, more experienced professionals recommended that I consider OSHA as a potential employer. The innuendo I sensed in this advice was that if I worked for the Occupational Safety and Health Administration (OSHA), got to know influential people, and…
Do You Trust the Food You Eat?
ISO
The global food industry has never faced more challenges. From tainted dairy products to contaminated beef, high-profile cases crop up regularly to dent consumer confidence, while leading companies work hard to reclaim lost faith. So how trustworthy is your food? Food safety is something we tend…
NIST’s Newest Watt Balance Brings World One Step Closer to New Kilogram
NIST
A high-tech version of an old-fashioned balance scale at the National Institute of Standards and Technology (NIST) has just brought scientists a critical step closer toward a new and improved definition of the kilogram. The scale, called the NIST-4 watt balance, has conducted its first measurement…
Fighting Fires With Science
Sam Manzello
I’m a dragon wrangler. Although that might sound like something straight out of Harry Potter or Game of Thrones, this isn’t fantasy—it’s serious science. As a fire researcher, or more colloquially, a dragon wrangler, my job is to help protect people and property from fire’s devastating effects.…
Eight Reasons Why Your Design Controls and Risk Management Processes Fail
Jon Speer
Design controls and risk management processes should be tools to ensure that medical devices are designed, developed, and manufactured to be safe and effective, and to address indications for use, too. All too often, however, design controls and risk management are viewed as a pile of “stuff”…
The FDA Forms New Partnerships to Ensure Product Safety
Howard Sklamberg
Globalization is posing challenges for public health. For the U.S. Food and Drug Administration (FDA), part of that challenge is the ever-increasing volume and complexity of FDA-regulated products coming to America’s shores. In fiscal year 2015, there were more than 34 million shipments of FDA-…
A ‘Certified’ Stamp for the Smart Grid
Cuong Nguyen
When I go home after work, my wife and I are typically focused on the present moment, and especially on our young son. As new parents, we benefit from many innovative products and services—from improved car seats and creative toys to safer cribs and video baby monitors. One of the first products…
Science, Science Fiction, and Superheroes
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 and Partners Create Standard to Improve Sustainable Manufacturing
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…
Bringing Clarity to the Cloud
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…
Changes and Implementation Strategies for AS9100 Revision D
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…
What Is a Leader to Do?
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…
Safety Standards for Ambulances—STAT
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…
National Inventor’s Month: You Can Make It If You Try
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,…
Passing an FDA Quality System Inspection
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…
Make a Mint Using Measurement Science
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,…
Photonic Pressure Sensors vs. Mercury-Based Standard
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…
Benefits of Environmental Certification
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…
Chemical Detective Hot on the Vapor Trail
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…
Four Steps to An Audit-Proof Measurement System
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/…
The Rise and Fall of Theranos
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…

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