All Features
Stefan Geib
While the fallout of the United Kingdom’s decision to exit the European Union has sent shockwaves throughout the political and economic world, Brexit is merely a footnote in the global supply chain risk story. According to the latest risk index from the Chartered Institute of Procurement &…
Pam Bethune
One of the newest parts of ISO 9001:2015 and related management standards are the concepts of context and interested parties. What do these mean, and how can you apply them to your organization?
What the standard says
When making sense of Clause 4.1—“Understanding the organization and its context…
Daniel Blake, Caterina Moschieri
Pulling out of a country is an expensive proposition for a multinational firm, but it is sometimes required for the corporate bottom line. If the host country changes laws or even expropriates a subsidiary, it is often time to leave or divest.
Divestiture—pulling out assets or closing down part…
Mary McAtee
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Technical and commercial media sources are constantly discussing how design safety and security has not kept pace with quickly evolving technologies. Pundits are pointing to issues with everything from self-driving cars to new holiday toys that latch on to your home Wi-Fi and…
Tim Lozier
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For quality management to be effective, a solid corrective action process is critical. ISO standards and general best-practice guides suggest—and even mandate—a set procedure and proper documentation for addressing and correcting issues.
In fact, 72 percent of quality…
Thomas R. Cutler
Two words no manufacturing organization wants to hear: product recalls. By their very nature, product recalls are unpredictable events.
The cost to a company transcends potentially expensive litigation and settlements. Product recalls and the effects that product failures have on companies that…
DNV GL
According the International Organization of Standardization (ISO), there are more than 300,000 certifications to ISO 14001 in 171 countries around the world, making it the most relied-upon symbol of environmental stewardship and sustainable business practice. True to its core tenant of continual…
Katherine Watts
While at the National MACRA MIPS/APM Summit in Washington, D.C., I heard much discussion centered on how to create and implement strategies that pay physicians fairly, while controlling spending in the Medicare program. It’s a question we’ve wrestled with for almost 20 years and a challenge we…
Dara Corrigan
For FDA professionals focused on drug quality and safety, the rapid increase in imported drugs from nations where we devote limited inspection resources is of great concern. One way to address this concern would be to create an expanded inspectorate, one where investigators and inspectors from the…
Jessica Gabel Cino
Forensic science has become a mainstay of many a TV drama, and it’s just as important in real-life criminal trials. Drawing on biology, chemistry, genetics, medicine, and psychology, forensic evidence helps answer questions in the legal system. Often, forensics provides the “smoking gun” that…
Mike Richman
Before I dive into this column, a quick programming note: You may have noticed some formatting changes in today’s issue of Quality Digest. Starting today, on each Thursday we will present a special edition of our newsletter, with a pair of particularly thought-provoking articles from our library…
Fred Schenkelberg
If you have been a reliability engineer for a week or more, or worked with a reliability engineer for a day or more, someone has asked about testing planning. The questions often include, “How many samples?” and, “How long will the test take?” No doubt you’ve heard the sample-size question.
What…
Pat Toth
They say opposites attract. Although my husband and I have many important things in common, we are complete opposites in one area. He’s a “risk taker,” and I’m... well, not so much. Rather than being labeled as “risk averse,” I prefer the term “caution giver.”
I’m a federal employee. I come from…
Penelope B. Prime
Chinese goods seem to be everywhere these days. Consider this: At the Olympics in Rio this summer, Chinese companies supplied the mascot dolls; much of the sports equipment; the security surveillance system; and the uniforms for the volunteers, technical personnel, and even the torch-bearers.
Do…
Tannaz Mirchi
With airfares at their lowest point in seven years and airlines adding capacity, this year’s holiday air travel is slated to be 2.5 percent busier than last year. The system we use to coordinate all those flights, however, is decades old, and mostly depends on highly trained air traffic…
Greg Fox
It’s that time of year again. The time when eggs get nogged, pudding gets figgy, and it becomes socially acceptable to speak in rhyme. So on that note, and with apologies to Clement Clarke Moore, I bring you this timely and heartfelt public service announcement. Enjoy.
’Twas the week before…
Michael A. Witt
Editor’s note: This is part two of a two-part series. Read part one here.
While globalization has benefited humanity in many ways, its continued progress is in serious doubt. As I wrote previously, the two leading political science theories, liberalism and realism, both predict that globalization…
Joe Schlecht
According to the ISO/IEC Guide 99—“International vocabulary of metrology—Basic and general concepts and associated terms (VIM),” the traceability of a measurement result is demonstrated through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty. This…
Mark Whitworth
For 17 years, ISO/TS 16949 was the leading standard for quality system requirements in the automotive industry. The technical specification was jointly developed by the International Automotive Task Force (IATF) and the International Organization for Standardization (ISO) in 1999. In October 2016…
Timothy Woodcome
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If your organization has yet to make the transition from ISO 9001:2008 to ISO 9001:2015, you’re not alone. It’s estimated that less than 20 percent of the more than one million organizations certified globally have made the transition to the latest version of the standard (as of…
Kara Baskin
Care.com co-founder Donna Levin played a key part in that company’s growth, and the passion was personal. Levin’s work plans were curtailed when her son was 11 weeks old and had a seizure following a difficult pregnancy. Tests were inconclusive. Her daycare situation evaporated; she and her…
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Manufacturers often hold suppliers to a rigid quality process that dictates tight controls on all raw materials. Nonconforming material can potentially halt the production line, wasting time and money. Unfortunately, material mix-ups are a reality in critical manufacturing…
American Customer Satisfaction Index ACSI
(ACSI: Colorado Springs, CO) -- Customer satisfaction with banks is up, according to the American Customer Satisfaction Index (ACSI). Its recent report covers the finance and insurance sector, which includes retail banks, credit unions, health insurance, property and casualty insurance, life…
AssurX
Life sciences companies around the world should make sure their corrective and preventive action (CAPA) plans are in good shape before a Food and Drug Administration (FDA) inspector comes calling. Looking at a deep pool of letters issued this year domestically and internationally, it’s clear the…
The new revision of AS9100D is now out, and clause 10.2—“Nonconformity and corrective action” will require us to “evaluate the need for action based on human factors to ensure nonconformities do not recur.” In addition, clause 7.1.4 of both ISO 9001:2015 and AS9100D require us to consider human…