All Features
Rachel Mann
With medical cannabis being legal in Canada since 2002, and recreational use becoming legal in 2018, Prime Minister Justin Trudeau’s promise to his country has caused a storm.
This legal framework has given Canadian companies the leverage to lead the cannabis industry to new heights. Not only…
Alla Katsnelson, Knowable Magazine
In August 2011, a can of Great Value peas joined the nonperishables in my pantry, one of several panic purchases as Hurricane Irene barreled toward my home on the northeast U.S. coast. But the emergency passed, and the can, with its unassuming blue-on-white outline font, remains on my shelf seven…
Tom Taormina
Outsourcing is historically one of the most misunderstood concepts in quality management system (QMS) implementation and operation. Prior to ISO 9001:2015, the requirement for outsourced processes was limited to a few sentences in the standard’s clause 4.1. This article will present, through a case…
Claire Harbour, Antoine Tirard
Born to a Dalit family, Megha was raised in Southwest India and learned English at her convent school. As a child, she aspired to be a fashion designer or a cardiologist, but her parents insisted that she become an IT engineer. After four years of higher education, Megha found a job in the booming…
Kelly Kuchinski
Imagine building a brand over decades. Hundreds of millions of dollars invested in design and development. Sponsorships with celebrity athletes and professional and college teams. Leading-edge marketing making your company one of the top 20 brands in the world. It only takes one incident to unravel…
NIST
Engineers at the National Institute of Standards and Technology (NIST) needed a way to secure smart manufacturing systems using the digital thread, so they turned to the new kid on the block... blockchain, that is.
According to a new NIST report, the security system better known for underpinning…
Laurel Thoennes @ Quality Digest
Compliance to U.S. Food and Drug Administration (FDA) regulations has come a long way in the past 30 years. Here are the main changes. Have they affected your business?
1988: Food and Drug Administration ActOfficially establishes the FDA as an agency of the Department of Health and Human Services…
Dirk Dusharme @ Quality Digest
As the United States struggles with rising healthcare costs, reducing the amount of money pharmaceutical companies spend dealing with regulation, while at the same time meeting drug safety requirements, would seem to be competing interests.
The goal of any honest pharmaceutical company is to make…
Taran March @ Quality Digest
It’s been a year and a month since Stephen McCarthy switched C suites, moving from Johnson & Johnson, where he served as vice president of quality system shared services, to Sparta Systems, where he’s now vice president of digital innovation. His focus has switched as well.
At J&J, he…
Zac Cooper
The role of quality starts with product design and moves rapidly across the supply chain to the selling and buying experience, which includes the bidding process. When operating a formal continuous process improvement program, nearly all manufacturing engineers are tasked with some level of quality…
Dirk Dusharme @ Quality Digest
We interview Stanley Chao, author of Selling to China: A Guide for Small and Medium-Sized Businesses (iUniverse, 2018), about the impact of the current U.S.-China trade war. Does China really care, and where do U.S. multinationals go from here? Also, a quick look at Conformance Manager, a web-based…
Stanley Chao
This past year has created havoc for Western companies purchasing raw materials, furniture, high-tech components, auto parts, and power tools from China. And the rocky relationship continues into 2019 as both countries continue to negotiate while kicking the can down the road toward a new March 1,…
Richard Harpster
On Oct. 13, 2018, the Automotive Industry Action Group (AIAG) sponsored a webinar on the status of the AIAG Core Tools Software (AIAG CTS). John Cachat, AIAG project manager for the AIAG CTS project, was the presenter for the webinar. The presentation provided information on why the AIAG was…
Mark Schmit, Ken Voytek
Manufacturers throughout the United States are facing a new set of challenges and exciting growth opportunities. Given the manufacturing industry’s important role in providing both direct and indirect jobs, how firms react to these changing conditions is critical not only to the companies…
Wudan Yan, Knowable Magazine
Nearly every month, it seems, comes a new report. In March 2018, there was news of contaminated romaine lettuce, which eventually led to five deaths and sickened more than 200 people across the United States and Canada. In May 2018, about 100 people in California got sick after eating raw oysters…
Devshree Golecha
In this era of artificial intelligence, where bots can mimic human minds and outperform humans, a new-age process automation tool called “robotic process automation” (RPA) has been creating a lot of buzz. It is highly versatile and can be used by every industry to streamline and optimize their…
Dirk Dusharme @ Quality Digest
The Dec. 31, 2018 deadline looms for medical device companies that sell their devices in Canada. On that day, any company that sells medical devices to Canada will either need to hold an MDSAP certificate or show proof that they are on track to be MDSAP certified, or they won’t be able to sell…
Brian Maskell
If you are a CEO of a manufacturing company with many value streams, it’s impractical to think that you have the time to review all the performance measures of every value stream in your company. Yet you need to know the operational impact of lean on your entire organization.
The traditional…
Anthony Chirico
In my first article, the merits and cautions of AS9138 c=0 sampling plans were discussed and a simple formula was provided to determine the required sample size to detect nonconforming units. In the second article, the process control properties of MIL-STD-105 c>0 sampling plans were…
Anthony Chirico
In my previous article, I discussed the merits and cautions of the “acceptance number” equal zero (c=0) sampling plans contained within AS9138. A simple formula was provided to determine appropriate sample size, and it was illustrated that twice the inspection does not provide twice the consumer…
Chad Kymal
Omnex began working in the automotive industry by assisting Ford powertrain suppliers in 1986. The U.S. automotive industry’s Big Three used GM’s Targets for Excellence, Ford’s Q 101, and Chrysler’s SQA standards to qualify its supply bases. The automotive industry was making deep reductions in its…
Anthony Chirico
Aerospace standard AS9138—“Quality management systems statistical product acceptance requirements” was issued this year (2018), a few years after its accompanying guidance materials in section 3.7 of the International Aerospace Quality Group’s (IAQG) Supply Chain Management Handbook. The new…
Dirk Dusharme @ Quality Digest
In this all-manufacturing episode, we look at the STEM pipeline into manufacturing, supplier development, how to make sense of manufacturing data and, no, manufacturing is not dead.
“Strengthening the STEM Workforce Pipeline Through Outreach”
NIST does more than just research and come up with…
Sam Golan
Technological innovations on all fronts are evolving quickly and are developed, manufactured, and sold worldwide in aerospace, medical device, communications, automotive, and many other industry segments. It’s hard to keep up with these breakthroughs because they are growing exponentially. But…
Christina Fattore
Harley-Davidson was one of President Trump’s favorite companies less than six months ago. Now it’s the latest business to feel his wrath.
That’s because on June 25, 2018, Harley-Davidson announced it will move some of its production overseas. The iconic American motorcycle brand said it was doing…
