All Features
Matthew M. Lowe
While most business sectors have welcomed the efficiencies and benefits that cloud technologies and software-as-a-service (SaaS) offerings bring, the life sciences industry has been slow to embrace external cloud networks. Merely a decade ago, in fact, an International Data Corp. survey showed that…
Alex Bekker
Do you know what a retailer and a tightrope walker have in common? They both have to balance. For the tightrope walker, the logic is clear. But what’s the balance that a retailer is looking for?
A typical dilemma of shortages vs. storage costs
Although the dilemma of shortages vs. storage costs is…
Bill Laverty
Operations management plays an important role in the manufacturing process, but similar to a stage crew at a theater, operations managers do all their best work behind the scenes. The best operations managers strive to go unnoticed, and why shouldn’t they? A seamless supply-chain process should…
Terry Onica
Since the Automotive Industry Action Group (AIAG) and Odette International introduced the Materials Management Operations Guideline/Logistics Evaluation (MMOG/LE) more than 16 years ago, it has become the de facto standard for evaluating supply chain processes in the global automotive industry.…
Robyn Metcalf
In an outbreak that has now run for more than 28 months, at least 279 people across 41 states have fallen ill with multidrug-resistant Salmonella infections linked to raw turkey products. Federal investigators are still trying to determine the cause. In response to food company recalls, more than …
Matthew M. Lowe
It’s human nature to resist change, and the life sciences industry is not exempt from a change-averse mindset. The proof: Life science organizations (LSOs) lag far behind counterparts in other sectors in implementing digital technologies that are designed to streamline business and manufacturing…
Richard Ruiz
When a customer asks to see your layered process audit (LPA) documentation, will you be ready? For many manufacturers, the answer is no.
Instead of having proof of an effective audit process, many companies are left scrambling for data that show low audit compliance and few actual results.…
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…
