All Features
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Grant Ramaley
The FDA Quality System Regulation (QSR) 21 CFR Part 820 was written in 1997 to harmonize with ISO 13485:1996. The goal was to relieve some of the burden of manufacturers having to meet two different criteria, the FDA’s and ISO 13485.
But by 2003, ISO 13485 had changed so significantly that the FDA…
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Jill Roberts
Florida’s outbreak of listeria has so far led to at least one death, 22 hospitalizations, and an ice cream recall since January 2022. Humans get sick with listeria infections, called listeriosis, from eating soil-contaminated food, undercooked meat, or dairy products that are raw or unpasteurized.…
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Becky Ham
In February 2020, MIT professor David Simchi-Levi predicted the future. In an article in Harvard Business Review, he and his colleague Pierre Haren warned that the new coronavirus outbreak would throttle supply chains and shutter tens of thousands of businesses across North America and Europe by…
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Jorge Gonzalez Henrichsen
In April 2022, China's manufacturing output fell to its lowest level in two years, according to official data. The figures were the latest sign of economic pain as Beijing maintains its uncompromising zero-Covid response.
Dozens of cities, including Shenzhen and Shanghai, have been partially or…
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Hayder Radha
It’s hard to miss the flashing lights of fire engines, ambulances, and police cars ahead of you when you’re driving down the road. But in at least 11 cases from January 2018 to July 2021, Tesla’s Autopilot advanced driver-assistance system did just that. This led to 11 accidents in which Teslas…
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Prashant Yadav
During the past two and a half years, we’ve seen unparalleled innovation and private-public collaboration in the global fight against Covid-19. The rapid development and rollout of new vaccines, diagnostic tests, and therapeutics have saved millions of lives.
However, these developments haven’t…
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Richard Harpster
On Dec. 7, 2021, Ford Motor Co. updated its IATF 16949—“Customer specific requirements” (CSR), which require the use of reverse FMEAs (RFMEA) on new equipment (“tooling”). The first sentence of the reverse FMEA requirement reads: “Organizations are required to have a process in place that ensures…
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Naresh Pandit
Rather than rebounding in 2022, economic conditions in the United Kingdom have deteriorated. Forecasts for growth in 2022 and the year after have been cut dramatically.
The reasons for this are well documented. Take your pick from soaring energy costs, supply chain disruptions, the effect of Covid…
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Kari Miller
Quality management is essential to the growth and performance of any organization. It’s a valuable resource in the effort to ensure that products and services satisfy the highest quality requirements and deliver positive customer results.
Pharmaceutical manufacturers must ensure that the…
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Kevin Ketels
The conditions that led to a shortage of baby formula were set in motion long before the February 2022 closure of the Similac factory tipped the U.S. into a crisis.
Retailers nationwide reported supplies of baby formula were out of stock at a rate of 43 percent during the week ended May 8, 2022,…
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Albert Rees, Joe Vernon
The pandemic had many consequences for manufacturing companies, the most prevalent being supply chain disruption. In light of these disruptions, it is paramount that organizations establish robust and reliable operations to ensure productivity targets are met—especially as consumer demands continue…
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NIST
A vulnerable spot in global commerce is the supply chain: It enables technology developers and vendors to create and deliver innovative products but can leave businesses, their finished wares, and ultimately their consumers open to cyberattacks. A new update to the National Institute of Standards…
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Brandon Cornuke
Manufacturers work hard to minimize disruptions to their operations and invest significant resources to minimize production risk. They also are under constant pressure to find new ways to deliver more value to their customers. Sustainable business growth is critical to delivering this value. Many…
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Rick Gould
As the world enters the third year of the Covid-19 pandemic, the climate crisis remains the biggest long-term threat facing humanity, according to the Global Risks Report 2022. Extreme weather due to climate change is seen as the second most serious short-term risk, with biodiversity loss coming in…
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Eric Pauley
Organizations’ failure to properly manage the servers they lease from cloud service providers can allow attackers to receive private data, as research my colleagues and I conducted has shown.
Cloud computing allows businesses to lease servers the same way they lease office space. It’s easier for…
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Jonathan Gilpin
Regardless of how much we, as a society, are able to implement and use technologies in business, global supply chains will always be dependent on the ways in which people interact with one another.
Even local supply chains can be problematic, but it’s predominantly global ones that can pose…
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Marc Lepere
As the war in Ukraine rages, finance professionals on Wall Street and in Europe recently attracted outrage by suggesting that investing in arms manufacturers should be treated as ethical investing. In the fight against tyranny, they argued that such an investment “preserves peace and global…
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William A. Levinson
Ryan Day1 describes how the rise of independent auto dealers is a “gray swan” event for the automobile industry. This was not only bound to happen, as observed by the author, but also long overdue. The article states, “...current state laws prohibit OEMs from selling new vehicles directly to…
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Anthony Tarantino
In 2007, Nassim Taleb described black swans as highly improbable events that had dramatic or even catastrophic effects on markets and economies. Until recently, it seemed that such events were indeed rare.1 There’s now a major rethinking with the world entering the third year of the Covid-19…
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Jonathan Gilpin
The world of procurement is often tricky. It involves choosing one appropriate candidate, ultimately benefiting them while rejecting and disadvantaging others.
That said, it isn’t just the businesses picked that will profit from winning the contracts; it’s also their supply chain, their local…
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Tinglong Dai
Francis Fukuyama, the U.S. political scientist who once described the collapse of the Soviet Union as the “end of history,” suggested that Russia’s invasion of Ukraine might be called “the end of the end of history.” He meant that Vladimir Putin’s aggression signals a rollback of the ideals of a…
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Georgia Tech News Center
With the United States’ semiconductor chip shortage likely to continue well into 2022, a Georgia Tech expert predicts that the U.S. will need to make major changes to the manufacturing and supply chain of these all-important chips to stave off further effects, including making more of them here at…
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Jonathan Gilpin
The sheer scope of public-sector organizations’ requirements means many rely on the global supply chain. This involves buyers across the world procuring both goods and services from suppliers in destinations throughout the world. A global supply chain has benefits, many associated with price, but…
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Kenny Tsang
The e-commerce industry is forecast to see substantial growth in 2022. Retail e-commerce sales in 2021 totaled $4.9 trillion, and may reach $5.42 trillion this year. Exponential growth in the sector has given rise to an ecosystem of millions of third-party sellers on sites such as Amazon that make…
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Gary Steinberg
Disruptions in the global supply chain have led to a new dynamic for many small and medium-sized manufacturers (SMMs)—the need to be more strategic about “second sourcing” and reshoring. The biggest increase is in what’s referred to as second sourcing, which adds redundancies such as a second…