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Could Pressure for Covid-19 Drugs Lead the FDA to Lower Its Standards?
Leigh Turner
Given the death, suffering, social disruption and economic devastation caused by Covid-19, there is an urgent need to quickly develop therapies to treat this disease and prevent the spread of the virus. But the U.S. Food and Drug Administration (FDA), charged with the task of evaluating and…
It’s Time to Start Really Using Our Data
Dirk Dusharme @ Quality Digest
Blame it on Moore’s law. We live in a digital Pangaea, a world of borderless data driven by technology, and the speed and density with which data can be transmitted and handled. It’s a world in which data-driven decisions cause daily fluctuations in markets and supply chains. Data come at us so…
The Problem With Unexamined Processes
Ryan E. Day
It’s no secret that manufacturing companies operate in an inherently unstable environment. Every operational weakness poses a risk to efficiency, quality, and ultimately, to profitability. All too often, it takes a crisis—like Covid-19 shutdowns—to reveal operational weaknesses that have been…
Understanding AIAG-VDA’s FMEA Process and Approach
Mary Rowzee
During the first six months after the publication of its first edition in June 2019, the AIAG & VDA FMEA Handbook gained popularity in the global automotive industry. Both U.S. and European OEMs have started to require the AIAG VDA approach to failure mode and effects analysis (FMEA) in their…
We’re All Essential Workers
Jeff Dewar
‘We shouldn’t be calling some jobs essential.” That line got me into a lot of trouble the other day when chatting with friends about how the term “essential worker” degrades the stature of all the “nonessentials,” when, in fact, we all play an essential role in the millions of supply chains across…
Partnering With PRiMEX for AS9100D Certification and QMS Improvements
Puerto Rico Manufacturing Extension
El-Com Systems Corp. is a wholly-owned subsidiary of El-COM Systems Solutions based in California. The local company has been in Puerto Rico since 2016 operating in Caguas. The company is dedicated to manufacturing complex electromechanical subsystems and assemblies for the global aerospace and…
Why Is It So Hard to Aid Small Businesses Hurt by a Disaster?
Maria Watson
The U.S. government has committed hundreds of billions of dollars to help small businesses weather the coronavirus pandemic. But early reports suggested larger companies were gobbling up much of the aid, while many of the neediest ones—particularly those with only a few dozen employees—weren’t…
IIoT, Coronavirus, and the Supply Chain
Ryan E. Day
The Covid-19 pandemic is disrupting business across the globe, and supply chains are being stressed to their limits by sudden and drastic increases in online commerce. As organizations strive to continue delivering physical product, the industrial internet of things (IIoT) is being considered as a…
Fake PPE on the Rise: Don’t Get Fooled
Dirk Dusharme @ Quality Digest
Around the world, local agencies and institutions have scrambled to find personal protective equipment (PPE) to protect their essential employees from Covid-19. Not just healthcare workers, but also the men and women who to work to keep our cities and counties up and running, from emergency…
This Time, It’s Not All China’s Fault
Stanley Chao
‘Can you help me source PPEs from China?” asks a caller on the phone. I have received dozens of these inquiries since March from local governments, medical clinics, and mom-and-pop shops after hospitals and first responders began reporting massive shortages of N95 masks, latex gloves, and surgical…
The Problem With Fake N95 Masks
Quality Digest
It’s easy to assume that something as simple as a mask wouldn’t pose much of a risk. Essentially, it’s just a covering that goes over your nose and mouth. But masks are more than just stitched-together cloth. Medical-grade masks use multiple layers of nonwoven material, usually polypropylene,…
Possible Cure for Outbreak of Fake Certificates From Covid-19 Pandemic
Grant Ramaley
The International Accreditation Forum (IAF), the association of conformity assessment accreditation bodies worldwide, held an emergency meeting after confirming what appears to be an outbreak in the use of fake ISO 13485 certificates. ISO 13485 is a quality management system standard particular to…
How to Prevent Failure When Shifting to Working From Home
Gleb Tsipursky
So many companies are shifting their employees to working from home to address the Covid-19 coronavirus pandemic. Yet they’re not considering the potential quality disasters that can occur as a result of this transition. An example of this is what one of my coaching clients experienced more than a…
Big Tech Is Rewiring Healthcare in the Platform Revolution
Sangeet Paul Choudary
The digitization of patient data and the adoption of cloud-based healthcare management systems have created efficiencies and new business models across the value chain. Advancements in AI provide superior decision support systems to doctors, while connected devices enable the remote delivery of…
Coronavirus and Supply Chain Disruption: What Firms Can Learn
Knowledge at Wharton
Long stretches of empty supermarket shelves and shortages of essential supplies are only the visible impacts to consumers of the global supply-chain disruption caused by the Covid-19 pandemic. Unseen are the production stoppages in locations across China and other countries and the shortages of raw…
The Future of Industrial Quality Control
Evident Scientific
F unction often relates to form, and this is particularly true within the world of manufacturing. Rigorous quality assessment procedures ensure that components are manufactured according to their precise specifications before being assembled into the fully functioning whole. These assessments might…
Five Ways to Stay on Top of Manufacturing Quality Management While Under Pressure
Jason Chester
Even in the midst of the pandemic, product safety and quality remain critical. For many manufacturers, complex quality management systems and procedures stand in the way of agile responses and effective operational optimization. Cloud technology provides the means to dramatically simplify quality…
The Art of Business Continuity
Kathleen Wybourn
Business continuity is a relatively simple idea. Plan ahead so you can keep your business successful during times of difficulty. Key management transitions, loss of a major customer, the impact of a lawsuit, perhaps a fire or an earthquake. But what if that “difficulty” is a global public health…
Waiting for the Covid-19 Peak
Donald J. Wheeler, Al Pfadt
Each day we receive data that seek to quantify the Covid-19 pandemic. These daily values tell us how things have changed from yesterday, and give us the current totals, but they are difficult to understand simply because they are only a small piece of the puzzle. And like pieces of a puzzle, data…
What Makes Food ‘Local’?
Stephanie Parker, Knowable Magazine
This story was originally published by Knowable Magazine. An anthropologist looks at the myriad ways we link food to place—and whether it really could make a difference. “Local food” is a term loaded with virtue for many people. Some with environmental concerns lean toward local because food…
Break the Curve and Keep It Broken
William A. Levinson
The phrase “flatten the curve” means to slow the transmission of the coronavirus (Covid-19) in order to spread the total number of cases out over a longer period of time. This will avoid overwhelming the healthcare system.1 The model is accurate as presented throughout the internet, but it also…
Coping With Covid-19: Digital Transformation Enables a Flexible and Agile Workforce
Jason Chester
The Covid-19 pandemic has hit every industry with a barrage of challenges. The impacts on the manufacturing sector are already extending far beyond factory walls. And for now, the depth of those impacts and the expectation for recovery are unknown. Fortunately, manufacturers are a highly adaptable…
Supplying the Front Line of the War on Coronavirus
Lee Seok Hwai
In the trenches of the battle against Covid-19, critical defensive gear and medical equipment are in short supply. Doctors and nurses fighting the nonstop onslaught of the highly contagious coronavirus desperately need more ventilators, test kits, surgical masks, shields, and gowns. In Spain,…
Weathering the Crisis: Tactical Solutions You Can Quickly Put In Place
Jason Chester
Manufacturers routinely face uncertainty, risk, and volatility in everyday operations. It’s understood that organizations must be ready for anything, from supply chain interruptions, supplier quality issues and process variations, to volatility in market demand, competitor activities, and political…
When Restaurants Close, Americans Lose Much More Than a Meal
Rebecca Spang
Arnold Schwarzenegger tweeted a video of himself on March 15, 2020, saying: “No more restaurants.” Seated in his palatial kitchen with two miniature horses, Whiskey and Lulu, beside him, the former California governor pronounced: “We don’t go out; we don’t go to restaurants. We don’t do anything…

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