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The Paradox of Risk
Steve McKee
The Philippine Department of Transportation got into a bit of a fix recently for publicly thanking the coronavirus. In an attempt to “provide an enlightening and awakening narrative” that might cause people to see a silver lining in the viral cloud over their heads, the DOT instead found itself…
Fake PPE on the Rise: Don’t Get Fooled
Dirk Dusharme
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…
What Is Tribal Knowledge?
Corey Brown
Many industrial businesses have heard of the dangers of relying on tribal knowledge. But what exactly does tribal knowledge mean? How does tribal knowledge impact an organization? How do you capture tribal knowledge? Organizations spend substantial time and resources developing the knowledge and…
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…
What You Need to Know for an Effective Risk Assessment
Jon Speer
Historically, risk management has been a complex and polarizing subject, with various stakeholders assigning different values on the probability and severity of harm. In the medical device industry, risk management’s high importance has led to the publication of standards such as ISO 14971,…
Embracing Work-From-Home
Ryan E. Day
As shelter-in-place orders make work-from-home (WFH) the new normal, some organizations are struggling with the transition to working as a remote team. But there are companies that have been doing so for quite some time, and we can benefit from their experience. Covid-19 is forcing thousands 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…
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…
Why Not?
Bruce Hamilton
Most lean folks use 5 Whys daily to problem solve, but relatively few are familiar with a clever problem-solving device developed 30 years ago by Deming Prize winner Ryuji Fukuda, called the why-not diagram.  Because objection is a natural human response to new ideas, Fukuda created the why-not…
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…
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…
Being a Digital Leader Has Never Been More Important
Knowledge at Wharton
When the Mosaic browser, with its consumer-friendly interface, was released to the world in 1993, most had no idea how radically this first foray into the internet era would transform our lives, both personally and professionally. As humans, we are generally poor at detecting and acting on early…
Using Layered Process Audits to Close the Loop on Safety
Eric Stoop
According to the National Safety Council, the rate of preventable workplace fatalities per 100,000 workers has flattened or risen slightly since 2009 after decades of steady improvement in occupational safety. Companies conducting layered process audits (LPAs) can help get the United States get…
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,…
What the Trump Administration Could Do Now to Remedy the Ventilator Shortage
James Anderton
While healthcare professionals globally struggle to contain the Covid-19 pandemic, acute care patients are taxing ICU units worldwide. Critical to the care needed for the most serious cases is breathing support through mechanical ventilators. In Italy, the worst-hit nation in Europe, the lack of…
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…
Bringing Critical Supply Chains Back From the Brink
Lee Seok Hwai
Hong Kong scientists teaching a panicked populace to make their own surgical masks with paper towels and metallic wire must surely rank as one of the most Kafkaesque moments of the new coronavirus disease outbreak. But the worst is yet to be if global medical supply chains, already stretched in…
The One Huge Mistake Quality Professionals Make in Preparing for Covid-19
Gleb Tsipursky
The Covid-19 coronavirus has developed into a widespread pandemic. With growing outbreaks of diagnosed cases in all 50 states, and vastly larger numbers of undiagnosed cases, there’s serious cause for concern. Yet quality professionals who follow the official advice on Covid-19 coronavirus prep…
Keep Manufacturing During Supply Chain Disruptions
Jennifer Grant
With Covid-19 continuing to impact many businesses, lead time as well as sourcing new suppliers is increasingly difficult. If you currently outsource manufacturing overseas, it is likely you have encountered some turbulence to your supply chain. Rapid prototypes and large-quantity production of…

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