All Features
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…
Tom Taormina
Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall…
Vanessa Bates Ramirez
Long before coronavirus appeared and shattered our preexisting “normal,” the future of work was a widely discussed and debated topic. We’ve watched automation slowly but surely expand its capabilities and take over more jobs, and we’ve wondered what artificial intelligence will eventually be…
Taran March @ Quality Digest
What is quality intelligence, exactly? It’s more than marketing spin. More, even, than the sum of its many control charts. It’s not collecting data simply to further go/no-go actions. And it doesn’t mean turning the cognitive wheel entirely over to artificial intelligence, either—far from it.
We…
Ryan E. Day
An organization can achieve great results when everyone is working together, looking at the same information generated from the same data, and using the same rules. Changes can be made that affect a company’s bottom line through operational improvements, product quality, and process optimization.…
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…
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…
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…
M. Tina Dacin, Laura Rees
A small business has been given the green light to reopen amid the Covid-19 pandemic. What does it need to consider for employees and customers?
Small-business owners are reorganizing physical space to account for continued distancing requirements, and rethinking supply chains to deliver products…
Ken Levine
Lean Six Sigma (LSS) professionals have an enormous opportunity to add value to organizations and to our communities during this coronavirus pandemic. We have the objective orientation, methods, and tools to help. Process improvement is currently more important than ever in this “new normal”…
Jessica Reiner
For more than 20 years, a class of man-made, potentially cancer-causing chemicals called per- and polyfluoroalkyl substances (PFAS) has commonly been found in humans and the environment. These chemicals are used in a variety of industries and can be found in many consumer products, such as food…
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…
Anne Trafton
When MIT announced in March 2020 that most research labs on campus would need to ramp down to help prevent the spread of Covid-19, Canan Dagdeviren’s lab was ready.
For the past two years, Dagdeviren and her lab manager, David Sadat, have run the Conformable Decoders Group using “lean lab”…
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…
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…
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…
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,…
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…
Hari Abburi
If there’s one thing the global business community is learning from the Covid-19 pandemic, it’s the outright imperative for companies to be agile “from top to bottom.” This lesson continues to ebb, flow, and unfold daily, wreaking having on bottom lines in every corner of the world.
In fact,…
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…
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…
Tom Taormina
Each article in this series presents new tools for increasing return on investment, enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system. They will help implementers evolve quality management to overall business…
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,…
Greg Hoeting
Nuclear power has long been a clean, dependable source of energy throughout the world. However, as power plants age, concerns grow about their continued reliability. Many components make up the infrastructure of a nuclear power plant with the design intent to reduce radiation and contamination…
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…