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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,…

Brian Lagas
When most people think of lean processes, they believe the goal is to optimize things in a step-by-step approach. The result that companies using lean methods can look forward to is incremental improvements brought about by the elimination of waste.
Individuals who stick with this definition often…

NIST
Scientists at the National Institute of Standards and Technology (NIST) have devised a novel, accurate, easy-to-operate, time- and labor-saving way to provide calibrated scale-bar standards for testing the performance of terrestrial laser scanner (TLS) systems.
TLS technology is widely employed to…

Carrie Van Daele
Crossing the street or stepping backward when you encounter another person has already become a habit, as has a routine elbow bump, instead of a handshake.
And that is definitely what is needed during a health crisis. But when the time is right, as a society we must bounce back to social…

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…

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…

Jason Chester
During the last several decades, many forward-thinking manufacturers have adopted factory automation for all that it promises—greater efficiency, consistency, productivity, and cost savings. In fact, if you walk through most modern manufacturing plants, you’ll see lines of machines performing a…

Charles Tarrio, Thomas Lucatorto
In 2019, after decades of effort, manufacturers used a new technology to create smartphones with individual circuit features as small as 7 nanometers (nm), or billionths of a meter, enabling them to cram 8.5 billion electronic devices, known as transistors, on a single small chip. Fitting more…

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…

Annette Franz
There’s a little bit of irony in the title of this article. Why do we have to make sure the customer—and employee—experience is crisis-ready? Well, as John Kennedy said, “The time to repair the roof is when the sun is shining.”
Back in November 2012, I wrote an article titled, “Are You Ready for…

Celia Paulsen
Nobody likes business to be slow. If you’re in a fast-paced world like manufacturing, seeing your machines or employees idle can drive a person insane. If you’re used to your production line working to capacity and suddenly business slows down, it can be a frustrating time.
When I was in the U.S.…

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…

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…

Alan Rudolph, Raymond Goodrich
We [Alan Rudolph and Raymond Goodrich] are both biotechnology researchers and are currently seeking to repurpose an existing medical manufacturing platform to quickly develop a vaccine candidate for Covid-19.
This process is used for the treatment of blood products such as plasma, platelets, and…

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…

Mark Rosenthal
Training Within Industry (TWI) job instruction is built around a four-step process titled “How to Instruct.”
Steps two and three are the core of the process: • Present the operation • Try out performance
I want to discuss step three: Try out performance
Teaching back as learning
All too often I…

Donald J. Wheeler
Lean production of multiple products is built on the assumption that the process aim can be properly set for each short production run. This article will describe how to set the process aim so that your short production runs can be on target.
In a lean production environment, without a bank of in-…

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…

Cheryl Carleton
The labor market is changing rapidly with the onset of the coronavirus pandemic.
Many organizations are laying off almost all of their workers, while others are considering which workers to lay off, which to furlough, and which to keep. Alternatively, some are expanding their labor forces.
When…

Amber Dance, Knowable Magazine
This story was originally published by Knowable Magazine.
As Covid-19 cases fill the hospitals, among the sickest and most likely to die are those whose bodies react in a signature, catastrophic way. Immune cells flood and attack the lungs they should be protecting. Blood vessels leak; the blood…