Dirk Dusharme @ Quality Digest’s picture

By: 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 responders to maintenance workers.

Told by President Trump to fend for themselves, states that couldn’t find local PPE sources have signed contracts directly with overseas manufacturers or distributors claiming to represent them. Given the problems of getting it themselves or competing with the federal government for the same supplies, governors of seven Eastern states even agreed to work together on purchasing medical equipment.

Quality Digest’s picture

By: 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, designed to meet specific standards for how big and how many particles they can block. And they are tested and certified to determine how well they do that job.

Healthcare and other frontline workers usually use either a surgical mask or an N95 mask. Both protect the patient from the wearer’s respiratory emissions. But where surgical masks provide the wearer protection against large droplets, splashes, or sprays of bodily or other hazardous fluids, an N95 mask is designed to achieve a very close facial fit and very efficient filtration of submicron airborne particles.

The “N95” (or “KN95”) designation means that the respirator blocks at least 95 percent of very small (0.3 micron) test particles. If properly fitted, the filtration capabilities of N95 respirators exceed those of face masks.

Gleb Tsipursky’s picture

By: 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 year before the pandemic hit. Myron is the risk and quality management executive in a medical services company with about 600 employees. He was one of the leaders tasked by his company’s senior management team with shifting the company’s employees to a work-from-home setup, due to rising rents on their office building.

Specifically, Myron led the team that managed risk and quality issues associated with the transition for all 600 employees to telework, due to his previous experience in helping small teams of three to six people in the company transition to working from home in the past. The much larger number of people who had many more diverse roles they had to assist now was proving to be a challenge. So was the short amount of time available to this project, which was only four weeks, and resulted from a failure in negotiation with the landlord of the office building.

Jason Chester’s picture

By: 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 management.

If you’re like many quality pros and manufacturing leaders right now, you’re working crazy hours, possibly on a different schedule or from a remote location. You’re struggling to find new ways to get the data that operators are collecting on the plant floor and support workers as they adapt to rapidly changing demands. You’re also likely scrambling to coordinate with your plant managers and create custom reports for your executive teams.

It’s a challenging time, and if you’re lucky, you’re keeping on top of the unique demands this time has put on you. But even in the middle of this sprint, product safety and quality remain paramount.

Multiple Authors
By: 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 only begin to make sense when they are placed in context. And the best way to place data in context is with an appropriate graph.

When using epidemiological models to evaluate different scenarios it is common to see graphs that portray the number of new cases, or the demand for services, each day.1 Typically, these graphs look something like the curves in figure 1.


Figure 1: Epidemiological models produce curves of new cases under different scenarios in order to compare peak demands over time. (Click image for larger view.)

Eric Stoop’s picture

By: 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 back on track reducing the workplace fatality rate by conducting daily checks to help identify safety nonconformances and fix them before they cause safety incidents.

With daily checks of high-risk processes, layered process audits lead to more conversations about safety, also demonstrating that leadership prioritizes safe work—both critical to creating a culture of safety.

Achieving this level of reliability, however, doesn’t happen overnight. Organizations must first make a key mindset shift, and take a strategic approach to uncovering and resolving instances where people don’t follow standards.

The quality-safety link

Quality and safety may occupy two different departments in the average manufacturing organization, but the reality is that safety is itself an aspect of quality.

Rupa Mahanti’s default image

By: Rupa Mahanti

We are currently living in the digital age and are drowning in an ocean of data. Organizations have a large number of data entities and data elements, and a large volume of data corresponding to the same, and they continue to amass more and more data with each passing day. With the large amount of data coming in, it’s important to know what is “quality” data, and what isn’t.

Data entities, elements, dimensions... oh my!

Before we continue, let me explain a little data terminology as it pertains to databases, or data storage. “Data entities” are the real-world objects, concepts, events, and phenomena about which we collect data. “Data elements” are the different attributes that describe the data entity. Thus, a data entity serves as the container that comprises all the data elements that describe it.

Consider a machine shop that has many types of machines: CNCs, lathes, presses, and the like. A “machine” would be the data entity representing a physical object sitting on the shop floor, and the data elements might be machine type (e.g., CNC), machine ID, machine name, machine make, machine location, machine uptime, and so forth, which store attribute values for the different machines.

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Multiple Authors
By: Sheng Lin-Gibson, Vijay Srinivasan

Biopharmaceuticals, also known as biological drugs or biologics, are manufactured from living organisms, or contain living organisms that have been genetically engineered to prevent or treat diseases. Biologics are chemically and structurally complex, and often highly heterogeneous; therefore, controlling and maintaining quality remains a challenge. The potential for new therapeutics to cure and treat previously untreatable diseases is enormous, but there is still a long way to go before they can be manufactured at the required scale, with predictive control of quality, and at a lower cost. NIST’s Vijay Srinivasan and Sheng Lin-Gibson discuss their recent paper on some of the challenges and solutions associated with manufacturing these life-saving drugs.

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Randall Goodden’s picture

By: Randall Goodden

The manufacturing industry, stock market, and new product development have really taken off in the past four years, and there’s a lot of focus now on moving offshore manufacturing back into the United States. With all of this growth, it is also apparent that many manufacturing corporations are primarily focused on marketing their new products, increasing sales, and hopefully, ensuring their products are safe and will live up to expectation.

But with all the records being set in the stock market and employment, record numbers of product recalls and product liability lawsuits are also happening. What further compounds that problem are executive management teams making assumptions that their employees know how to prevent product recalls and product liability lawsuits, that it’s basically “common sense.” This false perception has led to an ever-growing trend in product recalls, record-breaking numbers of product-liability lawsuits, and manufacturing corporations going bankrupt.

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Quality Digest’s default image

By: Quality Digest

As usual with Quality Digest’s diverse audience, this year’s top stories covered a wide range of topics applicable to quality professionals. From hardware to software, from standards to risk management, from China trade to FDA regulations. It’s always fun to see what readers gravitate to, and this year was no different.

Below are five articles that garnered a lot of interest from our readers. As you can see, the topics are quite diverse.

Improve Risk Management and Quality Across the Value Chain by Increasing Visibility
by Kelly Kuchinski

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