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Scott Gottlieb
There’s new technology that can improve drug quality, address shortages of medicines, lower drug costs, and bring pharmaceutical manufacturing back to the United States. At the U.S. Food and Drug Administration (FDA), we’re focused on propelling these innovations, collectively referred to as…
Mike Figliuolo
Legislative and regulatory changes can cause massive upheaval for your strategic plan. Elections happen all the time. New rules and regulations are proposed, implemented, or repealed on a daily basis. Court cases can change an entire industry landscape.
To stay on top of all these changes and to…
Mark Miller, Lucas Conley
Recently, General Electric—the last remaining member of the Dow Jones Industrial Average’s original 1896 index—was removed from the world’s most prestigious equity benchmark. News of the venerable brand’s dismissal from the Dow, the index of 30 large, publicly traded U.S. brands reflecting the…
Glenn S. Wolfgang
Flow quality management (Flow QM) is a logistical alternative to handling product in lots for the purpose of assessing and mitigating defects. It features a streamlined, automated acceptance sampling methodology, is built on empirical metrics, and facilitates timely, meaningful performance…
Steven Brand
While manufacturers have traditionally been hesitant to invest in their operations due to cost, a recent National Association of Manufacturers (NAM) survey of more than 500 manufacturers reveals that 65 percent plan to increase capital spending during the coming years. Where is the money going to…
AssurX
Proposed in 2012 and now in effect, the general data protection regulation (GDPR) is the newest landmark of data protection legislation. GDPR compliance legislation is designed to better protect personal data of individuals in the European Union (EU) by making companies more accountable for how…
William A. Levinson
Quality and manufacturing practitioners are most familiar with the effect of variation on product quality, and this is still the focus of the quality management and Six Sigma bodies of knowledge. Other forms of variation are, however, equally important—in terms of their ability to cause what…
Vanessa Burrows, Suzanne Junod, John Swann
During the early 20th century, Americans were inundated with ineffective and dangerous drugs, as well as adulterated and deceptively packaged foods.
A cosmetic eyelash and eyebrow dye called Lash Lure, for example, which promised women that it would help them “radiate personality,” in fact…
Jeffrey Phillips
Ihave been thinking a lot lately about innovation and how we may have emphasized one component at the expense of another. Here I’m talking about something that should appear obvious—the focus of innovation in building new things. We are constantly reminded that innovation is about building new…
Gwendolyn Galsworth
The world of work shares a single basic transaction, used millions of times a day: translating vital information into human behavior. But operationalizing this formula is not that simple. Workplace information can change quickly and often—schedules, customer requirements, engineering specifications…
Bruce Hamilton
Who remembers VisiCalc, often referred to as the first killer app? In 1978, this spreadsheet software ushered in the personal computing boom. Although it only ran on Apple’s priciest computer (the one with massive 32K RAM), its ability to calculate and recalculate arrays had much to do with the…
Dirk Dusharme @ Quality Digest
If asked whether you guard your company’s secrets, most of us would say, “Well, of course I do.” But I’m guessing that if you are a remote worker, or do any work while on the road, you are blithely handing out company secrets and don’t even know it. If nothing bad has happened yet, it’s only…
Jane Stull
As companies seek to gain efficiencies in the workplace, provide choice for employees, and attract and retain talent, strategies involving agile working and free-address have gained traction. When our Gensler La Crosse office relocated last year, we leveraged the opportunity to support an agile…
Thomas R. Cutler
Although automation has been successful in replacing repetitive, simple tasks, the human workforce still plays a critical role in manufacturing. Even the most sophisticated and automated manufacturing operations rely on human operators to configure, run, and properly maintain production equipment…
Fred Schenkelberg
Reliability activities serve one purpose: to support better decision making. That is all they do. Reliability work may reveal design weaknesses, which we can decide to address. Reliability work may estimate the longevity of a device, allowing decisions when compared to objectives for reliability.…
Aiman Sakr
Does your organization benefit from lessons learned? Does it learn from previous quality issues? A vast amount of learning takes place every day in every manufacturing facility. Do global manufacturing companies share experiences gained from resolving quality issues between overseas plants? And…
Rick Barker
Return on investment (ROI) is the subject of many discussions about ergonomics, and rightfully so. Musculoskeletal disorders are an expensive and preventable workplace injury, with total costs averaging nearly $30,000 per case, according to data from the Occupational Safety and Health…
Jim Benson
I love to cook. When I make good food and share it with others, they will take a bite and look as excited to eat it as I was to create it. They might not understand the subtleties that went into it, but they understand the product. Satisfied eater, satisfied chef.
When we do something and are…
Richard Wilson
According to the Verdantix global survey of 382 EHS decision-makers, 57 percent expect to use mobile apps in 2018 either widely across all their facilities, at multiple facilities, or as a pilot project at one facility. Mobile has become a game changer for modern quality management systems (QMS).…
Stephen Salata
It’s an open secret that many automotive and aerospace manufacturers have unacceptably high defects and costs. And where defects are on the rise, quality costs aren’t far behind.
Even one defect could mean recalling an entire batch, a problem that can cost thousands of dollars per minute if it…
NIST
Story update 7/13/2018: This story was updated with a link to the released version of standard E3125–17.
Large-volume 3D laser scanners play an essential role in manufacturing large products (e.g., airplane wings), making measurements for large-scale construction (e.g., bridges), and other…
Taran March @ Quality Digest
We are here, and it is now. Further than that, all human knowledge is moonshine. —H. L. Mencken
I ran across the term “moonshine shop” while reading about a kaizen blitz at Ontario-based communications firm Cogeco. “Brad, [Cogeco’s] maintenance leader, coordinates all projects relating to modifying…
Qi Alfred Chen, Z. Morely Mao
The day when cars can talk to each other—and to traffic lights, stop signs, guardrails, and even pavement markings—is rapidly approaching. Driven by the promise of reducing traffic congestion and avoiding crashes, these systems are already rolling out on roads around the United States.
For…
Harish Jose
I have written about sample size calculations many times before. One of the most common questions a statistician is asked is, “How many samples do I need—is a sample size of 30 appropriate?” The appropriate answer to such a question is always, “It depends!”
In today’s column, I have attached a…
Sharona Hoffman
On June 12, 2018, the American Medical Association announced that drug shortages pose an urgent public health crisis. This crisis should be of concern to all Americans.
The Food and Drug Administration (FDA) defines a drug shortage as a “period of time when the demand or projected demand for a…