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The QA Pharm
This three-part series will discuss how to respond to the U.S. Food and Drug Administration’s Form 483 (FDA 483), which is issued at the conclusion of an inspection to document potential violations to the Federal Food, Drug, and Cosmetic Act. We’ll look at how to assess the work needed to address…
Jack Dunigan
His was a politically unpopular act. The tension between Britain and the American colonies had heightened. The resentment against the crown had grown, and the mere presence of British troops only made feelings more bitter.
A small platoon of British soldiers stood sentry on King Street in Boston…
Gary Phillips
Every manufacturing company that gets audited, anywhere in the world, is required to do gauge repeatability and reproducibility (R&R) studies. In some cases, this one study is the only chance to find unknown problems with measurement quality. (When problems do occur, it is often downstream…
Bruce Hamilton
There was a time when it was unfashionable for managers to associate with front-line employees. Alluding to an old adage, I used to joke that you could not even lead the horse (i.e., the manager) to water, let alone make him drink. Division of labor at that time was a great divide. In my early…
Donald J. Wheeler
There is no virtue in obedience when we do not have a choice. But when we have a choice it helps to understand both the law and the reason behind the law. This column is about bad choices that are being made on a daily basis by the users of statistical software. These bad choices violate the laws…
Quality Digest
BioCision was founded in 2007 by Rolf Ehrhardt and Brian Schryver when they realized, having spent many years in the clinical and laboratory environment, that there were critical unmet needs in the handling of temperature-sensitive biospecimens and biologics.
The rapid adoption of their first…
Walter Garvin
The foundation of lean manufacturing is kaizen, or continuous improvement. Although this principle usually targets manufacturing processes, it can also extend to the people who plan and implement lean projects—individuals that grow professionally and personally as a result of new skills and…
Alexandra Brown
The past five to 10 years, hospitals and physician offices have been in a mad dash to implement electronic health records (EHRs) to meet governmental regulatory requirements. Now that most projects are either complete or well on their way, what are we doing with all of the data that EHRs promised…
Robert Bellinger
The age of advanced digital microscopy is here—highly sophisticated image processing can now be performed with the same ease of use one would expect from a smartphone, tablet, or digital camera. Specifically designed for the needs of industrial QA/QC control labs, digital microscopes like the…
Danei Edelen
With multiple projects vying for your budgetary dollars, every purchase is scrutinized. With regards to statistical process control (SPC) software, companies view it primarily as a production efficiency tool, but they should expect more from their SPC software solution.
When evaluating SPC…
Sculpteo
The Rosetta spacecraft was launched in 2004 with the intent to give the most in-depth understanding of a comet that humanity has to date. Last August, the spacecraft became the first to successfully rendezvous and orbit with a comet. Currently, Rosetta is mapping the comet to determine the safest…
Rob Harrison
In 2014, 21 percent of companies reported that they had completed an enterprise quality management software (EQMS) deployment, and an additional 40 percent reported being in the planning stages of one. In order to justify the budget for such an investment, a watertight business case is a…
Matthew E. May
Of the more than 10,000 business books that are published each year, few, if any, focus their attention on the all-but-forgotten midsized company. Armfuls of books on startups and Fortune-level organizational practices won’t help a business moving into young adulthood.
“There are almost 200,000…
Georgia Manufacturing Extension Program
Twenty-six years ago, a few friends wanted to make a difference by providing healthy meals to other close friends affected by AIDS. Today their efforts continue through Open Hand, an Atlanta-based nonprofit organization that manufactures and delivers 4,500 freshly prepared meals a day to seniors…
Ryan E. Day
We all know what happens to a squeaky wheel, right? But just how loud does a wheel need to squeak before it’s squeak-worthy of replacement?
During my years of auto repair, one of the interesting tidbits I was hipped to was this: What human ears perceive as a squeak is actually a high-frequency…
Arun Hariharan
According to a recent press report, it may soon become mandatory for automobile companies in India to recall vehicles if they receive 100 or more complaints about the same problem. From time to time, we hear about manufacturing companies—most visibly in the auto industry—recalling their products…
Quality Digest
Matthew Philips from Bloomberg Businessweek wrote, “There is no skills gap.” James Bessen, in the Harvard Business Review, heartily disagrees in his article, “Employers Aren’t Just Whining—the ‘Skills Gap’ Is Real.” And in his January 2014 State of the Union address, President Obama declared the…
Dawn Bailey
For veterinarian Dr. Rona Shapiro, running a small business can be challenging. “Many times, I’m the person pushing the broom, and being the veterinarian, and answering the phone,” she says. “Running my own business—sometimes it tends to run you and you don’t run it.”
Then Shapiro began using the…
Dave Cranmer
A while back, I spent an afternoon with some folks at the Delaware Valley Industrial Resource Center (DVIRC, one of the MEP centers in Pennsylvania), becoming enlightened on a topic known as “digital intensity” (DI). The phrase, coined by Irene Petrick, a Penn State professor and managing director…
Harry Hertz
Intuition would say (at least to me) that I should read, listen, question, and maybe read or listen again to learn. So, I was caught by surprise when I recently read a Washington Post article by Barry Ritholtz in which he said, “Writing is a good way to figure out what you think.”
It suddenly…
Katherine Watts
Healthcare in 2014 is in a state of flux. The Affordable Care Act (ACA) health insurance exchange marketplace opened in October of 2013 with a rough start, and it has still not gained traction. Meanwhile, Medicare and Medicaid are squeezing reimbursement, and there is a growing population paired…
Paul Sloane
One of the most common obstacles to effective decision making by teams is groupthink. The term is used to describe the observation that many groups make poor decisions because they try to reach a consensus and minimize conflict. In doing so they suppress dissenting viewpoints, eschew controversial…
Tom Nelligan, Daniel Kass
Nondestructive testing (NDT), as the name implies, is a methodology used for examining the hidden internal structure, measuring the thickness, or characterizing the material of industrial parts without cutting or otherwise damaging them.
NDT offers important tools for ensuring both safety and…
Duan Jiaheng
Handan Iron & Steel Group (Han Steel) was established in 1958 in the Hebei province, China. The company is capable of producing up to 10,000,000 tons of steel annually and plays a vital role in China’s steel production. To maintain quality control in the production process, Han Steel relied on…
Bob Emiliani
Have the leading figures in the lean community walked the “Respect for People” talk? Not in my view.
Most of these leaders have only recently begun to understand and embrace the “Respect for People” principle. Although there are many dimensions to the “Respect for People” principle within lean,…
