All Features
Publically announced breaches of secured information are so common today that they almost seem routine. Last year, in the United States alone, financial companies like JPMorgan Chase and retailers such as Target and Home Depot were victimized by information system hackers that allegedly gained…
Rob Harrison
Managing risk in a quality management system (QMS) is considered a clear maturity indicator and a way to determine that an organization has shifted from a reactive and less controlled state toward an agile, proactive and anticipatory approach to quality management.
In this post we are going to…
The QA Pharm
Responding to FDA 483 observations was my focus in part 1 of this series. Responses lead to commitments, and commitments lead to changes that are intended to prevent recurrence of the underlying problem that led to the observation.
Here, I’ll share my views on getting the work done to fulfill…
James Soto
Imagine: You find someone you’d like to connect with on LinkedIn. You email the person to ask if you can pick his or her brain. A coffee date is set. You’ve just become part of the phenomenon that’s taking over industrial sales: zombie coffee. This no-frills networking strategy, fueled by a lethal…
Jesse Lyn Stoner
Story update 11/10/2014: We clarified the meaning of the 16% response in the Bamboo HR report.
Mark was upbeat at the end of his first day at his new job as a programmer for a small tech company. He was shown around, introduced to his co-workers, and given a desk and a computer. He had spent most…
Dan Nelson
ISO 9001 certification is like a driver’s license test. To prepare for a driver’s license test, a new, unlicensed driver requests a booklet from the state. This booklet explains the laws and conventions of driving in that state. From ISO, a new, unregistered company receives two booklets…
Michael Causey
After a flurry of activity, it’s been relatively quiet lately on the FDA warning-letter front, though three device makers did get some bad news in recent weeks.
FDA’s Philadelphia office hit Pittsburgh-based Zoll Manufacturing Corporation, a maker of Class III medical device life vests, with a…
Dave Cranmer
Some things are just meant to be, apparently. Sept. 23, 2014, marked an interesting waypoint in the career of someone concerned about standards of measurement, because on that day, I became a standard reference human.
Having started working for the (then) National Bureau of Standards (NBS) almost…
Christine Schaefer
The following tips have been compiled from interviews with representatives of Baldrige Award-winning organizations during the 2014 Quest for Excellence conference.
How to get started using the Baldrige framework
Communicate. Make sure you have the support of senior leadership and employees.…
Johns Hopkins University
A weekend design challenge to develop new protective gear for health workers fighting Ebola drew students, faculty, and clinicians from across Johns Hopkins University and beyond, along with $25,000 in state seed grants to support further development of the best ideas.
Jhpiego, a nonprofit global…
Mike Figliuolo
One of the biggest barriers to creating new ideas is the raw inertia of organizations. Personally, I’m not satisfied with the “way we’ve always done it.”
Whenever I’m given an explanation of how the organization does something, I ask, “Why?” five times. That’s my maxim for generating new insights…
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…
