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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…
Siemens PLM Software
(Siemens PLM: Plano, TX) -- Siemens has added new applications to its Sinumerik Integrate for Production software suite for networking machine tools with production-level IT systems. The new release now includes Manage MyMaintenance (MMM), an effective maintenance-tasks management system, and…
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…
Hexagon Manufacturing Intelligence
(Hexagon: North Kingstown, RI) -- Hexagon Metrology, Inc. has announced its customer CRCoachworks (CRC, Lakewood, WA) will be featured using a ROMER arm this season on the TV show “Corvette Nation.” Airing on Discovery’s Velocity channel, this weekly series is dedicated to America’s sports car—the…
DeEtta Jones
Do you ever feel overwhelmed as a manager? Being overburdened by the responsibility of having to figure out what the people on your team want and need from you is a familiar feeling shared among leaders. Fortunately, there is a “best practice” for obtaining just the kind of information needed to…
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.…
ISO
(ISO: Geneva) -- From responding to major disease outbreaks to everyday medical treatment, having the right information in the right place at the right time is vital for any national health system. Now health organizations around the globe can improve the management of their information—and in…
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…
SAE International
(SAE International: Troy, MI) -- Northrop Grumman Corp. recently celebrated the grand opening of its Fabrication Laboratory (FabLab) at the company’s Space Park facility in Redondo Beach, California. The 5500-ft² laboratory was inspired and developed by a group of more than 70 employees, providing…
Steinbichler
(Steinbichler: Plymouth, MI) -- Steinbichler has introduced a newly updated and completely redesigned worldwide website for 3D scanning metrology solutions. Significantly restructured and customized for easy navigation and application support, the new Steinbichler website offers users the ability…
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…
(Sciemetric: Ottawa) -- Sciemetric Instruments, a pioneer of technologies used by many global manufacturers to increase yield, improve quality, and optimize manufacturing processes, has unveiled a new leak-test system with an unmatched combination of accuracy, speed, and affordability.
Leak…
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…
SAE International
(SAE: Warrendale, PA) -- A new on-demand presentation from SAE International will explore how Maplesoft’s modeling and simulation platform, MapleSim, can bring together theory and applications in effective ways to engage students, enrich their understanding of engineering systems, and reinforce…
