All Features
The QA Pharm
Just when you think that the Food and Drug Administration (FDA) has to stick to the script by quoting chapter and verse of current Good Manufacturing Practices (CGMPs), it gets very progressive and offers straight talk about corporate commitment and leadership.
I have reported before that the FDA…
Bill Kalmar
By way of background, I am a senior citizen but not too technically challenged. I know how to operate my HD television and the DVR; I have a cell phone and understand how to use the speaker phone; OnStar is in my car along with a TomTom GPS. As a way to connect to the past, though, I do have a Sony…
Don Sayre
There is a new international standard published June 9, 2011, that might just warrant your attention. This standard’s purpose is help organizations follow a systematic approach to improving energy performance, including energy efficiency, energy use, and consumption. It applies to variables that…
William A. Levinson
In “Why Companies Fail Quality Audits” (Manufacturing Engineering, May 1996), Robert M. Bakker cites control of documents as one of the three major sources of QS-9000—now ISO/TS 16949—nonconformances, and there is indeed plenty that can go wrong, even with an electronic system. Conflicting…
Quality Transformation With David Schwinn
As I was recently going through some old papers, I came across a letter that my good friend and fraternity brother, Ron Sparling, and I had sent to the general manager of a General Motors Corp. (GM) division where another close friend and fraternity brother had worked.
Our fraternity brother, Mark…
Donald Jasurda
Across the life cycle of delivering a product to market, engineers face many obstacles. They often find themselves spending a lot of time reworking or repairing parts that fail inspection but may fit and function properly when assembled; or, they might pass inspection but do not fit with other…
The Un-Comfort Zone With Robert Wilson
“Who wants to be chairperson of the fundraising committee?” asked the company president.
The room became quiet, and as I glanced around the table, I saw a dozen perfect poker faces. No one wanted this responsibility. No one was going to commit.
“This is our most important committee,” the president…
Joelle K. Jay
What if there are things you are doing—or not doing—that are sabotaging your success? What if there are a few key things you’re missing that could help you get even better results? There’s only one way to find out, and that’s by getting feedback.
Unfortunately, feedback is sometimes given a bad…
Angelo Lyall
Clarity is extremely valuable for building profitable strategies and conducting sustainable business. Without clarity many firms refrain from taking strategic steps in fear of the unknown, leaving them stagnant and eventually uncompetitive. Only by understanding the key concepts that underpin…
NIST
A metasurface or metafilm is a 2-D version of a metamaterial, popularized recently in technologies with seemingly unnatural properties, such as the illusion of invisibility. Metamaterials have special properties not found in nature, often because of a novel structure. NIST’s metasurface is a small…
ACLASS
Keith Greenaway, vice president of ACLASS, a brand of ANSI-ASQ National Accreditation
Board that provides accreditation, gave a brief talk titled “Focus on Inspections and Compliance” at the FDA Food Safety Modernization Act public meeting held on June 6, 2011. His prepared remarks follow:
The…
Steven Ouellette
Although we may use the define, measure, analyze, improve, control (DMAIC) mnemonic to help guide us through our problem solving, that doesn’t really give us a lot of specific direction (as I bemoan in my Top 10 Stupid Six Sigma Tricks No. 4). Good experimental design technique is critical to being…
Michelle LaBrosse
I sat in a window seat on the plane with my nose stuck in my newly purchased book. It was one of those books that suck you right in, leaving you completely unaware of your surrounding, which is exactly what I needed to save me from what otherwise would have been a monotonous travel day, full of…
FARO
Ariel Corp. is an innovative manufacturer of gas compression equipment. Based in Mt. Vernon, Ohio, Ariel has been at the forefront of modern compression technology with market-driven innovation. The company takes pride in its manufacturing processes and product designs. Quality is the foundation…
Robert Parsons
The aerospace standard, AS9100C—“Quality management systems—Requirements for aviation, space and defense organizations,” (aka AS9100:2009 Revision C) has been released for some time now, and the early results are in. For the most part, our customers, those of National Quality Assurance (NQA), that…
It seemed like a good idea at the time to Jon Shupenus, U.S. Army Forces Command’s process improvement specialist and lean Six Sigma Black Belt. Shupenus was attending a Department of Defense performance management seminar in 2010 when Kirk Nicholas, director of the Army’s continuous process…
Bruce Hamilton
The following is a true story that occurred during a nine-month period.Paul had been with a machine shop for 32 years. At the time he held the position of a shift supervisor, and keeping the work schedules was his job. His manager, Bob, related this to me: “Paul is a hard worker who has held…
Georgia Institute of Technology
When working with others in the office, most know it is better to approach a colleague who is relaxed and drinking a cup of coffee versus a frazzled co-worker buried under a pile of paperwork.
Unfortunately, e-mail doesn’t offer users the same social cues—until now.
Eric Gilbert, an assistant…
Jack Thornton
Just What Is Immersive Engineering, Anyway?
Immersive engineering is a digital technology, engineering practice, and methodology, all in one, for solving multifaceted engineering problems in the design, assembly, and maintenance of large, complicated structures (e.g., automobiles…
Matthew R. Philip and Lori Cross
A whole-team approach is an agile practice in which an entire team works as a unit of generalists to share the responsibility for producing high-quality deliverables. It’s a kind of “glue” that holds a lot of other agile practices together. Lisa Crispin and Janet Gregory, co-authors of Agile…
James Robertson
Delivering high-value decision support information is the reason why decision makers implement enterprise resource planning (ERP) systems. In fact, precision configuration to support the delivery of decision support information is critical to a successful ERP. There are numerous reasons why.…
Tracker Handbook by Art Kietlinski
Back in the early 1990s, before the laser tracker—the portable measurement system that relies on a laser beam to measure and inspect—had the reputation it has now, it was viewed simply as an inspection tool. As part of a quality control group, I would check dimensional and geometrical accuracies…
Edward D. Hess
For many, achieving the American Dream means taking control of their destiny, quitting their 9 to 5, and opening the doors to their very own business. These brave entrepreneurial souls have shaped American enterprise, and today, they're playing the critical role of helping to drive…
Stewart Anderson
Not all customers are equally profitable. Different customers have different needs, and hence different costs to serve. The overall profitability of a business is a function of the profitability of individual customers and customer groups.
Many businesses measure customer satisfaction but they…
British Assessment Bureau BAB
According to data from The British Assessment Bureau’s (BAB) independent 2011 Client Satisfaction Survey, 44 percent of respondents said that they had won business as a result of becoming certified to ISO 9001, the quality management system standard from the International…
