All Features
The U.S. Food and Drug Administration (FDA) is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.
Under new regulations that govern the drug approval process, FDA's Center for Drug Evaluation and Research (CDER) will no longer issue…
(FDA: Washington, D.C.) -- The U.S. Food and Drug Administration’s “Food Protection Plan Progress Report,” in conjunction with the “Interagency Working Group on Import Safety Action Plan Update,” shows significant areas of activity to further improve the safety of America’s food supply since…
James Jardine
The International Organization for Standardization has developed more than 17,000 international standards on numerous subjects. For medical device companies, the most important of these standards is ISO 13485, which provides internationally recognized guidelines pertaining to quality management…
Quality Digest
(ANSI: New York) -- Two months remain for the nomination of documents that will be included in this year’s survey of Standards That Make a Difference.
First organized by the American National Standards Institute (ANSI) in 2002, the survey compiles information about standards that are “making a…
ISO
(ISO: Geneva) -- The International Organization for Standardization has published a combined book and CD giving organizations advice on how to make integrated use of management system standards.
The integrated use of management system standardsThe integrated use of management system standards…
ASQ
(ASQ: Milwaukee) -- While athletes from around the world prepare to spotlight their exceptional physical skills in the 2008 Beijing Summer Olympics this August, behind the scenes Olympic coaches are taking a new approach to building a winning performance. They are turning to business improvement…
knowledge.emory.edu
Harley-Davidson knows how to build ownership. For decades, the motorcycle company has attracted and retained a client base that shows no signs of waning. People purchase its products without solicitation, and collectively they gladly spend millions of dollars to wear its advertising on clothes,…
WCBF
(WCBF: Chicago) -- WCBF’s Global Six Sigma & Business Improvement Awards has announced that Mark Pigott, chairman and CEO of PACCARhas been named Six Sigma & Business Improvement CEO of the Year.
Six Sigmahas played a major role in PACCAR’s worldwide growth and profitability since 1997. The…
Steven Ouellette
I read an article in Wired magazine the other day that got me to thinking about the relationship between statistics, engineering knowledge, and theory. The article claimed that with the era of massive data storage and analytical capabilities, the scientific concept of the “theory” was becoming…
(LAI International Inc.: Scottsdale, Arizona) -- A Six Sigma program recently completed by LAI International Inc.—a supplier of precision components and subassemblies for original equipment manufacturers—has reduced production time by 20 percent for a critical structural aerospace component.
A…
(Avery Point Group: Atlanta, Georgia) -- After years of steady gains, lean has achieved a slight edge over Six Sigma as the more desired skill set. The accelerating demand for lean talent is an indicator that companies are increasingly looking to lean as a means to help them combat the current…
(Minitab Inc.: State College, Pennsylvania) — A new, complimentary e-book will help companies get a jump-start when implementing Six Sigma programs.
Quality Companion—Getting Started provides an excellent introduction to Minitab’s process improvement software. “Quality Companion is an ideal tool…
(NIST: Gaithersburg, Maryland) -- Using an ultra-fast method of measuring how a transistor switches from the “off” to the “on” state, researchers at the National Institute of Standards and Technology recently reported that they have uncovered an unusual phenomenon that may affect how manufacturers…
The Axio Scope.A1 from Carl Zeiss for routine materials microscopy offers flexibility and high performance.
(Carl Zeiss: Thornwood, New York) -- Carl Zeiss, a provider of microscopy solutions for a variety of research, clinical, and industrial applications…
M. Scott Tillison
As the skilled, baby-boomer workforce nears retirement, years of technical expertise is exiting as well. Factories are watching years of knowledge leave their organizations, and how to replace these skilled workers has manufacturers concerned.
In a 2008 survey of 100 senior manufacturing…
Mike Micklewright
Question: Many modern enthusiasts claim that feng shui is Chinese for the practice of arranging objects (such as furniture) to help people achieve their goals. What is the American corporation translation of feng shui?
Answer: 5S (5 = feng, S = shui)
A very good client (definition: one in…
Mike Thelen
I received an interesting piece of junk mail recently. What caught my attention and provoked me to open it was simply that it was from an overseas automobile manufacturer and my lean obsessiveness engaged.
I know this manufacturer isn’t necessarily using the Toyota production system, but I…
Niraj Goyal
Abbreviations
t
Thickness of stack of product
T
Batch average of t sampled in the hour
Ta
Average if batch averages T…
Akhilesh Gulati
A recent conversation with the general manager of a manufacturer that was in the process of implementing lean methodologies provided insights as to their ongoing results. He was excited about what was happening in his company. Initiatives in the past had not been successful, and he now understood…
ASQ
(ASQ: Milwaukee) -- An executive order issued by President Bush that establishes mechanisms for improving government performance was greeted by ASQ as a welcome measure for ensuring effective and efficient application of taxpayer resources.
“We commend the president for his farsightedness in…
National Committee for Quality Assurance
(NCQA: Washington, D.C.) -- The National Committee for Quality Assurance recently released its 2007 annual report, “Coming Home to Better Care.” The report looks at the promise of the patient-centered medical home, a promising approach that seeks to strengthen the patient-physician relationship…
Denise Robitaille
A few months back, I wrote about the choices an organization makes regarding its quality management system (QMS). At that time, I talked about the overall system, with particular focus on management’s investment and support.
Today I’d like to spend some time talking about the choices within the…
(ANSI: New York) -- Nearly 90 participants gathered together from June 24-25 for the 2008 Open Forum for Standards Developers, hosted by the American National Standards Institute (ANSI) in Washington, D.C.
The second-largest open forum to date, this year’s event was attended by representatives…
(H.H.S.: Washington, D.C.) -- Significant improvement has been made since last year to enhance the safety of imported products, according to a new report released by the Interagency Working Group on Import Safety.
Entitled the “Import Safety—Action Plan Update,” the report outlines steps taken…
(ANSI: New York) -- The Association Française de Normalisation (AFNOR) has submitted a new work item proposal to the International Organization for Standardization for a standard on performance requirements for purpose-built anticounterfeiting tools. As the U.S. member body to ISO, the American…
