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FDA Clinical Trial Conference
(FDA: Dallas, Texas) -- The U.S. Food and Drug Administration (FDA) Dallas District, in cooperation with the Society of Clinical Research Associates (SoCRA), is holding a conference on FDA Clinical Trial Requirements Regulations, Compliance, and GCP. This two-day program for the clinical…
Standardized Medical Imaging Forum
(Drug Information Association: Horsham, Pennsylvania) -- The Drug Information Association (DIA), in collaboration with the U.S. Food and Drug Association (FDA), the Medical Imaging Contrast Agent Association, the Council on Radionuclides and Radiopharmaceuticals, and the American Medical…
FDA Revises List of Recognized Standards
(FDA: Rockville, Maryland) -- The U.S. Food and Drug Administration (FDA) has issued new revisions to its list of accepted standards for use in pre-market reviews of medical devices. The FDA Modernization Act of 1997 authorized the agency to recognize voluntary consensus standards developed…
Green Sigma
(IBM: Armonk, NY) -- The constraints and costs of energy and water usage are rising at an accelerating rate, with a significant effect on business operations and financial performance. In addition, companies are coming under increasing pressure from governments, advocacy groups, investors,…
@RISK 5.0 to Lead Practitioners to Monte Carlo Simulation
(Palisade Corp.: Ithaca, NY) -- Palisade Corp. is now in partnership with the management consultancy Rath & Strong, based in Lexington, Massachusetts. The firm’s current consulting and training emphasizes lean Six Sigma, and the goal of its new partnership with Palisade is to expand the role…
Black Belt for Sale
Mike Micklewright
Question: What is the proper way of wearing a Black Belt once you’ve earned it? Answer: as in …. I’m a changed man. I’m an American Society for Quality (ASQ)-certified Six Sigma Black Belt. To obtain the ASQ Black Belt, I had to pass a test and then show proof to someone within…
Lean Nesting
Thomas R. Cutler
One of the most demanding problems lean manufacturing faces in discrete manufacturing is control of first operations, where raw material may be cut into multiple parts. First operations such as laser or CNC Punch Press processes dictate what parts are available to subsequent operations, thereby…
Apple, Google Surge in Customer Satisfaction
American Customer Satisfaction Index ACSI
(ACSI: Ann Arbor, Michigan) -- Customer satisfaction continues on a bumpy path without momentum or trend in the second quarter, according to the American Customer Satisfaction Index. After a small uptick last quarter, ACSI slips 0.1 percent to 75.1 on a 100-point scale. The ACSI second quarter…
ISO and IAF Schedule Implementation of Accredited Certification to ISO 9001:2008
ISO
(ISO: Geneva) -- The International Organization for Standardization and the International Accreditation Forum (IAF) have agreed on an implementation plan to ensure a smooth transition of accredited certification to ISO 9001:2008, the latest version of the standard for quality management systems (…
New Disease Management Quality Measures Released for Public Comment
National Committee for Quality Assurance
(NCQA: Washington) -- The National Committee for Quality Assurance has unveiled for public comment the first set of quality measures to assess disease management clinical outcomes. When finalized, the 12 measures, covering five chronic disease areas, will allow employers, health plans, consumers,…
Articulating the Business Problem
Akhilesh Gulati
"We have had a series of power outages even though we have central and local uninterrupted power supply (UPS) systems. This disruption causes a loss of service to our customers. While we don’t necessarily lose data, it’s an irritant, and also results in loss of productivity. Perhaps we could…
Integrating SPC and Acceptance Sampling
Douglas C. Fair
I travel too much. Invariably, though, it enriches me. I typically return with some unusual experience or a new story with which to regale my colleagues. One day, while sitting in another aluminum tube with wings, I struck up a conversation with the person next to me, an engaging, interesting…
Leveraging Five Whys
John J. Casey
When I was a boy, my grandmother used to read me nursery rhymes to entertain me and teach me about the world. One has resonated with me for years: "For want of a nail the shoe was lost For want of a nail the horse was lost For want of a horse the warrior was lost For want of a warrior the…
WCBF Selects Six Sigma Awards Finalists
(WCBF: Chicago) -- WCBF has recently announced the shortlist of finalists for the 2008 Global Six Sigma & Business Improvement Awards program. A total of 40 entries from 12 categories have been selected by the independent judging panel to go forward to the final stages of the judging process…
Information and Data Quality Conference
(IAIDQ: Lutz, Florida) -- Registration is open for The International Association for Information and Data Quality (IAIDQ) 2008 Information & Data Quality (IDQ) Conference to be held September 22–25, at The Marriot Riverwalk in San Antonio, Texas. All interested in state-of-the-art information…
A Measured Approach to Going Green
(IBM: Armonk, New York) -- A new IBM consulting offering can help clients lower their environmental impact, increase efficiency, and reduce costs by applying lean Six Sigma principles to energy and water usage throughout their operations. “There’s a fundamental truth to understanding and…
Revolutionary Video Standard Receives Emmy Award
(ISO: Geneva, Switzerland) -- The U.S. Academy of Television Arts & Sciences awarded the prestigious Emmy Award for Excellence to the International Telecommunication Union (ITU), the International Organization for Standardization (ISO), and the International Electrotechnical Commission (…
NIST Requests Comments on Next Generation C/A Process
(NIST: Gaithersburg, Maryland) -- The National Institute of Standards and Technology (NIST) is asking for public review and comment on a major revision to its security certification and accreditation guidelines for federal information systems. A substantial rewrite of the original document,…
Confidence in Leadership Is Plummeting
(DDI: Bridgeville, Pennsylvania) -- Confidence in leaders is at an eight-year-low, according to the Global Leadership Forecast 2008|2009, a biannual study conducted by Development Dimensions International (DDI), a global human resources consulting firm. According to the report, HR confidence…
KRQ Has a New Digital Face
(KEMA-Registered Quality Inc.: Chalfont, Pennsylvania) – In a new phase of strategic brand development in accordance with KEMA corporate, KEMA—Registered Quality Inc. (KRQ) has developed and released their new web site with a refreshed logo. Along with information regarding standards and…
Boeing Plant Gets ISO 14001 Certification
(Boeing: Salt Lake City) -- The Boeing Co. fabrication manufacturing facility in Salt Lake City, has been awarded an ISO 14001 environmental management system certification from Det Norske Veritas, an accredited certification body of quality, environmental, and safety management systems. ISO 14001…
FDA New Policies Regarding Transparency
(FDA: Rockville, Maryland) -- The Food and Drug Administration (FDA) plans to implement several improved policies and procedures strengthening its management advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting…
FDA Guidance Increases Drug Safety
(FDA: Rockville, Maryland) -- The U.S. Food and Drug Administration (FDA) issued a final regulation that makes early phase 1 clinical drug development safe and efficient by enabling a phased approach to complying with current good manufacturing practice (CGMP) statutes and FDA investigational…
Pharmaceutical Industry Addresses Drug Contamination
(ASPEX: Pittsburgh, Pennsylvania) -- Following the U.S. Food and Drug Administration’s recent decision to join European and Australian authorities in the inspection of overseas drug manufacturing facilities, the pharmaceutical industry is re-examining its approach to quality control. In response…
No News is Not Good News
Steven Ouellette
In the Six Sigma world, we give a lot of lip service to the importance of the customer; we even have an official name for it—voice of the customer, or VOC. The problem is that many businesses don’t really have a good system for giving the customer what they ask for, much less one for listening to…

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