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Final FDA Rule on Dietary Supplements
Sharon Phillips
In June 2007, the U.S. Food and Drug Administration issued the dietary supplement current good manufacturing practice (CGMP) final rule (21 CFR Part 111). In essence, the final rule requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling…
United States and China Outline Progress on Agreement on Food and Feed Safety
(HHS: Washington, D.C.) -- U.S. Secretary of Health and Human Services (HHS) Mike Leavitt has signed a joint progress statement with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People’s Republic of China.…
Enhanced Presubmission Compliance Checks
Octagon Research Solutions Inc.
(Octagon Research Solutions Inc.: Wayne, Pennsylvania) -- Octagon Research Solutions Inc., a provider of software and services to the life sciences industry, has announced a new service offering, CheckPoint. The new service provides more than 300 separate validation checks of electronic…
Final FDA Rule on Dietary Supplements
Sharon Phillips
In June 2007, the U.S. Food and Drug Administration issued the dietary supplement current good manufacturing practice (cGMP) final rule (21 CFR Part 111). In essence, the final rule requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling…
New ISO 9001 This Fall
(ISO: Geneva) -- A new edition of ISO 9001 is being submitted for voting as a final draft international standard. Subject to formal approval by the ISO membership, the publication of the revised version is expected to be published this fall.The proposed ISO 9001:2008 doesn’t introduce additional…
Standards Enhance Musical Performances
(ANSI: New York) -- In auto-tune programs, notes are altered to match the nearest exact pitch. If a singer hits a note that’s just a little flat, or a little sharp, auto-tune will pull that note into the accurate pitch with the touch of a button. Generally, auto-tune is used in a way that is…
Baldrige Improvement Day(s) Call for Comments
NIST
(NIST: Gaithersburg, Maryland) -- The Baldrige National Quality Program strives to continuously improve all aspects of the program to deliver greater value to its customers and stakeholders and to improve the effectiveness of our processes. To that end, the program is offering opportunities for…
SPC, the Big Picture
Douglas C. Fair
A few weeks ago, I found myself and my family on a beach making a sand castle. It was the last day of our vacation and shortly after we began working the warm South Carolina sand, an official approached us and asked if we would like to be contestants in the weekly sand sculpture contest. Why not?…
Keeping It Real
Steven Ouellette
I was working with a client to create their business’s critical performance measures the other day, and one of the managers said, “We should set the target higher than we want it—you know, aim high to hit low.” This set off one of my rants, and I thought I would share it with you. When I…
Six Sigma Pays Health Care Dividends in Turkey
Quality Digest
(NOVACES: New Orleans) -- One year after pioneering the first lean Six Sigma deployment at a health care facility in Turkey, Kent Hospital shared its success stories at the Six Sigma & Lean Conference held in Izmir, Turkey, on May 9-11. Organized by the Chamber of Mechanical Engineers, the…
US Oncology Producing Quality and Efficiency Improvements
by US Oncology Corporate Communications
(US Oncology: Houston) -- A new oncology practice management model adapted from a successful manufacturing process is yielding substantial results for enhancing patient access to advanced cancer care while improving efficiency. The model, developed by the US Oncology Practice Quality and…
Comprehensive Guide to Design for Six Sigma in Medical Devices
Wiley
(John Wiley & Sons Inc.: Hoboken, New Jersey) -- Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness, by Basem S. El-Haik, Ph.D., and Khalid S. Mekki (John Wiley and Sons Inc., May, 2008) presents the complete body of knowledge for Design for Six Sigma (DFSS), as…
ASQ’s Next Big Thing
The U.S. Department of Homeland Security (DHS) has solely sourced a grant to the American Society for Quality and the ANSI-ASQ National Accreditation Board (ANAB) to develop a national voluntary conformity assessment accreditation and certification program for private sector emergency preparedness…
ASQ to Spotlight Quality Education
(ASQ: Milwaukee, Wisconsin) -- If you are part of a successful school team, the American Society for Quality invites you to participate in its Education Team Excellence Award, which will showcase the nation’s most outstanding improvement efforts at the 16th Annual National Quality Education…
Changing to Lean, Part 5
Mike Thelen
As is the case with any lean implementation in a traditional environment, culture change is the most difficult obstacle to success. A company can hire consultants, develop work teams, and begin lean initiatives, but if it only talks the talk, the initiative soon becomes just talk. Why do we do lean…
Eighty-five Try for a Baldrige Award
(NIST: Gaithersburg, Maryland) -- Eighty-five organizations—the highest number of applicants since 1992—are in the running for the 2008 Malcolm Baldrige National Quality Award, the United States’ highest recognition for excellence. Applicants include three manufacturers, five service companies,…
New Clinician-Level Measures Unveiled for Public Comment
(NCQA: Washington) -- The National Committee for Quality Assurance, in collaboration with Mathematica Policy Research and the American Medical Association-convened Physician Consortium for Performance Improvement, recently released a set of measures assessing clinician performance in four areas of…
Changing to Lean, Part 5
Mike Thelen
As is the case with any lean implementation in a traditional environment, culture change is the most difficult obstacle to success. A company can hire consultants, develop work teams, and begin lean initiatives, but if it only talks the talk, the initiative soon becomes just talk.Why do we do lean…
Fifth-Grade Wisdom
Dave Heberling
When my daughter, Anna, was in the fifth grade, her teacher asked the students to write down their personal goals. Anna’s goals are still displayed in our home, so we obviously feel that there was something special about this assignment. Not bad for a fifth grader, huh? Could you do better? How? Is…
Uncertain About Uncertainty?
Fred Mason
When thinking about measurement devices and systems, the subject of accuracy comes up. Accuracy has been discussed in past columns of “Measurement Matters.” In the context of measurement system specifications, there’s more concern about the uncertainty of measurement, not its accuracy. So, what is…
Upgraded FEA Software Suite
Dassault Systmes
(Dassault Systèmes: Paris, France, and Providence, Rhode Island)– Dassault Systèmes, a leading supplier of 3-D and product life cycle management (PLM) solutions, has announced the availability of Abaqus 6.8, its technology-leading unified finite element analysis (FEA) software suite from…
Calibration Solution for XRF Analysis
Malvern Panalytical
(PANalytical: Almelo, The Netherlands) -- PANalytical has introduced a series of new petrochemical standard sets for X-ray fluorescence (XRF) spectroscopy that make reliable and accurate calibration a simple, convenient, and cost effective procedure. The standard sets are made to PANalytical…
Uncertain About Uncertainty?
Fred Mason
When thinking about measurement devices and systems, the subject of accuracy comes up. Accuracy has been discussed in past columns of “Measurement Matters.” In the context of measurement system specifications, there’s more concern about the uncertainty of measurement, not its accuracy. So, what is…
Measuring Economic Trends in the Metrology Sector
Robert W. Baird amp Co.
(Robert W. Baird & Co.: Milwaukee) -- The Test and Measurement (T&M) industry Spring 2008 report, created by Robert W. Baird & Co.’s investment banking department, highlights capital market and merger and acquisition (M&A) trends and events that affect middle-market companies…
Dress Rehearsal
Denise Robitaille
I recently had a client who went through a pre-assessment in anticipation of his company’s certification audit. It’s kind of like a dress rehearsal for the real thing. Over the years, I’ve discovered that organizations tend to garner more value from pre-assessments than I had originally thought…

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