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Reshaping Pharmaceutical Quality
ISPE
(ISPE: Tampa, Florida) -- The June 2008 issue of the Journal of Pharmaceutical Innovation (JPI) is publishing the first scientific papers outlining the progress made on the International Society for Pharmaceutical Engineering’s (ISPE) product quality life cycle implementation (PQLI) initiative…
ISO Standard for IT Governance
(ISO: Geneva) -- Because inadequate information technology (IT) systems can hinder the performance and competitiveness of organizations or expose them to the risk of not complying with legislation, the new ISO/IEC 38500 standard provides broad guidance on the role of top management in relation to…
NCQA Program to Evaluate Health Promotion
(NCQA: Washington) -- The National Committee for Quality Assurance today released for public comment proposed standards and measures for a new Wellness and Health Promotion (WHP) product evaluation suite. The program will examine organizations that provide services to employers and health plans…
What’s in It for Me?
Joseph J. Caylor
As a consultant, I have been asked numerous times by management teams that are considering quality management systems (QMSs) such as ISO 9001, QS 9001, ISO/TS 16949, AS 9001, or TL 9000, “What’s in it for me? Companies complain that QMSs, such as ISO 9001, take up their employees’ time and cost too…
What’s in It for Me?: Work Instruction No. 1
Joseph J. Caylor
ABC Company Work Instruction Purpose: To initiate a DMR for internal nonconformance, subcontractor nonconformance, rework, or sorting. Work description: A DMR is used to determine the nature of defect(s), establish a temporary remedy, determine the apparent root cause, establish corrective…
What’s in It for Me?: Work Instruction No. 1
Joseph J. Caylor
ABC Company Work Instruction Purpose: To initiate a DMR for internal nonconformance, subcontractor nonconformance, rework, or sorting.Work description: A DMR is used to determine the nature of defect(s), establish a temporary remedy, determine the apparent root cause, establish corrective action,…
What’s in It for Me?: Work Instruction No. 3
Joseph J. Caylor
ABC Company Work Instruction Purpose: To determine root cause for external nonconformance (customer complaints), internal nonconformance (rework, sort, subcontractor), and quality audit nonconformance findings.Work description: Nonconformance-generated CPARs and DMRs are analyzed for apparent…
What’s in It for Me?: Work Instruction No. 2
Joseph J. Caylor
ABC Company Work Instruction Purpose: To initiate corrective and preventive action for customer complaints, vendor nonconformance, and internal quality audits. Work description: A CPAR is initiated to determine apparent root cause, corrective action, and preventive planning for customer complaints…
What’s in It for Me?: Work Instruction No. 3
Joseph J. Caylor
ABC Company Work Instruction Purpose: To determine root cause for external nonconformance (customer complaints), internal nonconformance (rework, sort, subcontractor), and quality audit nonconformance findings. Work description: Nonconformance-generated CPARs and DMRs are analyzed for…
What’s in It for Me?
Joseph J. Caylor
As a consultant, I have been asked numerous times by management teams that are considering quality management systems (QMSs) such as ISO 9001, QS 9001, ISO/TS 16949, AS 9001, or TL 9000, “What’s in it for me? Companies complain that QMSs, such as ISO 9001, take up their employees’ time and cost too…
Noise Thermometry
Photograph of circuit used in NIST’s Johnson noise thermometry system. The system relies on the “noise” of jiggling electrons as a basis for measuring temperatures. It is extremely precise in part because it is based on the predictable quantum effects of superconducting elements…
How to Succeed in Manufacturing
Abe Eshkenazi
With increasing productivity and focus on efficiency, good manufacturing jobs can still be found in the United States, but they are becoming more complex, and the people who succeed in the field need advanced training, education, and support.According to the Office of the U.S. Trade Representative…
Putting a Dollar Value on Human Life
A thorny question lies at the heart of meaningful health care reform. How much is human life worth? New research from Wharton and Stanford based on Medicare kidney-dialysis data shows that the average figure—$129,090 per additional year of quality life—is higher than prior studies have shown.…
NQF Endorses Standards for Hospital Care
National Quality Forum
(NQF: Washington, D.C.) -- Recognizing that patient safety remains a major hurdle in the United States, the National Quality Forum (NQF) endorsed 48 voluntary consensus standards focused on measuring the performance of acute-care hospitals, including measures addressing pediatric safety, hospital…
Quality Critical to Health Care Reform
(NCQA: Washington, D.C.) -- The Quality Crossroads Group, a group of stakeholders drawn together to identify strategies to address the complex challenges confronting the United States health care system, recently proposed a five-point agenda that examines quality in patient safety, the…
Medtral New Zealand Internationally Accredited Hospitals
Medtral
(Medtral: Auckland, New Zealand) -- With a growing number of international medical travelers concerned about hospital accreditation, Medtral New Zealand, a health care organization based in New Zealand that coordinates medical travel packages from North America, addresses some of the pressing…
Plan to Reduce Health Care Costs by $145 Billion
Americaaposs Health Insurance Plans
(AHIP: Washington, D.C.)-- The U.S. could reduce total health care spending and improve the quality of patient care if the plan recently proposed by America’s Health Insurance Plans (AHIP) is implemented. PricewaterhouseCoopers reviewed AHIP’s proposals and estimates, and concluded that if…
Developing a Lean Six Sigma Army
Jacqueline M. Hames
Lt. Gen David Melcher, military deputy for budget, Office of the Assistant Secretary of the Army (Financial Management and Comptroller). Photo by Jacqueline M. Hames   (Army News Service: Washington D.C.) -- The Army’s top uniformed budget officer…
Six Sigma at Ball State
Ball State University
(Ball State University: Muncie, Indiana) -- Ball State University is incorporating a nationally recognized business management strategy and an immersive learning experience into the core of a new minor as a result of a gift-in-kind valued at $1.4 million from a prominent alumnus.Mikel Harry,…
The Balanced Scorecard and Beyond
Over the years, scorecards have progressed through many changes, good and bad. Although scorecards often evolve into a meet-the-numbers game, regardless of the consequences to an enterprise as a whole, restructuring can produce dramatic improvements for any organization. This results in counter-…
HITSP to Sponsor Health Care IT Webinars
(ANSI: New York) -- The Healthcare Information Standards Technology Panel (HITSP) announced today the launch of a new education and outreach campaign that will build awareness of the importance of health care information sharing, the role of the HITSP in enabling health care information technology…
Get the Best Out of the ISO 9000 Family
the International Organization for Quality
(ISO: Geneva) -- ISO recently published on its web site a new electronic edition of its advice for managers, “Selection and use of the ISO 9000 family of standards.”The ISO 9000 family consists of 17 international quality management standards and guidelines (plus a corrigendum), and has earned a…
Got Empowerment?
Bill Kalmar
I think most of us would agree that there are a handful of attributes that separate average companies from those that should be held up as role models. Some of those traits would be: a strong and achievable strategic plan, management interaction with staff and customers, well-trained employees, a…
ASQ Team Excellence Awards
(ASQ: Milwaukee, Wisconsin) -- A rigorous finalist competition for the 23rd International Team Excellence Award Process at the ASQ World Conference recently in Houston, Texas, included 26 teams from around the world. The Boeing Co. won the Gold Award.“Boeing is elated to be awarded this top honor…
FDA Seeks Civil Penalties from California Device Maker
(FDA: Rockville, Maryland) -- The U.S. Food and Drug Administration is seeking a $2.2 million penalty against a California hearing device manufacturer, Advanced Bionics LLC and its president and co-CEO, Jeffrey H. Greiner, for violations of federal law, including manufacturing standards…

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