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The Advancement of Controlled Clinical Trials
From an antacid to a new cancer treatment, every drug must be proven safe and effective in controlled clinical trials before the U.S. Food and Drug Administration (FDA) allows it to be sold in the United States. When federal law first required controlled clinical trials in 1962, most people…
Improving Import Safety
(HHS: Washington) -- Last year, the United States imported more than $2 trillion worth of products, from roughly 825,000 importers, through more than 300 ports of entry. All projections indicate that this volume will continue to rise sharply over the coming years as the scale and complexity of…
Applying Lean Six Sigma to Minimize Shrink
(SSA & Co.: New York)-- Shrink, a measure of the difference between the amount of goods a company should have on hand and its actual inventory, cost United States retailers more than $40 billion in 2007, according to SSA & Co. However, by changing the way they approach the problem of…
Lean Six Sigma Conference
(ASQ: Milwaukee) -- The American Society for Quality (ASQ) is hosting the 2009 Lean Six Sigma Conference, March 2–3, 2009, in Phoenix. The conference will teach professionals the skills they need to sustain a lean Six Sigma culture at their companies. This year ASQ will offer its largest…
Innovation Template
Innovation Template   Owner: ______________  Date Submitted: ________________ New Product/Service Name: _____________________ Description: (what it is, how it works, how we monetize it): Market Opportunity (Target market, market size…
Creating a Sustainable Innovation Process
Today’s hyper-competitive business environment is creating a need for even more new products, new services, and new processes. Design for Six Sigma (DFSS) offers a generalized and effective approach for designing new products and services from the ground up. One of the more popular DFSS…
Acceptable Losses?
By the time you read this, the amazingly long U.S. presidential election will be over. All U.S. citizens will be wandering around aimlessly bumping into objects, pressing their hands to the sides of their heads as the indignation poisons slowly leave their bodies, leaving them with a hangover-like…
Joint Commission Accreditation Changes
(The Joint Commission: Oakbrook Terrace, Illinois) -- Beginning Jan. 1, 2009, under a new Joint Commission policy, laboratory accreditation decisions will no longer immediately affect hospital accreditation decisions. This policy establishes comparability in the way that a laboratory with an…
ISO Standard Promotes Consistency in Sensory Analysis
(ISO: Geneva) -- When trying to describe the taste, smell, or feel of a product, a universe of terms and sensations will come to mind. This can be problematic when comparing products through sensory analysis. A new International Organization for Standardization (ISO) standard will reduce this…
Thinking Outside the Corrugated Box
Lean theory suggests that the possibilities for quality improvement exist everywhere. Rarely does that concept translate to a damaged corrugated box in a warehouse—but it should. The cost of damaged packaging, particularly cardboard containers, is very significant in bottom-line costs (damaged…
To Root or Not To Root: Part 1
Jodi Ullman glanced at her watch: 10:25 a.m. She pushed back from her desk, stood up, and stretched—after first peeking out the door of her office toward the cubical maze to make sure no one was watching. She’d been staring at the screen of her laptop for two hours, poring over the latest…
Making Medicare Work for Seniors
(Centers for Medicare and Medicaid Services: Washington, D.C.) -- As the beginning of the annual election period for the Medicare Prescription Drug Program nears, many seniors and their caregivers are in the dark about how the program works and how to make the most of it. This is something Esther…
Public Reporting Creates Spike in Patient Satisfaction
(Press Ganey Associates Inc.: South Bend, Indiana) -- By analyzing patient satisfaction data representing 1.5 million patients and 1,158 hospitals across the nation from January 2007 through June 2008, Press Ganey Associates Inc. found a dramatic upturn in patient satisfaction, strengthening the…
Evidence-Based Medicine Restores Focus on ROI
A well-respected surgical group requests a new surgical device that they swear will revolutionize how surgery is performed in your hospital. The price tag is well into seven figures, with significant annual maintenance and training costs. A competing hospital is advertising to consumers that they…
HHS Issues Interim Support for Patient Safety Organizations
(AHRQ: Rockville, Maryland) -- The Patient Safety and Quality Improvement Act (Patient Safety Act) authorized the creation of patient safety organizations (PSOs) to improve safety through the collection and analysis of data on patient safety events. By providing privilege and confidentiality, PSOs…
Guidelines for Consumer-Focused Public Reporting
(National Quality Forum: Washington, D.C.) -- To support consumer engagement and improved quality in health care, the National Quality Forum (NQF) endorsed guidelines for consumer-focused, internet-based public reporting. These guidelines will assist report sponsors to present information about…
Six Sigma and Business Improvement Awards Announces Its 2008 Winners
(WCBF: Chicago) -- The winners for all categories and the special awards were announced at the Global Six Sigma & Business Improvement Awards Gala Dinner on Oct. 15, held at the Gaylord Palms Resort and Convention Center, in Orlando, Florida. Mark Pigott, chairman and CEO of PACCAR received…
Wal-Mart China Seeks Sustainability
(Wal-Mart Stores Inc.: Beijing, China) -- Wal-Mart Stores Inc. took the next step in its sustainability journey by hosting an unprecedented gathering of more than 1,000 leading suppliers, Chinese officials, and nongovernmental organizations (NGO) in Beijing, China. Wal-Mart outlined a series of…
Most Companies Lack Effective Information Management
(EIU: New York) -- Is information governance important to a company’s success? Yes, according to “The Future of Enterprise Information Governance,” published by the Economist Intelligence Unit Ltd. and sponsored by EMC Corp., headquartered in Hopkinton, Massachusetts. Despite the seemingly…
Don’t Think Logically!
A physics exam question asked students to describe how they would use a barometer to measure the height of a skyscraper. One student who failed the test contested that his answer was correct. He was given a second chance to defend his position, verbally, to the professor. When the student didn’t…
The Effect of One Microliter
Pharmaceutical processes typically take place on the scale of gallons or liters, even tens of thousands of liters. So why would anyone worry about one little microliter? Because in some situations, deviations as small as one microliter can mean the difference between success and failure. Modern…
Runners and Their Corporate Counterparts
For the past 35 years or so, I have been a runner. My daily routine consists of a five-mile run followed by a seven-mile bike ride. Over the years, I have competed in numerous 10K (6.2 mile) events, 5Ks (3.1 mile), a marathon (26.2 mile), several half marathons; and for the past 21 years, I have…
FDA Updates IT Infrastructure
(FDA: Rockville, Maryland) -- In a bid to extensively modernize the Food and Drug Administration’s (FDA’s) data management, data warehousing, information technology (IT) infrastructure, and IT security, FDA has awarded 10 contractors a total of $2.5 billion to implement the FDA’s Information…
Quality Control Breakdown at Ranbaxy Manufacturing Plants
(FDA: Rockville, Maryland) -- Due to quality control problems at two Ranbaxy Laboratories Ltd. manufacturing plants in India, the U.S. Food and Drug Administration (FDA) issued two warning letters and an import alert for generic drugs produced by the company. “With this action we are sending a…
Problem Solving in a Lean Organization
(Bosch Rexroth Corp.: Buchanan, Michigan) -- Developed with lean manufacturing expert Jamie Flinchbaugh, as episode six of Bosch Rexroth's lean manufacturing podcast series, “Daily Problem Solving in a Lean Organization” explores principles and work practices that businesses, which have already…

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