Can you imagine the stream of firms that venture into their respective FDA district offices to give presentations on their warning letter response and to offer their assurance that they truly “get it?” You can be sure these firms had several dry runs and dress rehearsals to hone their material…

How safe is our food? It is a question asked all over the world on a daily basis as food-scare stories fill the media and governments act to calm consumer fears. There is a real and tangible concern among the public; an IBM consumer confidence survey in 2009 found that 80 percent of those…

According to the National Center for Health Care (NCHC), emergency department (ED) crowding has been a concern in U.S. hospitals for more than a decade. The Centers for Disease Control and Prevention (CDC) report the number of visits to EDs rose 19 percent from 1995 to 2005, even as the number of…

This is one of the first questions that executives always ask me. Because it is a broad question, the answer is often challenging. I usually respond with a few examples that have been gathered in Juran Institute’s 20-year benchmarking practice database, such as Company A is this, and Company B is…

Critical care units at St. Joseph’s Hospital Health Center in Syracuse, New York, were faced with a formidable task. They had applied to receive the Beacon Award for Critical Care Excellence, a distinction given only to the top intensive care units in the United States. One of the components on…

Welcome to Quality Digest Daily 2.0! This new format represents a significant re-imaging of our flagship brand (the industry’s only daily newsletter), which we first launched nearly two years ago. I hope you notice that we’ve added more video content to the newsletter as well as greater editorial…

“Under-promise, over-deliver” is a phrase taught to me many years ago by my friend and colleague, PQ Systems’ owner Michael J. Cleary. It may have always been true. It may always be true. It is certainly true today. I am in the middle of a sabbatical that requires me to buy and learn to use new…

“What makes a personal kanban any better than a to-do list?” asked Julie, crossing out a completed task on her “ta da!” list with exaggerated strokes. “With personal kanban you visualize your work, it becomes tangible, you get kinesthetic feedback, it’s flexible, contextual, and it promotes…

A March 30, 2011, Food and Drug Administration (FDA) Warning Letter to Ningbo Smart Pharmaceutical Co. revealed that it had reported conformance to specifications on certificates of analysis, when in fact no testing was done—among other issues. The FDA rather understatedly informed Ningbo Smart, “…

Companies aren’t perfect, and neither are the people who work for them. Since this is a fact rather than a judgment, it’s reasonable to expect errors in manufacturing and process management. When an audited company continues to show a flawless record for, say, a food-safety audit, chances are it…

Read this. It won’t be a waste of time. Time gets lost. People kill time. Time flies. It gets wasted. Time weighs heavy on our hands. We spend time. Time passes. It drags on or it hurries by. Those behind bars are said to be doing time. Sometimes, we have no time left; we’re out of time.…

Under the Food Safety Modernization Act (FSMA), food manufacturers and processors who import food ingredients and raw materials will be required to implement a Foreign Supplier Verification Program, essentially mandating that foreign suppliers undergo the same rigor and scrutiny as domestic ones.…

Under the Food Safety Modernization Act (FSMA), food manufacturers and processors who import food ingredients and raw materials will be required to implement a Foreign Supplier Verification Program, essentially mandating that foreign suppliers undergo the same rigor and scrutiny as domestic ones.…

By the time a consent decree comes along—which happens when a firm repeatedly violates current good manufacturing practice (cGMP) requirements and the Food and Drug Administration (FDA) forces it, through legal channels, to make specific changes—it’s no longer a discussion about responses to…

By the time a consent decree comes along—which happens when a firm repeatedly violates current good manufacturing practice (cGMP) requirements and the Food and Drug Administration (FDA) forces it, through legal channels, to make specific changes—it’s no longer a discussion about responses to…

If you’re in the business of manufacturing drugs, medical devices, nutraceuticals, or manufacturing or importing any product in the United States that falls under current Good Manufacturing Processes (cGMP) regulations, your facility will be inspected by the U.S. Food and Drug Administration (…

It turns out that I am not the only one who has noticed that food regulation is sometimes a little, well, silly. The federal government recently “identified a mother lode of government waste and duplication” and decided that getting rid of it “could potentially save billions of tax dollars annually…

The recent brouhaha involving a class-action suit against Taco Bell alleging that their beef filling is more filling than beef really got me thinking, but not about what’s in the tacos. Instead, it got me thinking about quality control, quality assurance, and particularly about customer…

In business there’s a saying: Time is money. The more time it takes for something to get done, the more money is wasted. Companies that can figure out a way to compress the time it takes for something to happen can realize significant cost savings and also get their products into the market faster…

If a manufacturer were to ask its clients how they evaluated goods or services, the three most common metrics would be goods at a fair price, on-time delivery, and quality. Ask which could be most valuable and in all likelihood the most significant response would be quality. When included in the…

Most pharmaceutical companies have an internal current good manufacturing practices’ (CGMP) auditing program administered at the site and corporate levels of the organization. Auditors are typically part of the quality assurance or regulatory compliance function, and the usual approach is to…

Researchers from the Georgia Institute of Technology have created a new sampling device that could prevent thousands of people worldwide from dying of pneumonia each year.  Called PneumoniaCheck, the device created at Georgia Tech, is a solution to the problem of diagnosing pneumonia, which is a…

Twitter is not at all what I expected. After a few months, I now use Twitter to improve my knowledge in health care quality, expand my professional network, and save time. Through Twitter, I’ve connected with an amazing variety of people, including health care providers, marketing pros, e-patients…

A young man in PQ Systems' hometown survived a dramatic auto accident last summer in which police-captured video footage of his spectacular, airborne vehicle was broadcast throughout the nation. That was just the beginning of his problems, for during his hospitalization, his medical records were…

For most of us, food safety is a topic that, at best, only lurks at the edges of our brains. It rarely becomes something we really think about until we open up our refrigerator and try to figure out what’s growing in the back corner of the bottom shelf, or until we hear stories about people being…