People often ask me how best to prepare for a Food and Drug Administration (FDA) inspection when you know that you have problems. My first response is that they have already taken the first step: acknowledging that there are problems. Believe me; that is a huge first step. Just like Alcoholics…

Pharmaceutical manufacturer Johnson & Johnson, which for decades has enjoyed a trusted reputation for soothing babies and overcoming head colds, is currently facing criminal investigation by the U.S. Food and Drug Administration (FDA). The company’s McNeil Consumer Healthcare unit closed a…

Digital pen technology is an efficient data management solution that offers better operational visibility, enabling manufacturers to react quickly to the production process and respond to issues via immediate data access. Hyla Soft’s FactoryScribe is a lightweight web application built around…

A new year always brings new hope, new plans, and new perspectives. While looking ahead is the most direct route to progress, looking back is essential to understanding the present. After all, the past creates the consequences that will shape the future. With this in mind, the editors of…

Ken Appel is the manager of regulated industries for Veriteq. In part 1 of this article, we discussed the pros and cons of various systems for stand-alone monitoring instruments (e.g., chart recorders and data loggers) and wired networks, with and without power over Ethernet (POE). In the…

Ken Appel is the manager of regulated industries for Veriteq. T he U.S. Food and Drug Administration (FDA) and its European Union counterparts recently agreed to cooperate on pharmaceutical plant inspections to enable stepped-up enforcement of safety guidelines. These agreements will help…

Food safety standards are becoming increasingly stringent. Although government legislation has long been implemented, your customers may be driving an even higher standard of food safety through the Global Food Safety Initiative (GFSI) or Safe Quality Food (SQF) Institute, which require third-…

My definition of “specification” is rather simple: It’s a promise. Just like any other promise, you’d better be sincere when you make it and be able to keep it. Failure to keep a promise brings disappointment. Frequent failure leads to distrust. And consciously breaking a promise is nothing less…

A recent article appearing in the Quality Digest Daily e-newsletter (“Why Lean? Why Now?” by Dean Bliss http://www.qualitydigest.com/inside/health-care-news/why-lean-why-now.html) discusses the value of lean in a health care setting. In his editorial, Bliss writes about the manufacturing origins…

It is no secret that the health care industry is undergoing revolutionary changes. Are you responding by re-evaluating your approach to process improvement? In a world where doing more work with fewer resources is the norm rather than the exception, now is the right time to update your own work…

We hear much about the importance of listening to customers and meeting their needs. Lean Six Sigma devotees say that metrics from the customer’s vantage point are at the center of their philosophy. Many pharmaceutical companies embed their high view of the professional community and patients…

Figure 1: Closed-loop process for managing regulatory compliance In Part I, Part II, and Part III of this compliance series, I have described the benefits of using a closed-loop process for managing regulatory compliance (illustrated in figure 1). Readers of this series…

Lean thinkers see the waste in health care when they are at the hospital gemba. I think this is true whether you are a lean person who is new to health care or if you’re a long-time hospital person who has learned lean. Experts (doctors) ranging from John Toussaint to Patricia Gabow to Don Berwick…

Melanoma is one of the less common types of skin cancer, but it accounts for the majority of skin cancer deaths (about 75%). The five-year survival rate for early-stage melanoma is high (98%), but the rate drops precipitously if the cancer is detected late or there is recurrence. So a great…

One of the regulatory responsibilities of the quality control department is the release decision for drug batches into the market. When I was first given that responsibility early in my quality assurance (QA) career, it was impressed upon me to not count the cost of the batch when making that…

On July 8, the Food and Drug Administration (FDA) announced an initiative “… to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003 Guidance for Industry Part 11, Electronic Records; Electronic Signatures—Scope and…

In Part I and Part II of this series we discussed the benefits of using a closed-loop process for managing regulatory compliance called the “circle of compliance,” pictured in figure 1. I also showed how setting up key performance indicators (KPIs) that monitor performance to goals is a good way…

Medical device manufacturers may gain a one-year exemption from Food and Drug Administration (FDA) inspections if their establishment has been audited under one of the regulatory systems implemented by the Global Harmonization Task Force (GHTF) founding members using ISO 13485. Manufacturers must…

For quite some time, polls have indicated that public approval for Congress remains at an all-time low. Congressional gridlock is difficult to watch for U.S. citizens who care about any issue and how our legislative process resolves the problems of our time—no matter what their party affiliation…

Approximately three-fourths of product safety recalls in the United States are the result of some design flaw in the product rather than a manufacturing or other defect. Most violations of the U.S. Consumer Product Safety Commission (CPSC) “small parts” standard, for example, are the result of…

The compliance department’s primary function is to ensure that the company complies with all applicable regulations, rules, and laws. Regardless of the industry—life science, energy and utilities, or financial services—this is a universal mandate. As someone who serves customers across many…

The Toyota Production System and U.S. health care improvement share a long history. What lessons can health care leaders learn from Toyota’s recent production troubles? A few experts recently discussed this on WIHI, an audio program sponsored by the Institute for Healthcare Improvement (IHI). Here…

A surgical technician prepares her back table for the next laparoscopic surgery. Instruments are removed from their containers and packages, and placed neatly on the back table. Chemical indicators show that sets and instruments are sterilized; the patient is prepped. The surgeon begins the…

(Academy Leadership Publishing: King of Prussia, PA) -- When news headlines trumpet story after story about fiscal mismanagement, unchecked greed, massive bankruptcies, and rampant downsizing, it’s hard to believe there’s any good news about the business world. Indeed, it’s almost impossible not…

In the classic Aesop fable, “The Fox and the Grapes,” a fox desires some grapes hanging high overhead. When he is unable to come up with a way to reach them, he convinces himself that the grapes are probably sour and therefore not desirable anyway. “Sour grapes” has become an idiomatic expression…