Rachel E. Sherman
Across the clinical research enterprise, there is a growing awareness of serious shortfalls in the current model for generating the scientific evidence that supports medical product evaluation and...
Paul Voss
Not long ago, most Americans could safely ignore congressional deliberations about Federal Aviation Administration (FAA) authority, leaving the details to industry experts and lobbyists. But this...
Tim Lozier
When we look at business dynamics, regardless of industry, we see an increasing rate of change in products, processes, and regulations. One process affects the next, and with a growing focus on...
Jon Speer
If you’re still using failure mode and effects analysis (FMEA) as your methodology to capture medical-device risk management activities, then your risk management process is out of date. Let me...
Ken Miller
Please pardon me, but I feel a little like a modern-day Paul Revere alerting you to the start of the second wave of Health Insurance Portability and Accountability (HIPAA) compliance audits.
Last...
Bruno Scibilia
Sponsored Content
Suppose that on your way to a summer holiday resort (a very distant place), your car breaks down. You might just call roadside assistance and wait for your car to be towed to a...
Jill Hartzler Warner
Combination products represent an important and growing category of therapeutic and diagnostic products under the U.S. Food and Drug Administration’s (FDA) regulatory authority. These products...
FDA
One of the vivid images that sticks with me from my tenure at the Food and Drug Administration (FDA) is of the port of entry at Nogales, Arizona. There, I saw large trucks from Mexico lined up as...
MIT News
In March 2011, Leonardo Bonanni was preparing to defend his Ph.D. thesis about Sourcemap, software that lets consumers map every connection of a product supply chain on a digital map, when tragedy...
Gilles Hilary
Phil used to be a very senior financial executive. When asked for a number, he would typically provide with a rough ballpark answer, such as, “It’s about 5 percent.” He’d then be peppered with...
Dan Jacob
Airbags, ignition switches, and even emissions software; although large recalls make the news at a regular pace, these are surrounded by scandal. News reports include claims of illegal or unethical...
Mike Micklewright
When considering any effort toward performance improvement, you should always start by looking at the organization’s principles and culture, and making sure these are aligned so they not only...
Manufacturing Extension Partnership MEP
Whether it’s for performance management or for risk, it’s important to know who your suppliers are and have a close business relationship with them.
It’s a given you should already have a strong...
Timothy Lozier
There’s been a shift in how companies view quality and compliance, and as a result, businesses are looking for a more comprehensive method for measuring operational efficiency. Risk management...
William A. Levinson
ISO 9001:2015 has created a new focus on risk with regard to context of the organization and the needs and expectations of interested parties.
The Army Techniques Publication ATP 5-19 Risk...
Chris Howells
Reputation is fast becoming one of the most important risks to manage. Build quantifiable arguments to get boards on board.
Corporate reputation, the close cousin of a firm’s brand, is one of the...
Benjamin Kessler
These days, even a cursory scan of the headlines brings fresh reminders of risk, from the ramifications of climate change to shocking terror events such as the recent attacks on Paris by the...
Gilles Hilary
Eric (not his real name) was under pressure from his sales department. He was hesitant to close a large financing deal with a Chinese corporation but had little beyond his intuition to back up his...
Dawn Marie Bailey
I heard the example that best helped me understand work systems and supply chains at a Baldrige training event right after the very sad 2011 earthquake and tsunami in Japan. A colleague was talking...
Timothy Lozier
Compliance is a broad term. It can mean compliance to financial obligations, quality and safety, or general compliance to any regulation that is driving the organization. When you look at the...
