All Features
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 week, Jocelyn Samuels, director of the Health and Human Services’ Office of Civil Rights (OCR),…
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 repair shop. But suppose that you think you’re smarter than that, and you would like to solve the issue…
Jill Hartzler Warner, Thinh Nguyen
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, which combine a drug, device, and/or biological product (referred to as “constituent parts”) with one…
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 far as the eye could see, awaiting entry into the United States, many loaded full with fresh produce…
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 struck in Japan. Although the deadly earthquake and tsunami occurred half a world away, the events…
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 questions about how he had arrived at that figure.
After a while, he got tired of this questioning and…
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 activity executed by individuals or larger groups of people. Unfortunately, as new reports expose…
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 permit positive changes to occur, but also ensure that the changes will be sustained over the long run. By…
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 relationship with your key suppliers, but how often does your supplier request the following items? •…
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 processes are proving to be an effective option for this. ISO 9001:2015 now promotes risk-based thinking…
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 Management, by the United States Government, U.S. Army (CreateSpace Independent Publishing Platform, 2014)…
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 most intangible assets a company has. If a brand is the inside-out perception of a firm, reputation…
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 Islamic State. Now more than ever, companies need risk managers.
Paradoxically, however, the new ubiquity…
Gilles Hilary, Arnaud Lagarde
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 position.
The company’s stock price had gained a whopping 600 percent in one year. Nevertheless,…
Dawn 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 about automakers in the United States and elsewhere whose suppliers were located in the devastated…
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 current state of quality management and safety management with respect to compliance, most of the…
Sonal Sinha
In a recent poll, employees (22.9%) were identified as the top source of supply chain fraud risk, followed by vendors (17.4%) and other third parties (20.1%), including subcontractors and their vendors. In calling new attention to the old cliché of “an inside job,” the statistics may prove to be…
Fred Schenkelberg
Why do so many avoid confronting the reality of failure? In plant asset management, we are surrounded by people who steadfastly don’t want to know about nor talk about failures. Yet failure does happen; let’s not ignore this simple fact.
The blame game
Unlike a murder mystery, failure analysis (…
Quality Digest
Born in Bulawayo, Zimbabwe, and raised in Cape Town, South Africa, Wayne Visser, Ph.D. is, as CSRWire USA says, “. . . one of the most prolific, creative, and original thought leaders on corporate social responsibility.” That begs a question, however—should we use the term “social” or “sustainable…
Akhilesh Gulati
The big data revolution is requiring a seismic shift inside organizations, both in the way we build relationships and the way we make decisions. Each is now driven by data rather than intuition.
In general, decision making is accomplished via a thought process of selecting a logical choice from…
Mary McAtee
Technology is evolving more rapidly than at any point in history. We tend to think of seminal moments in history, such as the inventions of the steam engine or powered flight, as literal moments in time.
The reality is that the invention of the steamboat by Robert Fulton was only possible…
William A. Levinson
The requirement for risk-based thinking is among the most significant changes in ISO 9001:2015. Army Techniques Publication (ATP) 5-19, Risk Management is a public domain reference that supports this requirement.
ATP 5-19 includes a risk assessment approach that is similar to failure mode and…
Yo Delmar
In June 2015, it was initially reported that the U.S. Office of Personnel Management (OPM) experienced a massive data breach, potentially affecting as many as 4 million current and former federal employees. Updated reports indicate that the actual number of people compromised is more than five…
Randall Goodden
E
very year in the United States, an estimated 80,000 product liability lawsuits are filed, and thousands of products recalled—and that’s happening to companies with certified quality programs in place.
In 2014 alone, some of the highest fines were imposed by government agencies because…
Jesse Lyn Stoner
Delegating is often one of the hardest things for a manager to do. You give away your authority to make decisions but are still responsible for the outcome if something goes wrong.
Often managers don’t delegate because they hold one or more of these beliefs. Do any sound familiar?
“If you want…
