Risk Management Article

Matthew M. Lowe’s picture

By: Matthew M. Lowe

While most business sectors have welcomed the efficiencies and benefits that cloud technologies and software-as-a-service (SaaS) offerings bring, the life sciences industry has been slow to embrace external cloud networks. Merely a decade ago, in fact, an International Data Corp. survey showed that 75 percent of CIOs and IT executives in life sciences and healthcare fields surveyed said that security risks were their primary reason for opposing cloud technologies.

Cloud-averse attitudes are slow to change, and industry research shows that companies that manage health information continue to show major resistance to cloud technology.

James J. Kline’s picture

By: James J. Kline

The term “risk-based thinking” (RBT) is familiar to those in the quality profession. This familiarity comes in part from its inclusion in ISO 9001:2015, the International Organization for Standardization (ISO) quality management system standard. Although numerous articles and several books have been written on how to implement ISO 9001:2015 in the private sector, little has been done with regards to the public sector.

This reflects two facts. First, the idea of systematically managing the risks governments face is relatively new. Second, where risks are being managed by government organizations, there is no consistent approach. Some are using ISO 9001:2015 and others are using ISO 31000. ISO 31000, revised in 2018, is an enterprise risk management standard.

This article looks at what public-sector organizations are thinking about, and doing, to manage risks.

Kevin Price’s picture

By: Kevin Price

In the world of risk management, maintenance of mission-critical equipment drives priorities and budgets. It is the ultimate test of proactive maintenance and smart decision making. Managing assets that “cannot be allowed to fail” is more than an emotionally charged mandate that forces managers into a continual state of alert. It is the harsh reality for technicians tasked with ensuring continuous performance or service. The stakes are high. Fortunately, technology can help mitigate the risks.

Multiple Authors
By: Venkat Viswanathan, Shashank Sripad, William Fredericks

As electric cars and trucks appear increasingly on U.S. highways, it raises the question: When will commercially viable electric vehicles take to the skies? There are a number of ambitious efforts to build electric-powered airplanes, including regional jets and planes that can cover longer distances. Electrification is starting to enable a type of air travel that many have been hoping for, but haven’t seen yet: a flying car.

Ronda Culbertson’s picture

By: Ronda Culbertson

The AS9100 family of standards has completed very important updates, raising the business management quality bar again for aerospace and defense suppliers and OEMs. The transition to the new standards caught quite a few organizations somewhat flat-footed; particularly with the emphases on risk management and top-management participation (leadership). Getting it right is important; certification to one of the standards is rapidly becoming a requirement of the aerospace and defense industry.

The updated standards have proven challenging for small to midsized supplier organizations that need certification to advance their positions in the global supply chain. Even for larger companies and the major OEMs, the new revision of the standards is demanding.

Much like recent updates to core ISO standards (ISO 9001, ISO 14001, and ISO 45000), the revisions to AS9100, AS9110, and AS9120 demand a broader view of quality and organizational impacts. Some of the changes are very specific and technical; others are conceptual.

AssurX’s picture

By: AssurX

Last month an investigative report revealed that the U.S. Food and Drug Administration (FDA) has millions of “hidden” serious injury and malfunctions reports on medical devices.

Ryan E. Day’s picture

By: Ryan E. Day

More and more, manufacturers are becoming the target of hackers, but what can they do about it, if anything? It seems every month, maybe even every week, we hear about some sort of data breach or cyberattack. Think Facebook, Google, and Marriott. As consumers we’ve almost become inured to the idea that our data are not really all that secure. But it isn’t just consumer companies and consumer data that are at risk; manufacturers are under attack as well. According to one report, manufacturing has surpassed any other sector, including financial services, as the greatest industry susceptible to cyber threats.

According to Information Age, in 2018 almost half of UK manufacturing companies were subjected to cyber attacks, and the problem may be similar in the United States. Although most of us may tend to think of cybersecurity on a personal level, hacking or data theft is just as important for manufacturers. So, how big of a problem is cybersecurity amongst manufacturers, and what can they do to protect themselves against attacks?

Multiple Authors
By: Beth Humberd, Scott Latham

Walmart recently announced it plans to deploy robots to scan shelves, scrub floors, and perform other mundane tasks in its stores as the retail giant seeks to lower labor costs.

Paul Foster’s picture

By: Paul Foster

When you look at standards like IATF 16949 or ISO 9001, the requirements boil down to two essential elements: improving customer satisfaction and reducing risk.

They go hand in hand because effective risk management means safer products and happier customers—and fewer problems for their suppliers.

To help automotive suppliers proactively avoid quality and safety issues, we’re looking at four important places to focus on for improving risk management and reducing costs.

Jeffrey Phillips’s picture

By: Jeffrey Phillips

One of my favorite quotes comes from George Bernard Shaw, who said that all change in life originates from unreasonable people. Reasonable people, he said, will accept the status quo and change their lives to adapt to the status quo. Unreasonable people won’t. Unreasonable people force change rather than accept the status quo. So, he argued, all change is dependent on unreasonable people.

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