Risk Management Article

Davis Balestracci’s picture

By: Davis Balestracci

During the late 1970s, quality began to evolve from its historically Neanderthal, passive inspection approach to its current Cro-Magnon state, where its more proactive, project-based approach is bolted on to the operational status quo. Joseph Juran was a pioneer in such efforts. Various subsequent adaptations such as Six Sigma and lean evolved it further, but over time, it has become comfortably stuck in a misguided focus on tactical improvements at the expense of strategic improvements—i.e., doing things right as opposed to doing the right things right.

In 2011 Jim Liker, a professor of industrial and operations engineering at the University of Michigan, wrote the following to leadership expert Jim Clemmer (emphasis mine):

Clifton B. Parker’s picture

By: Clifton B. Parker

An underlying theme emerged from the Stanford Institute for Human-Centered Artificial Intelligence’s fall conference: Artificial intelligence (AI) must be truly beneficial for humanity and not undermine people in a cold calculus of efficiency.

Titled “AI Ethics, Policy, and Governance,” the event brought together more than 900 people from academia, industry, civil society, and government to discuss the future of AI (or automated computer systems able to perform tasks that normally require human intelligence).

Discussions at the conference highlighted how companies, governments, and people around the world are grappling with AI’s ethical, policy, and governance implications.

Gleb Tsipursky’s picture

By: Gleb Tsipursky

When was the last time you as a quality professional saw a major failure in implementing decisions? What about in project or process management? Such disasters can have devastating consequences for high-flying careers and successful companies. Yet they happen all too often, with little effort taken to prevent failure.

For example, many leaders stake their reputations on key projects such as successful product launches. However, research shows that most product launches fail. Nike’s FuelBand, launched with much fanfare in 2012, flopped on arrival. By 2014, Nike fired most of the team behind FuelBand, discontinuing this product.

David Hart’s picture

By: David Hart

Climate plans are the order of the day in the presidential primary campaign because carbon pollution is a global threat of unique proportions. But it’s worth asking whether candidates’ plans are based in the reality of the climate, the economy, and the election.

All three dimensions must come together for any climate plan to achieve its goals—and this is especially true when the subject is electric vehicles (EVs). There is no point in putting forward an EV plan that is so aggressive that it cannot be implemented even under the most auspicious economic circumstances. Nor is there a point in advancing an EV plan that would not yield significant climate benefits. And, if such a plan might hurt a candidate’s chances in the election, it would be worse than pointless.

Following the lead of Governor Jay Inslee, who dropped out of the race earlier this fall, Senators Cory Booker, Bernie Sanders, and Elizabeth Warren said they would require all passenger cars sold in the United States to be zero-emissions by 2030, while Senator Kamala Harris and Mayor Pete Buttigieg set a 2035 deadline.

Heather Thompson’s picture

By: Heather Thompson

Software as a medical device (SaMD) is a growing sector in medical device technology. Through the use of artificial intelligence and machine learning, SaMD has the power to influence health on a global scale as well as allow for personalization in medicine and life-saving therapies.

Medical device companies developing these products can take advantage of the FDA’s new programs designed to advance trusted companies so they can get products to market efficiently and effectively.

Equally important, if you want to be part of the SaMD trend and its accompanying regulatory pathway, the FDA is clear: Make sure your quality management system (QMS) is exemplary.

Matt Kunkel’s picture

By: Matt Kunkel

Third-party vendors are increasingly working with their own third parties (fourth and fifth parties), spreading your data across many different vendors. This can make your company an easy target for cybersecurity threats, especially if your organization is a hospital or part of the healthcare system. You have to be aware of the risks associated with third parties. If you aren’t, you’re playing with fire.

Failing to address third-party risk can be costly and often just as damaging as risks that stem from within the organization. Thus, it’s critical that you don’t compromise private data in exchange for the convenience of services provided by third parties. These data are especially important in the healthcare industry because confidential records, clinical information, or medical data could end up in the wrong hands.

ISO’s picture

By: ISO

As artificial intelligence (AI) becomes increasingly ubiquitous in various industry sectors, establishing a common terminology for AI and examining its various applications is more important than ever. In the international standardization arena, much work is being undertaken by ISO/IEC’s joint technical committee JTC 1—Information technology—Subcommittee SC 42—Artificial intelligence, to establish a precise and workable definition of AI. Through its working group WG 4, SC 42 is looking at various use cases and applications. The convener of SC 42/WG 4 is Fumihiro Maruyama, senior expert on AI at Fujitsu Laboratories.

Currently, there are a total of 70 use cases that the working group is examining. Health, for example, is a fascinating area to explore. Maruyama himself describes one use case in which a program undertakes a “knowledge graph” of 10 billion pieces of information from existing research papers and databases in the medical field. The application then attempts to form a path representing the likely development from a given gene mutation to the disease that deep learning has predicted from the mutation.

Chad Kymal’s picture

By: Chad Kymal

With the advent of the internet, cloud, and electronic workflows, what is the future of documented management systems? Do we continue with a structure of quality manual, processes, work instructions, and forms and checklists? How do we imagine the future of documented management systems?

For enterprise and site documentation, there’s a need for all entities, from site to department to individuals, to have their own documented management system structure. The documented management system should be a repository of organizational knowledge, in the form of documentation, records, projects, audits, dashboards, customer and/or interested party needs and expectations, calibration data, and much more. How is this possible?

Furthermore, documented flows should give way to virtual electronic workflows that help implement and sustain an integrated management system.

Dileep Thatte’s picture

By: Dileep Thatte

According to information from the Centers for Disease Control and Prevention (CDC), every year 48 million people in the United States get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases. That means one in six people in the United States get sick from contaminated food every 12 months. These statistics are important to take note of and address because the U.S. food supply also represents a huge economic asset, contributing almost $1 trillion to the national gross domestic product (GDP) each year.

Boris Liedtke’s picture

By: Boris Liedtke

In May 2019, a California jury found Monsanto’s weed killer, Roundup, to be a “substantial factor” in the cancer suffered by a couple and ordered the U.S. agrochemical company to pay them $2 billion in damages. This was the third and largest verdict against Monsanto, now owned by German pharmaceutical giant Bayer, over its decades-old product.

A judge slashed the award to $86.7 million in July 2019 after Bayer appealed, but it is cold comfort for the company. An estimated 13,400 similar Roundup cancer cases are pending in state and federal courts across the United States. European investors and Bayer’s management are in shock at the size of the settlements.

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