As usual with Quality Digest’s diverse audience, this year’s top stories covered a wide range of topics applicable to quality professionals. From hardware to software, from standards to risk management, from China trade to FDA regulations. It’s always fun to see what readers gravitate to, and this year was no different.

Below are five articles that garnered a lot of interest from our readers. As you can see, the topics are quite diverse.

Improve Risk Management and Quality Across the Value Chain by Increasing Visibility
by Kelly Kuchinski

Eric, a 40-something married father of three, runs a successful startup. Given his demanding career, he and his wife decided she would be a stay-at-home mum. Eric believed the attention he devoted to his family was adequate, and that he had fully harmonized his work as CEO and life as a family man.

On a recent family trip, Eric continued working as much as he could, as he always did. While taking a conference call, he dropped his phone and, without hesitation, leapt to catch it at the risk of hurting himself. Seeing this, his 13-year-old son blurted out, “I don’t know if you would have jumped after me like that.” Only then did Eric realize that his son didn't think he prioritized their family. Eric had been oblivious that his family felt neglected; he had been unaware or was in denial.

In late November 1999, a TV producer called me about an alarming report that 44,000 to 98,000 Americans were being killed each year by preventable errors in hospitals, and another 1 million were being injured. Could that be true? Based on my research, I replied, the estimate seemed low.

The “To Err is Human” report from the Institute of Medicine has been called a “seminal moment” in the patient safety fight. The public furor sparked by the group’s assertion that medical mistakes were deadlier than breast cancer, auto accidents, or AIDS prompted new laws, as well as vows to meet the Institute of Medicine’s goal of cutting medical errors in half in five years.

Twenty years after the report’s release, how safe is our medical care?

Weekly CGMP Quiz 1: Part 210 & 211 Subpart A General Provisions. Use with your team for training credit!

This is the first of eleven quizzes on CGMPs that will appear weekly on QA Pharm. Try it yourself, and use it as a discussion tool for your staff groups.

Also, each quiz will have one letter tile at the bottom. Collect all eleven tiles and unscramble the letters for an important message.

When you have completed all 11 quizzes, you will have satisfied the requirement in 21CFR211.25(a) for continuing CGMP training. Be sure to document this training according to your established procedures.

An answer key will be provided after the eleventh quiz to use for further discussion.

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.

The company Grace Science was born through an inversion of the normal business sequence. Typically, if an entrepreneur launches a startup and it succeeds, the founders will create a nonprofit, declaring, “We want to give back.” In this case, the nonprofit spawned the startup.

The company’s inception accelerated when Matt Wilsey first met with Carolyn Bertozzi in 2015. Bertozzi is the Anne T. and Robert M. Bass Professor of Chemistry and professor of chemical and systems biology and of radiology (by courtesy) at Stanford University.

Wilsey’s daughter, Grace, has an ultra-rare disorder caused by a mutation in a gene known as NGLY1. Only 54 people in the world have been diagnosed with the disease. In 2014, Wilsey and his wife, Kristen, created a nonprofit, the Grace Science Foundation, in their quest to find a cure. The foundation has raised about $9 million to date.

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.

Any patient scheduled for surgery hopes, and maybe assumes, that his surgeon will do a high-quality job. Surgeons know better. Nearly three decades of research have made clear that some hospitals and surgeons have significantly better outcomes than others.

Exactly how to measure the quality of a surgeon’s skills, however, is up for debate. Surgical volume—the number of operations of a specific kind performed at a hospital or by an individual surgeon—is known to be a good marker for quality. But it’s not perfect. For example, looking only at hospitals that perform at least 125 bariatric surgeries per year, a recent review found that the rate of serious complications ranged from less than 1 percent to more than 10 percent.

Technology companies are frequently driven by their engineering processes. Of course product quality is regarded as most important, and that quality can be tested and measured with numbers and data. Such companies also frequently align their core identity with the engineering that belies their innovation. Their top executives often started out as engineers and keep looking primarily through their engineering lens as they become company leaders. Although it makes perfect sense, this approach is misguided.

I didn’t understand what people were asking me when I was a kid. The question would come in several different forms. Sometimes it was, “What are you?” Other times it was, “Where are you from?” I would answer with things I knew to be true, like, “I’m a girl,” or, “I’m a person,” or, “I’m from Maryland,” in a sincere, but failed, effort to satisfy my questioner.

I later came to understand that these people actually wanted to know my ethnicity. I grew up in a stereotypical melting-pot USA kind of place, otherwise known as Howard County, Maryland, where many neighbors and classmates were of various ethnic backgrounds. Even in this melting pot, I was different. I am of mixed ethnicity: My mom’s half is Afro-Caribbean by way of Jamaica, and my dad’s half is East Indian by way of the West Indies. I couldn’t be placed in one bin, and I was keenly aware from the questions I received that I was different. This made me want to understand this “otherness,” and that is what sparked my love of human genetics.

Credit: Mark Esser/NIST