Yosef Ayzencot’s picture

By: Yosef Ayzencot

Starting a business is a costly investment. According to U.S. Bureau of Labor statistics, more than half of businesses fail within the first five years of opening. Adding to this pressure were the nationwide staffing challenges during the “Great Resignation” and then the “Great Reshuffle.” This type of workforce back and forth leaves business owners and human resource managers with constant whiplash while the needs of the business continue to go unmet. The problem is finding quality employees and keeping them engaged.

As a co-founder of 26 Motors, a full-service and independent pre-owned car dealership, I can only speak from experience within the niche car sales market. Still, the principles should be much the same no matter what your business sells or provides.

Grant Ramaley’s picture

By: Grant Ramaley

The FDA Quality System Regulation (QSR) 21 CFR Part 820 was written in 1997 to harmonize with ISO 13485:1996. The goal was to relieve some of the burden of manufacturers having to meet two different criteria, the FDA’s and ISO 13485.

But by 2003, ISO 13485 had changed so significantly that the FDA QSR was no longer aligned. Now the FDA wants to update the QSR to align it with ISO 13485:2016. But will that solve the problem? Can the FDA and industry use the new QSR in a cooperative way?

Why the FDA needs to cooperate better with industry

A 2008 U.S. Government Accountability Office (GAO) report indicated that foreign manufacturers see an FDA inspector about once every 26 years, unless they make high-risk devices. Overseas high-risk device makers are visited perhaps once every six years. These numbers haven’t significantly changed. A review of foreign inspections saw a bump in 2012, but a small bump—not one that would satisfy the mandate to audit all manufacturers, worldwide, every two years.

The issue is manpower: To say the FDA has “capacity issues” and is unable to meet its congressional mandate to inspect every two years is an enduring and extreme understatement.

Gleb Tsipursky’s picture

By: Gleb Tsipursky

Imagine you’re driving along the highway and you see an electric sign that reads, “79 traffic deaths this year.” Would this make you less likely to crash your car shortly after seeing the sign? Perhaps you think it would have no effect?

Neither are true. According to a recent peer-reviewed study that just came out in Science, you would be more likely to crash, not less. Talk about unintended consequences.

The study examined seven years of data from 880 electric highway signs that showed the number of deaths so far this year for one week each month as part of a safety campaign. The researchers found that the number of crashes increased by 1.52 percent within three miles of the signs on these safety campaign weeks, compared to the other weeks of the month when the signs didn’t show fatality information.

That’s about the same effect as raising the speed limit by four miles or decreasing the number of highway troopers by 10 percent. The scientists calculated that the social costs of such fatality messages amount to $377 million per year, with 2,600 additional crashes and 16 deaths.

Gleb Tsipursky’s picture

By: Gleb Tsipursky

The pandemic has made organizations aware of the need for a new C-suite leader, the CHO, or chief health officer. This has been driven by recognizing the importance of employee health for engagement, productivity, and risk management, along with lowering healthcare insurance costs. At the same time, more employees report mental and physical health challenges.

To keep employees safe, and productivity and morale up, organizations realize that simply offering yoga and other wellness programs through employee assistance programs won’t cut it. This awareness helped create a top executive whose sole focus is on optimizing employee health, both physical and mental, for the sake of company bottom lines.

Thus, say hello to the chief health officer, the new C-suite leader who is both captain and curator of an organization’s health policies, and deals with the employees’ health on all levels.

Susan Robertson’s picture

By: Susan Robertson

A debate you frequently hear in business circles is whether working online or in-person is more creative. The short answer? Both. Or neither. It’s solely dependent on how the meeting is structured and managed.

When it comes to creativity, a recent study found that online interactions result in less creativity than face-to-face. The reason: When online, people mostly stare at the screen rather than letting their eyes wander around, which sparks more divergent thought. But the flaw with this study was that the conditions that actually result in creative thinking were not set; not in the online nor the in-person experiments. So, even though the in-person interactions were slightly more creative, neither were very creative at all in the absolute.

Effective creative thinking requires adherence to specific guidelines. If done casually, without guidelines, it won’t be effective, regardless of online or in-person.

Donald J. Wheeler’s picture

By: Donald J. Wheeler

Walter Shewhart made a distinction between common causes and assignable causes based on the effects they have upon the process outcomes. While Shewhart’s distinction predated the arrival of chaos theory by 40 years, chaos theory provides a way to understand what Shewhart was talking about.

Assignable causes

W. Edwards Deming described assignable causes as special causes. He then would say that the special causes are “not part of the system.” Thus, he considered a special cause as a temporary cause—fleeting and ephemeral. Shewhart saw things differently. He sometimes wrote of assignable causes as temporary, but at other times he had a different model in mind. For example, Shewhart defined “a state of statistical control” to exist when “the chance fluctuations in a phenomenon are produced by a constant system of a large number of chance causes in which no cause produces a predominating effect.” Here Shewhart clearly implies that when a chance cause begins to have a dominant effect it becomes an assignable cause.

Gleb Tsipursky’s picture

By: Gleb Tsipursky

Elon Musk recently demanded that all Tesla staff return to the office full-time, according to an email sent to executive staff and leaked on social media. Musk said those who don’t want to come to office should “pretend to work somewhere else,” insinuating that those who work from home aren’t actually working.

This authoritarian, top-down approach rooted in mistrust and false assumptions goes against best practices. It speaks to an illusion of control that will undermine employee productivity, engagement, innovation, retention, and recruitment at Tesla.

William A. Levinson’s picture

By: William A. Levinson

Quality-related data collection is useful, but statistics can also deliver misleading and even dysfunctional results when incomplete. This is often the case when information is collected only from surviving people or products, extremely satisfied or dissatisfied customers, or propagators of bad news about relatively rare incidents. This is simply an extension of the basic principle that a sample should reflect the entire population rather than just a portion—especially a portion that might self-select for the indicated reasons.

Survivor bias

Survivor bias occurs when samples include only people or items that survive harmful conditions. When World War I started in 1914, the soldiers of most armies wore cloth or leather caps that provided almost no protection against shrapnel and small arms fire. The French, for example, replaced their world-famous kepi with the equally recognizable Adrian helmet only in 1915. The British followed suit and introduced the Brodie, later called “Tin Kelly,” helmet. Even the famous German spiked helmet was made of leather and not steel, to be replaced by the Stahlhelm a year into the war.

Kate Zabriskie’s picture

By: Kate Zabriskie

‘They’re here, but they’re not here. My staff isn’t committed, and it’s obvious to me and our customers. We’re in trouble.”

“To say that initiative is lacking is an understatement. My staff doesn’t think beyond the basics. If they hit a wall, they stop. The idea of looking for a window never crosses their minds. Frustrating!”

“Maybe it’s them. Maybe it’s me. Our team just goes through the motions. I wish there were a magic formula to get people focused and motivated.”

Although there isn’t an instant solution for increasing enthusiasm, focus, and initiative, there are steps any leader can take to orchestrate success.

Step one: Communicate the direction

It’s hard for people to reach a destination if they don’t know what it is. Whether you call it mission, purpose, or something else, employees need to have a solid understanding of the organization’s why, the team’s why, and their why. Leaders who promote engagement regularly connect day-to-day tasks and expectations with the bigger picture.

Multiple Authors
By: Faustino Gomez, Sepp Hochreiter

With ongoing global shortages of all kinds of goods, from cars to lumber to cooking oil, both consumers and companies are struggling. The Russian invasion of Ukraine, along with renewed Covid outbreaks in China, are two things that are likely to make things worse before they get better.

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