One fine morning in 1909, Henry Ford made a surprise announcement during a company meeting. In the future, Ford Motor would stick to a single car model, the Model T, in black only. No other choices, or as he said, “Any customer can have a car painted any color that he wants so long as it is black…

CEOs are stepping forward to confront public policy issues that often extend beyond their core business, in part at the urging of their employees, write Caroline Kaeb and David Scheffer in this opinion piece. Kaeb is co-chair of the Business and Human Rights Pillar and a senior fellow of the…

‘Any customer can have a car painted any color that he wants,” said Henry Ford in 1909, “so long as it’s black.” Ford’s strategy of standardization and efficiency made a runaway success of the Model T car and built Ford Motor Co. into one of the world’s biggest automakers. But 110 years on,…

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…

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…

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…

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…

Someone recently asked me why quality failures and safety incidents continue to occur despite organizations communicating their quality and safety visions to the workforce, developing and implementing quality and safety management systems, and campaigning day in and day out about quality and safety…

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…

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. According to the report from Kaiser Health News, “Since 2016, at least 1.1 million incidents have flowed into the…

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…

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. Although the retail giant did not say which jobs, if any, might be lost as a result, the announcement—and the many more…

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…

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…

In an outbreak that has now run for more than 28 months, at least 279 people across 41 states have fallen ill with multidrug-resistant Salmonella infections linked to raw turkey products. Federal investigators are still trying to determine the cause. In response to food company recalls, more than …

Boeing has been rife with issues lately. While the recent Ethiopian Airlines crash has dominated headlines and elicited an FBI investigation into the company, another federal body has stated it will be keeping a closer eye on Boeing’s safety shortfalls. Boeing is now in hot water with the U.S. Air…

It’s human nature to resist change, and the life sciences industry is not exempt from a change-averse mindset. The proof: Life science organizations (LSOs) lag far behind counterparts in other sectors in implementing digital technologies that are designed to streamline business and manufacturing…

History indicates that major technological changes can take about half a century to go from the first lab drawings to society. Alan Turing first proposed the Turing machine, laying the foundations of computation, in 1936; the first general-purpose “Turing-complete” system was built in 1945, and “…

Your own voice will likely become the most significant focus for food retailers and restaurants in the immediate future. Voice searches are increasingly becoming the norm. A recent study suggests that more than 50 percent of all online searches will be voice-activated by 2020. To a lesser extent,…

According to the International Labor Organization, around the world every day 7,600 people die from work-related accidents or diseases—that’s more than 2.78 million people every year. To address the issue, the International Organization for Standardization (ISO) has developed a standard, ISO 45001…

In the wake of the Lion Air and Ethiopian Airlines crashes of Boeing 737 Max planes, people are thinking about how much of their air travel is handled by software and automated systems—as opposed to the friendly pilots sitting in the cockpit. Older commercial airliners, such as the Beechcraft 1900…

With medical cannabis being legal in Canada since 2002, and recreational use becoming legal in 2018, Prime Minister Justin Trudeau’s promise to his country has caused a storm. This legal framework has given Canadian companies the leverage to lead the cannabis industry to new heights. Not only…

In a crisis, time is not on your side. A crisis creates a vacuum, an informational void that gets filled one way or another. The longer a company or other organization at the center of the crisis waits to communicate, the more likely that void will be filled by critics. That’s exactly what’s…

Given the number of meetings most organizations have, you’d think everyone couldn’t help but be on the same page. Sort of a natural, automatic byproduct of spending so much time together. Nice idea, but not really true. In fact, organizing is one of the most difficult things for an organization to…

Outsourcing is historically one of the most misunderstood concepts in quality management system (QMS) implementation and operation. Prior to ISO 9001:2015, the requirement for outsourced processes was limited to a few sentences in the standard’s clause 4.1. This article will present, through a case…