Tag Archive for: Preliminary Hazard Analysis

avoid product recall with functional safety and risk management

While a positive brand reputation takes years to nurture and build, irrevocable damage to a brand — and a business — can happen in only moments.

As innovative companies are asked to move faster than ever to bring products to market, it’s worth taking a moment to step back and look at the cost — financial and otherwise — of a misstep that could lead to product recall or failure. In addition to fines, regulatory reprimands, and decreased market share, a product recall inevitably impacts your brand and can have a major impact on your bottom line.

Brand erosion, for instance, is one consequence of a major product recall. As the name suggests, brand erosion is the gradual destruction or diminution of your organization’s reputation when your products are deemed unsafe, unfit for the marketplace, or simply don’t perform as marketed.

If you’re working in an industry where functional safety is a top priority, like automotive or aerospace, guarding against these types of scenarios means getting crystal clear on the standards and regulations that help protect your product. That also means ensuring proper risk management techniques like Preliminary Hazard Analysis (PHA) and failure modes and effects analysis (FMEA) are being performed correctly.

Often times, penalties come as a result of companies not properly performing these functions, and instead rushing to deliver products that haven’t met benchmarks for quality, compliance, and — in the case of many industries — functional safety. Other times, companies simply fudge the data. Let’s look at a few famous examples:

Ford Motors’ 1980 Failure to Park Product Recall

While product recalls can happen in any industry, some of the most notorious and detrimental have happened to automotive companies. Such was the case for Ford Motors which, in 1980, was determined by the Department of Transportation to have more than 23 million cars and light trucks in circulation that contained a functional safety defect that permitted the vehicle to accidentally slip from park into reverse, although to the driver the placing of the shift lever appeared to be in park.

And while the company would have faced financial ruin if all 23 million automobiles had been recalled, regulatory authorities ruled that instead of recalling all vehicles involved, Ford could make amends by sending out a sticker for drivers to place on their dashboard warning that “unexpected and possibly sudden vehicle movement may occur” if the car was not properly parked.

The failed safety catch was found to have led to 6,000 accidents, 1,700 injuries, and 98 deaths, and Ford was tied up in litigation for years, costing the company tens of millions of dollars. The “failure to park” issues continued even after the sticker warning was issued.

While the cost of this functional safety error included lost revenue and expensive lawsuits, the safety malfunction may have additionally cost Ford the trust of their consumers. Especially in industries that are highly regulated — and thus highly trusted — recalls related to safety and reliability can cause devastating harm to the foundation of the organization.

Learn how how a Fortune 100 semiconductor company is meeting the challenges of developing automotive-related technology by downloading our case study.

Volkswagen’s “Defeat Device” Scandal

 While some product failures and recalls are the result of honest mistakes, such as the example above, others can be attributed to downright dishonesty. Such was the case for Volkswagen in September of 2015, when the company admitted that they had installed software in 550,000 automobiles that could figure out when the cars’ emissions were being tested and modify their performance to meet mandated standards.

Initially, Volkswagen spokespeople claimed that a “few software engineers” were struggling to meet stringent U.S. emissions standards while also producing a diesel engine that would perform well. That, the spokesperson said, was the reason those individuals decided to design a “defeat device,” a system to switch on emissions controls when the cars were being tested and turn them off when the automobile was driving normally. What we now know is that knowledge of this system went much higher, and some believe awareness could have been as high as the CEO, who resigned and was later indicted.

The scandal cost the company over $29 billion dollars in recalled automobiles, but the damages didn’t stop there. After losing the trust of the public, the company posted their first quarterly loss in 15 years, showing that consumers weren’t likely to invest their money in an organization that had deceived them.

A recent study by Edelman shows that consumers are more interested than ever in purchasing from organizations that they believe are “doing the right thing.” The study revealed that 64% of consumers around the world — up 13% from 2017 — now buy on belief, meaning that they will choose, switch, avoid, or outright boycott a brand based on where the organization stands on issues they care about.

The same study showed that consumer trust dropped 10% (from 58% to 48%) in the last year, and that nearly half of consumers don’t trust businesses to “do what is right.” And organizations whose products are recalled due to deceiving functionality are certainly not going to earn a reputation for doing what’s right for their customers.

An additional 8 million cars were sold in the E.U. with the same “defeat device,” but because emissions standards are much lower there than in the U.S., Volkswagen legally committed no crime in the E.U.

NASA’s Costly Math Mistake

On December 11th, 1998, NASA launched a robotic space probe called the Mars Climate Orbiter into space with the hope of studying the Martian climate, atmosphere, and surface changes. Nearly 10 months later, in September 1999, the $125 million probe burst into flames and fell to pieces in outer space. While this was certainly not the first, or last, failed space expedition, what sets this one apart is that the reason for failure comes down to a simple math error.

 The navigation team at the Jet Propulsion Laboratory (JPL) used the metric system of millimeters and meters in its calculations, while the team that designed and built the spacecraft, Lockheed Martin Astronautics in Denver, provided crucial acceleration data in the English system of inches, feet, and pounds.

The result was that the software controlling the orbiter’s thrusters was faulty. The software calculated the force that the thrusters needed to exert in pounds of force, while a second piece of code that read this data assumed it was in the metric unit— newtons per square meter. And while fortunately no lives were lost, this simple mistake pushed the orbiter dangerously close to the planet’s atmosphere, destroying the spaceship and killing the mission.

Despite NASA’s next Mars mission also resulting in a lost spaceship, the organization did bounce back from the ordeal. They recovered over the following years by returning to the basics, rebuilding the Mars program based on conservative strategies and concepts that had already been tried and tested.

In the case of NASA’s space mishap, detriment took the form of missed opportunity and lost ground in their research efforts. Because of the immense time, money, and resources it takes to launch a space mission, failures and missteps can result in years of setback. What was supposed to be the first weather observer in another world became a $125 million mistake.

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How Better Requirements and Risk Management Can Help You Avoid Product Recalls and Failure

Developing complex systems and products requires teams to have the ability to effectively define and track requirements, adhere to safety-critical regulations, collaborate and communicate effectively across teams and functions, and evaluate and mitigate potential risks. Failure to do so may result in product recalls or failure, and in the case of safety-critical products, injury or worse.

According to the CHAOS Reports from The Standish Group, three of the biggest contributors to projects that fail are lack of user input, incomplete requirements and specifications, and changing requirements and specifications.

Unfortunately, too many organizations struggle with requirements and risk management and the effects, some outlined above, can be devastating.

In the case of the Mars Climate Orbiter, the simple miscommunication between JPL and Lockheed Martin not only shows how small mistakes can lead to mission failure, but also highlights the need for teams — especially those in different physical locations — to work collaboratively instead of in silos, and for organizations to invest in solutions that help teams achieve this.

With the Jama Connect Risk Management Center, development teams can participate in risk management techniques including PHA and FMEA in accordance with industry-specific standards like ISO 14971 and IEC 60812. By working with live data, teams can efficiently identify and mitigate risks early in the development process, ensuring quality and safety in complex product development.

To learn more about how Jama helps organizations thrive in critical product markets by reducing risk and providing a single source of truth, download Frost & Sullivan’s recent executive brief,“Safeguarding Regulated Products Amidst Growing Complexity.”