How to Ensure Long-Term Success with Risk-Based Product Design

Risk-based product design spans the entire life cycle of a product and has the potential to more broadly anticipate and mitigate a product’s impact on manufacturers, end-users, and the general public.

April 6, 2015

6 Min Read
How to Ensure Long-Term Success with Risk-Based Product Design

When it comes to ensuring product safety, many manufacturers design to comply with regulations and industry standards. When necessary, they also use independent third-party testing. This standards-based approach can ensure acceptance from regulators, wholesalers, distributors, retailers and consumers; however, it does not do a complete job of mitigating overall risk.

Risk-based product design spans the entire life cycle of a product and has the potential to more broadly anticipate and mitigate a product's impact on manufacturers, end-users, and the general public. Risk-based design considers not only composition and intended use, but materials, how a product will actually be used, and environmental issues related to its use and ultimate discarding.

Limitations of Standards-Based Design

There are several limitations to standards-based product safety assessments. The development of standards and regulations inevitably lags behind the advancement of technology. The process is lengthy and often based on technologies when the standards are created. As technology continues to rapidly evolve, standards are simply not able to keep up, let alone anticipate the future.

Even when standards covering a product's design elements exist, compliance with multiple standards does not guarantee zero risk with the product. Many times products are used outside their intended function, posing risks. At other times, risks that weren't originally considered emerge, as a product is more widely used.

Take, for example, the hair dryer. While clearly never intended to be immersed in water, the very setting in which they are commonly used - the bathroom - presents multiple water sources: sinks, bathtubs, showers, and toilets. From 1984-1990, there were 91 reports of death by electrocution related to hair dryers coming into contact with water. After implementing a voluntary 1991 standard to include an immersion detection circuit interrupter in the design of hair dryers, electrocution risk greatly declined.

A standards-based approach can also impede innovation. Instead of spending resources developing breakthrough approaches that might lead to inherently safer products, time goes toward pursuing less innovative, more compliant designs.

Recognizing Risks

By testing to standards only, manufacturers may miss some of the fundamental long-term risks to a product and ultimately, their business, such as:

  • Inherent Safety - Issues related to inherent safety are usually a result of inadequate design or using dangerous or inappropriate materials. These risks typically generate the greatest attention and often result in increased regulations and standards.

  • Product Functionality - It is difficult to anticipate all of the possible scenarios in which a product may be used, so addressing potential safety can be challenging. The hair dryer is a good example. Another is a popular infant seat intended to be used on the floor. Some parents perched the seat at higher levels such as on counters or couches. This resulted in falls and injuries and, in turn, a recall and redesign of the seat to include a buckle. As in both cases, repeated, well-publicized incidents were needed to prompt manufacturers to consider such risks.

  • Liability Issues - Manufacturers are exposed to liability risks from regulators, which can range from mandated product recalls to monetary fines and forfeitures. The magnitude of this risk can become greater when private litigation - civil lawsuits or class actions - come into play.

  • Financial Implications - As a result of liability issues, financial risks can be significant. In addition to fines, recalls, and litigation, manufacturers face financial risks in the form of direct expenses for recalls, redesigns, or safe disposal of dangerous items. Automakers, for example, have lost billions of dollars encountering recalls with pedal mechanisms or, more recently, ignition switches. Another financial risk is loss of future sales of a product or an entire line or brand, due to stigma from safety issues.

  • Impact on Reputation - As mentioned above, stigma from a recall or failure can impact reputation. Failure to act swiftly and with transparency can result in consumers electing to stop using a product and/or change allegiance to a competitor. In the best of cases, a brand can re-emerge, though it may take time to repair a reputation. In the worst scenarios, financial hits and tarnished images can lead to bankruptcy, liquidation, or technological irrelevance.

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Adopting a Risk-Based Strategy

A risk-based approach starts with the premise that a product poses a wide range of risks, as outlined above. Adopting a risk-based approach can be complex and requires risk analysis teams that understand the principles and procedures of the approach. Development schedules must allow risk analysis to be performed early in the design process, offering the opportunity to make modifications. Ultimately, the process can save manufacturers from higher costs, disrupted sales, regulatory scrutiny, and damage to brands.

Risk-based strategies should include the following:

  • Foreseeable Use Assessment - As seen in the discussion of risks, it's important to consider how a product might be used in real-world conditions, in addition to its intended use. First, identify as many potential uses associated with the product concept as possible, then evaluate them against data such as injury/fatality statistics, human factor assessments, and critical parts research. This can help predict a wider range of possible risks associated with how a product may be used in the real world.

  • Design Hazard Analysis - A design hazard analysis should follow the foreseeable use assessment, typically at the design specification stage. This analysis can uncover potential risks introduced by choices made during the design process, i.e., sharp edges or corners posing the risk for injury. After assessing a product's foreseeable use and design hazards, potential risks can be addressed through design modifications early on, when such changes are less costly, easier to implement, and will have a softer impact on production schedules.

  • Physical Hazard Assessment - Could a product inadvertently result in suffocation, strangulations, unintended impact or burns? For some products, a physical hazard assessment will identify potential interactions between a product and end-users to determine if such issues are factors in a product's design.

  • Product Testing and Certification - Compliance testing to international product safety standards is still necessary in a risk-based strategy. Certification through a Nationally Recognized Testing Laboratory (NRTL) illustrates to regulators, retailers, and consumers that a product meets safety standards and requirements.

  • Risk Assessment Screening - A comprehensive screening can identify and evaluate risks in both new and existing products by considering all possible angles. This can not only weed out potentially unsafe products, it illustrates due diligence in ensuring the safety of all products.

Providing Peace of Mind

Risk-based strategies are gaining broader acceptance and provide manufacturers with greater assurance about the overall safety of their products. Minimizing risks can reduce costs and exposure, mitigate hits to a brand's reputation, and provide confidence to all stakeholders, from manufacturers to consumers, in a product's safety and performance.

Michael Brousseau is the Operations Manager at Intertek's Boxborough, MA laboratory. In nearly 20 years with Intertek, he has worked with electrical manufacturers across a wide range of industries - including medical, IT, industrial, lighting, and more - to meet regulatory, industry, and market requirements around the world.

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