Risk assessment is an essential step in product development that often goes unnoticed and is often skipped by the product development team.

Product development refers to the process of designing and creating new products, systems, or devices that are efficient, effective, and fit for a specific purpose. 

There are many documented processes for product development, each company seems to want to put their own spin on it.  That being said, product development processes usually have steps like those listed below:

  1. Project Planning
  2. Concept Generation
  3. Patent Search/Review
  4. Design Development
  5. Design Analysis
  6. Overall Layout
  7. Prototyping
  8. Testing and Refinement
  9. Risk Assessment
  10. Drawing Package
  11. Patent Preparation

In my experience, step number 9: risk assessment, is the most overlooked of all steps in this process. Likely, this is because the product engineers are excited to have a working product and the businesses funding the product are excited to take it to market. Yet, effective risk assessment is vital to ensure the overall effectiveness, safety, and reliability of the product.

As a result, it is essential to understand how this process works and why it should never go unnoticed.


Risk Assessment in Product Development

Risk assessment is the process of identifying potential risks or hazards associated with the product during its development.

It enables the product development team to identify any risk before the product is launched, and avoid consequences that could lead to serious safety issues for consumers.

Additionally, a thorough risk assessment also helps in complying with safety regulations set by various governing bodies. Safety standards like ANSI B.11 (a series of standards by the American National Institute regarding the safety of machinery) provide guidelines for hazard identification, risk analysis, and control measures that manufacturers are required to adhere to. 

By performing a risk assessment in accordance with these standards, manufacturers can ensure that their products meet regulatory requirements and avoid potential legal liabilities.

Therefore, risk assessment in product development can prevent issues that could lead to costly recalls or lawsuits, thus harming the manufacturer’s reputation.

The Benefits of Risk Assessment

There are many benefits in conducting proper risk assessments in product development. Here are some of the most relevant in detail.

Increased Safety

Assessing potential risks allows the product development team to identify the critical components of the product and understand how they would respond to various conditions, such as temperature, pressure, or stress while in operation.

This understanding helps in designing a safer, more reliable product that can prevent accidents or significant failures.

Cost and Time Savings

Risk assessment can save a lot of money and time in the long run. Identifying and mitigating risks early in the product development process can prevent costly production delays and recalls.

Perhaps the most evident example of how costly product recalls can be is found in the automotive industry. According to the National Highway Traffic Safety Administration (NHTSA), “In 2022, there were 932 vehicle safety recalls affecting more than 30.8 million vehicles in the United States.”

However, this is not the only industry affected. According to a report provided by Sedwick to PR Newswire, “more than 1 billion units of food, drugs, medical devices, automobiles, and consumer products were recalled in the US” in 2022.

While the number of units might not say much about the cost, if we take the specific example of the Takata Airbags in 2008 that resulted in tens of millions of cars being recalled, we find out that the company was fined $1 billion by the Justice Department, $975 million of which was for restitution to automakers and consumers, according to Yahoo Finance. Clearly a high financial loss, not to mention the reputation loss that combined resulted in the company going bankrupt.

Of course, it is very likely that, at least some of these losses, could have been avoided if proper risk assessment was conducted before the product went into production.

Improved Product Quality

Another benefit of risk assessment is that it helps project engineers and managers create a better product. 

By identifying potential risks, you can design a product that is more robust, durable, and efficient, and thus increase brand loyalty and brand value. 

Risk assessment can also improve the product’s usability by identifying potential user-related risks and addressing them in the design phase. A product that has gone through a thorough risk assessment is more likely to satisfy consumers and gain a competitive edge in the market.

Competitive Advantage

Companies that incorporate risk assessments into their product development process can differentiate themselves from competitors by providing safer and higher quality products. This can lead to increased market share and improved brand reputation, an invaluable intangible asset.

Legal Compliance

Risk assessment is necessary to comply with regulatory standards. In the mechanical engineering field, there are several regulations and standards that products must adhere to apart from the ANSI B.11, such as OSHA, ANSI, ASTM and ISO.

Proper risk assessment can ensure that a product complies with these standards, preventing any legal issues or fines.

Future-Proofing Production

Risk assessments can also help manufacturers identify potential risks and opportunities for improvement in future product iterations.

This can lead to ongoing product development and improvement, keeping companies at the cutting edge of their industry.


The Importance of Risk Assessment in Mechanical Engineering

Risk assessment is especially important in the product design process for Mechanical Engineers. This is because mechanical engineers are responsible for creating and developing complex machines and devices that must perform optimally under different conditions, including harsh environments.

Moreover, mechanical engineering products can pose various types of risks, such as mechanical failure, electrical malfunction, fire, explosion, chemical exposure, radiation, noise, vibration, thermal stress, and environmental impact.

Therefore, identifying potential risks during the development phase in mechanical engineering is crucial.

But risk assessment is not only about the physical hazards. It is also about business risks.

According to a study performed by Gitnux, 70% of projects fail in the product development stage, and only 20% of new products survive longer than 2 years after being launched.

It may not be clearly stated by the report, but it is very likely that those numbers could improve with properly conducted risk assessments.

Tools Used to Conduct Risk Assessment

To ensure a comprehensive risk assessment, mechanical engineers can make use of these powerful tools:

  1. Failure Modes and Effects Analysis (FMEA)
  2. Finite Element Analysis (FEA)
  3. Fault Tree Analysis (FTA)
  4. Hazard and Operability Analysis (HAZOP)
  5. Probabilistic Risk Assessment (PRA)
  6. Risk Matrix

1. Failure Modes and Effects Analysis (FMEA)

This method involves an in-depth analysis of potential failures and the effects they could have on the product, with the aim of identifying their causes and devising measures to prevent or mitigate them. FMEA also helps engineers prioritize the risks according to their severity and likelihood, allowing them to allocate resources and address the most critical issues first.

FMEA can also be applied during the design development and design analysis. Here, a ‘D’ is added to the acronym to represent the Design Failure Mode and Effects Analysis (DFMEA).

DFMEA focuses on the impact of product design on performance, safety, and overall reliability. This allows for potential design flaws to be identified and corrected prior to release, reducing the overall risk for end-users. It also helps engineers identify potential design flaws that could contribute to increased manufacturing costs, thus providing the cost-saving benefit mentioned above.

2. Finite Element Analysis (FEA)

Finite Element Analysis (FEA) is a cutting-edge simulation technique used in product development to conduct risk assessments with utmost precision. This essential tool empowers engineers to analyze the structural behavior of a product under various loading conditions and assess potential failure points before releasing it into the market.

FEA is based on numerical analysis and works by dividing a complex product into small, simpler elements, where the behavior of each element is calculated based on its material properties, geometrical shape, and applied loads. By simulating the product’s response to a wide range of operating conditions, FEA provides engineers with valuable insights that enable them to optimize product design and improve product performance. 

FEA has numerous advantages over traditional testing methods and has proven to be an indispensable tool in conducting risk assessments within the product development process. By using FEA, engineers can identify potential design issues early in the development process and prevent costly recalls and safety risks down the line.

Additionally, FEA allows for a reduction in material costs, improved functionality, and shorter development times, resulting in greater efficiencies and cost savings. This is why it is a key part of our product development services as well as our design analysis services.

3. Fault Tree Analysis (FTA)

FTA is a systematic approach that helps identify potential system-level failures and their root causes. This method uses a tree-like diagram to represent complex systems, allowing engineers to analyze the impact of failure events and determine the critical factors that lead to them.

In other words, engineers use the Fault Tree Analysis to decompose a complex system into its parts in such a way that the causes and effects of an undesired event are clear and transparent. It usually starts from an undesired or accident scenario and then systematically adds potential faults that could be the cause of the undesired event.

In the product development process, this tool can be applied when undesired events occur while testing the prototype of the product.

4. Hazard and Operability Analysis (HAZOP)

This technique is used to identify potential hazards and operability problems in a new or existing process. It consists of a team of engineers reviewing each step of the process and brainstorming potential hazards and ways to mitigate the risk.

In general, this technique helps to identify potential system malfunctions, human errors, and environmental risks. As with the previous analysis, this one can be useful at the prototype testing stage of product development

5. Probabilistic Risk Assessment (PRA)

This is a quantitative analysis technique that predicts the likelihood of incidents occurring during product development.

This tool is particularly useful in complex systems, where identifying potential failures and assessing their probability would be otherwise challenging. PRA helps engineers calculate the risks involved, allowing them to develop effective safety measures and risk mitigation strategies.

6. Risk Matrix

A risk matrix is a tool that helps engineers measure the risk associated with each identified hazard, which is why is generally used as a complement to any of the other tools mentioned, especially de DFMEA. 

It involves assigning a likelihood and severity rating to each hazard, which helps in prioritizing the risks and guiding risk management decisions.


Why Risk Assessment is Often Overlooked in Product Development?

Perhaps the main reason is because of its perceived time-consuming nature. This makes the process seem to take away from the primary focus of product development–achieving a minimum viable product (MVP) as quickly as possible, and then taking it to market. However, it is clear that it actually achieves the opposite. 

Also, companies may not have a dedicated team with the necessary expertise to conduct thorough risk assessments. This is particularly true for smaller companies with limited budgets, where product development is often handled by a handful of individuals with overlapping responsibilities.

According to a survey performed by Deloitte in 2019 regarding risk management, “companies tend to realize benefits from external risk advisers”. So, here is where relying on a team of experts such as the one we have at Alpine Engineering and Design pays off.


Risk Assessment – The Alpine Engineering Way

Clearly, risk assessment is a crucial step in product development that project engineers and managers should never overlook.

Not including this step in the product development process means you are jeopardizing the effectiveness, safety, and reliability of your product, the satisfaction and the safety of the consumer, as well as the reputation of your company.

Therefore, at Alpine Engineering, we offer you a team of certified safety professionals that always follow the process outlined in ANSI B.11, and other standards and regulations relevant to your project.

Put your product development and risk assessment processes in the hands of real experts. Call us now at (801)763-8484 to learn more about these and other expert services we offer.