New product development engineers are managing risks, daily, with each design decision: unknown risk in creating something new, risk introduced through a failure, human factors risk, and other risks related to products and services. Their design decisions affect downstream activities (from production through disposal) and the bottom-line success of the product in the market. How can engineers manage these risks through the design process?

Proactively managing risks can be an iterative part of product design engineering. Risks can be managed at the early concept phases of development when changes to the design are easier to make. Finding and addressing risks also helps the team to avoid surprises late in development and after the product has been released to the market. The results are not only managing risks but also managing the design process for a more successful product.

Managing risks are from the perspectives of the entire product system (everything the customer would receive and interact with to be able to effectively use the product to achieve their goal) and that the new product development process is a learning process (the team is continuously learning about the product through development and makes decisions based on what they’ve learned).

There are at least five ways to manage risks during new product development.

1. Teams can proactively prioritize risks and address the highest risk items first. A subsystem may carry the highest risk because it has the highest severity, or it has risk events that happen the most often. A component may introduce a lot of risks. If the team analyzes concepts and addresses these risks early, then it makes the project more predictable. A way to assess and prioritize risks is with methods such as tree analyses or FMEA (failure mode and effects analysis).
2. Engineers can test for failure to better understand risks. The team can focus on testing the subsystems that have priority to reduce risk. They can also test to discover which ones are the riskiest. Reliability Engineering tests like HALT (highly accelerated life test) and ALT (accelerated life test), and finite element analysis are all methods that engineers can use to evaluate components.
3. Design with redundancy. Teams may manage risks by considering redundancy of parts or of the design effort itself. Redundancy of parts is a design technique to improve reliability and reduce risk by adding a backup or fail-safe part. Regarding the design effort itself, the team can consider redundancy in their design development efforts to manage risks during development. For example, the team works on design A and design B in parallel. Design A is the team’s target design, but it also has new parts that introduce unknown risks. Design B is the team’s second choice because it is more expensive but has less risk. Using redundant design efforts may help a team meet timeline, performance, safety, and reliability targets.
4. Risk or reliability apportionment is to focus risks on one or two subsystems or components instead of spreading the risk out over all the parts. This increases the chance of achieving a design goal. If the team has a part that is unreliable, the team chooses to use other parts in the design that are more reliable. The team can focus more closely on the unreliable part, learning more about its limitations through testing and development efforts. Reliability block diagrams can help a team make decisions about apportionment.
5. Engineers can manage risks by avoiding them, which can be done in many ways.

• Reverse decisions. The team gives themselves permission to change their mind based on their risk assessments. Risk management planning will help guide the team to analyze risks against acceptance criteria.
• Engineers may communicate the risks they discover to downstream development functions like manufacturing, supplier management, and quality. Together, they can work to avoid or control risks.
• Mistake-Proof. Teams can avoid use-related risks by mistake-proofing, evaluating where things can go wrong during the use of the product and designing purposefully to address it. Engineers can borrow from quality’s poka-yoke principles and process analysis tools to help them do this.
• Reusing components, or using standard parts, is a managed way that teams can avoid risk. By reusing standard parts where it makes sense, they avoid adding unknown risk to the new product development project.

There are many ways that new product development engineers can proactively manage risk within new product development. Engineers can get the best information about risk by working with their cross functional team. Quality and reliability tools and frameworks can help engineers assess and manage their product’s risk, communicate with the cross functional team, and consider their design choices within the context of the larger product system.

Author Bio:

Dianna Deeney is president of Deeney Enterprises, LLC and founder of Quality during Design. She has worked in manufacturing for over 25 years, developing an engineering career from the manufacturing floor to manufacturing process engineering, product design, quality and reliability engineering, and quality management systems. Through her experience, she recognized a gap in understanding between people that design products and the quality techniques and input from quality professionals. She knows that bridging this gap could make a significant, positive difference in the outcome of the design and its design cycle. It can also save on total costs by solving design questions earlier.

Dianna founded Quality during Design with a mission of using the company as a communication tool, to bridge product managers and designers (entry-level to seasoned) to the world’s quality initiatives and quality-minded people. Her vision is a world of products that are easy to use, dependable, and safe – possible by strategically using Quality during Design for products others love, for less. Visit her at www.QualityDuringDesign.com.