Key Points

• Design risk assessment is similar to traditional risk assessments.
• What makes design risk assessment stick out is the ability to allow design teams to conduct their own risk assessment.
• Design risk assessment is an integral part of DMADV.

Is your team developing a new process or product? If so, you will want to perform a design assessment. Similar to traditional risk assessments, design risk assessments prepare design teams to identify and manage risk throughout and upon completion of the design project. Design risk assessment provides a design team with a framework to perform risk assessment. 

Design risk assessment can be performed using the DFMEA tool. It may also be adapted based on the design and the team’s needs. 

What Is Design Risk Assessment?

Design risk assessment is to a DMADV project as FMEA is to a DMAIC project. Design risk assessment is a risk identification and mitigation planning framework used during the design process. 

The key differentiator between design risk assessment and other risk assessment frameworks is the systems-level approach to analyzing risk. The team evaluates all risks associated with the design process and not solely the project outcomes or outputs. 

Much like the FMEA tool, design risk assessment requires a systematic assessment of the process and products. However, design risk assessment is done with a holistic view of the organization. 

In simpler terms, design risk assessment asks the design team to evaluate process or product and system-wide risk before an incident occurs. However, design risk assessment should not be confused with DFMEA. DFMEA is a tool used for tracking failure modes and risks associated with specific processes or products. 

Questions to Ask

Rather than a specified tool, teams performing a design risk assessment should answer the following questions: 

1. What could go wrong? Another way to word this question is, “What are the risks?” Brainstorming what could go wrong is the starting place for performing a design risk assessment.
2. Who is affected? Design risk assessment is sometimes referred to as a health and safety assessment because of the focus on assessing the risk associated with the entire organization. One consideration that makes design risk assessment more comprehensive than an FMEA or DFMEA is assessing individuals impacted by the risk should the risk happen, which of course, we do not wish to happen.
3. How serious are the consequences? This question paves the road for the risk/benefits conversations. In that case, the significant risk is that the intended readers do not review the packaging before use, which may or may not be a significant risk (depending on your industry or product).
4. How likely is it to occur? As the team performing the design risk assessment evaluates the impact of the risk, they should also assess the possibility of the risk occurring.
5. What can we do about it? Another way to word this question is, “How can we mitigate this risk?” During this part of the assessment, the team needs to focus on actionable recommendations such as removing, substituting, integrating poka-yoke, etc. 
6. Who do we need to notify of the risk? One of the frequent breakdowns in any risk assessment or management activity is communicating to the stakeholders.

The answers to these questions need to be documented and tracked with the design and project documentation for the team to reference as they progress through the design phases. 

Why Aim for Design?

Traditional risk assessments aren’t going to consider the design or implementation of your production line. This is where design risk assessments shine. Since the design team can implement them, that means you’ve got less bouncing between teams to address issues as they arise.

Benefits of Design Risk Assessment

While not generally considered a DMADV tool, risk assessment is a valuable addition to the design process because identifying risk decreases uncertainty (which is a key factor in effective change management) and increases the chances that the design will meet the objectives. 

Alleviates Uncertainty and Discomfort

Risk assessment is a loose term that encompasses risk identification, assessment, and mitigation. At the core of risk assessment is fear of the unknown or a sense of dread that comes from uncertainty. Any risk assessment activity is to identify possible risks and ways to prevent or minimize those risks before they happen. Design projects have higher levels of uncertainty because of the lack of precedent for the process or product. 

Design risk assessment takes risk assessment a step further by performing a holistic analysis. Performing risk assessments during any project decreases discomfort by exploring the unknown before the opportunity for the risk emerges; however, given the higher levels of uncertainty associated with design projects, investing in exploring potential risks is a valuable use of team time. The exploration and analysis of potential risks provide team members and stakeholders with reassurance that the team has considered the possibilities and would be prepared should a risk arise. 

Challenges Us to Consider Health and Safety Risks

Design risk assessment is sometimes referred to as a “health and safety assessment” because of the system-wide focus. In addition to evaluating the risk to the process or product being designed, design risk assessment requires teams to assess the risk within the organization or system, including the impacts on employees and stakeholders. This systems-wide view shifts from other risk assessment tools by including the people side of the potential risks or consequences. 

Connects Risks With Stakeholder Needs

Often when teams work on a project, they focus on the process or product and overlook the people aspects of the design work. Design risk assessment specifically addresses who is affected by the risk and explores the risks inherent in the design process itself. 

Is Flexible

Unlike other risk assessment or analysis tools, design risk assessment is dependent on the design and system. Similar to how no two designs or projects are the same, no two design risk assessments are the same. 

Teams should use the above questions to brainstorm and challenge themselves to consider answering additional questions to prepare the team and organization for uncertainty. 

Why Is Design Risk Assessment Essential to Understand?

Assessing for risk is vital for any project in any organization, but it’s especially important in a design project where the project team’s objective is to create something new based on a vision. Design work has inherent risks because the team is developing something new or unique; thus, there is limited (or no) past data from which to develop conclusions or projections. 

Uncertainty Can Undermine Progress

Without a robust design risk assessment, project teams may be derailed by over-engineering solutions to minimize risk. Instead, if the team commits to revisiting the risk assessment, the designers can focus on meeting customer objectives rather than mitigating adverse outcomes. 

Design Teams Have Limited Data To Work With

In the DMADV process, during the verification phase, project teams gather information about real-world performance. However, before the verification, teams have limited, if any, performance data. Therefore, teams must invest in robust risk assessment to identify and mitigate as many risks as possible before prototyping and verifying that the product or process meets the customer’s needs and requirements.  

An Industry Example of Design Risk Assessment

Design risk assessment is prevalent in the construction industry because construction projects start as design projects that move into construction projects, and unanticipated risks may have significant impacts. 

In 2019, Denver International Airport experienced significant delays, ultimately terminating a contract over concrete. Specifically, the existing concrete in the Great Hall of the terminal did not have the compression strength needed to complete the remodeled design. Had the design team performed an in-depth design risk assessment, the team may have identified alkali-silica reaction as a risk (due to deterioration) to using the existing concrete. 

Examples of risks commonly identified during design risk assessment for construction projects include: 

• Environmental concerns (e.g., Denver International Airport)
• Clients are not participating at the appropriate level (too little or too much)
• Design changes during construction
• Lack of stakeholder coordination
• Lack of specificity in the risk assessment (note here, a risk is the risk assessment itself) 

Best Practices When Thinking About Design Risk Assessment

The best way to perform and facilitate a design risk assessment is by performing and updating the risk assessment to the project tasks, similar to how you would include a communication plan or timeline review. Regular review ensures that the team invests sufficient time and energy into developing a robust assessment. 

Understanding that, here are three tips for performing robust assessments.

Earlier Is Better

Design risk assessment is best when performed iteratively. Therefore, teams should start early and often revisit as the design process progresses. 

Consider the Design Process in Assessment

When facilitating the team to perform a design risk assessment, prompt the team to analyze the risks to the design process itself, such as resource constraints. 

Be Flexible

Much like performing a root cause analysis, design teams need to allow themselves to be open-minded and explore the “what if” scenarios to perform a robust design risk assessment. 

Other Useful Tools and Concepts

Looking for other tools? Learning how to properly implement corrective actions in your problem-solving can see stopgap fixes turn into long-term solutions. These take a proactive means of problem-solving intended to readily fix issues as they arise.

Additionally, you might need to look into multi-generational product planning. This is an approach intended to get a minimum viable product out while focusing on future generations and new products. This approach is flexible and allows you to pivot toward shifting customer demands as needed.

Conclusion

Including risk analysis in the design process is vital to DMADV or design projects because risk assessment decreases uncertainty. Performing a design risk assessment assures stakeholders that all scenarios have been considered and mitigated. Facilitators leading these projects should approach design risk assessment as an iterative activity throughout the project lifecycle to optimize the value of the activity.