iSixSigma

Design Risk Assessment

Definition of Design Risk Assessment:

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, but may also be adapted based on the design and the team’s needs. 

Overview: What is design risk assessment? 

Design risk assessment is to a DMADV project as FMEA is to a DMAIC project. Cheeky comparison aside, design risk assessment is a risk identification and mitigation planning framework used by practitioners and teams during the design process. 

The key differentiator between design risk assessment and other risk assessment frameworks is that design risk assessment uses a systems-level approach to analyze risk, meaning 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. 

Rather than a specified tool, teams performing a design risk assessment, or assessing the risks associated with their organizations, systems, processes, or product designs, 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. If this design results in stuck accelerators, these are dire consequences. But, suppose the design results in a smaller font on the packaging. 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 (depends on your industry or product).
  4. How likely is it to occur? When I was younger, I was obsessed with volcanic eruptions. As I got older, I discovered that while a volcanic eruption would be a high-impact event, there was an extremely low likelihood of experiencing an eruption in my lifetime. As the team performing the design risk assessment evaluates the impact of the risk, they should also assess the possibility of the risk occurring. Using the packaging example from the previous question, there is a high likelihood that micro-font on the label will result in customers not reading the packaging.
  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 remove, substitute, integrate 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. Teams analyzing risk need to communicate to stakeholders both the hazards identified and suggestions for mitigation every time the team assesses for risk.

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. 

Top 3 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. 

1. 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 provides team members and stakeholders with reassurance that the team has considered the possibilities and would be prepared should a risk arise. 

2.  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 to employees and stakeholders. This systems-wide view shifts from other risk assessment tools by including the people-side of the potential risks or consequences. 

3. 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. 

4. 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 verify phase, project teams gather information about real-world performance. However, before the verification, teams have limited, if any, performance data. Therefore, teams need to 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 very 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 that ultimately resulted in 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-silca 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) 

3 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 to performing robust assessments.

1. Earlier is better  

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

2. Consider the design process in the 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. 

3. 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. 

Frequently Asked Questions (FAQ) about Design Risk Assessment

1. What is the purpose of design risk assessment?  

A design risk assessment is a risk management activity that decreases the uncertainty in the design product or process. Performing a design risk assessment requires the team to consider all aspects of each phase of the design process including the final product, design process, and project environment.

2. When is design risk assessment required? 

Teams should perform design risk assessments when they are working on projects that have a design component. Some projects are not “design projects” where the outcome of the project is a new design, but they may include design aspects, such as creating a new process or updating a product. 

For project planning and progression, the team should formally assess the risks with the design during the analyze phase of the DMADV project. 

3. Is there a design risk assessment template?  

No. You can find case study examples of completed design risk assessments, but unlike other risk assessment tools, design risk assessment is dependent on the system context and needs to be tailored to the specific system being assessed. 

Design risk assessment from “Oh, geez” to “Yes, please” 

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. 

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