Hi traceymraw,
In the past for projects at work, I’ve used brainstorming and the Fishbone Diagram for identifying and organizing potential risks in projects. I find the Fishbone Diagram most beneficial because it helps visually break down the root causes of issues into clear categories. When we were running into some issues on an ice plant project this diagram was making it easier to address the actual issue itself. Brainstorming is great for generating ideas in the early stages, but the Fishbone Diagram organizes those ideas into actionable insights. It is especially useful when working in teams.

I have used FMEA and Fish Bone Diagrams in past projects to identify and analyze potential risks systematically. FMEA is my preferred tool because it provides a structured approach to prioritize risks based on severity, occurrence, and detectability, making it highly effective for complex systems. Fish Bone Diagrams are also useful for brainstorming and identifying root causes of issues but are less detailed compared to FMEA. I find FMEA particularly beneficial for documenting risk management decisions in compliance with regulatory standards like ISO 14971. While brainstorming is great for generating ideas, I prefer tools that offer more actionable insights and clear prioritization.

I have used FMEA before in my role as Mission Assurance Specialist for a NASA Workforce Development Program. I find it very helpful when doing risk assessments because it has all the necessary information you need to effectively evaluate the potential for certain risks to occur. It also includes the effects of potential risks and how the risks can be mitigated or prevented. I have not used a Fishbone Diagram, but I would be interested in using one.

In past projects, I’ve used brainstorming and the Failure Mode and Effects Analysis (FMEA) method the most. Brainstorming is great for quickly generating ideas and identifying possible risks from different perspectives, but I find FMEA to be the most beneficial overall. It helps break down each potential failure, analyze its cause and effect, and prioritize which risks need immediate attention. I like how structured and data-driven FMEA is; it provides a clear roadmap for prevention and continuous improvement instead of relying only on opinions or guesswork.

In past projects, I’ve primarily used Failure Mode and Effects Analysis (FMEA) because it provides a structured and quantitative way to assess potential risks. By breaking down each step of a process or component function, FMEA helps identify possible failure modes, their causes, and the severity of their effects. This method is especially valuable in biomedical device development, where compliance and traceability are crucial.

That said, I also find brainstorming to be an excellent first step in risk identification. It encourages open discussion among team members from different disciplines and helps uncover risks that might not surface through structured tools alone. However, once the ideas are gathered, FMEA becomes the preferred tool because it translates those insights into measurable data and clear prioritization for mitigation.

Overall, combining brainstorming for creativity and FMEA for structured analysis creates a balanced and effective risk management approach.