*Identify the Potential Gaps in your Product Development Process*
| General Questions About Your Company |
| How does your company approach risk? |
| What is the risk culture? [This will cause you to ask important questions] |
| Is your organization siloed? If so:a. How is each group’s risk management process integrated into your overall corporate process?b. What challenges have you experienced with this arrangement? |
| Your Risk Management Program |
| What are its strengths? |
| What could be improved? |
| What do you want to gain by improving your risk management program? |
| Is your risk process manual? a. If so, how effective is it?Note: Only a 100% effective manual risk process can be automated. |
| Which risk items does your periodic management review include? |
| Audits |
| Which audit findings have been related to risk? |
| a. Have there been any repeating CAPAs? |
| Risk Management Mechanics |
| Do you use one or both of these risk analysis approaches? a. FMEA (bottom up – product-centric)b. FTA (top down – process-centric) |
| If you use the FMEA approach, how do you calculate P1, P2 and P risk values? a. As a group – Determine all risk factors at one time.b. Separately – Then bring them together. |
| Risk Mitigations |
| How do you capture mitigations? a. Combined in one document (such as a PRD)b. Split among multiple documents (such as a PRD and UIRD) |
| How do you verify risk mitigation? |
| a. How do you calculate residual risk? |
*If you are challenged by any of these Questions, maybe it’s time for a Free Review with a Process Expert. Contact us today.
