*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?
|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.
|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.