Quality Questionnaire – Find The Gaps in Your Product Development Process

*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.

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.