If you’re managing risk in Excel but your requirements are in a separate tool, you are creating a gap that has significant time costs to manage and increases the possibility of errors. - How hard is it to keep your risk register updated as requirements change? - Do you know the current status of your mitigating actions? - Can you assign actions, see who is responsible for each action, and see if they are making progress? - And, most importantly, can you relate all this information back to your requirements? Review this webinar presentation to learn more about closing the gap between risk and requirements. Using an FMEA as an example, Gordon Alexander, Seapine Software solutions consultant, explains how an integrated risk and requirements management solution can save you time and help you systematically and continuously manage risks and requirements.

1. Closing the Gap Between
Risk and Requirements

2. I work with customers to help them get the most out of
TestTrack
Who Am I?
Gordon Alexander
Seapine Solutions Consultant

3. Using Excel or a separate tool to manage your risks
creates a Gap which you must control through
procedures
It is Time Consuming
It increases the chance of Human Error
Gap between Requirements
and Risks

4. Automate Traceability
Control your process Status, Ownership, Sign off
Keep risks register up to date as requirements
Change
Report a single End to End version of the truth
Close the Gap

5. Everyone does risk slightly
differently

6. FMEA

7. ISO 14971

8. An illustration using FMEA

9. Integrated Risks and Actions in your document
Add risk records
Add mitigating actions
Status and signoff for requirements, risks, actions
Other Integrated views
End to end trace matrix
List views of risks or actions
Change - Impact analysis and suspect flagging
Requirements, Risks and
Actions

10. Demo

11. Q&A

12. Gordon Alexander
alexanderg@seapine.com