Risk management is one of the most important QA activities in the development of safety-critical devices and software. The more complex a product (and its development project) gets, the more difficult it is to identify, keep track of, and reduce or mitigate all risks. Check out this webinar to learn more about: -Analyzing and managing hazards -Risk management in complex mission-critical product development -Risk management best practices, conducting Failure Mode and Effects Analysis documenting and reporting on your risk management lifecycle.

1. Hazard and Risk
Management in Safety-
critical Development
Ben Hörömpöly
16 November 2016

2. 2
Agenda
1. Risk management in a nutshell
2. Risk management lifecycle
3. Risk management process
4. Live demo of codeBeamer ALM

3. 3
Intland Software
Webinar info
o Live demonstration will be followed by
a Q&A session
o Webinar recording will be available at
www.intland.com/webinars-events/
o Please register to our upcoming
webinars
o Using Requirements-based Testing in
Safety-critical Development

4. 4
Intland Software
About us
o Founded in 1998
o Headquarters in Stuttgart,
Germany
o codeBeamer ALM
o Office in Silicon Valley, CA, USA
o Partners: Lufthansa Industry
Solutions
o Resellers: in UK, China, Korea,
Taiwan, France, Italy

5. 5
Our Clients
Medical
Automotive
Aviation &
Defence
High Tech &
Embedded
Other
2016

6. 6
Risk Management
• Identifying
• Understanding
• Controlling
• Preventing
failures that
may result in
hazards
http://vignette1.wikia.nocookie.net/fall
out/images/c/c0/VaultBoyFO3.png/revi
sion/latest/scale-to-width-
down/750?cb=20110809182235

7. 7
Risks – Possible Causes and Software Risk Management
Software Process:
• Identify software items
• Identify causes of contribution
hazards
• Define risk control measures
• Verify risk control measures
• Document Traceability
Possible Causes:
• Known Knowns
• Known Unknowns
• Unknown Unknowns

8. 8
Risk Management Lifecycle
• Realize systematic risk definition,
documentation, and mitigation
• Easier risk effect analysis and impact
assessment
• Better monitoring on risk status,
mitigation, and documentation
• Quick overview on responsibilities of the
actions according to workflows
• Historical queries of each risk item
• Full traceability on risk dependencies and
changes

9. 9
Risk Management Process
Overall risk management process: Risk control measures:
http://www.wipro.com/documents/resource-center/library/Whitepaper_Medical_Devices_Basic_Principles_of_Risk_Management_for_Medical_Device_Design.pdf
http://www.prestonhire.com.au/site/DefaultSite/filesystem/images/safety/hazard-diagram3.png

10. 10
codeBeamer – Live demo

11. Thank you for your attention!
Any questions?
sales@intland.com