For more check out this thread:
http://elsmar.com/Forums/showthread.php?t=21190
The core idea behond Risk Analysis & Management is:
At each stage of product development (from concept to post-market) you must say "what are the risks", "are there any dangers", "what can go wrong", and "how can someone make a mistake.
If you find a potentional hazard you must say, in the following order, "can we reduce this by changing the design (round instead of sharp edges)", "can we reduce this by some protective measure in the device or manufacture of the device (like an alarm in the device)", and "can we reduce this with information (warning label or good instructions for use)"
Finally, you must document when you asked yourself these questions, what the answers were .
There are many ways you can do this but the way you document should be suited to your organization's needs and resources.