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Risk Reduction by Risk Control: IEC:62304-Class C

cwilburn

Starting to get Involved
#11
What you state in your post is what is indicated in Section 6.2.2.6 "Process as a risk control measure" of IEC/TR 80002-1. Do you know anyone who has successfully done this and what did they use to show effectiveness?

I find it interesting that the standard suggests providing "evidence that there are no or very infrequent software failures." Most software people know that just because defects aren't found doesn't mean they aren't there and that it is good to find defects because they are always there!

Perhaps the number of defects remaining when the software is released could be used as finding/fixing defects is part of a rigorous software development process. It might also be good if you could show that the number of defects introduced decreases once you are finished adding new features, which is what you hope happens as you stabilize your software.
 

cwilburn

Starting to get Involved
#12
What you state in your post is what is indicated in Section 6.2.2.6 "Process as a risk control measure" of IEC/TR 80002-1. Do you know anyone who has successfully done this and what did they use to show effectiveness?

I find it interesting that the standard suggests providing "evidence that there are no or very infrequent software failures." Most software people know that just because defects aren't found doesn't mean they aren't there and that it is good to find defects because they are always there!

Perhaps the number of defects remaining when the software is released could be used as finding/fixing defects is part of a rigorous software development process. It might also be good if you could show that the number of defects introduced decreases once you are finished adding new features, which is what you hope happens as you stabilize your software.
It's been 2 years since I asked if anyone has successfully used process as a risk control measure. Anyone?
 
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