Documenting Software Safety Classifications

[cwilburn]

My company provides software engineering services to medical device manufacturers, and we have documented/tracked software safety classifications of software systems and items in different ways. I was wondering how others do it and what you think is best.

Most of the time, we include the software systems and a break down into software items, each with their classifications, in the software architecture document. But for some clients, we have had a separate form that lists each software system and item with its corresponding classification. We also have a column in our traceability matrix for the software item and its classification.

Where do you document the software safety classifications of your software systems and items?

Thanks!
Cathy

 

[yodon]

I generally prefer to put it in the Software Development Plan since that frames up what has to be done. I don't think there's a specific, "right" answer, though.

 

[mihzago]

concur with Yodon.

Software development plan is a good place for the safety classification, which is where I typically put it, but as long as you have the classification somewhere, and it's properly referenced, and included in your Technical File (or DHF), then you should be good.

 

[cwilburn]

Would either of you that responded post a scrubbed version of an SDP showing how you do it?

 

[glork98]

Would either of you that responded post a scrubbed version of an SDP showing how you do it?

I'll tell you how I do it.

First off, there are reference documents (A) on the product and/or software architecture(s) that allow specific software systems to be identified.

Then there are hazard analyses (B) of the product and software system(s) that provide a basis for the classification(s).

Then in the SDP a section says "Software System X, as defined in document A, is classification Y based on document B per SOP 123."

Then the fun really gets going as the SDP describes how the quality practices for X will be performed for Y per SOP 123. Might be multiple of each X, A, Y, B and 123, to be sure.