What is a Processor and Software in Context of Reliability Analysis?

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How is a "processor" defined when considering requirements on developing a  
design?  A project I am on is shoving software into HDL to design an FPGA w
hich is being considered "hardware".  I'm not fighting it because FPGAs are
 what I do.  Board level design is a necessary evil to support the FPGA. If
 not for the desire to make approval easier the FPGA would not be on the bo
ard.  

I'm concerned that the thinking it will take less effort to get approval on
 the FPGA than approval on the equivalent software running on an MCU.  I'm  
not seeing a basis for this comparison.  

The context is medical equipment, specifically a ventilator.  I'm working o
n one of the many open source projects that have sprung up in response to C
OVID-19.  

The functionality of the FPGA is to detect the alarm conditions.  To do tha
t the FPGA requires sensor readings of pressures, O2 levels, temperature an
d a couple of voltages.  Fixed calculations will be performed, not under co
ntrol of any software, rather state machines.  The issue is whether any of  
this constitutes "processor software" since at some level there is source c
ode that is compiled by tools.  

Compare to the C programs being developed for the MCU as well as to the sch
ematic editors and layout software that are used to generate the Gerber fil
es and pick and place files for automated assembly.  

Where does the definition of "processor software" begin and end?  

--  

  Rick C.

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Re: What is a Processor and Software in Context of Reliability Analysis?
On 03/09/2020 18:45, Rick C wrote:
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My understanding (which is not definitive) based on working with people  
in Aerospace several years ago but some are still buddies, and more  
recent work on making a device potential capable of being certified for  
use on civil aeroplanes:

A long time ago (10 years) FPGAs kind if slipped under the software  
regulations radar. This led to people trying to hide stuff in FPGAs.
The regs are now much tighter and whatever is inside an FPGA and the  
software tools to make and test it are subject to the same regime as  
software as we've always know it. This may be a pain but it does make sense.

You would need to be an expert on medical regulations (and I'm certainly  
not) but I would expect them to up with the rest. Which would mean that  
every line of code in your HDL will need to be traceable back to a  
requirement and traceable forward to a test that proves it did whatever  
it was for, correctly.

But if you are worried about potential litigation rather than the exact  
letter of the rules, then you must assume that a US court would expect  
you to apply "best practice" anyway.

My starting point with these things is that all this software quality  
methodology doesn't work very well, and you should assume that the  
micro, FPGA or whatever behaves as if guided by malevolent intelligence  
to do the worst thing it possibly can. You protect the system with some  
external hardware that prevents the bad stuff from happening.

You'll need an expert to say if you can partition the system and apply  
different rules to different parts of it.

I think I've argued myself into thinking that you should consult an  
expert in medical electronic system regulatory approval :-)

MK




Re: What is a Processor and Software in Context of Reliability Analysis?
On Friday, September 4, 2020 at 10:21:04 AM UTC-4, Michael Kellett wrote:
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g a design?  A project I am on is shoving software into HDL to design an FP
GA which is being considered "hardware".  I'm not fighting it because FPGAs
 are what I do.  Board level design is a necessary evil to support the FPGA
. If not for the desire to make approval easier the FPGA would not be on th
e board.
Quoted text here. Click to load it
l on the FPGA than approval on the equivalent software running on an MCU.  
I'm not seeing a basis for this comparison.
Quoted text here. Click to load it
ng on one of the many open source projects that have sprung up in response  
to COVID-19.
Quoted text here. Click to load it
 that the FPGA requires sensor readings of pressures, O2 levels, temperatur
e and a couple of voltages.  Fixed calculations will be performed, not unde
r control of any software, rather state machines.  The issue is whether any
 of this constitutes "processor software" since at some level there is sour
ce code that is compiled by tools.
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 schematic editors and layout software that are used to generate the Gerber
 files and pick and place files for automated assembly.
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se.
  
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Yes, I am aware of this.  I've asked questions about how this is going to c
ome about and the thinking is that a company will be found capable and will
ing to improve the design so it can be approved and then market the machine
.  This seems to be the project management version of "and then a miracle h
appens".  

I'm an older guy, essentially at the end of my career, and I have been lear
ning about the non-technical aspects of engineering the whole time.  Virtua
lly every project I've been on was poorly managed.  But none were done with
 such inexperience that essential aspects were for all practical purposes,  
ignored... until now.  

On the other hand, it is amazing how much progress has been made on the tec
hnical side of things.  It's also fun to work with people on the other side
 of an ocean.  

I hate preparing documents, but I appreciate how important it is to have a  
proper set of detailed, accurate requirements before starting work... espec
ially if time is of the essence.  Lincoln once said that if he had but an h
our to chop down a tree, he would spend the first 30 minutes sharpening the
 ax.  

I should add that to the beginning of the document.  

--  

  Rick C.

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