Derek,
 
I think I agree with you more than my last message may seem to indicate.  This
topic has, in the past, been a somewhat sore subject for me, for several
reasons.
 
I can't speak for the software that you have written or support. However, I
have had issues with a couple of COTS packages (one in particular) that shall
remain nameless, and I am sure it is not the one you support. :-)
 
And, I can only speak for the auditors that I have had experience with. Some
are better than others.  Yes, they do want evidence that the measurements are
accurate, regardless of COTS or in-house. But, in my experience with software
I have written, "in-house" waves all sorts of red flags, WHICH IT SHOULD, but
my point was that COTS software does not seem to draw the attention from the
auditors that it should, at least that is my opinion from the experiences that
I have had. This problem does not exist, to this extent, in the FDA world,
everything must be validated to the nth degree.
 
I went to work for a lab that was using COTS software that was installed,
setup and tested by the software vendor, and the lab assumed all was well.
When I started working there, I found multiple problems with the setup files
and instrument drivers. Now, I know that this experience is limited to just
one software package and is probably worse-case scenario, but it is this worst
case that I base my argument on. (This was an internal, mostly pre-compliance
lab).
 
I agree 100% with your point about some standards being vague. The MIL
standards and automotive standards are (mostly) better in this respect. Having
written software for both, I can say it is much better to write software to
clear specifications. Vague specs allows a programmer to take shortcuts.  The
labs can also take shortcuts when it comes to test procedures, but that is
another topic.
 
Your points 4 - 7 I can agree with, with regards to your own experience and
practices. Again, I speak from my experience with vendors, one in particular.
I apologize for sounding like I was making a blanket statement about all
vendors. The point about letting engineers be engineers instead of programmers
is very well taken. I always say "beware of an engineer with a compiler". 
Would I recommend a lab write their own software? No. If I were running a lab,
I would buy COTS software, but I would also be extremely picky about what I
purchase, and I would thoroughly test it for flaws.
 
I will say, however, that I learned a LOT about EMC (standards, test methods,
instrumentation) by writing software for it. And, it was all flexible enough
to change instruments without having to recompile. (Some things we learn the
hard way!!!) :-)
 
Great discussion!
 
Cheers,
 
Bob Richards, NCT.


[email protected] wrote:

Ahh, Bob,
 
seems we disagree on this one..
 
Point 1 Both the software I install, and our biggest competitor are installed
by chaps with many, many years of practical experience. In my case 26 years,
and I'm sure my competitor is just as much... 
 
Point 2 As a Lab Assessor myself, I take issue also wit that point also. We (
the group of us to chat you know... ), require users of software to show that
the results are as expected. What we don't ask for is a line by line
validation of the code. With 100+ installations of our SW, each one validated
to the extreme by very very picky clients ( and trust me, they find errors!! )
means the code is much more reliable than any assessor could ever hope to
check during an assessment, or any individual could achieve. Why make a lab
pay for this pointless act. What we check is that they know how to use it.
Now, if I were assessing a lab with non-COTS software, I would expect to see
evidence of every aspect of the program.
 
Point 3 As I've stressed, the standards are so poorly written that there are
interpretations of how the test should be run. A good software package has the
flexibility to enable a user to have it do what THEY want, so they can stand
behind their approach. Goes back to point 2, the lab has ultimate
responsibility, BUT the software does what it's supposed to which is what the
lab want.
 
Point 4 Instrument drivers are key: but all COTS SW drivers are different, and
are certainly not interchangeable. And I beg to differ that drivers are
written with Rented equipment: you should talk to our insurers that pay out
for equipment damaged in transit! Further, in the case of my software, the
drivers are tied to the model and SERIAL number of the instrument. So unless
it is a deliberate action, instruments can't be swapped out. On top of this,
with a team of 6 people world wide ( collectively 100 years of instrument
control ), with experience on almost every instrument made, we know a few
tricks.... An internal test lab ( with few exceptions ) just cannot call on
that wealth of knowledge.
 
Point 5 Good software should work with ANY instrument. After all, if it's
written for dedicated equipment that suffers prolonged damage, the lab would
be off line until the WHOLE process is done again..... What a serious
financial and chronological hit to a laboratory!
 
Point 6 While experience is beneficial, after all I boast about it above, past
experience IS NO indicator of future performance. After all, we all ( well,
most of us ) rush out and upgrade to the newest version of windows or Office
when it comes out, because the new features are typically over come the
resentment we hold cos' the darn software crashed on us many times.
 
Point 7 Having written my own EMC test software 20 years ago, and having COTS
now, it's a no brainer. As a lab manager, I'd rather my EMC techs and
engineers be working in their field rather than trying to be programmers...
Yes, I'm biased, but I'm also battered and bruised from MANY MANY years of
testing.
 
Right, back to the possible reasons that Manual and Automated testing may
differ.
 
Cheers,
 
Derek Walton
L F Research
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