This is great topic.
In my mind, this is also a in many instances a great waste of time. No offense to the people who are doing it, but - let's think about this.
As this relates to second and third tier manufacturers and suppliers that provide Medical Device Companies with a products such as a machined component or a stamping, how many instances has Excel failed to correctly reproduce data that was originally entered thus causing a failure for a feature on a part?
The majority of what my customers seem to be telling me is that they need justification that a Microsoft application is not, assuming the data is entered correctly, manipulating the data and giving false output by which we are basing acceptance or rejection of a products feature on. To which I say - show me an instance where it did? I have never had any of them able to produce results of that nature. So, what are we doing here? We are now spending a lot of money and tying up resources because we have no instances by which to base true Risk Analysis? That's kind of like forgetting about SPC,
FMEA and all of the other diagnostic tools in our toolbox and going on the gut isn't it? You can't show me a failure or impact, but you think the possibility is there, so, now we are going to do it?
It is mind boggling to me that as Quality Professionals we allow industry's to dictate excersises in futility and we just go along with it. Now, I have heard the story of the failure of the machine in the 80's that burned people from the inside out due to some software coding that was incorrectly interpreted in the programming. I do feel bad for the affected victims, but, give me an example of a device or a machine that failed based soley on the fact that data that was entered into Excel came out with a CPK Level of 1.35 instead of 1.28 because the background calculation that Microsoft uses failed thus causing a major issue in the field.
None of my Medical Customers can do it. In fact, none of them can provide me with any kind of a Risk Analysis that shows me how they arrived at deciding that Excel or any other Microsoft application needs validation as it relates to their product. These people should start to practice what they preach before they come and suck the resources out of our facilities.
As you can probably tell, this whole thing leaves a bad taste in my mouth and it certainly is not because I don't understand it - in fact, several of my customers have complimented me on my knowledge of GAMP, JETT, etc. etc. But, I still cannot find a document or instance which explains it without sounding like the tower of babble - which leads me to believe this is one of those CYA excersises in the Medical Device Industry - get out the pocketbooks everyone, but, just because it's here to stay doesn't make it right.