ISO 9001:2008 clause 7.6 - Confirming and Reconfirming Software

[Minda]

He asked for confirmation documentation for Word, Excel, and TrackPro because all three are being used in our QMS for various applications. For the most part the MS programs are just documents, but the few spreadsheets we have do not have very complex formulas, and they are password protected for both read and write access.

I believe that the auditor, just like you yodon, found these three questions to be lacking in producing objective evidence since we have nothing documented. The only way I can see to close this out would be to make a simple little chart with the three questions down the left side and the three programs across the top. I can fill in the date the software was "reconfirmed" and have it for future use.

I'm definitely trying to see what can be improved and how we can learn from this, but all of the resources I come across on the web for software confirmation are no help whatsoever since these are "off the shelf" products.

 

[AndyN]

You have nothing to improve. The customer auditor is the one who needs to learn a thing or two...

 

[Big Jim]

He asked for confirmation documentation for Word, Excel, and TrackPro because all three are being used in our QMS for various applications. For the most part the MS programs are just documents, but the few spreadsheets we have do not have very complex formulas, and they are password protected for both read and write access.

I believe that the auditor, just like you yodon, found these three questions to be lacking in producing objective evidence since we have nothing documented. The only way I can see to close this out would be to make a simple little chart with the three questions down the left side and the three programs across the top. I can fill in the date the software was "reconfirmed" and have it for future use.

I'm definitely trying to see what can be improved and how we can learn from this, but all of the resources I come across on the web for software confirmation are no help whatsoever since these are "off the shelf" products.

The lesson you need to learn is to ask "show me the shall" when an auditor makes up his own rules. He reached far beyond what the standard says. Not even the wildest imagination could capture the meaning he is trying to project.

Quit beating yourself up over an officious buffoon.

 

[yodon]

The only way I can see to close this out would be to make a simple little chart with the three questions down the left side and the three programs across the top.

I work in medical devices so I tend to view things through those goggles. What the auditor is asking for is quite common in the lifesciences (well, with the exception of suggesting Word be validated - that's just plain silly).

Since your procedures say to answer those 3 questions, yes, you may want to do a simple little chart (memo to file in your Quality Records). You may want to add some additional rationale like stating (presuming so) that there are no formulas in the Excel spreadsheet that would warrant validation and (for all tools) any failure would be obvious with no impact on quality and so validation is not required.

Agree with everyone else that the auditor was overreaching and that based on your use, the effort should be (quite) minimal.

 

[JaneB]

This illustrates one of the problems with customer audits and why it is a really Good Idea for audits to have:

• a defined scope
• the standard(s) to be used
• competent auditor
• a procedure

Missing any one of those = difficult. In combination, can be disastrous, and suck up huge amounts of time.
I do empathise - had experience of being on the 'cleaning up the fall-out' end a couple of times.