Software Observation during ISO 9001 Audit - Validate and Re-validate Software

[Coury Ferguson]

Re: Software Observation during ISO 9001 audit

Nope - not even a little bit. As I asked earlier: "Where would it end?" Next we'll have auditors telling us we need to validate Word, PowerPoint, etc.

It probably would never end. But, it appears that both of us have a difference of opinion on the definition or application, which is fine.

As for the original post, there was no paragraph that was called out for the observation. So, if Allen wishes to take into consideration the auditor's observation that is their choice. There is no other action required on the observation.

 

[CarolX]

Your auditor is grasping at straws. The whole purpose of the 'validating software' is the control of those items which can affect decisions regarding product/process performance.

Andy - grasping at straws here is an understatement.

All the standard says is that software validation is needed when used in the monitoring and measurement on specified requirements.

For example -

I have a part digital scanner that will color code the image of a part based on it's deviation from nominal. All I have to do during my calibration process is verify that my master, which has features known to be .xxx from nominal, appear in correct color on the monitor.

Using Excel or even homegrown software to make business decisions unrelated to specified requirements is out of the bounds of the standard.

 

[al40]

Andy - grasping at straws here is an understatement.

All the standard says is that software validation is needed when used in the monitoring and measurement on specified requirements.

For example -

I have a part digital scanner that will color code the image of a part based on it's deviation from nominal. All I have to do during my calibration process is verify that my master, which has features known to be .xxx from nominal, appear in correct color on the monitor.

Using Excel or even homegrown software to make business decisions unrelated to specified requirements is out of the bounds of the standard.

Carol,

This was my interpetation as well, I could not find any references to home-grown software in any ISO specification.

Thanks,

Allen

 

[AndyN]

I'm concerned that an auditor would even make an 'OFI' for this point. I've always had a probelm with "OFI's" because (to me) it represents sloppy auditing. Instead of delving into the use of the spreadsheet to see what it was being used for and then providing evidence that it's use was causing issues, it's easier (lazyier) to 'light the fuse' and then leave - causing folks like Allen to have to work to find out if it's even a valid issue...........

Apparently the 'ANAB' have seen the same thing and have issued an advisory notice to registrars about 'soft' grading of non-conformances.

There is, of course, an opportunity to help Allen's management who were being quizzed about such things. Did they defer to the 'process owner' and have them answer (it could have been either the IT manager, or the Calibration System owner)???

Those folks should have been capable (if they know their process and how it meets the ISO requirments) of rebutting the issue.

Andy