Document control of software? Software packages that produce documents

rstocum

Involved In Discussions
#1
Like many companies, we have various software packages that output documents which we use in manufacturing of product. CAD/CAM package produces CNC programs, Gage calibration package produces calibration reports and stickers that go on the gages. Management software produces travelers, shipping pick lists, quotes, etc.

We control these documents by printing a sample copy, numbering it as an "exhibit", and entering the control number in our document control software. Going on 5 years as ISO registered, and no problems with this method.

The QM has recently started wondering if we need to "control" the software packages themselves. I find no specific requirement to do this in the standard, but I imagine there is a way to 'back door' such a requirement.

Can anyone tell me, is it required (or even just a good idea) to document control your software packages that produce documents that are controlled in your QMS? If so, please give an example of your method for doing this.
 
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GStough

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#2
Re: Document control of software?

If it hasn't been an issue until now, I would question why the QM has suddenly begun to think about it. Has anything changed to warrant this sudden concern?
 
T

Ted Schmitt

#3
Re: Document control of software?

Like many companies, we have various software packages that output documents which we use in manufacturing of product. CAD/CAM package produces CNC programs, Gage calibration package produces calibration reports and stickers that go on the gages. Management software produces travelers, shipping pick lists, quotes, etc.
Be aware of 7.6 last paragraph... since you are certified already, I imagine that you are taking this into consideration...

We control these documents by printing a sample copy, numbering it as an "exhibit", and entering the control number in our document control software. Going on 5 years as ISO registered, and no problems with this method.

The QM has recently started wondering if we need to "control" the software packages themselves. I find no specific requirement to do this in the standard, but I imagine there is a way to 'back door' such a requirement.

Can anyone tell me, is it required (or even just a good idea) to document control your software packages that produce documents that are controlled in your QMS? If so, please give an example of your method for doing this.
Sounds like extra work and Jim´s idea of infinite regression... I wouldn´t think this is necessary and as Gidget put it, if during the 5 years, nobody picked up on it or asked for it, leave it be or soon you might start controlling your Microsoft Office versions... :notme:
 

rstocum

Involved In Discussions
#4
Re: Document control of software?

Section 7.6 - yeah, we run an SPC analysis program called SQCpack. It crunches the numbers on our gage R&R, and runs histograms on our SPC data which we then provide to the customers who want it. I'm glad you mentioned this because I have no idea what objective evidence we have that we verified it's ability to satisfy the intended objective. I can easily answer the registrar's question about how often we have reconfirmed that - "Well Joe, it's never been necessary...".

I'm not sure what has got the QM wondering about this. He may have got a bug in his ear from one of his QM buddies, or heard about it on some crazy forum or something. He would be delighted to hear that it is not required, and not necessarily a good idea - which is what I thought in the first place.
 
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Paul Simpson

Trusted Information Resource
#5
Why control?

Like many companies, we have various software packages that output documents which we use in manufacturing of product. CAD/CAM package produces CNC programs, Gage calibration package produces calibration reports and stickers that go on the gages. Management software produces travelers, shipping pick lists, quotes, etc.

We control these documents by printing a sample copy, numbering it as an "exhibit", and entering the control number in our document control software. Going on 5 years as ISO registered, and no problems with this method.

The QM has recently started wondering if we need to "control" the software packages themselves. I find no specific requirement to do this in the standard, but I imagine there is a way to 'back door' such a requirement.

Can anyone tell me, is it required (or even just a good idea) to document control your software packages that produce documents that are controlled in your QMS? If so, please give an example of your method for doing this.
Why use examples as evidence of control of these documents at all? :confused:

Taking one of your examples. travellers are records of a planning process traceable to a job number. They need to be controlled as records.

If your travelers say how you make something then the document control procedure should describe how the content is managed (who can change the data in the software database) and that a record is generated with each traveler. More akin to what your QM is describing.

Your system should concentrate on the elements of 7.5.1, not 4.2.3.

It's no wonder we get the "document control guys" label when we seem to be obsessed with putting form numbers and issue levels on anything that doesn't move too quickly. :lol:

P.S. not sure why this ws moved to the software control section!
 
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