Transition to Electronic Paperless System - How is Record Retention Addressed

[Lord Ituralde]

Hi All,

I dont know exactly where to put this topic but can anyone please tell me how i can make our reports paperless (through intranet or email) and how would the record retention fit in.

Do we need to have a hard copy of say, a weekly report, or can we get away with just saving it in a hard disk?

oh, and yes, i know this is bordering ambiguity as i can't properly put to words what i have in mind. <sigh>

cheers!

[D.Scott]

To my knowledge, QS and ISO are in agreement on this.

QS states "Documents and data can be in the form of any type of media, such as hard copy or electronic media."

A side note though. If you have a lab, your original data has to be saved. If you make your test calculations on a paper napkin, save the napkin.

Dave

[Jerry Eldred]

The major company I work for has had a long standing goal of becoming as completely paperless as possible. I won't disagree with the comment in the previous reply about saving your original data, as I am not in that specialty area.

That said, if you take data electronically, you could also save electronically.

The catch with saving everything electronically (which I support), is that you need to have adequate measures to assure you don't lose data. We have a very extensive system of backups to a level where it sometimes gets pretty annoying.

Our document control is set up where the electronic copy of a spec, held in the electronic repository is the official copy, and paper copies are considered "Uncontrolled" (unless you make allowances in individual cases).

Our official reporting is web-based, and the servers used to hold all the web-based information are in a well operated back-up system.

I would even contend that hand written paper copies could be scanned, put into PDF (or TIF, JPG, GIF, or what ever works best), then electronically archived.

With the right operational safeguards (i.e.: data security, good backups, etc..) that a paperless system is easier to deal with. You could be in an office in China, an auditor wants to see original data taken in a lab in New York two years ago (assuming your record retention policy requires that data to be retained). In an electronic data retention system, you could easily pull up the original handwritten document in electronic format for the auditor.

I'll stop short of saying that you could dispose of the original piece of paper (based on the previous reply). I wonder whether in such a comprehensive documentation system whether even in his circumstances you could legitimately discard the piece of paper and archive the electronic facsimile of it? I'm not sure on that one.

My company, by the way, is QS9000 (soon TS16949).

[Lord Ituralde]

hey guys,

Thanks a bunch.

Will saving data electronically provide issues about authenticities? for example, if I scanned a calibration certificate, and it has a dry seal on it, and save it in a hard disk, would it (the scanned certificate) still be authentic? .

Thanks again,

Cheers!

[M Greenaway]

Lord

I guess when we need to consider authenticity that carefully then perhaps we should consider legal advice.

It might be OK for running your system, but is it admissable in court in defence of a product liability claim to produce scanned documents ??

I dont know ?

[Lord Ituralde]

M,

Thanks. I haven't really thought about that but i can see it does present complications. I think as long as the original and the copy of the document are notarized, then its ok. (Though of course, its very impractical)

Keeping the legalities aside, do you think we don't violate any standards (ISO/QS) in scanning a calibration certificates?

Cheers!

[M Greenaway]

Neither of the standards you quote are specific on any certification requirements - so as far as compliance to these standards you are OK.

[Jerry Eldred]

As I said in my previous reply, under most circumstances, there is no reason a paper copy must be maintained. However, in legal liability situations, it does seem conceivable to need a true original with the raised seal etc.

So I will be very specific that I would not recommend going paperless in such circumstances without some legal advice.

I would be interested to hear a valid, authoritative opinion on this one.