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!

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

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).

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!

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 ?

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!

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

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.

According to the law signed by ex-president Bill Clinton (your local country laws may vary), digital signatures are every bit as valid as those on a piece of paper.

Therefore, to digitally sign a document is as legal as a raised seal and a signature. All the web-based tax forms that are e-filed are actually sent as digitally signed files. Adobe Acrobat has this as a standard feature on the last few releases, hence, just about every web-based document that has to be legal is in pdf format with the digital signature.

Oh, and the hand written original data must be kept if you are running an ISO 17025 system, even if it is on a bar napkin (my stationary of choice). Copies of the original findings are not allowed.

Ryan

Just an added thought about scanning documents.

I tried scanning a documents signed by so and so and an unsigned document saying that "I am so stupid -signed.." then, since it is an image, I copied the signature and then pasted it in an unsigned document. Then saved it in pdf format.

With this procedure, I can tamper documents to a degree before I compile it and save in an electronic media.

Having said that, people can also easily deny signing such documents.

Let me provide an example (fictitious);

In a calibration lab such as ours, we have documents that said "I want such and such equipment be impounded, and permanently removed from the records, signed --"

Then a year passed and this same man asked us about that particular equipment and so we showed him the original paper he signed. Then that is settled.

If the document was scanned, and I showed him a scanned document, he can deny signing such document. He can say that this document can easilly be tampered.

yes, it all falls with trust with your co-employee but my point is, scanned documents are not as settling as an original document.

My question is, how can we provide a paperless environment and still provide a .. umm... I dunno... something that is very convincing something?

cheers!

Lord:

There are also considerations if there is a possability of someone's work becoming involved in a patent application. I am not sure how this area has developed recently, but a few years ago you absolutely had to have hand written lab notebooks to back up your claims, or so I was told. Any mistakes or corrections had to have a line drawn through them, and be initialed by the author. White-out was forbidden.

With my notebooks, there was little doubt they had been in the lab. Along with the scrawling, they always had water and other stains on the pages. Fortunately, there were very few burn marks, however....

Craig

Although electronic signatures are a perfectly acceptable way to we must be carefull that there is a process to ensure that signatures are valid.

I think there has to be a computer program or system that can nullify attemts to "break" signatures. In real life these systems are readily available through current technology, whether PC or Mac. What is required is an "overseer" that has the final responsibility and authority to administer said system.

That said, I believe that less that .1% would actually try to circument such a system and that those who do would be discovered and dealt with in the appropriate manner.

Just some humble thoughts.

Al...