AS9100C 4.2.3 - Obsolete Electronic ERP Documents

D

dbhuff369

#1
We have an entirely electronic system. All current documents are stored in the ERP system which is also our master document record and change control system. When we up-rev or obsolete documents, we keep records for historical purposes including possible repair, historical record, etc. Any work done on a project MUST use the version of the document stored in ERP per our procedure.

Here's my issue, according to an interpretation of this standard, we would need to electronically mark each and every document that was retained for any purpose that was not the official copy in the ERP. This becomes burdensome to say the least. Note, our process ONLY allows any work to be done using the official copy in ERP, so if anyone were to pull a different copy off the server or use a paper copy, it would be in violation of procedure.

We are now considering if this clause means some watermarking of all the document copies that we deal with, examples being "For Quotation", "Historical", "Draft", etc respectively for drawings from customers during the business development process, obsolete old document copies, and copies in the process of being modified. This seems like a lot of make-work with no value add, is anyone aware if there is another way to handle this?

Thanks in advance!
 
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Mikishots

Trusted Information Resource
#2
We have an entirely electronic system. All current documents are stored in the ERP system which is also our master document record and change control system. When we up-rev or obsolete documents, we keep records for historical purposes including possible repair, historical record, etc. Any work done on a project MUST use the version of the document stored in ERP per our procedure.

Here's my issue, according to an interpretation of this standard, we would need to electronically mark each and every document that was retained for any purpose that was not the official copy in the ERP. This becomes burdensome to say the least. Note, our process ONLY allows any work to be done using the official copy in ERP, so if anyone were to pull a different copy off the server or use a paper copy, it would be in violation of procedure.

We are now considering if this clause means some watermarking of all the document copies that we deal with, examples being "For Quotation", "Historical", "Draft", etc respectively for drawings from customers during the business development process, obsolete old document copies, and copies in the process of being modified. This seems like a lot of make-work with no value add, is anyone aware if there is another way to handle this?

Thanks in advance!
The standard says that if you decide to keep obsolete documents, you have to make it obvious to anyone that they are not current.

That's all.

We simply mark them obsolete. If people are able to pull obsolete documents off the server that are not identified as obsolete in some manner, then those documents are not controlled.
 
D

dbhuff369

#3
Yep, here's the issue, its all electronic. I get copies for quoting, create copies in our purchase orders, email copies to various people in our supply chain, etc. These are all 'retained' to the extent that they exist electronically somewhere in the the various systems we have. I can't go around marking them obsolete electronically, at least not without a tremendous amount of effort. And many of these documents are necessary to retain, e.g. purchase orders.

The intent is to prevent the misuse of a document, which should be enforced by the ERP requirement, but that isn't one way of reading the wording...
 

dsanabria

Quite Involved in Discussions
#4
Yep, here's the issue, its all electronic. I get copies for quoting, create copies in our purchase orders, email copies to various people in our supply chain, etc. These are all 'retained' to the extent that they exist electronically somewhere in the the various systems we have. I can't go around marking them obsolete electronically, at least not without a tremendous amount of effort. And many of these documents are necessary to retain, e.g. purchase orders.

The intent is to prevent the misuse of a document, which should be enforced by the ERP requirement, but that isn't one way of reading the wording...
For clarification -

4.2.3 g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

You are over thinking this - this apples to document not records. The concept behind is to minimize people reading an obsolete work instruction, procedures and prints as examples (there are more). Once you place a number on the document - they become a record and you entered into another subject.

Most company place a statement on the footer - "Printed documents are obsolete", but if you want to retain a revised document then it must be identified.
 
D

dbhuff369

#5
OK, that's a start. We could put "versions not obtained from the ERP system directly are obsolete" or something. My concern is with, for example, an RFQ to a supplier. In that RFQ is a copy of the drawing. That drawing could be 'looked at' by someone...although it is part of a larger document. Another would be an earlier rev of a drawing kept for historical purposes. Again, that note on the drawing would provide some protection, but does require some entry on every document coming in (e.g. drawing packages from customers during the quotation process, for instance).

Is the conclusion then that we need to modify each retained document with some statement of control? Our process that requires using the ERP isn't sufficient? Keeping in obsolete directories I know doesn't work.

added: we might get a drawing package to quote and build of a couple hundred prints. We typically get these into our quote process for evaluation where they stay as a record. Then we might win the bid in which case we'll requrest a fresh drawing package with any updates or copy drawings over from the Sales directory. (First retained in sales). The quote process might involve some iterations of some documents, we usually keep them all as a record. All of these drawings in the sales directory, per the standard, now need to be marked? After the official drawings are installed in our ERP system, if a change happens, we run an ECN and replace the document. But we keep the old ones for a) history, and b) in case older parts come back for some reason. However, these retained docs need to be marked? This is quickly turning into a massive administrative task to purge or mark non-production copies of documents even though we thought we'd solved the problem by requiring access through the ERP for any business purpose...
 
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dsanabria

Quite Involved in Discussions
#6
OK, that's a start. We could put "versions not obtained from the ERP system directly are obsolete" or something. My concern is with, for example, an RFQ to a supplier. In that RFQ is a copy of the drawing. That drawing could be 'looked at' by someone...although it is part of a larger document. Another would be an earlier rev of a drawing kept for historical purposes. Again, that note on the drawing would provide some protection, but does require some entry on every document coming in (e.g. drawing packages from customers during the quotation process, for instance).

Is the conclusion then that we need to modify each retained document with some statement of control? Our process that requires using the ERP isn't sufficient? Keeping in obsolete directories I know doesn't work.
OK - for RFQ - that is not an obsolete document. For the print - if it still in the system, then it is not obsolete. Many companies keep previous version of the same drawing in a controlled electronic file just in case someone wants a previous version of that part or product. I

In your procedure, make a statement that previous version of the drawings are in file and controlled through configuration management or something in that nature... so that anyone reading your process clearly understand the process.

If a print is obsolete then it must be taken out of the system and identified as obsolete.

Hope this helps ;)
 
S

SmallBizDave

#7
I think there's a difference between technical docs that are part specifications and quality procedures. For procedures I normally apply a footer that says something like "User is responsible for verifying that this version is the latest." The same could be done for technical docs as some have suggested.

But for technical docs they will all have a revision on them. I would argue that the revision shows whether its current or not, so long as the general user has a means to check what the correct revision is. Otherwise, a statement similar to the statement above ought to suffice.

I've got several avionics customers who deal with multiple revisions being active and I've never had an auditor question the use of revisions as the control mechanism.
 
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