What are "Controlled" Drawings

[markkillion]

I need to make changes in our procedures. The problem is that I believe the original documents, the only one's that are "controllable" are the electronic files in the computer. Everything printed from those files are "reference" only since these are only referring to the electronic drawings. What has been the arguments on this topic and how have people handled it. Thanks in advanced.

Mark

 

[Marc]

Not much to say. Your controlled copies are on the computer and any printouts are Reference. This is a common practice.

 

[Mike S.]

Mark,

Printed copies can be controlled if you want/need to. In our place, not everyone has computer access. So, one "copy" is on the computer in a master file and password protected; an original hardcopy that was passed-around for approval signatures is in a file in QA with a red "controlled copy" stamp; thus every "approved" document has 1 hardcopy and 1 e-file. If anyone needs a controlled printed copy, a copy is made, stamped with a red "controlled copy" stamp, and added to the distribution list. When a revision is made, hardcopies are found via the distribution list and destroyed and replaced with the new rev. Works okay for small shops (i.e. <150 people or so) though all electronic is the best way for larger palces IMO. And of course you can have uncontrolled copies if you want (we do) but someone has to verify it is the latest rev. if they use it for production.

Hope this helps.

 

[markkillion]

So then do you stamp "Reference" on any drawings printed that the shop floor will use to build to? Do you need to date it for revision verification? Is it a must that a log of who has copies of drawings be kept and if so can I get an example of one of these logs (assuming Excel spreadsheet)? Is it just written into our ISO that electronic drawings are "controlled" or do we need to specify on the electronic file noting it is controlled? Please help.

Thanks,

Mark Killion

 

[Mike S.]

Mark,

You do not need to stamp "reference only" on uncontrolled drawings unless your internal procedure says so, but you can choose to do it if you want.

Date can be used for revision indicator if you want. My doc. control procedure says that I will use rev. A for the initial release, B, C, etc. for revisions.

If your only controlled copies are on a certain computer hard-drive, just state that in your doc. control procedure. I use the windows file directory as my master list of documents.

If you have paper copies as well you need a distribution list so that you know where controlled copies are in the event of a revision so you can retrieve the old revision and distribute the new. I list on the document itself where controlled copies are located and also that the “master” copy is on the computer.

I hope this makes sense and that I understood your questions. If not write back.

 

[Icy Mountain]

I agree with Mike S. We have the "master" drawing in electronic format in a file on a hard drive. The 4.2.3 requirements are covered by our Engineering Change Order system except for d), e), and f). Paper copies issued for use in manufacturing product or otherwise operating the QMS are marked "controlled". Nifty little msAccess database for tracking All Locations where a given Drawing/Revision has been issued (and vice-versa All Drawings/Revisions at a given Location) makes recalling obsolete and issuing new revisions a snap.
-John
P.S. - Database very nice for making sure no one produces an old revision QA Manual in front of any auditor.

 

[Craig H.]

markkillion

Welcome to the Cove.

As far as electronic copies go, we have several docs that reside in a computer. That copy is the (only) controlled copy. In the footer, there is a statement, "document not controlled if printed.'" You could add "check version level" to that as a reminder.

Craig

 

[noboxwine]

Control Everywhere

Mark K: Most importantly, write the procedure to suit your best business practices, ensuring the correct drawing is always used. There are no rules regarding how you control, what media is used, stamps, etc. Make it useful for you ! Depending on how your jobs are issued, you may be able to use this procedure that I have had much success with:

“……..any drawing, in any media, which matches the drawing number and revision level in the job packet (Bill of Materials), is considered controlled and permitted for use……”

Now, if a company uses the drawing itself, instead of a BOM, to drive the current revision, you could store the “control” information (dwg # & rev level) on a computer and note that any hard copy that matches the information on the computer is controlled and OK for use.

Just something to think about.

Let us know how ya do and have a day !

 

[howste]

So then do you stamp "Reference" on any drawings printed that the shop floor will use to build to?

I'm not a fan of stamping "reference" on anything. What does stamping "reference" on it really mean anyway? If you're using a document to do work then it must be controlled, even if the control is just verifying that it's the latest version.

[rant on]
I've seen too many companies that just start stamping everything with "reference," thinking that they can do anything they want to with it now. Suddenly it's like it's exempt from the system. It's their excuse for turning off their brains and not controlling documents or calibrating gages. As an auditor, nonconformities are often not far off when I find something marked as reference only...
[/rant off]

My $.02 (rant not directed at anyone here)

 

[db]

I'm not a fan of stamping "reference" on anything. What does stamping "reference" on it really mean anyway? If you're using a document to do work then it must be controlled, even if the control is just verifying that it's the latest version.

[rant on]
I've seen too many companies that just start stamping everything with "reference," thinking that they can do anything they want to with it now. Suddenly it's like it's exempt from the system. It's their excuse for turning off their brains and not controlling documents or calibrating gages. As an auditor, nonconformities are often not far off when I find something marked as reference only...
[/rant off]

My $.02 (rant not directed at anyone here)

Okay, I'll second that. When someone tells me something (either document, or measuring device) is "for reference only", I simply ask: "What are you referencing to it, or what are you referencing from it?" Just stamping "unofficial" does not make any difference if the item is used in a manner that requires control. If someone is using a "for reference only" document for their jobs, I should be able to rip it up and they should still be able to do their job. If not, it can't be "for reference only". The same applies to measuring devices. To me "for reference only", mean the same as not necessary.