What should be the control points to be included in a good Document Control Procedure for a company maintaing all documents as soft copy.I would be thankful to members if someone could provide me a good procedure for Document Control .

Hello Kapoor,

I can't offer you a procedure (Our stuff is in Swedish, and I don't care much for translating it), but I'm certain some of the others can come up with something. However, have discussed this topic several times under Documentation and forms. Have a look there or run a search. For starters I suggest the thread Control and distribution of document (http://www.qs9000.com/Forums/showthread.php?s=&threadid=5584). There are also several other relevant threads.

/Claes

I would be very nervous having all documents maintained in soft copy. I would want to have a backup disk(s) if nothing else. And it doesn't hurt to have critical docs in printed form for those times when computer access is not available.

Lucinda said:

I would be very nervous having all documents maintained in soft copy. I would want to have a backup disk(s) if nothing else. And it doesn't hurt to have critical docs in printed form for those times when computer access is not available.

Ah, come on, Lucinda, walk on the wild side!:biglaugh:

The only time we've had a problem with e-docs is the day before the auditor shows up, happens every time!

Best preventive measure for web based QMS - have a web that you only use for viewing, with a working copy that you use for all your revisions, publish from your working web to the viewing web. If anything ever happens, you've still got one complete and current web.

Back-up disks? We don' need no steenking back-up disks.:vfunny:

Sorry, it was a long day with too many unwanted surprises!

Lucinda said:

I would be very nervous having all documents maintained in soft copy. I would want to have a backup disk(s) if nothing else. And it doesn't hurt to have critical docs in printed form for those times when computer access is not available.

Well, We can use any type of medium we want (4.2.1 note 3) but naturally we also have to follow the requirements in 4.2.3e and 4.2.4.

SteelMaiden said:
Back-up disks? We don' need no steenking back-up disks.

Sorry, it was a long day with too many unwanted surprises!

Like problems with e-docs? ;)

/Claes

We have used the "CAD is master" for some time now. So it fits that our e-docs are master. We have a central location with a Master List that includes "hot links" to the procedures, forms and flows. We have our disaster recovery plan in place, mainly daily backups on 2 sets of magnetic tapes, one is stored off site. We also have a mirrored server at a remote location. The back up is mainly due to the amount of CAD data we require at any given time (Master Body Gages, Die Developments, etc.) so most may not have the resources necessary. The mag tapes have worked for years and can survive for over 7 years (accounting data).
When a document is posted in the designated location it is considered approved and current. The doc control person is the only one that can post to this folder. Our procedure states that all printed copies are considered uncontrolled and must be verified by the user to be current.
Hope this helps.

'Cinda -- Read my signature, let go of the hardcopies!!!!:biglaugh:

kapoor said:

What should be the control points to be included in a good Document Control Procedure for a company maintaing all documents as soft copy.I would be thankful to members if someone could provide me a good procedure for Document Control .
Kapoor,

Others have posted some sage advice regarding e-docs. But if for some strange reason it must be all paper (soft-copy) I would seriously suggest that either all docs are stored in a fireproof safe or that backup copies are stored in a fireproof safe or off site.

Of course, you have to clearly identify issue currency -- using a red "controlled copy" or "latest revision" stamp for current revisions and maybe an "obsolete - do not use" stamp for obsolete docs you might want to keep for "knowledge preservation". Maybe a master list or other easy method so everyone can easily determine the latest rev. of any doc.

Also consider how you will review and approve them; format and content issues; and handling customer docs.

Write somethign that works for you and the users of the docs. If you doubt your procedure, post it here for the members to review and critique -- post it as text instead of an attachment if you want everyone to be able to view it. Hope this helps. Good luck.

Randy Stewart said:
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'Cinda -- Read my signature, let go of the hardcopies!!!!:biglaugh:

Great minds, Stew...:D

And our setup seem to be more or less identical to yours.

Mike S. said:
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But if for some strange reason it must be all paper (soft-copy)
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As for paper or electrons: Who says that paper is safer than digital media?

/Claes

Claes Gefvenberg said:




As for paper or electrons: Who says that paper is safer than digital media?

/Claes
Ummm, I dunno. I didn't say that, did I Claes? :confused:

Whups.... No Mike, you didn't. I was actually trying to get across that I agree with you, but I seem to have botched that job.:o Sorry about that...:agree:

/Claes

A bit of a misunderstanding....I love having documentation online. We used it at my last two companies. It makes sense and saves trees.

But you don't want <b>all</b> of your documentation in soft form (Mike, paper is hard copy, not soft...). And that's why Stew and Claes (and almost everyone I would hope) also have hard copy available, such as mag tapes or disks. And in other orgs, they have a paper hard copy of the biggies like for ex. Disaster Recovery. If your 'puters are down due to disaster, how would you know what to do to restore operations? (Just an example folks, please don't pick this apart.)

Anyway, that's all I was saying.

All of our documentation is accessible online. There are no hardcopies.....EXCEPT (isn't there always an exception??? ;) ) for documents that should be available in case the computers decide to pull a :bonk: on us. In that case, assuming production is still functioning properly, we will continue to manufacture and these documents contain the chemical "recipes" and product dimensions for our finished goods. Highly needed information!

For these controlled Hard Copies, they are clearly identified via a non-black ink stamp stating "Controlled Copy" and an electronic Paper Distribution Record is maintained for the document indicating all hard copy locations. The Document Author is responsible for updating the hard copies and PDR when a document is modified and approved for release.

Sure beats the system I had when I first got involved with ISO back in 1993. My boss hated computers so everything had to be hard copy....two plants about 1 hour apart and head office in the middle of the two. 14 binders of documentation. 30+ people required for signatures acknowledging receipt of the hard copy. Man, did I ever get paid for mileage! :smokin:

Lucinda said:

(Mike, paper is hard copy, not soft...).
Lucinda,

You are right! That was pretty stupid of me, wasn't it! :bonk: I saw one thing and my brain understood it as something different. Thanks for correcting me!

FWIW, we go hard copy (at least one copy of all docs. in hard copy [PAPER!] form) and soft copy (electronic media) for all docs. as well. The e-copy is on both the QA computer and server hard-drives and is also periodically backed-up on tape or CD for safe storage as well.

We have our documentation online (HTML & Word) with the master list in the same directory. Everyone can read from this directory but I am the only person who can change anything. Paper copies are printed "Good for 24 hours" in the footer. Any documents needed for a longer period are laminated to discourage changes. Backups are made weekly at a minimum and I keep a copy at home. I do maintain 3 hard copies(covered in procedure), one for me for emergencies and 2 for internal audits. This makes it easy for our auditors to look things up and prepare for the audit. I use email for document updates by sending the changed file along with a change sheet to the authority who approves that particular document. They send it back to me by "forwaqrding" it after filling in the approval form. I save these in their own "Document History" directory as .msg files in order to save the attachments with the approval email. I keep a copy of these at home for safe keeping too. The hardest part of doing approvals this way is teaching everyone "how" to return them. And then re-teaching them!

I have a couple departments that regularly "borrow" documentation for jobs including Control Plans. The problem I have with this practice is that it sets us up for obsolete documents in job folders when a change goes thru and the "updated" control plan is sent out to the correct location, yet this obsolete copy "may" still be out there in another department. In the past I have always issued duplicates and kept track of them in the directory where they are stored. This is the safest way I see. Any suggestions?

Hi Russ,

Got a question...you said in your first post that documentation is online and printed copies state hard copy good for 24 hours. What about this "borrowed" documentation. Is it hard or soft copy? If hard, isn't it stamped with the 24 hour message? Or are the soft copies being used. If so, can you protect the document in some way? Perhaps convert to .pdf for all forms accessed by everyone? Just some thoughts.

CarolX

Carol...Control Plans & Specs(blueprints, process prints) are hard copy and kept where they are used. When a change goes thru they are replaced with the updated copy. We keep a "Master Folder" which has the updated copy in electronic form. This is seperate from the quality system documentation which is only in electronic form with a few exceptions. These control plans and process prints are laminated to inhibit changes being made to them. They are thus not required to be stamped "Good for 24 hours". I just wanted to see if anyone else saw a problem with this "borrowing" and the problems it could cause?

Russ- Let me see if I understand. You "borrow" Control Plans from one part to use on another because (I assume) the process is similar/same. If so, how do you know where these control plans are? In other words, you use the CP for part 123 on part 456 because the process is the same. One problem I see, if you update the CP for 123, how do you capture the CP for 456?

Am I on the right track?

CarolX

Carol..
I guess I left one part out. This happens when a part is scheduled in another department to run across a similar machine because the original department can't get to it. This happens too often because of scheduling snafus! So the control plan fits the job it just wasn't originally issued to the department which is now running the job. Now what happens if it doesn't get returned and it gets updated? If it is not where it belongs it will be left in a job folder "somewhere" and be obsolete. That is the scenario that I see. What happens the next time this job ends up there and they have an obsolete control plan and it isn't caught in time? I guess the question is, should I impose more control over this borrowing?

Go with Claes,

Doc control is easy to document by procedure but hard to enforce. The best bet is to control as little as possible.:)

Russ,
Not knowing how your job kick-offs are, let me say this. In another life, I had the responsibility of job set up verification and gage tech. What we did was that with each job set up the Control Plan, X bar & R chart and gages were issued to the operator(s). Upon completion of the run, the operators were required to return the issued gages and documentation to me. It was very easy to keep track of the CP's that way. Even if the job was moved from 1 machine to another, in the other building or to a different department. If engineering changed the CP, the obsolete version was either on a machine or in the file.

Randy,
That's the direction I am going with this. I just need to get enough people thinking that way to get it done. Until that near perfect world arrives I am trying to exercise the control needed to avert possible catastrophy. I don't know maybe I'm just being paranoid!