ISO 9001 Documentation Control

[Bruce Muretisch]

I have spent the last 6 months preparing for ISO 9001 implementation at my Company and am about to implement all the Quality Management Procedures, Work Instructions, and supporting documents (forms, charts, etc...).  I am trying to minimize the extent of controlled "hard copy" issuances and not create the need for a department of clerical people to maintain them. My question is:

1. In this electronic age, how do smaller companies (200 - 500 employees) typically control their Quality System documents yet make them accessible to the employees, without the fear of mulitiple uncontrolled copies being printed and/or distributed outside of the company (security issue)?  If anyone has any examples of how other ISO 9001 companies do it, please share....

Thanks for shedding light on this one!

 

[Bruce Muretisch]

Thanks for the quick response! Is your company ISO 9001 certified? What is the extent of your documentation? I'm dealing with 60+ Procedures and about 300-400 Work Instructions. Both document types are separate from my Quality Manual. I assume that your initial controlled copies were distributed to department heads, foremen, or centrally located in the manufacturing area. Have any auditors commented on the uncontrolled copies of instructions or procedures found in the possession of the workers?

Bruce

 

[ALM]

Well, we have a network...

I am the almighty controller of the PHYSICAL changes to the documents. Therefore... I have them in a directory under my user name that gives read access to all employees on the network anytime they so desire. (Changes may be suggested at all levels and approval is still done by appropriate authority and turned-in to me for change on the network.)

Now, I haven't eliminated all hard copies yet, but we are getting there as the proliferation of computers spreads to the manufacturing areas.

Prior to the network, I would have to chase down 19 SEPARATE controlled copies of manuals. I am down to 7, all of them in the manufacturing area.

It is wonderful.

Next question, "well, how do you control documents if they are printed out by computer users?" Simple. In our document control procedure... it states that, "Any procedures that are not physically within the current hard copies are UNCONTROLLED documents and no guarantee of it's current revision status exists. Only the network copy and approved hard copy manuals are considered of current revision status." Also, employees are strongly urged NOT to print out the documents. If they do, for training, or reference for a given situation, they must destroy it upon completion for that use.

I can't wait until I don't have to hump around the shop for ANY hard copies!

ALM

 

[ALM]

Bruce...

My company is ISO9002 certified and very close to registration to QS9000 (ugh!).

As for the extent of procedures/work instructions... about 60-100 level two's and perhaps thousands of work instructions. However, we administer to the WIs slightly differently from the "manuals." Being in the proverbial "job shop" environment, we custom make parts using every conceivable material out there and some not even discovered yet. (In other words, a lot of stuff). There is a separate program (database) that contains all of the work instruction for every job and every customer. Without getting into too much detail, it was designed to be controlled by; a) allowing only one WI for any one part at any given time. (No repeat entries). b) specifies revision level, drawing number, etc., etc. to ensure that it is current. c) Only authorized individuals have write-access to the system to make changes to WI.

Our distribution was pretty much as you described.

As for comments from auditors re: uncontrolled copies in the possession of staff... well, let's be honest here, it is like pulling teeth to get them to utilize the CONTROLLED copies. We really have nothing to worry about with uncontrolled copies. In fact, I might secretly applaud the person who took the liberty of printing out a copy of a procedure "illegally" for some legitimate reason. At least then I'd know for sure someone was actually using them from time to time! LOL!

ALM

 

[Bruce Muretisch]

ALM,

Thanks for the insight and honesty you expressed about the "real world" scenarios of uncontrolled copies. You've helped me a great deal!

Bruce

 

[Kevin Mader]

You may want to consider placing a disclosure at the bottom of your documents (perhaps only your level 1 and 2 docs) stating that the printed copy is considered an uncontrolled copy and the responsibility of the user who prints it out. Then add to your Document Control SOP that these copies are considered uncontrolled due to the fact they do not have proper controls attached (i.e. stamping, signatures, distribution log, etc.) but become legitimate working copies provided the user ensures that the document revision level is the same as recorded in the Master List (also available on line). The user must then initial and date the working copy, demonstrating this review has occurred and is only current through the date it is initialed. If a user has kept and used the document for three days, then I would expect to see three separate initial and date entries in the margin or somewhere.

Agree ALM, glad to see folks interested in maintaining the continuity of the system. I just might take it a step further to control the opportunity that an outdated or obsolete document is errantly used. To do this, I require the above process and use internal audits to canvas the area for documents that may be printed. They look for the required assurance check and make any noted deviations as part of their audit report. So far, so good. When a noted deviation has occurred, consideration was given to add the user onto a physical distribution or to retrain the user on document control. Currenly, retraining has been the only required activity.

Regards,

Kevin

 

[Bruce Muretisch]

Kevin,

Your suggestion about disclosure statements and confirmation of current working copies are definite possibilities for my company, especially in the areas of multiple procedures and greater complexities (ie..Design Control).

Thanks for the input!

Best regards,
Bruce

 

[Kevin Mader]

Anytime, just drop a line.

 

[pdboilermaker]

Bruce:
We are a 9002 and a 14001 registered company that is operating under 16949. We are prepared to do the registration audit as soon as the registrar requirements are released.
We to use our LAN, our system is set up like a home page on the internet, if you wish to see the level 1 16949 or 14001 manual, you click on that icon. If you want to see your departments or any other departments level 2 procedures, you click on that departments name.
All level 1 and two procedures are listed by element name rather than number to help iso laymen e.g. "Process control" rather than 4.9.
Each department maintains their own level 3 procedures.
We have only 3 hard copies of the level 1 and 2 procedures. Copy 1 me, the management rep, copy 2 my two auditors, copy 3 the QA manager. I felt 3 copies were important, all 3 are used daily and every 6 months it is easier for the external auditors to have a hardcopy to carry around rather than to look at a monitor.
Dean Hill
[email protected]

 

[Andy Bassett]

I go along with everything said so far.
I do not get involved with any QM/ISO System unless it is based on an Intranet.

My way of dealing with the issue of uncontrolled print-outs is to have a hidden message that only appears on a print-out that says 'UNCONTROLLED COPY, REFER TO INTRANET FOR LATEST ISSUE'. I know this is possible in Word.

Additionally i structure the documentation so that Work Instructions belong to departements, and give specific personnel within the dept the right to change.

The changes can them be monitored weekly by the QM to ensure that they comply with the standard (This was the compromise accepted by the auditor for such 'vagrant flexibility').

Finally, i agree that it does not matter what you write, or where you write them, they are unlikely to be looked at again. Of course if they are once created and the personnel trained, possibly there is not need to look at them again if they are not changed.

In reality the best thing is to do is carryout 'Work Instruction reviews' as part of a Internal Auditing/Continuous Improvement programme. Otherwise do not let it break your heart if your beautifully constructed manual or Intranet is never reviewed by anyone.

Lastly, i always insist that new employees are given an introduction to the system in their first few weeks, this is the time to catch them before they develop bad habits.

Regards




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Andy B