ISO 9001 Documentation Control

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!

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

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

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

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

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.