Form Number for Master List of Controlled Documents - ISO 9001:2000

We are preparing for for ISO certification in 2007. We have an excel workbook called "Master List of Controlled Documents" wherein we have about 15 tabbed worksheets that record procedure., rev., level, controlled locations etc.. in order to fulfill clause 4.2.3.

Do we need to maintain a form #, rev level and revision history for a database that is dynamic and not normally used or distributed as hard copy?If so, there does not seem to be a way to accomplish this other than create custom footer for every page, and revise it as required after every change.

Does the form# and rev. level have to be seen on every page if we print this? Pure muda in my book!

Will a simple, non-printing statement as to form#and Rev. in file/properties/summary meet an auditor's expectation?

Thanks for your help with this long-winded question.

Paul

Re: ISO 0991:2000 Form number for Master List of Controlled Documents

I don't. It's a living document and its only use is as an electronic filing cabinet. I don't put a revision on my filing cabinet everytime I add, subtract, or modify a file folder in it.

Re: ISO 0991:2000 Form number for Master List of Controlled Documents

Do what your procedures say.
If your procedures don't call out a Master Document List, don't control one.
If your procedures call one out then you better have one.

I call one out because it's handy and auditors seem to like them, but I could just as well open the folder on the network where our controlled copies are kept for an auditor if he/she wants to see a list of our controlled documents.

Re: ISO 0991:2000 Form number for Master List of Controlled Documents

SteelMaiden said:

I don't. It's a living document and its only use is as an electronic filing cabinet. I don't put a revision on my filing cabinet everytime I add, subtract, or modify a file folder in it.

Click to expand...

Excellent point. It's the same thing I think of whenever I hear someone referring to a "computer error." No one ever blames file cabinets for their own mistakes.

Hello Paul:

If it is pure muda, then don't do it. All of the requirements that you have to meet related to control of documents are listed in 4.2.3 of ISO 9001:2000.

Most companies don't do the following but I cannot stress this enough. First define what a "Controlled Document" is and why your organization does it. Define the principles of the "Control of Documents." Once you have defined the principles of the Control of Documents, then you can begin to apply those principles to any type of document and decide for yourself if it needs to be *controlled.*

Also, there are many, many threads on this type of discussion. Find those other threads at The Cove. In those other threads, you will find references to supporting information also.

Lots of discussion on "Does our XXX document have to have a date and revision number?" "Are we requried to put a date on every document?" Do we have to use a letter to identify revisions or can we use numbers?"

Regards,

Dirk

vanputten said:

Most companies don't do the following but I cannot stress this enough. First define what a "Controlled Document" is and why your organization does it. Define the principles of the "Control of Documents." Once you have defined the principles of the Control of Documents, then you can begin to apply those principles to any type of document and decide for yourself if it needs to be *controlled.*

Click to expand...

Right on. This seems like such a simple concept, but you're right--it's often misunderstood or missed altogether.

I agree with Steelmaiden and Jim. Basically, it is an electronic filing cabinet. The information going into it has to be right but the actual 'cabinet' does not need to be numbered. I use a freeware program called MyDMS. We refer to it in our documentation system as the storage location for all of our information. We don't have any paper copies other than forms and all info about the documents is recorded in the electronic file.

Take a look at these sceenshots of the MyDMS program. We have been using it for about three years and have had NO issues with it at all. It maintains all of our documents, revised copies and numbering system.
PS: I am in no way affiliated with or benefit from MyDMS. I just endorse it and always have at the cove.

Paul

In my opinion many people go overboard on this clause. Let's get back to basics. Documents should be easily (and uniquely) identifiable just so there is no possible confusion (errors) in knowing what document you are talking about and so they can be easily found and managed.

All this guff about Issue & Revision is, although relevant for large organisations, a load of muda as you say.

Document numbers can be handy or a pain. Its handy to say Form 123 instead of a long title but a pain if you have complex document numbering systems. For simplicity, I would use the document title and date as the Document ID. And it helps but not needed to have other useful info like type, brief description, author/owner/responsibility etc.

I would not advice having your documents on different spreadsheet tabs. Have them all in one long list with a column to group them. The column would equate to your tab name. You can then simply use excels filter function to filter the list if ever you need it.

The key is the extent (and complexity) of your document control should be right for your business. Screw what the auditor expects. Just prove that no errors can occur through people using the wrong documents. And don't forget that documents must be periodically reviewed so it may be wise to show when last checked and by whom.

I would make maximum use of windows and ms-office features. Word knows when a document was Last Modified and you can set documents to print properties like last modified date in the footer.

Thanks to all of you for your prompt responses, perspective and advice. This has been a big help. As a new member to this forum, I am very impressed.

The preparation for certification seems to be a constant battle between the need be sure of compliance, and the necessity of a utilitarian approach, otherwise known as K I S S. It seems that time spent up front is multiplied in savings over time through a QMS that really works for the registered company.

Back to tha battle...

Best regards,

Paul