Ensuring Documents of External Origin are Identified and Distribution Controlled

[Crodge]

In need of some help… I am running out of time before we have our Audit and have so much work to catch up on!!

The requirement states that we have to “ensure that documents of external origin are identified and their distribution controlled”… Can anyone give me some pointers as to a good way to do this please. We are a services / manpower company and we receive many documents memos etc (some with a high security content, some without) How do I go about identifying them? What do you do?

Also, with one of our contracts the procedures we use for our staff are provided by our customer, is this acceptable or do I need to write a whole new lot of procedures?

I may be posting quite a bit over the coming weeks, hope you don’t all get bored with my questions.

Thanks

 

[mshell]

I pulled this from our document control procedure. It may need a little work but it should get you started.

EXTERNAL DOCUMENTS
The ASQ Q9001-2000, Quality Management Systems Requirements, ASQ Q9000-2000, Quality Management Systems Fundamentals and Vocabulary and ASQ Q9004-2000, Quality Management Systems Guidelines for Performance Improvements are documents of external origin that shall reside in the ISO Coordinator’s office.

Electronic Drawings
Upon receipt of an electronic drawing, the employee receiving the drawing will forward it to the Engineer Tooling Design & Fabrication and delete it from his/her system. The Engineer Tooling Design & Fabrication will save the drawing in the applicable folder (Preliminary, Quote, Controlled, Obsolete) depending upon what stage the product is in (Design & Development, First Article, etc.). These folders are located on the network server with permissions applied to preclude their modification. The System Administrator, Engineer Tooling Design & Fabrication and the Vice President of Operations are the only personnel with these permissions.

Printed Drawings
Customer/Vendor provided drawings shall be identified “Controlled Document” and filed within the Drawing File for the applicable part number. When a Customer drawing has been replaced it shall be identified “Obsolete” and filed within the appropriate obsolete drawing file. Obsolete Vendor drawings are discarded upon receipt of new drawings. Other miscellaneous documents of external origin received from the customer/vendor shall be maintained within the applicable Miscellaneous/Quote File and/or Vendor History File.

Management personnel are the only personnel permitted to retrieve Customer/Vendor drawings and/or Miscellaneous Quote Files. When retrieving a drawing or quote file, personnel must sign out the applicable file in the Customer Drawing & Related Information Log, QF-31D. The Customer Drawing & Related Information Log, QF-31D shall be maintained in accordance with OP 4.3Z, Control of Records.


I hope this helps.

 

[Douglas E. Purdy]

External Documents Library

Crodge,

This is not a cure all, but I establish an external Documents Library that typically controls external Industry, Requlatory, & Statutory Standards and Specifications. A Master List of these documents is maintained as well as a Controlled Distribution if any copies are being utilized in the performance of a function.

Doug

 

[Laura M]

In your description of receiving "memos" that sounds job specific to me. Still an external document, but I would think it is identified with the specific PO, and retained with that job. If the memo changes a drawings or specification, it can be process like a change order, then relevant docs are updated and the memo may or may not need to be retained as proof of authorization.

Other external documents (standards, manuals, customer specific specifications) may have application across several jobs and need a library type system.

At one company, we have a very small library, and many other external documents. Because it wasn't cost beneficial to purchase updated documents as they were revved - not knowing if a customer spec would ever reference them again, we simply state that for any reference specifications in customer contracts, the engineer responsible will ensure the latest version of the document is obtained.

 

[Todd_w]

Ruling please

In order to define, limit and make value added this requirement, we are using the following definition for documents of external origin:

"“Documents of External Origin” are procedures, standards and instruction manuals developed by companies or agencies outside (my company). Examples are:

Customer-supplied test methods
Industry, national or international standard test methods used as work instructions
Equipment/Instrument manuals
Industry specifications

When these documents are used without modification within the quality system or when they are explicit directions in company policies, procedures or work instructions to use these documents, they must be controlled."

The last paragraph limits the scope of these doc's. Can anyone comment as to whether they believe this statement to be within the "intent" of the standard?
Todd

 

[Matt F]

Hi

Can anyone help along the same lines. We having test methods and similar standards controlled by ISO. A list/library of these documents is all well and good but we're having problems how we identify that the standards are always up to date. If we're carrying out 10-20 tests a day do we need to physically check the revision of the standard that many times? Overkill I know but just an example.

Would checking the standard every, say, 6 months and whenever a procedure/process which relates to that test methods is changed be suitable to satisfy 9001?

Thanks

 

[SteveK]

Hi

Can anyone help along the same lines. We having test methods and similar standards controlled by ISO. A list/library of these documents is all well and good but we're having problems how we identify that the standards are always up to date. If we're carrying out 10-20 tests a day do we need to physically check the revision of the standard that many times? Overkill I know but just an example.

Would checking the standard every, say, 6 months and whenever a procedure/process which relates to that test methods is changed be suitable to satisfy 9001?

Thanks

Matt,

You cannot be too far away geographically! If you are worried about standards (and therefore tests) being up to date etc, one way is to be a member of BSI (like I am – this is not an advert!). If you register all the standards you have/require with them, amongst other things, they will automatically send you updated standards, their status etc (obviously this costs but as a member usually 50% of normal rate). The free option is to go to www.bsi-global.com to check what is current.

Steve

 

[JaneB]

Another free method is to register with something like 'Standards Watch' at www.saiglobal.com.au

You'll then get an automatic notification by email if a Standard changes.

It's a bit fiddly to set it up in the first place (not 100% intuitive) but you can't beat the price!!