External Document Control Procedure advice wanted

H

hitesh

#1
Hi,

Currently we have a document control procedure in place. It addresses both internal and external document controls.

The procedure is more explicit on internal document control but not on external document control.

As per the procedure, we assign document control number for the addition or revision of an external document but we do not identify the exteral document with any document number, internal document name or issuance date.

For example, If we receive a new ISO standard, it will be scanned and added in the standards library and all affected persons are notified of it. However, the scanned copy does not have any internal document control number, internal document name or issue date.

If any one has effective or proven external document control procedure, please provide me a draft for review. Additionally, I am looking for the criteria to determine if the external document needs to be controlled or not.

Regards,
Hitesh
 
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R

Roland Cooke

#2
Re: External Document Control

I can't (won't!) help with the answer to this one, but I do find this is an area where controls are often extremely weak. People tend to latch on to standards, and maybe regulations, as documents that they need to control, but that is often as far as it goes.

I then spend the rest of the audit pointing out all the other documents of external origin that they have around the place.

Did we identify all documents?

(For a particular one)
Did we write it?
Does it matter if it changes?
If yes, what are our measures to ensure control?
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#3
Re: External Document Control

Name of document
Revision number, date
Who has copies (hopefully) or the documents' locations
Nature of changes since last revision (would be nice, but don't count on it)

Maybe I'm having a weak moment, but for external document control I find little else is needed. But don't just listen to me, feel free to explore the links to related threads - see the bottom of this page.
 
#4
One challenge of 'external documents' is knowing when they are changd. Now, as we all know, ISO 9000 has a much heralded revision, but what of those lesser standards? ANSI's, SAE's, BS's etc. etc.? Who keeps an eye on them to ensure the most applicable version is available?

You'd be well advised to get signed up with an updating service...........they'll look after this task for you for a (somewhat reasonable) fee.
 
R

Roland Cooke

#5
Off the top of my head, in addition to standards and regulations, here are some other examples of documents of external origin that might also require control:


Customer specifications documents
Equipment maintenance manuals
Commercially-available software programmes, which are subject to occasional patching
MSDSs
Supplier documentation, for materials whose information may change over time
 
M

MEDQA

#6
Regarding checking for updates of external documents.

At the very least, we perform an annual document review of all docs that have not been updated in the last year. Part of this is verifying external documents have not been updated.
 

Patricia Ravanello

Quite Involved in Discussions
#7
Off the top of my head, in addition to standards and regulations, here are some other examples of documents of external origin that might also require control:


Customer specifications documents
Equipment maintenance manuals
Commercially-available software programmes, which are subject to occasional patching
MSDSs
Supplier documentation, for materials whose information may change over time
Here's a few more Documents of External Origin which might warrant control:

  • Customer Purchase Order
  • Customer Purchase Order Amendments
  • Service Agreement with Customer
  • Product Engineering Drawings (if customer defined)
  • Engineering Standards
  • Material Specifications
  • Customer-specific Requirements
  • Customer Procedures
  • Customer’s Approved Supplier List
  • Statutory/Regulatory Requirements
  • Labor Laws/Codes
  • Health and Safety References
  • ISO 9001 Standard
  • MSA, SPC, FMEA, APQP, MMOG Manuals
  • Customer-specified Manuals (P.S.O. etc)
  • Equipment/Machinery Manuals
  • Supplier Product Catalogues
  • Equipment Service/Maintenance Agreements
  • Supplier Pricing Lists

Also, I've attached a "Verification Log" for documents of External Origin which is sometimes employed to verify that the latest revision is known and accessible at points of use, and provides a record of the verification process.

Many auditors will ask for the information recorded on this log.

Patricia Ravanello
 

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P

Polly Pure Bread

#9
Re: Can I control externally generated document even without a document code?

I can't (won't!) help with the answer to this one, but I do find this is an area where controls are often extremely weak. People tend to latch on to standards, and maybe regulations, as documents that they need to control, but that is often as far as it goes.

I then spend the rest of the audit pointing out all the other documents of external origin that they have around the place.

Did we identify all documents?

(For a particular one)
Did we write it?
Does it matter if it changes?
If yes, what are our measures to ensure control?
We established a procedure on controlling of externally generated document. I’m not pretty sure if our controls are sufficient or deficient. 4.2.3f says “…to ensure that documents of external origin are identified and their distribution controlled…” We don’t put a document control code. What we are the receiver/addressee identifies EGD through as to what specific area or personnel is concerned with such document. Leaders are responsible for reviewing and approving the EGD prior to use. DC is responsible for registering on external document masterlist, stamping the document “Externally Generated Document”, and routing to recipient. Recipient is responsible for implementing and maintaining the EGD throughout its lifecycle. In case that a revision of EGD is made, DC withdraws the old document and issue new one. Is the existing process can stand without the document code?

:confused:
 

Stijloor

Staff member
Super Moderator
#10
Re: Can I control externally generated document even without a document code?

We established a procedure on controlling of externally generated document. I’m not pretty sure if our controls are sufficient or deficient. 4.2.3f says “…to ensure that documents of external origin are identified and their distribution controlled…” We don’t put a document control code. What we are the receiver/addressee identifies EGD through as to what specific area or personnel is concerned with such document. Leaders are responsible for reviewing and approving the EGD prior to use. DC is responsible for registering on external document masterlist, stamping the document “Externally Generated Document”, and routing to recipient. Recipient is responsible for implementing and maintaining the EGD throughout its lifecycle. In case that a revision of EGD is made, DC withdraws the old document and issue new one. Is the existing process can stand without the document code?

:confused:
A document "code" is not required but you should be able to identify these "EGD" documents (perhaps by title/description) and you have to ensure the up-to-date version. Somebody has to do this. You include this activity in your document control procedure.

Stijloor.
 
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