Controlled Document vs. Uncontrolled Copy - Stamp requirements

W

wonderfulong

#1
:eek: :mad: Dear all,
One of our customers auditted us for such NF:" None of the controlled documents shown to audit team had the required stamp nor identification number"
We explaint that these documents are not released to them and they are original documents with authorized signature.So we don't stamp these controlled documents.But they still give us a NF.

Do all controlled documents includes the orginal hard copies should be stamped with"controlled copy". The meaning of stamp "controlled copy" on the document is to recogize or notify the holders of documents that they get the most update one.If we don't release to anyone, should all documents should be stamped too?IF that is ture,When we want delete some documents, then there will have 2 stampes on the paper,which do confused us!!!

Any comments, your veteran guys?
 
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S

sridharafep

#2
D&c

In my view, you can have them without any stamp if the documents not moved from the master location. If you distribute them then it should have a reference for the status.
 

Wes Bucey

Quite Involved in Discussions
#3
wonderfulong said:
:eek: :mad: Dear all,
One of our customers auditted us for such NF:" None of the controlled documents shown to audit team had the required stamp nor identification number"
We explaint that these documents are not released to them and they are original documents with authorized signature.So we don't stamp these controlled documents.But they still give us a NF.

Do all controlled documents includes the orginal hard copies should be stamped with"controlled copy". The meaning of stamp "controlled copy" on the document is to recogize or notify the holders of documents that they get the most update one.If we don't release to anyone, should all documents should be stamped too?IF that is ture,When we want delete some documents, then there will have 2 stampes on the paper,which do confused us!!!

Any comments, your ve:eek: teran guys?
Welcome to the Cove!:bigwave:
We have an often used response here in the Cove when we encounter situations like this:
"Show me the 'shall'!"

This simply means you are not required to accept any finding from a customer's auditor or a third party auditor unless they can cite chapter and verse in a document you agree applies to your operation which proves the assertion of nonconformity.

There is absolutely no comment anywhere in ISO 9001:2000 nor TS16949 nor AS9100 which addresses the issue of stamping or signing any documents. The only possible alternate documents which can contain a procedure you don't conform to in this instance are
  1. Contract between you and customer
  2. Your own written procedures or work instructions.
I doubt the contract from your customer would be so specific, so the only remaining option is your own procedure. There is a possibility you have adopted a procedure from another organization which does not exactly fit your operation. If this is the case, you may accept the finding of nonconformance and formally change your procedures to eliminate this requirement which does not seem to apply to your operation. Thus you will have implemented a Corrective Action which should satisfy all parties.

Moral:
If an organization adopts a Procedure, it must abide by that Procedure or be nonconforming to its own rules. It is necessary, therefore, to look carefully at all your Procedures (the purpose of an internal audit) and see whether or not the members of the organization follow those procedures.

If the procedures are not followed, two courses of action are available:
  1. require employees to follow procedures
  2. modify the procedures to something which makes sense and which employees can follow.
 

Helmut Jilling

Auditor / Consultant
#4
Wes' answer is accurate and well stated. And, I fully agree with his comments.

I did have one question. If I read your original statement correctly, it implied you do not distribute controlled documents. If you use these documents, for instance, on the shop floor, those kinds of copies need to be controlled - using whatever methods your procedure requires. However, I agree, the auditor's copies do not need to be stamped or controlled.

There are simpler methods than using stamps and all that.
 
W

wonderfulong

#5
Wes,
Thanks for your reply!
We have our Document Control Procedure,which did't define when and how stamp the document.The customer auditor doubt our methods if we can control our document very well!They have their own approach ,but they seemed force us to use theirs.But we are in two defferent industries.We are logistics service provider and they are in manufacturing .
 

Wes Bucey

Quite Involved in Discussions
#6
wonderfulong said:
Wes,
Thanks for your reply!
We have our Document Control Procedure,which did't define when and how stamp the document.The customer auditor doubt our methods if we can control our document very well!They have their own approach ,but they seemed force us to use theirs.But we are in two defferent industries.We are logistics service provider and they are in manufacturing .
At this point, I suspect several things, but I can't be sure because I don't have both sides of the story.
This quote
required stamp nor identification number
is pretty specific. Where do the auditors get the idea that the stamp and identification number are required?

If they found something in your own documentation that requires this, then you have to follow my suggestion above in post #3.

If they are citing their own rules or procedures, they have to demonstrate where your organization contractually agreed to follow those rules or procedures.

Practically speaking, though, this is a situation which calls for tact and you probably will have to elevate the discussion to higher level bosses to negotiate a compromise which is livable and workable for your organization and yet gives the customer assurance you can, and do, make sure no obsolete or unapproved document can reach a point in your production where your workers will make an error by following a wrong document.

I apologize that these sentences of mine are complicated and complex for a non-native English speaker.

Here's the short and sweet version.
  1. Customer wants to be sure nobody uses old or unapproved documents when working on his stuff.
  2. Customer's auditor was not convinced by what you said or showed him.
  3. Customer's auditor will feel secure if you use his method.
  4. You and your bosses have to decide whether to convince auditor's bosses your method works
    OR
    You and your bosses have to swallow pride and adopt customer's method to keep customer happy
  5. If you make the change to satisfy customer, you have to decide if you deserve more money from customer because he has changed the terms of the contract by forcing you to adopt his method of document control.
Please come back and tell us how it all works out for you.
 
A

alekra

#7
Question to Wonderfulong

Wonderfulong,
Would you mind telling us how do you control your documents? Do you fullfill the requirements of ISO 9000? What is written in your Control of Documents Procedure?
 
W

wonderfulong

#8
Wes Bucey said:
Welcome to the Cove!:bigwave:
We have an often used response here in the Cove when we encounter situations like this:
"Show me the 'shall'!"

This simply means you are not required to accept any finding from a customer's auditor or a third party auditor unless they can cite chapter and verse in a document you agree applies to your operation which proves the assertion of nonconformity.

There is absolutely no comment anywhere in ISO 9001:2000 nor TS16949 nor AS9100 which addresses the issue of stamping or signing any documents. The only possible alternate documents which can contain a procedure you don't conform to in this instance are
  1. Contract between you and customer
  2. Your own written procedures or work instructions.
I doubt the contract from your customer would be so specific, so the only remaining option is your own procedure. There is a possibility you have adopted a procedure from another organization which does not exactly fit your operation. If this is the case, you may accept the finding of nonconformance and formally change your procedures to eliminate this requirement which does not seem to apply to your operation. Thus you will have implemented a Corrective Action which should satisfy all parties.

Moral:
If an organization adopts a Procedure, it must abide by that Procedure or be nonconforming to its own rules. It is necessary, therefore, to look carefully at all your Procedures (the purpose of an internal audit) and see whether or not the members of the organization follow those procedures.

If the procedures are not followed, two courses of action are available:
  1. require employees to follow procedures
  2. modify the procedures to something which makes sense and which employees can follow.
Wes,
Many thanks for your very thoughtful and detailed answers!
I do understand your words clearly,though my English is not very well as a native english speakers.:)
Recent days till this afternonn, we are still working on their audit.We reviewed our CAR for a long time.Seems the stamp problem is less argued....At least they agreed that we could not stamp on our original documents.But here is the big concern both in our internal parties and our customers that if we should control all documents like SOP,WI or flowchart.
We are a very big joint venture enterprise in world wide.We have many branches in whole China with many defferent types of operation,like freight management ,contract logistics,etc..In order to maintain our Quality and Safety system(registered in ISO9001,OHSAS18001) in high efficiency, we will not or unable to controll all SOP,WI ,Flowchart in our corporated QSH system.Then ,some of SOP ,WI,flowchart specialzied for certain departments or certain customers will be controlled by department themselves.As a quality engineer and MR of corporate, I am supposed to controll all these documents of our QSH system.However, what our auditor found some flow charts without any info on approved or controlled stamp on it.So they gave us an NC.So I stand at a nonplus!If we controlled all SOP,WI or flowchart.then our QSH manual will be piled to hill,which cause numerous paper working and low efficiency to update.So we would like to develop another document control process specialzed for this auditted station which define one of their department will controll those important documents whereas the MR.
Do you think this approach is workable?or what your better suggestions.

Another queries:Do all SOP,WI,flowchart of key process or speical process should be controlled?If yes, then how to balance the numerous documents VS an efficient quality managment system?Could I ask each station develop their own internal document controll process to controll their own important documents.
 
W

wonderfulong

#9
alekra said:
Wonderfulong,
Would you mind telling us how do you control your documents? Do you fullfill the requirements of ISO 9000? What is written in your Control of Documents Procedure?
alekra,
we registered for ISO9001,and OHSAS18001.
Our document control process have clearly defined who will initiate whill are authorized to approve,how stamp the controlled documents only when need release controlled copies to related parties etc.....
There is not evidence that our auditor find that the documents of our QSH system are noncontrolled.
 
A

alekra

#10
wonderfulong said:
However, what our auditor found some flow charts without any info on approved or controlled stamp on it.So they gave us an NC.So I stand at a nonplus!If we controlled all SOP,WI or flowchart.then our QSH manual will be piled to hill,which cause numerous paper working and low efficiency to update.So we would like to develop another document control process specialzed for this auditted station which define one of their department will controll those important documents whereas the MR.
Do you think this approach is workable?or what your better suggestions.

Another queries:Do all SOP,WI,flowchart of key process or speical process should be controlled?If yes, then how to balance the numerous documents VS an efficient quality managment system?Could I ask each station develop their own internal document controll process to controll their own important documents.

Wonderfulong,
It depends on the way your precesses are described and realized and if the steakholders really need controlled documents. I think the best way for all is to introduce the easier control you can, for example:
- if you use eletronic documents or intranet, use stamps with the words: "uncontrolled when printed" or "valid for 24 hours after printed"
- if you use printed copies, you can xerox and stamp the number of the controlled copy, protocoll (hard work, I´ve done this a lot in my life...) or try the "uncontrolled copyies" or "specyfic copies" (I´ve seen this for technical drawings once)

Of course you can delegate the controll for the different areas, but the committment is another risk that must be considered.

Please, keep us "informed" and good luck!
 
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