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Author Topic:   Controlled Documents
roadrunner5_2000
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posted 07 April 2000 08:43 PM           Edit/Delete Message   Reply w/Quote
A question was brought up today on the subject of how many copies of a controlled document a person can have that is stamped "Controlled Document".All the copies are of the same document.
Our policy does not cover this nor can we find anything mentioned in the QS-9000 3rd edition QSR.
Anybody know?
One person here says he can have as many copies as he wants all stamped "controlled".
and only he can make changes.

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barb butrym
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posted 08 April 2000 03:40 PM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
what is your definition of control? Typically it means that if a change is made, the "copy" is retrieved and replaced...or some variation of that.

so ...the answer then becomes,,,,as many copies as he needs, as long as they are retrieved and replaced when updated...so that would have to be noted somewhere....perhaps a master distribution list? Potentially dangerous ....a 'gimme a nonconformance' situation.

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Marc Smith
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posted 08 April 2000 08:36 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
quote:
Originally posted by roadrunner5_2000:

A question was brought up today on the subject of how many copies of a controlled document a person can have that is stamped "Controlled Document". All the copies are of the same document.


True - you can have as many as you want.
quote:
Our policy does not cover this nor can we find anything mentioned in the QS-9000 3rd edition QSR. Anybody know?

One person here says he can have as many copies as he wants all stamped "controlled" and only he can make changes.


The key is that every 'controlled' copy, whether 1 or 1000, has to be identified - there has to be a distribution list or other mechanism to ensure that every copy is defined and accounted for and that when a change is made to the master document each 'controlled' copy is addressed.

How you address the change is up to the company. You can send each 'owner' a memo which advises them of the change and says something like "It is your responsibility to remove the prior version from your manual and destroy it". I have also seen some companies that require that the old version be returned to the document owner/distributor or that a signed form be returned where the recipient 'swears' that s/he understands the change, has removed and replaced the old version. In extreme situations (I used to see this in my military manufacturing days) you send someone out to physically take the old document and replace it with the new document. In those days if you 'lost' a controlled document that was issued to you, you had to sign a statement to that affect before you got your copy of the latest revision.

The question is, how many controlled copies do you need?

Also - don't forget that often a document change requires training on the document revision(s).

Much of this is becoming moot by electronic control and distribution.

[This message has been edited by Marc Smith (edited 08 April 2000).]

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AJPaton
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From:Fayetteville, NC USA
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posted 10 April 2000 09:13 AM     Click Here to See the Profile for AJPaton   Click Here to Email AJPaton     Edit/Delete Message   Reply w/Quote
We've moved to an electronic drawing database for most of our controlled documents, which simplifies paper control.
However, everyone who actually works with the product likes a paper copy of the product in front of them.
Our ISO auditor said all data used to perform a job must be controlled, and our printouts are not.
We've talked about putting expiration dates on the printouts or a datestamp and a procedure stating that X# of days after the printing the document has expired.
This doesn't seem to cover ISO 4.5.2 "Invalid and/or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use".
How much do we have to do to satisfy our auditor that we're "assuring against unintended use"? Do we have to do daily sweeps of the work areas to pick up expired documents?

Thanks,

AJP

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Marc Smith
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posted 10 April 2000 11:02 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
quote:
Originally posted by AJPaton:

We've talked about putting expiration dates on the printouts or a datestamp and a procedure stating that X# of days after the printing the document has expired


This should satisfy the '...or otherwise assured against unintended use..." requirement. I would stamp each document footer.

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Jim Biz
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posted 10 April 2000 03:09 PM     Click Here to See the Profile for Jim Biz   Click Here to Email Jim Biz     Edit/Delete Message   Reply w/Quote
I have observed similar instances where documents are controlled mainly in electronic databases > what was done was to insert at the top of the document "valid on print date XX/XXx only"
(But I wouldn't be real sure that some external auditors would allow it.)

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David Mullins
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posted 10 April 2000 09:28 PM     Click Here to See the Profile for David Mullins   Click Here to Email David Mullins     Edit/Delete Message   Reply w/Quote

ROADRUNNER: Anyone can make changes to this guys documents, not just him, but they do have to go through the review and approval cycle. If he has multiple copies of the same documents (and same versions) find out WHY, or is he simply off his medication.

AJP: It sounds like you still have a hard copy drawing system with electronic file backup. If that's what they want, then I'd describe the system that way. Hard copies = controlled documents (no expiry dates), and electronic back-up of files is provided for safeguarding data, and for future revisions. In a conventional QMS it's just like having hard copy documents distributed, while the original WORD file (or whatever) is kept on your PC - no different.

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AJPaton
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From:Fayetteville, NC USA
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posted 11 April 2000 05:35 PM     Click Here to See the Profile for AJPaton   Click Here to Email AJPaton     Edit/Delete Message   Reply w/Quote
Nope, we have a electronic drawing system, controlled by our off-site design center (with their own ISO certification). We're registered to ISO 9001 through their design activities. No design in our plant.
They control the design, we provide computers in each assembly area with access to the electronic drawings.
Problem 1 - the computers don't move to the components being installed so people like a hard copy of what they're building, for occasional reference.
Problem 2 - there's been considerable expense for this system, and it's being considered in other locations.
Summation: we're looking for a simple way to control the printouts and encourage a paperless facility.

AJP

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David Mullins
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posted 11 April 2000 08:46 PM     Click Here to See the Profile for David Mullins   Click Here to Email David Mullins     Edit/Delete Message   Reply w/Quote
AJ,
I'm assuming here you're in the electronic fabrication area.
If you're making prototype or one off jobs, the revision status of the drawing should be sufficient, with the relevant procedure stating that hard copy version status must be confirmed (still not a perfect system). If it takes you several days to fabricate a job, printing "valid on date of printing only" doesn't work either, unless they print off the job every morning. This is not very paper-less.

If you're making a number of components, you're more likely to have processes set up for this and shouldn't need the drawings for manufacture.

Manufacturing also involves "break point" issues, where a particular drawing may become invalid half way through a shift as the design or componentry change.

We do prototype electronic fabrication work using electronically controlled drawings. And yes they print out the drawings for each job. I can send you the relevant procedures we use if you like.

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AJPaton
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From:Fayetteville, NC USA
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posted 12 April 2000 10:26 AM     Click Here to See the Profile for AJPaton   Click Here to Email AJPaton     Edit/Delete Message   Reply w/Quote
I've looked at our system again with the help of the comments, and I'd like to describe it more fully.
Our local facility is an "assembly" plant, of more electrical than electronic components.
Using the parts from other divisions of our parent company, design parts from our design center and parts customed per UL standards we assemble per customer order.
Rarely are two orders exactly the same.
The order paperwork is "paper"-work, and we too have problems with that portion of the system. However, the design center parts and UL standards for custom parts are electronically issued from a remote location.
We're going to try the expiration date system for pre-designed parts, but your procedures might help us with our "job specific" paperwork, David. My e-mail address is patona@squared.com.

Thanks
AJP

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Marc Smith
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posted 12 April 2000 06:50 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
quote:
Originally posted by AJPaton:

Problem 1 - the computers don't move to the components being installed so people like a hard copy of what they're building, for occasional reference.


You train your operators to understand the system - how to find out the current revision of a document. This may be "Ask the supervisor..." or you can teach them to operate the computer. You also ensure your system notifies operators of relevant changes - this is often doine during a shift change meeting. You technically define the copy the operator keeps as Uncontrolled. There is no requirement which says you cannot have 'reference' documents.

This, company to company, may or may not work - in part because one has to take into consideration the turnover rate of the employees performing the work as well as complexity of the operator responsibilities (for example complexity of an assembly operation). You have to use some common sense here.

Let's say you have a low turn over rate (assemblers) and low complexity, consistent assembly - Your assemblers will probably not need much documentation to perform their job.

Let's say you have a high turn over rate (assemblers) and high complexity, but consistent, assembly - Your assemblers will probably need more documentation to perform their job than in the previous 'case'.

When I encounter this at client facilities the first question is: "...so you say you need a copy of the assembly drawing from time to time. Why is this? Specifically what information do you get off of the copy you keep at your station as a reference? Is this information which should be available all the time? Why do you only need the reference now and again?

From the answers to these questions I come up with my plan. Often they really don't ned the reference copy. But I have many clients where the assemblers keep a 'reference' copy. The key to acceptance during an audit is --> The assembler has to be ready to answer the above questions (such as what info do they use and how do they know if there has been an 'important' change) and the auditor's escort (or whoever in management is appropriate) should be ready to explain why this is a low risk situation.

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AJPaton
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posted 27 April 2000 03:54 PM     Click Here to See the Profile for AJPaton   Click Here to Email AJPaton     Edit/Delete Message   Reply w/Quote
We can't get around the hard copies of the electronically controlled documents. Our assemblers may have been around for years, but they have dozens to hundreds of assemblies that they may be called upon to build.
The assemblies are standard, but for instance, our wiring department cannot be expected to remember the exact terminal callouts for each wire on more than 20 wiring assemblies.
The drawings are not for reference only, the assemblers can't remember all the details from looking at the computer screen and then going back to their station, and we're not putting workstations at each assembler's location.
Our solution of putting datestamps on the drawings when they're plotted has run into a combination hardware/software problem. Our IS and ES (Engineering Systems) departments report that the printers and the software used for the drawings will not support a datestamp on the same page.
We're using a short-term solution of manually requiring datestamps on printouts, pending further developments.
Besides bemoaning the "crappiness" of our current hardware and software, (which we are doing quite well, thank you.), any suggestions?
(Hardware - HP plotters, Software - RxHighlight from Rasterex Co.)

Thanks,

AJP

[This message has been edited by AJPaton (edited 28 April 2000).]

[This message has been edited by AJPaton (edited 28 April 2000).]

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