Controlled Copy vs. Uncontrolled Copy - What are the definitions and differences?

Can someone give me an ISO or QS interpretation definition of what is a "Controlled and Uncontrolled Copy" I would like to know when a company should consider what they must control and what they can consider for reference use only.

[barb butrym]

Its a very fine line.....and sometimes very registrar dependant.

BASICALLY
A Controlled copy is always at the correct/latest revision level. When a change is made, it is retreived and replaced.

An Uncontrolled copy is a bit harder to get you hands around, and is where the variation comes in. Other than it is not replaced when a new rev is issued.....it could mean anything.

What you need to do is define each for your purpose, and control accordingly.

Personally, I wouldn't use an uncontrolled copy for process/acceptance of product unless there is a mechanisim to verify it is at the latest revision.

[Marc]

Any document from which you 'make engineering or other business decisions' (including mfg, etc.) has to be controlled. How to control is a course in its self as there are many, many types of documents and many, many ways to control them.

Any document from which you DO NOT make engineering or business decisions does NOT have to be controlled.

[barb butrym]

So many document types and ways.....that you can have several within one quality system...As Marc says its a course in itself.

You need to clearly define/document what when where and how....and cover the requirements of the standard for approval and retreival in that definition or document.
But if the control is clear and there is evidence that it works...then it should be acceptable. But beware....you may not be seeing the forest for the trees.

Thats why I do Doc Control first when I start a company

This topic always makes me laugh. In my opinion, there is no real difference between controlled and uncontrolled documents.

With both, you must be able to prove/verifiy revision level upon audit. The base line is how do you know you're using the right document, and you need to be using the most current verision at all times because most of what you do affects quality. So whether you call the document controlled or uncontrolled you're still sutck making sure that you have the correct revision before use.

The difference is how good is your distribution system and how trustworthy is it? this is the realy difference, in my opinion , between controlled and uncontrolled documents. One you can trust because it is monitored and controlled, the other you can't so you verify before use.

6 of 1 1/2 dozen of the other.

[Marc]

In my earlier response I over simplified - as is pointed out in the responses that followed.

Rather than belabour the issue, I will say I agree with barb and with Leslie. In addition, there are lots of other documents such as records - another 'document control' issue in the strictest sense.

[Marc]

It's been a while for this thread. Six years after the original, brief discussion, I ask folks now - What are your definitions for each and what are the differences in your opinion? Be as technical as you like!

[Cari Spears]

Originally Posted by Marc

Any document from which you 'make engineering or other business decisions' (including mfg, etc.) has to be controlled...Any document from which you DO NOT make engineering or business decisions does NOT have to be controlled.

I like this alot. I also include in the scope of our document control procedures a statement to the effect that we only control living (revisable) documents. This stems from years ago; a PJ auditor and I "debated" the necessity to control things like a decimal/millimeter equivalent chart - no, I'm not kidding.

Vendors drop these things off all the time and they are hanging all over tool cribs and tool boxes. She argued that they were being used as a work instruction. I argued that if she followed that logic, we'd have to control calendars, machinist handbooks, my old Metrology 101 text book I keep in my office, etc. I argued that there was no need to control these things as they were fact, not revisable. She argued that they should be reviewed for accuracy (like printing errors, typos ) before they were hung out in the shop. She wrote a minor nonconformance, I did not concur and did not provide corrective action. I never heard about it again from the registrar.

I further describe a controlled document as one that is subject to ammendment action. This means I know where every copy of this document is, and if there is an ammendment, I will go get and destroy all of the obsolete copies and replace them with the current revision. I use a colored logo in the header of controlled documents. If the logo is in color, then it is an original, controlled document. If the logo is black/white, then the user knows that it is an uncontrolled copy and that he is responsible for verifying that he is using the latest revision.

For engineering drawings, we use a red "controlled if red" stamp. If the stamp is black/white, then the user knows he is using an uncontrolled copy of a drawing. We allow for this here because we only have one controlled copy in the manufacturing area and that one is attached to the router (another indication that it is the controlled copy) and our machinists often make copies of sections of drawings so they can scribble and calculate.

For documents of external origin - like Supplier Requirements Manuals provided by our customers or MSDS sheets or MIL specs - we also use the "controlled if red" stamp.