Document Control Defined? Determining what documents must be controlled

[ScottK]

My rules of thumb:

when it comes to work instructions or procedures if it's worth documenting it's worth controlling.

As far as records - if you or your customers or a regulatory body require you maintain the record, it must be controlled.

Defining how you "control" is another ball of wax...

 

[JoAnne W]

I have worked in multiple type of Manufacturing and what I teach the organizations is "if the absence of instruction, procedure etc... adversely affects product quality or the company. then it should be controlled".

 

[Randy]

Are you talking about documents in a 9001 based system? If so the answer has already been supplied to you and you're failing to recognize it. The answer to your question is very clearly defined and documented in clause 4.2.1., it's up to you to figure out how to apply it to meet your needs. All this other stuff being previously told to you is nice and cool and neat, but the standard itself has the answer you need.

Now if you're wanting the specific names of "all" the documents you have to control, the task of counting the stars in the sky would be more easily accomplished.

 

[Jim Wynne]

Are you talking about documents in a 9001 based system? If so the answer has already been supplied to you and you're failing to recognize it. The answer to your question is very clearly defined and documented in clause 4.2.1., it's up to you to figure out how to apply it to meet your needs. All this other stuff being previously told to you is nice and cool and neat, but the standard itself has the answer you need.

Now if you're wanting the specific names of "all" the documents you have to control, the task of counting the stars in the sky would be more easily accomplished.

If only everything were as clear-cut as you seem to think it is, 75% of this forum would be unnecessary. Perhaps the OP is looking for advice on "how to apply it to [her] needs."

How about an example question: I have a form that's used to record final inspection results. Does the form need to be controlled? Please look in 4.2.1 and give us the "clearly defined" answer.

 

[JaneB]

We are currently putting together a team to "DEFINE" what criteria to use to determine what documents should be controlled and what doesn't need to be controlled. So if it meets this....controlled, if it doesn't meet this...doesn't need to be controlled. My personal opinion is that if an organization has a process that is critical to the end result customer (building something, contracts etc) it should be documented. Thoughts?

I feel for you Hillary. Best of luck in trying to come up with such criteria, but as you've perhaps seen from the range of answers, it's a ticklish question.

The broad criteria for things that DO require control have already been given along the lines of a document being one that has a bearing on the quality of your product or service, and where people need to have the correct information. But that, of course, is very broad! And you'll also have seen that many people will speak (not unsurprisingly) from their own context, be that aerospace, manufacturing, or whatever.

It really will vary, depending upon the nature of your organisaton and the types of documents it deals with. It would be helpful if you provided some background information that gives me some idea of these. Then I can can give you some examples of the types of documents that typically need control in such an organisation.

But I still doubt you will be able to get the criteria beyond anything necessarily broad.

 

[kgott]

I can appreciate the dilema JaneB articulates here and as I see it, its get even more complex when one tries to determine if, and if so, to what extent, does a given document impact on "the effective planning, operation and control of (its) processes." (4.2.1)

A previous employer of mine was given an NC by the certification body because the results of an electrical device (a light bulb in a circuit) test that only determines if electrical current flows or does not flow, were not recorded. If current did not flow the circuit was inspected to the find the reason why and fixed and retested.

They argued that the results were integral to the manufacture of the component and therefore the results were part of the quality records of manufacture. (The strength of current in the completed product circuit was measured at a later stage and recorded.)