Control of Documents Scope - Product Specifications

neash83

Starting to get Involved
#1
Hello all,

I'm just looking for some further clarification and opinions as to the scope of the Control of Documents clause in 9001.

Would you be of the opinion that it applies to product specifications?

We have internal product specifications that detail the components, components numbers, dimensions, colours etc and while these are controlled to a usable extent, they aren't controlled in accordance with 4.2.3:
-Changes do not appear to be identified between revisions
-There doesn't seem to be a formal approval route between revisions

I want them in accordance with the standard irrelevant of the scope of 4.2.3, but won't have the same clout in getting it this way if they are considered outside the scope of 4.2.3.

So thoughts????

Thanks
 
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#2
The answer would probably found in 4.2.1 d). Are these documents necessary for the planning, operation and control of your processes? In other words, if the documents were incorrect, would it have negative impact? If the information correctness is important, then they have to be controlled.

ISO 9001 is very general as to how these will be controlled. In the two areas you mentioned (identification of changes and approval), there is a lot of flexibility. Your use of the word "formal" brings an image of filling out some form, and having sign-offs for the document. But that might not be necessary. Don't tie your hands here. You want control, but it must be balance with the amount of flexibility that you need. Too much of either can create a system to fail.
 

insect warfare

QA=Question Authority
Trusted Information Resource
#3
On top of what Dave has said, 4.2.3 (c) more specifically requires that "changes and the current revision status of documents are identified". This can mean very different things to very different companies.

For example, "changes" (such as revision history tables for controlled documents) may be present in every document at one company, but at another company those changes would not be readily available to its user, but rather these tables might be stored on a local machine, and only made available by the document controller upon request.

Likewise, "current revision status" may mean a version number or letter to one company, but to another it may mean simply "approved" or "draft" or "obsolete".

Whatever your case may be, the core component to meeting this requirement (or any other requirement) is how "effective" it is at achieving the results you had planned to achieve. Gap analyses and internal audits should be the first weapons you use to evaluate and determine if such controls are in fact appropriate and effective. NOTE: "Effectiveness" is defined in ISO 9000:2005 as the "extent to which planned activities are realized and planned results achieved".

Brian :rolleyes:
 

neash83

Starting to get Involved
#4
Thanks for the opinions.

The reason I think it needs to be controlled better around the two issues I mentioned is because of the importance of the product specifications within the business.

If the product specification changes during the lifecycle of a product it requires external recertification (managed by QA). Now obviously if we don't have a formal approval route for new revisions, changes can get made to the specification without QA being aware. While I've not found any objective evidence (yet) I'm fairly confident there will be incidents in which this has happened, meaning we will have product specifications which do not tie up with their original external certification due to uncontrolled amends.

My second point around change history ties in with this, if product specification revisions are occurring and even if they were controlled 100%. QA would still need to specifically know what those changes were in order to acquire the necessary recertification.

Thanks again.
 
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