4.5 Document Control and Shop Aids - Do shop aids need to be controlled?

J

Jim H

#1
#1
Do shop aids need to be controlled under 4.5 other than to mark them "Shop Aid" and document that shop aids are not controlled? By shop aid I mean a drawing that is "marked up" by an operator so that he may perform his job more efficiently. As long as he does not change the intent of the drawing and uses it to highlight important areas.
 
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D

David Mullins

#2
#2
What if I spent may hours writing a procedure for a critical activity, and then gave a copy of the procedure to the one person who was going to use it but I didn't bother to control the document, would I have a 'quality system'?
I would say not. The poor person performing the task is relying on the fact he has the correct and latest data - if the drawing is not controlled how can we prove that he has?
I would expect that the drawing number and issue status is controlled by the drawing office.
The term "marked-up" worries me. If marking-up involves any changes to the numbers or specifications on the drawing, then the marked-up copy needs to be returned to the drawing office so that the drawings can be updated to a current state. If you didn't do this, firstly your inspector (presuming some form of checking by yourself or customer)would hit the wall because things don't match, secondly if you gave the non-updated original drawing to another operator and said make this thing, you will not get an identical product.
All of this raises the potential for questioning the design approval process and much more!

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B

barb butrym

Quite Involved in Discussions
#3
#3
someone needs to authorize the mark ups, and it must be clear to anyone what the original drawing and revision is..typically an initial and date label is enough...a procedure for local control allowing this needs to be in place. I see your question as highlights, color coding, operator specific stuff..not global...am I right?
 
Marc

Marc

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#4
#4
The original is controlled, correct? So - if it changes (officially) it will be replaced. As is noted above, the question is "What is marked?" If the operator, for example, makes notes on the document which do not change the document (such as dimensions) I see no problem. The auditor is going to be suspicious, however, and ask questions: "Why does the operator need to mark up drawings with....?" "If it's important enough for the operator to mark up the document, should those markups not be officially added?"

If you can provide a decent answer, you should be OK. I see this quite a bit in machine shops where operators make notes on prints quite often. The print is controlled, however, so the print (or other document) had best be the latest release.

Barb said: "...someone needs to authorize the mark ups..." which is true if any criteria is changed. I might also discuss the 'markups' with the operator to see just why s/he puts the markups there and whether communication is maintained. If the operator indicates s/he 'needs' the markups, I would have questions about the adequacy of the document in and of its self.

A last thought is consideration as to whether operators take info from one controlled document and put it on another - which I see quite often. In that case there is a problem. If the derivitive document (from where the info came from) changes there is no guarantee that the note(s) on the receiving document will be changed - which is obviously a problem.

Just some thoughts.
 
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