Form Change Control - Should forms be cosigned?

D

darkafar

#1
Our customer told us to follow the cosigning procedure when the forms are changed. I think the best way to show this is to let the cosigners sign the forms. This brought a question, should the forms be cosigned? Most forms I saw don’t have cosigners’ signatures. Most people I meet are against the idea. ISO/TR10013 did not say the forms should have cosigners’ signatures.

Then how can I meet customer’s requirement-the forms should go through the cosigning procedure? I think the customer’s requirement is quite reasonable.
 
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Wes Bucey

Prophet of Profit
#2
ISO/TR 10013:2001
Guidelines for quality management system documentation
[FONT=arial,helvetica][SIZE=-1]International Organization for Standardization (Technical Report)
[/SIZE][/FONT][FONT=arial,helvetica][SIZE=-1]01-Jul-2001 [/SIZE][/FONT]
I am not familiar with any Standard requiring "cosigning." In nearly 40 years of dealing with Quality Systems, I have seen some paperwork processes which called for redundant signatures.

The process of "document approval" for new or revised documents may be what your customer refers to. We may have a translation issue when you speak of "forms" - most forms are merely data entry sheets and may be frequently modified for typography, letterhead, etc., but the data to be entered remains the same whether the data entry box is at the top or bottom of the page. Such minor changes may be left for only one person to change and approve, BUT the change must be communicated to EVERY person concerned and decision made whether to continue using old forms until they are used up or to withdraw old forms and issue the new ones.

I have some suspicions about the reason for the customer's request. I suspect there have been some instances of nonconformance or mixed use of old and new forms because the change was not communicated to everyone and old forms not withdrawn.

Alternately, if we are talking about documents other than data entry forms, a product or service could have been made to the old document instead of the new one. You indicate a relatively small organization. The customer may feel there is a high probablity one of the two cosigners would catch a mistaken use of wrong document.

Will you please tell us the circumstances surrounding customer' request?
 
D

darkafar

#3
Our forms are kind of different. They are not merely data entry sheets. Some forms have important criteria printed on them, and the change of these criteria might invoke ECR. So the forms are used to entry data as well as to give a conclusion. I prefer to treat them like ordinary documents.

I justify the customer’s requirement, because some engineers seek to bypass the ECR procedure. If we leave the authority of changing forms to a single engineer, he might abuse this authority, and don't go through the ECR procedure.

There are indeed some instances of mixed use of old and new forms and the customer indeed discovered them. So we stipulated in the procedure that when the new forms are released, the old forms become obsolete at once, but the customer seems unsatisfied.
 

Wes Bucey

Prophet of Profit
#4
In the case you describe, merely saying the documents are "obsolete" is no longer sufficient, since you got caught. You need a proactive process to collect old documents and have signoff from everyone who could possibly use the old document they are aware the old document is withdrawn and the new document is in effect.

Please research the concept "configuration management."
 
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