Document and Record Control - One Procedure or Two? TS 16949

Jim Wynne

Forum Moderator
Moderator
#2
Re: TS 16949 Document and Record Control

Should 4.2.3 and 4.2.4 control of documents and records be one procedure or two?

What would be the preference?
I don't have a preference, but if I did, it would be in favor of consolidation, on the grounds that the requirements are similar, and the fewer documents the better.
 

AndyN

A problem shared...
Staff member
Super Moderator
#5
My preference is to create two procedures.

I agree that you could have one, but people (in general terms) seem to have a problem differentiating between documents and records and, therefore, the controls required for them. I'm not in agreement that the requirements for control are similar, more that they are the 'alpha' and 'omega' of the documentation.....

Andy
 

Jim Wynne

Forum Moderator
Moderator
#6
My preference is to create two procedures.

I agree that you could have one, but people (in general terms) seem to have a problem differentiating between documents and records and, therefore, the controls required for them. I'm not in agreement that the requirements for control are similar, more that they are the 'alpha' and 'omega' of the documentation.....

Andy
If people aren't smart enough to understand the distinctions, despite having everything written down for them, having separate documents won't help.
 

Dean Frederickson

Forum Moderator
Moderator
#7
I would think because records can not be changed, you would process them differently from documents that can be changed. More to avoid mistakes than anything else, I am trying to say if you have them together and someone goes to change a document and they grab an original record by mistake it may cause serious problems down the road.
 

Jim Wynne

Forum Moderator
Moderator
#8
I would think because records can not be changed, you would process them differently from documents that can be changed. More to avoid mistakes than anything else, I am trying to say if you have them together and someone goes to change a document and they grab an original record by mistake it may cause serious problems down the road.
The question wasn't about mixing documents and records in the same file cabinet, or database, it was about addressing the requirements for them in one written procedure or two.
 

SteelMaiden

Super Moderator
Super Moderator
#9
my addition to this discussion is to do what works for you and not be pushed into something because that is the way someone else does it.

We have, actually, three procedures for document and record control. one for doc control, one for record control, and one for computer back-ups/retreivability. It works for us, but don't do it that way for yourself unless it works for you.
 

Jim Wynne

Forum Moderator
Moderator
#10
I would think because records can not be changed, you would process them differently from documents that can be changed.
The idea that records can't be changed is a common misconception. Do you think that records that are known to contain erroneous information should be allowed to go unamended? At hand is a report from an independent test lab. Two types of testing were done, and two different ASTM standards were used. Problem is, the references to the ASTM standards were transposed, so that Test "A" references the ASTM standard for Test "B." The lab will furnish an amended report, but it will be the same report, with a note explaining the amendment appended. Sometimes records must be changed, but how and when it's done is a matter of control.
 
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