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  QS-9000
  Date & initials for cross outs of records?

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Author Topic:   Date & initials for cross outs of records?
Casana
Forum Contributor

Posts: 26
From:Cranford, NJ
Registered: Sep 2000

posted 16 August 2001 03:20 PM     Click Here to See the Profile for Casana   Click Here to Email Casana     Edit/Delete Message   Reply w/Quote
I have a colleague that insists that when a record is changed, say a technician crosses out a result and writes a new one, that an explanation for this change is required ALWAYS. Plus the cross out has to be dated & initialed. She even has a form that is attached to the record to explain why the cross out was required.
Try as I can, I can't find any requirement for this behavior in QS...
Since some of our work affects her group, she insists that WE follow this behavior as well, which my group is resisting because they don't see the value of it.
Any comments out there?

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tomvehoski
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Posts: 33
From:Southfield, MI
Registered: May 2001

posted 17 August 2001 08:41 AM     Click Here to See the Profile for tomvehoski   Click Here to Email tomvehoski     Edit/Delete Message   Reply w/Quote
This is not a specific requirement under QS-9000. Initialing and dating can be used to satisify document approval requirements (4.5) if you are makeing handwritten changes to drawings, specs, procedures, etc. If you are correcting a mistake on a form, it is not a requirement. It is a matter of preference for many people, and even some auditors. You will see some earlier discussions about the use of pencil and white out in the forums.

This IS a requirement under ISO 17025 laboratory accredation.

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D.Scott
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Posts: 53
From:Wellington, OH USA
Registered: Feb 2001

posted 17 August 2001 08:50 AM     Click Here to See the Profile for D.Scott   Click Here to Email D.Scott     Edit/Delete Message   Reply w/Quote
I am no expert, but I think it is common practice in Labs and definately in accounting to require a single stroke through the original number so that the original is still readable. I have seen the practice of initialing and dating the change on legal/accounting documents as well.

I know of no QS requirement to do this but if your lab is accredited, you might find it in another requirement. Your accounting and legal departments will probably require it even if there is no requirement.

I guess the bottom line has to be - who is the woman doing the insisting? If she has made it a procedure for her department/function to do it that way you have to live with it till you can get the procedure changed. If you can't change it, it becomes just as auditable as any other requirement.

Good luck

Dave

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Sam
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Posts: 275
From:
Registered: Sep 1999

posted 17 August 2001 09:08 AM     Click Here to See the Profile for Sam   Click Here to Email Sam     Edit/Delete Message   Reply w/Quote
Having workd for a number of years in the government sector,(electronics) the first word that would come to mind is "fraud".
Remember the guy who bailed out in Iraq and found that his radio did not work; that was a result of altered test documentation.
No records should be changed with out adequate information stating the nature of the change.
Too your friend, I say keep up the good work.

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Casana
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Posts: 26
From:Cranford, NJ
Registered: Sep 2000

posted 17 August 2001 11:32 AM     Click Here to See the Profile for Casana   Click Here to Email Casana     Edit/Delete Message   Reply w/Quote
Hmmm... it still feels like over regulating a simple writing mistake. I agree that mistakes should be crossed once only (not scratched out or - heaven forbid - whited out)but once you do that,I see no need to initial/date/explain this new number unless there's a reason (like a re-test). It makes it much harder to read, especially when you're trying to squeeze in the data into the small boxes on the paper. (I'd fix the space issue but its not my form to fix).
Ah well, back to reality...

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Dawn
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Posts: 266
From:St. Marys, PA
Registered: Sep 98

posted 17 August 2001 07:44 PM     Click Here to See the Profile for Dawn   Click Here to Email Dawn     Edit/Delete Message   Reply w/Quote
Casana,
What if you have an employee who made a change and you need to know who and why? and when? It is not a QS shall to do it this way but it is a shall to document changes. The easiest way I know of and what I wrote into the procedure is one line through , sign and date (initials). They do it automatically now without even thinking and everyone in the establishment does it.
I believe probably the reasons for its existence is to prevent tampering and falsifying documentation.

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Al Dyer
Forum Wizard

Posts: 814
From:Lapeer, MI USA
Registered: Oct 2000

posted 17 August 2001 08:38 PM     Click Here to See the Profile for Al Dyer   Click Here to Email Al Dyer     Edit/Delete Message   Reply w/Quote
Dawn,

Agreed, but from the standpoint of an auditor it would sure raise my eyebrow and make me dig very deep if I saw records changed, even if it is written in the procedure.

Auditors look for consistency and as soon as one red flag is raised we/they get worried. More so on the initial audit than the survs. I suspect.

Just a point to ponder.

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