AS 9100 4.2.4 Process for making changes to records is not fully effective

M

mlaurie

#1
I'm responding to a Stage 2 NC. The auditor found receiving records "X" out but not initialed or dated. Just a minor but on review I see a lot of White Out corrections made. So I instructed the clerk to initial and date each one. Question is, Can White Out be used to correct / modify records? Do they have to be verified with initials, date?
Thanks
 
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Big Jim

Trusted Information Resource
#2
I'm responding to a Stage 2 NC. The auditor found receiving records "X" out but not initialed or dated. Just a minor but on review I see a lot of White Out corrections made. So I instructed the clerk to initial and date each one. Question is, Can White Out be used to correct / modify records? Do they have to be verified with initials, date?
Thanks
There is nothing in the standard that prohibits that. This is a very common misconception.
 
A

andygr

#4
The use of white out is not prohibited by the standard. Ask to see where the requirement is stated.
BUT
Single line initial and date was good practice but does not apply to electronic documents and records. So it has similar issues as white out did with paper.

You have to look at your system and show compliance to:
7.5.3 Identification and Traceability
Where appropriate, the organization shall identify the product by suitable means throughout product realization.
The organization shall maintain the identification of the configuration of the product in order to identify any differences between the actual configuration and the agreed configuration.
The organization shall identify the product status with respect to monitoring and measurement requirements throughout product realization.
:2cents:
 

Mikishots

Trusted Information Resource
#5
I'm responding to a Stage 2 NC. The auditor found receiving records "X" out but not initialed or dated. Just a minor but on review I see a lot of White Out corrections made. So I instructed the clerk to initial and date each one. Question is, Can White Out be used to correct / modify records? Do they have to be verified with initials, date?
Thanks
If you have no other regulatory requirements that say you can't, then no, there is no requirement.

I say this because where I work, we also need to abide by Transport Canada Standard 561, which states that if changes are needed on established records, they are to be made in such a manner that the reason for the change and the identity of the person making the change are also shown, and that the original information is still available. This means no white-out.
 
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