Traceability with no rules to control labels?

qualprod

Trusted Information Resource
#1
Hi everybody

I have to questions about treaceability.
in 8.5.2
1-The organization shall control the unique identification of the outputs when traceability is a
requirement,
and shall retain the documented information necessary to enable traceability.
Why the standard sees this as option?, if I think for everyone is a almost a "must" to apply it
in order to identify the raw material or product.


2-For the traceability is there a rule regarding how to control the labels to code the product?
I mean if I use a piece of paper with just to write down a number is it correct?
or I have to use a form with control on it, I mean document number and revision?
Thanks
 
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Jim Wynne

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Admin
#2
in 8.5.2
"The organization shall control the unique identification of the outputs when traceability is a
requirement,
and shall retain the documented information necessary to enable traceability."

Why the standard sees this as option?, if I think for everyone is a almost a "must" to apply it
in order to identify the raw material or product.
The question isn't about identification, it's about traceability. As an example, If you make some product x and later discover a problem with the materials used, you may want to identify the products that were made with that particular lot of material. Traceability can be a matter of practicality or a requirement of a standard or customer requirement. Lot control may or may not be necessary in all cases.

2-For the traceability is there a rule regarding how to control the labels to code the product?
I mean if I use a piece of paper with just to write down a number is it correct?
or I have to use a form with control on it, I mean document number and revision?
Thanks
Once you establish your traceability requirements, you apply lot control methods that will satisfy the need. Whether or not you should control forms or labels (or whatever) is a matter of choice and practicality.
 
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