Is it required to stamp obsolete hard copy DHR's "obsolete"?

Ronen E

Just a person
Staff member
Super Moderator
#4
A change order obsoleted old product documentation and the associated DHRs.
Sorry, I don't get it. Even if some product documentation changed or got obsoleted, you still have made the products covered by that particular DHR, so no matter what, it is supposed to still be valid - regardless of what happened to the products.
 

JoshuaFroud

Involved In Discussions
#5
I'm with Ronen here, are you certain you mean "DHR: Device History Record" a DHR is essentially a batch record and can therefore never be obsolete as it was and always will be correct as of the day that product was produced.

A version of your DMR: Device Master Record, may become obsolete with documentation changes. The previous versions will remain correct for anything produced prior to the changes.

Please see the information on the following link "DHF vs DHR vs DMR" it quite clearly outlines the differences been these documents.

Have a read and let us know if we can help more !
 

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Trusted
#6
A DHR is the record of that production data used during its production. Its like the credits at the end of a film...they are eternal.

DHF is like Coca Cola the entire production changes from initial development, production processes, testing, improvements and customer feedback, etc.

DMR is like Coca Cola, then New Coke, then Classic Coke, then Vanilla Coke, the recipe for each sub type of Coca Cola.

DHR is like 1200 Cases of Classic Coke made in Chicago from 3/1/208-3/4/2018 with these lots codes and this equipment and these employees.

If you update the DMR to make a new product and no longer want to "accidentally" make the old product you should have a method to obsolete the old recipe in your QMS so it cannot be used any longer. The BOM should list as Obsolete or similar if Sales tries to order it. The old catalog items should be removed from marketing materials.
 
Last edited:

Top Bottom