Retroactively applying procedures in ISO 9001:2008

C

ChuckCrosby

#1
Can an ISO 9001 registered quality system change a procedure and then retroactively apply this procedure to quality data (i.e., complaints) that were filed before the change? Specifically, there is a desire to move several complaints out of the complaint system into a CAPA tool so that the complaint system metrics look good. In my past I recall this was not allowed, but I would like to be able to cite a standard. Thanks for any help!
 

John Broomfield

Fully retired...
Trusted
#2
Can an ISO 9001 registered quality system change a procedure and then retroactively apply this procedure to quality data (i.e., complaints) that were filed before the change? Specifically, there is a desire to move several complaints out of the complaint system into a CAPA tool so that the complaint system metrics look good. In my past I recall this was not allowed, but I would like to be able to cite a standard. Thanks for any help!
Chuck,

You may have applied the same procedure before you decided to document the change.

That would not be retroactive and would therefore be valid.

Please study the definition of a procedure and you'll see that it may not necessarily be documented to be called a procedure.

Hence we have procedures and documented procedures.

John
 
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PaulJSmith

Quality Manager
#4
Hi, Chuck:

One thing you might keep in mind when moving a complaint to another location is the question; Why are we doing this? If it's merely to artificially pad the numbers in one system, then you're probably doing yourselves a disservice in the long run. Simply moving it does nothing to address it. If, however, you're doing it because that's the right tool for the job, then that's all together different.

I don't know that there's any standard that forbids this, though, unless your own (documented) internal procedures forbid it.
 

somashekar

Staff member
Super Moderator
#6
Specifically, there is a desire to move several complaints out of the complaint system into a CAPA tool so that the complaint system metrics look good.
Who has the desire ...Why ?
What is metrics look good mean ?
Complaints would need a CA and hence can still be addressed within your whatever CAPA tool you have.
The core questions is., Are we addressing the issues holistically and moving forward and improving the system
 
#7
Can an ISO 9001 registered quality system change a procedure and then retroactively apply this procedure to quality data (i.e., complaints) that were filed before the change? Specifically, there is a desire to move several complaints out of the complaint system into a CAPA tool so that the complaint system metrics look good. In my past I recall this was not allowed, but I would like to be able to cite a standard. Thanks for any help!
If the concern is that there has not been enough activity in the new system to be able to demonstrate that the system is effective, I see no problem with including old data. There might a problem if the old data is moved selectively with intent to make things look better than they actually are.
 

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