Procedure Revision Control/Approval Process

Q

qcman012856

#1
We are ISO9001:2000. Current practice to revise a procedure is to generate an engineering change notice to document the revision change. However, this means that every manager in the organization must review and approved the change, regardless of who owns the process. This process is lengthy and far from "lean". Anyone have any tried and true alternatives? Is ther any reason why we can't establish a database to track changes? Cut the approval process to the procedure owner? Does every manager need to review every procedure change? BTW, the same system is used to revise work instructions.
 
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R

RickRay

#2
In our system, which also uses the ECO proces, only those parties affected by the procedure need to sign-off on the ECO. So if it only affects two departments, then the managers for those two departments sign-off on the ECO and the procedure is released. Sounds like your ECO process is limiting?
 
J

Joe Cruse

#3
No reason not to write it that way, as the standard does not mandate what you are doing now; you are doing that to yourself.

When we went to the 2000 standard, we changed it to where the department/process manager (document owner) and the quality manager (keeper of the QMS) were the only ones who had to review and approve changes. We currently use a software program to handle this, but will likely go to a database to track changes and handle review and approval by email.
 
S

SteveK

#4
We are ISO9001:2000. Current practice to revise a procedure is to generate an engineering change notice to document the revision change. However, this means that every manager in the organization must review and approved the change, regardless of who owns the process. This process is lengthy and far from "lean". Anyone have any tried and true alternatives? Is ther any reason why we can't establish a database to track changes? Cut the approval process to the procedure owner? Does every manager need to review every procedure change? BTW, the same system is used to revise work instructions.
One advantage of being the “Quality Department” in a SME is you can personnally fully control the QMS and procedures. I have an Excel spreadsheet with a unique reference (DCN - document change number) and basic description of the change. This reference is added to a document history page in the procedure (at the end) – describing all the basic changes. This keeps it simple – though I do get input from managers and the MD (he signs off) – but kept informal. Note the history page is very similar to what is used in a much more complex system DMS (GxPharma). I recall once using this system and it took 6 months and 13 sign-offs to get approval of a change to a pH meter. I know which I prefer.

Hope this helps.

Steve
 
I

Intesar

#5
1- procedures owner usually initiate the changes and effected parties should review and agree those changes

2- quality audit output is another tool for making changes (improve) procedures.


I hope this will help>>>>>


intesar
 
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