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7.3.3.2 - Process approval acceptance criteria - Approval vs. Acceptance

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D

dbzman

#12
#12
Soooo......

Does this mean that your would have set of steps for process approval (process) and you have to determine what criteria you need to accept itthis process?

:bonk:
 
D

D.Scott

#13
#13
IMHO - sort of. You could use successful completion of the process steps/controls as the acceptance criteria. The point is, whatever you use as your acceptance criteria, you have to include it in your process design output.

Dave
 
Paul Simpson

Paul Simpson

Trusted Information Resource
#15
#15
How do you know the process is right?

Process approval acceptance criteria are the results you plan to use to assess the process is operating effectively. Typically it is things like process capability, defect rates. If all your pre defined acceptance criteria are met then the process is "approved" and you go ahead with the control plan developed to manage the process.

If not then the corrective action programme kicks in and you have to put in place some containment (e.g. extra inspection) until the process is operating effectively.
 
A

arunk372

#16
#16
Sam, your input is awesome but that of D.Scott is no less. very helpful discussion. so, as per Section 8.3.5.2k, "process approval acceptance criteria" is a set of product & process Characteristics on Control Plan, emerged as output of the Manufacturing process design output. and as D.Scott said, all these parameters should be qualified for the acceptance of the product for further use.

thanks :)
 
M

morteza

Trusted Information Resource
#17
#17
Hi,

there are several criteria for acceptance of a designed manufacturing process such as Cpk, lead time, value added time/lead time, changeover time, capacity, Ergonomics, etc.
usually during prelaunch production phase these criteria are evaluated for manufacturing process approval.
Before this approval, manufacturing processes are verified by review of manufacturing process design documents.
 
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