Validating a Process Based on Lot Release Criteria

[GTJunghoon]

I'm validating a liquid filling process. The risks associated with the product failure have been assessed and preventative measures have been put in place. So, I am confident that the product will rarely fail the QC inspections.

It appears that the Jefes' want to eventually release a product lot of up to 1400 items after QC inspects and passes 2 items selected from that same product lot. I suppose this means I have to prove that the process is capable of this "lot release criteria".


How do I statistically prove that the defect rate of a process is so low that a lot of 1400 items is released after inspecting 2?

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!

 

[Ronen E]

I'm validating a liquid filling process. The risks associated with the product failure have been assessed and preventative measures have been put in place. So, I am confident that the product will rarely fail the QC inspections.

It appears that the Jefes' want to eventually release a product lot of up to 1400 items after QC inspects and passes 2 items selected from that same product lot. I suppose this means I have to prove that the process is capable of this "lot release criteria".


How do I statistically prove that the defect rate of a process is so low that a lot of 1400 items is released after inspecting 2?

Hi,

It seems that according to the AQL-based methodology you would need to sample at least 5 units for a lot size of 1400. If all 5 are pass, the lot passes. If one fails, the lot fails. This regime correlates with an AQL not worse than 2.5 (Normal inspection).

Cheers,
Ronen.

 

[somashekar]

I'm validating a liquid filling process. The risks associated with the product failure have been assessed and preventative measures have been put in place. So, I am confident that the product will rarely fail the QC inspections.

It appears that the Jefes' want to eventually release a product lot of up to 1400 items after QC inspects and passes 2 items selected from that same product lot. I suppose this means I have to prove that the process is capable of this "lot release criteria".


How do I statistically prove that the defect rate of a process is so low that a lot of 1400 items is released after inspecting 2?

What is the container made of ... Is it transparent ... Do you have some sort of a scale marked on the container as it gets processed (comes from your design)
How does QC inspect ?
If I had it as said above, I would not be much bothered, as QC can inspect more samples based on your AQL selection easily.
Validation is a exercise done prior to putting the liquid filling process into use. Lot release criteria is more a check of your process effectiveness / Validation effectiveness.