H
hitesh
Hi,
We are in a process of implementing incoming inspection plan as per ISO 2859-1. In order to implement the sampling plans, we need to determine what AQL values to be used.
We would like to select three AQL values
1. for Critical Characteristics
2. for Major Characteristics
3. for Minor Characteristics
Based on nature of characteristic, engineering can choose AQL value from above three catagory. I would like to know what are the standard or most commonly used AQL values in Medical Device Manufacturing Industry for Class II devices.
Does anyone know if FDA has any guideline for AQL selection for inspection of Class II Medical Equipments or raw material used to manufacture the equipment?
I will appreciate if I can get a quick response from any Cove member.
Regards,
We are in a process of implementing incoming inspection plan as per ISO 2859-1. In order to implement the sampling plans, we need to determine what AQL values to be used.
We would like to select three AQL values
1. for Critical Characteristics
2. for Major Characteristics
3. for Minor Characteristics
Based on nature of characteristic, engineering can choose AQL value from above three catagory. I would like to know what are the standard or most commonly used AQL values in Medical Device Manufacturing Industry for Class II devices.
Does anyone know if FDA has any guideline for AQL selection for inspection of Class II Medical Equipments or raw material used to manufacture the equipment?
I will appreciate if I can get a quick response from any Cove member.
Regards,