Is this QC Testing a requirement or a standard?



Hi, Guys, its me again. In our company, we are doing QC Testing based on 0.1% AQL sampling size and it is being done every lot. My question is, is this QC Testing is a requirement or a standard that needs to be performed every lot? Can you guys help me to determine what documented standard such as JEDEC, TS16949 it is written? on what section and page it is.

Hope that someone will help me here. Thanks.


Super Moderator
Since you posted under 13485, I'll fall back on that for the reply.

In section 7.5, Production and Service Provision, one of the requirements is for the implementation of monitoring and measurement.

Later on, in section 8, Measurement, analysis, and improvement are 2 requirements that elaborate somewhat:
* 8.1 General: ...implement monitoring, measurement, ... to demonstrate conformity of the product.
* 8.2.4, Monitoring and Measurement of product: Evidence of conformity with the acceptance criteria shall be maintained.

If you *don't* sample every lot, it would be difficult in my mind to comply with the above. The standard is not prescriptive on how you implement the requirements, though, that's up to you to define (and be able to defend).
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