GRR Study on a Finished Product - Batch Manufacturing

[VK1234]

Hello all

My question is regarding GRR

We are the OEM of Medical devices, We manufacture 2 Products per year. I need to conduct GRR study on a finished product . currently we have only one product.

I have 2 Methods in mind
1) Conducting Nested GRR with 3 Operators and 5 parts ( Considering 5 repeats on a same product as as 5 parts) and 3 repeats
2) Conducting Type 1 gage study with 3 operators instead of 1 operator with 30 repeats.

Please let me know which method should i go with.Suggestion of any other methods will be appreciated.

Thanks in advance

 

[Miner]

Why are you considering a nested vs. a crossed R&R study? There was nothing in your post that indicates that you would need this.

Increasing the number of parts is more important to a good study than increasing the number of repeats.

A Type 1 study focuses solely on repeatability. As soon as you add more operators it is no longer a Type 1 study. Stick with a full R&R unless operator is a non-issue. Since you intended to add operators, that is obviously not the case.