AQL Practice in the Medical Device

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#1
Re: Discussion Forum;

I am just wondering about the AQL usage within the Medical device.

Are you using it? How effective is it?
Have you attempted to correlate AQL to Ppk?

Are you using AQL in Design Engineering or strictly at the plant?

Also, another discussion forum...

Design Verification: What are some of the issues that you currently face? Do Engineers know what sample size to use? If so, what are some of the formuals/concepts you are following?

Process Validation: What are some of the issues that you currently face? Do Engineers know what sample size to use? If so, what are some of the formuals/concepts you are following?

I appreciate comments/feedback on starting this discussion/forum.
 
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Bev D

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#3
I am just wondering about the AQL usage within the Medical device.

Are you using it? How effective is it?
We do not use AQLs for acceptance sampling. we use RQLs and we calcualte them directly we do not use the negotiated tables published in the Mil-Std / ANSI docs. The RQL approach ahs been very effective for us much more than past practices which included AQLs and random sample sizes...

Have you attempted to correlate AQL to Ppk?
Why would one want to do that? Ppk is process capability and AQL (or RQL) is established to ensure a specific shipped quality level whic shoudl be dictated by teh needs of yoru customers. The two things are not related; they are independent of each other.

Are you using AQL in Design Engineering or strictly at the plant?
AQL (and RQL) are not appropriate in Design Engineering. AQLs are intended for acceptance sampling...Work done in Design engineering should utilize sample size calculations related to the type of data (categorical or continuous) and the amount of variation, the level of risk and the amount of difference that one wants to detect. These two situations are very different from each other (although based in the same fundamental statistics). One doesnt' substitute for the other as they have different intents.

Also, another discussion forum...

Design Verification: What are some of the issues that you currently face? Do Engineers know what sample size to use? If so, what are some of the formuals/concepts you are following?

Process Validation: What are some of the issues that you currently face? Do Engineers know what sample size to use? If so, what are some of the formuals/concepts you are following?

I appreciate comments/feedback on starting this discussion/forum.
this last set of questions should probably be moved to a separate posting? It is difficult to manage responses when there are so many questions in a single post and the questions diverge from each other...
 
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