What is the Appropriate AQL for Purchased Implantable Devices?

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blackholequasar

blackholequasar

The Cheerful Diabetic
#3
#3
My previous work with implantable devices was 100% visual inspection, at minimum. We would sometimes do a tightened AQL on parts that had observable dimensions.
 
C

ColoNative

Registered
#4
#4
outdoorsNW said:
While I do not work with implantable devices, sampling seems highly riskly. What makes you think sampling is a good idea?[/QUOT
Click to expand...
outdoorsNW said:
While I do not work with implantable devices, sampling seems highly riskly. What makes you think sampling is a good idea?
Click to expand...
What makes you think you cannot sample under the right conditions using a recognized sampling standard? 100% inspection is not 100% effective
 
O

outdoorsNW

Quite Involved in Discussions
#5
#5
You are right that 100% inspection is not 100% effective, but 100% is more likely to catch a problem than AQL. Implantables are a high risk product.

Depending on what is being inspected and the method, some types of inspection are over 90%. Visual inspection has a much lower detect rate. Even so, 100% visual inspection is more likely to catch a intermittent problem or a hard to see problem because there are more opportunities to see the problem.

In some cases AQL might be acceptable, such as inspecting at an intermediate step when there is a good inspection later in the process. Destructive testing is another area where AQL might be acceptable. Double checks of the process where a sample is subjected to greater inspection detail, outside inspection service checks, or similar is another case where AQL may be acceptable.

But without details about how you are thinking about using AQL sampling, it is hard for anyone to help you.
 
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