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hc255 replied to the topic Sample Size Based on Risk Analysis in the forum Risk Analysis for Medical Devices 7 years, 6 months ago
As a Quality Engineer, we have AQL levels in place in our drawings for the Quality Inspectors to use when inspecting incoming product that is to be used on the manufacturing floor. As neb2 stated, AQLs are Acceptance Quality Limits which indicate what sample size can be used depending on the requirement being tested on the drawing specification. Our AQL levels run from 0.65, 1.0 and 4.0. 0.65 is the highest risk which typically allows for a higher sample size. A minor cosmetic defect is not an issue however when the occurrence is frequent it does become an issue because of our supplier specs.