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Best method for designing a statistically sound sample plan for a pharmaceutical packaging process? – In the packaging process we are looking at several different attributes varying from critical defectives (AQL .065) to minor defectives (AQL 1.5). It is the goal to use one sample size that would statistically cover the different AQL range. If we have a batch size of 20,000 and a samples size of 315, would it be safe to say that the pass/reject level for AQL .065, 0-1 and 10-11 for an AQL 1.5. Is it statistically sound that we just pull one sample size?

791 viewsOctober 10, 2022DrugsPharmaceutical
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Sam Smith11.38K December 31, 2020 0 Comments

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Blogolu28.38K Posted December 31, 2020 0 Comments

It is common in sampling plans to use a single sample to inspect multiple attributes. As you stated a sample size of 315 could be inspected with an accept number of 0 for critical defects and 10 for less critical defects.

The sampling statistics would be:
Sample Size Acc Re AQL LTPD

315 0 1 0.02% 0.73%

315 10 11 1.97% 4.85%

These are the actual values compared to the Z1.4 tabled values.

Keep in mind you are inspecting more units for minor defects, but if all defect types can be inspected simultaneously it might not be an issue.

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