Heated Sealed Packages - Sample Size for OQ (Operational Qualification) and PQ

#11
it would be relatively simple to calculate sample size based on past peel testing (variable data) with mean and stdev, against the min spec limit (1lbs) to determine sample size to meet single-sided 95% confidence 95% lower bound limit for instance as the average for most of the packaging types were high enough from the spec limit. However, for attribute data, I am having a hard time coming up with a justification that is generic enough to say since i tested 30 bubble tests (95%confidence 90% acceptable) and all passed ( - I will be able to test n=X (some lower number of samples) because ".....". Is there a reasonable way to justify less attribute samples to be tested for re-qualification?
 
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#12
We have variable data on lower peel spec of 1lbs and avg adn stdev from past IQOQ. that was tested to 95% confidence 95% lower bound confidence interval would be above 1lbs. Sampling based on the stdev, and one sided spec, i think we can lower the sample size to get similar statistical statement on requirements. n=11, can be done. can push down to n=7 but getting close to potentially not being able to meet the spec.

ON attribute test, 30 samples were tested to meet 90/95% to pass (bubble/burst etc). Looking for a justification on how to reduce the n=30.
 
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