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In other words, if there are zero failures in the sample of 100, as many as 23 failures could be found in the next 1000.FDA recognizes the limitations of endpoint testing.

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The American Society for Quality further defines AQL in its “Note on the Meaning of AQL” in ANSI/ASQ Z1.4, as follows: When a consumer designates some specific value of AQL for a certain nonconformity or group of nonconformities, it indicates to the supplier that the consumer's acceptance sampling plan will accept the great majority of the lots or batches that the supplier submits, provided the process average level of percent nonconforming (or nonconformities per hundred units) in these lots or batches be no greater than the designated value of AQL.

A good understanding of the operating characteristics of various sampling plans and the limitations of statistics should enable manufacturers to better balance the risks and costs of achieving sterile device packaging.

Quantifying a Small Rate of Failure It makes sense to score a football game.

But does it make sense to score the healthcare industry for the sterility assurance of packaged medical devices? How reliable would the measurement of that score be?

For this discussion, the score is defined as the percentage of devices that are sterile upon opening the packages at the time of use.

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