ASTM E2709-19(2023)

4.1?This practice considers inspection procedures that may involve multiple-stage sampling, where at each stage one can decide to accept or to continue sampling, and the decision to reject is deferred until the last stage.

4.2?The methodology in this practice defines an acceptance region for a set of test results from the sampled population such that, at a prescribed confidence level, the probability that a sample from the population will pass the acceptance procedure is greater than or equal to a prespecified lower bound.

4.3?This methodology was originally developed (1-4)3 for use in two specific quality characteristics of drug products in the pharmaceutical industry but will be applicable for acceptance procedures in all industries.

4.4?Mathematical derivations would be required that are specific to the individual criteria of each test.

1.1?This practice provides a general methodology for evaluating single-stage or multiple-stage acceptance procedures which involve a quality characteristic measured on a numerical scale. This methodology computes, at a prescribed confidence level, a lower bound on the probability of passing an acceptance procedure, using estimates of the parameters of the distribution of test results from a sampled population.

1.2?For a prescribed lower probability bound, the methodology can also generate an acceptance limit table, which defines a set of test method outcomes (for example, sample averages and standard deviations) that would pass the acceptance procedure at a prescribed confidence level.

1.3?This approach may be used for demonstrating compliance with in-process, validation, or lot-release specifications.

1.4?The system of units for this practice is not specified.

1.5?This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.6?This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.