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**Significance and Use**

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.

4.2.1 Having test results fall in the acceptance region is not equivalent to passing the acceptance procedure, but provides assurance that a sample would pass the acceptance procedure with a specified probability.

4.2.2 This information can be used for process demonstration, validation of test methods, and qualification of instruments, processes, and materials.

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. Scope**

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.

**2. Referenced Documents** *(purchase separately)* The documents listed below are referenced within the subject standard but are not provided as part of the standard.

**ASTM Standards**

E456 Terminology Relating to Quality and Statistics

E2282 Guide for Defining the Test Result of a Test Method

E2586 Practice for Calculating and Using Basic Statistics

**ICS Code**

ICS Number Code 03.120.30 (Application of statistical methods)

**UNSPSC Code**

UNSPSC Code 81141500(Quality control)

**DOI:** 10.1520/E2709-12

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