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ASTM E1169-18
Standard Practice for Conducting Ruggedness Tests
13 стр.
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Разработчик:
Зарубежные/ASTM
ICS:
19.020 Test conditions and procedures in general / Условия и методика испытаний в целом
Сборник (ASTM):
14.05 Statistical Methods; Hazard Potential of Chemicals; Thermal Measurements; Manufacture of Pharmaceutical and Biopharmaceutical Products / Статистические методы; Потенциальная опасность химических веществ; Измерения теплопроводности; Производство фармацевтических изделий
Тематика:
Quality Control
Описание
Значение и использование

5.1 A ruggedness test is a special application of a statistically designed experiment. It is generally carried out when it is desirable to examine a large number of possible factors to determine which of these factors might have the greatest effect on the outcome of a test method. Statistical design enables more efficient and cost effective determination of the factor effects than would be achieved if separate experiments were carried out for each factor. The proposed designs are easy to use in developing the information needed for evaluating quantitative test methods.

5.2 In ruggedness testing, the two levels for each factor are chosen to use moderate separations between the high and low settings. In general, the size of effects, and the likelihood of interactions between the factors, will increase with increased separation between the high and low settings of the factors.

5.3 Ruggedness testing is usually done within a single laboratory on uniform material, so the effects of changing only the factors are measured. The results may then be used to assist in determining the degree of control required of factors described in the test method.

5.4 Ruggedness testing is part of the validation phase of developing a standard test method as described in Guide E1488. It is preferred that a ruggedness test precedes an interlaboratory (round robin) study.

Реферат

This practice covers conducting ruggedness tests. The purpose of a ruggedness test is to identify those factors that strongly influence the measurements provided by a specific test method and to estimate how closely those factors need to be controlled. This practice restricts itself to designs with two levels per factor. The designs require the simultaneous change of the levels of all of the factors, thus permitting the determination of the effects of each of the factors on the measured results. Conducting a ruggedness test requires making systematic changes in the variables, called factors, and then observing the subsequent effect of those changes upon the test result of each run.

This practice recommends statistically designed experiments involving two levels of multiple factors. The steps to be conducted include identification of relevant factors; selection of appropriate levels (two for each factor) to be used in experiment runs; display of treatment combinations in cyclic shifted order, which assigns factors and levels to runs; execution of runs arranged in a random order; statistical analysis to determine the effect of factors on the test method results; and possible revision of the test method as needed.

Область применения

1.1 This practice covers conducting ruggedness tests. The purpose of a ruggedness test is to identify those factors that strongly influence the measurements provided by a specific test method and to estimate how closely those factors need to be controlled.

1.2 This practice restricts itself to designs with two levels per factor. The designs require the simultaneous change of the levels of all of the factors, thus permitting the determination of the effects of each of the factors on the measured results.

1.3 The system of units for this practice is not specified. Dimensional quantities in the practice are presented only as illustrations of calculation methods. The examples are not binding on products or test methods treated.

1.4 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.

1.5 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.

Ключевые слова:
foldover; fractional factorial design; half-normal plot; Plackett-Burman; ruggedness; screening design;