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ANALYTICA EBC

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14.1 - Ruggedness Testing of Methods (IM)

Testing of analytical procedures for ruggedness, before collaborative study, to determine the method conditions which have a significant influence on the test method results in terms of precision. Descriptors: test result from the frst replication from trial i, test results from the second replication from trial i, sum of the two replications from trial i, difference of the two replications from trail i, sum of the squares of the differences, Main effects error variance, Standard error of the main effects, Experimental error variance, sum of squares of the difference

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14.2 - Collaborative Trial to Determine the Precision of a Measurement Method

Providing an aid to the correct understanding of the results of precision experiments and of the terminology employed. Descriptors: the true value, the laboratory component of bias under repeatability conditions, the random error occurring in every measurement under repeatability conditions, the estimate of the variance of B (between laboratory variance), the estimate of the repeatability variance (vatiance of e), the estimate of the reproducibility variance, the first test result of laboratory i at level j, the second test result of laboratory i at level j, the general mean for level j, The reproducibility variance for the j level, The repeatability limit at the 95 % probability level, The reproducibility limit at the 95 % probability level, the number of laboratories reporting at least one test result for level j, the intracell standard deviation calculated with the formula given in 7.1.4, the mean of all observations, the standard deviation of the observations.

It is necessary to use EBC Method 14.1

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14.3 - Trueness of a Standard Measurement Method

The determination of the laboratory bias when a measurement method is applied. Descriptors: Differences between trueness and precision, the predetermined magnitude of laboratory bias that the experimenter wishes to detect from the test results, the repeatability standard deviation of the measurement method, one of the test results (k = 1,2,...n), the average of n test results, the true or accepted reference value of the test property.

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14.4 - Sampling Design

To take a sample from all product or raw materials which cannot be examined in entirety.

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14.5 - Specification and Tolerance Bands

The design of minimal specification bands using either Statistical Process Control Theory or by application of ISO 4259 to analytical precision data. The determination of precision data for total process capability, sampling error and averaging error is beyond the scope of this procedure. Descriptors: parts per million, parts per billion.