Introduction:

Gauge studies allow gaining information about the performance of processes and are very useful tools for quality control and identification of variability sources. The objective of the present study was design and analyzes measurement systems for the Heckel and Ryshkewitch-Duckworth models for characterizing materials, through Gauge R&R studies.

Method:

Crossed Gauge R&R study for the evaluation of weight measurement system and nested Gauge R&R study for the system of tablet hardness.

Results:

Both studies fulfilled with the assumptions of normality, constant variance and data independence, therefore it was possible to estimate the significance of variation sources (factors) through ANOVA and their contribution percentage. The crossed Gauge R&R study showed that the flat punches contributed to variability of the measurement in a significant manner in 97.38% of the total variation of the study; operators did it in less than 1% and they were not statistically significant and there was no Part-Operator interaction. With respect to the nested Gauge R&R study, it was found that the operator did not influence in a statistically significant way in the variability of the measurement and it was attributable in 95% to the existing differences between the tablets evaluated.

Conclusions:

Design, run and analysis of the measurement systems was performed, we remark that in both of the studies the main source of variability were the parts evaluated and that operators did not contribute to variability in the measurements; therefore, both studies could be used to evaluate the Heckel and Ryshkewitch-Duckworth mathematical models and also for statistical process control.

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