Using Repeatability and Reproducibility Studies to Evaluate a Destructive Test Method

Phillips, Aaron; Jeffries, Rella; Schneider, J. R. L.; Frankoski, Stanley P.

doi:10.1080/08982119708919135

Cited by 9 publications

(5 citation statements)

References 0 publications

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“…The homogeneity of batches is absolutely critical for the successful implementation of the Crossed Gauge R&R study as have been consistently emphasised in previous literature sources (e.g. Gorman and Bower, 2002;Mast and Trip, 2005) and research studies (Han and He, 2007;Phillips et al, 1997). Findings of the current study supported those inferences relating to the homogeneity of batches.…”

Section: Discussion Of the Resultssupporting

confidence: 86%

Validating a destructive measurement system using Gauge R&R — a case study

Sharma

Sahni

Sharma

2019

Engineering Management in Production and Services

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The research study aims to evaluate the precision of the measurement system using Gauge R&R. An experimental research design adopting a positivist empirical approach with deductive strategy was followed to assess the effectiveness of Crossed Gauge R&R technique for validating a measurement system using destructive testing. Crossed Gauge R&R technique in Minitab was found to be highly effective in quantifying different components of measurement variation relative to process variation. Clue generation from the Crossed Gauge R&R study combined with manufacturing and measurement process know-how helped in identifying and eliminating the root causes for measurement variation. Overall Crossed Gauge R&R proved successful in validating the burst strength test equipment. However, it should be noted that manufacturing and test equipment played an equally important part in developing and executing the gauge R&R study and accurately analysing the results. So, Crossed Gauge R&R should be used as an aid rather than the solution for measurement system validation.

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Section: Discussion Of the Resultssupporting

confidence: 86%

Validating a destructive measurement system using Gauge R&R — a case study

Sharma

Sahni

Sharma

2019

Engineering Management in Production and Services

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show abstract

“…Two mechanically calibrated USP Apparatus 2 units were used in this study. Based on a previous study,12 use of poorly trained or inexperienced operators can compromise the validity of a gauge R&R study. Thus two trained operators carried out dissolution tests with the NCDA#2, 10 mg prednisone tablets.…”

Section: Methodsmentioning

confidence: 99%

“…Gauge repeatability and reproducibility (gauge R&R) studies have been widely used for assessing the precision of a measurement system 10–13. The variation observed when a single operator measures the same part consistently is called repeatability or pure error.…”

Section: Introductionmentioning

confidence: 99%

Studies of variability in dissolution testing with USP apparatus 2**Opinions expressed in this report are those of the authors and do not necessarily reflect the views or policies of the FDA.

Gao

Moore

Smith

et al. 2007

Journal of Pharmaceutical Sciences

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“…This variability raises the issue that tablets from within the same batch may yield significantly different results. One way to address the high withinsample variation is to increase the number of measurements per sample set, using the following formula 12 :…”

Section: Design Of Experiments For Gauge Randr Studymentioning

confidence: 99%

“…Gauge repeatability and reproducibility (R&R) studies have been widely used for assessing the precision of a measurement system and identifying its sources of variability, including the contributions from operator, instrument, and random effects. [10][11][12][13] The variation observed when 1 operator measures the same part is called repeatability or pure error. The variation observed when 1 operator duplicates the measurement of another operator on the same part is called reproducibility.…”

Section: Introductionmentioning

confidence: 99%