ASTM E1323-15(R2020) pdf free download

ASTM E1323-15(R2020) pdf free download.Standard Guide for Evaluating Laboratory Measurement Practices and the Statistical Analysis of the Resulting Data
1. Scope
1.1 This guide covers key elements of an evaluation of a laboratory’s measurement practices and the statistical analysis of the resulting data. This guide addresses an evaluation that covers a broad range of in-house quality measurements, some of which may be directly related to accreditation requirements. 1.2 This guide provides an overview of the documentation needed for verification and monitoring of the practices used in the laboratory for measurement. In addition, it guides the user in verifying that the extent of documentation and the quality of statistical evaluations performed on the data being generated is sufficient. The user is advised to fully document all work covered by the scope of this guide as a general principle of laboratory practice and for audit purposes, whether internal or external. 1.3 This guide is not designed to be exhaustive for all aspects of work realized under its scope. The user is encour- aged to thoroughly realize (achieve in practice) the principles set forth in this guide, consulting other relevant standards and industry documents when appropriate. 1.4 This international standard was developed in accor- dance with internationally recognized principles on standard- ization established in the Decision on Principles for the Development of International Standards, Guides and Recom- mendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
4. Significance and Use
4.1 This guide is intended to provide guidance for labora- tory quality managers, accrediting bodies and assessors in evaluating the measurement practices of a laboratory, the protocol for statistically analyzing the resulting data from these practices, and the statistical results from these practices. 4.2 This guide is generic in the sense that it covers the entire range of in-house quality measurement practices found in a testing laboratory, and the results of the described evaluation may be used by accrediting agencies for assessment purposes to determine whether their requirements can be satisfied through the laboratory’s existing quality data program. 4.3 It is not the intent of this guide to serve as sole criterion for evaluating and accrediting laboratories. Evaluation of measurement practices is only one aspect in a comprehensive quality program.
5. Purpose of Evaluating Measurement Practices and the Statistical Analysis of the Resulting Data
5.1 Data generated from the measurement practices of a laboratory are evaluated to determine its bias and precision performance, and to determine if the laboratory correctly and efficiently analyzes and reacts to its own data.
6. Documentation of Measurement Practices and the Statistical Protocol for Analyzing the Resulting Data
6.1 Documentation Relative to Calibration: 6.1.1 The material to be measured should be documented together with its source, expiration or shelf-life date, the accuracy, and any preparations or conditions required which are specific to this material before it can be utilized as a calibration material. Any additional components, reagents, or physical sources used along with this material, which could potentially alter the reliability of the material, should also be documented. 6.1.2 The identification of the equipment used, together with the date and operator responsible for the run, and any preparations involved with the calibration run should be documented. 6.1.3 The type of data representation to be used, including the exact number of data points to be used in the computation of an average, standard deviation, or range, as well as how and when these data points are to be generated should be docu- mented. This requires information regarding testing of replicates, duplicates, or single runs tested on one day, a series of days, or a specific time interval to be clearly stated for each set of data. 6.1.4 The mathematical formula for obtaining control limits, the frequency of computing new limits together with rules of acceptability of the new limits, should be documented when- ever control limits are applied to a chart. 6.1.5 The corrective action taken whenever data points indicate that an out of control condition exists, or whenever trend analysis indicates a change or shift in the instrument response should be recorded. 6.1.6 A table of actual measured values for each calibration or calibration check, the corresponding reference value, and the corresponding date should be documented.