Fitness For Purpose: Overview Of Astm Guides For Quality Assurance Of Data From Nuclear Analytical Laboratories

Year
2020
Author(s)
Michael Brisson - Savannah River National Laboratory
Abstract

Analytical laboratories in the nuclear industry must meet stringent requirements for the quality of their measurements. This is particularly true with measurements used for safeguards or nuclear material accountancy, but also for product assay and process control. Expectations for the nuclear industry go above and beyond those described in the ISO/IEC 17025 standard that specifies general requirements for the competence of testing and calibration laboratories and is used as a basis for laboratory accreditation. Method uncertainty, for example, is more stringently controlled in the nuclear industry than in many other fields. Reliance on international consensus standards is increasing due to the benefits they can provide, such as time savings in method development and consistency of results. Analytical test methods from ASTM International and the International Organization for Standardization (ISO) are well known and widely utilized. However, ASTM International has also developed a series of guides that describe best practices for ensuring the quality assurance of data from nuclear laboratories. These standards provide guidance on quality assurance programs, qualification of measurement methods, preparation of working reference materials, calibration for nuclear measurement methods, and measurement system quality control programs. A key concept espoused in these standards is the concept of “fitness for purpose”; that is, ensuring that a measurement process produces data that enables correct decision-making by an end user for a specified purpose. Implicit in the concept is that the method has the appropriate level of rigor to meet data quality objectives - “appropriate” being neither too little nor too much rigor. This paper presents an overview of the six guides developed by ASTM International to address quality assurance needs for nuclear analytical laboratories, including recent updates that have been completed or are currently in progress. These guides can be used to build a framework for ensuring the quality of data generated by these laboratories.