Significance and Use
4.1 This is one of a series of guides designed to provide guidance for implementing activities that meet the requirements of a sound laboratory quality assurance program. The first of these, Guide C1009, is an umbrella guide that provides general criteria for ensuring the quality of analytical laboratory data. Other guides provide expanded criteria in various areas affecting quality, producing a comprehensive set of criteria for controlling data quality. The approach to ensuring the quality of analytical measurements described in these guides is depicted in Fig. 1.
FIG. 1 Quality Assurance of Analytical Laboratory Data
4.2 The training and qualification of analysts is one of the elements of laboratory quality assurance presented in Guide C1009, which provides some general criteria regarding qualification. This guide expands on those criteria to provide more comprehensive guidance for qualifying analysts. As indicated in Guide C1009, the qualification process can vary in approach; this guide provides one such approach.
4.3 This guide describes an approach to analyst qualification that is designed to be used in conjunction with a rigorous program for the qualification and control of the analytical measurement system. This requires an existing data base which defines the characteristics (precision and bias) of the system in routine use. The initial development of this data base is described in Guide C1068. The process described here is intended only to qualify analysts when such a data base exists and the method is in control.
4.4 The qualification activities described in this guide assume that the analyst is already proficient in general laboratory operations. The training or other activities that developed this proficiency are not covered in this guide.
4.5 This guide describes a basic approach and principles for the qualification of laboratory analysts. Users are cautioned to ensure that the qualification program implemented meets the needs and requirements of their laboratory.
Scope
1.1 This guide covers the qualification of analysts to perform chemical analysis or physical measurements of nuclear fuel cycle materials. The guidance is general in that it is applicable to all analytical methods, but must be applied method by method. Also, the guidance is general in that it may be applied to initial qualification or requalification.
1.2 The guidance is provided in the following sections:
Section
Qualification Considerations
5
Demonstration Process
6
Statistical Tests
7
1.3 This standard does not apply to maintaining qualification during routine use of a method. Maintaining qualification is included in Guide C1210.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.