Document: NRC Regulatory Guide
Document ID: a5cfec96-8785-464b-ada8-dc4424b90606
Document Type: regulatory_guide
Title: Quality Assurance for Radiological Monitoring Programs
Source: NRC Regulatory Guide Division 4
Source URL: https://www.nrc.gov/docs/ML0630/ML063060429.pdf
Revision Date: 2023-06
Chapter: 
Section ID: RG-4.15
CFR Part: 
CFR Title: 

Content:
onstration that the method selected for the analysis of a particular analyte in a given matrix is capable of providing analytical results to meet the project’s MEASUREMENT QUALITY OBJECTIVES and any other criteria in the ANALYTICAL PROTOCOL SPECIFICATIONS. Compare with data and software VALIDATION. minimum detectable concentration: The minimum detectable value of the analyte concentration in a sample. The smallest (true) value of the net state variable that gives a specified probability that the value of the response variable will exceed its critical value (i.e., that the material analyzed is not blank). minimum quantifiable concentration: Minimum quantifiable value of the analyte concentration, defined as the smallest concentration of analyte whose presence in a laboratory SAMPLE ensures that the relative standard deviation of the measurement does not exceed a specified value, usually 10 percent. performance-based approach: Definition of the analytical data needs and criteria of a project in terms of measurable goals during the planning phase of a project. In a performance-based approach, the project-specific data objectives that are determined during a DIRECTED PLANNING PROCESS serve as measurement performance criteria for selections and decisions regarding the conduct of the laboratory analyses. The project-specific analytical data objectives are also used for the initial, ongoing, and final evaluation of the laboratory’s performance and the laboratory data. In method selection, a performance-based approach is the process wherein a validated method is selected based on a demonstrated capability to meet defined quality and laboratory performance criteria. Appendix A to DG-4010, Page A-5 performance evaluation (PE) program: A laboratory’s participation in an internal or external program of analyzing performance-testing samples appropriate for the analytes and matrices under consideration (i.e., PE program traceable to a national standards body, such as the