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
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CFR Title: 

Content:
time (for continuous discharges) or number of batches (for batch discharges). Procedures for continuous sampling should use methods that are designed to ensure that the sample is representative of the volumes being discharged. 8. Verification and Validation The V&V of certain aspects and support activities of the radiological measurement process or monitoring program are essential to the QA program. These aspects and activities include data and computer software V&V and project method validation. Project method validation is the demonstration that a method (radioanalytical or radiation measurement) using performance-based method selection is capable of providing analytical results to meet a project’s MQOs and any other criteria in the APS. Acceptable method validation is necessary before the radiological analysis of samples or the taking of measurements in a monitoring program. Chapter 6 of MARLAP presents detailed guidance on project method validation for radioanalytical methods. In addition, Section 5.2.7 of ANSI N42.23-2003 and Section 5.4.5 of ISO/IEC 17025-2005 provide limited guidance for radioanalytical method validation. 7 The Institute of Electrical and Electronics Engineers (IEEE) Standard 1063, “IEEE Standard for Software User Documentation,” issued December 2001; EPA Directive 2185, “Good Automated Laboratory Practices,” issued 1995; Subpart 2.7 of ASME NQA-1-1994; Regulatory Guide 1.168, “Verification, Validation, Reviews, and Audits for Digital Computer Software Used Safety Systems of Nuclear Power Plants,” issued February 2004; and Section 8 of ANSI N42.14, “Calibration and Use of Germanium Spectrometers for the Measurement of Gamma-Ray Emission Rates of Radionuclides,” issued 1999, also provide guidelines on software V&V. DG-4010, Page 15 Chapter 8 of MARLAP gives detailed guidance and applicable tools for the radioanalytical data V&V evaluation process as well as information for developing a data V&V plan, determining acceptable