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:
ge 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 criteria and tests, and applying data qualifiers for radioanalytical data validation, as related to MQOs. EPA QA/G-8-2002 provides guidance for nonradioanlaytical data V&V. Computer programs used in the implementation of the radiological environmental monitoring program should be documented, verified, and validated before initial routine use and after each modification of the program. As described in Section 5.4.3.2 of MARLAP, the laboratory’s quality manual should include the criteria for computer software V&V and documentation. The software data reduction and reporting functions should be verified to perform as expected.7 9. Assessments and Audits Assessments, audits, and surveillances are elements used to evaluate the initial and ongoing effectiveness of the QA program to monitor and control the quality of a radiological monitoring program. Management having responsibility in the area being reviewed should document and review the results of these activities. Assessments that are independent of the day-to-day operations should be performed routinely, including management surveillance, peer reviews, and READINESS REVIEWS for new or revised systems and methods. Key performance indicators should be tracked and trended, with periodic management reporting. The QA program or project plan should outline the scope, frequency, and schedule of assessments, audits, and surveillances. A plan should be developed for each assessment audit or surveillance for each area of the monitoring program being evaluated. A report of these activities should be generated according to the outline, format, and content established in the plan. Only qualified QA staff (see Section C.2), supported as needed by experts in the technical areas under evaluation, should conduct assessments, audits,