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:
formance or programmatic deficiencies, and initiating appropriate corrective or preventive actions. The QA program for radiological effluent and environmental monitoring programs should contain both a continuous-improvement program and a program for implementing corrective actions when conditions adverse to quality have been identified. In addition, needed improvements and potential sources of nonconformance should be identified and reported as part of a preventive action initiative of the continuous-improvement program (ISO/IEC 17025-2005, Sections 4.10–4.12) — for example, a condition-reporting program. Investigations should be initiated for degrading conditions, and corrective actions should be taken when conditions fall outside quality or regulatory acceptance criteria. For conditions that are adverse to quality, the corrective action process includes the following basic elements: • identification and documentation • classification • cause analysis • corrections • followup Findings and corrective actions should be documented, tracked, and reported to management. Followup reviews should be performed to verify the effectiveness and adequacy of the corrective actions. Section 2.10 of ANSI/ASQC E4-1994 provides specifications and guidelines for developing the process, programs, and procedures necessary to detect and correct items of nonconformance and for implementing continuous quality improvement. When conducting an audit or surveillance of laboratory services, a prime area of review should be the effectiveness of the laboratory’s corrective action program (MARLAP, Section 7.4.2). Section 4.11 of ISO/IEC 17025-2005 provides general guidance on preventive and corrective action programs for laboratories. Annex C of ANSI N42.23-2003 provides additional guidance that should be considered in developing a corrective action program, including root cause analysis for radioanalytical services. D. IMPLEMENTATION The purpose of this section is to provide