Document: NRC Regulatory Guide
Document ID: 244ba017-304c-4f86-818e-a1339242d8c1
Document Type: regulatory_guide
Title: Evaluating Deviations and Reporting Defects and Noncompliance Under 10 CFR Part 21 + HISTORY - HISTORY 11/2023 – DG-1416 , Proposed Revision 1 07/2017 – DG-1291 , Proposed Revision 0 (Rev. 1)
Source: NRC Regulatory Guide Division 1
Source URL: https://www.nrc.gov/docs/ML2318/ML23187A549.pdf
Revision Date: 2023-11
Chapter: 
Section ID: RG-1.234
CFR Part: 
CFR Title: 

Content:
ractice, an organization should designate individuals capable of assisting the staff in part 21 evaluation, reporting requirements and training requirements. The NRC’s position regarding training of personnel involved in 10 CFR Part 21 activities is that this training would be covered under 10 CFR 50.120, “Training and qualification of nuclear power plant personnel.” If an employee covered by 10 CFR 50.120 is required to perform tasks associated with 10 CFR Part 21, including the evaluation of a reportable condition under 10 CFR Part 21 training, the systems approach to training would evaluate and train covered employees on the related elements. The staff’s position on this point relates to the requirements of 10 CFR 50.120, rather than 10 CFR Part 21, and thus should not be understood to contradict the guidance in NEI 14-09. 4. Section 2.7, “Deviation,” of NEI 14-09 states that “Counterfeit and fraudulent items are considered to be deviations.” Section 7.4, “Deviation in a Delivered Basic Component,” of NEI 14-09, clarifies this and states that “A deviation in a basic component delivered to a purchaser for use in a facility or an activity subject to 10 CFR Part 21 must be evaluated.” Other than just referencing counterfeit and suspect items, NEI 14-09 does not formally define CFSI. To provide clarity and ensure consistency when addressing related NRC oversight activities, for the purposes of this guidance, the NRC staff understands CFSI to mean “Items that are intentionally manufactured or altered to imitate a legitimate product without the legal right to do so (Counterfeit); intentionally misrepresented with the intent to deceive (Fraudulent); or reasonably suspected of being Counterfeit or Fraudulent (Suspect).” The NRC staff considers CFSI to be a deviation to be treated according to the guidance in NEI 14-09. DG-1416, Page 6 D. IMPLEMENTATION The NRC staff may use this regulatory guide as a reference in its regulatory processes, such