§21.3. Definitions.

Commercial grade item. (1) When applied to nuclear power plants licensed under part 50 or 53 of this chapter, commercial grade item means an SSC, or part thereof that affects its safety function, that was not designed and manufactured as a basic component. Commercial grade items do not include items where the design and manufacturing process require in-process inspections and verifications to ensure that defects or failures to comply are identified and corrected (i.e., one or more critical characteristics of the item cannot be verified).

Defect means:

Deviation means a departure from the technical requirements included in a procurement document, or specified in early site permit information, a standard design certification or standard design approval.

Director means an individual, appointed or elected according to law, who is authorized to manage and direct the affairs of a corporation, partnership or other entity. In the case of an individual proprietorship, director means the individual.

Discovery means the completion of the documentation first identifying the existence of a deviation or failure to comply potentially associated with a substantial safety hazard within the evaluation procedures discussed in § 21.21(a).

Evaluation means the process of determining whether a particular deviation could create a substantial hazard or determining whether a failure to comply is associated with a substantial safety hazard.

Notification means the telephonic communication to the NRC Operations Center or written transmittal of information to the NRC Document Control Desk.

Operating or operation means the operation of a facility or the conduct of a licensed activity which is subject to the regulations in this part and consulting services related to operations that are safety related.

Procurement document means a contract that defines the requirements which facilities or basic components must meet in order to be considered acceptable by the purchaser.

Responsible officer means the president, vice-president or other individual in the organization of a corporation, partnership, or other entity who is vested with executive authority over activities subject to this part.

Substantial safety hazard means a loss of safety function to the extent that there is a major reduction in the degree of protection provided to public health and safety for any facility or activity licensed or otherwise approved or regulated by the NRC, other than for export, under part 30, 40, 50, 52, 53, 60, 61, 63, 70, 71, or 72 of this chapter.

Supplying or supplies means contractually responsible for a basic component used or to be used in a facility or activity which is subject to the regulations in this part.