Frequently Asked Questions about Quality Assurance for New Reactors
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10 CFR Part 21 FAQs
For other 10 CFR Part 21 FAQs, see: Revision 1 to the NRC Responses to questions concerning 10 CFR Part 21.
Are there any plans for the NRC to clarify the requirements in 10 CFR Part 21?
SECY 16-009, dated January 31, 2016, provided the results of the Project AIM re-baselining of agency activities and requested Commission approval to implement recommendations on work to be shed, de-prioritized, or performed with fewer resources. On April 16th, 2016, the Commission approved the staff's recommendations to shed a number of rulemaking activities, which included 10 CFR Part 21 Rulemaking. The Staff will continue development of Part 21-related guidance documents: (1) DG-1291, "Evaluating Deviations and Reporting Defects and Noncompliance," and (2) DG-1292, "Dedication of Commercial Grade Items."
Does 10 CFR Part 21 apply to anyone supplying parts and services or only those supplying a basic component?
Part 21 regulations apply to each individual, corporation, partnership, or other entity, and each director and responsible officer of such an organization, that supplies basic components (i.e., safety-related SSCs) for a facility or activity licensed under the NRC regulations. As defined by § 21.3, basic component includes safety related design, analysis, inspection, testing, fabrication, replacement of parts, or consulting services that are associated with the component hardware, design, design certification, design approval, or information in support of an early site permit application, whether these services are performed by the component supplier or others.
Since Part 21 is a federal regulation, does it apply to all domestic suppliers whether or not they have an Appendix B to 10 CFR Part 50 (Appendix B) quality assurance (QA) program?
Yes; Part 21 applies to all domestic suppliers of basic components (i.e., safety-related SSCs).
Is Design Certification Document (DCD) engineering work a basic component?
Yes, DCD engineering work is a basic component because it is a safety-related design activity. As explained in the statement of considerations for the 2007 changes to Part 52 (72 FR 49352, August 28, 2007) the NRC regards the standard design certification applicant as supplying a component of an activity which is otherwise regulated by the NRC. The activity that is regulated by the NRC is the design certification rulemaking, and/or the Part 52 regulatory regime in which a design certification rule may be referenced in a subsequent licensing application.
Commercial Grade Dedication FAQs
For other Commercial Grade Dedication FAQs, see: NRC Responses to questions concerning Commercial Grade Dedication and General Topics.
How should a vendor respond to a request to provide a commercial grade dedicated item for a nonessential-to-function part, having no safety functions (e.g. packing, gaskets or parts that are solely used for maintenance)?
The commercial grade dedication process is intended to verify that there is reasonable assurance that a CGI to be used as a basic component will perform its intended safety function. The purchaser needs to include the appropriate level of detail in the purchase order to allow the supplier to address technical and quality requirements of the basic component. Appropriate interface between the utility and the vendor is necessary to identify and characterize the design and functional parameters of specific parts or components.
At what point does the licensee or third party dedicating entity QA program directly apply to a CGI? Is it at dedication?
The licensee's QA program would be applicable when the licensee identifies a CGI for dedication. The dedicating entity's QA program would be applicable when the dedicating entity identifies a CGI for dedication. The dedication process must be conducted in accordance with the applicable provisions of 10 CFR Part 50, Appendix B. The dedication process is considered complete when the item is designated for use as a basic component.
At what point is a "part" dedicated for use? Is it at the verification of the critical characteristic or at the completion of the process?
As stated in 10 CFR 21.3, definition for dedication (When applied to nuclear power plants licensed pursuant to 10 CFR Part 30, 40, 50, 60), the dedication process is considered complete when the item is designated for use as a basic component. As such, the part is only dedicated for use when the dedication process is complete.
Enforcement FAQs
What is a notice of violation and what must be included in a written response to the NRC for a notice of violation?
10 CFR 2.201, "Notice of Violation" states that: (a) In response to an alleged violation of any provision of the Act or this chapter or the conditions of a license or an order issued by the Commission, the Commission may serve on the licensee or other person subject to the jurisdiction of the Commission a written notice of violation; a separate notice may be omitted if an order pursuant to § 2.202 or demand for information pursuant to § 2.204 is issued that otherwise identifies the apparent violation. The notice of violation will concisely state the alleged violation and may require that the licensee or other person submit, within 20 days of the date of the notice or other specified time, a written explanation or statement in reply if the Commission believes that the licensee has not already addressed all the issues contained in the notice of violation, including:
(1) Corrective steps which have been taken by the licensee or other person and the results achieved;
(2) Corrective steps which will be taken; and
(3) The date when full compliance will be achieved.
(b) The notice may require the licensee or other person subject to the jurisdiction of the Commission to admit or deny the violation and to state the reasons for the violation, if admitted. It may provide that, if an adequate reply is not received within the time specified in the notice, the Commission may issue an order or a demand for information as to why the license should not be modified, suspended or revoked or why such other action as may be proper should not be taken.