10 CFR 63.144, Quality Assurance Program Change
Quality assurance program change
Changes to DOE's NRC-approved Safety Analysis Report quality assurance program description are processed as follows:
(a) DOE may change a previously accepted quality assurance program description included or referenced in the Safety Analysis Report without prior NRC approval, if the change does not reduce the commitments in the program description previously accepted by the NRC. Changes to the quality assurance program description that do not reduce the commitments must be submitted every 24 months, in accordance with paragraph (b)(1) of this section. In addition to quality assurance program changes involving administrative improvements and clarifications, spelling corrections, punctuation, or editorial items, the following changes are not considered reductions in commitment:
- (1) The use of a quality assurance standard approved by the NRC which is more recent than the quality assurance standard in DOE's current quality assurance program at the time of the change;
- (2) The use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles;
- (3) The use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or alternatively, the use of descriptive text;
- (4) The elimination of quality assurance program information that duplicates language in quality assurance regulatory guides and quality assurance standards to which the licensee is committed; and
- (5) Organizational revisions that ensure that persons and organizations performing quality assurance functions continue to have the requisite authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations.
(b) DOE shall submit changes made to the NRC-accepted Safety Analysis Report quality assurance program description that do reduce the commitments to the NRC and receive NRC approval prior to implementation, as follows:
- (1) By an appropriate method listed in § 63.4 of this chapter, the signed document must be submitted to the Nuclear Regulatory Commission, addressed: ATTN: Document Control Desk; Director, Office of Nuclear Material and Safeguards; U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and one copy to the appropriate NRC Resident Inspector, if one has been assigned to the site or facility.
- (2) The submittal of a change to the Safety Analysis Report quality assurance program description must include all pages affected by that change and must be accompanied by a forwarding letter identifying the change, the reason for the change, and the basis for concluding that the revised program incorporating the change continues to describe how the requirements of § 63.142 will be satisfied and continues to satisfy the criteria of § 63.142 and the Safety Analysis Report quality assurance program description previously accepted by the NRC (the letter need not provide the basis for changes that correct spelling, punctuation, or editorial items).
- (3) DOE shall maintain records of quality assurance program changes that do reduce commitments.