180 NAC 13-022. CHANGES TO QUALITY ASSURANCE PROGRAM

022. CHANGES TO QUALITY ASSURANCE PROGRAM. 022.01 SUBMISSION AND IMPLEMENTATION. Each quality assurance program approval holder must: (A) Submit a description of a proposed change to its Department-approved quality assurance program that will reduce commitments in the program description as approved by the Department. The description must identify: (i) The change; (ii) Reason for the change; and (iii) Basis for concluding the revised program incorporating the change continues to satisfy the applicable requirements of 180 NAC 13-021; and (B) Not implement the change before receiving Department approval. 022.02 PREVIOUSLY APPROVED QUALITY ASSURANCE PROGRAM. Each quality assurance program approval holder may change a previously approved quality assurance program without prior Department approval, if the change does not reduce the commitments in the quality assurance program previously approved by the Department. Changes to the quality assurance program that do not reduce the commitments must be submitted to the Department every 24 months. In addition to quality assurance program changes involving administrative improvements and clarifications, spelling corrections, and nonsubstantive changes to punctuation or editorial items, the following changes are not considered reductions in commitment: (A) Use of a quality assurance standard approved by the Department that is more recent than the quality assurance standard in the licensee’s current quality assurance program at the time of the change; (B) Use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles, provided there is no substantive change to either the functions of the position or reporting responsibilities; (C) Use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or alternatively, the use of descriptive text, provided there is no substantive change to the functional relationships, authorities, or responsibilities; (D) Elimination of quality assurance program information that duplicates language in quality assurance regulatory guides and quality assurance standards to which the quality assurance program approval holder has committed to on record; and (E) Organizational revisions that ensure 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. 022.03 RECORDS. Each quality assurance program approval holder must maintain records of quality assurance program changes. APPENDIX 13-A DETERMINATION OF A1 AND A2 I. Values of A1 and A2 for individual radionuclides, which are the bases for many activity limits elsewhere in these regulations, are given in Table A-1. The curie (Ci) values specified are obtained by converting from the Terabecquerel (TBq) value. The curie values are expressed to three significant figures to assure the difference in the TBq and Ci quantities is one tenth of one percent or less. Where values of A1 or A2 are unlimited, it is for radiation control purposes only. For nuclear criticality safety, some materials are subject to controls placed on fissile material. II. a. For individual radionuclides whose identities are known, but which are not listed in Table A-1, the A1 and A2 values contained in Appendix 13-A, Table A-3 may be used. Otherwise the licensee must obtain prior Department approval of the A1 and A2 values for radionuclides not listed in Table A-1, before shipping the material. b. For individual radionuclides whose identities are known, but which are not listed in Table A-2, the exempt material activity concentration and exempt consignment activity values contained in Appendix 13-A, Table A-3 may be used. Otherwise, the licensee must obtain prior Department approval of the exempt material activity concentration and exempt consignment activity values for radionuclides not listed in Table A-2, before shipping the material. c. The licensee must submit requests for prior approval, described under paragraphs II.a. and II.b. of this Appendix, to the Department, according to 180 NAC 1-012. III. In the calculations of A1 and A2 for a radionuclide not in Table A-1, a single radioactive decay chain, where radionuclides are present in their naturally occurring proportions, and where no daughter radionuclide has a half-life either longer than 10 days, or longer than that of the parent radionuclide, must be considered as a single radionuclide, and the activity to be taken into account, and the A1 and A2 value to be applied must be those corresponding to the parent nuclide of that chain. In the case of radioactive decay chains where any daughter radionuclide has a half-life either longer than 10 days, or greater than that of the parent radionuclide, the parent and those daughter radionuclides must be considered as mixtures of different nuclides. IV. For mixtures of radionuclides whose identities and respective activities are known, the following conditions apply: a. For special form radioactive material, the maximum quantity transported in a Type A package is as follows: Where B(i) is the activity of radionuclide i in special form, and A1(i) is the A1 value for radionuclide i. b. For normal form radioactive material, the maximum quantity transported in a Type A package is a follows: where B(i) is the activity of radionuclide i in normal form, and A2(i) is the A2 value for radionuclide i. c. If the package contains both special and normal form radioactive material, the activity that may be transported in a Type A package is as follows: where B(i) is the activity of radionuclide i as special form radioactive material, A1 (i) is the A1 value for radionuclide i, C(j) is the activity of radionuclide j as normal form radioactive material, and A2 (j) is the A2 value for radionuclide j. d. Alternatively, the A1 value for mixtures of special form material may be determined as follows: where f(i) is the fraction of activity for radionuclide i in the mixture, and A2(i) is the appropriate A1 value for radionuclide i. e. Alternatively, the A2 value for mixtures of normal form material may be determined as follows: Where f(i) is the fraction of activity of radionuclide i in the mixture, and A2(i) is the appropriate A2 value for radionuclide i. f. The exempt activity concentration for mixtures of nuclides may be determined as follows: Where f(i) is the fraction of activity concentration of radionuclide i in the mixture, and [A](i) is the activity concentration for exempt material containing radionuclide i. g. The activity limit for an exempt consignment for mixtures of radionuclides may be determined as follows: Where f(i) is the fraction of activity of radionuclide i in the mixture, and A(i) is the activity limit for exempt consignments for radionuclide i. V. a. When the identity of each radionuclide is known, but the individual activities of some of the radionuclides are not known, the radionuclides may be grouped and the lowest A1 or A2 value, as appropriate, for the radionuclides in each group may be used in applying the formulas in paragraph IV. Groups may be based on the total alpha activity and the total beta, gamma activity when these are known, using the lowest A1 or A2 values for the alpha emitters and beta, gamma emitters. b. When the identity of each radionuclide is known but the individual activities of some of the radionuclides are not known, the radionuclides may be grouped and the lowest [A] (activity concentration for exempt material) or A (activity limit for exempt consignment) value, as appropriate, for the radionuclides in each group may be used in applying the formulas in paragraph IV of this appendix. Groups may be based on the total alpha activity and the total beta, gamma activity when these are known, using the lowest [A] or A values for the alpha emitters and beta, gamma emitters, respectively. ATTACHMENT 1 39 CFR Part 111, §111.1