ML25280A236
| ML25280A236 | |
| Person / Time | |
|---|---|
| Site: | 07003103, 07100940 |
| Issue date: | 10/07/2025 |
| From: | Louisiana Energy Services, URENCO USA |
| To: | Office of Nuclear Material Safety and Safeguards |
| Shared Package | |
| ML25280A231 | List: |
| References | |
| LES-25-142-NRC | |
| Download: ML25280A236 (1) | |
Text
SECTION 3 Design Control Quality Assurance Program Description Revision 45c Page l 13 SECTION 3 DESIGN CONTROL The elements of the UUSA QA Program described in this section and associated procedures implement the requirements of Criterion 3, Design Control, of 10 CFR 50, Appendix B, and the commitment to Basic Requirements 3 and Supplement 3S-1 of NQA-1-1994 Part I as revised by NQA-1a-1995 Addenda of NQA-1-1994. See Section 4 Procurement Document Control for specific UUSA exemptions to 10 CFR Part 21.3 for the definitions of commercial grade item, basic component, critical characteristics, dedicating entity, and dedication. The UUSA QA Program also implements the commitment to Part II of NQA-1-1994 Subpart Part 2.7, Quality Assurance Requirements of Computer Software for Nuclear Facility Applications, as revised by NQA-1a-1995 Addenda of NQA-1-1994. These commitments also apply to computer software that is used to produce or manipulate data that is used directly in the design, analysis and operation of structures, systems and components relied on for safety. Part I, Supplement 11S2, Supplementary Requirements for Computer Program Testing, requirements for computer software qualification and use are also implemented by the UUSA QA Program.
The quality classification of NRC Licensed Transportation Packages willmay not be revised using the UUSA Design Control process. These modifications must be made by the NRC Certificate Holder. The Certificate Holder is responsible for design and licensing controls for these components under the provisions of an NRC General License for Radioactive Material Transportation Packages under 10 CFR 71. The UUSA "10 CFR 71, Subpart H Quality Assurance Manual for Packaging and Transportation of Radioactive Materials for Urenco USA" provides allowance for UUSA to perform limited scope design analysis for 30B product cylinders within DN30 Transportation Packages. The limited scope of the 30B design analysis is restricted to enrichment-related analyses, such as criticality physics and radiation shielding calculations.
Measures are established in procedures to ensure that applicable requirements are correctly translated into design documents for quality activities controlled under the QAPD. Design inputs are specified on a timely basis. Controls are established for the selection and suitability of application of materials, parts, equipment and processes that are essential to the functions of structures, systems and components relied on for safety. Design interfaces are established in applicable procedures. Procedures detail the controls for design input, design process, design verification, design changes and approval. These procedures include appropriate quantitative and/or qualitative acceptance criteria for determining that activities have been satisfactorily accomplished. UUSA design documents are prepared, reviewed, and approved by qualified individuals. Design is verified by one or more of the following verification methods: design reviews, alternate calculations or qualification tests. Design changes are governed by control measures commensurate with those applied to the original design. The design process and design verification practices and procedures shall be reviewed and modified, as necessary, when a significant design change is required because of an incorrect design. These and any other design deficiencies discovered during the design process on subsequent design related activities that affect the design of SSC shall be entered into the Corrective Action Program (CAP) according to Section 16, Corrective Action. If these deficiencies cause constructed or partially constructed items (systems, structures or components) to be deficient prior to being placed into service, then, the affected items shall be controlled in accordance with Section 15, Nonconforming Items. Configuration management is maintained in accordance with the applicable procedure and the applicable procedures including those established to control changes to the various types of design documents.