ML23047A502
| ML23047A502 | |
| Person / Time | |
|---|---|
| Site: | 07103098 |
| Issue date: | 07/31/2022 |
| From: | Boyle R, Vescovi P Nuclear Fuel Industries, Ltd, Orano TN Americas |
| To: | Garcia-Santos N Storage and Transportation Licensing Branch |
| Garcia-Santos N | |
| References | |
| A33010, EPID L-2023-DOT-0002 NFK-MPCF-2210002 | |
| Download: ML23047A502 (14) | |
Text
NFK-MPCF-2210002 Explanation of quality control methods, etc. (limited to those relating to design) relating to the packaging July, 2022 Nuclear Fuel Industries, Ltd.
(a) Explanation of quality control methods, etc. (limited to those relating to design) relating to packaging (a)-A Quality management system The applicant, Nuclear Fuel Industries, Ltd. (hereinafter referred to as "the Company") has submitted an application for approval of package design (Kumagen No.22-004, dated June 20, 2005 (Kumagen No.22-014, dated July 20, 2022), which is a part of the application for approval of package design). (Partially amended by Kumagen No.22-014 dated July 20, 2022)) for a packaging, the applicant shall submit an application for confirmation of the technical standards and transportation as stipulated in laws and regulations, or an application for packaging approval. In order to manufacture the packaging in conformity with the design specifications and manufacturing methods indicated in the application for confirmation of technical standards and transportation as stipulated by laws and regulations or the application for packaging approval, the following quality management system shall be established, documented, implemented, and maintained in our company.
A.1 Quality Manual The top management of the quality management system is delegated by the President, and is jointly headed by the General Manager of the Kumatori works, the General Manager of the Tokai works, and the General Manager of the Engineering Division. (Hereinafter referred to as "Top Management"). Top management shall prepare and maintain a quality manual that includes the scope of application of the quality management system, established and documented procedures for the quality management system, and descriptions of the interrelationships among the processes of the quality management system. The quality management plan that defines the quality management system operations is established based on this quality manual and its subordinate rules.
A.2 Document Control Procedures are established for approval, review, and identification of documents required by the quality management system in accordance with the quality manual and its subordinate rules.
A.3 Quality Record Management In order to create and maintain quality records that are legible, identifiable, and retrievable, the quality manual and its subparts establish the necessary control procedures for the identification, storage, protection, retrieval, retention period, and disposal of quality records. The quality records shall include quality records submitted by packaging manufacturers, etc., and the retention period shall be determined taking into account the validity period of packaging approval and design approval.
(a)-B Responsibilities of the applicant B.1 Top Management in the Quality Management System Top management, as the highest responsible party for the manufacturing of packaging, shall set the quality policy and have the relevant departments shown in (a) Figure B-1 set quality objectives based on the policy. He/she shall also be responsible for conducting management reviews, reviewing the implementation of the quality management system, and continuously improving its effectiveness.
1
B.2 Administrator Top management shall appoint administrators from each of the Kumatori works, Tokai works, and Engineering Division. These administrators are responsible for and have authority over the following matters in their respective business units, regardless of their original duties.
(1) Ensure that a quality management system is established, executed and maintained; (2) Notify the Top management of current status of activities of quality management system.
B.3 Quality Assurance Department of Kumatori Works The Quality Assurance Department manager of Kumatori Works has the following responsibilities and competences:
(1) Prepare and develop a draft of a quality management system; (2) Execute quality audits at NFIs internal sections and at the facilities of outsourced packaging manufacturers and other service providers, examine the results of audits, and stipulate corrective measures if applicable; (3) Perform as-received inspections, periodical voluntary inspections and pre-shipment inspections of transport packages; (4) Prepare records of completion inspections; (5) Verify and report the effectiveness of corrective actions.
B.4 Nuclear Fuel Manufacturing Department of Kumatori Works The Fuel Manufacturing Department manager of Kumatori Works has the following responsibilities and competences:
(1) Prepare documents concerning to the manufacturing, handling, maintenance, etc. of packaging; (2) Evaluate the technical competences of outsourced packaging manufacturers and other service providers, and approve outsourced packaging manufacturers which meet the requirements; (3) Prepare documented specifications related to orders placed with outsourced packaging manufacturers and other service providers; (4) Examine documents submitted by outsourced packaging manufacturers and other service providers, and issue approval of such documents; (5) Manage the manufacturing operations for packagings; (6) Manage the transport of nuclear fuel materials.
B.5 Fuel Cycle Engineering Department of Engineering Division The Fuel Cycle Engineering Department manager of Engineering Division has the following responsibilities and competences:
(1) Design and obtain official permissions and authorizations for packages; (2) Prepare documents concerning the designing of packagings; (3) Create, evaluate, and manage quality verification tests of packagings.
2
B.6 In-Core Fuel Management and Safety Engineering Department of Engineering Division The In-Core Fuel Management and Safety Engineering Department manager of Engineering Division has the following responsibilities and competences:
(1) Conduct criticality and shielding analysis of packaging.
B.7 Environmental Safety Department of Kumatori Works The Environmental Safety Department manager of Kumatori Works has the following responsibilities and competences:
(1) Draw up and execute plans for the material accountancy/measuring control of nuclear fuel materials; (2) Establish relevant standards and regulations for material accountancy/measuring control of nuclear fuel materials, and manage the conformity.
B.8 Installation and Equipment Administration Department of Kumatori Works The Installation and Equipment Administration Department manager of Kumatori Works has the following responsibilities and competences:
(1) Conduct periodical inspections of measuring instruments.
B.9 Osaka Sales Branch of Kumatori Works The Osaka Sales Branch manager of Kumatori Works has the following responsibilities and competences:
(1) Carry out communicate with customers and outside parties, and execute contractual agreements.
B.10 Nuclear Fuel Manufacturing Department of Tokai Works The Fuel Manufacturing Department manager of Tokai Works has the following responsibilities and competences:
(1) Handle and conduct maintenance operations for packagings.
3
Quality Assurance Quality assurance, Department of inspection Kumatori Works Nuclear Fuel Production, Manufacturing Order management, Department of Transport management Kumatori Works Fuel Cycle Design, quality Management review Engineering verification test Department of Engineering Division In-Core Fuel Management and Criticality, Top management Safety Engineering Shielding analysis Department of Engineering Division Environmental Safety Administrator Department of Control of nuclear fuel material Kumatori Works Installation and Equipment Periodic inspection of Administration measuring instrument Department of Kumatori Works Communicate with customers Osaka Sales Branch of and execution of contracts Kumatori Works Nuclear Fuel Manufacturing Handling and maintenance Department of Tokai Works (a) Figure B-1 The organization of design and Manufacturing of packaging in NFI 4
(a)-C Education and training The Quality Assurance Department manager of Kumatori Works, the Nuclear Fuel Manufacturing Department manager of Kumatori Works, the Fuel Cycle Engineering Department manager of Engineering Division, the In-Core Fuel Management and Safety Engineering Department manager of Engineering Division, the Environmental Safety Department manager of Kumatori Works, the Installation and Equipment Administration Department manager of Kumatori Works, the Osaka Sales Branch manager of Kumatori Works and the Nuclear Fuel Manufacturing Department manager of Tokai Works assigns persons considered satisfactory in education, training, skills and experience related to the manufacturing of packaging to activities which may affect the quality of manufactured transport packagings. For this purpose, the following items shall be implemented (1) Define the skills and abilities required of persons performing activities which may affect the quality of manufactured packagings; (2) Educate and train the personnel so that they may acquire such skills, or take other appropriate measures; (3) Evaluate the effectiveness of education and training and other measures taken; (4) Ensure that the department personnel fully understand the meaning and importance of their activities and become aware of how to contribute to achieving the quality objectives; (5) Keep relevant records of education, training, skills and experience.
5
(a)-D Design Management To ensure that the design of nuclear fuel packages will meet the design requirements, the Fuel Cycle Engineering Department manager of Engineering Division take the measures shown in the following paragraphs:
D.1 Design Management (1) Clarify customer requirements, technical standards of laws and regulations, and performance and functional requirements, and implement the design. When a part of design is outsourced, design requirements based on customer requirements, technical standards of laws and regulations, and performance/functional requirements shall be clarified in the order specifications and presented to the outsourcing party.
(2) To adopt new designs, new technologies and/or special materials, the Fuel Cycle Engineering Department manager of Engineering Division exchanges information on the contents of technical specifications in relation to safety, the background of technical specifications determined and other relevant matters with designers and material manufacturers as required to allow the designers to fully understand NFIs design requirements.
(3) The Fuel Cycle Engineering Department manager of Engineering Division reviews submitted design documents (including drawings, calculation notes, and analysis documents) to check that they correctly take account of NFIs design requirements, and approves satisfactory documents.
D.2 Design Verification To adopt new designs, new technologies and/or special materials based on such satisfactory designs, the Fuel Cycle Engineering Department manager of Engineering Division verifies the designs in demonstration tests and/or alternative calculations as required.
D.3 Design Changes When modification of the current design specifications is proposed, the Fuel Cycle Engineering Department manager of Engineering Division reviews specific, clearly documented modifications and approves such proposals if they are satisfactory.
If any modification of design specifications necessitates having the designer or the designing service provider modify the design, the Fuel Cycle Engineering Department manager of Engineering Division reviews the newly submitted design documents (including drawings, calculation notes, and analysis documents) to check that they correctly take account of modified requirements, and approves the satisfactory documents. The Fuel Cycle Engineering Department manager of Engineering Division notifies the departments concerned in writing of any approved modifications.
6
D.4 Evaluation of design contractors To commission designing activities for transport packaging from an external party, the Fuel Cycle Engineering Department manager of Engineering Division checks that the external party has appropriate staff, appropriate technical competences and an appropriate quality management system.
Solely regarding the quality management system, the Fuel Cycle Engineering Department manager of Engineering Division requests the Quality Assurance manager to check through an initial qualification review that the external party has an appropriate quality management system.
7
(a)-E Instruction to Manufacture Packagings To ensure that transport packagings will meet the procurement requirements based on customers requirements and standards, the technical specifications stipulated in the applicable laws, ordinances and regulations, the design specifications stated in the Application for Design Approval, and the manufacturing process indicated in the Application for Packaging Approval, the department managers concerned take the measures shown in the following paragraphs:
E.1 Evaluation of Packaging Manufacturer To choose a packaging manufacturer, the Nuclear Fuel Manufacturing Department manager of Kumatori Works evaluates the manufacturers technical competences, organizational composition and quality assurance system. The Nuclear Fuel Manufacturing Department manager of Kumatori Works reviews and approves the results of such evaluations.
Such evaluations may take account of the following:
(1) Technologies, personnel and equipment for manufacturing transport packagings; (2) Packaging manufacturers quality-related principles and plans, and implementations of such principles and plans; (3) Records of distributions of transport packagings or similar products; (4) Records of applications and quality of transport packagings or similar products; (5) Qualities of prototypes and samples submitted.
E.2. Requirements for Quality Management System of Packaging Manufacturer To place an order for manufacture of a transport packaging, the Nuclear Fuel Manufacturing Department manager of Kumatori Works defines in a document of order specifications the matters listed below in order to allow the packaging manufacturer to achieve desired product quality:
(1) Scope of services provided by the packaging manufacturer; (2) Technical requirements in terms of designing, manufacturing, inspection and applicable laws, ordinances and regulations; (3) Matters related to submission of quality plan; (4) Matters concerning visits for quality audits to the packaging manufacturers facilities; (5) Matters related to submission of documents and submission and storage of records; (6) Handling and eliminating of unconformities; (7) Matters related to the application of procurement requirements to the packaging manufacturers suppliers.
The Nuclear Fuel Manufacturing Department manager of Kumatori Works specifies in an order specifications document the following matters:
Quality management is performed in conformity to the ISO 9001 and other international standards; NFIs personnel and/or officials from the competent authorities may visit the facilities of the packaging manufacturer and his suppliers for inspections of manufacture and quality management conditions; NFI takes measures enabling it to review and approve the packaging manufacturers criteria for selecting 8
suppliers; NFI takes measures for defining in a contract the relationship of responsibility between business entities for the purpose of manufacture of transport packagings, and takes measures enabling it to check the selection of suppliers by the packaging manufacturer; NFI takes measures to ensure that the packaging manufacturer and his suppliers fully understand the meaning and importance of safety-related values or figures specified for the materials by NFI; NFI takes measures for promoting close exchanges of information and technical matters between the business entities engaged in the manufacture of transport packagings with regard to the processing, analysis and inspection as part of the manufacturing process if any special materials of importance to safety are used; For any processes which concern more than one business entity engaged in the manufacture of transport packagings, NFI takes measures for promoting correct and timely operating instructions and specific arrangements such as setting of delivery dates for the purpose of close cooperation between these business entities; Any product unconformity that appears possible to be eliminated by simple retouch should be reported in writing to the Nuclear Fuel Manufacturing Department manager of Kumatori Works for instructions; In case of critical modification in the packaging manufacturing process, the packaging manufacturer should notify the Nuclear Fuel Manufacturing Department manager of Kumatori Works from NFI without delay for approval; The packaging manufacturer should take the following measures:
(a) Evaluate the competences and skills of subcontractors in accordance with section E.1; (b) Instruct the packaging manufacturers suppliers to meet the requirements or requests transmitted by NFI to the packaging manufacturer in accordance with sections E.2.(1) to (7);
(c) Perform quality audits and verifications of products delivered by the packaging manufacturer suppliers in accordance with section E.3, PROVIDED THAT:
(i) The suppliers are subcontractors who are affected by any of the inspection items defined in the Application for Packaging Approval; (ii) The packaging manufacturer does NOT directly perform quality audits; (iii) The manufacture is NOT performed according to an official standard (e.g., JIS standard) or in an official qualification scheme; (iv) The manufacture is NOT concerned with products for general purposes, products for which check items are simplified or for which nothing other than verification by as-received inspections at NFI is regarded as necessary.
9
E.3 Verification of the manufacture of packaging To verify that a transport packaging meets the procurement requirements, the following measures are taken:
(1) The Quality Assurance Department manager of Kumatori Works defines a quality audit plan and a quality audit procedure and carries out quality audits of the packaging according to the plan and procedure. The Nuclear Fuel Manufacturing Department manager of Kumatori Works defines a quality audit plan and a quality audit procedure according to which the Quality Assurance Department of Kumatori Works conducts quality audits of the packaging.
(2) The Quality Assurance Department manager of Kumatori Works inspects the quality of the packaging manufacturer, and also that of the packaging manufacturers suppliers as required.
(3) With regard to inspections of transport packagings, the Nuclear Fuel Manufacturing Department manager of Kumatori Works defines checking procedures such as those for attending inspections and checking records in consideration of the official standards and official qualification schemes, the current practices of quality management applied by the packaging manufacturer and his suppliers, taking into account the importance of safety-related matters.
10
(a)-F Handling and maintenance In order to maintain the technical standards of the laws and regulations and the design specifications of the design approval application for nuclear fuel transportation, the Fuel Manufacturing Department manager of Tokai Works shall develop, handle, and maintain the following procedures in accordance with the descriptions in Chapter (C) of the Safety Analysis Report.
F.1 Handling To ensure safety in packages during transport, the Fuel Manufacturing Department manager of Tokai Works defines the procedures for the following categories of package handling operation and makes them known to every person of all the organizational units concerned:
- Packing Procedure
- Receiving Procedure
- Delivery Procedure.
F.2 Pre-shipment Inspection The Fuel Manufacturing Department manager of Tokai Works defines a procedure for performing pre-shipment inspections of packages and makes them known to every person of all the organizational units concerned to ensure safety in packages during transport. For this purpose, the Nuclear Fuel Manufacturing Department manager of Kumatori Works takes the following measures:
(1) Establish pre-shipment inspection standards including standardized forms of Inspection Record Sheets to be used for the purpose; (2) Store data recorded during pre-shipment inspections by filling out the packaging-type-specific inspection record sheets; F.3 Storage and maintenance For storage, maintenance and inspection of packaging, a "management guideline" for packaging is established and implemented, and the performance of packaging is continuously maintained.
F.5. Periodical Voluntary Inspections The Fuel Manufacturing Department manager of Tokai Works defines Periodical Voluntary Inspection Procedures for transport packagings, makes them known to every person of all the organizational units concerned and checks that the transport packagings conserve the required performance.
For this purpose, the Fuel Manufacturing Department manager of Tokai Works takes the following measures:
(1) Carry out periodical inspections of approved models of packaging at least once a year (or at least every ten transport missions of the packaging if the packaging is used at least ten times a year) for the required periodical voluntary inspection items depending on the information given in the appropriate Safety Analyses; (2) Arrange a periodical voluntary inspection plan for transport packagings in consideration of their actual operations to ensure that the planned periodical voluntary inspections are completed before the expiry date fixed for the packagings; (3) Establish periodical voluntary inspection standards including standardized forms of Periodical Voluntary 11
Inspection Sheets to be used for the purpose; (4) Store data recorded during periodical voluntary inspections by filling out the packaging-type-specific inspection record sheets; F.5 Outsourcing Handling and Maintenance The handling and maintenance described in F.1 to F.4 may be entrusted to a contractor of pellet manufacturing, etc.
The Fuel Manufacturing Department manager of Kumatori Works clarifies the necessary specifications for handling and maintenance to the contractors, and confirms and maintains the records of handling and maintenance performed by the contractors.
12
(a)-G Measurement, Analysis and Improvement G.1 Internal Quality Audit The Quality Assurance Department manager of Kumatori Works periodically conducts internal audits to verify that the quality management system is being applied and maintained effectively. The Quality Assurance Department manager defines in appropriate procedure documents how such internal audits are to be planned and conducted. . The inspectors do not inspect their own operations.
The responsible persons of the area being inspected take immediate measures to eliminate all detected unconformities and their causes.
G.2 Management of non-conforming products The Nuclear Fuel Manufacturing Department manager of Kumatori Works identifies and manages non-conforming products. The Nuclear Fuel Manufacturing Department manager of Kumatori Works defines management methods, responsibilities and competences for treating and disposing of non-conforming products in appropriate procedure documents.
G.3 Corrective and preventive measures (1) Corrective measures NFI takes measures for eliminating the causes of unconformities to prevent their recurrence. NFI defines in specific documents the requirements for verification of unconformities, identification of their causes, measures for preventing recurrence of such unconformities and recording of effects of such measures.
(2) Preventive measures NFI defines the measures to be taken for eliminating the causes of potential unconformities to prevent occurrence of such unconformities. NFI defines in specific documents the requirements for identification of unconformities and their causes, measures for preventing occurrence of unconformities and recording of the effects of such measures.
13