ML22277A744
| ML22277A744 | |
| Person / Time | |
|---|---|
| Site: | 07103097 |
| Issue date: | 08/03/2022 |
| From: | Boyle R, Shaw D TN Americas LLC |
| To: | Division of Fuel Management |
| Garcia-Santos N | |
| Shared Package | |
| ML22277A716 | List:
|
| References | |
| A33010, L-2022-DOT-0008 | |
| Download: ML22277A744 (8) | |
Text
Unrestricted Orano Orano NPS 0
SAFETY ANALYSIS CHAPTER 1.9 REPORT QUALITY ASSURANCE Formulaire : PM04-4-MO-6 rév. 03 Prepared by FCC4 orano Verified by Identification : DOS-19-021166-008-NPV Version : 1.0 Page 1 / 8 Table of contents Status of revision 2
- 1. PRINCIPLES 3
- 2. QUALITY ASSURANCE CLASSES APPLICABLE TO FCC4 PACKAGE MODELS 4
- 3. COMMON QUALITY ASSURANCE PROVISIONS 5
- 4. DESIGN AND STUDIES QUALITY ASSURANCE 8 Non-proprietary version
Formulaire : PM04-4-MO-6 rev. 03 Unrestricted Orano Orano NPS Identification : DOS-19-021166-008-NPV Vers. 1.0 Page 2 of 8 Status of revision Version I Date I Purpose and record of revisions I Prepared by / Verified by Old reference: DOS-13-00081778-090 00 25/04/2021 First issue I I I New reference: DOS-19-021166-008 Update of the applicable versions 1.0 See 1st page I IPrecision concerning the quality assurance provisions I Non-proprietary version
Formulaire : PM04-4-MO-6 rev. 03 Unrestricted Orano Orano NPS Identification : DOS-19-021166-008-NPV Vers. 1.0 Page 3 of 8 The rules and classification of activities relating to the FCC4 package models defined below are applicable to all activities starting after 30 April 2022.
For activities starting before 30 September 2013, the rules and classification defined in paragraph 7 of the Safety Analysis Report TFX DC 2158 Rev. H are applicable.
This chapter describes general quality assurance provisions applicable to the various activities (design, manufacturing and testing, operation, maintenance and transportation). Quality assurance arrangements specific to manufacturing, operation and transport activities are defined in Chapter 1.7 of this Report, while the provisions specific to maintenance activities are defined in Chapter 1.8.
- 1. PRINCIPLES The transport regulations in force as of the date of this Chapter require the application of quality assurance programmes covering:
Design, Manufacturing and testing, Use, Maintenance, Transport for packages designed to hold radioactive materials.
These activities are the responsibility of various parties (applicant, owner, prime contractor, constructors, users, shippers, transporters, maintenance companies, etc.), who must all draw up their own appropriate quality assurance programmes and draw up and archive supporting documents (records) relating to their activity.
It should be noted that the owner must have in its possession at all times all relevant records relating to the package, and the shipper must be in possession of all documents relating to shipping of the package.
As of the date of this document, the quality assurance programmes (or management systems depending on the text) may be based on the requirements set forth in one or more of the following documents referenced by way of example and to the extent applicable:
Code GS-R-Part 2 "Leadership and Management for Safety, Safety Series TS-G-1.4 "Quality Assurance for the Safe transport of Radioactive Material" published by the IAEA, Code 10 CFR 71 Subpart H published by USNRC, ISO 9001 - 2015 version "Quality Management Systems".
A management system is a set of interlinked or interacting elements defining a policy and objectives used to achieve these objectives in an efficient and effective manner.
The document versions given in this chapter are those in force at the date of the operations (design, manufacture and testing, operation, maintenance and transport).
This safety analysis report, which contains safety analysis studies validating the design of the FCC4 package model, has been drawn up as part of Orano NPS and Framatome's Quality Management Systems which meet the requirements of the GS-R-Part 2 Code and ISO 9001-2015 standard.
Non-proprietary version
Formulaire : PM04-4-MO-6 rev. 03 Unrestricted Orano Orano NPS Identification : DOS-19-021166-008-NPV Vers. 1.0 Page 4 of 8 The distribution of the responsibilities and the interfaces between the two entities are defined by an organizing document of actions shared between Orano NPS and Framatome concerning the FCC4 product.
These Management Systems also cover the maintenance and manufacturing activities for which Orano NPS and Framatome are responsible.
The Quality Safety & Environment Management System (QSE-MS) applied by Orano NPS is described in a Manual supplemented by the set of documents referenced therein. This set of documents is referred to as the Methodological Reference. It covers all Orano NPS processes and provides a basis for continual improvement of the QSE-MS system.
The Integrated Management System applied by Framatome is described in a specific document Manuel du Systme de Management Intégré de Framatome. It is then divided up by directives, processes, fuel procedures and completed of procedures and fuel functioning notes. It manages the whole processes of Framatome Fuel and organises the continuous improvement of Framatome.
The management system defines and delimits the scope of authority and the responsibilities of the organisation and departments carrying out activities having an impact on safety, quality, health, security and the environment.
The Management System is supported by Quality Assurance arrangements designed to ensure that the activities, products or services conform to client requirements and/or objectives as well as internal, statutory and regulatory requirements. These arrangements include checks and inspections of the activities, products and services concerned.
- 2. QUALITY ASSURANCE CLASSES APPLICABLE TO FCC4 PACKAGE MODELS 2.1. Rules A modulation of the Quality Assurance Requirements is applied due to the unequal safety-related importance of the activities and components relating to the FCC4 packages.
Activities relating to the FCC4 packages are subject to Quality Assurance requirements in accordance with their safety-related importance: various classes are defined. The components of the package are classified with reference to their importance to safety, reliability and maintainability.
The QA (Quality Assured) class corresponds to the application of a quality assurance programme compliant with the requirements of Code GS-R-Part 2 and ISO 9001-2015 standard.
The NQC (Non Quality Classified) class applies to standard or catalogue equipment, or simple services for which a certificate of conformity is the only requirement.
The classification is initially determined by the entity requesting package approval, whose activities are QA classified, particularly those involving design and safety studies.
The other parties involved define, cascade-wise and with the agreement of their respective clients, the applicable classes of Quality Assurance programmes relevant to their various activities, and, where necessary, apply specific monitoring and inspection requirements.
The requirements transmitted may be derived either directly from GS-R-Part 2 or equivalent standards, for example ISO 9001-2015 standard supplemented as appropriate.
Non-proprietary version
Formulaire : PM04-4-MO-6 rev. 03 Unrestricted Orano Orano NPS Identification : DOS-19-021166-008-NPV Vers. 1.0 Page 5 of 8 2.2. Classification of activities relating to FCC4 package models.
Activity Applicable QA Class Packaging and components Design and modification QA Manufacture QA Maintenance QA Package Preparation of packages QA Loading, unloading and shipping QA Transport commissioning QA Transport QAP*
- Quality Assurance Programme adapted to the activity, for example as defined in IAEA Safety Series TS-G-1.4.
2.3. Classification of components of the FCC4 package model The following table lists the quality assurance classes applicable to the manufacture of the various components.
Components Applicable QA Class Resin pouring QA Shock absorbing covers QA Other components and services NQC Unless otherwise stated, this classification is applicable to finished equipment, ready for use or integration.
The manufacture of this equipment may be broken down into sub-assemblies, components and/or elementary services, which in turn may be classified according to their individual contributions to the quality of the equipment. The level of inspection to carry out on the components is detailed in Chapter 1.4 of this Report.
- 3. COMMON QUALITY ASSURANCE PROVISIONS This section describes general quality assurance arrangements to be applied across all activities (design, manufacture, maintenance, transport, etc.) for the various types of operations associated with compliance with a safety requirement (technical inspection, handling of non-conformities, archiving, etc.).
3.1. Arrangements relating to technical inspections associated with compliance with a safety requirement All non-documentary inspections are referred to as technical inspections. Technical inspections must be carried out by competent operators on the basis of documents specifying the tests involved and, where appropriate, verification of these tests. The verifications must be carried out by competent operators other than the persons who carried out the tests. The scope of these tests and verifications is adapted according to the safety impact of the products and services concerned.
The tests and verifications must be documented (inspection or test reports issued and signed by the operators carrying out the tests and verifications, etc.).
Before carrying out a technical inspection associated with a safety requirement, the operator must:
Note the identification of the equipment used and check the validity of the calibration date.
Non-proprietary version
Formulaire : PM04-4-MO-6 rev. 03 Unrestricted Orano Orano NPS Identification : DOS-19-021166-008-NPV Vers. 1.0 Page 6 of 8 Make sure that the equipment is capable of achieving the required accuracy and reliability and that the ambient conditions are suitable.
3.2. Handling of non-conformities All non-conformities found must be described and an appropriate resolution process defined through the necessary channels. The implementation and proper application of the decisions taken must be verified before the issue is signed off.
The impact of the non-conformity on safety must be assessed and taken into account in the decision-making process. Any variances between the package model as described in the drawings and requirements of this Report and the actual equipment will only be accepted following an additional analysis demonstrating that the variances do not call into question the conclusions of this Safety Analysis Report.
If the competent authorities of the countries through which or to which the package is to be transported have defined declaration criteria, these authorities must be informed of any non-conformities with respect to their requirements.
3.3. Document control 3.3.1. Production of documents Documents must be drawn up, checked, and if necessary approved, then distributed appropriately. The author(s) and checker(s) of the documents must be chosen having regard to the skills and competence required.
All documents containing safety-related requirements must be checked.
The person checking the document must be a person other than the author.
The approval signature signifies that a document is fit for use and confirms that the author and checker have the necessary competence to undertake these tasks.
In the case of manufacturing activities, maintenance and operation of the package (depending on the type of documentation not issued by the designer), the entity responsible for these operations (manufacturer, maintenance contractor, operator, etc.)
is responsible for ensuring the conformity of the documentation issued (operating procedures, etc.) with the requirements of the safety analysis report received either directly or through a third party. This third party will then be required to guarantee the conformity of the transmitted documents with the safety analysis report.
3.3.2. Document archiving All documents must be archived according to their importance for safety:
Documents meeting one of the following criteria must be permanently archived (the archiving period must be at least equal to the service life of the equipment concerned):
Proof of capability of the equipment to operate safely, Periodic inspections, maintenance and, where necessary, repairs and modifications of the equipment, Determination of the cause of an accident or equipment failure, Regulatory, legal or contractual requirement, Other documents must be archived, as the case may be, in accordance with legal, regulatory or contractual requirements.
Non-proprietary version
Formulaire : PM04-4-MO-6 rev. 03 Unrestricted Orano Orano NPS Identification : DOS-19-021166-008-NPV Vers. 1.0 Page 7 of 8 3.3.3. Traceability Current document versions must be recorded. These records must be used as a reference by all document users.
3.4. Management of subcontracting 3.4.1. Evaluation The monitoring of subcontracted services must be carried out by means of inspections and/or audits. Inspections and audits must be carried out by qualified personnel authorised to perform these tasks. Inspections and audits must be formalised and documented in reports.
3.4.2. Subcontracting of manufacturing activities In the case of manufacturing, the application of Quality Assurance arrangements in relation to the type of subcontracted manufacturing services (production processes and inspection/test procedures) is obligatory.
The requirements must be defined in a set of manufacturing specifications containing general quality-related requirements, construction drawings, production and procurement specifications.
This document set must be checked to ensure conformity with the applicable requirements defined in the Safety Analysis Report and those relating specifically to Quality Assurance.
3.4.3. Design, studies and tests Where part of the study, calculations or tests are subcontracted, a study specification must be issued for use by the service provider. The specification must properly cover the applicable requirements, in particular those relating to Quality Assurance.
3.4.4. Transport activities For transportation and its related services, the application of Quality Assurance arrangements is required depending on the mode of transport and/or type of content transported.
The requirements must be defined by a set of documentation containing general quality-related requirements, technical requirements relating to the operations to be carried out (tie-down, handling, etc.) and to the modes of transport (road, sea, etc.).
This document set must be checked to ensure conformity with the applicable requirements defined in the Safety Analysis Report and those relating to Quality Assurance.
3.4.5. Maintenance For maintenance services, the application of Quality Assurance arrangements is required depending on the type of equipment and activities concerned (processes and inspections).
The requirements must be defined in a set of documentation containing general quality-related requirements and the technical requirements relating to the operations to be carried out.
Non-proprietary version
Formulaire : PM04-4-MO-6 rev. 03 Unrestricted Orano Orano NPS Identification : DOS-19-021166-008-NPV Vers. 1.0 Page 8 of 8 This document set must be checked to ensure conformity with the applicable requirements defined in the Safety Analysis Report and those relating to Quality Assurance.
- 4. DESIGN AND STUDIES QUALITY ASSURANCE 4.1. Engineering Before starting design work, the basic design data must be validated and all regulatory requirements listed.
4.1.1. Design drawings These drawings must define the essential parameters as well as the functional dimensions of the package used in the calculations supporting this Safety Analysis Report.
The drawings must be verified in accordance with § 3.3.1.
4.1.2. Design output data The output data from the design work comprises design definition documentation (design drawings, calculations, specifications, operating instructions, etc.) together with documents demonstrating compliance with safety-related requirements (safety analysis report, calculations, etc.).
All of these documents must be checked in accordance with § 3.3.1 prior to use.
4.2. Calculations This section relates to the performance of calculations requiring the use of computer codes.
The verification of the calculations must be documented indicating the scope of the checks carried out. The verification of the results must be formalised by a signature. The checker must be a person other than the preparer or the author.
The use of computer codes is subject to the issuance or preparation of a qualification/validation document defining the scope and validity of the code.
4.3. Qualification tests Qualification tests are carried out on models or systems (possibly at reduced scale). The representative nature of the model must be formally studied. The applicable requirements and criteria must be defined in a test programme.
The models must be constructed in compliance with the procedures applicable to the manufacturing activity as defined in Chapter 1.7 of this Report.
A list of inspections and checks to be carried out during the test must be drawn up. These inspections and checks must be carried out in accordance with § 3.1.
The "measured" results obtained during the tests (dimensional measurements, leakage measurements, acceleration curves, etc.) must be documented in test reports.
Non-proprietary version