ML19270F771
| ML19270F771 | |
| Person / Time | |
|---|---|
| Site: | 07100003 (XN-NF-439) |
| Issue date: | 03/01/1979 |
| From: | SIEMENS POWER CORP. (FORMERLY SIEMENS NUCLEAR POWER |
| To: | |
| Shared Package | |
| ML19270F772 | List: |
| References | |
| 12216, XN-NF-439, NUDOCS 7903270148 | |
| Download: ML19270F771 (36) | |
Text
l 7. AV?? C.
l XN-NF 439 I
REV.1 I
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QUALITY ASSURANCE PROGRAM FOR I
NUCLEAR FUELS DEPARTMENT SHIPPING CONTAINERS g
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MARCH 1979 l
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RICHLAND, WA 99352 I
l ERON NUCLEAR COMPANY,Inc.
I IEN5 730327O/48g
XN-NF-439, Rev. 1 issue Date: 03/08/79 I
EXXON NUCLEAR COMPANY, INC.
QUALIFY ASSURANCE PROGRAM FOR NUCLEAR FUEL 3 DEPARTMENT SHIPPING CONTAINERS I
j p
Prepc'ed by:
'W.,
[A W I# ' ' D Manager, Quality Assurance-Nuclear Fuels Date
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2[P Concurred by:
/
y Vics President & Executive in Charge, Da t'e Nuclear Fuels JZ/[77 Approved by:
7 Mana r,QualityAgurance Dhte I
Summary of changes: This revision updates organizational titles / responsibilities, I
clarifies scope, and applies graded approach to QA Program applicability to the extent justified by the relative im-portance of the characteristic involved.
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I XN-NF-439, Rev. 1 EXXON NUCLEAR COMPANY, INC.
QUALITY ASSURANCE PROGRAM FOR NUCLEAR FUELS DEPARTMENT SHIPPING CONTAINERS TABLE OF CONTENTS Page No.
E 0.0 I!1TRODUCTIO!i 1
0.1 Purpose 1
0.2 Scope 1
0.3 Implementation 1
0.4 Authority 1
0.5 Supporting Documents 2
0.6 Definitions 2
1.0 ORGANIZATION 5
1.1 Chief Executive Officer 5
1.2 Vice President & Executive in Charge, Projects 5
1.3 Manager, Quality Assurance 5
1.4 Manager, Licensing 5
1.5 Manager Licensing & Compliance 5
1.6 Manager, Quality Assurance - Nuclear Fuels 6
1.7 Vice President & Executive in Charge, Nuclear Fuels 6 1.8 Manager, Manufacturing 6
1.9 Manager, Quality Control 6
1.10 Manager, Auxiliary Operations 7
1.11 Manager, Nuclear Fuels Engineering 7
1.12 Manager, Materials and Purchasing 7
1.13 Manager, Traffic 7
1.14 Accountability and Responsibility Matrix 7
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XN-NF-439, Rev. 1 I
TABLE OF CONTENTS (Continued)
P e No.
2.0 QUALITY ASSURANCE PROGRAM 10 2.1 Indoctrination and Training 10 2.2 Personnel Qualification 10 2.3 Management Review 10 2.4 Temporary Deviations 10 - 11 2.5 Revisions 11 3.0 DESIGN C0liTROL 12 3.1 Design Criteria 12 - 13 3.2 Parts List 13 3.3 Specifications 13 3.4 Drawings 13 3.5 Calculations la 3.6 Design Reviews la 3.7 Modifications 14 5
3.8 Maintenance 14 4.0 PROCUREMENT DOCUMENT CONTROL 15-4.1 Content of Procurement Documents 15 4.2 Procurement Document Review 15 5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS 16 6.0 DOCUMENT CONTROL 17 7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT 18 AND SERVICES 7.1 Supplier Evaluation and Selection 18 7.2 Control of Supplier Performance 18 - 19 7.3 Surveillance and Source Inspection 19 7.4 Receiving Inspection 19 I
)(ti-flF-439, Rev. 1 I
TABLE OF CONTENTS (Continued)
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8.0 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS 20 I
AND COMPONENTS 9.0 C0flTROL OF SPECIAL PROCESSES 21 10.0 INSPECTION 22 11.0 TEST C0flTROL 23 12.0 CONTROL OF MEASURIflG AND TEST EQUIPMENT 24 13.0 HANDLING, STORAGE AND SHIPPING 25 14.0 If4SPECTION, TEST AND OPERATIf4G STATUS 26 15.0 fl0N-CONFORMING MATERIALS, PARTS AND COMP 0f1ENTS 27 16.0 CORRECTIVE ACTION 28 17.0 QUALITY ASSURANCE RECORDS 29 18.0 AUDITS 30 I
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Xti-t1F-439, Rev. 1 I
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EXXON NUCLEAR COMPAtlY, IflC.
QUALITY ASSURANCE PROGRAM FOR I
NUCLEAR FUELS DEPARTMENT SHIPPltiG CONTAltiERS LIST OF FIGURES Page flo.
Figure 1.1 Organization - Exxon fluclear 8
Figure 1.2 Accountability & Responsibility Matrix 9
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E XN-NF-439, Rev. 1 QUALITY ASSURANCE PROGRAM FOR NUCLEAR FUELS DEPARTMENT I
SHIPPING CONTAINERS
0.0 INTRODUCTION
0.1 Purpose I
The purpose of this plan is to define the Exxon Nuclear Company quality assurance program for shipping containers used by the Nuclear Fuels Department that are required te be licensed per 10 CFR 71, Appendix E.
0.2 Scope k
0.2.1 The scope of this program includes design, procurement, fabrication, assembly, maintenance, modification, and repair of shipping containers intended for use to ship unirradiated nuclear fuel and radioactive material.
0.2.2 This program applies to the nuclear and radiological safety-related and functional performance characteristics of I
shipping containers to the extent justified by the rela-tive importance of the characteristic involved.
Certain major features, such as fuel bundle container strongback design and material type will receive prime attention, whereas standard nuts, bolts and packaging materials warrant little QA/QC effort.
0.2.3 In cases where changes are being made to an already li-censed container, this program shall be limited to the design, procurement, fabrication, and assembly activities associated with the change being made and not to the entire previously existing container design.
0.2.4 The use of shipping containers to store and ship fuel is I
outside the scope of this document and is covered under XN-NF-1.
0.3 Implementation 0.3.1 Implementation of this CA plan for new designs commences 3
with the start of preliminary design.
0.3.2 Applicable portions of this QA plan shall be implemented for I
procurement to a design that is already licensed or mainten-ance and modification of existing containers.
A thority 0.4 3
0.4.1 10 CFR 71, Appendix E.
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Xil-fiF-439, Rev. 1 0.5 Supporting Documents 0.5.1 Exxon fiuclear Company, Inc. Quality Assurance Program for Nuclear Fuel Design and Fabrication, XN-fiF-1 which meets the requirements of 10 CFR 50, Appendix B.
0.6 Definitions Accept:
The accept function is assigned to responsible I
Exxon Nuclear line managers to whom approval authority is not delegated, but who must accept the documented require-ments as operable, within budget and consistent with the I
execution of their assigned responsibility.
Approve: The approve furction is reserved for responsible line managers who have been delegated approval responsiblity.
I The approval signifies line management approval for all aspects within the scope of delegated authority.
Audit: An activity to determine, through investigation, the adequacy of and adherence to established prccedures and instruction, and the effectiveness of implementation.
Characteristic: Any property or attribute of an item, process or service that is distinct, describable, and measurable, as conforming or nonconforming to specified I
quality requirements.
Quality characteristics are generally identified in specifications and drawings which describe the i tem, process, or service.
Concur: The concur function is assigned to staff managers or others and is exercised in the areas of responsibility I
delegated and signifies agreement.
Defective Material-A material or component which has one or more characteristics that do not comply with specified I
requirements.
Design Criteria: Exxon fiuclear imposed requirements com-I bining safety, technical, materiai choice, quality control, and compatibility factors which serve as the basis for design, including design methods, engineering, process, environmental impact, and appropriate standards and codes.
Design Package: A compilation of a Parts List, Product and Material Specifications and Drawings.
Together, they uniquely i
define the specific container design or modification.
Deviation: A nonconformance or departure of a characteristic I
or procedure from specified requirements.
XN-NF-439, Rev. 1 Documentation:
Any written or pictorial infonnation describing, defining, specifying, reporting, or certifying activities, I
requirements, procedures, or results.
Execute:
The execute function is assigned to line organ-I ization managers respcnsible for carrying out a specific function or task.
Guidelines:
Particular provisions which are considered good I
oractice, but which are not mandatory.
The term "should" denotes a guideline; the term "shall" denotes a requirement.
Inspection:
A phase of quality control which by means of examination, observation or measurement determines the conformance of materials, components, parts, or processes to predetermined quality requirements.
Item: Any level of unit assembly, including subassembly, component, part, or material.
Major Change:
Any modification to an existing shipping con-
_3 tainer design which sufficiently changes the safety-related aspects such that a license amendment is required.
Minor Change: Any modification other than those classified as major.
Modification:
Process of changing from an approved drawing or specification.
Nonconformance: A deficiency in characteristic, documentation, or procedure which renders the quality of an item unacceptable or indeterminate.
Examples of nonconformances include:
physical defects; test failures; incorrect or inadequate documentation; and deviation from prescribed processing, inspect. 1, or test procedures.
Parts List:
List which displays by numbers and revision all Product Specifications, Material Specifications and drawings I
required to define the container.
The Parts List shall be the sole authoritative definition of the shipping container.
Prepare: The prepare function is assigned to organization 8
managers for preparation and compilation of a designated body of work. Unless otherwise specified, the " prepare" assignment indicates responsibility and accountability I
for preparation of a program element, arranging for appro-priate review, resolution of differences and ultimate approval of the program element.
Procedure: A document that specifies or describes how an activity is to be performed.
It may include methods to be employed, equipment or materials to be used and sequence of 5
operations.
I X N-tiF-43 3, Rev. 1 Quality Assurance: All those planned and systematic actions necessary to provide adequate confidence that a shipping I
container or component will perform satisfactorily in service.
Quality Control:
The detailed and systematic inspection, I
testing, and documentation to ensure that a material, process, or component, is in accordance with predetermined quality and design requirements.
Repair: The approved process of restoring a nonconfonning characteristic to a condition such that the capability of an item to function reliably and safely is unimpaired, even I
though that item still may not conform to the original requirement.
I Rework: The process by which a nonconforming item is made to conform to a prior specified requirement by completion, remachining, reassembling or other means.
Source Surveillance: A review, observation, or inspection for the purpose of verifying that an action has been accomp-lished as specified at the location of material procurement I
or manufacture.
Specification:
A concise statement of a set of requiren.ats I
to be satisfied by a product, a material, or a process indicating wherever appropriate the procedure by means of which it may be determined whether the requirements given are satisfied.
Supplier: Any organization under contract to furnish items or services to Exxon Nuclear.
It includes the terms Vendor, Supplier, Contractor, and sub-tier levels of these where appropriate.
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I XN-NF-43% Rev. 1 1.0 ORGANIZATION The Exxon Nuclear organization applicable to shipping containers quality assurance is shown in Figure 1.1.
A responsibility matrix summarizing responsibilities is shown i
in Figure 1.2.
General responsibilities for key individuals are contained I
relate to shipping container activities are summarized below in XN-NF-1, Part II.
Additional responsibilities as they and are discussed in greater detail in subsequent sections of this document.
1.1 Chief Executive Officer The Chief Executive Officer of Exxon Nuclear is ultimately responsible for establishing the Corporate Quality Assurance Policy and ensuring that all Company operations are carried out in full compliance with that policy.
This responsibility is extended to the shipping container Quality Assurance Program.
1.2 Vice President and Executive In Charge, Projects The Vice President and Executive in Charge, Projects reports to the Chief Executive Officer and has responsibility for I
Projects, and Quality Assurance.
1.3 Manager, Quality Assurance The Manager, Quality Assurance reports to the Vice President and Executive in Charge, Projects and is responsible for I
providing Quality Assurance program management for the shipping containers.
He has overall responsibility for the implemen-tation of the quality assurance related activities within the responsibility assigned to the Manager, Quality Assurance Department including stop work authority.
In matters per-1 taining to Quality Assurance, he has direct lines of commu-nication to both the Vice President and Executive in Charge, A
I Projects and the Vice President and General Manager, Nuclear
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Fuels Department.
1.4 Manager, Licensing The Manager, Licensing reports to the Vice President and Executive in Charge, Technology and Overseas Fuel Supply.
I He is responsible for licensing the shipping containers.
- 1. 5 Manager, Licensing and Compliance The Manager, Licensing and Compliance reports to the Manager, Licensing and is responsible for implementation of the I
licensing activities related to shipping containers.
I XN-NF-439, Rev. 1 1.6 Manager, Quality Assurance - Nuclear Fuels The Manager, Quality Assurance - Nuclear Fuels reports to the Manager, Quality Assurance and is responsible for the direct quality assurance activities related to the Nuclear Fuel Department including shipping containers.
His duties and responsibilities for shipping containers include:
a.
Preparing, interpreting, revising and administering the quality assurance program, proceaares and requirements.
j b.
Ordering work stopped whtn the seriousness of a 5
condition adverse to ;;'li+y warrants such action in order to maintain the requisi;? quality.
g c.
Performing quality assurance audits of design, g
procurement, fabrication, inspection and testing activites and reporting deviations from established quality assurance practices and procedures.
I d.
Conducting audit followup and monitoring corrective actions.
e.
In matters pertaining to shipping container Quality Assurance, he has direct lines of communication to I
the Vice President and Executive in Charge, Nuclear Fuels Department.
1.7 Vice President and Executive in Charge, Nuclear _ Fuels The Vice President and Executive in Charge, Nuclear Fuels I
reports to the Chief Executive Officer.
He is responsible for the Nuclear Fuels Department activities, facilities and for ensuring that the Nuclear Fuels Department's activities are g
carried out in compliance with the Quali y Assurance Program t
3 and procedures.
As such, he is respomible for quality control, design, engineering, purchasing and maintenance activities related to shipping containers.
1.8 Manager, Manufacturing The Manager, Manufacturing reports to the Vice President and Ey mutive in Charge, Nuclear Fuels.
The Manager, Manufacturing 1
is responsible for the overall management of the Exxon Nuclear fuels fabrication plants including the functions of quality 8
control, maintenance, and document / records control.
These responsibilities are extended to shipping containers.
1.9 Manager, Quality Control The Manager, Quality Control reports to the Manager, Manu-facturing.
He is responsible for implementing the Quality I
Control Program relating to vendor inspection requirements, offsite source surveillance, and required inspections as related to shipping containers.
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XN-NF-439, Rev. 1 1.10 Manager, Auxiliary Operations The Manager, Auxiliary Operations reports to the Manager, Manufacturing and is responsible for document control and related activities for shipping containers.
1.11 Manager, Nuclear Fuels Engineering The Manag, Nuclear Fuels Engineering reports to the Vice r Tsident und Executive in Charge, Nuclear Fuels.
His responsibility for shipping containers includes preparation of design criteria, parts lists, specifications, and drawings, I
and providing assistance in preparation of license documenta-tion. Major changes to existing shipping container designs, 1
which require license amendment, are identified with concur-3 rence by Licensing.
He is also 'esponsible for the accep-3 tance of the final design and for testing required as a condition for container licensing.
1.12 Manager, Materials and Purchasing The Manager, Materials and Purchasing reports to the Vice I
President and Executive in Charge, Nuclear Fuels.
He has 1
overall responsibility for shipping container activities including procurement of new containers and custodial He shall I
responsibility for existing shipping containers.
provide overall project coordination for design, funding, procurement, fabrication and testing of shipping containers.
Specific responsibilities are as indicated in Figure 1.2.
1.13 Manager, Traffic The Manager, Traffic reports to the Manager, Materials and Purchasing. He has deta l responsibility for the implemen-i tation of activities within the overall responsibility as-I signed to the Manager, Materiols & Purchasing.
1.14 Accountability and Responsibility Matrix The principal accountabilities, authorities and interrela-tionships among managers are shown in Figure 1.2, " Exxon Nuclear Accountability and Responsibility."
Failure to obtain the required signatures for the documents shown in Figure 1.2 shall prevent their use unti esolution I
is obtained at the respective level or through higher levels of management, if need be.
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M M
M M
M M
M M
M M
E M
M M
M FIGURF. 1.1 EXX0il NUCLEAR ORGANIZATION (Related to Shipping Container Activities) h Chief Executive Officer
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V.P. & Executive in Charge V.P. & Executive in Charge V.P. & Executive in Charge Nuclear Fuels Projects Technology and Overseas Fuel Supply
(
(
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Manager Manager Manager Manager Manager Manufacturing Nuclear Fuels Materials &
, Quality Assurance Licensing Engineering Purchasing
!1anager Licensing and Manager Manager Manager Compliance Quality Auxiliary Traffic Control Operations Manager Manager Maintenance Quality Assurance -
Nuclear Fuels x?s A
NOTE:
Only organizations having QA responsibilities for shipping containers are shown y
on the organization chart.
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KEY TO SYMBOLS I
P = PREPARE - Lead role, primary responsibility for document prepara-tion and coordination.
Must assure, where applicable, ag acceptance of the documented requirements as operable, within budget and schedule.
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- The concur function signifies agreement in the individuals C = CONCUR assigned area of responsibility including, where appli-cable, acceptance of the documented require:nents as I
operable, within budget and schedule.
A = APPROVE - Overall approval.
Denotes that factors which impact the company internally, and its external _ relationships have been appropriately accommodated within dosignated area of responsibility.
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I XN-NF-439, Rev. 1 2.0 QUALITY ASSURANCE PROGRAM The Quality Assurance Program for shipping containers shall be implemented through the use of written procedures and instructions and the documentation of inspections, personnel I
and procedure qualification, tests and audits.
In complying with the Quality Assurance Program requirements, procedures and instructions shall be controlled in the following areas:
I design, procurement, fabrication, inspection, testing, licensing, maintenance and modification.
2.1 Indoctrination and Training Personnel performing activities significantly affecting quality shall receive Quality Assurance indoctrination and training. The Manager, Quality Assurance - Muclear Fuels is I
responsible for assuring that the training is performed in a timely manner.
2.2 Personnel Qualification The specific manufacturing processes of fabrication, inspec-I tion, testing and assembly requiring performance by specially qualified personnel shall be defined in the Specification (s).
Qualification shall be as per established requirements and shall be documented.
Quality Assurance lead auditors shall be qualified.
2.3 Management Review Review of the scope, status, implementation and effective-I ness of the Quality Assurance Program shall be conducted by management for the portion for which they have designated responsibilities.
The reviews shall be conducted and documented at least once during a two calendar year interval.
k 2.4 Temporary Deviations Temporary Deviations from procedures or instructions may be approved, provided the following conditions are met:
1)
The Temporary Deviations are not used for deleting license requirements and do not decrease assurance of product quality; 2)
The Temporary Deviation or addition is approved by the Manager, Quality Assurance - Nuclear Fuels and the I
responsible manager; 8
XN-NF-439, Rev. 1 3)
The Temporary Deviation is documented prior to use and a description of the change is distributed to all affected individuals and to signators of the original document.
Any one of the individuals who signed the original document may ask for a full review of the change; and 4)
The Temporary Deviation includes the effective dates, not to exceed 30 days.
2.5 pevisions I
The Manager, Quality Assurance - Nuclear Fuels shall be responsible for soliciting comments from the Nuclear Fuels Department Managers on proposed changes to this document.
I New or revised Quality Assurance Program requirements shall be implemented within 90 days following issue unless addi-tional time is approved by the Manager, Quality Assurance -
Nuclear Fuels.
Temporary deviations or additions to this document may be made with the approv,1 of the Manager, Quality Assurance -
I Nuclear Fuels and acceptance by the Vice President and Executive in Charge, Nuclear Fuels, and the responsible manager.
Revisions to quality assurance program documents shall be approved prior to implementation of the change.
Major revisions to quality assurance program documents shall be I
approved by the same signators as the original document.
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I XN-NF-439, Rev. 1 3.0 DESIGN CONTROL New designs of shipping containers or major modifications to previously licensed designs shall be controlled to assure:
I Design requirements are correctly translated into a.
specifications, drawings, procedures, nd instructions; b.
Appropriate quality standards are specified and included h
in design documents and that deviations and changes I
from such standards are controlled;
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c.
Proven technology is used as the basis for selection of
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parts, materials, and processes.
In situations where I
this technology does not exist, special development and/or qualification tests must be prescribed for those intended services that involve nuclear safety related I
items; d.
Where applicable, design analysis, such as structural and criticality analysis is performed; e.
Proper design verification methods, such as design I
review, and qualification testing are performed; f.
Major changes to previously approved design documents have the same approval requirements as the original I
documents; g.
Identification and control of design interfaces and coordination between organizations is established and k
I Design documents, records and changes thereto are collected, implemented; h.
stored, issued, and maintained in a systematic and controlled manner; and I
i.
Necessary licensing data are obtained, approved and submitted.
8 Design control for shipping containers shall be maintained through the use of controlled and approved Design Criteria, Parts Lists, Specifications, Drawings and Calculations to support modifications to existing licensed designs.
Shipping container design may be assigned to a Contractor rather than an Exxon Nuclear engineering group.
Design I
control by a Contractor shall meet the requirements of this Quality Assurance Program.
Contractor designs shall receive an Exxon Nuclear final design review as defined by the Quality Assurance Program as per figure 1.2.
3.1 Design Criteria The Design Criteria shall combine mechanical, materials, inspectability, licensability, usability, and criticality i
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I XN-NF-439, Rev. 1 requirements of the design modification to be licensed.
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shall be consistent with the latest applicable Federal regulatory requirements.
3.2 Parts List The Parts List shall display, by number and revision, the specifications and drawings required to define the container or modification in the case of an existing licensed container.
3.3 Specifications For new container designs the Product Specification, Material and Purchase Specification described below are applicable.
In the case of modifications to previously existing designs, I
requirements may be defined in a less formal manner; e.g.,
Purchase Order with appropriate inputs from QA and other involved functions.
Product Specifications shall provide for the control of material and fabrication to ensure meeting the design requirements.
As such, they provide detailed, and measurable I
requirements which each component, sub-assembly and final assembly must meet.
Also included are definitions of what l
constitutes a sampling lot, special traceability requirements if necessary, and where performance may be affected, special e
shipping and handling specifications. Whenever possible, dimensional details will be contained in Design Drawings.
Material Specifications define the material requirements and supplemen+ the Product Specifications in certain cases where 8
relatively broad applicability and procurennt action make a separate specification convenient.
Purchase Specifications are a composite of product / material I
specifications, drawings and Quality Assurance / Quality Control requirements, and are the specific documents deliver-ed to a vendor for compliance and further bases for internal I
acceptance and audit.
The various required specification data may be combined into one document and designated as the Specification for a 8
particular shipping container design.
3.4 Drawings Design Drawings provide the detailed component, sub-assembly, and final assembly dimensions, configuration, physical I
arrangement, and fabrication details which cannot be conve-niently detailed in the Product Specification and are, in v
that respect, supplemental to the Product Specifications.
Sign-offs of the Parts List in accordance with the Account-I ability and Responsibility Matrix, Figure 1.2 constitutes approval of the listed drawings.
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XN-NF-439, Rev. 1 er 3.5 Calculations Non-computerized calculations shall be documented and identified as to subject, date and individual performing the calculation.
Inputs for these calculations shall also be I
documented.
Calculations shall be performed using methods which permit reconfirmation at a later date.
3.6 Design Reviews Design reviews are critical reviews to provide assurance that design documents are co) ect and satisfactory.
Design reviews may be condutted at the conceptual and preliminary I
design phases at the discretion of the Manager, Nuclear Fuels Engineering.
Before fabrication is initiated, a final design review shall I
be conducted and signed off as per tne Accountability and Responsitility Matrix, Figure 1.2.
A final design review is not required prior to fabrication of a prototype for testing, I
or an already licensed design.
Engineering review, design verification, and test results analyses shall be conducted as designated by the Manager, Nuclear Fuels Engineering with the concurrence of the Manager, Licensing and Compliance.
3.7 Modifications Modifications to shipping containers shall be authorized and I
documented by revising the Parts List. Modifications shall k
be accomplished per approved procedures. Modifications shall be classified as major or minor by Nuclear Fuels I
Engineering, with Licensing concurrence.
Major changes require a license amendment.
In the case of previously approved licensed containers where no parts list exists, the Parts List shall cover at least those parts to be modified, I
along with the main assembly drawings of the model container being modified.
3.8 Maintenance Maintenance and repair of shipping containers shall not I
degrade or change the approved design.
Replacement parts, welding requirements and non-destructive examinations shall meet specified requirements.
Minor repair operations not 1
affecting safety related
.cacteristics may be performed I
without the formal docume..uation and QA-related activities which would otherwise be required.
Xil-f4F-439, Rev. 1 i
4.0 PROCUREMEtiT DOCUMEf1T C0flTROL 4.1 Content of Procurement Documents Procurement documents for the purchase of material, products I
and services shall include provisions for the following, as applicable.
a.
A statemer.t of work to be performed by the supplier.
b.
Technical requirements regarding specific drawings, I
specifications, codes, regulations, procedures or instructions that describe the items or services to be furnished.
c.
Quality assurance requirements appropriate to the items or services being procured.
d.
The right of purchaser, and other authorities to I
access to the supplier's and any subsupplier's facilities and records during the course of the contract for purposes of inspection and audit.
e.
Identification of documentation required to be submitted, I
including quality assurance program, quality assurance procedures, quality assurance records, for the information, review or approval of the Purchaser.
I f.
Requirement for control and approval of supplier non-conformances.
g.
Requirements for extension of applicable requirements I
to subtier procurements.
h.
Certification from the vendor that the container, or components were fabricated to required drawings and specifications.
Purchase requisitions and purchase orders shall be retained as QA records.
4.2 Pror,urement Document Review R
Responsible Materials and Purchasing personnel shall prepare 3
purchase orders for shipping containers to be purchased by Exxon fluclear. These shall contain or reference applicable prov:sions outlined above in Section 4.1.
The purchase orders shall be reviewed and signed by the originator's super /isor, and other appropriate managers pri. to being processed.
The review is made to verify that documents 8
include appropriate provisions to assure items or services meet the specific requirements and to assure that the dacuments are complete and contain the applicable requirements
'specified in Section 4.1.
Changes made in procurement I
documents as a result of bid evaluations or preprocurement negotiations shall receive a review of such changes and their effects, prior to contract award.
Significant changes ar.d revisions to procurement documents shall receive the same review and sign-off as the original documents as indi-cated in Figure 1.2.
I Xft-flF-439, Rev.1 I
I 5.0 It'STRUCTIOriS, PROCEDURES A!!D ORAWINGS I
Applicable policies, procedures and instructions shall be used to implement the Quality Assurance Program.
These include:
(a) Quality Assurance Procedures (b) Quality Control Standards and Procedures (c) Design Control Procedures (d) Procurement Control Procedures (e) Maintenance Procedures (f) Other procedures, documents, and instructions required in Figure 1.2.
Instructions, procedures and drawings shall be prepared, I
reviewed and approved as per the Responsibility and Account-ability Matrix, Figure 1.2.
Adherence to approved documents shall be mandatory for all personnel.
Changes shall receive the same approvals as the original.
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I XN-NF-439, Rev. 1 6.0 DOCUMENT CONTROL The Responsibility and Accountability Matrix, Figure 1.2, defines the responsibility to prepare, concur, and approve, h
specific quality assurance related documents.
Documents shall I
be numbered per Document Identification and Control System, XN-?" -500,001.
The organization assigned responsibility for preparing a I
document shall also be responsible for obtaining the re-quired reviews and approval signatures, specifying the distribution, and initiating modification, as required.
Document control requirements shali be administered by the Supervisor-Document Control per established prteedures I
and as defined in XN-NF-1, Exxon Nuclear Company, Inc.
Quality Assurance Program for Nuclear Fuel Design and Fabrication.
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XN-NF-439, Rev. 1 7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES 7.1 Supplier Evaluation and Selection The selection of suppliers shall be based on evaluation of I
their capability to provide material, equipment or services for shipping containers and shall be in accordance with the requirements of the procurement documents.
Determination of I
supplier capability shall involve an integrated action of "aterials and Purchasing, and Quality Assurance -Nuclear Fuels organizations, based upon the classification and complexity of the item or service being procured.
Evaiua-I tion of supplier sources shall include any one or combina-tion of the following methods prior to award of the contract or purchase order:
Evaluating the supplier's history of providing a a.
quality product based on analysis of supplier survey records, audit reports, or other appropriate methods; b.
Evaluating supplier's current quality records including the supplier's QA program, manual, and nrocedures, as I
appropriate; and Performing pre-award source surveys at the supplier's c.
I plant to determine current capability to satisfy all procurement requirements.
7.2 Control of Supplier Performance Exxon Nuclear shall monitor and evaluate shipping container suppliers' performance to the requirements specified in the 8
Methods used shall include pro-visions for the following as applicable:
Establishing written understanding between purchaser a.
and supplier of the provisions, and specifications of the procurement documents; b.
Evaluating the supplier's planning techniques and processes to be utilized in fulfilling procurement document requirements; Controlling documents which are generated or processed c.
during activities fulfilling procurement requirements; d.
Identifying and processing necessary change information; I
I XN-NF-439, Rev. 1 Assuring that information exchange between purchaser e.
and supplier is documented; f.
Requiring fabrication release prior to supplier com-mencing work af ter documentation required is approved I
by Quality Assurance, and Materials and Purchasing; and 9
Auditing QA program implementation of supplier during time work is in progress.
7.3 Surveillance and Source Inspection Surveillance and source inspection may be performed at the shipping container supplier's facility by Exxon Nuclear representatives, to assure that the requirements of the I
purchase order are being met.
In addition, Exxon Nuclear may identify selected witness and I
hold-points to be witnessed by appropriate Exxon Nuclear quality control or engineering personnel where the relative importance or complexity of the item warrants Exxon Nuclear's participation.
7.4 Receiving Inspection Purchased items are received by Materials and Purchasing personnel who perform checks for shipping damage and for proper documentation.
Receipt inspection shall be performed I
by Quality Control personnel for conformance to specifications and drawings in accordance with an approved Receiving Inspection Standard.
Nonconformances shall be identified, tagged, segregated and controlled.
Known non-conforming items shall I
not be shipped to ENC unless it is covered by an ENC approved Nonconformance Report.
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E Xff-flF-439, Rev.1 I
8.0 IDENTIFICATION & C0lTROL OF MATERIALS, PARTS & COMP 0!iETITS Procurement documents shall provide the requirements for identification and control of material and fabricated products. The specific identification and control system used by the supplier shall be described in procedures that are reviewed and approved by Exxon fluclear as part of the suppliers' QA Program. The system used must assure that I
identification is maintained either on the item or on records traceaole to the item throughout fabrication, and shipment. Traceability requirements shall be consistent I
with applicable specifications, codes and standards as referenced in the procurement documents. Those items requiring specific traceability data shall be so designated in the purchase documents.
As required by Xfi-flF-1, Exxon tiuclear maintains identification and control of shipping containers being used including data I
on modification, repair, inspection and test.
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Xtt-t4F-439, Rev. 1 5
9.0 C0i1 TROL OF SPECIAL PROCESSES The instructions, procedures, specifications and drawings used for control of special processes shall be documented.
This documentation shall include the methods used, and the I
results as required by applicable codes, regulations, specifications and procedures.
The special processes involve structural welding and nondestructive examination I
such as penetrant inspection.
Special processes requiting ocedure and personnel qualification shall be specified in purchase specifications or material instructions for maintenance by reference to applicable industry codes and standards or I
by stated requirements.
Suppliers' special process qualifica-tion data shall be submitted to and approved by Exxon Nuclear.
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I Xil-NF-439, Rev. 1 I
10.0 INSPECTION Supplier and Exxon Nuclear inspections shall be performed using approved procedures and by personnel who are trained and qualified and indepe1 dent of the activities being inspected.
Inspection results shall be documented on inspection forms I
or cards which become part of the QA records.
The identi-fication of the person completing the work and the date of completion shall be included on each record sheet.
Hold points which require inspection and formal release plus any special inspection requirements shall be identified in procurement documents.
Preparation and approval of Exxon Nuclear Q. C. Inspection Standards and Procedures are defined in the Matrix, Figure 1.2.
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XN-NF-439, Rev. 1 I
11.0 TEST CONTROL Test requirements shall be defined in the Design Criteria.
I Major testing such as drop tests to confirm that a design meets federal regulatory or performance requirements shall be authorized by Design Test Authorizations (DTA) approved and accepted in accordance with Figure 1.2.
The Authorization I
should include the following as appropriate:
a)
Justification; b)
Identification of material and equipment to be used; c)
Requirements or acceptance limits contained in applic-I able design documents, if applicable; d)
Duration of test; e)
Effect on production material or precesses including provision for controlled environmental condition; f)
Priority of the work; g)
Nuclear safety requirements; h)
Calibrations required; i)
Mandatory inspection or hold points, if required; j)
Assignment of responsibilities including use of appropriately trained or qualified personnel, k)
Record requirements; 1)
Disposition of material and equipment; and m)
Return of work areas to original condition.
Testing required per the design criteria shall be documented and become part of the QA records.
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XN-NF-439, Rev. 1 I
12.0 CONTROL OF MEASURING AND TEST EQUIPMENT The organization or supplier responsible for inspecting and testing of material, parts, components, equipment, and end products shall also be responsible for proper identification I
and control of measuring and test equipment used to determine conformance with specified requirements of drawings and specifications.
The procedures used to control measuring I
and test equipment shall provide for:
a.
Identification of measuring and test equipment; b.
Calibration standards having valid relationships to nationally recognized standards or where no national I
standards exist, the basis for calibration is documented; c.
Calibration standards used are in accordance with the accuracy tolerances reconinended by the manufacturer; I
d.
Establishment of a " frequency of calibration" schedule; e.
Maintenance of calibration records; f.
Assurance that inspection measuring and test equipment I
used to determine the acceptability of products is calibrated in accordance with applicable frequency schedule and per written calibration procedures; g.
Assurance that damaged or inaccurate measuring and test I
equipment or equipment that has exceeded calibration due date is removed from service; and h.
Assurance that proper storage and handling facilities I
and practices are provided for inspection measuring and test equipment.
Provisions for suppliers' control of measuring and test I
equipment shall be included in procurement documents.
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I Xft-NF-439, Rev. 1 I
13.0 HAf4DLIflG, STORAGE Aft 0 SHIPPING Any special handling, storage and shipping requirements for The suppliers shall be specified in purchase documents.
I packaging, handling and shipping practices of suppliers may be subject to audit by Exxon fluclear.
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XN-NF-439, Rev. 1 I
14.0 INSPECTION, TEST AND OPERATING STATUS Exxon fluclear and suppliers responsible for inspecting and testing items shall establish and implement procedures I
describing measures for indicating the status of tests and inspections performed upon materials, parts and components by use of tags, followers and checklists. The procedure shall provide for the identification of items which have
- tisfactorily passed required inspections and tests, where necessary to prevent the inadvertent by-passing of such inspections and tests. The procedures shall specifically I
cover control of reject or nonconforming items, control of repair, rework, and reinspection.
Supplier procedures shall be reviewed for adequacy by Exxon fluclear as part of the overall review of the Supplier's Quality Assurance Program.
In addition, Exxon Nuclear I
personnel shall perform periodic audits, source surveillance and source inspection as required to verify that these programs are being implemented and properly controlled.
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XN-NF-439, Rev. 1 I
15.0 NON-CONFORMING MATERIALS, PARTS OR COMPONENTS Non-conforming or defective materials, parts or components shall be controlled to prevent their further use in fab-I rication or assembly, pending a decision as to the dis-position of the nonconformir.g or deviating item. The dis-carding of miscellaneous expendables such as common nuts and I
bolts that are found to be defective and which do not require "necific traceability does not require documentation.
Non-conformances may originate during supplier fabrication, I
ENC receipt inspection, in-process inspection or during testing. Non-conformances shall be recorded on a Deviating Material Report or the equivalent suppliers' non-conformance form. Approval of dispositions on Deviating Material Reports is as indicated on the Matrix Figure 1.2.
Suppliers shall be required to advise Exxon Nuclear in I
writing of nonconformances from procurement documents at the time nonconformances are detected and verified.
All non-conformances for which the recommended disposition is "use-I as-is" or " repair" shall be required to be approved by Exxon Nuclear prior to their implementation by the supplier or subsupplier.
(This includes corresponding proposed repair procedures.)
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I XN-f1F-439, Rev. 1 I
16.0 CORRECTIVE ACTI0il The term " corrective action" as used herein refers to a documented commitment of specific action planned or being I
implemented to resolve a known and identified condition or conditions adverse to quality. The commitment shall include a date or specific period of time by which the action is expected to be completed.
Conditions adverse to quality, such as failures, malfunctions, deficiencies (including design deficiencies, audit defi-I ciencies, and procedural deficiencies), deviations, defective material and equipment, and nonconformances shall be promptly identified and corrected.
In addition, significant conditions I
adverse to quality, such as conditions involving suspension of activities or conditions having a major impact on the quality, shall be reported in writing to appropriate manage-ment to assure that the cause of the condition is determined I
and that timely and effective corrective action is taken to preclude repetition.
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I XN-NF-439, Rev. 1 I
17.0 QUALITY ASSURANCE RECORDS Sufficient records shall be prepared as work is perforno to furnish documentary evidence of the quality of items and of I
activities affecting quality.
Records shall be consistent with applicable codes, standards, specifications and contracts, and shall be adequate for use in management of the program.
The records shall be identifiable and traceable to end items I
and retrievable.
Typical quality asssurance records include:
a.
Design Criteria I
b.
Parts List c.
Specification (s) d.
Drawings e.
Supplier Certifications and test data I
f.
Receiving inspection records g.
Test data sheets h.
Audit repor s I
i.
Deviating Material Reports j.
Fabrication records including rework, repair and reinspection k.
Quality Control Standards and Procedures 1.
License documentation in.
Design Review reports n.
Unpriced Purchase Orders.
Records shall be stored in Central files.
Satellite files may be used for working records. Record retention times I
shall be based on established procedures and shall be con-sistent with licensing commitments.
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XN-NF-439, Rev. 1 18.0 AUDITS Planned quality assurance internal and supplier audits shall be performed by personnel who are appropriately trained and have no direct responsibilities in the areas being audited.
I The audits shall be performed using written procedures or checklists.
The audits shall determine degree of conformance to approved procedures and quality assurance documents and shall provide objective evidence to evaluate the effectiveness
' the Quality Assurance Program. The basic elements include:
Flanning and performance of audits; reporting of results to management, including recommendations for corrective action; I
and followup to assure achievement and effectiveness of corrective actions. Uncorrected deficiencies shall be carried as open items until corrected.
Audit frequencies are based on the status and safety importance of the activities performed and are adjusted based on results of previous audits and known problem areas.
Copies of audit reports shall be provided to appropriate Exxon Nuclear management who shall initiate necessary I
corrective action.
Audit reports and related corrective action shall be maintained as quality assurance records.
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I XN-NF-439, Rev. 1 I
Issue Date: 03/08/79 EXXON NUCLEAR COMPANY, INC.
QUALITY ASSURANCE PROGRAM FOR NUCLEAR FUELS DEPARTMENT I
SHIPPING CONTAINERS CONTROLLED DISTRIBUTION LIST I
COPY NO.
COPY TO 1
RK Robinson 2
R. Nilson 3
TL Davis I
4 RW McCullugh 5
JA Perry 6
RB Nicholson 7
JF Patterson 8
GA Sofer 9
LE Hansen 10 Document Control Library Copy 11 CJ Volmer 12 JB Edgar 13 DL Cornell I
14 Returned 15 RH Purcell 16 PG Sarafian I
17 Document Control Central File Copy 18 - 25 NRC Submittal 26 - 33 Extras 34 80 Foster I
35 EN Harbinson 36 HB Thiss 37 WS Nechodom I
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