ML19305A287
| ML19305A287 | |
| Person / Time | |
|---|---|
| Site: | 07001308 |
| Issue date: | 07/14/1978 |
| From: | Zahn L GENERAL ELECTRIC CO. |
| To: | |
| Shared Package | |
| ML19294A755 | List: |
| References | |
| NEDO-20776, NEDO-20776-R4, NUDOCS 7903130051 | |
| Download: ML19305A287 (80) | |
Text
NEDO-20776 SPEnf FUEL. SENICE8 OPEMTlon QUAllfW Assumnoi!
PLnn P
G E N ER ALM E LECTRIC Oh E790313 00Ff
DISCLAIMER OF RESPONSIBILITY This document was prepared by or for the General Electric Company. Neither the General Electric Company nor any of the contnbutors to this document:
A.
Makes any warranty or representation, express or implied, with respect to the accuracy, completeness, or usefulness of the information containedin this docu-ment, or that the use of any information disclosed in this document may not infringe privately owned rights; or B.
Assumes any responsibility for liability or damage of any kind which may result from the use of any information disclosed in this document.
NUCLEAR ENERGY BUSINESS GROUP GENERAL ELECTRIC COMPANY, I/5 CURINER AVE.. SAN JOSE, CALIFORNIA 95125 NUCLEAR ENERGV PROGRAMS DIVISION STATEMENT OF AUTHORITV It is tite policij of Ble Spott Fuel Services Operation to provide services and prodnets of a quality tliat meet tite atrtial and continu,ing needs of otut customers as described in applicable specifications and consistent talth good engineering practice, and in doing so, to be tiie leader in quality reputation in ute nuclear energtj bu.siness.
Thu Quallty Assurance Plan is used by Die Spott Fuel Services Operation to implematt this policij. Att matagers taithin Die Spent Fuel Services Operation teltit qualtty-related responsibiLLtij have flie auntoritij to implement utis program tecthin Breir respective areas of responsibiLLty. Development of procedures to accomplish titis Qualttj Assurance Plan is a basic responsibiLLtij of each of tite organizations secthat tite Spent Fuel Services Operation.
The purpose of this plan is to describe metitods used to comply teltli tite NRC Federal Regulation 10CFR Part 50, Appendix B, " Quality Assurance Crlteria For Nuclear Poteer Plants and Fuel Reptocessing Plants," and 10CFR71, Appendix E, "Qualitij Assurance Crlteria For Shipping Packages For Radioac,tive Materlat."
The Plan also describes tlie system ptoviding for compliance salt}t tite fottetcing polici documents:
j
- Corporate Organiza. tion & Policy Guide No. 20.9, Product Quality Division Organization & Policij Guide, No. 70-1, Produet Quallty e
e Division Instruction No. 70-11, Standard Quallty System Requirematts e SFSO Practices and Procedures Manuat, Section 70, Qualcty Assurance The implementation of this Qualtty Assurance Plan in support of tite Spott Fuel Services Operation policy has tite unqualified endorsement and supp of Go tal Ele tic SFSO management.
- 1; Date:
July 14,1978 L. L.
ah, Jr., Man ger Spen Services OpeAation Revision:
4
GENERAt h ELECTRIC SPENT FUEL SERVICES OPER ATION SUBJECT NUMBER TABLE OF CONTENTS NEDO 20776 issue Date STATEMENT OF POLICY AND AUTHORITY 4
7/14/78 TABLE OF CONTENTS 4
7/14/78 GLOSSARY OF TERMS 4
7/14/78 1.0 ORGANIZATION 4
7/14/78 1.1 Purpose 1.2 General 1.3 Statement of Authority 1.4 Functional Organization Responsibilities Related to Quality 1.5 Internal Organizational Interfaces Relating to Quality 1.6 External Organizational Interfaces Relating to Quality Figure 1-1.
Spent Fuel Services Operation Organizations Figure 1-2.
SFSO Engineering and Regulatory Organizations Figure 1-3.
Morris Operation Organization Figure 1-4.
Quality Assurance Organization (San Jose)
Figure 1-5.
Quality Assurance and Safeguards Organization (Morris Operation) 2.0 QUALITY ASSURANCE PROGRAM 4
7/14/78 2.1 Purpose 2.2 Function
.O DESIGN CONTROL 3
7/14/78 3.1 Purpose 3.2 General 3.3 Responsibilities 3.4 Design Control System Figure 3-1 Design Control Flow Sheet -Issuing Design Bases / Criteria Figure 3-2 Design Control Flow Sheet - Generating Design Documents within SFSO Figure 3-3.
Dcsign Control Flow Sheet - External Fabrication / Construction Figure 3-4.
Design Contro! Flow Sheet - Engmeering Changes 4.0 PROCUREMENT DOCUMENT CONTROL 3
7/14/78 i
4.1 Purpose 4.2 General 4.3 Responsibilities 4.4 Implementation Figure 4-1.
Procurement Control (San Jose)
Figure 4-2.
Procurement Control (Morns Operation)
ISSUED BY MANAGER, QUALITY ASSUR ANCE PROGRAMS DATE ISSUED July 14,1978 H.W. HUNTLEY
,1EVISION 4
4 OF f ORM SF0-31 1 (2/78)
(lUALITY ASSURANCE PLAN NEDO-20776
' NUMBER TABLE OF CONTENTS (Continued)
Issue Date 5.0 INSTRUCTIONS, PROCEDURES, AND DRAWINGS 3
7/14/78 5.1 Durpose
- 2 Responsibilities 51 Documents Affecting Quality Table 5-1.
Documents Affecting Quality 6.0 DOCUMENT CONTROL 3
7/14/78 6.1 Purpose 6.2 General 6.3 Responsibilities 64 Document Control System 6.5 Control of the Quality Assurance Plan 6.6 Control of Document Revisions 6.7 Document Master Lists 6.8 Document Masters Table 6-1.
SFSO Controlled Documents Figure 6-1.
SFSO Document Control 7.0 CONTROL OF PURCHASED MATERIAL.
EQUIPMENT. AND SERVICES 3
7/14/78 7.1 Purpose 7.2 Genera' 7.3 Responsibilities 74 Implementation Figure 7-1 Procurement 8.0 IDENTIFICATION AND CONTROL OF
'l 7/14/78 MATERIALS. PARTS. AND COMPONENTS 8.1 Purpose 8.2 General 8.3 Responsibilities 8.4 Implementation Figure 8-1.
Identification and Control nf Materials. Parts, and Components 3
7/14/78 9.0 CONTROL OF SPECIAL PROCESSES 9.1 Purpose 9.2 Responsibilities 9.3 Special Process Procedures 9.4 Special Process Personnel 9.5 Records Figure 9-1.
Control of Special Processes O
2 e,
4 nm,s,e~
ge, FOHM SFO-312 42/ 781
QUAllTY ASSURANCE PLAN NU MBE H NEDO.2077G TABLE OF CONTENTS (Continued)
Issue Date 10.0 INSPECTION 3
7/14/78 10.1 Purpose 10.2 General 10.3 Responsibilities 10.4 Implementation 11.0 TEST CONTROL 3
7/14/78 11.1 Purpose 11.2 Applicability 11.3 General 11.4 Responsibilities 11.5 Implementation 12.0 CONTROL OF MEASURING AND TEST EQUIPMENT 3
7/14/78 12.1 Purpose 12.2 General 12.3 Responsibilities 12.4 Control System 13.0 HANDLING. STORAGE, AND SHIPPlNG 3
7/14/78 13.1 Purpose 13.2 Applicability 13.3 General 13.4 Responsibilities 13.5 Implementation 14.0 INSPECTION, TEST, AND OPERATING STATUS 3
7/14/78 14.1 Pur pose 14.2 General 14.3 Responsibilities 14.4 Implementation 15.0 NONCONFORMING MATERIALS, PARTS OR COMPONENTS 3
7/14/78 15.1 Purpose 15.2 Nonconforming item Record (NIR) and Quality Hold Tag 15.3 Resolution of a Nonconformance 15.4 Deviation Disposition Request (DDR) 15.5 Corrective Action 15.6 Summary of Nonconforming item Records REVISION 4
PAGE 3
OF 4
FORM SFO-313 (2/78)
b QUALITY ASSURANCE PLAN NUMBER NEDO-20776 TABLE OF CONTENTS (Continued)
Issue Date 3
7/14/78 16.0 CORRECTIVE ACTION 16.1 Purpose 16.2 System Description 16.3 Responsibilities 16.4 Implementation 4
7/14/78 17.0 OUALITY ASSURANCE RECORDS 17.1 Purpose 17.2 Applicability 17.3 General Requirements 17.4 Responsibilities 17.5 Interim Generation of Records 17.6 Records Handling and Storage (Permanent) 17.7 Quality Assurance Organization Records Activities 3
7/14/78 18.0 AUDITS 18.1 Purpose 18.2 General 18.3 Quality Assurance Organization Audit Responsibilities 18.4 Reports 9
O 4
REVISION 4
4 OF GE, FORM SFO-312 t2/78 i
GENERAL h ELECTRIC SPENT FUEL SERVICES OPERATION SUBJECT NUMBER GLOSSARY OF TERMS USED IN THIS PLAN N EDO-20776 AUDIT (as petitioned by ANSI N45.2.12 Subcommittee)
A documented activity performed in accordance with written procedures or checklists to verify, by examination and evaluation of objective evidence, that applicable elements of the quality assurance program have been developed, documented and effectively implemented in accordance with specified requirements. An audit does not include surveillance or inspection for the purpose of process control, product acceptance or procedural compliance.
CAUSE The underlying determinant in design, material, procedures, workmanship, etc., which ultimately resulted in a nonconformance.
CHARACTERISTIC Any property or attribute of an item, process or service that is distinct, describable and measurable, as conforming or nonconforming to specified quality requirements. Quality characteristics are generally identified in specifications and drawings which describe the item, process or service (ANSI N45.2.10).
CLEANING The treatment for removal of surface contaminants su'.1 as oil residue, coatings, metal chips, entrapped water, or other forms of internal or external contamination which prevent utilization of basic material or finished products or would cause degradation of quality. Decontamination for disposal of radioactive items is not included in this definition.
COMPONENT A piece of equipment such as a vessel, piping, pump, valve or core support structure, which will be combined with other components to form an assembly (ANSI N45.2.10).
CORRECTIVE ACTION The action taken to correct conditions adverse to quality and deficiencies in the Quality Assurance Program or its implementation.
CORRECTIVE ACTION REQUEST (CAR)
A document used for reporting conditions having an aoverse effect on quality, the results of investigations of problems, and the corrective action taken to preclude recurrence.
DESIGN BASES Broad functiorial requirements, conditions or constraints chosen to assure that the design objectives of the facility structure. system or component are met.
DESIGN CONTROL A system or program such that desired design actions are accomplished and actions not desired are prevented.
DESIGN CRITERIA Mandatory performance limits, conditions or constraints specified to assure compliance with Corporate policy or Governmental regulations concerning safety, safeguards and ensironmental protection and which are aimed at assuring that the facility structure, system or component can be operated without undue risks to the health and safety of the employees and public, to the national security and to the environment.
ISSUED BY MANAGER, QUALITY ASSURANCE PROGRAMS DATENSSUED July 14,1978 PAGE._ 1 -
H.W. HUNTLEY REvlSION 4
6 OF EORM SFO-31.s (2n8)
QUAllTY ASSURANCE PLAN O
NEDO-20776 NUMBER DESIGN REVIEW A series of activities that produces an objective examination of a design.The design review may be informal or formal.
DEVELOPMENTAL ENGINEERING TESTS Tests conducted or planned to obtain information for use in determining design feasibility, design requirements, or justification for alternate approaches.
DEVIATION DISPOSITION REQUEST (DDR)
A form which may be used by a vendor in making changes to the original contract or purchase order.
DISPOSITION The determination of action to be taken concerning nonconformances such as Rework. Repair. Use As is, Return to Supplier, or Scrap.
ENGINEERING CHANGE NOTICE (ECN)
A document which records in detail the changes to an issued design document.When approved, the ECN becomes a part of the original document until the document is changed by incorporating the ECN.
ENGINEERING REVIEW MEMORANDUM (ERM)
A document that records the design documentation review of cognizant personnel.
EQUIPMENT VERIFICATION TEST (EVT)
A test of new, repaired, or modified components or systems under simulated operating conditions. EVT's are conducted to determine that operation of the item (or items) is in accordance with design criteria.
FACTILITY CHANGE NOTICE (FCN)
A Morris Operation (MO) documer;t which is used to record a description of the proposed change, modification, or addition plus review and approval information. This is the formal document retained with the design package as part of the MO Plant Engineering records.
FORMAL ENGINEERING REVIEW (FER)
A formal series of activities in the project or task schedule that will producs an objective examination of a design for the purpose of evaluating design adequacy and verifying that the design complies with all applicable requirements.
These activities are also called Formal Design Reviews.
HANDLING An act of physically moving items by hand or mechanical means, but not including transport modes (ANSI N45.2.10).
HOLD POINT A mandatory inspection point established either by the Quality Assurance Engineer or other responsible engineers.
INCOMING MATERIAL REPORT (IMR)
A document identical to the Source Inspection Report listing inspection criteria and utilized at Receiving inspection to record inspection results for incoming items.
INFORMAL DESIGN REVIEW (IDR)
An informal series of activities during a preliminary design for the purpose of reviewing objectives and determining that significant factors are included in the design analyses, including optimizing the design and arrangements, and obtaining interirn decisions for problems, responses to the NRC, evaluating alternatives, and interpreting design codes and standards.
AGE 2
OF 6
REVISION 4
FOR M SFO-312 (2/ 78)
QUAllTY ASSURANCE PLAN NUMBER N EDO-20776 INSPECTION A phase of quality control which by means of examination, observation or measurement determines the conformance of materials, supplies, components, parts, appurtenances, systems, processes or structures to predetermined quality requirements (ANSI N45.2.10).
INSTALLATION TEST Tests prepared in the format of check lists that assure completeness of installations to drawings and specifications.
For example, cleaning instructions, instructions for correct rotation / movement response to power or control signals, inspection records, lubrication instructions, etc.
LEVEL 1 The disposition of nonconforming items by the first supervisory level performing work that detected the nonconfor-mance, and by the associated Quahty Control representative.
LEVEL 2 The disposition of nonconforming items by the Quality Assurance Engineering and SFSO Engineering personnel.
LEVEL 3 (SEE MRD)
MANUFACTURING TEST A test of the item's ability to meet static or dynamic performance requirements. For example, hydrostatic, load, flow, certain proof or component tests, etc.
MATERIAL REQUEST (MR)
A document used for requesting purchase of materials, equipment or services. In addition, the form is used for obtaining a change in a previously issued MR, and for obtaining cost and lead-time information.
MATERIAL REVIEW BOARD (MRB)(LEVEL 3)
The organization which determines the disposition of nonconforming items beyond the scope of Level 2 authority.
This orgariization is Level 3.
NDE The abbreviation for nondestructive examination, sometimes called nondestructive testing (NDT).
NONCONFORMING ITEM RECORD (NIR)
The form used for reporting nonconforming items or characteristics to Quality Assurance and to record action taken to effect maragement disposition.
NONCONFORMANCE A deficiency in characteristic, documentation or procedure which renders the quality of an item unacceptable or indeterminate. Examples of nonconformance include: physical defects, test failures, incorrect or inadequate doc-umentation, or deviation from prescribed processing, inspection or test procedures (ANSI N45.2.10).
OPERATIONAL TEST A test to determine the ability of the component or system to function within licensing limitations and in accordance with design criteria and functional requirements.
PACKAGING The preparation of an item for shipping, handling, and/or storage so as to prevent physical damage and degradation of quality due to environmental effects.
REVISION 4 PAGE 3
op 6
FORM SFO-313 (2/78)
QUAllTY ASSURANCE PLAN NEDO-20776
' NUMBER PREREQUISITES Work, precautionary steps, or inspections that must be performed prior to running a soecific test so as to enable valid results to be obtained and not to damage the equipment nor violate safety requirements.
PRESERVATION The special preparation ofitems utilizing pruervatives, inert gas blankets, vapor-proof barriers with desiccants, etc.,
to prevent deleterious environmental effects.
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 operations.
PROJECT PLAN The document which describes the detailed elements, including classification, specific activities, responsibilities, schedules, and interfaces of components of a task.
PURCH ASE ORDER (PO)
The contractual document used by Purchasing to procure material, components, or services as ordered by the procurement initiating document (Material Request).
QUALITY Conformance to measurable criteria and requirements.
QUALITY ASSURANCE All those planned and systematic actions necessary to provide adequate confidence that an item or a facility will perform satisfactorily in service (ANSI N45.2.10).
QUALITY ASSURANCE PLAN (OAP)
A document prepared a'id issued by the Quality Assurance Subsection cf the Spent Fuel Services Oparation to provide an interpretation of the requirements of 10CFR50, Appendix B, and other documentsin the Plan and to outline implementation of the Plan.
QUALITY ASSURANCE ORGANIZATION Unless specified otherwise, all references to Ouality Assurance or Quality Assurance Organization are applicable to Quality Assurance functions located both in San Jose and at the Morris Operation.
QUALITY CONTROL Those quality assurance actions which provide a means to control and measure the characteristics of an item, process or facility to established requirements (ANSI N45.2.10).
QUALITY CONTROL INSTRUCTiGN (OCl)
A document issued by the Quality Assurance Organization covering unique, non-repetitive activities for which quality instructions are required.
QUALITY RECORDS FILE The file maintained (or designated to be maintained) by Ouality Assurance for storage of record *, to support quality-related activities.
O 4
OF 6
REVISION 4
GE FOH M SFO-312 (2/78)
QUAUTY ASSURANCE PLAN NUMBER NEDO-20776 OUALITY STANDING INSTRUCTION (OSI)
A document prepared and issued by the Quality Assurance Organization to provide instructions to quality personnel in that organization in performing standard repetitive quality-related activities. Quality Standing instructions are implementing procedures that describe the methods of applying the requirements outlined in the SFSO Quality Assurance Plan.
QUARANTINE The physical segregation of nonconforming material or items from conforming material by moving them to a designated hold area and attaching a Quality Hold Tag. When physical segregation is impractical, the attachment of the Quality Hold Tag constitutes quarantine.
REMEDIAL ACTION.
The action taken to prevent the same cause from generating problems in any other areas until the cause can be corrected and all existing problems cleared.
REPAIR The process cf restoring a nonconforming characteristic to a condition such that the capability of an item to function reliably and safely is unimpaired, even though the item still may not conform to the original requirement (ANSI N45.2.10).
REWORK The process by which a nonconforming item is made to conform to a prior specified requirement by completion, remachining, reassembling or other corrective means (ANSI N45.2.10)
SAFETY, SAFETY-RELATED As used in this Plan, refers to nuclear safety.
SOURCE INSPECTION REPORT (SIR)
A document used by the appropriate Quality Representative for reporting the results of an inspection at the vendor facility.
SPECIAL PROCESSES Special processes include welding, brazing, heat treating, cleaning, anodizing. plating, and associated nondestruc-tive examination.
STORAGE The act of holding items at the construction site or in an area other than its permanent location in the plant (ANSI N45.2.10).
SURVEILLANCE Routine or specific observation, evaluation, review or in-depth survey of methods, procedures, instructions or records to determine the degree of compliance of performing organizations, individuals or products in meeting specified requirements.
SYSTEM A group of components united by some interaction and functioning as a single unit. For example, a cask. service facility, f uel storage, etc.
REVISION 4 PAGE d _ OF 6
FORM SFO-31312/78)
QUAllTY ASSURANCE PLAN
' NUMBER N EDO-20776 TESTING The determination or verification of the capability of an item to meet specified requirements by subjecting the item to a set of physical, chemical, environmental or operating conditions (ANSI N45.2.10).
USE AS IS A disposition which may be imposed for a nonconformance when it can be established that the discrepancy will result in no adverse conditions and that the item under consideration will continue to meet all engineering functional requirements including performance, maintainability, fit, and safety (ANSI N45.2.10).
O O
PAGE 6 _ op 6-REVISION 4
F OR M SFO-312 (2/78)
GEN ER AL h ELECTRIC SPENT FUEL SERVICES OPERATION SUBJECT NUMBER 1.0 ORGANIZATION N EDO-20776 1.1 PURPOSE This section describes the organizational structure and the relationship among the organizations within the Spent Fuel Services Operation and defines the authority and responsibihties of these organizations in performing quality-related functions for design, construction, and operation of nuclear fuel storage facilities.
1.2 GENERAL 1.2.1 The Spent Fuel Services Operation (SFSO) is an organization within the General Electric Company's Nuclear Energy Programs Di6. ion at San Jose, California. SFSO is assigned responsibility for establish-ing technical and business functions, design bases, design criteria, and the engineering, licensing, and project management support leading to construction and operation of facilities to transport and store irradiated f uel assemblies. Additionally,in support of this primary f unction, SFSO provides similar service activities for major modifications to existing facilitiss, design, fabrication, licensing, and maintenance of nuclear fuel casks.
1.2.2 GEUMCO-Engineering is part of a wholly-owned subsidiary, General Electric Uranium Management Company (GEUMCO). GEUMCO-Engineering is ur. der the technical cognizance of the manager, SFSO and perform the advance engineering function for SFSO.
1.2.3 Existing facilities include the Morris Operation (MO) of the General Electric Company which is engaged in the storage of irradiated fuel assemblies under a license granted by the Nuclear Regulatory Commission (NRC)in accordance with Title 10, Part 70 of the Code of Federal Regulations.
1.2.4 Equipment used in conjunction with the MO storage facility includes irradiated fuel shipping equipment, licensed as required by the NRC in accordance with Title 10. Part 71 of the Code of Federal Regulations and Title 49, Part 173 of the Code of Federal Regulations (DOT).
1.3 STATEMENT OF AUTHORITY 1.3.1 The authority for implementation and control of SFSO Quality Assurance is vested in the Manager, Quality Assurance Programs, by the Manager, Spent Fuel Services Operation, except as specified in subpara-graph 1.3.2 of this Plan. The independence of SFSO Quality Assurance is shown in Figure 1-1.
1.3.2 The responsibility for imp!ementing this Quality Assurance Plan at the MO is delegated to the Manager, Morris Operation, by the Manager, Spent Fuel Services Operation.The MO Quality Assurance function (as approved by the Manager, SFSO) is vested in the Manager, Quality Assurance and Safeguards, and is separate from the engineering and operations functions. The Manager, Morris Operation, thus has the authority and organization required to implement the Quality Assurance Plan in accordance with applica-ble requirements as set forth in this document. The independence of MO Quality Assurance is shown in Figure 1-3.
ISSUED BY MANAGER, QUALITY ASSURANCE PROGRAMS DATE ISSUED July 14,1978 PAGE 1
H.W. HUNTLEY REVISION 4
9 OF E ORM SF O-31 1 (2/18)
QUAllTY ASSURANCE PLAN
' NUMBER NEDO-20776 1,4 FUNCTIONAL ORGANIZATION RESPONSIBILITIES RELATED TO QUALITY 1.4.1 The relationship among the functional organizations within SFSO is illustrated in Figure 1-1.
1.4.2 The Advance Engineering (GEUMCO/ Engineering) Projects, and Licensing Functions (see Figure 1-2) establish requirements and implement procedurcs which assure the following:
That technical and business activities comply with corporate policies for nuclear business a
ventures.
b.
That regulatory documents, such as the Environmental Report, and Safety Analysis reports are prepared and submitted.
c.
That required licensing activities have been accomplished.
d.
That preparation of design bases and design criteria use sound technology and that such bases and criteria have substantiating documentation, review and approval.
That design bases and design criteria for initial construction and modifications comply with e.
regulatory requirements and Company requirements.
f.
That design documentation in the form of drawings, specifications, and instructions describe required performance, materials, processes, operating characteristics, and quality requirements.
g.
That design documentation is reviewed, with appropriate independent verification for accuracy, methods of calculation, and assumptions used.
h.
That design documentation and procurement data are reviewed for appropriate quality require-ments.
i.
That procurement and construction of nuclear facilities and equipment comply with design bases and design criteria.
j.
That records are maintained and are retrievable to provide objective evidence of assigned quality related responsibilities.
1.4.3 The MO(see Figure 1-3)is responsible for establishing requirements and implementing procedures which conform to Spent FuelInstructions(SFI's) and appropriate " site specific" Quality Assurance instructions developed by the MO. The MO instructions assure the following:
That the operation of the MO complies with the design bases, safety analysis, and regulatory and a.
Company requirements, b.
That the structures, systems, components, and equipment are maintained in accordance with the design bases, safety analysis, and regulatory and Company requirements.
That transportation and storage of irradiated fuel elements are performed in compliance with the c.
design bases, safety analysis, and regulatory and Company requirements.
O GE 2
OF 9
REVISION 4
FORM sFO-312 (2/78)
(lUALITY ASSURANCE PLAN NUMB E R NEDO-20776 d-That environmental and radiological protection standards are maintained for operating personnel and the general public in accordance with the design basis, the safety analysis, and regulatory and Company requirements.
e.
That records are maintained and retrievable for plant operations and maintenance.
1.4.4 The Quality Assurance Organization (see Figures 1-4 and 1-5)is responsible for the following:
a.
Maintaining the quality program desenbed in this document.
b.
Establishing requirements (e.g., hold points, inspection, documentation) for verification o,f quality.
c.
Reviewing and approving quality related documents as required by applicable procedures and instructions.
d.
Ventying by audit, test, or inspection that quality requirements are met for materials, components, processes and plant and equipment modifications.
e.
Verifying that quality requirements are incorporated into applicable documents and activities and that such requirements have been met and are documented.
f.
Auditing for compliance to operating procedures and license requirenients established for the operation of the MO facility and equipment.
g.
Auditing for conformance to the rectrements of this Plan.
h.
Documenting end reporting (to responsible management) nonconforming activities, documenta-tion, and nonconforming items (hardware) discovered in the course of inspection, surveillance, or audit.
i.
Stoppmg unsatisfactory work, fabrication, delivery, or installation of nonconforming materials.
J.
Ensuring that corrective actions are effective and are accomplished in a timely manner.
1.5 INTERNAL ORGANIZATIONAL INTERFACES RELATING TO QUALITY 1.5.1 internal interfaces within the SFSO organization are estsblished by the Manager, Spent i uel Services Ope *ation, in broad terms, through organizational position descriptions that delegate authority and responsibility.
1.5.2 Specific interfa:es are establisheo by SFSO subsection managers. Implementation of specific interfaces may be delegated to responsible engineers.
1.5.3 During accomplishment of assigned work activity, interface questions are directed as follows:
a.
Basic technical, business, and operations planning requirements are directed to the Manager, GdUMCO-Engineering.
b.
Preliminary and final design, scheduling, procurement, fabrication, cost control, and construction are directed to the Manager, Fuel Storage Projects.
REVISION 4
PAGE 3
Op 9
F ORM sFO-314 (2/78)
QUALITY ASSURANCE PLAN
' NUMBER NEDO-20776 Plant operations, plant maintenance, and storage of irradiated fuel are directed to the Manager, c.
Morris Operation.
d.
Licensing and regulatory requirements, NRC contacts, preliminary and final design of irradiated shipping casks, and related equipment and transportation of nuclear m&teria!s are directed to the Manager, Licensing and Transportation.
Quality requirements, inspection, and associated documentation are directed to the Manager, e.
Quality Assurance Programs.
f.
Marketing, legal, finance, and department interf aces are directed to the Manager, Quality Assurance Prograrrs.
1.6 EXTERNAL ORGANIZATIONAL INTERFACES RELATING TO QUALITY 1.6.1 External organizational interfaces between SFSO and other organizations within the General Electric Company or major external contractors for products or services are established and controlled through policies, management directives, and instructions directed to the Manager, Fuel Storage Projects, by the Manager, Spent Fuel Services Operation, except as noted in subparagraph 1.6.3 1.6.2 Internal review, comment and approval of services or products developed by external contracts for utilization in General Electric's own facility are coordinated by the Manager, Fuel Storage Projects, within guidelines established in Paragraph 1.5, by the Manager, Spent Fuel Services Operation.
1.6.3 External organizational interfaces for products or services in direct support of the MO are coordinated through policies, management directives, and instructions directed to the Manager, Morris Operation, by the Managor Spent Fuel Services Operation.
O PAGE 4
OF 9
REVIS'ON 4
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QUALITY ASSURANCE PLAN NUMBER NEDO-20776 GEUMCO -
FUEL STORAGE LICENSING AND ENGINEERING PROJECTS TRANSPORTATION MANAGER MANAGER MANAGER I
TECHNICAL SCHEDULING AND LICENSING PLANNING COST ENGINEERING AND SAFETY TECHNICAL PROJECT TRANSPORTATION DEVELOPMENT ENGINEERING SYSTEMS PROCESS PROJECT '
ENGINEERING MANAGEMENT FACILITIES ENGINEERING OPERATIONS PLANNING SPECIAL PROJECTS DESIGN PROGRAMS Figure 1-2.
SFSO Engincaring and Regulatory Organizations qe.
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4 F ORM SFO-312 (2/ M
)
(lUALITY ASSURANCE PLAN NUMBE R N EDO-20776 MORRIS OPERATION MANAGER PLANT OPERATIONS PLANT ENGINEERING AND MAINTENANCE QUALITY ASSURANCE AND SAFEGUARDS RELATIONS AND ADMINISTRATION LICENSING AND RADIOLOGICAL SAFETY Figure 1-3.
Morris Operation Organization REVISION 4
PAGE 7
OF 9
FORM SFO-313 (2/78)
QUAllTY ASSURANCE PLAN
' NUMBER NEDO-20776 QUALITY ASSURANCE PROGRAMS MANAGER QA ENGINEERING O
MANAGEMENT SYSTEMS Figure 1-4.
Quality Assurance Organization (San Jose)
Qe ee e
ee,s,em FORM SFO-31-2 (2/ 78)
)
QUALITY ASSURANCE. PLAN NUMBER N E DO-20776 QUALITY ASSURANCE AND SAFEGUARDS MANAGER SPECIALIST FACILITIES QUALITY CONTROL SPECIALIST NUCLEAR MATERIALS SAFEGUARDS SUPERVISOR SAFETY SUPERVISOR ANALYTICAL Figure 1-5.
Quality Assurance and Safeguards Organization (Morris Operation)
REVISION 4
PAGE 9
OF 9
FORM SFO-313 (2/78)
GENERAL @ ELECTRIC SPENT FUEL SERVICES OPERATION SUBJECT NUMBE R 2.0 QUALITY ASSURANCE PROGRAM NEDO 20776 2.1 PURPOSE 2.1.1 This section summarizes the Quality Assurance Program established in the Spent Fuel Services Operation (SFSO) to implement the requirements of General Electric Corporate and Division Quality Policies. The program is designed to comply with the applicable requirements of the following:
a.
The Code of Federal Regulations. Title 10, Part 50, Appendix B, " Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants.'
b.
The Quality Assurance provisions specified in tnis document.
c.
Corporate Organization & Policy Guide, No. 20.9, " Product Quality.
d.
Division Organization & Policy Guide, No. 70-1, " Product Quality.'
e.
Division instruction No. 70-11. " Standard Quality System Requirements."
f.
The Code of Federal Regulations, Title 10 Part 71, Appendix E. " Quality Assurance Criteria for Shipping Packages for Radioactive Material."
2.1.2 The overall program described in this document applies to Class 1,2, and 3 items (and their controlling documentation) only. (Refer to subparagraph 2.2.2 for definitions of Classifications.) Class 4 items and their documentation are normally excluded from the scope of this document.
2.1 3 The SFSO Quality Assurance Program described in this section is summarized as follows:
Section N o.
Subject 2.2.1 Organization 2.2.2 Quality Assurance Program 2.2.3 Design Control 2 2.4 Procurement Document Control 2.2.5 Instructions, Procedures, and Drawings 2.2.6 Document Control 2.2.7 Control of Purchased Material, Equipment, and Services 2.2.8 Identification and Control of Materials, Parts, and Components 2.2.9 Control of Special Processes 2.2.10 Inspection 2.2.11 Test Control 2.2.12 Control of Measuring and Test Equipment 2.2.13 Handling, Storage, and Shipping 2.2.14 Inspection, Test. and Operating Status 2.2.15 Nonconforming Materials, Parts, or Components 2.2.16 Corrective Action 2.2.17 Quality Assurance Records 2.2.18 Audits ISSUED BY MANAGER, QUALITY ASSURANCE PROGRAMS DATE CSUED July 14,1978 PAGE I
H.W. HUNTLEY.
REv!SION 4
7 OF f68M SF0-31 1 (2/78)
QUAUTY ASSURANCE Pl.AN
' NUMBER NEDO.20776 2.2 FUNCTION 2.2.1 Organization 2.2.1.1 The Manager, Quality Assurance Programs,* reporting directly to the Manager, Spent Fuel Services Operation, has been delegated responsibility and authority for establishment of the Quality Assurance Program. The Manager, Quality Assurance Programs,is also responsible for reviewing, through the use of the techniques of inspection, verification, surveillance, and auditing, the quality-related activities of other organizations, the detection of problems (or potential problems', and recommending appropriate man-agement response to assure timely and effective corrective ar, tion to eliminate or mitigate the conse-quences of such problems and to prevent recurrence. While certain Quality Assurance Organization activities may be delegated to service or fabrication cetractors, the Manager, Quality Assurance Pro-grams, retains responsibility for the total Quality Assurarec Program.
2.2.1.2 Management has established Quality Assurance as an organization which is separate from those organi-zations with responsibilities for engineering, production, maintenance, procurement, and other services, and has provided the Managers in this organization with the authortty and organizationalindependence to carry out their responsibilities. As a result, the Quality Assurance functions listed below have the authority and responsibility to identify quality related problems; to stop unsatisfactory work. processing, delivery, or installation of nonconforming materials until cleared by applicable Quality Assurance Organization procedures; to initiate, recommend or provide solutions; and to verify that implementation of positive corrective action has been achieved Quality Assurance function in San Jose - Part of the overall SFSO Quality Assurance Organiza-a.
tion" physically located in San Jose.
b.
Quality Assurance function at the MO-Part of the overall SFSO Quality Assurance Organization" physically located at the MO.
2.2.1.3 The Manager, Quality Assurance Programs,is responsible for the coordination of the overall SFSO Quality Assurance Program.
2.'t.2 Quality Assurance Program 2.2.2.1 Each of the subsections of SFSO participate in the implementation of the Quality Assurance c'rogram as described in Section 1.4. The SFSO Quality Assurance Program includes implementing instructions to ensure that, throughout the design, procurement, fabrication, installation, construction, and operation of facilities ~and equipment, appropriate controls are provided over the activities which affect the quality of nuclear safety-related and other essential systems and components to an extent consistent with their importance to nuclear safety and to plant and equipment operation. Provision is made to ensure that all activities which affect quality are accomplished under suitably controlled conditions. Controlled condi-tions include, but are not limited to, the use of proper equipment, suitable environmental conditions for accomplishing the activity, special controls, processes, test eouipment, tools, procedures, instructions, and skills to obtain the desired quahty, and the verification of quality achievement by inspection and tests.
The Quality Assurance Program requires the indoctrination and training of personnelin the application of this document and other activities which affect quality. In addition, regular revievt of status and adequacy
- Where this Plan denotes "M anager," delegation to the appropriate individualin the organization is irnphed unless exp essly prohibited by exception.
The Manager, however, retains overall responsibihty.
" As used herein, references to the Quality Assurance Organization refers to the overall C1ahty organization which is comprised of organizational elsments located both in San Jose and at the MO.
PAGE 2
OF 7
REVISION 4
FORM SFO.312 G/78)
QUAUTY ASSURANCE PLAN NUMBER NEDO-20776 of the Quality Assurance Program through quality assurance a'iditing and surveillance is required.
Managers of organizations, participating in the quality program, regularly review the status and adequacy of the portion of the Quality Assurance Program for which they are responsible.
2.2.2.2 The Quality Assurance Program is implemented by the issuance of this Quality Assurance Plan and various instructions, which lead to development and issuance of documentation for design, construction, and operation of facilities and equipment.
2.2.2.3 Structures, equipment, systems, and components are classified in regard to their importance to nuclear-safety and to other essential plant functions so that the appropriate levels of quality activities can be achieved. Four Functional Classifications are used as follows:
a.
Class 1 and Class 2 (nuclear-safety-related structures, equipmer,t, systems, and components that require all phases of quality and quality affecting activities to be considered). The safety-related items falling in these classes are contained in certain equipment in the f uel storage system such as spent fuel storage racks.
b.
Class 3 (structures, equipment, systems, and components that are not related to nuclear safety but that are placed under a Quality Assurance Program).
c.
Class 4 (other, not related to nuclear safety).
2.2.2.4 Classification of projects, tasks, or equipment is the responsibility of the manager with design responsibil-ity for that project, or equipment. The Functional Class (1,2,3 or 4) reflects nuclear safety and the commercial effect on Corporate objectives. Quality Assurcnce Effort Required (OAER) is specified by levels. These levels of QAER are based on the degree of activity necessary to identify, analyze, verify, and document those attributes that are required to achieve a specific level of confidence in a project. or item (s) of equipment. The SFSO Classification System as a combined designation. identifies both Functional Class and QAER needed to achieve control of SFSO activities. The structures, equipment, systems, and components covered by the SFSO Quality Assurance Program include those classified as Class 1,2 or 3.
Structures, systems, and components designated as Class 4 are not normally covered by this Program.
Class 4 items are normally processed in accordance with commonly accepted commercial practices.
2.2.3 Design Control Documented control systems are necessary to ensure that appropriate quality requirements are specified in design documents. The design control system is discussed further in Section 3.0.
2.2.4 Procurement Document Control Documented procedures are necessary to ensure that quality requirements are specified in documents used for the procurement of items and services. Changes in procurement documents are subjected to the same degree of control as the preparation of the original documents. Procurement documer.t controlis discussed further in Section 4.0.
2.2.5 Instructions, Procedures, and Drawings Quality requirements of an item design or fabrication, process, shipment, installation, operation, and maintenance are specified by documented procedures, drawings, instructions, or manuals, as applicable.
Procedures, drawings, instructions, or manuals include appropriate quantitative or qu alitative criteria for determining that significant quality activities have been satisfactorily accomplished. Use of instructions, procedures, and drawings is discussed further in Section 5.0.
REVIS.ON 4 PAGE 3
OF 7
FORM SFO-31-3 (2/78)
QUALITY ASSURANCE PLAN NUMBER NEDO.2077ti 2.2.6 Document Control Instructions and procedures applicable to each SFSO organization provide for control of the issuance of documents, including changes thereto, which prescribe activities affecting quality. Instructions and procedures require documents to be reviewed and approved by authorized personnel for release, and are available at the location where the activity is perf ormed. The systems for tracking the issue and dissemina-tion of documents provide control of interface documents between the General Electric Company and contractors and provide sufficient flexibility to allow for the establishment of mutually acceptable inter-face procedures. Document control is discussed further in Section 6.0.
2.2.7 Control of Purchased Material, Equipment, and Services 2.2.7.1 Documented procedures assure that purchased items and services conform to procurement document requirements. As appropriate, these procedures require source evaluation and selection, objective evi-dence of quality to be furnished by the vendor, inspection, or quality audits at the source, and examination of items upon delivery.
2.2.7.2 Evaluation and selection of vendors to General Electric include the use of historical quality performance data, vendor evaluations, or surveys. Control of purchased items is discussed further in Section 7.0.
2.2.8 Identification and Control of Materials, Parts, and Components 2.2.8.1 Procedures require the identification and control of materials, parts, and components, including partially fabricated sub-assembiies. These procedures ensure that only correct and acceptable items are used during fabrication or processing. Physical identification is used to the maximum extent practical. Where physical identification is either impractical or insufficient, physical separation, procedural control, or other appropriate means are employed. Identification is either on the item or on records traceable to the item, as appropriate.
2.2.8.2 Supplied items are normally identified by markings on the item. In those instances when it is not practical to provide identification markings on individual items, identification information is provided in doc-umentation that is transmitted with the item. The identification and control procedure is discussed f urther in Section 8.0.
2.2.9 Control of Special Processes 2.2.9.1 The special processes control system ensures that special processes, such as welding / brazing, heat treating, and nandestructive testing, are controlled and accomplished */ malified personnel using qualified procedures in accordance with applicable codes, standards, specifications, criteri or other special requirernents.
2.2.9.2 The system also ensures that special processes are controlled and that the process meets applicable requirements. T he system consists of process identification, process and operator qualification, surveil-lance of processes, documentation, and review. Special process control is discussed further in Section 9.0.
2.2.10
!% naMion O
PAGE 4
OF 7
REVISION 4 FORM SFO-3b2 t2/ 78)
QUALITY ASSURANCE PLAN NUMBER NEDO-20776 2.2.10.1 inspection of material, equipment, processes, or services is defined and executed in accordance with established, procedures or instructions to ensure that there is conformance to applicable drawings, specifications, instructions, and procedures.
2.2.10.2 Examinations or measurements of items in-process are performed as necessary to provide assurance of quality. Where a sample is used to verify acceptability of an item or lot, the, sampling procedure is based upon recognized standard sampling practices. Final inspection activities (release to inventory or ship-ping) are performed by persons other than those who performed the work being inspected.
2.2.10 3 If direct inspection of processed items is impossible or disadvantageous, indirect control by surveillance of processing methods, equipment, and personnel is provided. Both inspection and surveillance of processes are provided when control is inadequate without both. The results are documented and evaluated to ensure that requiiements have been satisfied. The inspection procedure is discussed f urther in Section 10.0.
2.2.11 Test Control All verification testing is identified and controlled by written procedures which incorporate or reference the requirements and acceptance limits of applicable design documents. These procedures ensure that all prerequisites for the given test have been met, that proper equipment is used for process control and product acceptance testing, and that the tests are performed under suitable conditions. The test program includes, as appropriate, testing of system components, equipment and system verification testing, in accordance with requirements of codes and regulatory ag9acies, and other testing as required by contract. Test control is discussed further in Section 11.0.
2.2.12 Control of Measuring and Test Equipment 2.2.12.1 Documented procedures and instructions defir s the controls and records needed to assure that tools, gages, instruments, and other measuring and testing devices used in activities affecting quality are properly controlled, calibrated, maintained, and adjusted at specified periods or use intervals. Calibra-tions are performed against measurement standards which have a known valid relationship to national standards where such standards exist.
2.2.12.2 The method and interval of calibration for measuring and test equipment are defined and are based on the type of equipment, stability characteristics of the equipment, required accuracy, use, and other conditions affecting measurement error control.
2.2.12.3 Control measures include requirements for test equipment identification and for determining calibration sta'us by markings either on the equipment or on records traceable to the equipment. Control of measuring and test equipment is discussed further in Section 12.0.
2.2.13 Handling, Storage, and Shipping 2.2.13.1 Handling, storage, and shipping of ite='. components, and products are conducted in accordance with instructions and/or specifications when quality of such items, components, and products could be affected. items covered by this Quality Assurance Plan are inspected t,y the Quality Control function of the Quality Assurance Organization and identified by tags with a Quality Control signature or stamp identifica-tion which is traceable to records.
REVISION 4 PAGE 5
OF 7
FORM SFO-3b3 (2/78)
(lUAUTY ASSURANCE PLAN NUMBER NEDO-20770 2.2.13.2 The Quality Control function provides surveillance of handling. storage, and shipping activities. Stored items are inspected for proper identification, appropriate segregation of nonconforming items, and to identify protential inadvertent damage or quality deterioration. Requirements are documented as part of the Quality Control f unction or Quality Assurance Organization audit and surveillance f un% tion. Handling, storage, and shipping procedures are discussed further in Section 13.0.
2.2.14 Inspection, Test, and Operating Status Procedures require indication (by tags, forms, and other documents) of the current status of inspections anc testing of materials, parts, components, subassemblies, assemblies, or systems. These indicators provide item identification and inspection or status (passed, failed, or are currently under required inspections and tests) in order to preclude inadvertent bypassing of required inspections and tests.
Inspection, test, and operating status procedures are discussed further in Section 14.0.
2.2.15 Nonconforming Materials, Parts, or Components Procedures require control of items which do not conform to specified requirements, in order to prevent their use or their release for shipment. Methods for identification, segregation, and disposition of such items, documentation and appropriate notification of affected organizations are included. Nonconform-ing items are reviewed and rejected, reworked, repaired, returned to vendor or accepted in accordance with procedures which delineate the responsibility and authority for the dispositioning of nonconfor-mances. Nonconformance controls are discussed further in Section 15.0.
2.2.16 Corrective Action Deficiencies in quality or activities affecting quality are reported by the Nonconformance item Record (NIR) or by initiating a Corrective Action Request (CAR). The CAR is issued to responsible individuals for corrective action. The CAR is closed by the Quality Assurance Organization upon satisfactory completion of corrective action. Details for preparation of CAR's, routing, responsibilities, etc., are covered by procedures and are discussed further in Section 16.0.
2.2.17 Quality Assurance Records Appropriate records are prepared as work is performed to furrish documentary evidence of the quality of items and of the activities affecting quality. Records generated, retained, transmitted, or maintained are required to be censistent with applicable codes, Company and regulatory requirements, and Government regulations. These records provide the evidence that quality characteristics were controlled. inspected or tested, and that those characteristics meet design and quality criteria. Quality Assurance records are discussed further in Section 17.0.
2.2.18 Audits 2.2.18.1 Audits are initiated by the Quality Assurance Organization:
, To review conformance of implementing instructions with the requirements of this document.
a.
license conditions, GE procedures,and instructions, applicable ind ustry codes and standards. and regulatory requirements.
b.
To review the conformance of actual practices with the requirements of this document and implementing instructions.
PAGE 6
OF 7
REVISION 4
~
FOR M sFO-312 (2F J i
QUALITY ASSURANCE PLAN NUMBER NEDO-20776 2.1 18.2 These audits are performed in accordance with written procedures and checklists by appropriately qualified personnel not directly responsible for areas audited. Corrective action is requested, and follow-up audits are performed as the need is indicated. Records of all audits performed are maintained by the Quality Asst. ance Organization. Audits are discussed further in Section 18.0.
FORM SFO-314 (2/78)
GENERAL h ELECTRIC SPENT FUEL SERVICES OPERATION NUMBER SUBJECT 3.0 DESIGN CONTROL NEDO-20776 3.1 PURPOSE This section describes the design control measures that are required to assure that applicable regulatory requirements and the design bases are correctly translated into drawings, specifications, proced ures, and instructions. Design control includes provisions to assure that appropriate quality standards are specified and included in design documents and that deviations from such standards are controlled.
3.2 GENERAL The design of SFSO products, equipment, or facilities is primarily the responsibility of the Manager, Fuel 3.2.1 Storage Projects or the Manager, Licensing and Transportation for transportation equipment. Certain design and field changes also are accomplished by the Morris Operation (MO). These changes are normally limited to facility changes initiated by MO and which do not involve nuclear safety-related items and are in accord with basic design criteria. See Section 2.0 of this Plan for definitions of safety and non-safety related classifications.
3.2.2 The design control procedures employed by SFSO require documentation of analyses of (as applicable) nuclear safety, stress, chemical reactions, compatibility of materials, accessiblity for inspection, mainte-nance and repair, disposal criteria, delineation of acceptance criteria for inspections and tests, and for documentation of the selection and review for suitability of application of materials, parts, equipment and processes essential to safety and to plant operations.
3.2.3 Design controls require verification of the adequacy of a design of all safety-related items byindependent review of the analyses and by design reviews of design progress, through the use of alternate or simplified calculational methods, or by the performance of a suitable testing program. The verification process is performed by individuals or groups other than those who performed the design, but who may be from the same organization. All design documents are reviewed for adequacy by the next higher level of management.
3.2.4 When a test program is used to verify the adequacy of a specific design feature in lieu of another verifying or checking process, the test program includes sen. ole qualification testing, under the most adverse conditions, of a prototype unit or a model or mock-up. When test are performed on models of mock-ups, scaling laws are established and verified.
3.2.5 All design changes, including field changes, involving nuclear safety-related items are subject to design control measures commensurate with those applied to the original design and are approved by the organization that performed the original design except as specified in sub-paragraph 3.4.2.2 of this Plan.
Editorial changes, such as typing or drafting errors, or similar discrepancies, are excluded from these controls.
YSSUED BY MAN AGER, QUAUTY ASSUR ANCE PROGR AMS DATE ISSUED July 14,1978 l
PAGE 7
H. W. HilNTLEY REVISION 3 op F ORM SFO-31 1 12/78)
QUAUTY ASSURANCE PLAN
' NUMBER NEDO-20776 3.3 RESPONSIBILITIES 3.3.1 The responsible manager with assistance from other affected SFSO subsection managers,is responsible for establishing design control procedures for their design activities in accordance with SFSO Practices and Procedures and the requirements specified in this Plan, subject to the limitations specified in sub-paragraph 3.2.1, 3.3.2 Unit Managers are assigned areas of design responsibility, usually by specific discipline, to accomplish the design objectives and are accountable to their subsection manager. This includes responsibilities for the following:
a.
Controlling design activities in accordance with design control procedures.
b.
Assuring that responsible engineers under their direction follow these design control procedures.
3.3.3 Responsible Engineers are responsible for specifying quality-related design requirements in design documents, such as drawings, specifications, and test procedures.
3.3.4 The Quality Assurance Organization is responsible for reviewing design documents to ensure the following:
a.
That Quality attributes are specified and that such attributes meet applicable quality assurance requirements.
b.
That quality attributes can be inspected.
c.
That design control procedures have been followed and that the design activity is documented.
d.
That adequate inspection planning is included.
3.4 DESIGN CONTROL SYSTEM 3.4.1 Basic SFSO System 3.4.1.1 The basic SFSO design control system is shown in Design Control Flow Sheets, Figures 3-1,3-2,3-3, and 3-4.
3.4.1.2 Key design control elements of the basic system are as follows:
a.
The Project Plan is formulated from the design bases and cnteria and designates the scope of activity, design objectives, nuclear safety requirements, organizational responsibilities and cafety classification.
b.
As design progresses, engineering reviews are scheduled to assess that design objectives and quality requirements are met. These engineering reviews are documented.
c.
C mpleted detailed design documents are reviewed for adequacy by responsible managers. Qual-ity AJsurance, and appropriate interface organizations in accordance with procedures. These review? are documented.
GE 2
OF 7
REVISION 3 FORM SFO-31-2 (2/78)
(lUALITY ASSURANCE PLAN NUMBER N E DO-20776 d.
Approved documents are forwarded to SFSO Document Control in San Jose to be released to controlled distribution.
3.4.2 Changes to Approved Design Documents 3.4.2.1 Proposed changes to approved documents are approved by responsible managers prior to altering the document (s).
3.4.2.2 Review and app oval of changes to nuclear safety-related items are performed by the same organization that reviewed and approved the original document unless another responsible organization has been delegated the responsibilit /. Reassignment or delegation of design review responsibility will normally be required as follows:
In instances where reviews by SFSO contractors (e.g., by Architectural Engineers, etc.) are not a.
feasible.
b.
In instances where cognizant individuals who approved the original design are no longer in positions which are responsible to review the proposed changes (e.g., due to job transfers, reassignment of responsibilities, terminations, etc.).
3.4.2.3 Changes to project or task definitions, SFSO implementing procedures, personnel assignment and authority, and administrative control functions such as distribution and interface reviews are accom-plished by formal letters or memoranda.
3 4.2.4 Changes to design documents such as drawings, specifications, and test procedures are authorized as shown in Design Control Flow Sheet, Figure 3-4.
3.4.2.5 Fuel Storage Projects and Licensing and Transportation utilize the Engineering Change Notice (ECN) for processing all requests for changes to design documents.
3.4.2.6 Morris Operation (MO) utilizes the Facility Change Notice (FCN), a Scope Committee and a Safety Committee for processing all requests for changes. Subsequently, MO uses the ECN for effecting changes to the design documents.
3.4.2.7 All safety-related changes initiated at MO are referred to Fuel Storage Projects for processing. Selected non-safety-related items (e.g., high cost items, items beyond plant capability, etc.) are also handled by Fuel Storage Projects.
PAGE 3
Op 7
REVISION 3
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APPLICABLE TO CONTRACTS REQUIRING EXTERNAL FASRfCATION SPENT FUEL FURNISHED BY SFSO (INCLUDES BOTH SFSO GENERATED AND/OR INSTRUCTIONS REVIEW MAY INCLUDE FORMAL FNGINEERING REVIEWS (FERs) AT 3
PURCHASE DESIGN REVIEWS, AND DESIGN VERIFICATION A T THE DISCRETION ORDER APPLICA8LE TO CONTRACTS WHICH REQUIRE BOTH GENGR ATION 4
FABRICATION / CONSTRUCTION BY THE SAME VENDOR. DESIGN CRI 5 INCLUDES CLASSIFICATION TO ALL PRODUCT DOCUMENTS.
s CONTRACT AWARD 6
INCLUDED Ifl MORRIS OPERATION IMPLEMENTING INSTRUCTIONS.
/
CE S
SFSO SOURCE INSPECTION SFSO RECEIVING INSPECTION M
TEST PROCEDURES TEST APPROVAL PO BY SFSO MODIFICATION Figure
NEDO 20776 CUMENTS NOTES APPLICABLE TO CONTRACTS WHICH REQUIRE GENERATION OF DESIGN DOCUMEN15 BY THE VENDO DESIGN CRITERIA FURNISHED BY SFSO.
APPLICABLE TO CONTRACTS REQUIRING EXTERNAL FABRICATION / CONSTRUCTION ONLY 2
FURNISHED BY SFSO (INCLUDES BOTH SFSO GENERATED AND/OR OTHER VENDOR GENERATED)
FUEL IONS REVIEW MAY INCLUDE FORMAL ENGINEERING REVIEWS (FERs) AT DESIGNATED HOLD POINTS, INFORMAL DESIGN REVIEWS, AND DESIGN VERIFICATION ATTHE DISCRETION OF SFSO RESPONSIBLE MANAGER.
APPLICABLE TO CONTRACTS WHICH REQUIRE BOTH GENERATION OF DESIGN DOCUMENT FABRICATION / CONSTRUCTION BY THE SAME VENDOR. DESIGN CRITERIA FURNISHED BY SFSO INCLUDES CLASSIFICATION TO ALL PRODUCT DOCUMENTS.
INCLUDED IN MORRIS OPERATION IMPLEMENTING INSTRUCTIONS.
/
~3 N
t Figure 3-3. Design Control Flow Sheat -- External Fabrication / Construction Page 6 of 7
P i
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,i D
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OPERATION)
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(ECN)
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CONTROL FROM FILES ENGINEER MORRIS AND FILES MANAGER 8
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NOTES SPENT FUEL DOR FOR COMACTS M8E MO MOWDES DESG NWEUS INSTRUCTIONS FOR EXTERNAL FABRICATION (SEE FIGURE 3-3)
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Engineering Changes Page ? of 7
GEN ERAL @ ELECTRIC SPENT FUEL SERVICES OPERATION SUBJECT NUMBER 4.0 PROCUREMENT DOCUMENT CONTROL NEDO-20776 4.1 PURPOSE This section describes the control measures for assuring that applicable regulatory requirements, design bases, and other requirements which are necessary to assure quality are included or referenced in procurement documents. The sequence of procurement to the preparation of the Request For Quotation (RFO) is shown in Figures 4-1 and 4-2, 4.2 GENERAL 4.2.1 Responsible eingeering personnel (e.g., the responsible engineer) ensure that quality requirements are included in the drawings and specifications for which they are responsible.
4.2.2 Classification of the Matenal Request (MR) is accomplished by the responsible engineer to reflect the nuclear-safety aspect of the procurement as well as the quality assurance effort required to implement the quality requirements.
4.2.3 The MR and the drawings, specifications and other accompanying documents, are reviewed for quality requirements by the Quality Assurance Organization. These requirements may inclJde the following:
a.
Access to vendor facilities.
b.
Source inspection.
c.
Material certifications.
d.
Personnel and procedure qualification records.
e.
Audit of vendor facilities.
f.
Inspection plans.
g.
Vendor approval.
h.
Hold points for General Electric (SFSO) inspection.
i.
Requirements for subtier vendors.
J.
Specific quality clauses.
k.
Other quality-related records.
4.2.4 To the extent necessary, procurerrant documents require vendors to provide a quality assurance program consistent with the requirement!. of this Quahty Assurance Plan.
4.2.5 The Quality Assurance Organization determines which quality activities are retained by SFSO and which are delegated to the vendor. The activities delegated to the vendor must meet the requirements of this Quality Assurance Plan and the criteria of the Code of Federal Regulations, Title 10, Part 50, Appendix B.
The determination to delegate or retain these activities is made prior to bid award and is based on vendor capability to perform the activities.
4.2.6 MR revisions are reviewed in the same manner as the original MR by the Quality Assurance Organization.
ISSUED BY M.\\ NAGER, QUALITY ASSUR ANCE PROGRAMS DATE ISSUED July 14,1978 l
PAGE H.W. HUNTLEY REv SION 3
op 4
FORM SF0418 t2H8)
(lUALITY ASSURANCE PLAN a
NUMBE R NEDO-20776 4.3 RESPONSIBILITIES 4.3.1 The responsible engineer is responsible for preparing the MR and including the classification and quality requirements.
4.3.2 The Quality Assurance Organization is responsible for reviewing the MR to ascertain that the applicable quality requirements have been incorporated in the MR.
4.3.3 Purchasing is responsible for submitting the MR package to prospective bidders.
4.4 IMPLEMENTATION 4.4.1 The sequence of procurement to the preparation of the RFO is shown in Figures 4-1 and 4-2.
4.4.2 The procurement process from receipt of the vendors' response to the RFO to the procurement on a Purchase Order, is detailed in Section 7.0.
O O
GE 2
OF 4
REVISION 3
FORM SFO-312 (2/78)
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GEN ER AL h ELECTRIC (lUALITY ASSURANCE PLAN SPENT FUEL SERVICES OPERATION SUBJECT NUMBER 5.0 INSTRUCTIONS, PROCEDURES, AND DRAWINGS NEDO-20776 5.1 PURPOSE This section describes the measures for ensuring that activities affecting quality are described in in-structions, procedures, or drawings of a type appropriate to the work being performed, and that the work is accomplished in accordance with those instructions, procedures, and drawings.
5.2 RESPONSIBILITIES 5 2.1 Organizations involved in preparation of instructions, procedures and drawings are responsible for ensuring that these documents adequately describe the activities affecting quality.
5.2.2 The Quality Assurance Organization is responsible for the following:
a.
Reviewing and approving instructions and procedures which affect quality.
b.
Performing verification of compliance with requirements of instructions and procedures.
NOTE: The Quality Assurance Organization review of design documents is covered in Section 3.0.
5.3 DOCUMENTS AFFECTING OUALITY 5.3.1 Table 5-1 lists documents which affect the perforr. lance of quality-related activities. Individual sections of this Plan describe their use.
5.3.2 Spacific responsibility for the preparation, approval, issuance and distribution of the documents listed in Table 5-1 is described in Section 6.0.
ISSUED BY MANAGER, QUALITY ASSURANCE PROGRAMS DATE ISSUED July 14,1978 PAGE 1
3 H.W. HUNTLEY REVISION 3 op F ORM 5FO-31 1 (2n8)
(lUAUTY ASSURANCE PLAN NUMBER NEDO-20776 Table 5-1 DOCUMENTS AFFECTING QUALITY Document issuer; Document Description Quality Elements (1) QA Plan issued by the Quality Assurance Defines the broad requirements Organization; describes the and responsibilities for quality overall Quality Assurance System activity.
followed by Spent Fuel Services Operation.
(2) Implementing issued by responsible organiza-Specific sequence, details of Instructions tion; the instructions implement review, approval, documentation, the requirements of the Quality records, and distribution.
Assurance Plan.
(3) Design Specit.;ations issued by responsible organizations: Defines the bases and quality.
establishes requirements (including requirements for design or quality) for design, fabrication, performance of components, or test of materials, components, systems, structures, or services as well as systems and structures.
as well as acceptance criteria.
(4) Test Instructions issued by responsible organi-Defines the functional test zation; describes the testing requirements for products and of components and verifies outlines criteria to verify proper operational conditions; in-operation as required by cludes equipment to be utilized, engineering drawings and/or and the test setup.
design specifications.
(5) Engineering Drawings issued by responsible organi-Defines quality characteristics zation; defines the item to and acceptance criteria be fabricated or modified.
by statements on the drawings or by references to applicable specifications.
(6) Engineering Chang issued by responsible organi-Defines quality criteria related Notice (ECN) zation; defines changes.
to changes to approved documents by statements on the change notice.
(7) Facility Change issued by MO; defines Defines quality criteria related Notice (FCN) changes
- to facilities. If design to changes to facilities by documents are affected, the statements on the change notice.
ECN is used to incorporate changes.
'Non-safety related only 9
GE 2
op 3
REVISION 3 FORM sFO-312 (2/ 78s
QUAllTY ASSURANCE PLAN NUM8ER N EDO-20776 Table 5-1 DOCUMENTS AFFECTING QUALITY (Continued)
Document issuer; Document Description Quality Elements (8) Standard Operating issued by MO; defines the includes quality requirements in Procedures (SOP) operating procedures for the procedures.
the plant or a plant system.
(9) Analytical Quality lesued by MO; specifies Defines requirements and respon-Assurance Manual analytical laboratory controls.
sibilities for quahty of laboratory operation.
(10) Analytical Equipment Issued by MO; describes Outlines criteria to maintain and instrumentation calibration control for the control of equipment and Manual laboratory.
instruments.
REVISION 3 PAGE 3
Op 3
FOHM SFCNit 3 (2/78)
GEN ERAL $ ELECTRIC SPENT FUEL SERVICES OPERATION SUBJECT NUMBER 6.0 DOCUMENT CONTROL NEDO-20776 6.1 PURPOSE This section describes the measures for ensuring that approved c'esign documents related to quality activities are controlled for issue and distribution. Such documents, including changes, are approvect for release by authorized personnel and ale distributeu to and used at the location where the prescribed activity is performed. Initiation, review, and adequacy of documents are covered in Section 3.0. Refer to Table 6-1 for a list of SFSO controlled documents.
6.2 GENERAL Document numbering, issuance, storage, revision control, and distribution are covered by appropriate implementing instructions and engineering or que!ity instructions. Vendor / contractor delegated docu-ment control functions are approved by the Quality Assurance Organization and are compatible with the requirements specified in this Plan.
6.3 RESPONSIBILITIES 6.3.1 The Document Control Function is the responsibility of the Project Engineering Unit of Fuel Storage Projects. Responsibilities consist of:
a.
Receiving, logging, maintaining revision status records, and distributing approved documents, includ.ng release of approved documents to authorized personnel for revision or permanent storage.
b.
Providing a controlled access repository for documents.
c.
Coordinating Engineering document numbering.
6.3.2 Individuals holding authorized copies are responsible for voiding or defacing superseded documents in such a manner that superseded documents are not used for subsequent work activity. See subparagraph 6.5.3(e) for handling of obsolete sections of the SFSO Quality Assurance Plan.
6.3.3 The Manager, Morris Operation is responsible for the document control activities at the MO according to the requirements of this Plan.
6.3.4 Specific Responsibilities a.
Responsibility for ensuring use and compliance with instructions, procedures, and drawings is defined in Section 5.0.
b.
Table 6-1 identifies Document Control responsibility for specific instructions, procedures, draw-ings, and other documents, covering review for adequacy, approval for issuance, revision control, and distribution.
ISSUED BY MANAGER, QUALITY ASSURANCE PROGRAMS DATE ISSUED July 14,1978 H. W. HUNTLEY REVISION 3 S
or F 0au SF o.31 1 (2/18)
QUALITY ASSURANCE PLAN NUMBER NEDO.20776 6.4 DOCUMENT CONTROL SYSTEM 6.4.1 Approved SFSO documeets and Vendor documents (except for this SFSO Quality Assurance Plan) are forwarded to the Document Control Organization for retention, for storage, and/or distribution. Figure 6-1 depicts a Document Control flow chart.
6.4.2 Changes to instructions, procedures, an i drawings which may affect safety-related items are reviewed and approved by the organizations that reviewed and approved the original document unless this responsibility is delegated to another organization.
6.4.3 Proposed changes to approved documents are reviewed and approved prior to release of the document from Document Control custody.
6.4.4 Distribution of documents is in accordance with instructions and authorized distribution lists.
6.4.5 Only approved copies are reproduced for final design, actual construction, and actual operation activities affecting quality.
6.5 CONTROL OF THE QUALITY ASSURANCE PLAN 6.5.1 Responsibility The Manager, Quality Assurance Programs,is responsible for the preparation and revision of this SFSO Quality Assurance Plan.
6.5.2 Assignment and Control of the Quality Assurance Plan a.
These documents are serialized and distributed in accordance with the distribution list maintained by the Quality Assurance function in San Jose b.
Copies of this SFSO Quality Assurance Plan are maintained at SFSO in San Jose and at MO by the Manager, Management Systems and the Manager, Quality Assurance and Safeguards, respectively, or by their delegates, and are available foi review and reference by customers, regulatory, and Company personnel.
6.5.3 Revision Control of the Quality Assurance Plan Requested changes, such as those arising from revisions to The Code of Federal Regulations, Title a.
10, Part 50, Appendix B or other applicable regulations and industrial standards, are coordinated with responsible management personnel and directed to the Manager, Management Systems.
b.
The Quality Assurance function in San Jose is responsible for preparing Quality Assurance Plan changes, coordinating reviews, and obtaining approvals (including the MO) prior to issue of revisions.
Revisions are normally made by section, rather than revisinq the entire Plan. The Table of Contents c.
includes the issue date of current revisions.
O GE 2
Op 5
REVISION 3 FORM SFO-312 (2/181
QUALITY ASSURANCE PLAN NUMBER N EDO.20776 d.
Revisions which may affect safe *y-related items or practices and changes affecting license condi-tions or technical specification conditions are reviewed by the Manager, Licensing and Safety. The Manager, Licensing and Safety is responsible for appropriate notification of the NRC.
e.
Revised copies are distributed ag Errata and Addenda Sheets, and require acknowledgement of the receipt of the revision and return of obsolete copies.
6.6 CONTROL OF DOCUMENT REVISIONS 6.6.1 Documents requiring revision are controlled, reviewed, and processed in the same manner as the original (new) issue document.
6.6.2 Procedures for revision control of instructions, procedures, and drawings are prepared by the responsible organization and are in accordance with requirements specified in this Plan and SFSO implementing instructions.
6.6.3 Document revisions which may affect safet)-related items or practices and changes affecting license conditions or operating limitations, are reviewed by the Manager, Licensing and Safety. The Manager, Licensing and Safety is responsible for appropriate notification of the NRC.
6.6.4 The Quality Assurance Organization, in reviewing revisions to applicable regulations and industrial standards for changes that affect the Quality Assurance Program, coordinates with responsible SFSO personnel to determine the most effective means of revising documentation.
6.7 DOCUMENT MASTER LISTS The originating organization is responsible for maintaining a document master list of all issued and approved documents, including current revision numbers. This responsibility may be delegated in part or in full to Document Control by management agreement.
6.8 DOCUMENT MASTERS 6.8.1 SFSO document masters are stored in Document Control and/or master files at MO under the control of Document Control personnel in San Jose and under control of management personnel at the MO.
6.8.2 Vendor / contractor document masters are stored in vendor controlled file (s) and/or Document Control files as defined in contract documents.
REVISION 3 PAGE 3
op 5
FOHM SF04N t2/78)
(lUALITY ASSURANCE PLAN NEDO-20776
' NUMBER Table 6-1 SFSO CONTROLLED DOCUMENTS
- Initiation At**
Document San Jose MO X
(1) SFSO Quality Assurance Plan (2) Implementing instructions:
X X
a.
Spent Fuel Instructions (SFI)
X b.
Projects Instructions (PI)
X c.
Licensing and Transportation instructions (LTl)
X d.
Quality Standing Instructions (OSI)
X e.
Advance Engineering Instructions (AE)
X f.
Morris Operation Instructions (MOI)
X X
(3) Design Specifications (4) Test instructions X
X X
X (5) Engineering Drawings X
X (6) Engineering Change Notices (ECN)
X (7) Facility Change Notices (FCN)
X (6) Standard Operating Procedures (SOP)
X (9) Analytical Quality Assurance Manual X
(10) Analytical Equipment and Instrumentation Manual
- Instial issue (or changes). approval, and distribution of these documents are covered in appropriate implementing instructions.
"Where two points of initiation are Shown either document control organization may introduce into Document Control system with notihcation sent to other unit for number coordination.
O 4
o, e
m,s,0~ S gee FOR M SFO-312 (2/18)
QUALITY ASSURANCE PLAN NUMBER N EDO-20776 SFSO INITIATED SFSO CONTRAGOR DOCUMENTS m
y APPROVED DOCUMENTS y
DISTRIBUTION DISTRIBUTION LIST DOCUMENT RECORD CHANGE MICROFILM
+
STORAGE AN Y
AUTHORIZED c;e4NGE CONTROLLED REQUEST FILE w
CHANGES Figure 61. SFSO Document COntrOI REVISIC'J 3 PAGE 5
op 5
F ORM SFO414 (2/78)
GEN ERAL $ ELECTRIC SPENT FUEL SERVICES OPERATION SUBJECT NUMBER 7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES NEDO 20776 7.1 PURPOSE This section describes the measures for controlling purchased material, equipment, and services in accordance with procurement documents. Figure 7-1 shows the procurement steps from receipt of the Request for Ouctation (RFO), described in Section 4.0, through the receiving inspection process.
7.2 GENERAL 7.2.1 Vendors must be approved by the Quality Assurance Organization. The source (vendor) quahty evaluation normally consists of one or more of the following:
a.
A review of performance history of a vendor supplying similar products or services and an evalua-tion of risk associated with past experience, including quality performance.
b.
A review of the vendor's facilities to establish capability of the quality system to control the required work. SFSO Engineering components and Purchasing may be requested to assist in evaluating this area.
c.
A review of the vendor's quality system to determine if programmatic control will be retained or delegated and to define specific responsibilities. This includes reviewing the vendor's methods associated with producing products and also includes qualification of individuals.
d.
An appraisal of historical data related to vendor's prod ucts and/or services being considered. These data may be documentation covering problems, complaints, or other pertinent information which reflect the capability of the vendor's quality system to control the required work.
7.2.2 The results of the vendor evaluation are summarized on a Vendor Capability Report and the report a transmitted to Purchasing and the responsible organization.
7.2.3 The vendor may be requested to provide objective evidence of his Quality Assurance Program to supple-ment the evaluation process.
7.2.4 Prior to bid award, the vendor's bid is reviewed by Purchasing and the responsible organization, the Material Request (MR) initiator, and the Quality Assurance Organization. Exceptions and/or deficiencies, if any, are resolved. When all items are resolved or appropriate action is designated, the Purchase Order (PO) is prepared.
The PO is reviewed by the MR initiator and the Quality Assurance Organization to ensure that all quahty requirements are incorporated. The Quality Assurance Organization venfies that the order has been placed with an approved vendor. If the PO requires correction, the MR initiator notifies Purchasing.
7.2.5 PO changes require appropriate review and documentation similar to that utilized in the original document.
ISSUED BY MANAGER. QUALITY ASSURANCE PROGRAMS DATE ISSUED July 14,1978 PAGE l
H.W. HUNTLEY REVISION 3 op 4
F0HM SF041 1 R/18)
QUAUTY ASSURANCE PLAN
' NUMBER NEDO-20776 7.2.6 Source inspection is performed by the Quality Assurance Organization. The inspection is accomplished in accordance with the requirements established in the MR and PO. Source inspection is always controlled or performed by the Quality Assurance Organization personnel at the vendor's facility. Source inspected material is released for shipment by a Source inspection Roport (SIR). Final acceptance of source-inspected material is made upon receipt at the SFSO destination.
7.2.7 All equipment (whether source-inspected or not)is inspected by the Quality Assurance Organization at the receiving facility. The receiving inspection procedure is prepared by the Quality Assurance Organization from information included on the MR and is forwarded to the receiving facility as an incoming Material Report (iMR) prior to arrival of the equipment. An IMR is the Quality Assurance Organization document which specifies the inspection criteria and on wtich the results of the inspection are recorded.
7.2.8 Documentary evidence that the material, equipment or service complies with the procurement require-ments is available at the point-of-use prior to installation or use of such material, equipment or service.
This evidence, as Quality Assurance related records, is specified in the PO. These records are generated by the vendor and are reviewed and approved by the Quality Assurance Organization. The Quality Assurance Organization documentation together wth the vendor's dccumentation comprise the Quality Assurance Records.
7.2.9 in the establishment of quality requirements in the MR (see Section 4.0) and in vendor evaluation, the Quality Assurance Organization concurs with the Quality Assurance activities to be performed by the vendor. These activities may include fabricatic:t tests, in-process tests, and final inspections. When these activities are performed, the Quality Assurance Organization conducts vendor surveilla. ice to ascertain compliance to the Quality Assurance requirements.
7.2.10 Vendor audits are conducted in a formal, and thorough review of the vendcr's compliance to Quality Assurance requirements. The results of audits are documented and discussed with vendor management
[ including corrective action (s) to be taken for any non-complying activities]. Work is suspended if significant deficiencies affecting quality are discovered.
7.3 RESPONSIBILITIES 7.3.1 The Quality Assurance Organization is responsible for:
a.
Evaluating (and approving) vendors b.
Assisting (if requested) Purchasing, the responsible organization and the Material Request initiator in reviewing approved potential vendors.
c.
ewing the PO to ascertain that quality related requirements are transferred from the MR to the PO.
d.
Conducting source inspection.
e.
t, inducting vendor surveillance.
f.
Conducting Quality Assurance audits.
O GE _ 2 op 4
REVISION 3
FOR M SFO-312 (2/18)
QUAllTY ASSURANCE PLAN NUMBE R NEDO-20776 g.
Reviewing, and approving, the vendors Quality Assurance Records.
h.
Conducting receiving inspection.
1.
Exercising their responsibilities with nonconformances and corrective action as detailed in Sec-tions 15.0 r.nd 16.0 7.3.2 The responsible organization (and the Material Request initiator)is responsible for:
a.
Evaluating (with Purchasing) approved potential vendors.
b.
Reviewing the PO to ascertain the? the requirements of the MR have been incorporated in the PO.
7.3.3 Purchasing is responsible for:
a.
Coordinating the visits fo the Quality Assurance personnel with the vendor.
b.
Evaluating (with the responsible organization) approved potential vendors, c.
Incorporating MR requirements, and the findings of the vendor review, into a PO.
7.4 IMPLEMENTATION 7.4.1 Figure 71 outlines the detailed procurement procedure from the receipt of the vendor's response through the receiving inspection process.
REVISION 3
PAGE 3
OF 4
FOHM SFO-313 (2/78)
QUAllTY ASSURAliCE PLAN
' NUMBER NEDO 20776 PROCURE MENT FROM SECTION 4
RESPONSE
RESPONSE UN APPROVE D APPROV E D VENDORS VENOOR NOBID REJECT REJ CT
RESPONSE
NSE j
QA REQUESTED PURCHASING TO EVALUATE COORDINATES INT 1A VENDOR PROCURE ME NT TOR REVIEW VENDOR QA EVALUATION VENDOR SELECTED f
REJECT ACCEPT po PLACED I f COPIES TO ANGE APPROVAL BY lD INITIA MR
^
F ABRICATION T
OR U
i SOURCE VENDOR INSPECTION (GE)
INSPECTION QA SOURCE INSPECTION q
SOUHCE f
INSPECTION.-
RECEIVING DA l!.SP ECTION QA REVIEW RECEIVING INSPECTION REWORK ACCEPT SPECTION Y
QA SCRAP REVIEW OOWNGRADE
+
REJECT SE GREGAT E D
~_RE JECT ACCEPT MAT E RI AL STORAGE STORAGE CONFORMANCE j
REPORT RESOLV E Figure 7-1.
Procurement O
FOR M SFO-312 (2/78)
GENERAL $ ELECTRIC SPENT FUEL SERVICES OPERATION SUBJECT NUMBER 8,0 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND NEDO-20776 COMPONENTS 8.1 PURPOSE This section describes the methods by which materials, parts, and components, including partially fabricated subassemblies, are identified and controlled. This identification and control verifies that only specified items, accepted by Ouality Assurance, are used in (1) construction / fabrication /erectionlinstalla-tion; (2) maintenance fabrication / repair / modification work: (3) production operations; or (4) laboratory operations. Figure 8-1 illustrates the identification process.
8.2 GENERAL 8.2.1 Identification of items is maintained by heat number, part number, serial number, or other appropriate means, either on an item or on records traceable to an item, throughout fabrication, erection, installation, and use N the item.
8.2.2 Identification is accomplished by permanent inking, stamping with metal dies, or attachment of a material control tag on the item as well as the maintenance of receiving and utilization documentation on bulk items (such as chemicals). The item, at receiving, is nonconforming unless so identified.
8.2.3 The identification is maintained on non-permanent items until they are consumed or otherwise utilizt J. If identification is destroyed prior to use, the organization responsible for use reidentifies the item utilizig procurement, fabrication, operational or quality records. If the item cannot be positively identified, either by direct marking or record traceability,it is not utilized in a Class 1 or 2 application (see Section 2.0 for definitions of Classifications).
8.3 RESPONSIBILITIES 8.3.1 The Quality Assurance Organization is responsible for surveillance of methods used for identification and control of items at SFSO and contractor /subco.. tractor / vendor facilities.
8.3.2 Organizations within SFSO are responsible for maintaining identification and control of items during the period the items cre in their custody. Specific responsibilities at the Morris Operation (MO) include the following:
a.
MO Plant Engineering and Maintenance is responsible for maintaining identification and control of items during fabrication, installation, repair, and modification work as well aas for spare parts storage.
b.
MO Plant Operations is responsible for maintaining identification and control of materials during receivin] and use by MO.
/
8.3.3 Vendors and contractors are responsible for maintaining identification and control of items (materials.
parts, or components) during fabrication / construction / installation while the items are under their jurisdic-tion and prior to final acceptance.
ISSUED BY MANAGER, QUALITY ASCURANCE PROGRAMS DATE ISSUED July 14,1978 PAGE l
H.W. HUNTLEY REVISION 3
3 op FORM SF041 1 (2n8)
QUAllTY ASSURANCE PLAN NEDO-20776
' NUMBER 8.3.4 Contractors and vendors are responsible for imposing identification requirements on their subtier vendors, and verifying comt ance to these requirements.
li 8.3.5 The Quality Assurance Orgen!zation is responsible for verifying identification (as described in sub-para-graph 8.3.3), to determine that identification procedures are adequately described in the contractor or vendor Quality Assurance Plan.
8.4 IMPLEMENTATION 8.4.1 The requirements for identification and control of materials, parts and components is imposed on the vondor in the Material Request as part of the vendor's Quality Assurance Program. The vendor Quality Assurance Plan is reviewed by the Quality Assurance Organization to ascertain whether the vendor uses procedures which result in an effective identification system and the vendor is surveyed to verify that the vendor's documented system is implemented.
8.4.2 Audits and surveillance are the principal methods by which the Quality Assurance Organization verifies compliance with identification control procedures, both SFSO and at a vendor's facilities.
O O
Q.2 o,
e e.ms.
3 FOR M SFO-312 (2/ 78)
QUALITY ASSURANCE PLAN NUMBER NEDO-20776 FROM SECTION 7 INCOMING SOURCE INSPECTION REPO T lf U
OUALITY CONTROL SPECIFIC RECEIVING e
INSTRUCTION INSPECTION (OCI)
OR GENERAL TAG
- 1. PO REQUIREMENT
- 2. MARKING
- 3. DOCUMENTATION REJECT
- 4. PRIOR INSPECTION DATA HOLD AND/OR c
RELEASE SEGREGATE IDENTIFICATION MATERIAL NON CONFORMANCE R EPORT U
STORAGE ILIZATION I
PARTS ASSEMBLY DISPOSITION RELEASE q
SHIP f
INSTALL Jr REJECT REWORK RETURN REPAIR FABRICATION CONSTRUCT ASSEMBLY y
INSTRUCTION INVOICE INSPECT
]f y g OR OA REVIEW RAP INSPECT TEST f
INSPECTION INSPECTION DATA INSPECTION DATA TEST U^ #
OA REVIEW OA RE%IEW OA REVIEW Figure 8-1.
Identification and Control of Materials, Parts and Components REVISION 3 PAGE 3
op 3
FORM SFO 313 (2nal
GENERAL h ELECTRIC SPENT FUEL SERVICES OPERATION SUBJECT NUMBER 9.0 CONTROL OF SPECIAL PROCESSES NEDO.20776 9.1 PURPOSE This section describes the requirements for assuring that special processes, such as welding. brazing, heat treating, cleaning, and Nondestructive Examination (NDE) are controlled and accomplished by qualified personnel using qualified procedures in accordance with applicable codes, standards, specifi-cations, criteria, ano oth'r special requirements. Figure 9-1 deh. Mates the control process.
9.2 RESPONSIBILITIES 9.2.1 SFSO Engineering components aru responsible for the following:
a.
Establishing and/or identifying special processes to be used for fabricating procured equipment.
Requirements may be established in the form of criteria, specifications, instructions, and proce-dures as appropriate.
b.
Developing special processes, whenever appropriate, in accordance with national codes and standards or other recognized data.
c.
Approving special processs and procedures developed by others.
9.2.2 The Quality Assurance Organization is responsible for the following:
a.
Reviewing special processes and personnel qualification requirements to assure that special processes and personnel can achieve stated quality requirements for a specific task.
b.
Reviewing qualification data on personnel prior to utilization of any special process.
c.
Approving special process procedures prior to use.
9.2.3 The Quality Assurance Fur,ction at Morris Operation,is responsible for verifying that qualified proce-dures and personnel are used for special processes.
9.3 SPECIAL PROCESS PROCEDURES 9.3.1 Special process requirements are specified on drawings or other design media. The required information includes the applicable procedure and the standard to which the procedure must be qualified.
9.3.2 Each special process is qualified using a written procedure according to the requirements of national standards or codes (where applicable) in specifications incorporating these requirements.
9.3.3 Applicable special process procedures sre utilized at the applicable work location.
9.3.4 Samples for process qualification are taken by or under the control of the Quahty Assurance Organize. tion.
ISSUED BY MANAGER, QUALITY ASSURANCE PROGRAMS DATE ISSUED July 14,1978 I
PAGE H.W. HUNTLEY REVISION 3
op 3
FORM SFO.J11 t2/18)
QUAllTY ASSURANCE PLAN
' NUMBER NEDO-20776 9.3.5 The use of special process materials is controlled by procedures. For example, weld filler metal and fluxes are segregated and maintained in a controlled area. These, or similar materials, are also identified and controlled throughout all stages of fabrication.
9.3.6 Equiproent which controls spect processes (such as heat controls, electrical controls and recording equipment) are calibrated on a planned frequency and the results are documented.
9.3.7 All other records reflecting on the quality of the process and procedure, such as heat treating furnace certification, furnace charts, welding records, and NDE test data are maintained as documentation of the fabrication / test process.
9.3.8 The Quality Assurance Organization provides a review of the fabrication /tast process, control of process qualification samples, review of process parameters and test result documentation, and in-process inspection for assuring the quality of the special process.
9.4 SPECIAL PROCESS PERSJNNEL 9.4.1 Each special process is performed by a qualified operator according to the performance requiremer'*r if the applicable specification. The operator who successfully performs the " Procedure Qualification".s automatically qualified for performance.
9.4.2 NDE inspection is performed by an operator qualified to the applicable portion of American Society for Nondestructive Testing Standard SNT-1C-1 A, " Recommended Practice for Nondestr uctive Testing Per-sonnel Qualifications and Certification"(or other applicable documents) as a Level 11(or higher) Inspector and is qualified to examine and evaluate indications to the applicable acceptance cr teria.
9.4.3 Samples for operator qualification /requalification are taken by or under the control of the Quality Assur-ance Organization.
9.4.4 Requalification of personnel is performed according to the requirements of the applicable process requirements.
9.5 RECORDS 9.5.1 The Quality Assurance function at MO maintains a list of qualified procedures and records to substantiate operator qualifications for all operations performed at MO. The records include name, type of certifica-tion, education, and experience backgraounds as well as results of the qualifying examination.
9.5.2 Contractor / vendor process procedures and records are reviewed and approved prior to initiating work at contractor / vendor locations.
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REVISION 3 FORM SFO-312 42/78)
QUALITY ASSURANCE PLAN NUMBER NEDO-20776 SPECIFICATION TEST INSTRUCTION ENGINEERING NATIONAL ORAWING
=l DET ERMIN ATION 4
STANDARD OR CODE U
WRITE USE NATIONAL SPECIFICATION DECISION
=
OR EXISTING SPECIFl v
y SPECIAL PROCESS SPECIFICATION V
DOCUMENT m
APPROVAL r
if f
OUALIFY OU AllFY NDE 4
OU ALIF Y y
PERSONNE L PROCEDURE PERSONN E L I
If 1f DOCUMENT DOCUMENT OUAL FICATION EXAM OVALIFICATIONS QUAllFICATION U
v Ns P
p DOCUMENT OVAllFICATION L
ENGINE ERING/QA q
REVIEW U
U U
PERFORM FILE WORK FUNCTION Figure 9-1.
Control of Special Processes REVISION 3 PAGE 3
op 3
FORM SFO 314 (2/18)
GENERAL h ELECTRIC SPENT FUEL SERVICES OPER ATION SUBJECT NUMBER 10.0 INSPECTION NEDO-20776 10.1 PURPOSE This section describes the inspection program for verifying conformance of organization activities with dpcumented instructions, procedures, and drawings.
10.2 GENERAL 10.2.1 Inspection procedures are prepared from drawings and specifications by the Quality Assurance Organiza-tion prior to performing the inspection.
10.2.2 Eraminations and me.,rements or tests of materials, components, or products, are performed for each work operation when required by the classification system.
10.2.3 Inspection activities are performed using preplanned check lists which specify the value of the charac-teristic which must be verified. After measurement, the results of the inspection are certified by the inspector's symbol (stamp, name, etc.) which is traceable to each inspector.
10.2.4 Inspection activities are performed by personnel other than those who performed the actual work activity.
10.2.5 Inspectors are qualified by appropriate training or experience to perform the required inspections.
10.2.6 Nondestructive Examination (NDE) personnel are certified in accordance with the American Society for Nondestructive Testing Standard SNT-TC-1 A, " Recommended Practice for Nondestructive Testing Per-sonnel Qualifications and Certification," or with other applicable requiremen's.
10.2.7 Current inspectors' qualifications and certifications are maintained in Quality Assurance Organization files and are available for review and reference by regulatory and Company personnel.
10.2.8 Contractor's/ vendor's inspection procedures are evaluated by the Qua'ity Assurance Organization to ascertain compliance with these requirements.
10.3 RESPONSIBILITIES 10.3.1 The organ' allon(s) preparing procedures, specifications and drawings is responsible for specifying Classification for equipment and identifying significant quality characteristics and the required Quality Assurance Effort Required (OAER) Levels (see Section 2.0 for Classification and QAER definitions).
10.3.2 The Quality Assurance Organization is responsible for:
a.
Reviewing equipment Classification to determine whether the OAER will provide the level of quality expected.
ISSUED BY MANAGER, QUALITY ASSURANCE PROGRAMS DATE ISSUED July 14,1978 PAGE I
H.W. HUNTLEY REVISION 3
OF 2
F QH M SF O-31 1 (2D8)
(lUAUTY ASSURANCE PLAN NEDO.20776
' NUMBER b.
Planning and establishing the frequency and methods of inspection to be used to attain required quality levels and how quality levels are verified.
Verifying that inspectors (both SFSO and contractor / vendor personnel) are qualified (through c.
training or experience) to perform the inspection function.
d.
Assuring that appropriate requirements for process monitoring are established and that quality inspection process (es) meet these requirements.
10.4 IMPLEMENTATION The Quality Control function of the Quality Assurance Organization performs the required inspection in accordance with Quality Assurance Organization instructions, usMg established inspection forms or other documentation.
10.4.1 Source inspection. Requirements for items, to be inspected by Ouality Assurance personnel at a vendor or subcontracting source, are specified on a Source inspection Report (SIR). The SIR (stating the characteristics and values) may be prepared by the Quality Assurance Organization when the Material Request is reviewed or after the Purchase Order has been let, or the SIR may be prepared by the SFSO Representatitve in residence at the vendor.
10.4.2 Receiving Inspection. Receiving inspection is performed using an incoming Material Report (IMR). The IMR (as does the SIR) defines the inspections to be performed and metnods of accomplishment for the sequence of activities performed during receiving and receivinginspection. The IMR, SIR, certification, test reports and other quality-rclated records of receiving are maintained in the Quality Assurance Organization Files.
10.4.3 In-Process Inspection. in-process inspection mandatory hold points are established by the responsible engineering organization using e=tablished work documents. When in-process inspections are per-formed, the responsible individual signs and dates the appropriate work documents, indicating whether the item is acceptable or nonconforming.
10.4.4 Testing. Testing is conducted where appropriate to ensure quality. Testing is performed in accordance with written and approved test procedures. Section 11.0 describes the test control requirements.
10.4.5 Process Monitoring. Process monitcring is used to control quality related activities when an intoectionis not possible. When appropriate, an integrated program or process monitoring and inspection is used.
10.4.6 Nonconformances. Nonconformances detected during performance of quality-specified inspections or process monitoring are documentei and processed as described in Section 15.0.
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REVISION 3
FORM SFO-312 (2/78 i
GEN ER AL h ELECTRIC SPENT FUEL SERVICES 07dATION SUBJECT NUMBE R 11.0 TEST CONTROL NEDO 20776 11.1 PURPOSE This section describes the test prcgrams used for demonstrating that structures, systems, and compo-nents perform satisfactorily in service, and are identified and performed in accordance with approved procedures which incorporate the requirements and acceptance limits of applicable design documents.
11.2 APPLICABILITY Test controlis applicable to all SFSO or external contractor organizations which are required to perf orm a test function in conjunction with work activities as specified in design documents, contracts, or material codes.
11.3 GENERAL 11.3.1 Test programs include, as applicable, manufacturing tests prior to installation, installation tests, equip-ment verification tesis, operationa! tests, and developmental engineering tests.
11.3.2 Teving is conducted by appropriately qualified personnelin accordance with documented and approved test procedures.
11.3.3 Testing procedures include provisions for assuring that all prerequisites for the given test have been met, that adequate test instrumentation is available and used, and that the test is performed under suitable environmental conditions.
11.3.4 Test results (test data) are documented and evaluated by responsible Engineering and/or Operations Components to assure that all test require,ments have been satisfied.
11.4 RESPONSIBILITIES 11.4.1 The Engineering and/or Operations Components are responsible for the following:
a.
Incorporating testing requirements and acceptance limits in applicable des:gn documents.
b.
Preparing the basic test instructions and/or procedures.
11.4.2 Fuel Storage Projects is responsible for the fF.owing:
a.
Planning and scheduling all tests by contractors an. ulorris Operation (MO) which are related to project design and construction activities for which Projects has respons:bility.
b.
Reviewing and approving applicable test procedures as specified in (a) above, including test status and results.
c.
Directing MO activities related to performing applicable tests as specified in (a) above (also see subparagraph 11.4.3).
ISSUED BY MANAGER, QUALITY ASSURANCE PROGR AMS DATE ISSUED July 14, 978 l
PAGE H.W. HUNTLEY REVISION 3
2 op FORM SFO-31 1 (2n8)
QUAllTY ASSURANCE PLAN NUMBER NEDO 20776 11.4.3 MO is recponsible fer the following:
Conducting Equipment Verification Tests (EVT's) to verify operational condition of new, repaired, or a.
modified equipment. EVT procedures are prepared by MO Operations personnel (or by the Project Responsible Engineer) and are approved as in 11.4.2.b.
b.
Conducting operational tests (procedures prepared by MO Operations and approved as in 11.4.2.b) and providing instructions and training to operating personnel.
Coordinating with Fuel Storage Projects in establishing test schedules.
c.
11.5 IMPLEMENTATION 11.5.1 Responsible organizations perform testing in accordance with written and approved procedures.
11.5.2 The Quality A'ssurance organization performs audits and surveillance for adherence to the test program for activities affecting quality in accordance with Sections 15.0,16.0,17.0 and 18.0.
11.5.3 The Quality Assurance organization reviews applicable test procedures and results to assure activities affecting quality are controlled and that quality requirements of the applicable design documents have been met.
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REVISION 3
FOR M SFO 312 (2/ 78 I
GENERAL h ELECTRIC SPENT FUEL SERVICES OPERATION SUBJECT NUMBER 12.0 CONTROL 07 MEASURING AND TEST EQUIPMENT NEDO.20776 12.1 PURPOSE This section describes the measures used for ensuring that tools, gages. scales, and other measuring and testing devices (instruments) used during fabricatio 1, inspection, construction, maintenance operation, and modification are properly controlled, calibrated, and adjusted at specified periods to maintain accuracy within necessary limits.
12.2 GENERAL 12.2.1 Measuring and test equipment used for deterniining compliance with specifications, are adjusted and calibrated at prescribed intervals using certified equipment having known valid relationships to nationally recognized standards. If no national standard exists, the basis for calibration is documented.
12.2.2 When non-calibrated measuring and test equipment is found, a nonconforming inspection report is prepared and an evaluation is made of the validity of previous inspection or tests results and the acceptability of system cr items inspected or tested since the last calibration check.
12.2.3 Each organization provides an area whure calibrated measuring and test equipment ie stored.
Environmental conditions of.orage arcas are appropriate to the type of calibration performed. Use of out-of-calibration instr mentation is precluded by controlled access or administrative control as appropriate.
12.2.4 Personnel responsible for calibration tasks are 'Jained to perform these duties. Overall direction is assigned to a respons;ble management individual (e.g., foreman, supervisor, manager) with authority to issue and recall.
12.3 RESPONSIBILITIES 12.3.1 Each organization possessing measuring and test equipment is responsible for control and calibration of electrical, mechanical, or other t/ pes of measuring and tes' equipment used during fabrication and inspection, construction, operation, or maintenance work. The same organization is responsible for identifying ali equipment that requires calibration, the frequency of calibration, and issuance control.
12.3.2 A specific management individual within each organization is assigned responsibility to ensure that measuring and test equipment is controlled, calibrated and issued to authorized groups is a systematic manner. This individual is responsible (directly or by delegation) to ensure that calibrations are recorded, instruments have current calibration stickers attached, and that instruments are recalled for periodic recheck.
12.3.3 Users of equipment are responsible for returning instruments for periodic recheck and/or recalibration if damage or malfunction is suspected.
ISSUED BY MANAGER, QUALITY ASSUR ANCE PROGRAMS DATE ISSUED July 14,1W8 l
PAGE H. W. HUNTLEY REviStora 3
2 op F ORM SF 041-1 (2/78)
QUALITY ASSURANCE PLAN
" NUMBER NEDO-20776 12.3.4 Each organization is respcnsible for ensuring that personnel using measuring and test equipment are appropriately trained as required for installatio: checkout, use, and understanding of data readout used in recording data.
12.3.5 The Quality Assurance Organization is responsible for the following; a.
Resolving nonconformances resulting from suspect instruments or equipment discovered not in calibration.
b.
Auditing and surveillance d these activities as well as for complying with all requirements (if it is the
" user" crganization).
c.
Ascertaining that appropriate corrective action of nonmnformances is accomplished.
d.
Ascertaining that contractor's or vendor's calibration programs comply with SFSO requirements.
12.4 CONTROL SYSTEM 12.4.1 Standards. Instruments (standards) used to calibrate production instrumentation and other tools requir-ing calibration have an uncertainty (error) of no more than 1/4 of the tolerance of the equipment being calibrated. A greater uncertainty may be acceptable when limited by the " state-of-the-a<t". These stan-dards are calibrated by the National Bureau of Standards or from a certified source having f aceability to the National Bureau of Standards. These standards are checked and calibrated on an ar nual basis.
12.4.2 Production Instruments. Mechanical and electrical instruments and tools used to control a critical processor used to test components, subassemblies, or final products are identified with a Calibration" label and calibrated according to a specific time schedule.
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REVISION 3
FOR M SFO-312 (2/ 78 i
GENERAL $ ELECTRIC SPENT FUEL SERVICES OPERATION SUBJECT NUMBER 13.0 HANDLING, STORAGE, AND SHIPPING N EDO.20776 13,1 PURPOSE This section describes the measures used for controlling the handling, storage, and shipping of nuclear and non-nuclear materialin compliance with license requirements and in accordance with instructions, procedures, or crawings to prevent damage, deterioration, or loss.
13.2 APPLICABILITY This section applies to all organizations that participate in the packaging, shipping, storage. and handling of items to be incorporated or used in construction or operation of a nuclear fuel storage facility. These items include, but are not limited to, irradiated nuclear fuel, shipping casks, construction materials, fabricated assemblies, and parts.
13.3 GENERAL 13,3.1 Nuclear Materials a.
Nuclear safety is of prime concern in the handling and shipping of nuclear materials. The use of approved procedures and training of personnel to follow such procedures during handling and shipping activities are required. Items of specific concern include the following:
1.
Maintaining, testing, handling, and oecontaminating irradiated fuel shipping casks.
2.
Transporting and in-transit handling of irradiated fuel shipping casks.
3 Removing irradiated fuel from the shipping casks at the Morris Operation (MO).
4.
Transferring irradiated fuel assemblies into basin storage baskets and/or casks.
5.
Handling, compacting and storage of nuclear waste materials.
b.
Nuclear safety is of prime concern in the storage of nuclear materials. The use of approved containers or equipment, placing in authorized storage areas,use of approved procedures for fuel identification and operations, and monitoring to assure compliance to procedures are required.
Prima,y storage features include the following:
1, Storing irradiated fuel assemblies in baskets or racks designed for criticality safety within the fuel storage pools.
2.
Verifying the nuclear safety of storage coritinuously by using instruments and/or by person-nel observations to maintain surveillance of the degree of containment of nuclear materials.
3.
Maintaining and testing fuel handling equipment.
ISSUED BY MANAGER, QUALITY AS6URANCE PROGRAMS DATE ISSUED July 14,1978 PAGE I
H.W. HUNTLEY REVISION 3
3 op FORM SFO-31 1 (2/78)
QUALITY ASSURANCE PLAN
- NUMBER NEDO-20776 13.3.2 Non-Nuclear Materials Handling, shipping, and packaging is performed in accordance with requirements specified in a.
specifications, drawings, and/or specialinstructions to prevent damage or degradation of quality.
b.
The identification (and status) of items during handling (including subdivision or joining in the fabrication process), packaging, and shipping are described in Section 8.0 and Section 14.0.
Storage activities include retention of identification, inspection status of items (Section 14.0) c.
through tagging or marking, controlled distribution, preservation of the item from environmental deterioration, and unauthorized access or modification.
13.4 RESPONSIBILITIEL 13.4.1 Fuel Storage Projects is responsible for the following:
Incorporating requirements for handling, storage, and shipping into design documents such as a.
drawings, specifications, special instructions, and where applicable, Material Requests (MR's).
b.
Incorporating requirements for project-related handling, storage, and shipping into Purchase Orders, contract documents, including directing related fabrication / construction activities per-formed by major and subtier contractors.
13.4.2 Licensing and Transportation is responsible for shipping of irradiated fuel casks in conformance with licensing requirements.
13.4.3 Morris Operation (MO) is responsible for handling, storage, and shipping activities performed by MO personnel as part of routine fuel storage operation and maintenance of the facility as well as for maintenance and testing of equipment in acct" dance with licensing requirements.
13.4.4 The Quality Assurance Function at MO is responsible for reviewing proper handling, storage, and shipping procedures.
13.4.5 The Ouality Assurance Function in San Jose is responsible for surveillance and audit of activities pertaining to handling, storage, and shipping of items for SFSO.
13.5 IMPLEMENTATION 13.5.1 The requirements for cleaning, marking packaging, preservation methods, shipping, storage and han-dling are incorporated in design documents, specialinstructions, and the MR by the responsible engineer.
These requirements are reviewed and approved by appropriate management.
13.5.2 Organizations perform;ng specific tasks (such as Licensing and Transportation in cask design and licensing, and MO in their shipping and storage activity) implement these tasks by the development and/or use of detailed procedures.
13.5.3 Specific procedures for irradiated fuel handling and storage are developed by MO in accordance with the Quality Assurance Program.
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REVISION 3
FOR M SFO-312 (2/ 78 I
QUALITY ASSURANCE PLAN NUMBE R N EDO-20776 13.5.4 Fuel Storage Projects coordinates and directs handling, storage and shipping between major contract organizations during the design, procurement and construction phase of SFSO projects.
13.5.5 The Quality Assurance function in San Jose reviews SFSO handling. storage and shipping activities using detailed procedures which cover their audit and surveillance activities.
REVISION 3
PAGE 3
Op 3
F ORM SFO 314 (2/78)
GENERAL $ ELECTRIC SPENT FUEL SERVICES OPERATION SUBJECT NUMBER 14.0 INSPECTION, TEST, AND OPERATING STATUS NEDO-20776 14.1 PURPOSE 14.1.1 This section describes the measures used to indicate the status of inspections and tests performed upon individualitems during fabrication and assembly, and subsequently used in a nuclear f uel storage f acility.
Such measures p eclude the use of nonconformingitems due to inadvertent bypassing ofinspections and tests.
14.1.2 This section also describes the measures used to indicate the operational status of structures, systems, and components of a nuclear f uel storage f acility to prevent inadvertent operation while these structures, systems, and components are not in conformance with licensing requirements.
14.2 GENERAL 14.2.1 inspection and test status of individual itents are indicated by stamps, tags, labels, routing cards, or other suitable documentation.The using organization ascertains that the status of the equipment is indicated by this type device prior to use.
14.2.2 Such documentation provides for the identification of items which have satisfactorily passed required inspections and tests.
14.2.3 Operational status of the plant, which is dependero on the operational status of the structures, systems, and components, is indicated by tagged valves, tagged switches, lockouts, etc.,in conjurdon with log book entries that document status to prevent unauthorized adjustment or operatio'-
14.3 RESPONSIBILITIES 14.3.1 The Manager, Morris Operation (MO)is responCble for detailing documentation of plant coerational statuc. This includes the following:
Plant Engineering and Maintenance (in conjunction with Engineering Components it' San Jose)is a.
responsible for all engineered items, pipe, fittings, valves, instruments, pumps, blov,ers, etc., used in facilities assigned to MO.
b Plant Operations is responsible for using approved operating procedures teid for plant readiness as well as providing an interface with fuel Storage Projects.
The Quality Assurance function at MO is responsible for the inspections and test requirements of c
facility parts and components used in plant operations and maintenance.
14.3.2 Fuel Storage Projects is responsible for procedures detailing project related documentation of test and inspection status of items, structures, systems, and components during construction or modification.
ISSUED BY MANAGER, QUALITY ASSURANCE PROGRAMS DATE ISSUED July 14,1978 I
PAGE H. W. HUNTLEY REVISION 3
2 op m-c_
QUAllTI ASSURANCE PLAN O
' NUMBER NEDO 20776 Vendors are responsible for procedures (approved by GE) detailing documentation of tes' and inspection 14.3.3 status of items under their control.
The Quality Assurance Organization is responsible for verifying that procedures for the status of 14.3.4 inspections, tests, and operations are utilized by applicable organizations.
14.4 IMPLEMENTATION Inspection, test, and operating status of incoming irradiated fuel is covered in part in Section 13.0.
14.4.1 nspection, test, and operating status of incoming and in-process maintenance and construction items are 14.4.2 covere' in Sections 7.0 and 13.0. Functional Class 1,2, or 3 items ars V.intified by a Material Control Tag or a '.sadily recognized identity such as a heat number or serial number (see Section 2.0 for definitions of Classifications).
14.4.3 Nonconforming material and items are handled in accordance with Section 15.0.
The operating status of all systems is controlled by Lock and Tag procedures.The use. J these procedures 14.4.4 prevents inadvartent operation of a system undergoing mairirenance or repair. Basic " Lock-out" tags used are as follows:
CANGER-DO NOT OPERATE tags placed on pieces of equipment that are not in service due to a.
maintenance or processing reasons and if operated could result in a hazardous condition to personnel and/or equipment.
CAUTION or status tags placed on valves, switches, or controls that indicate condition of applicable b.
systems. The instructions, contained on the tag, specify steps that must be taken in sequence to operate the equipment in question.
Status of functional tests of structures, systems, and components are covered in Section 11.0.
14.4.5 Tho Quality Assurance Organization verifies inspection, test, and operating status by surveillance of the 14.4.6 fabrication, receiving, test, and inspection processes, and audits of the processes, documentation pro-duced, and equipment utilized in design, fabrication, inspection, and test of equipment used by SFSO.
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REYlSION 3
FLHM SFOJi. E
GENERALh ELECTRICQUAllTY ASSURANCE PLAN SPENT FUEL SERVICES O$ ATION SUBJECT NUMBER 15.0 NONCONFORMING MATERIALS, PARTS, OR COMPONENTS N EDO-20776 15.1 PURPOSE This section describes the measures used for controlling materials, parts, systems and structures which do not conform to requirements and which are normally detected through insp2ction, test, operation, or audit. Additionally, the measures used to document and control nonconfermances discovered during process operations are described as well as the vehicle for deviating fror.1 the original contract.
15.2 NONCONFORMING ITEM RECORD (NIR. AND QUAL M HOLD TAG 15.2.1 Nonconformances noted by SFSO in material, parts, or components, systems and structures are doc-umented in N:R's.
15.2.2 The nonconforming item is identified by a " Hold Tag" and the affected organization is notified. Where practical, the item is segregated in a quarantine area to prevent its inadvertent use.
15.2.3 The item remains on hold, properly tagged, until restored to an acceptable condition or scrapped. Only OA has the authority to effect a release from quarantine or removal of the '"dold Tag."
15.2.4 in certain instances, items may be nonconforming only from the standpoint of the type of service for which the item is purchased, but may be acceptable for other services. In such instances, the Quality Assurance Orgarization signs the NIR teleasing the item for a service to which the item conforms.
15.2.5 The Material Review Board (MRB) may authorize continuing processing of an assembly penuing disposi-tion of a nonconforming component.
15.2.6 Vendor Quality Assurance Programs contain requirements equivalent to those of SFSO, consistent with their scope of work.
15.3 RESOLUTION OF A NONCONFORMANCE 15.3.1 Nonconforming materials, parts, or components are identified, dispositioned, and restored in accordance with the following:
a.
Level 1 1.
Disposition is by the first supervisory level performing work that detected the nonconfor-mance. The authority for disposition at Level 1 is restricted to the following; (a)
Part, item, or assembly may be reworked to meet existir.g specifications.
(b)
New scheduling or revision to design or fabrication documentation is not required.
2.
The Quality Control function of the Quality Assurance Organization signs Level 1 dispositions.
ISSUED BY MANAGER, QUALITY ASSURANCE PROGRAMS DATE ISSUED July 14,1978 PAGE 1
H. W. HUNTLEY 3
REVISION 3
op rORM SFO 31-1 t2/18)
QUAllTY ASSURANCE PLAN
' NUMBER NEDO-20776 3.
If the nonconformance cannot be corrected within the limits of Level 1 authority, the NIR is referred to Level 2 or Level 3 by the supervisory or Quality Control personnel.
4.
Level I correction is reinspected for conformance to stated requirements.
b.
Level 2 1.
Disposition authority for Level 2 requires the Quality Assurance Organization (Quality Engineering) and SFSO Engineering approval as a minimum. Disposition is to rawork, scrap, return to supplier, repair, or "use as is." Disposition to "use as is" or " repair" may be made at this level provided such disposition does r;ot adversely affect f unction, fit-up, safety, or basic design requirements of the manufacturing plan, supporting documents, design documents or contractual agreements.
2.
Nonconformances which cannot be resolved by the Level 2 Quality Assurance and Engineer-ing Organizations are referred to Level 3.
3.
Level 2 correction is reinspected for conformance to dispositioned requirements.
c.
a.evel 3 Material Review Board (MRB) 1.
Level s involves any of the unresolved nonconform?nces from Level 2. Dispotition authority for Level 3 is referred to a MRB and require? approval of this Board.
2.
As a minimum, the MRB consists of representatives ftom Fuel Storage Projects, the Ouahty Assurance Organization, and other Engineering Organizations as determined t'y the Man-aqer, Fuel Storage Projects or the Manager, Morris Operations, as applicable. Representa-tives from Purchasing and other groups (such as Operations) c'e included in the MRB as appropriate.
3.
Level 3 correction is reinspected for conformance to MRB requirements.
15.3.2 The Quality Assurance Organization closes the NIR when all appropriate actions are taken and maintains appropriate records of the NIR.
15.4 DEVIATION DISPOSITION REQUEST (DDR) 15.4.1 The DDR is the vehicle by which tha vendor requests changes to the original contract or purchase order.
15.4.2 Disposition of the DDR requires the signed concurrence of SFSO Project Management, project Enc,ineer-ing or Licensing and Transportation and SFSO-OA Engineering.
15.5 Potentially sigr ificant safety deficiencies are reported to the Nuclear Energy Projects Division and the NRC (if appropriate) according to procedures.
15.6 CORRECTIVE ACTION 15.6.1 The Quality Assurance function in San Joso is responsible for.the correction of generic deficiencies that exist in either the Quality Assurance Program or its implememation.
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REVISION 3
FOR M SF O-31-2 (2/781
QUALITY ASSURANCE PLAN NUMBE R NEDO-20776 15.6.2 The Corrective Action Request (CAR) is prepared to implement corrective action (see Section 16.0).
15.6.3 The action requested is directed to the Manager who is responsible for correction. Upon the satisfactory completion of action initiated by the CAR, the request is closed by the initiator and filed by the Quality Assurance Organization. The Quality Assurance Organization is responsible for authorizing closure of all CAR's.
15.7
SUMMARY
OF NONCONFORMING ITEM RECORDS 15.7.1 A periodic summary of applicable open and closed NIR's is provided to the SFSO Manager and the Managers of Morris Operation (MO), Fuel Storage Projects, and major contracts by the Quality Assurance funct;on in San Jose or MO. Such reporting may be part of routine management reports to the SFSO Manager covering SFSO design and construction status related to facility changes, major projects, and tasks.
FORM SFO413 t?I78)
G EN ER AL h ELECTRIC QUALITY ASSURANCE PLAN SFENT FUEL SERVICES OPERATION IE'.T NUMBER 16.0 CORRECTIVE ACTION NEDO 20776 16.1 PURPOSE Th;s section describes the measures used for ensuring that conditions adverse to quality and deficiencies in the Quality Assurance Program, design, fabrication, construction and modification or their implemen-tation or in plant operation are promptly identified and corrected. In the case of significant conditions adverse to quality, the measures ensure that the cause of the condition is determined and corrective action is taken to preclude repetition. The identification of significant conditions adverse to quahty, the cause of the conditions, and the corrective action are documented and reported to appropriate levet d management.
16.2 SYSTEM DESCRIPTION 16.2.1 Corrective action is requested and documented on a Corrective Action Request (CAR) when conditions are detected that have or may have an adverse affect on quality. CAR's may be initiated as the result of a Nonconforming item Record (NIR) or to document deficiencies found in a quality audit. CAR's may be written against vendors as well as the internal organization.
16.2.2 A CAR may be requested by anyone but only Ouality Assurt.nce may initiate the form.
16.2.3 A CAR is initiated when any of the following conditions exist:
a.
A condition exists which could jeopardize the quality of a product or service, although there has been no specification violation. (Cases involving specification violations are reported on a NIR.)
b.
An audit discloses the need for corrective action.
16.3 RESPONSIBILITIES 16.3.1 The Quality Assurance Organization is responsible for coordinating specific activities relating to the corrective action. This includes the following:
a.
Determining whether the reported or observed condition or incident warrants corrective action.
b.
Initiating CAR's.
c.
Providing copies of completed CAR forms to responsible components.
d.
Determining which organizational component is accountable for corrective action and requesting investigation (s) and documenting the action plan, e.
Reviewing and approving the action plan.
f.
Providing assistance in investigations when requested by an involved component (s).
ISSUED BY MANAGER,QUAUTY ASSURANCE PROGRAMS DATE ISSUED July 14,1978 I
PAGE H.W. HUNTLEY REV4SION 3
2 op FORM SFO.31 1 (2/78)
QUAL.lTY ASSURANCE Pl.AN NEDO.20776 NUMBER g.
Performing followup to ensure that corrective measures ale implemented.
h.
Maintaining files of all completed CAR forms.
16.3.2 The Accountable Organizational Component is responsible for the following:
Conducting an investigation for the cause of the incident or condition.
a.
b.
Documenting investigation results and corrective action on the CAR form and returning to the Quality Assurance Organization.
c.
Determining the method for resolving the CAR.
d.
Consulting with the Quality Assurance Organization when investigative assistance is needed.
e.
Initiating corrective acton as required.
16.4 lMPLEMENTATION 16.4.1 Corrective action is documented on a CAR in accordance with established procedures.
16.4.2 The procedures detail CAR preparation, Quality Assurance Organization and management review,inves-tigation, resulting documentation, reporting of corrective action to prevent recurrence, follow-up audit procedure, and CAR distribution.
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REVISION 3
GE FOR M SFO-31-2 (2/ 78 i
GENERAL $ ELECTRIC SPENT FUEL SERVICES OPERATION SUBJECT NUMBER 17.0 QUALITY ASSURANCE RECORDS NEDO 20776 17.1 PURPOSE This section describes the measures for ensuring that sufficient records are maintained to furnish evidence of activities affecting quc!ity, and that such records are stored, maintained, and safeguarded for an adequate period utilizing a systematic means of retrieval. The requirements of this Plan, and those record-keeping requirements establithed by regulatory agencies, specify the logs, records, and reports required to ensure that comprehensive records of design, fabrication, construction, and operation are ma;ntained.
17.2 APPLICABILrrY This section is applicable to all activities for which SFSO is responsible and which provide evidence of quality in the design, fabrication, construction, and operation of nuclear storage facilities.
17.3 GENERAL REQUIREMENTS 17.3.1 Documents which furnish evidence of the quality of items and provide information relating to activities airectmg quality are maintained by the originating or otherwise responsible component as specifiad herein until completion of a task or project when the originating (or otherwise responsible) component transfers these records into the SFSO document centrol system.
17.3.2 Records pertaining to the quality of items or activities of the plant facility are retained in accordance with regulatory requirements.
17.3.3 A documentation indexing system assures that all records are readily identifiable and retrievable. It is the responsibility of organizations that generate quality-related records to idantify and index such records with appropriate cross references in accordance with document cont 01 procedures presentedin Section G O. Inspection and test records identify the inspector or tester, the date, the type of observation, the results, tlN Acceptability, and the action taken in connection with any deficiencies noted (Section 15.0).
17.3.4 All records are egible (in original or reproduced form) and adequately identifiable to the item or activity involved.
17.4 RESPONSIBILITIES 17.4.1 During the interim generation of records, the originating organization is responsible for providing control of such documents commensurate with their ability to replace them.
17.4.2 The Quality Assurance Function in San Jose is responsible for the establishment of specific record-keeping requirements applicable to inspection, tests, operation, and other quality-related activities as well as for the establishment and implementation of surveillance anJ audit procedures to verify that other SFSO organizations are complying with these requirements.
ISSUED BY MANAGER, QUALITY ASSURANCE PROGRAMS DATE ISSUED July 14,1978 PAGE 1
H.W. HUNTLEY REVISION 4
3 OF FORM SFO-31 1 (2D8)
QUALITY ASSURANCE PLAN
' NUMBER NEDO-20776 17.4.3 Document Controlin San Jose is responsible for the system for storage, retention, and retrieval of all quality assurance records.
17.5 INTERIM GENERATION OF RECORDS 17.5.1 Fuel Storage Projects maintains all design-related documents, including the following:
a.
Drawings, specifications.
b.
Vendor information files.
c.
Tests, procedures, and reports.
d.
Procurement cata for design and construction projects and tasks.
e.
Engineering change notices.
f.
Engineering Review memorandum.
17.5.2 Licensing and Transportation maintains documents such as:
a.
Official responses to regulatory and licensing correspondence.
b.
Regulatory and licensing regulations.
c.
Calculations in support of cask licensing.
d.
Licenses, permits, and amendments.
17.5.3 The Quality Assurance Organization maintains documents such as the following:
a.
Inspection reports and acceptance test reports.
b.
Nonconformance item Records (NIR's).
c.
Deviation Disposition Requests d.
Corrective Action Requests (CAR's).
e.
Audit reports.
f.
Material certifications and test reports.
g.
Secial process records.
5.
Special process personnel training and certification records (inspection processes).
i.
Accountability records.
O FORM SFO-31-2 (2n81
(lUALITY ASSURANCE PLAN NUMBER N EDO.20776 17.5.4 Documentation specifically concerned with plant maintenance, repair, and uperations is maintained at Morris Operations (MO).
a.
MO Plant Engineering and Maintenance maintains records such as the following:
1.
Plant drawings.
2.
Facility Change Notices (FCN's).
3.
Instrument ca'ibration records.
4.
Radioactivity exposure records.
S.
Accident reports.
6.
Records of unusual events and abnormal occurrences.
7.
Maintenance records.
b.
Plant Operations maintains recr rds such as the following:
s 1.
Plant operation logs, reports, and procedures.
2.
Qualification records for personnel 3.
Operational, Equipruent Verification Test (EVT), and similar results.
17.6 RECORDS HANDLING AND STORAGE (PERMANENT) 17.6.1 Records are maintained in a vault, or in Record Centers in San Jose as well as at the MO. Storage of two complete sets of records at remote facilities complies with regulatory requirements concerning the permanency of Quality Assurance Records. Permanent records are maintained for the lifetime of the item (or facility).
17.6.2 Storage is accomplished by retention of complete (hard copy) documentation, microfilm, or other reproductions. Items such as radiographs are not reproduced,'but retained as originals.
17.6.3 An index system for ease of retrieval is established for all records being stored in the Record Centers.
17.6.4 Records (document) control is established so that permanent records, originals, and/or copies of doc-uments are retained in the Records Centers. A master list of such records is maintained by Document Controlin San Jose. The Record Center at MO utilizes the identical indexing system used in San Jose.
17.7 QUALITY ASSURANCE ORGANIZATION RECORDS ACTIVITIES In addition to the responsibilities of the Quality Assurance Organization pertaining to the generation of records unique to its activities (see sub-paragraph 17.3.2), the Quality Assurar:ce function in San Jose verifies compliance of other SFSO organ!zations with regulatory record requirements through surveil-lance and audit.
REVISION 4' PAGE 3
OF 3
FOHM SFO413 (2/78)
GEN ER AL @ ELECTRIC SPENT FUEL SERVICES OPERATION SUBJECT NUMBE R 18.0 AUDITS NEDO.20776 s
18.1 PURPOSE This section describes the system and respo' ebilities for conducting planned and periodic reviews
,(audits) of activities related to the design and fabrication, construction, and operation of a nuclear fuel storage facility by the assessment of performance of quality assurance and quality control and com-pliance with stated requirements. Quality Assurance Organization surveillance is a routine activity to verify performanco of activities affecting quality (may be unscheduled).
18.2 GENERAL 18.2.1 Types of Quality Audits a.
Customer Audit-Audits may be conducted by customers to assure that SFSO is in compliance with contractual agreements, b.
SFSO Audit-The Quality Assurance function in San Jose audits SFSO organizational elements in San Jose and at Morris Operation (MO) to verify that objectives of the Quality Assurance Program are being met.
c.
Division Quality Assurance Audit-Audits are conducted to verify compliance to applicable Divi-sion and Department policies and procedures.
d.
MO Quality Assurance Audit-Audits by MO uf the Quality Assurance Program as implemented by their own organization and audits of selected vendors may be performed by MO.
e.
Vendor Audit-Audits of vendor's facilities may be conducted by either of the Quality Assurance functions (located in San Jose or at the MO).
18.2.2 Audits a.
Audits are formal, they are scheduled by advance notification which specifies the general area and/or specific activities and documents to be investigated.
b.
Audits are conducted utilizing a written p;ocedure (checklist)to assure thoroughness of the review.
Checklists may be standardized (for review of compliance to the Code of Federal Regulations, Title 10, Part 50, Appendix B, for example), or they may be prepared for specific audits.
c.
Audits are performed by qualified personnel; these personnel do not have direct responsibility in the area being audited.
d.
The responsible management of the function being audited is apprised of the details of the pending audit by the auditing team prior to the investigation.
ISSUED BY MANAGER, QUALITY ASSURANCE PROGRAMS DATE ISSUED July 14,1978 PAGE 1
H.W. HUNTLEY REVISION 3
3 op E OR M SFO.31 1 (2/78)
QUAllTY ASSURANCE PLAN NEDO-20776
' NUMBER The findings of the audit team are discussed with the responsible management of the audited e.
function; this management receives a formal notification of the audit findings and areas requiring correction and establish appropriate measures to effect the changes.
f.
Deficiencies are reaudited until corrective action has been accomplished.
All activity during audits is documented in the Quality Assurance Organization files. This includes g.
audit notices, minutes of meetings, audit team composition, audit findings, corrective action, and subsequent follow up activity.
Froquency of audits is de: ermined by the need and importanc9 of activities being reviewed.
h.
18.2.3 Surveillance The degree of surveillance, the areas of investigation and depth of review, observation, and a.
evalmtion are not structured, but are determined by need and importance of the activities being performed.
b.
Surveillance activity and findings are documented and retained in the Quality Assurance Organiza-tion files. These reports are forwarded to appropriate management for information and required action.
Correction of deficiencies is verified by reinspection (by the Quality Assurance Organization) to c.
asccrtain satisfactory correction of deficiencies.
18.3 QUALITY ASSURANCE ORGANIZATION AUDIT RESPONSIBILITIES The Quality Assurance Organization is responsible for conducting quality audits. This does not preclude the appointment of a technical and/or administrative representative to participate directlyin the audit or to serve as a consultant. Specific Quality Assurance Organization responsibilities include the following:
Scheduling, coordinating and reporting customer, vendor, and Division quality audits.
a.
b.
Establishing an audit schedule.
c.
Generating audit checklists which define the requirements.
d.
Conducting, or coordinaing the performance of, audits as planned.
e.
Issuing audit reports.
f.
Initiating Corrective Action Requests (CAR's) as required.
Conducting follow-up audits to determine the implementation and effectiveness of corrective g.
action (s) taken on significant quality problems.
Analyzing audit findings to detect quality trends and effectiveness of the Quality Assurance h.
Program.
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REVISION 3
FOR M SFO-312 (2/78)
l (lUALITY ASSURANCE PLAN
' NUMBER NEDO-20776 i
13.4 REPO.TS 9
The Quality Assurance Organization may include significant audit findings in periodic reports to man-agement or in special reports.
l i
l t
GE 3
op 3
REVISION 3
FORM SFO-31-2 (2/ 78 i