ML20003H787
| ML20003H787 | |
| Person / Time | |
|---|---|
| Site: | 07001308 |
| Issue date: | 02/16/1981 |
| From: | GENERAL ELECTRIC CO. |
| To: | |
| Shared Package | |
| ML20003H782 | List: |
| References | |
| 18746, NEDO-20776, NEDO-20776-R06, NEDO-20776-R6, NUDOCS 8105070447 | |
| Download: ML20003H787 (26) | |
Text
G GENER AL h ELECTRIC
"" ^" '"
AND SERVICES GENERAL ELECTRIC COMPANY,175 CURTNER AVE SAN JCSE, CALIFORNIA 95125 D1 VISION STATEMENT OF AUTHORITY lt h de policy of de Sped Fue.L Se,tvices Ope.tation to ptovide se,1 vices ar4 pteduct.s af a qualtty nat meet de initi:L and continuing needs of ou.1 custctne.ts as desetibed in applicable specifications ar4 consisted ath good engheeting puttice, and h dchg so, to be de leade.1 in qu:Lity.teptiation h &c nucleat ene~4y buskus.
This Qualtty Assa.unce Plan b used by de Spent Fue,L Services Opet tion to implemen.t 6,is policy. ALL manage,ts u:sthin de Spent Fuel Se,wices Opstatica ich quality.tel1ted.tespensibdig have &z autho,~.i.ty to implement this ptog.~a
.ctthut theit tespective a, teas of.tesponsibiLLty. Developneri of ptocedu.tes to acccmplish this Quality Assutance PL:n is a basic ~espcnsibiLLty of each of de o.1gani:1tions a:tthin de Spent Fuel Se,1 vices Ope,tation.
The putpcse of this plan is to de.sc~.ibe me&cds used to ccmply a:Lu de qu1LLQ as saunce ptegtan.tequLte. men.ts of NRC Fede.ut Regulation 10 CFR P1st 50, Appendh 8,
" Quality Assu,1:nce Critetia Fa.t Nucleat Pcut,t Plants ar.d Fuel Reptocesskg Plads",
10 CFR P1tt 71, Appenda E, " Quality Assu,~.ance Critetia Fct Sippkg Packages Fat Radicactive Mete ~ial", ard othet quality assu,unce etiteti1 aw.licable to the Sped Fuel Se,tvices Ope.~a, tion fct sto.uge and/c.t tunspcMatt.cn of.tadicactive l
ma.teti:Ls. These etLietia include Genetal Eteettic irittn1L qu:LLty system
.tequ.itemeds such as &cse set fctth in the folica:ing documents:
(1) NE5G Policy No. 70-1, "P-teduct Qu1LLLy"; and (b) NE5G Insttaction No. 70-11, "Standatd Qualtty System RequLtenents".
Implimerlar.icn af this Quality Issu,tance PL:n has the unqualified erdo.tsemed of Gene.tal Electric Ccepany Spent Fuel Setvices Ope, tat <.cn managemert.
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. E. Van HocmLssen, Manage,1 Date:
Feb.tua.ty 16, 1981 brent Fuel Se1 vices Ope,tation Revi, ion: 6 l
810s0709f7
GEN ER AL $ ELECTRIC SPENT FUEL SERVICES OPERATION NUMBER SusJECT TA8LE OF CONTENTS NEDO-20776 issue Deh STATEMENT CF POLICY AND AUTHORITY 5
7/15i80 TABLE CF CONTENTS 6
2/1& 81 i
GLOSSARY OF TERMS 5
2/16/81 1
1.0 ORGANIZATION 5
7/15/80 1.1 Purpose 1.2 General 1.3 Statement of Authonty 1.4 Functional Organcation Responsibilities Related to Quality 1.5 Internal Organcational interfaces Relat:ng to Quality 1.6 External Organcational Interfaces Relating to Quality Figure 1-1.
Spent Fuel Services Operation Organuations Figure 1-2 SFSO Engineenng and Regulatory Organcations Figure 1-3.
Morris Operation Organization Figure 1-4.
Quality Assurance Organization (San Jose)
Figure 1-5.
Quality Assurance and Safeguards Organgation (Moms Operation) 2.0 CUALITY ASSURANCE PROGRAM 4
7/14/78 2.1 Purposo 2.2 Function 1
l 3.0 DESIGN CONTROL 3
7/14s78 3.1 Purpose 3.2 General 3.3 Responsibilities 3.4 Design Control System Figure 3-1.
Design Control Flow Sheet - Issuing Design Bases /Cnter a Figure 3-2 Design Control Flow Sheet - Generating Design Documents within SFSO Figure 3-3.
Dessn Control Flow Sheet - External Fabncation/Construc' ion Figure 3-4.
Cesign Controi Flow Sheet - Engineenng Changes 4.0 PROCUREMENT DOCUMENT CCNTROL 3
7/14/78 l
4.1 Purpose l
42 General 4.3 Respons4bilities 4.4 Implementation Figure 4-1.
Procurement Control (San Jose)
Figure 4-2 Procuretrent Control (Morns Operation) l l
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tSSUED 8Y MANAGER,QUAUTY ASSURANCE PROGRAMS DATEISSUED g
FEBRUARY 16. 1981 PAGE 4
RmstoN 6 op H.W. HUNTLEY FORMSF Nt.: t2/78#
QUALITY ASSURANCE PLAN NEDO 20776
- NUMBER TABLE OF CONTENTS (Continued) lasue Date 5.0 INSTRUCTIONS. PROCEDUkES, AND DRAWINGS 3
7/14/78 5.1 Purpose 5.2 Responsibilities 5.3 Documents Affecting Quality Table 5-1.
Documents Affecting Quality 4
2/16,81
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6.0 DOCUMENT CONTROL 6.1 Purpose 6.2 General 6.3 Responsibilities 6.4 Document Control System 6.5 Control of the Quality Assurance Pfan 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 General 7.3 Responsibilities 7.4 Implementation j
(
Figure 7-1.
Procurement 8.0 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS. AND COMPONENTS 3
7/14/78 8.1 Purpose 8.2 General j
8.3 Responsibilities 8.4 Implementation Figure S-1.
Identification and Control of Matenals, Parts, and Components 9.0 CONTROL OF SPECIAL PROCESSES 3
7/14/78 9.1 Purpose l
9.2 Responsibilities l
9.3 Special Process Procedures 9.4 Special Process Personnel 9.5 Records Figure 9-1.
Control of Special Processes 10.0 INSPECTION 3
7/14/78 10.1 Purpose 10.2 General 10.3 Responsibilities 10.4 implementation l
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REVISION 6 GE Op FOR M SFO-31-212/ 7dl l
QUAUTY ASSURANCE PLAN NUMBER NEDO-20776 TABLE OF CONTENTS (Continued)
Issue Date 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 SHIPPING 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 Purpose 14.2 General 14.3 Responsibilities 14.4 Implementation 15.0 NONCONFORMING MATERIALS, PARTS, OR COMPONENTS 4
2/16/81 l
15.1 Purpose 15.2 Nonconforming item Record (N!R) 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 16.0 CORRECTIVE ACTION 3
7/14/78 16.1 Purpose 16.2 System Description 16.3 Responsibilities 16.4 Implementation 17.0 OUALITY ASSURA NCE RECORDS 5
2/16/81 l
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17.1 Purpose l
17.2 Applicability l
17.3 General Requirerrents 17.4 Responsibilities 17.5 Interim Document Storage 17 6 Records Handling and Storage l
17.7 Ouality Assurance Organization Records Activities REVISION 6 PAGE OF FORM SFO-31.J (2/ 78)
QUALITY ASSURANCE PLAN NEDO-20776
' NUMBER TABLE OF CONTENTS (Continued) lasue Date l
18.0 AUDITS 4
2/16/81 18.1 Purpose 18.2 General 18.3 Quahty Assurance Organization Audit Responsibilities 18.4 Reports L
l kAGE OF REVISQN 6
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GEN ER AL $ ELECTRIC SPENT FUEL SERVICES OPERATION NUMSE R suRECT GLOSSARY OF TERMS USED IN THIS PLAN NEDO 20776 AUDIT An activity to determine through investigation, the adequacy of, and adherence to. estabhshed procedures, mstructions, specifications, codes, and standards or other appucable contractual and licensing recuirements, and the effectiver'ess of irnpiementation (ANSI N45.2.10).
CAUSE The undertying determinant in design, material, procedures, workmansnip, etc., which ultimately resulted in a nonconformance.
CHARACTERISTIC Any prcperty or attnbute of an item, process or service that is distinct,desenbable and measurable, as conforming or nonconforming to specified quahty requirements. Cuality charactenstics are generally scentified in specifications and drawings wnich desenbe the item, process or service (ANSI N45 2.10).
CLEANING The treatment for removal of surface contaminants such as oil residue, coatings, metal cnics, entrapped water, or other forms of internal or external contamination wnien prevent utilizat:on of basic material or finished products or would cause degradation of quality. Decontamination for disposal of radioactive items is not ir.cluded in this definition.
COMPONENT A piece of equipment such as a vesset, piping, pump, valve or core support structure, which will be combined with other components to form an assembly (ANSI N45.2.10).
CORRECTIVE ACTION Ine action taken to correct conditicns adverse to quality and deficiencies in the Cuahty Assurance Program or its implementation.
CORRECTIVE ACTION REOUEST (CAR)
A document used for reporting conditions having an adverse effect on quality, the results of investigations of prcclems, and the corrective action *.aken to preclude recurrence.
DESIGN BASES Broad functional requirements, conditions or constraints chosen to assure that the design cejectives of the fac;iity structure, system or component are met.
DESIGN CONTROL A system or program such th.at desired design actions are accomphsned and actions not desired are prevented.
DESIGN CRITERIA' Mandatory performance hmits, conditions or constraints spec:fied to aswre comphance wrth Corporate policy or Governmental regulations concerning safety, safeguards and environmental protection and wnich are aimed at assunng that tne facshty structure. system or component can be operated without undue nsus to the mealth and safety of the employees and public, to tne national secunty and to the environment.
ISSUED BY MANAGER,QUAUTY ASSURANCE PROGRAMS OATE ISSUED FEBRUARY 16, 1981 PAGE I
H, W. HU NTLEY REVISION 5 op 6
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QUALITY ASSURANCE PLAN NEDO.20776 NUMBE R DESIGN REVIEW A senes 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 onginal 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 modifie.1 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.
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l FACILITY CHANGE NOTICE (FCN) i A Morns Opera: ion (MO) document which is used to record a description of the proposed change, modification, or addition plus review and a pproval information. This is the formal document retained with the design package as part of the MO Plant Engineenng records.
FORMAL ENGINEERING REVIEW (FER)
A formal series of activities in the project or task schedule that will produce an objective examination of a design for the purpose of evaluating design adequacy and venfying that the design complies with all applicable requirements.
These activities are also cance Formal Design Reviews.
HANDLING An act of physically moving ite ns by hand or mecha tical means, but not including transport modes ( ANSI N45.2.t 0).
HOLD POINT A mandatory inspection point established either by the Quality Assurance Engineer or other responsible engineers.
l INCOMING MATERIAL REPORT (IMR)
A document identical to the Source inspection Report listing inspection c nteria and utilized at Receiving inspection to record inspection results for incoming items.
INFORMAL DESIGN REVIEW (IDR) l An informal ser es 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 interim decisions for problems, responses to the NRC, evaluating alternatives, and interpreting design codes and standards.
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REVISION 5 FoHM SFO-312 a2HS)
4 QUAllTY ASSURANCE PLAN NLM8E R NEDO-20776 INSPECTION A phase of quality control which by means of examination, observate or measurement determines the conformance of matenais, supplies, components, parts, appurtenarm 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 uample, cleaning instructions. instructions for correct rotation / movement respcnse to power or control signals, inspection records, lubrication instructions, etc.
LEVEL 1 The disposition level for nonconforming items not requinng an MRB, such as " Rework" or " Return to Vendor",
disposition may be made by the first supervisory level performing work that detected the nonconformance.
LEVEL 2 The disposition level for nonconforming items requinng MRB approval such as "Use As is" or " Repair".
LIFETIME RECORDS Lifetime records are those which would be of significant value in: (a) demonstrating capability for safe operation;(b) maintaining, reworking, repairing, replacing, or modifying an item; (c) determining the cause of an accident or malfunction of an item; or (d) those which would provide required baseline data for inservice inspections (N45.2.9).
MANUFACTURING TEST A test of the item's ability to meet static or dynamic performance requirements. Forexample, hydrostatic,ioad, flow, certain proof or component tests, etc.
MATERIAL REOUEST (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) l The informal organization wnich determines the disposition of nonconforming items beyond the scope of Level 1 authonty. This organization must include at least a responsible engineer and a OA engineer, but may include others as aopropriate CA will chair the MRB.
NDE The aooreviation for nondestructive examination, sometimes called nondestructive testing (NDT).
NONCONFORMING ITEM RECORD (NIR)
The form used for reporting nonconforming items or characteristics to Ouality Assurance and to record action taken to effect management disposition.
NONCONFORMANCE A deficiency in characteristic, documentation or procedure which renders the quality of an item unacceptable or j
indeterminate. Examples of nonconformance include: physical defects, test failures, incorrect or inadequate documentation, or deviation from prescribed processing, inspection or test procedures (ANSI N45.2.10).
NONPERMANENT RECORDS Any records which do not satisfy the requirements for lifetime records.
REVISICN 5 PAGE 3
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FGRM sFo-J1-3 t2/781
QUAUTY ASSURANCE PLAN NEDO-20776 NuM8E R OPERATIONAL TEST A test to determine the ability of the component or system to function within licensing limitationsand in accordance with design criteria and functional requirr,ments.
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.
PREREQUISITES Work, precautionary steps, or inspections that must De performed pnor to running a specific test so as to enable valid results to be obtained and not to damage the equipment nor violate Afet', requirements.
PRESERVATION The special preparation of stems utihzing preservatives, inert gas blankets, vapor-proof barners with desiccants,etc to prevent de;eterious environmental offects.
PROCEDURE A document that specifies or describes how an activity is to be performed. It may include methods to be e>nplcyed, equipment or matenals to be used and sequence of operations.
PROJECT PLAN The document whicn describes the detailed elements, including classification, specific activities, responsibilities, schedules, and interfaces of components of a task.
PURCHASE ORDER (PO) s The contractual document used by Purchasing to procure matenal, components, or services as ordered by the l
Material Regt.est.
QUALITY l
Conformance to measurable criteria and r?miirements.
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OUALITY ASSURANCE All those planned and systematic actions necessary to provide adequate confidence that an item or a facihty will l
perform satisfactonly in service (ANSI N45.2.10).
QUALITY ASSURANCE PLAN A document prepared and issued by the Quality Assurance Programs Suosecuen of the Spent Fuel Servicas Operation to provide an interpretation of the requirements of 10CFR50, Appendix B, and other quahty assurance requirements incumbent on the SFSO for implementation. The Quality Asst.rar ce Plan (this document) desenbes the impiementation of the SFSO Quahty Assurance Program.
QUALITY ASSURANCE ORGANIZATION Unless spectfied otherwise, all references to Quality Assurance or Quakty Assurance Organization are apphcabfe to Quahty Assurance functions located bcth in San Jose and at the Morns Operation.
QUALITY CONTROL Those quality assurance actions which provide a means to control and measure the charactenstics of an item, process or facihty to estab6isned requirements ( Ab Si N45.2.10).
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REVISICN 5 GE
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t QUAllTY ASSURANCE PLAN NUM8E R N E DO.20776 OUALITY CONTROL INSTRUCTION (OCl)
A document issued by the Quality Assurance Organization covenng unique, non-repetitive activities for wnicn quality instructions are required.
QUALITY RECORDS FILE The ' le mairitained (or designated to be maintained) by Cuality Assurance for storage of recorcs to support qual:ty-related activities.
QUALITY ASSURANCE PROGRAM The total of all quality assurance requirements imposed on SFSO either from outside, (e.g.: NRC regulations, GE Corporate policy, NEBG Instructions, customer requirements), or internally (e g.: SFSO internal ocerating instructions).
QUALITY 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 desence the methods of appaying the requirements outlined in the SFSO Quality Assurance Plan.
C%fARANTINE The physical segregation of nonconforming material or items from conforming matenal by moving tnem to a ces. grated hold area and attaching a Quality Hold Tag. W,1en physical segregation isimpractical. *he attachmentof the Cuality Hold Tag constitutes quarantine.
REMEDIAL ACTION The action tanen to prevent the same cause from generating problems in any other areas until the cause can be corrected and all existing proolems cleared.
REPAIR The process of restonng a nonconforming characteristic to a condition such that the capability of an item to function reliab'y and safely is unimpaired, even though the item still may not conform to the onginal regmrament (ANSI Na5.2.10).
REWORK The process by which a nonconforming item is made to conform to a prior specified requirement by completten, remacnining, reassembiing or other corrective means (ANSI N45.2.1C1 SAFETY, SAFETY-RELATED As used in this Plan, refers to nuclear safety.
SOURCE INSPECTION REPORT (SIR)
A document used by the appropnate Quality Representative for reporting the results of an inspection at the vendor facility.
SPECIAL PROCESSES Special processes include weiding, brazing, heat treating, cleaning, anodizing plating, and associated ncndestructive examination.
STORAGE The act of holding tems at the construction site or in an area other than its permanent location in the plant (ANSI N45 2.10).
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REVIsloN 5 PAGE 5 _ OF 6
f cH M Sko-31-3 (2/78)
QUALITY ASSURANCE PLAN NEDO-20776
' NUMBER SURVEILLANCE Rautine 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, fuel storage, etc.
TESTING The determination or verification of the capability of an item to mee 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 underconsiderat:on willcontinue to meetall engineering functional requirements including performance, maintainability, fit, and safety ( ANSI N45 2.10).
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asvisio n s FoH M SFO-312 i2178)
GEN ERAL $ ELECTRIC QUALITY ASSURANCE PLAN SPENT FUEL SERVICES OPERATION NUM8E R SUB.ECT 6.0 DOCUMENT CONTROL N EDO-20776 6.1 PURPOSE This section describes the measures for ensunng that approved dign documents related to quality activities are controlled for issue and distnbution. Such documents,i.",cluding changes, are approved for
. fease by authorized personnel and are distributed to and used at the location where the prescribed ac'.vity 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 numbenng, issuance, storage, revision control, and distribution are covered by appropnate implementing instructions and engineering or quality instructions. Vendor / contractor delegated document control functions are approved by the Quality Assurance Organization and are compatible with the requirements specifieu in thss Pfan.
6.3 RESPONSIBILITIES 6.3.1 The Document Control Function is the responsibility of Quality Assurance Program. Responsibilities l
consist of:
a.
Receiving, logging, maintaining revision status records, and distributing approved documents.
including release of approved documents to authorized personnel for revision or permanent storage.
b.
Providing a controlled access repository for documents.
I 6.3.2 Individuale 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 sucparagraph 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 MC according to i
the requirements of this Plan.
6.3.4 Specific ResponsitMlities a.
Responsibility for ensunng use and compliance with instructions, procedures, and drawings is defined in Section 5.0.
b.
Table 6-1 identifies Document Control responssoelity for specific instructions, procedures, drawings, and other documents, covering review for adequacy, aoproval for issuance, revision control, anti distnbution.
IS5UED SY MANAGER,QUAUTf ASSURANCE PROGRAMS DATE ISSUED FEBRUARY 16, 1981 PAGE H. W. HUNTLEY REvlS10N 4 op 6 F O R M 5F 041 1 (2/ 78
QUALITY ASSURANCE PLAN NEDO 20776 NUMBE3 6.4 DOCUMENT CONTROL SYSTEM 6.4.1 Approved SFSO documents and Vendor documents (except for this SFSO Quality Assurance Plan) are forwarded to the Document Control Organization for retention, for storage, and/or distn bution. Figure 6-1 depicts a Document Control flow chart.
6.4 2 Changes to instructions, procedures, and drawings which may affect safety-related items are reviewed and a;.oroved by the organizations that reviewed and approved the onginal document unless that responsicility is delegated to another organization.
6.4.3 Proposed changes to approved documen's are reviewed and approved pnor to release of the document from Document Control custody.
6 4.4 Distnbution of documents is in accordance wth instructions and authorized distnbution lists.
6.4.5 Only approved copies are reproduced for final design, actual construction, and actual operation activities I
affecting quality.
l 6.5 CONTROL OF THE OUALITY ASSURANCE PLAN 6.5.1 ResponWNtity The Manager, Quality Assurance Programs,is responsible for the preparation and revision of this SFSO Quality Assurance Plan.
6.5.2 Assignment and % trol of the Quality Assurance Plan i
a.
These documents are senalized and distnbuted in accordance with the distnbution list maintained by the Quality Assurance function in San Jose.
b.
Copies of this SFSO Quality Assurance Ptrn are maintainea in San Jose by the Manager, Quality Assurance Systems and tst MO by the Manager. Quality Assurance and Safeguards, respectively, and are available for review and reference by customers, regulatory, and Company personnel.
6.5.3 Revision Control of the Quality Assurance Plan a.
Recuested changes, such as those rising from revisions to The Code of Federal Regulations. Title
- 10. Part 50, Appencix B or other appiicable regulations and industrial standards, are coordinated l
with responsible management personnel and directed to the Manager, Quality Assurance Systems.
b.
The Quality Assurance function in San Jose is responsible for prepanng Quality Assurance Plan changes, coordinating reviews, and obtaining approvals (including the MO) pnor to issue of revisions.
c.
Revisions are normally made by section, rather than revising the entire Plan. The Table of Contents includes the issue date of current revisions.
FOR M SFO-312 (2/ 78)
QUAllTY ASSURANCE PLAN NUM8ER NEDO-20776 d.
Revisions which may affect safety-related items or practices and changes affecting license conditions or technical specification conditions are reviewed by the Manager, Licensing and Safet. The Manager, Licensing and Safety is responsible for appropriate notification of the NRC.
f e.
Revised copies are distributed using Errata and Addenda Sheets,and require acknowledgement of the receipt of it's revision and return of obsolete copies.
6.6 CONTROL OF DOCUMENT REVISIONS 6.6.1 Documents requinng revision are t.ontrolled, 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 ar'd are in accordance with requirements specified in this Plan and SFSO implementing instructions.
6 6.3 Document revisions which may affect safety-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 r(sponsible for apprognate notification of the NRC.
6.6.4 The Quility Assurance Organization, in reviewing revisions to applicable regulations and industnal 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 maintain:ng a document master list of all issued and approved docurreents, including current revision numbers. This responsibility may be delegated en part or in full to Document Control by manage.nent agreement.
6.6 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.
6A.2 Vender / contractor document masters are stored in vendor controlled file (s) and/or Document Control files as defined in contract documents.
REVISION 4 PAGE 3
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FORM SFO4N (2/ 78)
QUALITY ASSURANCE PLAN m
NUMBE R NEDO 20776,
Tatne 6-1 SFSO CONTROLLED DOCUMENTS
- Initiation At**
I Document San Jose MO (1) SFSO Quality Assurance Plan X
(2) implementing Instructions:
a.
Spent Fuel Instructions (SFI)
X b.
Morris Operation Instructions (MOI)
X (3) Design Specifications X
X (4) Test instructions X
X (5) Engineenng Orawings X
X
)
(6) Engineenng Change Notices (ECN)
X X
(7) Facility Change Notices (FCN)
X (8) Standard Operating Procedures (SCP)
X (9) Analytical Quality Assurance Manual X
l (10) Analytical Equipment and Calibration Manual X
- Instial issue (or cnanges), acorovel, and distnbute of these oocuments are covered in apprognate ernoiementmg matructions l
"Where two poents of metistion are shown either document control organaats may entroduce mto the Document Control system eith notification sent to other unst for numeer coordmate-l 1
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REVISION 4 FOR M SFO Jt-212d 781
4 QUAllTY ASSURANCE PLAN NUM6ER NEDO 20776 CMTR OR SFSO INifA ED REVt A D
-4 DOCUMENTS VENDOR DOCUMENTS pp w
V APPROVED
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DOCUMENTS y
oiSTRieUTION oisTaisuTioN usT DOCUMENT RECORO CHANGE
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MICROFIW
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STORAGE A
Y AUTHORIZED CHANGE CONTROLLED REQUEST FILE CHANGES Figure 6-1.
SFSO Document Control REVISION 4 PAG 5 5
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FORM SFO J1-J L2/78)
GENERAL & ELECTRIC SPENT FUEL SERVICES OPER ATION SUSJE CT NUMSER 15.0 NONCONFORMING MATERIALS, PARTS, OR COMPONENTS NEDO-20776 15.1 PURPOSE This stction descrites the measures used for centrolling materials. parts, systerrs and structures *nicn co not conform to requirements and wnien are normany cetected througn inscection, test. cceration, or audat. Additionally, the measures used to document and control nonconformances discovered donng orocess operations are cescnbed as weit as 'he venicle for ceviating from the onginal centract.
15.2 NONCONFORMING ITLM RECORD (NIR) AND OUAUTY HOLD TAG 15 2.1 Nonconfermances noted by SFSO in matenal, parts, or comocnents. systerns and structures are cocumented m NI A's.
15.2 2 The nonconforming item is scentified Dy a " Hold Tag
- and the affect 6d crganization ;s nctifrec. Where practical the item is segregated in a quarantme area to prevent its inadvertent use.
15.2.3 The item rema.as on noid procerty tagged, until restored to an accectacle condition or scracced. Only CA ras the %tnonty to effect a re! ease frcm quarantire or removal of the "Hoid Tag.~
15 2.4 in certain instances. items may be nonconforming only from the stancpoint of tne type of service for annen the item is purenased. eut may be acceptable for other services. In such instances.the Cuahty Assurance Orgari.zatien signs the NIR releasing the item for a service to which the item conforms.
15 2.5 The Vaterial Rev:ew Board (MAB) may authonze centmuing processing of an assembly cending disposition of a nonconforming component.
15 2.6 Vender Cuahty Assurance Programs conta n recuirements eQuivaient to tnose of SFSO. consistent *:th neir scope of nork.
15.3 RESOLL'.~lON OF A NONCONFORMANCE 15.3.1 Ncnconformmg matenais, parts, or components are icentdied. ciscosit.cned. and restored in acccreance with the following:
a.
Level 1 1.
Disposition is by tne first supervisory levet performmg work that cetected tre nonconformance. The autnerity for disposition at Levet 1 is restncted to the following:
(a)
Fart. stem, or assembly may be reworised to meet eusting specifications.
(D)
New scheduimg cr revision to ces.gn or facncation documentation is not requirec.
2.
The Ouality Controt function of the Ouahty Assurance Organ:zatien ans i svet 1 cispositions.
ISSUED SY WAN AGER. CUALITY ASSURANCE PAOGRAMS oATE JSUEO FEBRUARY 16, 1981 PAGE 1
H. W. HUNTLEY REvtSicN 4 op 3
_ a-
QUALITY ASSURANCE PLAN m
'NUM8ER 3.
If the noncc1formance cannot be corrected within the limits of Level 1 authority, the NIR is I
referred to Level 2 by the supervisor of Quality Control personnel.
4.
Level I correction is reinspected for conformance to stated requirements.
b.
Level 2 1.
Disposition authonty for Level 2 requires the Material Review Board (MRB). As a minimum, the MRB consists of representatives from Fuel Storage Projects, the Ovahty Assurance Organization, and other Engineering Organizations as determined by the Manager, Fuel Storage Projects or the Manager, Morris Operations, as applicable. Representatives from Purchasing and other groups (suen as Operations) are included in the M AB as appropriate.
2.
Disposition is to rework, scrap, return to supplier, repair, or"use as is." Disposition to "use as is" or " repair" may be made without customer notification provided such disposition does not adversely affect function, fit-up, safety, or basic design requirements of the manufacturing plan, supporting documents, design documents or contractual agreements.
Otnerwise the customer must be informed by appropriate notation on the Product Ouality Certification.
3.
Level 2 correction is reinspected for conformance to MRB requirements.
15.3.2 The Quality Assurance Organization closes the NIR when a!I appropriate actions are taken and maintains appropriate records of tha NIR.
j 15.4 DEVIATION DISPOSITION REQUEST (DDR) 15.4.1 The DDR is the vehicle by which the 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 Engineering or Licensing and Transportation and SFSO-CA Engineering.
15.5 Potentially significant 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 Jose is responsible for the correction of generic deficiencies that exist in either the Quality As,surance Program or its implementation.
[
l 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 Quahty Assurance Organization is responsible for authorizing cloNre of Pil CAR's.
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REVISION 4 7
FQR M SFO-J12 i2/ 78)
QUAllTY ASSURANCE PLAN NUM8E R N EDO-20776 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 Morns Operation (MO), Fuel Storage Projects,and major contracts by the Quahty Assurance function in San Jose or MO. Such reporting may be part of routine management reports to the SFSO Manager covenng SFSO design and construction status related to facihty changes, major projects, and tasks.
l l
REVISION 4 PAGE 3
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FOR M SFO J1 J (2/78)
GEN ER AL $ ELECTRIC SPENT FUEL SERVICES OPERATION NU MeE R SU8 JECT 17.0 QUALITY ASSURANCE RECORDS NEDO 20773 17.1 PURPOSE This section describes the measures for ensuring that sufficient records are maintair4d to furnish evidence of activities affecting quality, and that such records are stored, maintained, and safeguarded for an adequate period utilizing a systematic means of retneval. The requirements of this Plan and those record-keeping requirements established by regulatory agencies, specify the logs, records, and reports required to ensure that comprehensive records of design. fabrication. construction ed operation are maintained.
17.2 APPLICABILITY This section is apphcable i all activities for wnicn SFSO is responsible and w%ch provide evidence of quahty in the < mcn. fabrication construction, and operation of nuclear storage facihties.
l 17.3 GENERAL REQUIREMENTS 17 3.1 Documents which furnish evidence of the quahty of items and provide information relatmg to activities affecting quahty are maintained by the originating organizatico as specified nerein until completion of a task or project when the originating organization transfers these records into the SFSO document ce, trol system.
17.3.2 Records pertaining to the quality of items or activities of the plant facihty are retained in accordcNe with regulatory requirements as defined by SFSO internal instructions.
17.3.3 A documentation indexing system assures that all records are readily identifiable and retnevable. It is the responsibihty of organizations that generate quality-related records to identify and index sucn records mth appropnate cross references in accordance with occument control procedures prest.nted in Section f
6.0. Inspection and test records identify the inspector or tester, the cate. the type of observation, the results, the acceptabihty and tne action taken in cennection with any deficiencies noted (Section 15.0).
l All records are legible t n original or reproduced form) and adequately identifiable to the item or activity l
17.3.4 i
l involved.
l l
17.4 RESPONSIBILITIES 17.4.1 As records are originated, the originating organization is responsible for providing control of sucn l
documents commensurate with their abihty to replace them 1742 The Quality Assurance Function in San Jose is responoble 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 and audit procedures to venfy tnat other SFSO organizations are complying witn these requirements.
17.a.3 Document Control in San Jose is responsible for the system for storage, retention. and retneval of all cuahty assurance records.
oATEISSUED
' ISSUED SY MANAGER. QUAUTY ASSURANCE PROGR AMS 1
FEBRUARY 16, 1981 PACE 3
H.W. HUNTLEY REvtSION 5 op FO A M 5F O-J nii2/ 781
s QUAllTY ASSURANCE PLAN
~,
' NUMBER l
17.5 INTERIM DOCUMENT STORAGE 17.5.1 Fuel Storsge Projects maintains all design-related documents, including the following:
a.
Drawings, specifications.
b.
Vendor information files.
c.
Tests, procedures, and reports.
d.
Procurement data for design and construction projects and tasks.
e.
Engineering change notices.
f.
Engineenng Review memorandum.
17.5.2 Ucensing 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.
I J
d.
Licenses, penTiits, and amendments.
l 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.
Corrective Action Requests (CAR's).
d.
AuJit reports.
l l
e.
Material certifications and test reports f.
Special process records.
l g.
Special process personnel training and certification records.
h.
Product Quality Certifications.
l l
Vendor evaluation reports.
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REVi$lON 5 FOH M SFO-J1212/18n l
QUAL.lTY ASSURANCE PLAN NUMeER N EDO.20776 17 5.a Cocumentation specifically concerned with plant maintenance, repair, and operations is maintained at Morns Operations (MO).
a MO Plant Engineenng snd Maintenance maintains records sucn as the following:
1.
Plant draw:ngs.
2.
Facility Change Notices (FCN*s).
3.
Instrument cabbration records.
4.
Radioactivity exposure records.
5.
Accident reports.
6.
Records of unusual events and abnormal occurrences.
7.
Maintenance records.
b.
Plant Operations maintains records sucn as the following:
1.
FNnt ooeration togs, reports, and procedures.
2.
Qualification records for personnel.
3.
Equipment Venfication Test (EVT) data and similar operational information.
17.5 RECORDS Ht,NDUNG AND STORAGE 17.6.1 Recods are maintained in the NEBG off-site vault, or in Record Centers in San Jose as well as at the MO Storage of two complets sets of reccrds at remote facilities comp;ies with regulatory recuirements concerning the cermanency of quality a ssurance records. Lifetime records are maintained for tne infetime of the item or facility to whicn they pe tain.
~
I 1762 Storage is accomplisned by retention of complete (nard copy) documentation, microfilm, or other rep oductions. Items sucn as radiographs are not reproduced, but retained as originais.
1763 An index system for ease of retrievalis estabhsned for all records being stored by or for SFSO.
l 17 6.4 Records (document) control is estaotished so tnat lifetime records, originals, and/or copies of documerits l
are retair ed in the Records Centers. A master list of sucn records is maintained by Document Controlin San Jose. The Record Center at MO utilizes the identical indexing system used in San Jose.
l 17.7 QUAUTY ASSURANCE ORGANIZATION RECORDS ACTIVITIES in addition to the responsibilities of the Quality Assurance Organization pertaining to the generation of records unioue to its activities (see sub-paragracn 17.3.2), the Quality Assurance function in San Jcse venfies compliance of other SFSO organizations witn regulatory record requirements tnrougn l
surveillance and audit.
REVISICN 5 PAGE 3
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FC H M SFO-J1-J (2/ 781
\\
l
F av GENERAL & ELECTRIC QUAllTY ASSURANCE PLAN SPENT FUEL SERVICES OPER ATIDN SUBJECT NUMOE R 13.0 AULiTS N EDO-20776 18.1 PURPOSE This sect:en desenbes the system and responsibilities for conducting planned and periodic reviews (audits) of activities related to the design and f aencation, onstruction. and op3ratica of a nuclear fuel storage facihty by the assessment of performance of quality assurance and quahty control and compsiance with stated recuirements.
18.2 GENERAL 18.2.1 Types of Quality Audits a.
Extnnsic Audit - Audits may be conducted by customers or other external organizations sucn as the NRC to assure that SFSO is in comphance with contractual agreements.
b.
SF SO Audit - TM Quahty Assuranciit functien in San Jose audits SFSO organizational eiements in San Jcse and at Morris OperatK,n (MO) to verify that cb ectives of the Quakty Assurance Program i
are ceing met.
c.
NEBG Ouakty Assurance Audit - Audits are conducted to verify compharice to applicatie NEBG policies and procedures by P&OAO pemonnel.
d.
MO Quality Assurance Audit-Audits by MO of the Quakty Assurance Program as implemented by I
l their own organization.
e.
Vendor Audit - Audits of widor's facihties may be conducted by either of the Quahty Assurance functions (located in San Jose or at the MO).
I 18.2.2 General Requirements Audits are formal. they are scheduled by advance notification which specifies the general area and!
a.
or specific activities and documents to be investigated.
c.
Audits are conducted utilizing a written procedure (enecklist) to assure thorougnr ess of the review. Checkhsts may be standardized (for review of compliance to the Code of Federa!
Regulations. Title 10. Part 50. Appendix 8. for example), or they may be prepared for specific audits.
c.
Audits are performed by quahtied personnel (See 19 2.3); these personnel do not have direct I
responsibahty in the area being audited.
1 O.
Tne responsible management of the function t> sing audited is apprised of the details of the pending audit by the auditing team prior to the investigation.
ISSUED BY MANAGER. CUAUTY ASSURANCE PROGRAMS DATE ISSUED FEBRUARY 16, 1961 PAGE 1
H.W. HUNTLEY Revision 4 op 3
FCR M 5FM1 1 (2G8 I
QUAllTY ASSURANCE PLAN NEDO.20776
'NUM8ER The findings of the audit team are discussed with the responsible management of the audited e.
function; this management recenes a formal notification of the audit findings and areas requinng Correction.
f.
Management of the aufWd orgwization must establish appropriate measures to ccirnt the audit findings and must respond to the audit within 30 days after formal notification. Ynss response will state corrective action (s) to be taken; including a schedule for completion of corrective action (s).
or other specific response to the findings.
Deficiencies are reaudited until corrective action has been accomplished.
g.
All activity dunng audits is documented in the Audit Report which is maintained in Quality h.
Assurance Organization files. Subsecuent follow-up activity is also documented and filed with the onginal audit report.
18.2.3 Audit Team Composition and Qualificatione As a minimum, each audit team has a certified Lead Auditorin charge.The Lead Auditor is certified a.
by SFSO management as having appropriate quahfications.
b.
In addition to the Lead Auditor, there may be one or more quahfied individuals as members of the audit team. Each auditor will be selected by virtue of special abihties, specialized tecnnical training, pnor pertinent expenence, personal characteristics, and/or relevant education.
T 18.2.4 Audit Frequency
.j' Results of actions taw to correct deficiencies that affect safety and occur in facihty equipment, a.
structures. :omponents, or methods of operation will be reviewed or reaudited within six months after completion of corrective action.
b.
The cWormance of the facility oporation to requirements contained in license conditions will be auditeo at least once within 12 months of the initiation of the license requirements, and every twelve months thereafter.
1 The performance, training, and qualifications of the facility staff engaged in safety-related activities c.
will be audited at least once every 12 months.
d.
Audits will be performed to encure that all safety-rela'ed functions are covered within a period of 24 montns.
18.3 QUALITY ASSURANCE ORGANIZATION AUDIT RESPONSIBILITIES The Quality Assurance Organization is responsible for conducting quality audits. This does not preclude the aopointment of a technical and/or administrative representative to participate directly in the audit or to carve as a consultant. Specific Quahty Assurance Organization responsibihties include the following:
Scneduling. coordinating and report:ng extrinsic vendor, and NEBG avality assurance audits.
I a.
b.
Estabhshing an audit schedule.
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. EVISiON 4 FOR M SFO-31-2 i2/18) n 5, e
QUAllTY ASSURANCE PLAN NEDO-20776
' NUMBER c.
Generating audit chectlists *nich define tne requirements.
d.
Conducting, or coordinating the performance of, audits as planned.
e.
Issuing audit reports.
f.
Initiating Corrective Action Requests (CAR's) as required.
g.
Conducting fol'ow-up audits to determine the implementation and effectiveness of corrective action (s) taken on significant quality prob: ems.
h.
Analyzing audit findings to detect qu$ty trends and effectiveness of the Quahty Assurance Program.
18.4 REPORTS 18 4.1 At the cor.clusion of each audit and after all committed actions are documented on the CAR's, an audit report is to be prepared and distnbuted to concer ned and affected management. The audit report consists of: audit scope, identification of the audit team, audit contacts, summary of audit findings and follow up and close out responsibilities. Copies of the issued CAR's are attached to the audit report.
1842 The Quality Assurance Organization includes a listing of the status of all open SFSO quality assurance-related CAR's in the monthly management report to SFSO management.
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REVISION 4 FOR M SFO-31-2 :21781 1874G 1
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