ML19254F557

Sentinel Product Line QA Program Plan TES-3143,Revision B

ML19254F557
Person / Time
Site:	07100046
Issue date:	10/31/1979
From:	TELEDYNE ENERGY SYSTEMS
To:
Shared Package
ML19254F556	List: ML19254F555 ML19254F557
References
14413, NUDOCS 7911120025
Download: ML19254F557 (29)

Text

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P SENTINEL PRODUCT LINE QUALITY ASSURANCE PROGRAM PLAN TES-3143 June 1978 Revised October 1979 Licensco - Tcledync Energy Systems 110 W. Timonium Road Timonimn, Maryland 21093 1311 109 144130W 921120

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.PAGE DESCRIPTION DATE APPROVED cj A

A Revised cotrrlete document prior to internal release.

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TABLE OF CONTENTS Page Title Page Revision Shcot i

1. 0 Introduction 1

2

2. 0 Organization 5

3. 0 Quality Assurance Program 3.1 Design Control 9

3. 2 Procurement Document Control 11

3. 3 Instructions, Procedures and Drawings 12

3. 4 Document Control 13 3.5 Control of Purchased Material, Equipment and Services 14 3.6 Identification and Centrol of Materials, Parts and Components 16

3. 7 Control of Spec Processes 16

3. 8 Inspection 17

3. 9 Test Control 18 3.10 Control of Measuring and Test Equipment 18 3.11 IIandling, Storage and Shipping 19 3.12 Inspection, Test and Operating Status 20 3.13 Nonconforming Materials, Parts or Components 21 3.14 Corrective Action 22 3.15 Quality Ascurance Records 22 3.1G Audits of Quality Assurance Plan 23

4. 0 Specific Provisions 24 TES-3143

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1. 0 INTRODUCTION The Quality Assurance Program described herein has been prepared pursuant to Section 71.51, of 10 CFR Part 71 " Packaging of Radioactive Material for Transport and Transportation of Radioactive Material Under Certain Conditions. " TF.is Quality

. Assurance Pr,ogram is to be executed by Tcledyne Energy Systems in support of its commercial Strontium 90 fueled "Sentinc1" Radioisotopo Thermoclectric Generator (RTG) product line.

This document contains the Tcledync Energy Systems' functional organization arrangement and discusses the Quality Assurance responsibilitics of c.ach department.

The Quality Assuranca Program is fully delineated and the pertinent criteria of Appendix E of 10 CFR Part 71 addressed as individualitems.

The objective of the Quality Assurance Program 19 % establish and maintain an effective and economical system to provide re 1sonabic confidence that the licensed pach-age (s) will perform satisfactorily in scrvice. The program design has been based upon consideration of the Quality history of previous programs, the required design review and verification, and the necessity to impose controls and surveillance over critical manufacturing related activitics.

This program is in conformance with the general intent of the Quality Assurance Requirements as specified in Appendix E of 10 CFR Part 71.

Some of the requirements imposed by the recent revision to 10 CFR Part 71 arc entirely new; other Quality Assurance measures util! zed by Toledync Encrgy Syotems have been executed and documented as a matter of course within our normal modo of operation. The fully defined Quality Assurance Program contained herein will therefore becomo effective immediately followhig NRC approval, and will not be made retroactive.

TES-3143,

'Sentincl' program work for the past eight years has involved the fabrication of

" Catalog" items and hac not encompassed the creation of new designs. Some of the Appendix E criteria concerning " Design Control Reviews" are not documented for exist-ing models, but will be accommodated prior to the licensing for new Sentinel model designs.

The requirements of 10 CFR Part 71 Apnendix E are applied in a graded approach based in part on the successful Qualityhistory and degree of standardization of Sentinel units, and on the elmplicity of the packages.

With the issuance of this document, all of the Quality Assurance provisions sinied herein are mandatory requirements to be implemented and enforced on the

'Sentincl' program.

2. O ORGANIZATION _

The Tcledync Energy Systcms organization is shown in Figure 1.

The inter-relationship of Quality Operations to other management functions is clearly shown.

This organizational structure pernats a close relationship of Quality personnel with program activitics to achicyc high program efficiency while retaining unimpeded access to higher management. The Quality Operations Department has the required authority and organizational freedom to provide its inspection and control functions with indepen-donce from unduc influences and responsibilitics of costs and schedules.

Functionally, the Sentinel Program Manager has the overall responsibility to coordinate all of the activitics affecting the final package such that delivery can be made within schedule and cost goals. These activitics include the design, analysis, fabrication, assembly, test, quality control, handling and shipping. These activitics are accomplished through assigned representatives from the applicable operating departments who form

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\\1J TES-3143 President Quainy Vice President Materials Manufacturing Operations Administration Engineering & Test Quality Engr.

Contracts Mat'Is. Engr.

Mat'l. Control i

Quality Control Procurement licalth Physics Prod. Control 8

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Vice President Assy. & Test Technical Operations Program Central F~

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Thermal & Hyd.

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4 FIGURE 1: TELEDYNE ENERGY SYSTEMS ORGANIZATION

the program 'tcam," however, as indicated, each representative is responsible to a department manager to maintain unimpeded communication with high level management.

In brief, the Quality Assurance functions of each department or section are as follows:

a.

Central Engineering Section - Responsible for the functions related to the design, design reviews, analysis safety and reliability, and engineering documentation control.

b.

hianufacturing Department - Responsible for those functions affecting material control and production control, c.

hiatorials Engineering and Test Department - Responsible for activitics related to material usages, material and process specifications and health physics aspects of the handling, storage anil shipment of the package, d.

Quality Operations Department - Responsible for conducting inspection and control activitics to assure that out-of-spec hardware is identified and withhcid from use unless written and approved authority is roccived from a Corrective Action Board (AIRB). This activity includes the review of engineering documentation to assure that proper inspection and control measures arc incorporated.

The overall authority and responsibility for this Quality Assurance Program is maintained by the Program Manager. The individual assigned to this position must possess a college degrec, preferably in one of the engineering complexes, and must have a minimtun of five years experience in a responsible capacity on one or more

'hardwarc'-type programs. The Program Afanager must be familiar with the Company's Quality Assuranco Policies and Objectives and with interface relationships and Quality Assurance functions of each organizational element.

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The authority and duties of all persons performingQuality Assurance functions are documented. These persons are given the authority and freedom to identify Quality Assurance deficiencies; to initiate, recommend or provide corrections actions; and to verify that directions are implemented properly. CertainQuality Assurance positions, 4

namely, those of Program Manager, Program Task Leader, Quality Operations Manager, Quality Control and Quality Engineering Supervisors and the Manufacturing Supenisor t

and the Programs's Production Control representative are given the authority by this document to stop any work item or process which is suspect of compromising the end product.

In certain instances the execution of our Quality Assurance program may bc dc1cgated to an outsido crganization but TES retains the responsibility for the program h

and for the reliability of our 'Sentinc1' generators.

3. 0 QUALITY ASSURANCE PROGRAM The Quality Assurance Program described within this document applics the per-tinent requirements of Appendix E of 10 CFR Part 71, in a graded approach, to assure conformarec to the approved design specifications of cach individual ' package. ' Telodync's top Icyc1 management through periodic staff meetings, will assess the scope, status, implementation and effectiveness of the Quality Assurance program to assure adequate complianco with 10 CFR Part 71,' Appendix E criteria. Management's assessment of lB this program will be made with consideration of the most recent program audit results This docmnent will be formally issued by job release sheets to all as appropriate.

'Sentincl' team members, as delineated by a program memorandum, and each receipi-ent will be issued all subsequent revisions to the plan. Program staff meetings and organizational group meetings will emphasize that the Quality Policies and Procedures described in this Quality Assurance Program Plan are mandatory requirements which must be implemented and enforced.

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The purpose of the Quality Assurance Program is to document and carry out all of the activitics required to provide adequate confidence that the 'Sentincl' package will perform safely in so;vice. 'Sentincl' is Telodync Encrgy Systems' (TES) commer-cialline of radioisotopc thermoclectric generators with power levels ranging from 1 or 2 watts to a few hundred watts. These units, as transported, are classified as " Type B" packages. The Strontium 90 fuel used within the RTG is a transport Group II ma-terial and, since the fuel is in solid form and encapsulated, it meets the "special form material" requirements. The safety-related components to be controlled by the Quality Assurance Program are:

1.

Fuel capsule liner - fuel compatibility member 2.

Fucl capsule - fuel containment component 3.

Shield body and plug - biological shiciding 4.

IIousing and/or shipping container - package The Quality Assurance Program described witldn tids document has been es-tablished and will be implemented for the design, fabrication, assembly, testing, use and maintenance of packages designed for transport of 'Sentinc1' model RTG's.

Disputes arising during the enforecment of this Quality Assurance Program, involving differences of opinion between Quality Assuranec/ Quality Control personnel and other department personnel, will be resolved by actions of a Corrective Action Board (CAB). The CAB, consisting of Quality, Reliability, Materials and Design En-gineers, requires unanimous consent on " repair"or "use-as-is" dispositions or the item goes to an automatic " scrap" disposition. The oporations of the CAB are explained in Quality Directives 3.3 and 3. 7.

Tcledync Energy Systems has operated within the scope of numerous Quality Program Plans wider contract to various Government agencies and has evolved, over TES-3143

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the course of many years, a group of standards and policies which address most of the required Quality Assurance criteria. This document maximizes the use of these exist-ing mantials, by reference, where applicabic. These manuals which delineate procedure and policies regarding many Quality Assurance activitics are as follows:

1.

Quality Manual (ES-2G5) - This manual, maintained by the Quality Opera-tions Department, details the activitics of Quality personnel through indi-vidualQuality Directives.

2, Engineering Documentation Standards - This document, maintained by the Central Enginecrhig section describes drawhig and process preparation, i

release and revision controls, f

3.

Manufacturing Department Procedures Mant al - This document covers l

Receiving and Shipping, Material Control, Production Control and Tool Control.

Procurement Policies and Procedures Manual - This manual maintained 4.

i by the Administration Department, details activitics portaining to the pro-t curoment of materials, equipment and services.

These manuals arc available to any TES employee for reference, but are not lB widely distributed outside of the C,ontrolling Department.

In addition to the existing documents, a newly created plan, entitled " Sentinel Program Documc1.6ation Plan" (Drawing 001-01000) will be implemented for all Sentinel work after plan approval by NRC. The doctunentation plan delineates the requirements for the preparation, approval, relcase and retention of all engineering documentation.

The referenced documents are intended to ensure that all provisions of the puck-age design approval are satisfied Personnel responsible for performing Quality-related activitics will be instructed as to the purpose, scope and implementation of the program plan, instructions and TES-3143 jj }}8 procedures. Personnel performing Quality related activitics have been trained over the course of many years and are deemed qualified in the principles and techniques of the activitics to which they are assigned. New Quality Control personnel are given "on-the-job" training and periodic instructions from the Quality Assuranec/ Quality Control supervisors. Special skill training and certification requirements are docu-monted in Quality records and individual proficiency tests and rccertification examina-tions are given periodically where specified. Quality-related activitics are performed with equipment under special environ-mental conditions where specified by drawings, procedures or specifications, and where appropriate, prercquisites, such as, prcqualification runs are satisfied prior to inspection and test. A brief discussion of the applicable Quality Assurance Criteria requirements follow. The portinent requirements and the paragraph number under which each is dis-cussed are listed below: Design Coldrol 3.1 Procurement Document Control

3. 2 Instructions, Procedures and Drawings

3. 3 Document Control

3. 4 Control of Purchased Material, Equipmemt and Services

3. 5 Identification and Control of Materials, Parts and Components

3. G Control of Special Processes

3. 7 Inspection

3. 8 Test Control

3. 0 Control of Measuring and Test Equipment 3.00 TES-3143

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IIandling, Storage and Shipping 3.10 Inspection, Test and Operating Status 3.12 Nonconforming AInterials, Parts or Components 3.13 Corrective Action 3.14 Quality Assurance Records 3.15 Audits 3.10 3.1 Design Control The design control function is to assure that the applicabic regulatory require-ments, the package design configuration, and materials of construction, as specified in the license, are properly translated into drawings, specifications, procedures and special instructions. The package assembly, subassembly and component detail drawings will be ac-complished in the Design and Test Group of the Central Engineering section. Drawings are reviewed and approved by a checking group withing the same group to assure com-pliance with the applicable drafting practices. The drawings will also be reviewed for verification of design adequacy by the structural analysis, safety and reliability, and thermal and hydraulic sections, as applicabic. The design verification will be achieved by calculative methods. Additional review will be performed by the Alaterials section of the Alaterials Engineering and Test Department, if applicable, to assure the suit-ability of materials, components, equipment and processes for their intended applica-tion. The Llaterials Engineering and Test Department also will generate material and process specifications, as required, to achieve performance parameters. Each new 'Sentincl' design requires the preparation of a " structural, thermal and shiciding evaluation" report, which basically serves as a design verification document. TES-3143 1311 120 _9-

This document not only requires the approval of the Program Manager, but is submitted routinely to the NRC as part of a license application. Design verification or checidng is not permitted by the original designer, but in our small organization, is sometimes performed by the designer's supervisor. Design verification by the designer's supervisor is not considered to be a detriment to the proper accomplishment of a design review, and permits the supervisor a first hand evaluation of the designer's work performance. Ilowever, all engineering documentation is further reviewed and approved by the Quality Engineering group to acsure that the appropriate Quality inspection and Control instructions are specified and included in design documents. Quality Operations will record and document drawing and specification changes to assure that each delivered end item (package) is traccable back to the proper change level of the drawings and specifications defining it. Final Engineering document review and approval will be performed by the Project or Program Manager to assure that the proper acccptance criteria for inspections and test are delineated and that all of the appropriate approvals have been obtained. The procedures defining the activitics of drawing, spectiication and process pre-paration, release, and revisions are set forth in the " Engineering Documentation Systems" manual and " Sentinel Program-Documentation Plan. " The drafting practices specified in the manual basically conform to MIL-D-1000, Form 2 and to MIL-STD-100. Design and specification revisions are subject to the same controls and approvals that were appli-cable to the original dcsign. In cases where it is appropriate to verify design adequacy with a test program, a qualification test of a prototype unit under design conditions is used. TES- 0143 1311 121

) i i I L Although design reviews have been accomplished on existing Sentinel models, these activitics are not controlled by written procedures. A design review procedure, however, will be established prior to the initiation of any new Sentinel model design. The procedure will delineate the participating groups and their authority and respon-sibilitics. In summary, design verification is performed by either a Design Review Board, lB by alternate calculations, by qualification testing as appropriate or a combination of t i these methods. Design reviews at Tcledync are never accomplished by an individual, but rather by a 'tcam' composed of members from each of the various complexes, as required, i.e., Engineering Design, Structural Analysis, Safety and Reliability, Manufacturing and Quality Control. The responsibility to conduct the Design Review Board will bc i given to a qualified individual other than the designer and the designer's supervisor, usually by Quality Engineering personnel.

3. 2 Procurement Document Control Procedure have been established that clearly delineate the sequence of actions required to preparc, review, sign-off and controlprocurementdocuments. The appli-cable requirements of 10 CFR Part 71, Appendix E are to be identified by the Engineering originator and reflected in appropriate specifications and procurement documents indicat-ing that the specified requirements must be complied with and addressed in a supplicr's Quality Assurance Program. The design technical requirements including material and component identification requirements, applicable regulatory requirements, drawing, specifications, industrial standards and codes, special process instructions and icst and inspection critoria are contained or referenced on all appropriate procurement documents.

1311 122 TES-3143 Procurement documents also identify through an inspection coding system, any documen-tation that is to be prepared and submitted to the purchaser for review and approval. Examples of this type of required documentation are drawings, specifications, procedure, inepection and fabrication plans, inspection and test records, personnel and procedure I o i qualifications and chemical and physical test resu'.. of materials. i The standard terms and conditions printed on our procurement documents require the supplier to retain such records for a period of 3 yours. Although it is not general practice for Tcledync to require suppliers to retain, controll and maintain special records, where applicable, these records would bc kbk I t t TES-3140 -11a-l

( identified as deliverable items to the purchaser prior to use or installation of hardware. The terms and conditions stated on procurement documents provide the procuring agency's right to access to the s'tpplicr's facility and records for source inspection and/or audit. Revisions and changes to procurement documents require special amendment forms which are subject to the same review and approval as the original document. Procurement documents are reviewed by Quality Engineering to ensure that listed materials, equipment or services are clearly specified, to assure that adequate Quality controls are suitably included or referenced in the procurement documents, and to add the appropriato directions for certifications and source and/or rocciving inrpection in accordance with the requirements of Quality Directive 8.1, (Procurement Documents-t Quality Requirements). This directive in conjunction with the " Procurement Policies f. and Procedures Manual" constitute the control for processing of procurement documents or changes thereto. 3.3 Instructions. Procedures and Drawings All activitics affecting product quality are prescribed and accomplished in ac-cordance with documented instructions, procedures or drawings. Verbal directions are not accepted in any area of Tcledyne. The sequence of actions to accomplish the prepar-at;so, review, approval, and control of the various documents are delineated in the " Engineering Document Standards" manual and in the " Sentinel Program Doemnentation Plan. " The sequence requires a Quality Engineering Review and approval of inspection plans, testing, calibration ar.d special process procedures, drawings and specifications and revisions thereto. Tcledync Energy Systems uses three types of slecifications/ procedures in addition to engineering and vendor drawings and topical reports. i, I t h TES-3143 j } _),1 1 124 l

i The three types of documents employed are: test and/or assembly procedures, material specifications and process specifications. The latter two, of course, are only generated when there is no equivalent commercial or Government specification. i Test and/or assembly procedures are program-peculiar documents issued to i delineate a sequence of events, the use of.special equipment or facilitics, data require-monts not spec'ified by drawings or added compliance criteria. Material specifications are used to delineate minimum functional, physical, chemical, electrical or mechanical requirements of a material to assure design adequacy. i Process Specifications are used to describe equipment, materials, processing requirements andQuality Assurance provisions required for an acceptable product, i Activitics affecting the Quality Engineering Revicw and approval of these documents are specified in Quality Directive 2.2, " Review of Technical Documents" of the Quality Manual. Test and/or assembly procedures are generated in the design and test group of the Central Engineering Section. Mate-ial and process specifications are originated by the Materials Engineering and Test Department.

3. 4 Document Control The document control function is to assure that all Engineering documents in-cluding drawings, specifications and procedures are issued, properly reviewed and ap-

} proved, distributed and revised inuccordance with established procedures. These functions are achieved by the Central Engineering Department. Engineering document release and revision procedures are specified in the " Engineering Documentation Standards" manual and " Sentinel Program Documentation Plan. " The required document approval and document distribution list is delineated by Engineering Program Directive. i i 1311 123 TES. 3143 1 ;

The Quality Operations document control functions include review, approval and change level documentation for end item traceability. These activitics are de-lincated in Quality Directive 2.2, " Review of Technical Documents" and Quality Directive 2.1,,"ConfigurationControl. " These activitics assure that the documents IB and changes are adequate and include the Quality requirements. Doctunent revisions require review and approval by the same organizations that performed the original review. All approved changes must be included in instructions, procedures, drawings and other doctunents prior to implementation of such change. Documents and revisions thereto arc distributed to the designated personnel prior to commencing work. A master card file identifics the current revision status of all Engineering drawings, instructions and procedures and a compulcrized listing of process specifications delineates the revision status of these documents.

3. 5 Control of Purchased Material, Equipment and Services Supplier facility surveys and Quality audits are performed by TES Quality Engi-necring staff personnel on both an unscheduled and scheduled basis - depending on the supplier's previous Quality history and/or the criticality of the item or material being I

supplied. Quality Engineering por,sonnel selected for these audits have the necessary cxperiential and tecimical background congruent to ihc requirements of the audit and if necessary, export personnel from other departments assist in its performance. Evalua-tions consider items such as manufacturing capability, Quality Asaurance Program, inspection procedures, design control systems and personnel qualifications. Included within these evaluations is consideration of whether or not the supplier can comply with the elements of Appendix E of 10 CFR Part 71 applicable. Quality Engineering also re-views histories of suppliers who have provided similar items of the typo being procured. Results of all vendor surveys ar.d audits are maintained on file within TES Quality Opera-I tions Department. 1311 126 TES-3143 Where required, scheduled surveillance of suppliers during fabrication, inspec-tion, testing and s' 1pment is performcd in accordance with written TES procedures or standardized Quality Assurance checidists. This is planncd and accomplished in order to insure supplier conformance to the requirements of the applicable purchase order. In acco,rdance with TES Purchase Order requirements, the supplicr, where ap-plicabic, will provide the necessary documentation to provide identity and certification of the item or material supplied in conformance with any codes or specification that portain to the subject purchase order. While in most instances TES disallows shipment of nonconforming items, those licms roccived with supplier nonconformances must bc identified as such and be accompanied with a detailed nonconformance report and ex-planation of appropriate corrective action. Such nonconforming items are still subject to review and acceptance by TES Quality Engineering. l R ceiving inspection is conducted prior to use of purchased material, equipment l l i and services to nssure that they are correctly identified, accompanied with appropriate documentation and in conformance with the applicable P. O. requirements, specifications and codes. Inspection instructions and guidance is contained in Quality Directivo 3.G, " Quality Control of Procured Materials. " Detailed inspect;on requirements are applied as appropriate and in accordance with written instructions contained in the Purchase Order or othe; applicable documentation such as TES Engineering drawings and/or pro-cess specification. Items inspected are identified as to their status via acceptance tags or nonconformanc reports as applicable and in accordance with the procedures contained in Quality Directive 3.G and Quality Directive 3. 3, 'Teledyne Reporting System. " These records are availabic and accompany the item prior to its relcacc or storage within the Quality Withhold Area (if nonconforming). In the case of assemblics made from several TES-3143 13i1 127 i I f subassemblics and components a Quality Certification Log is created and accompanics I the entire assembly through its course within TES in order to provide both a history of its components and a status report of the overall assembly. l

3. 6 Identification and Control of Llaterials, Parts and Components Procured materials, parts and components are identified and controlled in ac-cordance with the procedures of the Manufacturing Department procedures manual.

Fabricated parts including partially fabricated subassemblics arc identified and con-trolled according to procedures set forth in Quality Directive 3.4, ' Quality Control of Energy Systems Division Fabricated Material." These procedurcs assure that identifica-tion is maintained either on the item itself or on records traceabic tothe it<"n to precludo the use of incorrect items. Identification of the safety-related components enables traceability to the appropriate drawing, specifications, purchase orders, manufacturing and inspection documents, deviation reports and material chemical and physical test reports. The location and method of identification is selected so as not to affect the i fit, function or quality of the item being identified. The correct identification of materials, parts or components is verified and documented by Quality Controlinspection prior to fabrication, assembly or installation. i

3. 7 Control of Special Processes Special processes such as welding, soldering, heat treating, cleaning and the like, are documented and procedurally controlled.

Special processes are documented on book form drawings, if peculiar to a partic-ular program, or Process Specifications if applicable to multiple programs. The control of these documents for release or revision is as discussed in Section 3. 4. The procedures, h, equipment a 1d personnel connected with special processes are qualified in accordance with applicabl' codes, standards and specifications and pre-qualification chech runs on l l TES-3143 1311 128 i i

certain select cases. Records of such qualification runs and personnel skill certifications are filed and kept current by Quality Operations. Periodically these procceses will be audited to the requirements of Quality Directive 5.3, " Periodic Internal Quality Audits. " Employec skills for such areas as potting, soldering, ponctrant inspection, Icak detection, etc., are dctormined and documemed in accordance with Quality Directive 9.1," Employee Skill Certification. "

3. 8 Inspection The Quality Operations Department Manager reports directly to the President of the Company as noted in Section 2. 0. This arrangement establishes a Quality Control activity that is separate from the functional departments and provides a direct line of communication with upper management. The Quality Control function is controlled by established procedures as defined in the Quality Manual (ES-2G51 This manual is made up of a namber of Quality Directives which delineate the procedures used by the Quality Operations Deparf ment in Conducting inspection and control functions. These directives are s"bjected to periodic audits in accordance with the requirements of Quality Directive

5. 3.

The inspection program is intended to verify conformance to the specified require-m ents. Individuals performing inspection aethines are independent and in diflerent I organizations from the individuals performing the activity being inspected. Quality in-- spectors are qualified in accordance with applicable industry codes and standards and/or through on the job training for the use of certain specialized instruments and equipment. Records of individual skill certifications for certain specialized training are maintained by the Quality Operations Department. Modifications, repairs and replacements are inspected in accordance with the original design and insp2ction requirements or approved alternatives. ) j] TES-3143 i ) i I

The established procedures require that a Quality Log is used in the accumula-tion of the insp"ction history and shows the acceptance status of the various components and subassemblics contained therein. This log also contains the direction for mandatory inspection points, and the recorded results as appropriate. Nonconforming parts or packages will be identified, tagged, and physically impotmded, where practical, until written disposition by proper authority is roccived.

3. 9 Test Control When a test program is required to demonstrate that an item or component will perform satisfactorily in service, a test procedure will be documented, reviewed and approved in accordance with the " Engineering Documentation Standards" manual. The applicable tect results will be documented, evaluated and their acceptability determined by their meeting specified acceptance criteria, or evaluated by the Program Manager in the case of development tests. Modifications, repairs and replacemer.t items are subject to the same tests and fest requirements as was the original design.

3.10 Control of Measuring and Test Eq.lipment All measuring and test instruments are calibrated at specified intervals based on the required accuracy, purpose, degree of usage and stability characteristics. A manufacturing and inspection equipment calibration and certification program is maintained in accordance with Quality Directive 7.1, " Standards imd Calibration," in order to schedule the calibration of inspection and test equipment used for determination of product acceptability. Each item of measuring and test equipment is identified by serial munber and traceable to its calibration test data. All reference and transfer standarda are traceable to nationally recognized standards; or, where national standards l do not exist, the basis for calibration is documented. i I l TES-3143 1311 130 -18 I i

i l f When measuring and/or test equipment is fotmd to be out of calibration, all identifiable previously inspected parts or components are " tagged" as nonconformance I items until the suspect items can be reinspected or otherwise dispositioned. This po-tentially serious problem, is casily taken care of on the Sentinel program, because of I the small number of piece parts involved. 3.11 Handling, Storage and Shipping Maryland is an " agreement state" therefore, Tcledync Energy Systems has a Radioactive Material License, No. MD-03-014-01, which expires May 31, 1981. All Maryland licensees have imposed upon them comprehensive regulations which provide extensive coverage for the handling, storage and shipping of radioactive materials. Additionally, the license identifies and imposes restrictions and limitations on personnel L who can supervisc handling of radioactive sources. In-plant locations for operational procedures and storage are also provided in the license. IIcalth Physics personnel supervisc receiving and shipping of radionuclido devices and are responsible for implementing all Federal and Stato regulations. They verify that radiation and contamination limits are satisfactory, specify location in an exclusion area, and define boundaries for the exclusion area. IIcalth Physics issues both general instructions concerning working in the area, also issues specific instructions covering specific devices. The Sentinel generators produced by TES are designed to satisfy all requirements of 10 CFR Part 71 and, in particular, Appendix A (Normal Conditions of Transport) and Appendix D (IIypothetical Accident Conditions). Further, in-plant movement of generators is restrictc? i The radionuclide always remains within the primary biological shicid, thus adequate radiation protection is always afforded. The gem.rators are self-contained and i I )) }} TES-3143 l l

passive and there is no requirement for external heat dissipation, therefore, power failures or ecolant system failures are not a consideration. hinterial selection for the generators are based on thermal, mechanical and cor-rosion considerations. As an example, the fuel capsule design can withstand the com-binded thermal effects of the radionuclide plus an external fire (30 minutes at 1475*F), external hydrostatic pressure to 10,000 psi without internal support and without yielding, or seawater corrosion for greater than 500 years. All handling of radionuclide devices is limited to qualified personnel and is con-trolled by comprehensive procedures which cover fabrication, cleaning, handling, storage, assembly and testing of all components and subassemblics for the generators. Concerning the shipment of Sentinel generators, a?' applicable regulations contained in the U.S. Department of Transportation Titic 40 Code of Federal Regulations, Parts 100 thru 100 and the U.S. Nuclear Regulatory Commission Title 10 Code of Federal Regulations Part 71 are followed. Necessary shipping papers, as required, are prepared by TES' Alarheting Department and IIcalth Physics. Prior to cach shipment, the shipper will notify the consignee and, for export shipments, the competent authority of the daic and time of shipment and expected arrival time and destination of the package (s). l 3.12 Inspection, Test and Operating Status Established procedures will be used for maintaining traceability and inspection status (acceptance, or rejection) and required test status of items used in the Sentinal l transport package. (Operation of the Sentinel transport package is not applicable in that the unit is passive in its protective function). The traceability and status of the package assembly is verified through the use of a Quality Certification Log which accompanics the related hardware through each step of its assembly and test. Procedures controlling the TES-3143 ' 1311 132

application and removal of inspection stamps and status indicators such as TAGS and labels are documented in the Quality Manual (ES-2G5). The Quality Certification Log is basically a Quality Plan that establishes the data collection and mandatory inspection re-quirements, in sequence, for the complete package. Since the required inspections, tests and other critical operations are listed sequentially in the Quality Contre? Log, an un-intentional by-passing of a step is casily detected. The by-passing of any required step or operation is noted on an "RS" (Reporting System) tag to be dispositioned by the Corrective Action Board. RS tags against any component, or the system become a per-manent part of the Quality Control Log. The status of nonconforming, inoperative, or malfunctioning (rejected) components is identified to prevent inadvertent use. Such parts are procedurally segregated until dispositioned "use-as-is," " rework," " repair"or " scrap. " 3.13 NonconformingMaterials, Parts or Components Established procedures, as defined in the Quality Manual are used for identifying, and documenting discrepancies, segregating the hardware and withholding from use in the transport package until authorized written disposition instructions are roccived. The documentation (RS tag) identifics the nonconforming item, describes the nature of non-conformance, corrective action required, the dispo sition of the nonconformance and the inspection requirements and includes approval signatures of the disposition by the ap-plicable personnel. The Quality Engineer may disposition hardware as " return to supplier," " rework to specification," or " scrap. " Dispositions of "use-as-is, " or " repair," however, requir the review and approval of a Corrective Action Board (MRB) and the issuance of a Correctivo Action Board Report in accordance with Quality Directive 3.7, " Corrective Action Board System. " The acceptability of rework or repair of materials, TES3143 }}}} }}} i

parts, compcnonts and systems is verified by reinspecting and rctesting the item as originally inspected and tested or by a method which is at least equal to the original, as directed by dispositioning instructions. 3.14 Corrective Action Nonconformances, failures, malfunctions, deficiencies, deviations, and defective material and equipment will be cause to evaluate conditions that may be adverse to quality to determine the need for corrective action. The conduct of such investigation is described in the Quality Alanual (ES-2G5). A Corrective Action Board is employed on the Sentinel program. Part of the responsibility of the Quality Engineer and the Corrective Action Board, is to determine the cause of the discrepant event, and conduct or recommend specialinvestigations and corrective actions as appropriate to preclude repetition of the event. Copics of the re-1 cased Corrective Action Board Report are distributed to appropriate individuals for information and appropriate action. A Corrective Action Status Report (CASR) system has been established to assure that follow-up reviews are conducted to verify proper implementation of corrective actions and to closc-out the Corrective Action Documentation. 3.15 Quality Assurance Records Quality Assurance Records for the Sentinel transport package will be maintained throughout the service life of the package. These records will include design definition records (drawings, specifications, procedures, etc.); purchase orders plus appropriate certifications; Quality inspection, acceptanec, control, shill certification and audit records; production accelCanec tests results and shipping records; and NRC Certifica-tion of Compliance Applications. LIicrofilm copics may be employed for record retention at the discretion of Toledync Energy Systems, Records portaining to Sentinel models are 2-

identifiable and retrievable. On Sentinel procams, a list of the required records and their locations will be maintained. Included in these records are: purchase orders, .natcrial con 'ications, reporting system tags, configuration record, outgassing test data and the generator fueling log and performance test results. In addition, the list-ing will include a file of each units fabrication / assembly log which includes nonconfor-mance reports, Corrective Action Reports, procedurcs, test results, inspection items and revision status of each component. Engineering drawings, specifications and pro-cedures are filed and retained for the life of the package. Design calculations related to safety items are documented in a " Structural, Thermal and Shielding Evaluation Report" and.. so retained in a Company file. Inspection and test records which are contained within a tmit's assembly log book include evidence of completing and verifying each manufacturing, inspection, or test operation; results of tests or inspection and inspector or data recorder identi-j fication. The log also contains information related to adverse Quality conditions such i as nonconformances and Corrective Action Reports. The completed log with all } appropriate inspection stamps, test results and Corrective Action Dispositions serves i as evidence that the package has been accepted to the critoria established on the Engineering Documentation. f 3.1G Audits of Quality Assurance' Plan Compliance to this Quality Assurance Plan will be assessed by a team of three l individuals approximately onec por year. The team members will be selected from service groups within the company--typically from Central Engineeriig, Afatorials Engineeriig and Test, and Quality Operations. The audit will be conducted, using h this plan, or a specially preinred check list as a procedure. Results of the audit will l be reported to Manngement along with recommended corrective actions for noted TES-3143 j'} } } }}} -h-t i

i deficiencies. Records of audit results will be maintained by the Quality Operations i Department in accordance with established procedures. (Lack of Sentinel program activity at the time of a scheduled audit will be justification to delay the audit until the program is again active. ) Follow-up to determine that action has been taken to correct deficiencies is provided by a special " Audit Reply' Form" which must be com-plcted before the audit can be closed-out. This action assures that deficient areas lB are re-audited to verify implementation of corrective actions.

4. O SPECIFIC PROVISIONS Specific provisions contained in existing NRC package approvals, applicable to the "Sentincl" product line, specify the fuel type and form, the maximum allowable fuel content and the fuel encapsulation materials.

These provisions have been controlled in the past, and will continue to bc con-trolled, by the following measures. The completc " heat source" requirements including fuel form, thermalin-ventory, welding and testing will be delineated by a TES document " Fueling Specifica-tion for Strontium 90 Radioisotope IIcat Sources. " This document will establish Quality AE,surance Provisions which require the fueling facility to establish and main-9 tain a Quality Control Program to verify degree of conformance to specification re-quirements. Certification will be required in writing for critical source data including fuel chemistry, fuel quantity, wohlQuality Assurance results (dyc ponctrant, leakage tests and metallographic examination of wcld samples) and test results for surface contamination. Fuel capsule, liner and wcld test components will be furnished to the fueling facility by TES. The heat sourco hardware will be fabricated and non destruc-l. tively (radiograph) tested in accordance with applicable engineering drawir.gs. Tcledync Energy Systems, through the use of the Quality Assurance measures described, will { retain responsibility for the complete package design. 1311 ,136 TES-3143 i f I i l The fuel processing, encapsulation, and RTG loading activitics have been per-formed at a National Laboratory (e.g., ORNL at Oak Ridge, Tennessec). These per-formance activitics and the duty of executing this portion of the Quality Assurance Program will be delegated to the fueling facility but compliance to specifications will be assured by,a signed and dated certificate of compliance. Deviations from speci-fication will require review and written approval of a Corrective Action Board (AIRU). Final acceptance of the pacimgo will be based on acceptable heat source data, satisfactory completion of the RTG loading procedure and acceptabic surface con-tamination and radiation levels sufficiently low to permit commercial shipment. \\3\\\\ \\5l TES-3143 }}