ML19312D113

QA Plan for Protective Packaging Div Products,Revision a

ML19312D113
Person / Time
Site:	07100046
Issue date:	02/06/1980
From:	Hall W TELEDYNE ENERGY SYSTEMS
To:
Shared Package
ML19312D112	List: ML19312D111 ML19312D113
References
TES-PPD-2, NUDOCS 8003210050
Download: ML19312D113 (23)

Text

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e QUALITY ASSURANCE PLAN c

FOR

' PROTECTIVE' PACKAGING DIVISION PRODUCTS

'TES-PPD-2 0

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iAPPROVED c'M e William-C. Hall.

.. Man _ age r,.

~ Protective ~ Packaging Divis;.-

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EYM PAGE DESCRIPTION DATE APPROVCD

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Revised Text to incorporate NRC comments for-2/6/80 d%[jf j,2 10CFR71, Appendix E application.

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Quality-Policy and Doctrine-The Management,of Teledyne Energy',Systdms subscribes to and supports a Quality Program-that; assures

product conformance to specifications.

iMeaningful' Pr duct Conformance to ' Specifications. must be designed, a'

scheduled and. built into the product.

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~ Meaningful Product Conformance ' to-Specifications can only be attained

' when supported by-all. management and functional. segments of the compan:

Meaningful Product:Conformance to Specifications creates satisfied customers and encourages new-and carry-on contracts for Teledyne Energy' Systems products.

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i LContents Page

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l Quality; Policy and' Doctrine

-: Sec tion 1.0-LIntroduction~

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.2 2.0L Organization..

13.0

~ Quality: Assurance. Program 4'

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. Design? control.

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-3.2 Procurement -Document Control 9

'3.3 Instructions,2 Procedures and Drawings 10

'3.4:

Document Control-11 3.5 Control ofLPurchased Material, 12

. Equipment -and Services 3.6 Identification and Control of Materials, 13

. Parts. and ' Components.

3. 7 Control of.Special Processes 14 3.8 Inspection 14 3.9-Test Control 15 3.10 Control of. Measuring and Test Equipment 15

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3.11.

' Handling, Storage and Shipping 16 3.12 Inspection,.. Test and Operating Status 17 3.~ 13.

Non-Conforming' Materials, Parts 1or-17

Components

! 3.'14 -

Cor'rective Action 18

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.Qualityf Assurance Records 18 3.16

' Audits.:-.of Quality Assurance Plan 19

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1.0-INTRODUCTION

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The, Quality Assurance Plan delineated within this document 10 CFR 50,

- has' been ' prepared to meet the intent of Appendix B,

" Quality Assurance Criteria for Nuclear. Power Plants and Fuel-

- Processing Plants" and Appendix E, 10'CFR 71, " Packaging of Radio-

- active Material for. Transport and Transportation of Radioactive

,. Material Under Certain conditions."

This plan will be executed by Teledyne Energy Systems in conjunction with radioactive waste

. processing and handling systems fabricated and-supplied by Teledyne Energy Systems, Protective Packaging Division.

~Teledyne Energy Systems' functional organization arrange-ment is incorporated within this document as well as a discussion of the Quality Assurance responsibility areas of each department (refer. to Fig. 1).. The Quality Assurance program is described and. the portinent critoria of A'ppendix B, 10 CFR 50 and Appendix E,.10'CFR 71-are addressed ~as individual items.

The objective of this Quality Assurance Plan is to establish' and maintain an effective and economical quality system

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to provide reasonable confidence that the systems and components

. fabricated and supplied will perform satisfactorily in service.

The Qual,ity Plan design has been. based upon consideration of the quality history of past programs, design review and verification, and the necessity to impose controls and surveillance over critical manufacturing and safety related activities.

Quality Assurance meacures contained within this plan and Lutilized-by Teledyne Energy' Systems have been executed and documented

.as a matter-of course.within our normal mode of operation on other The Quality Assurance Plan contained herein will become programs.

effective on February 1 11, 1980 and will not be made retroactive.

Upon the -issuance of this document,' all of the Quality Assurance provisions: stated herein are mandatory ' requirements to be implemented

- and enforced within the Protective Packaging Division.

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,x-ORGANIZATION

2. 0 '

i KThe'Teledyne'~ Energy Systems organization is shown in' Figure 1.

(The inter-relationship. of. Quality Operations to other management p

functlons is clearlygshown. 'ThisLorganizational structure permits a' close relationship of Quality l personnel with program activities

'toEachieve.high program efficiency ~while recaining unimpeded access The Quality Operations Department has the to higher management.

required auth'ority and organizational' freedom to provide its finspection and control functions with independence'from undue t

influence of costs and schedules.

Functionally,. the Division Manager has the overall responsi-

..bility to coordinate all of the activities affecting the final

. product such that delivery can be made within schedule and. cost -

fabrication, cg'oals.These activities-: include design, analysis, These asse'mbly, test, quality control, handling and shipping.

activitics.are accomplished through assigned representatives from the. applicable operating departments who form the division " team."'

As : indicated, each representative is responsible to a department manager.to maintain unimpeded' communication with high level manage-ment.

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

Central Engineering Section - Responsible for the a.-

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-' functions related to design, design reviews, ana ys s safety and, reliabilitiy, and engineering documentation control.-

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Manufacturing Department - Responsible for those ifunctionsf affecting material and production. control.

Materials Engineering :and-. Test. Department - Responsi-

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_ 'blelforEactivities-related to material s' election and w

" specification, process _ specifications and health physics-aspects of the -subject deliverable' hardware.

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Quality' Operations 0 Department.- The Quality Control-h

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. < function isirespons'ible for -conducting inspection a

~ - and control activities to ass'ure that.out-of-spec

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s hardware is identified and withheld from.use unless 4

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-written and.fapproved authority is' received.

Quality W

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Engineering is charged with the planning and auditing

' aspects of. Quality.

This activity also includes the freview of TES Engineering documentation to assure that proper-inspection and control measures are-incorpor-ated.

The'.overall.. authority"and responsibility for this Quality

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The indi-Assurance' Program'is maintained by the Division Manager.

vidual; assigned to ithis position must possess a college degree, preferably.in.one of.the' engineering complexes, and must have a minimum 1of.five~ years' experience in a responsible capacity on one or more ' hardware'-type programs.

The Division Manager must be familiar.'with the company's Quality Assurance Policies and objectives 7

and'with interface relationships and Quality Assurance functions of.each organizationar element.

The'. authority and duties'of all persons performing Quality Assurance. functions are documented.

These persons are given the Lauthority:and freedom to. identify Quality Assurance deficiencies; to" initiate, recommend' or provide corrective actions; and to verify

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- that' directions.are implemented properly.

Certain Quality Assur-

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anceLpositions, namely, those of Division Manager, Engineering Manager /' Quality-Operation's Manager, Quality, Control and Quality Engineering Supervisorsiand the Manufacturing 1 Supervisor and the

Div'ision's.' Production; Cont'rol representative' are given the authority

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by. this ;dcicument to stop.any work item or process which is suspect i of ; compromising. the' end product.

Disputes involving quality, iarising from a difference of opinion will be resolved through a E ivision! staff' meeting including, representatives-of Engineering, D

Quality, Materials-Engineering [and any other concerned parties.

,In certainiinstances the. execution of our Quality Assurance

programJmayEbe': delegated!to'an outside organization but TES retains s

the responsibility. for. the reliability of its. products.

3.0:

-QUALITY ^ ASSURANCE PROGRAM e

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t Th~e Quality - Assurance Program: described within this document

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lhasibeentestablish'edland[wil1J be ' implemented for' the design, fabrication,- a'ssembly, J.tssting, cuse and = maintenance of deliverable iproducts.y TheEProgram appIies' the? pertinent requirements of

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.I Appendix B,J10 CFR ' 50- and. Appendix E of 10 CFR 71, in a graded approach, to assure.conformance'to the approved design specifica-f tions of each.in'ividual unit..

Teledyne's top level management d

' through. periodic staf f meetings, will assess the scope, status,

' implementation'and effectiveness of the Quality Assurance program to assure adequate compliance with the aforementioned criteria.

' Management's assessment of this program will be made with the consideration of the most recent audit results as appropriate.

This document will be formally issued by job release sheets to all and PPD " team" members, ; as delineated by a Division memorandum, earh recipient will be issued cl1 subsequent revisions to the plan.

Division staff meetings and organizational group meeting will empha-size that the-Quality Policies and Procedures described in this Quality Assurance Program Plan are mandatory requirements which must be implemented and enforced.

The purpose of the Quality Assurance Program is to plan, document and carry out all of the activities. required to provide adequate confidence that the products will perform safely in service.

The safety-related components to be controlled by the Quality Assurance Program are:

1.

Shield ~ Bodies - Biological Shielding 2.

Housing and/or Shipping Containers - Package Teledyne Energy Systems has operated within the scope of numerous Quality' Program Plans under contract to various Government agencies and.has evolved, over the course of many years, a group.of standards and policies contained in manuals which address most

-Quality Assurance Criteria.

This document maximizes the use of The manuals these existing. manuals, by refarence, where applicable.

which delineate procedure'-and policies regarding many Quality Assur-ance activities are as follows:

Quality Manual- (ES-265) - This manual, maintained -

a.

details the by the Quality operations Department, activities 'of' Quality personnel through individual LQuality Dir'ectives.

Theidistribution and revision of this manual is controlled solely b-Quality Engineering.which maintains a master file of issuance-

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and revision.

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. Engineering Do'cumentation Standards-Manual This

-document, maintained by the Central Engineering section c

describes drawing.and process preparation, release

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an'd revision controls.

c.

Manufacturing Department Procedures Manual - This manual, maintained by -the Manufacturing Department covers receipt, identification, storage control and shipment of materials as well as tool control and equipment maintenance.

d.

Procurement Policies and Procedures Manual - This manual maintained by the Administration Department, details activities. pertaining to the procurement of materials, equipment and' services.

These manuals are available to any TES employee for reference, but they are not widely distributed outside of the controlling

' department.

The text of this plan, however, shall supersede and take precedence over all other documents.

In addition to the o.xisting documents, a newly created plan, entitled " Protective Packaging

-Division Documentation Plan" (TES 000002) will be implemented for all work within the Division.

The documentation plan delineates the requ,irements for the preparation, approval, release and retention of all engineering documentation.

-The referenced documents are intended to ensure that all provisions of the-product design approval are satisficd.

Personnel responsible for performing Quality-related activi-

. ties will be instructed as to the purpose, scope and implementation of the Division plan, instructions and procedures.. Personnel s

< performing Quality ' relate'd. activities have been-trained over the course L of many years.and 'are deemed qualified in the principles an'd-techniques'of the. activities to which they are assigned.~- New

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- Quality - Control' personnel are. given. "on-the-job" training and periodic instructions from the Quality Engineering / Quality Control supervisors.. Special' skill training and certification. requirements care documented in Qualityirecords and individual proficiency tests

,and'recertification. examinations are given periodically where specified..

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) 1 1 Quality-relates activities are performed with equipment under V

special environmental conditions wh'ere specified by drawings,

procedures.or' specifications, and whereL appropriate, prerequisites,

~ such as t prequalification~ runs are satisfied prior to inspection - and

. A brief discussion aof die applicable Quality Assurance test.

criteria requirements follow.

3.1 Design Control-

- The design control function is to assure that the applica-

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ble regulatory requirements, the product design configuration, and materials of construction, as desciibed in the applicable specifica-

tions,.are properly translated. into drawings, specifications, pro-cedures and special instructions.

.The product assembly, subassembly and component detail drawings will be accomplished in the Design and Test Group of the Central Engineering Section.

Drawings are reviewed and approved by a checking group within the same group to assure compliance with the applicable drafting practices.

The drawings will also be re-viewed for verification of. design adequacy by the structural analysis, safety and reliability, and thermal and hydraulic sections, as The design-verification will be achieved by calcula-applicable.

Additional = review will be performed by the Materials

[

tive methods.

if appli-

'Section'of the Materials Engineering and Test Department, a

cable, to assure the suitability of materials, components, equip-The Materials

-ment and processes. for their-intended application.

Engineering and Test Department will. also generate material and X:

. process specifications, as. required, to achieve performance parameters.-

' Each :new PPD. design requires the preparation ' of a " structural, thermal and shielding evaluation" report as applicable, which This document

basically serves as'a design verification document.

not only requires. the-approval' uof' the Program Manager, but will be

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submitted to~ the NRC asinecessary - for _ license application.

Design" verification or - checking is not permit'ted by 'the

' original designer, ' cut Lin Our small organization, is sometimes s

performed byfthejdesigner's supervisor.

Design verification by

.the designer's supervisorfis noticonsidered to be a detriment to

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' the. proper accomplishment of a design review, and permits the super-

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visor,a:first hand evaluationoof the designer's work performance.

All, engineering. drawings ~and specifications are reviewed-by theLQuality Engineering group to assure that the appropriate

/ Quality; inspection and' Control instructions'are specified and

' included in~ design documents.

-Quality 1 operations will record and document drawing and specification 1 changes to assure that each delivered end item Jpackage).is traceable b'ack to the proper change level of the

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. drawings and specifications defining -it.

These revisions are subject to the same controls' and approvals that were applicable to the original' design.

. Final' Engineering document review and approval will be performed by 'the Division or Engineering Manager -to assure that the

- proper. acceptance criteria for inspections and test are delineated and that all of the appropriate approvals have been obtained.

The procedures defining the activities of drawing, specifi-cation and process preparation; release, and revisions are set forth in the " Engineering Documentation Systems' manual and the

" PPD Documentation Plan".

The drafting practices specified in

the manual basically conform to MIL-D-1000, Form 2 and to MIL-STD-100.

In cases where it is appropriate to verify design adequacy s

-w ti h a test-program, qualification testing under design conditions willibe accomplished.

Although design reviews have been acccmplished on existing PPD products, these activities. are not controlled by written procc-

-dures.: A design review procedure, however, will be established

prior to the' initiation of sly new PPD product design.

The.proce-

' dure.will' delineate' the-participat'ing groups.and their authority and

- responsibilities.

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In: summary,Edesign verification is performed by either a

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. Design Review Board,cby alternate calculations, by qualification-testing as. appropriate. or; a : combination of these methods.

Design ~ reviews,at'.Teledyne are never accomplished by an

. individual, b'ut rather by a " team" composed of members from each

ofi.the various complexes,as required, i.e., Engineering Design' s

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'Struct' ural An'alysis,~ Safety'and. Reliability, Manufacturing and j.

j Quality Control.

The responsibility to conduct - the Design Review Board'will be given -to a qualified individ'ual other than the designor 'andL the designer's supervisor'.

'3;2 Procurement ~ Document Control Procedures have been established that clearly delincate the sequence of: actions required to preparo, review, sign-off and control. procurement documents.

The applicable requirements of 10 CFR 50,' Appendix B and/or 10 CFR 71, Appendix E are to be identified by the Engineering originator and reflected in appro-

priato specifications and procurement documents indicating that the specified requirements' must be complied with and addressed in a supplier's Quality' Assurance Program.

The design technical requiromen'ts including: material and component identification require-ments, 'applicabic regulatory requirements, drawing, specifications,

-industrial standards and codes, special process instructions and

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test and inspection - criteria are contained or referenced on all

'appropriato procurement -documents.

Procurement documents also

-identify through an' inspection coding system, any documentation that

-is to be prepared and submitted to the purchaser for review and approval.

Examples of this type of required documentation are drawings,-specifications, proceduro, inspection and fabrication plans, inspection. and test records, personnel and procedure-quali-fications~and chemical and physical. tost results of materials.

The standard terms and conditions printed on our procurement

-documents' require the supplier to retain such records for'a period

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s of'3 years.

,Although it is not: general practice for -Teledyne.to require suppliers to retain, control.nndimaintair, special records, where

.4 Japplicablo, : theso : records would be-identified as - deliverable items,

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to f 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 supplier's f acility and recor's'forfsource~ inspection and/or audit.

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. Revisions ~and changosfto procurement documents require

'special amendment forms which are subjeet to the same-review and

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approvaE as tho original Ldocument.

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w Procurement documents-are ireviewed by' Quality En,gineering we..

'to ensure that listed materials, ~ equipment or services are. clearly specified,t to assure that-adequato Quality controls are suitably included or roforenced in the procurement documents, and to add.

l the appropriate directions.for - cer'tifications ' and source and/or M'

receiving; inspection. in accordance with' the requirements of Quality This Directive 8.1,: (Procuremont Documents-Quality Requirements).

directive in: conjunction with the " Procurement Policios and Proce-dures' Manual" constitute the' control for processing of procurement documents orLchanges thereto.

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3.3 Instructions, Procedures and Drawings __

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All'activitics affecting product quality are prescribed and accomplished in accordance.with documented instructions, preceduros or drawings.

Verbal directions are not accepted in any area of Telodyne. 'The sequence of actions to accomplish the preparation, review, approval, and control of the various documents are delineated in - die " Engineering Document Standards" manual and in the' "Protoc-tivo Packaging Division Documentation ' Plan."

The sequence requires a_ Quality-Engincorin~g Review and approval of inspection plans, testing, calibration and special process procedures, drawings and

. specifications and revisions - thoroto.

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Telcdyne. Energy Systems ucos three types of specifications /

procedures in addition to engineering and vendor drawings and

topical 1 roports.

Thelthree; types of1 documents employed are:

test and/or assembly procedurcs, material; specifications and process specifi-

. ca tionsi

-Theilatter two, of course, are only generated when there is. no equivalent commercial or Government specification.

TeEt and/or assembly procedures are product-peculiar docu-

'ments? issued to delineate a sequence of events, the use of special equipment ori facilitics,1 data requirements not specified by drawings for' addedicompl'ianco criteria.

Matehial'specificationsaro'usedtodelineateminimumfunc-tional, physical,1 chemical, electrical ~ or mechanical requirements Loffa1 material:to assure design adequacy...

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' Process-Specifications are used to describe equipment, mater-

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?ials,fprocessingTrequirements and Quality Assurance provisions

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I Activities affecting the required for'an acceptable - product.

Engineering ReviewLand-approval of these documents are LQuality:

Directive:2.2, " Review of Technical Documents" specified -in Quality:

of the Quality Manual'.

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JTest. and/or assembly procedures are generated in the design Material and and ' test group of the Central Engineering Section.

process specifications. are originated by the Materials Engineering and. Test Department.-

Document Control 3.4 The document control function is to assure that all Engineering documents including drawings, specifications and. procedures are issued, properly reviewed and approved, distributed and revised in

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These. functions are achieved a'ccordance withEestablished procedures.

by1the Central Engineering Department.

Engineering document-release and revision procedures are

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specified in' dhe'" Engineering' Documentation Standards" manual and The required

" Protective Packaging Division Documentation Plan."

-document approval and document distribution list is delineated by

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'Engin'ering Program Directive.

c "he~ Quality Operations. document control functions include T

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review,' approval and_ change level documentation for end item trace-These activities are delineated in Quality Directive 2.2, ability..

" Review of Technical' Documents" and Quality Directive 2.1, "Configur-ation Control."

These activities assure that the documents and s

changesL are adequate and include 1the Quality requirements.

-Document revisions require' review.and approval by the same All-approved organizations th'at performed: the originalLreview.

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, -changes must be. included in instructions, procedures, draw ngs an Docu-

other 4 documents prior to implementation of such change.

., ment's an'dL revisions thereto 'are distributed to the designated A master card file' identifies

' personnel prior'to commencing. work.-

JC instruc-E the current revision status,of all Engineering drawings, Ltionsi and procedures.and -a computerized >-listing. of ? process speci-ffications. delineates (the. revision' status.of thes'e documents.

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- Control of-Purchased-Material, Equipment and Services SupplicrEfacility surveys and Quality audits are performed

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l bk TES Qua,lity' Engincering; staf f personnel on both an unsche u e

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dld and sch'c' uled basis Edopending on the supplier's previous Quality a

history and/or the -criticality of the -item 'or : material being Quality ' Engineering personnel selected for these audits supplied.-

-.have 'the.necessary experiential anditechnical background congruent to -the requirements' of the. audit and if-necessary, export personnel Evaluations

'from other d'cpartmentsiassist'in its performance.

i Assurance 4considercitems such as ' manufacturing capability, Qual ty Program, iibspection procedures, design control systems and personnel Included within -these evaluations is considera-qualifications.

tions of whether -or not the -supplier can comply -with the elements 10'CFR 50 and/or Appendix E, 10 CFR 71 applicable.

of Appendix B,

' Quality Engineering also reviews' histories of suppliers who have Results of all provided simil'argitems of the type being procured.

vendor surveys and-audits : arc maintained on file within TES Quality

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Operations Department.

Where required, scheduled surveillance of suppliers during

-fabrication, inspection, testing and shipment is performed in accordance with' written'TES procedures or standardized Quality Assurance checklists..This is planned'andLaccomplished in order

'to insure supplier conformance to the requirements of the appli-cable purchase order.

~

the In accordance with TES Purchase. Order' requirements, supplier, where applicable k will provide the necessary documentation to: provide _ identity andicertification of the item or material sup-plied 41n:conformance(with lany 1 codes :or specification that pertain to the. subject-purchase order.

While in most instances TES dis-allows shipment:Ef nonconforming items, those items received with

. supplicr nonconformances must be identified as such and' bc. accom-

~

d explanation of

.'panied with a detailo'd nonconformance report an i

'Such'~ nonconforming items are still 2appropriato; corrective-act on.

~ subject' toJ review and acceptance - by TES Quality-Enginecring.

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JReceiving. inspectionfis-conducted prior to -uso of purchased 74)-

Lmaterialk lcquipment and 'scrvices to assure - that' they are correctly

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Jidentificd',; accompanied -with ' appropriate documentation.and in e

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d cf f conformancefwith "the app.licable. P.O. requirements, specifications

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andIc' odes.. Inspection-instructions 4and guidance:is contained in

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Quality Directive H3.'6, < " Quality ' Control of Procured. Materials."

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/Detailedlinspectidn' requirements t are appli'ed as appropriate ' and in

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i accordanceiwith written instructions ~ contained'in'the Purchase f

40rderfor.other applicablehdocumentation such as TES. Engineering

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fdrawingsLand/or; process 1 specification. ' Items inspected-are identi' u

'fied asxt'o'their. stat'us via acceptance tags or nonconformance 1reportsvas% applicable;and in:accordance with the procedures contained Tin Quality Directive?3.6 :and Quality Directive 3.3, "Teledyne Reporting System."- These records are available and accompany the

. item prior to,its release ' or storage within the Quality Withhold

. Area' (if nonconforming).- ~In the case of assemblies made from

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several subassemblies and components a Quality Certification Log

'is. created and accompanies; the entire assembly through its course within LTES in. order to provide both a history.of its components and ia status report of the overall assembly.

3.6 Identification and Control of Materials, Parts and Components Procured. materials, parts andJcomponents are identified.and contr'olled in accordance ~with the procedures of the Manufacturing n

Department; procedures manual.

Fabricated parts including partially

-fabricatedJsubassemblies are identified and controlled acc.ording to-proce'dures set forth'in Quality Directive 3.4, " Quality Control J

of. Energy Systems. Division' Fabricated Material." - These procedures

" assure. that. identification is maintained either on the item itself tor on= records traceable ' to the item to preclude ' the use of incorrect

. items. _. Identification of ' the safety-related-components enables trace 5bilityf to thof appropriate drawing, specifications, purchase.

' orders,fmanufacturing:and inspection documents, deviation reports

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and'materialechemicalt and physical test reports.

The location and method' of identification 'is ' selected so 'as not to affect the fit,

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functionDor-qualityfof the item being-identified.

The correct identification of ' materials, parts :or, components is verified and 1 documented by Quality Control inspection prior-to ' fabrication,

assembly or install'ation.~

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' Control < of Speciab Processes c 3.' 7 ~

'Special1 processes 1suchias welding, soldering, heat treating,

-. cleaning'and,the:like, are documented and'procedurallyLcontrolled.

~Special processes are documented on book form drawings, if

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peculiar 1 o;a particular program,1or Process Specifications if t

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applicable toimultiple programs..The' control of these documents The

-for'roleaseLor. revision ~is as discussed in Section 3.4..

-procedures,) equipment and personnel connected with special processes are. qualified in accordance.with applicable codes, standards and specifications and pre-qualification check runs on certain select Records of such qualification runs and personnel skill-casos.

certifications 'are filed and kept current by' Ouality operations.

Periodica,llynthese processes will.be audited to the requirements

-of Quality' Directive 5.-3, " Periodic Internal Quality Audits."

,Employeo ' skills for such areas as potting, soldering, penetrant

inspection, leak. detection, etc., are determined and documented in accordance with Quality Directive 9.1, "Employco Skill Certifi-cation."

3.8 Inspection The Quality operations Department Manager reports directly.

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This-

- to-- the President' of the. Company as noted in Section 2.0.

Larrangement establishes 1a Quality Control activity that is separate

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from1the functional departments and provides a direct line of communicationLwith upper management.

The Quality Control function

'is ' controlled by established procedures as defined in the Quality

. Manual. (ES-265).

This manualiis-made up of a number of Quality Directives 'which delineate the procedures used by the Quality Operations Department in '.conductingfinspection and' control functions.

!These -directivos are subjected to' periodic audits JLn. accordance with. the"' requirements.of QualityJ Directive 5. 3.~

'The inspection e program is intended to' verifynconformance to the specified require-

. Individuals performing inspection activities ~are'indepen-ments.

-dent and in different organizations 1from the: individuals-performing

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1tia. activity. beingfinspected.

Quality. inspectors.are qualified in accordance with. applicable LiNdustry. codes and', standards 'and/or throughton:-:thoujobEtraining for: the use :of certain specialized

? ins truments 1 and' equipment.. Records.of1 individual skill certifica-i vtions ufor certain specialized -training are maintained by the. Qual ty

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! Operations Department.

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Modifications; repairs:and' replacements are inspected in

'Eu accordance:with the. original design and inspect' ion' requirements' zorJapproved alternatives.

The. established procedures require that. a' Quality Log is used in; the accumulation 1of;the inspection history and shows the t accept'ance Lstatuslof the various components and subassemblies contained therein.

This;1og.also contains the direction for man'datory inspection. points, ;and the~ recorded results as appropriate.

Nonconforming-parts? or packages will be identified, tagged, and Lphysically impounded,: where ' practical, until written disposition

.by. proper. authority. is received.

53.9-

. Test Control ~

'When a test program 'is ' required to - demonstrate that an item

. cur component will perform satisfactorily in service, a test >proce-dure will be. documented, reviewed and approved in 'accordance with the:" Engineering Document'ation ' Standards" manual.

The applicable testLresults will be documented, evaluated and their acceptability determined -by.-their meeting specified acceptance criteria, or evaluated by the Engineering Manager in the case of development tests. cModifications, repairs'and replacement items are subject to the.same tests and tes't requirements as was the-original design.

3.10'

-Contro'l of Measuring and Test Equipment All measuring and. test instruments are ' calibrated at specified intervals based;on the required. accuracy, purpose, degree of f usageLand stability J characteristics'.

A manufacturing;and inspection equipment calibration and

- certification program is maintained. in accordance with -Quality E

. Directive 7.15 '" Standards; and Calibration," in order to schedule ithe calibration of1 inspection and ' test equipment used for determina-

< tion n of E product" acceptability..Each. item of measuring and test equipment 'issidentified;by serial: number and traceable to its calibration - test data. - ~All' reference and transfer standards are traceable toinationally recognized standards; or, where national 1

ssandards ido' not' exist, the basis: for calibration is documented.

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iWhen: measur'ing an'd/or test equipment-is. found-- to be out of J

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ted parts =or compo-

-. calibration,'all. identifiable-provious y. nspec Enents 'are? ?f tagged"D as'nonconformance items until the suspect items

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-can1be' reinspected oriotherwise'disposit one.

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3.11

. Handling, Storage-and Shipping l Maryland Lislan?" agreement state" therefore, Teledyne Energy

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No. MD-05-014-01,

? Systems has La: Radioactive-Material License,2

'All Maryland licensees have imposed

'which; expires >May?31,-1981.

upon; them comprehensive regulations which provide extensive cover-

' age for.the handling,, storage and shipping of radioactive mater-che license : identifies and. imposes restric-

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ials. ' Additionally,

tions'-and limitations on personnel who can : supervise handling of In-plant. locations for operational procedures

' radioactive sources.

and ~ storage; are also provided in the license.

Health thysicsLpersonnel supervise receiving and shipping

.of1radionuclide devices and are responsible for implementing all Feder$1-and State. regulations.

They verify that radiation and in an 1 contamination limits are satisfactory, specify location Health exclusion ' area,- and define boundaries for the exclusion area.

Physics issues bo'th Lgenera1 ' instructions concerning working in the area, also issues specific instructions. covering specific devices.

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rocessing-All handling of radionuclide devices and ra was e p equipment is limited 'to qualified personnel and is controlled by comprehensive-procedures'which cover fabrication, cleaning, handling, storage, assembly and testing.of all components and subassemblies for PPD products.

'Concerning the shipment of PPD products, all applicable

regulations contained inTthe U.S. Department of. Transportation

Title 49, Code of E Federal Regulations, Parts 100 through 199 and

- thcl U.S.. Nuclear Regulatory. Commission Title' 10 Code o'f Federal Regulations.Part 711are.followed. 1Necessary shipping papers, as

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requ1 red,f are < prepared b'y-TES' Marketing Department and -Health'

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Physics.. Prior toleach-shipment, the _ shipper will nocify the consignee and,.for export shipments, the competent authority of the N

dateIan'dLtime of'sh'ipment'and expected 1 arrival-time'and destination Sofithe package (s)'.

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iEstablishediproce.du'res'will1 be? used for maintaining trace -

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_ abilityJand inspection : status?.(scceptsnce,J or rejection) operation istatus;andkrequired. test; status of. itemslused :in the product..

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bly is verified

,[ E heltraceability :andistatusiof the-product assem T

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{through. the use3fia Qualityi certification Log which. accompanies 7the1related hardware through'each step.of its assembly and test.

c Pro'cedures,controllings thel application and removali of finspection; tstampsfand status" indicators such-as tags and.. labels arel documented.

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The Quality certification Log is 2

4 inJthe Quality ' Manual (ES-265)'.

basicallyla Quality Plan thate establishes the data collection-and for the complete mandatory inspection: requirements, in: sequence, Lpabkage.-: Since the required. inspections, tests and other critical

- operations.. areilisted - seque'ntially. in the Quality - Control Log, an

unintentional by -passing of. a step is easily _ detected.

The by-

passing _of any' required step or operation-is noted on an "RS"

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'(Reporting System). tag to be.dispositioned by the - responsible Project Engineer._ RS tags agains t. any ' component', or the system

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The-status of ibecome - a; permanent part 'of the-Quality Control Log.

E.nonconfo'rming, ' inoperative,. or malfunctioning (rejected) components

.islidentified'toiprevent_ inadvertent use.

Such' parts are proce-

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durally* segregated..until dispositioned "use-as-is," " rework, "

' " repair" or-" scrap."

-_; 3.13 Nonconforming Materials, Parts or' Components

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Established procedures, as defined in-the~ Quality Manual

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arec.used'- for : identifying, Land ' documenting discrepancies, -segregating

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.thelhardware 'and ' withholding from use in the : transport package luntil authorized [ written disposition instructions are received.--

iThe5 documentation.(RS. tag) K identifies ; th'e l nonconforming item,

describesithe nature ;of non-conformance,. corrective. action required,

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itheldisposition of the n'onconformance.and the inspection require-

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mentisjandfincludes approval' signatures.of the disposition by the

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! applicable personneli tThe; responsible Project Engineer or his -

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0 designee inayfidisposition' hardware 'as " return _ to - supplier," ' " rework 1

i tofspecification,"3 ordscrap."' ' Dispositions of "use-as-is," or

" repair," j owever,Laretaddihionally subjected;to customer l approval

-! prior to:' implementation shen 0specified 'byf the contract specifications.

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a Theiacceptabilityfo'f; reworklor: r.epair of;; materials,. parts, componente

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. Corrective 1 Action-

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yNonconformances bfailures,1 malfunctions ~, deficiencies',

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QdediatiSns,Nand defective 1 material Landlequipment' will be cause;to t

,NQ eval'sateEconditionsfthat mayibefadverseJ o qualityIto. determine t

! $ 3thelneeM for;dorre'ctivelactidn.. The conduct'of suc.h investigation-(is described HinLthe];Q'uality, Manual ' (ES-265).

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sThe:responsibioity ofethe' Project' Engineer is to determine the-

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cause ofI the[ discrepant " event,-- and. conduct or re' commend - special 3

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Linvestii ations _ endEcorrective" actions 'as appropriate to preclude

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.'.l repetition of:the'e' vent..' Copies of:the. released Nonconformance i

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( -:LReport (RS tag) are distributed to ! appropriate' individuals-for

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~ cinformation.and~ appropriate action._ Division st i meetings

" include reviewsief required corrective action for aonconformances 4 -

inc order :to ensure proper follow-up and' close out of the corrective

' action = documentation..

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T3.'15 ! 'foualitv Assurance. Records D

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Quality' Ass 6rance' Records for..the product will be maintained e

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(thdoughodt J the service life 'of; the product., These records.will i

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(include des'ignfdeEinitiont records -(drawings,- specifications, pro 1

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' cedurcs,- etc.) ; f purchase f orders pl6s.rappropria'te i certifications ;

iQua11tylinspection, acceptance, controC skill'cortification?and~

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1auditirecords;' production acceptance tests results and shipping

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heco~rdk;1andlNRCL Certification of JCompliance Applications.. Micro '

Eglimicopiesomayibe employedjfor recordfretention'at-the discretion

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iofLTeledyne EnergysSystems. : Records pertaining to PPD products

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' Tare _cidentifiable and? retrievable, fA list'ofL the required records I5cluded in these records Land the'ir?locationsawill)be~ maintained.

labe:; : purchase (orders,[ matisrial ~ certifications, reporting system u*@,' '

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D : tags,c con figuration; record, atest data? and ' performance x test -- results.

iInYadditilbn',Utheflis. ting M11incliide a ^ fileaof Leach = units !fabri-

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! cation /assemblyilogiwhich -includes nonconformance reports, procedures.

n-2, ~ ctiestSresnits Winspection?2 items ? and f revision'. status. of.each component.

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i Engineering ' drawings,( specifications a$d proceciures "are - filedi and.

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/ retained?forEthe ilif.e iof : the product. ;Designicalculations related=

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s LIncpectioniand testirocordsEwhich ~ are contained within a

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~t tun'it'ssassemblyslog' book include 1 evidence'of completing and veri-

-fying each manufacturing finspection,_or' test operation; results

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.of[ tests L or in'spection t and inspector or data recorder identifica-tion.j:The-logfalso contains'information related to adverse Quality if conditions such?as.nonc'onformances.

The completod' log with all fappropriate xinspection stamps, _-test results and Nonconformance

. Dispositions; serves as? evidence.that'the packago has bcon accepted to the critoria established on tho' Engineering Documentation.

3.-16 Audits of Quality Assurince Plan Compli~ance. to this Quality. Assurance Plan will be assessed The by a team of; three individual; approximately once per year.

team members 'will be' selected from servico groups within the

' company--typically from Central Engineering, Materials Engineering and Test,fand Quality operations.

The audit will be conducted, using? this plan, or a specially prepared check list as a procedure.

iResults 'of ~ the audit will be. reported to Management along with irecommende'd corrective actions-for noted deficiencies.

Records lof = audit: results will be maintained by the Quality operations _-

. department:-in;accordance with established procedures.

Follow-up

to? determine that' action has been taken to correct deficiencies is provided by.a special " Audit-Reply Form" which must be completed

^beforcithe audit can beiclosed-out.. This action assures that i deficientiarcas-- are re-audited to verify' implementation of corrective actions.

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