ML20148B152

QA Program for Design,Fabrication & Use of Shipping Containers for Transportation of Radioactive Matls

ML20148B152
Person / Time
Site:	07106280, 07105948
Issue date:	11/15/1979
From:	J.L. SHEPHERD & ASSOCIATES
To:
Shared Package
ML20148B151	List: ML20148B146 ML20148B152
References
14824, NUDOCS 8001210096
Download: ML20148B152 (51)

Text

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.Irraskaten & 'Cattbration Eautoment QUALITY ASSUR ANCE PROCEDURES FOR DESIGN, FABRIC ATION 'AND USE OF SHIPPING CONTAINERS AND OVERPACKS USED FOR THE TR ANSPOR TATION OF R ADIOACTIVE MATERIALS DOCUMENT TITLE: Number QA-RM -001-A

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LICENSEE: J. L. Shepherd and Associates 740 Salem Street Gle ndale, California 91203 (213) 745-0187

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MANUFACTUHPRS ENGINEEC CONSUL TANT 3 8001210

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TABLE OF CONTENTS R e w s i on S he e t................................................ 2 Introdu c ti on.. '..................................... '........... 3 I. Organization

1. S tate me nt of R e s pons ibili ty..............................

4

2. Quality Planing Manual................................... 5

3. O rg aniz a tio n C h a r t...................................... 16

4. J ob D e s c rip tio ns....................................... 17

5. Job Description and Qualification - Head, Q. A. Program.... 25

6. S tatement of R e spons ibility............................... 26

.II.. Quality Assurance Program

' S ta te m e nts 1 - 5............................................ 2 7 S ta te m e nts 6 - - 7........................................... 2 8 III.. Design Control Statemen ts 1 3........................................... 2 9 S ta tem e n ts. 4 - 8.......................................... 3 0 IV. Procurement Document Control S ta te m e n ts 1 - 5.......................................... 31 S ta te nre n ts 6 - 7.......................................... 3 2

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V. Instructions, Procedures and Drawings S ta te m e nt s 1 - 3............................................ 3 3

'VI. ' Document Control S ta te m e n ts 1 - 5........................................... 34 VII. Control of" Purchased Materials, Parts and ~ Components S ta te m e n ts 1 - 5........................................... 3 5 Statemen t ' 6............................. ;................. '3 6 VIII. Identification and Control of Materials, Parts and Components S tate m e n ts 1 - 5........................................... 3 7 IX. Control of Special Processes

'S ta te m e n t s 1 - ~ 3........................................... 3 8 X. Inspec tion S ta te m e n t s 1 - 5........................................... 3 9 XI. Test Control S ta te m e n ts 1 - 3........................................... 4 0 C

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TABLE OF CONTENTS (continued) l 9.

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XII. Control of Measuring and Teat Equipment S ta t e m e n t s 1 - 4...........................

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'XIII. Handling, _ Storage and Shipping S ta tem e nt s 1 - 4.......................................... 4 2 XIV. Inspection, Tes t and Operating Status S ta te m e n ts 1 - 4.......................................... 4 4 XV. Nonconforming Materials S ta te me nts 1 - 4.......................................... 4 5 XVI. Corrective Action S tate m e n ts 1 -- 3.......................................... 4 6 XVII. Quality Assurance Records S ta te m e n ts 1 - 6........................................... 4 7 XVIII. Audits S ta te me n ts 1 - 5.......................................... 4 9 99024167 t

. P ye.2 REVISION SHEET Revision Number Date Summary Initials

'Q A-R M-001 -A 11/16/79 To.tal revision per neeipt of M FS 10CFR 71, Appendix.E g g' Acceptance Cri-teria - Trans-portation Packages for Normal.

Form R adioactive Material,

'from the U.S. N. R. C.

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INTRODUCTION J..L. ShepherJL.:and Associates manufactures shipping.cantainens.for radioactivemiaterials in Type A, Type B and~large quantit'i categories, in both "NornralTorm" and "Special Form",.for its own and other's use.

J.L. Shepherd and. Associates also.uses its own and other manu-facturer's containers for'the transportation of radioactive materials as desrcibed above. The Q. A. Program, " described in this manual, pertains to quality assurance in design, manuf acture and use of the above containers as called out in 10CFR 71', ' Appendix. E.

Because of the specialized nature of its business, i. e. products involving radio-activity, J. L. Shepherd and Associates maintains all necessary equip-ment for calibration and radiological control of its products. Membe rs of its stMf personally perform all test on equipment related to this aspect of operation.

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10 CFR 71, Appendix E. Acceptance Criteria

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I. ORGANIZATION JPage 'I

1. Statement of' Responsibility J. L. Shepherd and Associates implements.the Quality Control / Quality Assurance Program, as follows, as normal operational procedure in the de sign, manufacture and use of Type -A, Type B and large quantity categories of both " Normal Form" and "Special Form" shipping con-tainers for radioactive materials, for its-own and other's use and the use of these containers made by other manufacturers.

J. L. Shepherd and Associates is responsible for the continued imple-mentation of this program on future projects.

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Quality Control Manual P.a pe 5

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QUALITY ~ PLANNING For-each fob undez:taken by J. L. Shephe rd a Ass eriate s, priar to Se time purchase :orde rs are issued to subcontractors or :o vendors for raw materials,

.a work plan is drawn up for the contract. This work plan includes:

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A complete work schedule, including all outside purchase s:

2.

A complete cost schedule:

3.

A complete quality assurance program for both the raw materials and the subcontracting to be undertaken as part of the job.

This quality assurance program takes into considere. ion the quality control procedures that will be necessary for satisfactory performance of the contract and outlines detailed specifications for mate rials and subcontracting, as well as quality assurance check points, time of inspection instructions o vendors, related to manufacturing as well as equipmen: to be used in undertaking quality assurance programs.

Costs. As.part of the cost records of all jobs, all direct cos:s as attributed to quality assurance are included in a separaw ca e; ory and are available for purposes of evaluation and future planning. These costs include informa-g-

tion to identify the correction of non-conformig msterials:r.nd correction of defective work.

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Forms are.prepa red and forwarded to subcontrac tors cove rin'g the various areas of quality control to be checked b/ :he.se people, as out-lined above, and these are returned to J. L. Shephe:-di Associates.

In addition, itttermediate anddinal inspec tion forms and rec rds are pe r-manently maintained at J. L. Shepherd & Asscciate s, along with all.ecessaw radiological data, such as leak test certificates, calibration certificates, ex.ternal radia. tion levels, and other records that pe r:ain to the radiological

= aspect of the equipment, as required by law and good cuality assurasce 1

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Corrective procedures. A program for corrective procedures is maintained, which includes the following:

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Munitoring and review of corrective actions, to as-sure their effectiveness:

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Introduction of required improvements:

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Analysis of scrapped products to determine raasons for tTon-conformity:

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Analysis of methods arid processes of work performance.

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. Quality Control Manual YaSe b I

TACILITIES & STANDARDS Drawings and. Specifications. Engineering is to maintain therentral current drawing and specification file.

-Prior to_ release for fabrication, all drawings and specifications are to be reviewed for adequacy in regard to standard design practices and end-product Approval by engineering and quality assurance is required prior to use.

relea se.

Changes are to be documented through the use of Design Change Orders and Specification Change Orders. Changes require the approval of Engineering

-and Quality Assurance.

Engineering is responsible for obtaining Government approval for changes as. required and for-transmitting change information to the Government as required.

-Engineering is to be responsible for removisng obsolete drawings and speci-fications from all issue points and for recording effectivity points.

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i The following section of the Quality Assurance Program may be broken into three categories: (1) those shipping containers /overpacks made in confor-mance with specific DOT fabrication specifications as called out in' DOT regulations such as, but not limited to, Paragraphs 178.104 and 178.194; (2) shipping containers and overpacks made in conformance with DOT general

-packuging performance criteria such as, but not limited to, Paragraph 178.350; and (3) shipping containers and overpacks designed to ship large quantitier ofcradioactivity for which NRC Ccrtificate of Compliance and licenses are required.

(1) All drawings and. design specifications must be checked for conformance with fabrication specifications as called out in the per tinent DOT specifica-tion and approved by the cognizant Quality Assurance Manager or General

. Manager before release for fabrication.

(2) All drawings and fabrication specifications, and all outside purchase specifications for units out purchased, mest be checked and approved by the cognizant Quality Assurance Manager or General Manager prior to release for fabrication and/or purchasing. For this equipment, a prototype test of each class of containers which is the most likely to fail under the pertinent conditions of transport will either be tested or calculations will be made and

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approved by the cognizant Quality Assurance Manager of General Manager which show that the containers will meet the perti nent transport conditions.

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(3) All per tinent data and calculations, including drawings, as called out in 10 CFR part 71 related to license applications and Certificate of Compliance applications for Type B and large quantity containers will be checked and approved by the cognir, ant Quality Assurance Manacer or General Manager prior to submission of the package containing data to the NRC. After the Certificate of Compliance.and license have been issued and prior to the fabri-cation of the approved unit, all drawings and purchase specifics.tions for material must be checked and approved by the cognizant Quali:y Assurance Manager or G ene ral.Mana ge r.

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Quality Control Manual

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i PURCHASING As noted in previou's sections, J. L. Shephe rd & Associates prepares a schedule of materials to be purchased, as well as all subcontracting for each job prior to initiation of work on the contract. Purchase orders which are let include all pertinent data, including a description, requirements for manufacturing.

testing and packaging, and inspection, as well as any qualifications and approvals which must be met on Government contracts.

All pertinent drawings and manufacturing procedures are included as part of purchase orders.

J. L. Shepherd & Associates purchase orde rs also re-quire that all suppliers or subcontractors are to notify J. L. Shep herd &

Associates and obtain approval before any changes in design, ie: d rawing changes, inspection changes, etc., are undertaken.

In cases where shipment is made directly to the user, all instructions regarding shipment are included.

J. L. Shepherd & Associates maintains a qualified vendors list, from which vendors are selected, based upon past performance as related to the greater

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than ten years' expe rience of Messrs. Shepherd, Donelson, and Doonan in dealing with vendors in this area.

All raw materials which are purchased directly by J. L. Shepherd & Associate.s are inspected by J. L. Shepherd & Associates at time of arrival, either at J. L.

Shepherd & Associates' facilities or at the plant of the vendor who will be using these materials.

In cases where the subcontractor provides the matterials on subcontracts let by J. L. Shepherd & Associates, these vendors are required to establish quality assurance procedures and records for raw materials received, including per-formance of fabricated parts purchased.

In case of subcontracts for manufacturing, J. L. Shepherd & Associates per-forms vendors surveys and evaluation prior to the letting of the subcontracts.

In cases where materials of a radiological nature are subcontracted, J. L.

Shepherd & Associates requires control and quality assurance for these materials from vendors, who must submit to J. L. Shepherd & Associates detailed information for permsnent records relative to the quality of these products, ie: leak test information on sealed sources.

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The following terms and conditions related to quality control will apply to all purchase orders for any type of radioac+.ive sources purchased by J. L. Shepherd 90024174 o

Quality Control Manual 12 age Y

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and Associates:

No source shall have greate r than 1000 dpm remavable contamination at time of shipment; Each source shall have undergone a seven-day leak te st in accordance with URC and agreement state requirements prior to shipment; A signed leak test certificate which calls ou: the following:

(1) Source description (2) Source number (3) Date of leak test (4) Results of leak test (5) Method of leak test will be included with each shipment, attached to the packing list. A second copy will be sent via mail at tine of shipment.

Shields. All shipping containers will have the following maximum levels of removable contamination:

3 (1) B eta -gamma 200 dpm/100 cm

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(2) Alpha 100 dpm/100 cm2 Attached to each packing list prior to shipment will be a signed report form showing that the container has been checked-both for contamination and for external radiation levels and giving actual values ai the se tests.

All shipments will be nude in accordance with applicable I CC regulations, and all shipments will be properly labeled with the necessarf data, including Bureau

-of. Explosives number, where required.

Fa.ilure to comply with any o'f the above quality control requirements will result in rejection of the shipment and its immediate return.

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j MANUFACTURING CONTROL Materials Control.

• Quality Assurance will insure that all incoming material is inspected, tagged, and segregated as received.

Non-conforming Materials and Parts. A Material Review Board is to be estab-lished for determing disposition of non-conforming items. The MRB will include representatives of Engineering and Quality Assurance and the Government repre sentative.

Laboratory testing is to be employed as necessary and records of such tests maintained by Quality Assurance.

Processing Control. Engineering is responsible for establishing and maintaining detailed work instructions for processing operations, i

Engineering and Quality Assurance is responsible for establishing in-procssa inspection points. Such points are to be de signated by Engineering and approved by Engineering and Quality Assurance prior to release for fabrication.

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Quality Assurance is responsible for determining that these inspections are performed and that parts are properly identified and segregated. This applies also to sub-contractors and vendors.

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INSPECTION STA7US Quality Assurance is to provide the mecimnism for iden-ifying 9.e inspection status of parts and assemblies. This may include tags, s tamp s, or routing cards as appropriate.

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j SOURCE TEST PROCEDURES Quality Control. Pr'e-inspection--material certification, helium leak te st, dye penetrant.

Pre-weld test specimens--one liner, one capsule sectioned and checked for weld penetration; minimum penetration 75% of wall thickness.

I Post-weld test specimens--one liner, one capsule sectioned and checked for weld penetration; minimum penetration 75% of wall thickness.

Leak test, liner--Ethylene glycol to 10-4 cc/sec.

Leak te st, capsule--Ethylene glycol to 10-4 cc/sec.

Heat cycle te st, source--2 hours at 200 C., repeated after heat cycle.

Contamination test, source--0. 01 uc /100 cm2 by wipe test; maximum per source less than. 005 uc.

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Storage te st, source--7 days leak test and contamination test repeated after e

s to rage te s t.

Special Form Te sts. Free drop -- A free drop through distance of 30 feet onto a flat e ssentially unyielding horizontal surface, striking the surface in such a position as to suffer maximum damage.

Percussion -- Impa ct of the flat circular end of a 1" diameter steel rod weighing three pounds, dropped through a distance of 40".

The~ capsule or material is placed on a sheet of lead, of hardness number 3. 5 or 4. 5 on the Vickers scale, and not more than one inch thick, supported by a smooth, essentially unyielding su rf a ce.

Heating -- Heating in air to a temperature of 1,475 F. and remaining at that temperature for a period of 10 minutes.

Immersion -- Imme rsion for 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> in water at room temperature. The water shall be at pH6 - pH8, with a maximum conductivity of 10 micro-ohms /cm.

Final In spe c tion. Final inspection requirements are to be established by Engin-eering and Quality Assurance.

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Quality Assurance is responsible for assuring inspections are made and records of same maintained. Quality Assurance is also responsible for obtaining Govern-ment approvals as required.

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MEASURING AND TEST EQUIPMENT Quality Assurance is responsible for maintaining equipment in first class condition and establishing calibration requirements and frecuency. Records of all calibra-tions are to be maintained.

Quality Assurance is to monitor all vendors to assure that vendor's test equip-ment is properly maintained and calibrated.

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STORAGE, PACK AGING, DELIVERY Engineering is responsible for establishing requirements for storage, packaging and delivery, including any special requirements for radioactive materials.

Attention is to be given to Government regulations, such a s "F.C and ICC regulations, in addition to the contractual specifications.

Quality Assurance is responsible for assuring that these requirements are met and that records of such inspections are maintained.

An individual log sheet (sample enclosed) will be maintained for all Type B, Certificate of Compliance shipping containers /overpacks routinely used by J. L. Shepherd & Associates in conjunction with transportation of radioactive materials.

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Quality Control Manual Page IS AUDITS On an annual basis,' all log sheets covering container s : utinely used by J.L.

Shepherd & Associates as well as all pertinent data s':.ee s e reering shipping containers manufactured by J.L. Shepherd & Associs. e s will be audited by our Accounting Department.

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I. ORGANIZ ATION Page I7 g.

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4. Job Description - C. H. Prehoda Clara H. Preho'da, Se c re tary-Tre asu re r, Accounting, Purchasing.

Under the direction of J. L. Shepherd, Mrs. Prehoda is responsible for accounting and purchasing procedures and job cost records.

The company books are set up to maintain complete records of costs, both direct and indirect, on a job by job basis. She is also responsible for maintaining all pertinate correspondence, records and contracts, including customer's lice ns e s.

The " Voice" of J. L. Shepherd and Associates. Mrs. Preboda attended Columbia Union College, W ashing ton, D. C. and has twenty-three years' experience in customer relations in the nuclear field. She specializes in handling customer requests, inquiries and problems promptly, efficiently and cheerfully, aided by her excellent command of technical info rmation.

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ORGANIZATION Page !?

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Job Descriptions -- R. N. Donelson R.N. Donelson, Chief Engineer, and Quality Assurance Manager. M r.

Donelson is responsible for all engineering and for the quality assurance program of J. L. Shepherd & Associates (JLSLA). He has specific respon-sibility for vendor selection and qualification and vendor quality assurance programo, purchasing and control of raw materials, drawings and drawing change control. Mr. Donelson also has responsibility for quality assurance of radiological aspects of JLS&A products, including calibration, leak test-ing, and certification of radiological safety, both of units in which this work is performed at a vendor's facility, and those units on which work is per-formed in the field.

Radiation safety and engineering consultant, Mr. Donelson has a B.S. in Chen:ical Engineering from the University of Washington and is a Certi-

_j fied Health Physicist. His thirty-one (31) years of experience in the nuclear field include the design, engineering and installation of all type s of irradiation facilities and plants for handling radioactive materials, as well as prochtetion management. Mr. Donelson also acts as an independent consultant in ti.e radiation safety field.

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ORGANIZATION Page l '!

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Job De sc riptions -- Mary F. Shepherd

'lary F. Shepher'd, Production Control and GA.\\1anuals. AIs. Shepherd, working with R. N. Donelson (Engineering), Clara H. Prehoda (Purchasing) and Malford Irish (Shop), and under the direc tion of J. L. Shep herd, is responsible for correlating the progress in all departments on a daily job-by-job basis, expediting or delaying progress as warranted, and notification to the proper departments. She is also responsible for approximate scheduling of work in progress, and tests and inspections ts necessary in weekly bi-departmen-tal confe rences.

Ms. Shepherd's QA responsibilities include the distribution and update of f

QA Manuals as necessary.

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ORGANIZATION Page 7,0 4.

Job Description -- Malford Irish Malford Irish, Shop Foreman, worktuJ directly with J. L. Shepherd, R. N.

Donelson, Clara H. Prehoda, and Mary F. Shepherd, has the responsibility of delegating proper materials to the respective jobs and supervising the work in progress at JLS&A.

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ORGANIZATION Page 4.

Job Description -- Jerri S. Cohen Jerri S. Cohen, Pttrchasing Officer. Under the direction of R. N. Donelson and the Engineering Department, as well as Clara H. Prehoda, Ms. Cohen is responsible for proper documentation on purchase orders and the place-ment of them to vendors, with all applicable specifications. She is also responsible for notification on all delivery dates to Mary F. Shepherd, Prodttetion Control, so that production, testing, and inspection procedures can be scheduled accordingly.

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ORGANIZATION l

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Job Description -- Joseph Doonan Joseph Doonan, Chief Inspector. Under the direction of Mr. Donelson, Mr. Doonan has responsibility for inprocess inspection and sub-assembly inspection at various vendors' and contractors' facilities. Mr. Doonan also has responsibility for inspection of incoming materials, to assure that they meet specifications called out by purchase orders on which they are obtained, and for determining that these raw materials are properly tagged, either at time of receipt at the vendors' facilities or at time of shipment from JLS&A to vendors' facilities.

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ORGANIZATION Page L':

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Job Description -- Thomas J. Shepherd Thomas J. Shepherd, Engineering and QA Inspector. Under the direction of R.N. Donelson (Engineering), Mr. T. Shephe rd is responsible for the distribution of drawings and specifications to the appropriate departments after approval.

Working with Mr. J. Doonan (Chief, QA Inspector), Mr. T. Shepherd per-forms QA Inspections as required.

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ORGANIZATION Page 24.1 4.

Job Description -- Joseph S. Shephe rd Joseph S. Shephe'rd, QA Inspector and Radiological Safety Functions.

Working with J. Doonan (Chief, QA Inspector),

'.ir. J. S. Shepherd pe r-forms all inspections as necessary. Under 9.e direction of J. L. Shepherd and R. N. Donelson, Mr. J. S. Shephe rd is re sponsible for 9.e inspection of components related to radiological safety functions.

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I. ORGANIZ ATION Page e

5. Job Description and Qualifications - Head of Q. A. Program J. L. Shepherd, President, General Manager and Head of Q. A.

Program. Mr. J. L. Shepherd is responsibic for the general manage-ment of the company, - specifically related to sales, contrac t manage-ment products and quality assurance.

Mr. Shepherd is personally responsible for the final inspection of all products af ter completion, including those related to radiological safe:y, before delivery to the cus tome r.

Mr. J. L.

Shepherd has a B. S. from Loyola University of Los Angeles.

He did graduate wok at Notre Dame and University of California at Los Angeles, and has had Twenty-six years experience in product develop-ment, applic ations, e ngine e ring, s ale s, marketing and general management in the nuclear field. He specializes in the evaluation and selection of the optimum radiation sources and/or tracers and related equipment for nuclear applications, based upon the customer's total re quire me nts, including such parameters as licensing, radiation s afe ty, cos t and reliability and proper shipping containers as required, k.

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I. ORGANIZATION Page h t

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6. Statement of Responsibility.

J. L. Shepherd, C. H. Prehoda, M. F. Shepherd. M. Irish, J. Doonan, T. J. Shepherd and J. S. Shephe rd have the resposibility and authority to reject unsatisfactory materials, s top unsati.sf actory work and to supervise further processing af ter correc tionc have been made.

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R. N. Donelson A statement of this responsibility is signed by each individual and posted in a visible location.

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.a II. QUALITY ASSURANCb PROGRAM Page ? '1 1.

Statement of Verification of Assessmen ;f Qualire A ssurance Program The officers of the. Quality Assurance Prog ram (CAPI, in ad:iition to daily communication, hold weekly confe rences in conj unc: ion with appropriate departments, to review the status of each job in regard to design, purchasing, work release, work in progress, corrective procedures, inspections, te sting, l

safety, storage or shipment, proper documen a: ion, corrective action (if applicable) and shipment, on whichever phase af operation is pertinent to that job as well as overall views of all work in progress. Annual audits to determine compliance, as well as for accounting and inventory purposes, are performed and reviewed by the officers of de QAP.

2.

Distribution of Quality Assurance Program Manuals Each officer of the QAP retains a QA/QC Program Manual. A master copy is kept and a copy is also made available for any employee to refer to.

(Each new employee is made familiar with the manual as part of the Training Pro -

g ram. ) M. F. Shepherd is responsible for distributing approved revisions to all copies of the manual and advising the holders thereof of the revisions.

3.

Statement of Verification that Quality Assurance Program Requi*ements

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are applicable to Outside Vendors J. L. Shepherd & Associates retains the right :o supervise and inspect pro-ducts at vendor's and contractor's facilitie s and/or to reject nonconforming materials; and has agreements with vendors and c:n:ractors stating such to maintain our Quality Control mandatory recuirements.

4.

Safety-related Systems, Structures and Ccmponenis Controlled by Quality Assurance Program All mechanical, electrical, and electronic components, as well as all com-plete systems, are controlled and covered by de CAP.

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Statement of Verification of Resolution of Disputes If, and when, disputes arise concerning the cuality of a product between the different departments, a review of the product's functions. specifications, and compatability with the QA/QC Program, as well as NRC and DOT Cri-teria is made by the QA officers and appropriate offices. Reviews are made at the weekly conferences or as needed when all pertinent data is gathered.

Agreements are subject to review by J.L. Shepherd for final approval.

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11. QUALITY ASSURANCE PROGRAM Page i-6.

Statement of Verification that Trainia:, Program is implimented J. L. Shepherd & Associates maintains a training program for all new employees and employee s assuming additional responsibilities. This program provides a thorough examination of the QA/QC Program, the purpose of maintaining this program, each QA officer's authority delinea ted and how it is effec -

tive, as well as how the employee functions within the program.

In as much as Shepherd & Associates is a small business, each employee is not only responsible to the QA officers, but is directly responsible for his/her own work within the company. Hence, in the training program, each indivi-dual is trained (and continuously monitored in the system of checks and balances maintained in the weekly review by the QA officers to whom the employee is responsible) to be effective in the continuous effective functioning of the QAP.

A complete documentation of this program is on file at Shepherd & Associates.

All personnel are adequately licensed or certified, ie: Health Physicists, welders, machinists, for example, when applicable. All licenses and certi-fications are kept current. If an employee is not performing to the specifi-cations maintained by Shepherd & Associates, they are subject to a retraining

(

program before continuing with their responsibilities or their employment is i

te rminated.

7.

Statement of Verification that Quality-Related Activities a re Performed According to Predetermined Measures J. L. Shepherd & Associates performs all qualitp-related procedures, ie:

inspections and testing, in accordance with pre-determined procedures which specify the equipment to be used, if necessary, and environmental conditions.

Inspectors are required to determine and document that all prerequisites have been satisfied before inspection and/or testing.

l 90024194 i

I

TIL DESlGN CONTROL Page 7l 1.

Statement of Verification of Responsible Design Procedures J. L. Shephe rd & Associates has an established de sign procedure for its products.

Because of the nature of our business and products, ie: products involving radioactivity, all products are licensed by the pr'>per licensing authority and all new products have licenses pending. The refo re, in the initial design of a product, the first step is to provide licensing authorities with all pertinent d rawing s.

Sales drawings, if applicable, are made per customer requirements and licensing crite ria.

Engineering is to maintain the central current drawing and specification file.

Prior to release for fabrication, all drawings and specifications are to be reviewed for adequacy in regard to standard design practices and end-product Approval by engineering and quality assurance is required prior to use.

release.

Changes are to be documented through the use of Design Change Orders 2nd

{

Specification Change Orders. Changes require the approval of Engineering and Quality Assurance (QA).

Engineering is responsible for obtaining Government approval for changes as required and for transmitting change information to the Government as required.

Engineering is to be responsible for removing obsolete drawings and specifi-cations from all issue points and for recording effectivity points.

2.

Statement of Verification of Compliance with Regulatory Requirements in Drawings J. L. Shepherd & Associates Engineering Department and QA Department reviews all product drawings, specifications for materials, procedures and instructions, with a final review by J. L. Shepherd or R. N. Donelson on each job to verify that they meet all regulatory requirements and licensing criteria.

3.

Statement of Verification that Quality Standards are Maintained.

J. L. Shepherd & Associate s' Engineering Depa rtment maintains a complete list of specifications for each product. It issues a Bill of Materials to the

{

Purchasing Department with these specifications. Any changes f rom these specifications by the vendor or sub-contractor is subjected to review by the i

l 95024195

.c HI. DESIGN CONTROL Page

~0 Engineering Department and QA Department before purchase is made. Any change or deviation on a particular product la noted on the specification documents for tha't particular product. All purchases are individually checked on delivery to verify that they do meet specifications before they are accepted. The Shop Foreman is directly responsible to the QA Officers for production which is inspected at various stages of completion.

4.

Statement of Verification of Design Control J. L. Shepherd & Associates Engineering Department and QA Department reviews each product design with all revisions approved before release for manufac ture. Any deviation from this is subject to a review by the QA Department before approval or rejection. Inspection and test criteria are identified and made available to the QA Department before release.

5.

Statement of Verification of Adequacy of Design J. L. Shepherd & Associates QA Department and Engineering Department insures the proper selection of components and design verification of each unit by means of prototypes from which licensing is applied. The proto-

{

types are thoroughly tested and inspected in all stages to verify that they meet all licensing authority criteria and design specifications. All inspec-tion and test criteria are documented and made available to the QA Depart-ment, which documents acceptance or rejection and all pertinent data thereof.

6.

Statement of Verification of Design Department Controls J.L. Shepherd or R. N. Donelson of Shepherd & Associates are responsible for the final design verification review after reviews'by the Engineering Department and by the QA Department.

7.

Statement of Verification of Design Change Control J. L. Shepherd & Associates maintains design specification change controls on the same basis as the original designs.

w III. 1, 2, 3, 4, 5, & 6.

8.

Statement of Verification of Engineering and QA Responsibility and Authority J. L. Shepherd & Associates maintains written agreements delineating the areas of responsibilites and authority of each member of the Engineering Department and the QA Department, which are agreed upon and understood

{

at the completion of the Training Program.

95024196

IV. PROCUREMENT DOCUMENT CONTROL Page ?i 1.

Statement of Verification of Purchasing Department Procedure J. L. Shepherd & Associates' Purchasing Department maintains a definite l

sequence of action in any purchasing operation. A list of procedures is posted in the Purchasing Department (PD) Office and is explained in the employee training program.

2.

Statement of Purchase Orders--Appendix E Criteria Ve rification J. L. T' pierd & Associates' Purchasing Department routinely indentify

'.trt 71, Appendix E criteria, as applicable and is described in 10 CFF the QI engram proper. Standard purchase order forms designate spaces for thi" I rfermation.

3.

Statement of Appropriate Reference of Specifications on Purchase Orders J.L. Shepherd & Associates' Engineering Department provides appropriate references to technical requirements, ie: regulatory requirements, material and component identification requirements, drawings, specifications, codes and/or industrial standards, test and inspection requirements and special

{

process instructions, on the Bill of Materials which is submitted to the PD to be included on purchase orde rs, when applicable.

4.

Statement of Appropriate Reference of Documentation on Purchase Orders J. L. Shepherd & Associates' Engineering Department provides appropriate refe rence s of documentation, ie: d rawing s, specifications, procedures, inspection and fabrication plans, inspection and test records, personnel and procedures qualifications and chemical and te st 'results of material, on the Bill of Materials which is submitted to the PD to be included on purchase orders and provided to vendor, if applicable.

5.

Statement of Verification of Appropria:e Documents Retained by Vendor and Delivered to Purchaser J. L. Shepherd & Associates' Engineering Department provides the appropriate references of records, certification or test reports to be retained, controlled and maintained by the supplier and those delivered to the purchaser prior to use of item, on the Bill of Materials which is submitted to the PD to be included on the purchase order if applicable.

6.

Statem;nt of Verification of Purchase Order Containing Right of Access Clause

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94024197

~

IV. PROCUREMENT DOCUMENT CONTROL Page '22 J. L. Shepherd & Associates purchase orders contain an agreement clause

-ing the right to access to the supplier's facilities and records for a covs source inspection, audit, when applicable.

7.

Statement of Verification that Purchase Order Revision are Subject to Approval As stated in III, #3, " Any changes from these specifications by the vendor or subcontractor is subjected to review by the Engineering Department and Q A Department before purchase is made. Any change or deviation on a particular product is noted."

8 v

96024198

V.

INSTRUCTIONS, PROCEDURES & DRAWINGS Page 2

1.

Statement of Verification that Activities Affecting Quality are Accom-plished in Accordance with Specifications J. L. Shephe rd & Associate s (JLS&A) has established with the implemen ta-tion of the QA/QC program that activities affecting the quality of a prcduct are adhered to in all phases of operation accarding to prescribed documenta-tion of instructions, procedures and/or drawings.

2.

Statement of Verification of Clear Secuence of Actions Concerning Instruc-tions, Procedures, and Drawings JLS&A has established with the implimentation of the QA/QC Program that there is a clear sequence of procedure in the preparation of, review, appro-val, and control of instructions, procedures, and drawings.

3.

Statement of Verification of Quality Assurance Department Responsibility JLS&A QA Program Department has the autority and responsibility to review inspection plans: te st calib ration and special proce s s procedures; drawings and specifications; and all changes sereto and/or acceptable

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alte rnatives, under the provisions of the QA Prog ram, and does so.

t 96024199

.. =

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VL DOCUMENT CONTROL Page T3 1.

Statement of Verification that the Issue of Documents and Procedures thereof are Procedurally Controlled JLS&A Engineerin'g Department, working with the QA Department and Purchasing Department, have adequate procedural controls to check if review, approval and issue of documents and changes the reto, prior to release, on a product, are satisfactory to quality requirements.

2.

Statement of Verification that Changes to Documentation are Made by the Original Organization that Prepared Initial Document JLS&A Engineering Department, when notified of the need for change or modification by itself or other departments, in conjunction with the QA Depa rtment, reviews and approves or rejects revisions to the original document, as needed.

3.

Statement of Verification that Revisiens are Made on Appropriate Documents JLS&A Engineering Department is responsible for nnking all necessary

(

revisions on all related documents of a project, after approval thereof, prior to the implementation of these changes.

4.

Statement of Verification that All Pertinent Documents are Available at Site where They are to be Implemented i

JLS&A Engineering Department is responsible for all pertinent documents related to a job to be available at the site where they are to be implemented, j

prior to starting work. The Engineering Department is also responsible that the Purchasing Department has all pertinent documents to accompany the purchase order (if applicable) to the supplier before work begins on the project.

5.

Statement of Verification that Master Lists of Revisions are Current and Appear on Appropriate Documents i

JLS&A Engineering Department keeps a current msster listing of revisions on products so that revisions are identifiable and is responsible that the appropriate revisions are on documents and distributed thus, k

o 94024200

VII. CONTROL of PURCHASED MATERU.L, PARTS & COPONENTS

~Page

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1.

Statement of Verification that Qualitied Personne' Evaluate Suppliers for Acceptability R. N. Donelson, CItief Engineer and QA Manager si.".SL A. is qualified and responsible for vendor selection and qualification of cendor OA Program to provide materials that meet specifications.

2.

Evaluation of Suppliers R. N. Donelson, Chief Enginee r and QA Manager of JLS&A, who is respon-sible for supplier selection uses the following criteria for approving a vendor:

The supplier's capability to comply with the e'.emen:s of Appendix E to 10CFR Part 71 that are applicable to the tyre of ma:erial, equipment, or se rvice being procured.

A review of previous records and performances.i suppliers who have provided similar articles of the type being pr:curen.

,J A survey of the supplie r's facilities and QA Pracrams :: Ce cr-mine his capability to supply a product which reve:s the ?:.4i;;n, manufacturing, and quality requirements.

3.

Statement of Verification that Supplier Evaluati.ns are.

File JLSE.A maintains current files on the re sults of supplier evaluations made by R. N. Donelson, Chief Engineer and QA Manager, a s well a s current specifi-cations on products supplied.

4.

Statement of Verification that inspection and/or Supervisian of Supplie rs is Performed At the weekly meetings of the QA Department and appropria:- departments, it is dete rmined if and when it is required that the Chief Inspector or appro-priate office r be present du ring fabrication, testing and shipment of a pro-duct, to assure accordance with purchase order speci:icaticns.

5.

Statement of Ve rification of Minimum Record.< eupplied ::, Purchase r JI.SLA requires as a minimum from all vendors de :silowing documentation:

Documentation tha t iden tifie s the pu rcha sed ma:e rial or equip-g' ment and the specific procurement requiremen:s ie. g., c ode s, 96024201

VII. CONTROL of PURCHASED MATERLiL. PARTS & COMPONENTS Page '3 -

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standards, and specifications) met by the items.

Documentation that identifies any procurement requirements which have not been met together with a description of these nonconformances dispositioned " accept as is" or " repair."

Note: Contingent upon acceptance by JLSLA, all nonconforming items must be repaired or replaced and certification thereof.

6.

Statement of Receiving Inspectors A ceptability Criteria and Responsibilities The Chief Inspector for JLS&A is responsible for,and will not accept, products that do not meet the followit.; criteria:

The material, component, or equipment is properly identified and corresponds with the identification on receiving documenta-tion.

Material, components, equipments, and acceptance records are inspected and judged acceptable in accordance with predetermined

,,q inspection instructions, prior to installation or use.

Inspection records or certificates of conform tnce attesting to the acceptance of material and components are available prior to installation or use.

Items accepted and relea sed are identified as to their inspection status prior to forwarding them to a controlled storage area or releasing them for further work,

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96024203

l IX. CONTROL'of SPECIAL PROCESSES Page l

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Statement of Verification that Special Processes are Procedurally Controlled The Shop Foreman at JLS&A is directly respc.nsible, in conjunction with periodic QA officer inspections, on each job, for the procedural control of special processes such as welding, heat treating, non-destructive testing,

)

and cleaning for items in-house. The Chief Inspector is responsible for inspecting and controlling these processes at supplier's installations, as applicable.

2.

Statement of Verification that Procedure s, Equipment, and Personnel Related to Special Processes Meet Applicable Specifications, Codes, and i

S tandard s 1

JLSLA Engineering Department and Shop Foreman, in conjunction with the QA Department, are responsible for maintaining appropriate procedures, equipment, and personnel connected with applicable codes, standa rds, and specifica tion s.

3.

Statement of Verification that Qualificatio. Records Conce rning Special

(

Processes are Established and Current As part of the implementation of the QA Program, the Engineering Depart-ment at JLS&A maintains current qualification records of all areas associ-ated with special proce sse s.

In addition, copies of applicable records are filed in each job file.

I I

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96024204 o

l O

n.

X.

INSPEC TION Page ~:

1.

Statement of Verification that inspection Program Verifies Conformance of Articles in Accordance with Establishec erocecures l

All inspections performed by JLS&A, which check conformance with quality associated areas, are performed in accordance w!:h written and controlled procedures and are documented.

2.

Statement of Verification that Inspection Personnel are Independent from Individuals Performing Activity Being I.spected i

Inspection personnel at JLS&A are independent from the personnel perform-ing the activity being inspected, qualifications and independence determined by the QA Department.

j 3.

Statement of Verification that Inspectors are Qualified and Qualifications are Recorded The QA Department of JLS&A is responsible for maintaining qualified in-spectors (in accordance with applicable code s, s 2.ndards, and training programs) and the certifications and qualifica:icns : hereof are on file and

(+f kept current.

4.

Statement of Verification that Revisions z.re Inspected in Accordance with the Original Specifications Inspectors at JLS&A perform all inspections. including those on any modi-fication s, repairs, or replacements, in accordance with the original design specifications and procedures or acceptable c.1:ernatives; and all inspections are documented.

5.

Statement of Verification that Inspection Points are Established and Observed The Shop Foreman is responsible for the supervision of work, including holding work progress until it has been inspe::ed, a: the appropriate phases.

The Shop Foreman holds work for inspection in acccrdance with predeter-mined inspection specifications and for informing the QA Department of forthcoming inspections at weekly meetings and time of inspection.

t 96024205

.. - _ ~ _

XI. TEST CONTROL Page 40 1.

Statement of Verification that Test Programs are Established, Docu-mented, and Peformed Accordingly Test Programs to determine if an item will perform satisfactorily are performed by JLSLA Engineering and QA Departments and are performed in accordance with established documented specifications, and are fully documented.

2.

Statement of Verification that Revisions in Design are Tested in Accor-dance with Specifications of the Original Design JLS&A Engineering Department, in conjunction with the QA Department, tests all modifications, repairs or replacements to the original design in accordance with original specificatims or acceptable alternatives.

3.

Statement of Verification ~ that Test Re sults are Documented, Reviewed, and Accepted by Appropriate Department All test program results are fully documented. They are then evaluated and determined acceptable by qualified Enginee ring and QA Department office rs

, (

of JLS& A.

k 90024206

.~

>:a XII. CONTROL OF MEASURING & TEST EQUIPMENT Page k,

1.

Statement of Verification that Measurin; and Test Equipment are Pro-perly Calibrated J1SLA maintains properly calibrated mear ring and test equipment, basud upon required accuracy, purpose, degree :fusage, stability characteris-ties, or other conditions affecting the measurement. Instruments used involving the measurement of radioactivity are calibrated at three (3) month inte rvals: all other instruments are calibrated yearly.

2.

Statement of Verification that Measuring and Test Equipment are Identified and Traceable to Calibration Te st Data JLS&A requires and maintains serial numbers on all measuring and test equipment and requires all calibration test data to reference the instruments' serial number.

3.

Statement of Verification that Measurements are Taken, Documented, and Validated against Previous Measurements if Instrument is found to be out of Calibration

{.

JLSLA performs new tests or measures (which are documented) to validate previous inspections in the event that an instrument is found to be cut of calibration, and notifies appropriate parties, if applicable.

4.

Statement of Verification that Calibration Meets Appropriate Standards JLS&A maintains National Bureau of Standaris traceable calibration records on all instruments which measure radioac-ivity, and the se standards are r_eferenced on all appropriate documentarisa. Other' inspection instruments eithe r meet nationally recognized standards or manufacturer's specifica-tions which are documented and are on file at JLS&A.

h 96024207 I

XIII. HANDLING, STORAGE, & SHIPPING Page el i l.

Statement of Verification that Special Requirements are Accomplished by Qualified Individuals in Accordance with Work and Inspection Instructions In accordance with predetermined estab!!shed work and inspection instruc-tions, qualified employees of JLS&A pe rform work related to special hand-ling, preservation, storage, cleaning, packaging and shipping requirements.

2.

Statement of Verification that Conditions of the NRC and U.S. DOT Shipping Requirements are Satisfied before Shipment JLS&A performs a final inspection, befo re shipment, on all items pertinent to NRC and U. S. DOT specifications and conditions. Items must pass all criteria before shipment is snade.

3.

Statement of Verification that Shipping Papers are Properly Prepared JLS&A prepares (and keeps on file) all necessary shipping papers as required.

Shipping papers on shipments containing radioactivity include the following documentation:

Date of shipment

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Customer Licen se of Cust:mer Source information Shipping container type and device Radiation level at surface of shipping container Radiation level three feet (3') from surface of container Surface contamination In strumen t

)

Leak Test

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DOT class label Transport Index Truck placard requirement Shipping weight Freight Classification Also included with shipments are External Radiation Level Certificate, Leak Test Certificate, Calibration Certi:icate, Attenuator Certificate, if applicable.

4.

Statement of Verification that Shipment Time is Consistant with Safe Transportation Time JLS&A routinely uses motor freight for shipments because the weight inhibits

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fast delivery and our products' mtum doe s not demand it.

Departure occurs after a package has passed final inspection to meet NRC, DOT criteria and 90024208 t

l l

m XIII. HANDLING, STORAGE & SHIPPING Page d'

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4 the custome r has necessary licensing (if applicable > and is ready to accept de live ry. Shipments are monitored as applicable :: the mt:r f reight de-livery schedule and customer notification :af arrival.

h tg 90024209

u XIV. INSPECTION, TEST, & OPERATING STATUS

'U' Page l.

Statement of Verification that Status of Packages is Known by Affected Organizations JLS&A QA Department, in conjunction with other appropriate departments (such as shipping, engineering, production, secretarial), is responsible that the appropriate documentation and identification of inspection, test, and operating status of packages is known and received by affected organizations, such as inter-departmental,. shipping agents, and/or customers.

2.

Statement of Verification that Removal of Inspection and Status Indicators are Procedurally Controlled JLS&A requires that all inspection and welding stamps and/or status indi-cators such as tags, markings, labels, or stamps, when removed from an item for fabrication, be checked with the Shop Foreman at the time of removal (for ve rification purpose s) for records of "in-proce ss" wo rk. Any stamps or status indicators to be applied to an item are done so after the appropriate inspector has inspected and passed an item and is also documented a c c o rdingly.

3.

Statement of Verification that Bypassing of Inspection Tests or Other

{

Critical Ope rations is Controlled The bypassing of inspections, tests, or other critical operations is proce-durally controlled by documentation, work structure and procedure and daily communication,'as well as weekly meetings, between all departments an-J the QA Department.

4.

Statement of Verification that Nonconforming' Items are Identified The Chief Inspector at JLS&A is responsible for identifying and inspecting in-coming mate rials. Nonconforming items are so identified, not placed in inventory, but returned to vendor. If items are found to be defective or othe rwise nonconforming during procedural inspections, the se items are identified and either returned to vendor c placed in a special inventory for rework and retesting. These procedures are established to preclude the inadve rtant use of nonconfo rming materials.

(

96024210 1

eu X V.

NOlt CONFORMING MATERIALS

'Page 4 1.

Statement of Verification that Nonconforming Items are Procedurally Controlled JLS&A has established and enforced procedures during receiving inspection and for subsequent inspections to assure that the identification, documenta-

-tion, seg regation, review disposition are implemented,affected organizations are notified and that replacement and repair are carried out.

2.

Statement of Verification that Nonconforming item Documentation is~

C omplete When a non-conforming item is found during inspection or testing, the inspection or test individual of JLS&A is required to document' the reasons of nonconformance, identify the item, and signature the report; and sub-sequent appropriate action is taken.

3.

Statement of Verification that Nonconforming Items are Segregated from Acceptable Items JLS&A maintains a separate inventory locatian for nonconforming items,

((

which are identified as such, until appropriate action is taken.

4.

Statement of Ve rification that Repaired or Reworked Items are Subjected to Origint 1 Testing JLS&A inspectors subject all replaced, reworked, or repaired items to the same documentation testing procedures per the original inspection, or by acceptable alte rnative te sting procedure s.

96024211

. < r.,

XVI. CORRECTIVE ACTION Page 'i&~

1.

Statement of Verification that Evaluations are Conducted to Determine the Need for Corrective Action, if Required JLS&A does not accept or use nonconforming materials for use in a product, as established by procedural inspections at various phases of operation. In the event that an inspection determines there is a nonconformance, such as failures, malfunctions, deficiences, or defectiveness, the Engineering and QA Departments jointly evaluate the need for corrective actions in accor-dance with established procedures.

2.

Statement of Verification that Corrective Action is Initiated, if Required In the event of nonconformance, the Engineering and QA Departments of JLS&A evaluate all aspects of the nonconformance and determine the kind of corrective action to be taken to preclude reoccurance. This process is documented accordingly, before the corrective action is taken and reinspec-ted according to prescribed procedure s.

3.

Statement of Verification tint Fevieus ci Corrected Actions are Conducted ff The Engineering and QA Departments of JLSLA conduct inspections and follow-up reviews of corrective actions to determine if they are acceptable, and either close out required documentation and/or implement these actions as part of standard operations, whichever is needed.

k l

90024212 l

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4 4 8%&

XVIL QUALITY ASSURANCE RECORDS Page GT s

1.

Statement of Verification that Documentation is Maintained Concerning Evidence of Qualit;y and Safety of Items and Activities

[

The Engineering Department of JLSLA maintains all documentation con-cerning the quality and safety of items and activities which affect quality and safety areas, with revisions and updates made annually, or as needed, or as required.

2.

Statement of Verification that Safety and Quality Related Documents Contain Required Information JLS&A QA records, maintained by the Engineering Department include operating logs: re sults of reviews, inspections, te sts, audits, and material analyses; qualification of personnel, procedures, and equipment; and other documentation such as drawings, specifications, procurement documents, calibration procedures and reports; nonconformance reports; and correc-tive action reports.

In addition, pertinent documentation is included with each job file.

3.

Statement of Verification that Quality Assurance Documents are Identi-

{'

fiable and Retrievable JLSLA maintains a numerical and alphabetical system which cross references all QA documentation, as well as all associated documentation, throughout i

all filing systems in all departments. Through the implimentation of this system, all records are identifiable and retrievable.

4.

Statement of Verification that a List ni Required Records and Storage Locations is Maintained JLS&A maintains a master list of where required records may be located, which includes the use of the established numerical and alphabetical identi-fication system.

5.

Statement of Verification that Required Records are Kept on File JLS&A maintains complete files, including design related records, inspection and related QA documents, since the company was established in~ 1967, and update s taese files as recpired, ie., repairs or replacement parts, corres-pondence, e tc. These files are identifiable and retrievable per the master list discussed in XVII. 3 & 4.

I~

6.- Statement of Verification that Inspection and Te st Records Contain 90024213

X VII. QUALITY ASSURANCE RECORDS Page

'i' Appropriate Information JLSLA Engineering Department has established and maintains inspection a.d test records which include the following c riteria:

(1) A description of the type of observ:.: ion.

(2) Evidence of completing and verifying a manufacturing, inspecdon, or test operadon.

(3) The date and results of the inspec:ian or test.

(4) Information related to conditions c.dve rse to quality.

(5) Inspector or data recorder identification.

(6) Evidence as to the acceptability of :he results.

I 90024214 l

X VIII. AUDITS Page l.

Statement of Verification that Audits are Conducted in Pre scribed Manner JLSL A pe rforms a,udits in accordance with prescribed pro. edu res and chech-lists. All audits are pe rformed by employee s who do not have direct re sponsi-bilitics for the area being audited. Audits are pe rfo rmed inte rdepartmentally il those departments contain individuals who are qualified tc do so.

2.

Statement of Verification that Audits are Reviewed by Management JLS&A management personnel review all audits in their areas affected by the audit. Employees compile all audits and a complete report is made available to management for a comprehensive review.

3.

Statement of Verification that Management Reviewing Audits have the Re sponsibility to C orrect Deficiences The management personnel of JLS& A are responsible for correcting defici-encies as required after a review of the complete auding reports.

4.

Statement of Verification that Deficiences Revealed by Audits are Re-

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audited Regularly JLS&A, at the receipt of an order, make s total inventory and appropriate audits at that time, to dete rmine the correct sta tus of items. Special nota-tions and attention is made on items found previously deficient, or items f requently used.

5.

Statement of Verification that QA Program is Audited Annually Qualified JLS& A management personnel, in conjunc tion with the QA Depart-ment, annually audits and review the entire QA Program and its implemen-ta tion with special emphasis on the safe ty related feature s.

Other audits and reviews are pe rformed as nece ssa ry, if required.

e.f e m.,u we 90024215