ML20009C836

Updated QA Manual for Transport of Radioactive Matls

ML20009C836
Person / Time
Site:	07100122
Issue date:	06/08/1981
From:	Donelson R, Prehoda C, James Shepherd J.L. SHEPHERD & ASSOCIATES
To:
Shared Package
ML20009C832	List: ML20009C831 ML20009C836
References
19265, QA-RM-001-A, QA-RM-1-A, NUDOCS 8107220032
Download: ML20009C836 (53)

Text

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-' e artk kSSociafE1 a L-213/245-0187 740 Salem Street, Glendale, California 91203

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. Nuclear Applications Irradiation & Calibralton Equrperient QUALITY ASSUR ANCE PROCEDURES FOR DESIGN, FABRICATION AND USE OF SHIPPING CONTAINERS AND OVERPACKS USED FOR THE TR ANSPOR TATION OF R ADIOACTIVE MATERIALS DOCUMENT TITLE: Numbe r Q A-RM -001-A i

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LICENSEE: J. L. Shepherd and Associates

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TABLE OF CONTENTS jy i

u R e vi s i o n S h e e t................................................

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' I n t r o du c ti o n.................................................. 3

1. ; O rg anization 4

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

2. ; Qua li ty P l aning M a nu al................................... 5

. 3. O rg aniz ation Cha r t...................................... 16

~4., J ob D e s c r ip tio n s........................................ 17

.5.~ Job Desc ription and Qualification - IIcad. Q. A. Program.... 25

6. S ta te m e n t of R e s po ns ibili ty............................... 2 6

'II. - Quality Assurance Program

. S ta te m e n t s 1 - 5........................................... 2 7 S ta te m e n t s 7........................................... 2 8

. III. - Design Control

' S ta te m e n t s 1 - 3........................................... 2 9

_ S ta te m e n t s 8........................................... 3 0

'IV. Procurement. Document Control

- S ta te m e n ts 1 - 5........................................... 3 1

- S ta te m e n t s 6 - 7_........................................... 3 2 m.

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Procedures and Drawings

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V. Instructions,

- S tate m e n t s 1 - 3........................................... 3 3 l

VI. Document Control S ta t e m e n t s 1 - 5........................................... 3 4 VII. ' Control of Purchased Materials. Parts and Components S ta t e m e n t s 1 - 5........................................... 3 5 2 S t a te m e n t ' 6............................................... 3 6 l'

VIII. Identification and Control of Materials. Parts and Components S t a te m e n t s 1 -. 5........................................... 3 7 l

l IX. Control of Special Processes-L S ta te me nts 1-3........................................

.38 X. Inspection l

S ta te m e n ts 1 '- 5........................................... 3 9 XI. Test Control l-J S ta te m e n t s ) - 3.......................................... 40 s

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L-XII. - Control of Measuring and Tes t-Equipment

. S ta t e m e n t s.1

. 4.......................................... 4 1 i

XIII. Handling,- Storage and Shipping S ta t e m e n t s.1 - 4...........;............................... 4 2 r

il iXIV. Inspection,- Tes t and Ope rating Status

S ta te m e n ts 1 -. 4.... '...................................... 4 4

- ' XV. !N6nconforming Materials

' S ta t e m e n t s 1

~4....................................,,,,,,, 4 5 XVI.E Correc tive Ac tion c S ta t e m e n t s i l - 3.............. '............................ 4 6 XVIIfQuality Assurance Itecords

. S ta te m e n t s 1 - 6 '......................................... 4 7

- XVIII. :- Audits

. S ta te m e n ts 1 -1 5 ".......................................... 4 9 f

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4 Page 2 R EVISION SHEET

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Revision Number Date Summary Initials Q A-R M-001 - A 11/16/79 Total revision per receipt of M FS 10CFR 71, Appendix E g4 Acceptance Criteria - Trans-portation Packages for Normal Form R adioactive Material,

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

Page 16 Rev.1 02/09/80 from J. S. Cohen -Purchasing to 7Ft } 4 B. A. Howard - Purchasing and M FS from J. Doonan - Chief, O. A. In-spec tor to M. Brandon, Chief, Q. A. Inspector Pgs. 16 -cev. 2 08/21/80 from Alalford Irish, Shop For-AIFS

&20, llev. I man to Donald Brewer, Shop g

Forman Pgs. 16-Rev. 2 08/21/80 f rom AI. B randon to J.

Ferree, hlFS

& 22, Rev. 1 Chief, Q. A. Inspector M

O Pgs. 16-Rev. 3 From D. B rewer, Shop Foreman BH

& pgs. 20-22 3/29/81 to P. Wustrack; fro.n B. Howard Rev.2 purchasing to V. Towne; from J. Fe rrec, Chief, Q. A.

Inspector to M. Irish Pg. 5 & Sa, Rev.1 04/23/81 Records section revised to 2 pgs.

MFS MrS Pgs.: 6,10,14, 06/03/31 Rewording and name changes MFS 15,1619fl9A MD added, 20 & 27

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- INTRODUCTION

-J. L; Shepherd and Associates manufactures shipping containers for radioactive' materials in Type A,- Type B and large quantity categories,

in both." Normal Form" and "Special Form", for its own and other's use. 'J. L; Shepherd and Associates also uses its own and other manu-

. facturer's containe rs for the: transportation of radioac tive materials as desycibed above. The Q. A. P rogram, described in this manual,

. pertains. to quality assurance in design,. manufacture and use of the above containers as called out in 10CFIt71, 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. M embe rs of its staff personally perform all test on equipment related to this aspect of operation.

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10 CFR 71, Appendix E, Acceptance Criteria b)'

I. ORG ANIZATION Page 4

1. Statement of Responsibility J. L. Shepherd and Associates implements the Quality Control /Oualiv/

Assurance Program, as follows, as normal operational procedure in the design, 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.

J. L. SHEPnERD

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QUALITY PLANNING.

For each job undertaken by J. L. Shepherd and Associates, prior to the time purchase orders are issud.s subcontractors or vendors for raw materials, a work plan is drawn up for the contract. This work plan includes:

1. A complete work schedule, including all outside purchases;

2. A complete cost schedule;

3. A complete quality assurance program for both raw materials.and for L

' the subcontracting to be undertaken as part of the job.

This quality assurance program takes into consideration the quality control

~ procedures that will be necessary im satisfactory performance of the contract and outlines detailed specitications for materials and subcontracting, as well as quality assurnace check points, time of inspection instructions to vendors, related to manufacturing as well as equipment to be used in undertaking quality assurance programs.

Costs. As part of the c-it records for all jobs, all direct costs as attributed to quality ass erance are included in a separate category and are available

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V for purposea c,f evaluation and future planning. These costs include information to identify the correction of non-conforming materials and

' correction of defective work.

Records. Intermediate and final inspection forms and records are perneanently maintained at.J. L. Shephe rd and Associate s, along with all necessary radiological data, such as leak test certificates, calibration ce rtificates, external radiation levels, and other records that pertain to the radiological aspect of the equipment as required by law and good quality assurance prac tice s.

Prior to assembly, mechanical components and fabricated parts are checked for material and dimensions by the operator (or shop foreman) an:1 by a Q. A. Inspector. Also prior to assembly, all electrical eystem's components are checked fr,r operatio and/or function by the assembit r.

A bench check is performed by the assembler and O. A. Inspector wi;h specific operation being determined by the Operating Manual for each unit. Criteria for these inspections are determined by individual drawing, per individual unit, as called out by Engineering and the Q. A. /Q. C. Department.

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Prior to loading, assembled parte are inspected by the assembler (or shop

' foreman) and by a'.Q. A. Inspector, with criteria being determined by the individual drawing for the individual unit.

The '3ove Q. A. Forms are accompanied by Material Rejection Forms and/or Engir.eering Change Orders to be used in procedure as required and are also a part of the permanent file. See Corrective Procedures for de tail s.

Subsequent to loading, Health Physics performs a complete operational checic out on the ' unit (in accordance with the Operating Manual for that unit)

~ a minimum of 25 times, instrument calibration, calibration of unit, leak test, external radiation level measurements for unit and for shipping (as called out in Q. A. Procedures for Radiological Calibration). IIcalth Physics also prepares radiological shipment information, inspe<:ts shipment and then certifies the Bill of Lading for that shipment.

Forms are also prepared and forvrarded to subcontractors covering the various areas of quality control to be checked by them, as outlined in Quality Planning, and then returned to J. L. Shepherd and Associates to 7-()

be maintained in the permanent files.

Corrective procedures. ' A program for correctove procedures is maintained, which includes the following through the use of Material Rejection Forms of Engineering Change Orders:

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1. Monitoring and review of corrective actions to assure their effectiveness;

' 2. Introduction of required improvements;

? Analysis is scrapped products to determine reasons of non-conformity; 4.- Analysis of methods and processes of work performance.

5. Re-inspections in the normal course of procedures of the corrected difficiencies and records thereof.

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Quality Control Alanual Page 6 FACILITIES & STANDAltDS Drawings and Specifications. 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 use. Approval by engineering and quality assuance is required prior to release.

Changes are to be documented through the use of Engineering Change Orders for Design and/or Specification. Changes require the approval of Engineering and Quality Assurance.

Engineering is responsible for transmitting change information to the Government (or customer) as required.

Engineering is to be responsible for the removal of obsolete drawings and specifications from all issue points and for recording effectivity points.

The following seelions of the Q. A. Program may be broken into three categories: (1) those hipping containers /overpacks made in conformance with specific DOT fabrication regulations 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 packaging performance criteria such as, but not limited to, Pa ra graph 178.350; nd (3) shipping containers and overpacks designed to ship large quantities of radioactivity for which NltC Certificate of Con.pliances and licenses are required.

(1) All drawings and design specifications must be checked for conformance with fabrication specifications as called out in the pertinent DOT specification and approved by the cognizant Quality Assuance :\\lanager or General Alanager before release for fabrication.

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

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y (3) All per tinent data and calculations, including drawings, as called out in 10 CFR part 71 related to Ucense applications and Certificate of Compliance

_. applications for Type B and large cluantity containe rs.will be checked and

.' approved by the cognizant Quality Assurance Manager or General Manager 7 prior to submission of the package containing data to the NRC. After the Certificate of Compliance ' nd license have been issued and prior to the fabri-a cation.of the approved unit, all drawings and purchase specifications for material must be ' checked and approved by the cognizant Quality Assurance Manager or -

Gene ral Manager.

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Quality Control Manual Paget 8-

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v PURCHASING L As noted in previous 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 m' nufacturing, a

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.1J. L. Shepherd & Associates purchase orders also re-quire.that all suppliers or subcontractors a re to notify J. L. Shep herd &

Associates and obtain approval before any changes in design, ie: d rawing changes,. inspection changes, etc.,- a re n je rtaken.

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

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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. Shepher.d, Donelson, and Doonan in

dealing with vendors in this area.

All raw materials which are purchased directly by J. L. Shepherd & Associates 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 th'e subcontractor provides the materials on subcontracts let by

--J. L. Shepherd & Associate s, these vendors are required to establish quality assurance procedures and records for raw materials received, including per-formance of fabricated parts purchased.

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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 vend rs, who must submit to J. L. Shepherd & Associates idetailed information fer permanent records relative to the quality of these products, ie: leak test informa tion on scaled sources.

The following terms and conditions-related to quality control will apply to all

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purchase orders for any type of radioactive sources purchased by J. L. Shepherd l

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Quality Control Manual Page 9 i

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a'nd Associate s:

No source shall have greater than 1000 dpm remavable contamination at time of shipment;.

. Each source shall have undergone a seven-day leak test in accordance with MRC: and agreement state requirements prior to shipment; A signed leak test certificate which calls out the following:

(1) Source description

.(2) Source number (3) Date'of leak test

.(4). Results of leak te st (5) Method of leak test

.will be included with each shipment, attached to the packing list. A second copy will beisent'via mail at tine of shipment.

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

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

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[(2) Alpha 100 dpm/100 cm2

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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 of these tests.

All shipments will be made in accordance with applicable ICC regulations, and

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all shipments will be properly labeled with the necessary data, including Bureau of Explosives number, where required.

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

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,.MANUFACTUltING CONTitOL'

' Materials Control. Quality Assuranceivill insure that all' incoming inaterial'

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is inspected, tagged and segregated as received.

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Ron'-conforming Materials and Parts. A Material iteview 130ard is to be established for determining the continuing disposition of non-conforming

! pa rts. The Mlll3 will include representatives from Engineering,- Quality Assurance, and Government and/or customer as required.

Laboratory testing is to be' employed as.necessary and records of such tests

. maintained by Quality Assurance.

Processing Control. ICngineering is r9sponsible for establishing and

maintaining detailed work instructions for processing operations, in conjunction with Production Control.'

Engineering and Quality Assurance is responsible for establishing in-process

inspection points. Such points are to be designated 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

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performed and that parts are properly ~ identified and segrgated. This also applies to sub-contractors and vendors.

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LINSPECTION STATUS Quality' Assurance is to provide the machanism for identifying the inspection

-. status of parts and assemblics. This may include tags, stamps, or routing l

e cards as appropriate.-

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,s Quality' Control Manual-Page 12-ISOURCE TES

T. PROCEDURE

S Quality Control. Pre-inspection--material certification,- helium leak test,

. dye penetrant.

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

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

Leak te st, liner--Ethylene _ glycol.to 10-4 'ce/sec.

L' akliest, : capsule--Ethylene glycol to 10-4 cc/sec.

e licat cycle: test,L source--2 hours at 200" C., repeated after heat cycle.

LContamination test, source--0.01 uc/100 cm2 by wipe test; maximum per source less than. 005 uc.

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

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p-Special Form Te sts. Free drop -- A free drop through distance of 30 feet onto

.a flat essentially unyielding horizontal surface, striking the surface in such a jposition as to suffer muimum damage.

Percussion -- Impa et of the flat circular end of a 1" diameter steel rod weighing p

.three poutds, dropped through a distance of 40".

The capsule or material is placed on a shect'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 W

su rface.

' IIcating -- IIca g-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 bc.at pli6 - pII8,.with a maximum conductivity of 10 micro-ohms /cm.

Final Inspection. Final inspection requirements are to be established by Engin-cering and Quality Assurance.

Quality. Assurance is responsible for assuring inspections are made and records

,,j of same maintained. Quality Assurance is also responsible for obtaining Govern-ment approvals as required.

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Quality Control Manual ~

"Page 131

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MEASURING AND TEST EQUIPMENT 4

Quality. Assurance is responsible for maintaining equipment.in first class condition and establishing' calibration' requirements anct frequency. Records' of all calibra-

.itions are.to be maintained.

i Quality Assurance is to_ monitor.all vendors to assure that vendor's test equip-

? ment is properly maintained and calibrated.

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'STOll AGE, PACKAGING, DELIVE11Y

-Engineering and llealth Physics i.e responsible'for establishing requirements for

- storage, packaging and delivery, including any special requirements for radioactive materials ' Attention is given to Government regulations, such

.as NI1C and ICC regulations, in addition to contractural specifications, m

t Quality Assurance is responsible for assuring that these requirements are

> met and that rec.ords of such inspections are maintained.

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. An individual log sheet will be maintained for all Type H, Certificate of cCompliance shipping containers /overpacks routinely used by

-J. L.. Shepherd and Associates in conjunction with transportation of y radioactive materials.

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. On an annual basisi all log sheets covering containers routinelf used by I

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' covering shipping. containers manufactured by.I. L. Shepherd and.

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Associates will..be audited by Quality Assuance personnel and the Accounting-

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General Manager

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11. N. DONELSON C.11. Pit EllODA M. F. SHEPIIEllD B. A. IlOWARD P. WUSTRACK Chief, Engineering Accounting Q. A. Manual and Production Sh., Coreman Purchasing Records file Control

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Q. A. Manager Radiological Safety l

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I. -ORG ANIZ ATION Page.17

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4. Jcb Description - C. H. Prehoda Clar a H. Prehoda', Sec re tary-Treasure 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 direc t and -

indirect,_ on a job by job basis. She is also responsible for maintaining -

all'pertinate correspondence,. records and contracts including customer's licenses.

The'" Voice" of J. L. ' Shepherd and Associates, Mrs. Prehoda attended Columbia Union College, Washington, D. C. and has twenty-three years' experience in customer relations in the nuclear field. She specialize,

in handling customer requests, inquiries and problems promptly, efficiently and cheerfully, aided by her excellent command of technical info rm ation.

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ORGANIZATlON Page 18 -

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Job De scription s -- R. N. Donelson

' ' R. N. z Donelson, Chief Enginee r, and Quality Assurance Manage r.

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Donelson is responsible for all engineering and for th_e quality assurance program of J. L. Sheph~ erd & Associates (JLS&A). He has specific respon-sibility for vendor' sele ~ction and qualification and vendor quality assurance

- programs,. purchasing and control of raw materials, dra vings and drawing

' change control..- ' Mr. Donelson also has responsibility for quality assurance-

1. .. of radiological aspects of JLSLA 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. -

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. Radiation ' safety and engineering' consultant, Mr. Donelson has a B.S. in Chemical Enginee ring from the University of Washington and is a Certi-

-- fied Health Physic.ist. cHis thirty-one (31) years of experience in the nuclear field include the design,-. engineering and installation of all types of irradiation facilitics and plants for handling radioactive materials, as well as production management.. Mr. Doncison also acts as an independent

- consultant in the_ radiation safety field.

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~ ~4. Job Descriptions - _ Mary F. Shepherd

' M. ' Shepherd, Q. A. Manual-and itecords.

Ms. Shepherd's responsibilities -

fdistributiona and updates of manuals and internal Q. A. forms, maintaining ~-

1 the Q. A.; records file and' update of.NitC,. DOT and IAEA certificates.

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' Beth floward, Production Control. Ms. Iloward, working with Engineering,.

. Purchasing and the Shop Foreman, and under the direction of.J. L. Shepherd, is' responsible for correlating the prgress in all departments on a daily,

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Ljob-by-job. basis,. expiditing or. delaying progress as. warranted, and Onotification to proper departments. She is also responsible for.

approximate scheduling of work in progress, and tests and inspections as -

necessary.in weekly bi-departmental conferances, m

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ORGANIZ ATION -

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' 4. f Job.De scription ~ -- Paul Wustrack.

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[ Paul Wustrack, Shop Foreann,, working directly with J. L. Shepherd,-- R. N.

Donelson, Clara H.--Prehoda and Joseph S.' Shepherd, has the responsibility

',of delegating. proper ataterials to the respective jobs and supervising the l~

. _. -.work tin' pro'~gre s s a t J. L. S. & A.

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ORGANIZATION '

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.Page 21 4.

Job Description - Vickie Towne Vickie Towne,. Purchasing Officer, under the direction of R. N. Donelson

--and the Engineering Department, as well as Clara II. Prehoda, Ais. Towne is responsible for the proper documentation on purchase orde rs and the

- placement of them to vc adors, 'with all applicable specifications. She is also responsible for notification of'all delivery date s to J. L. Shepherd and to

^ Production Control so that production, testing and inspection procedures can be. scheduled accordingly.

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ORGANIZATION O

Page 22 4.

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

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ORGANIZATION Page 23 4.

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

Working with hir. J. Doonan (Chief, QA Inspector), hir. T. Shephe rd per-forms QA Inspections as required.

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-I. ' ORGANIZATION

.Page 24

. s I4. Job Description -- Joseph S. Shepherd

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

1 Working with.J. Doonan (Chief,- QA Inspector), M r. J. S. Shepherd pe r-forms' all inspections as necessary. Under the direction of J. L. Shepherd and R. N. Donelson, Mr. 'J. S. Shephe rd is re sponsible for the inspection -

of components related to radiological safety functions.

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I. ORGANIZ ATION Page 25

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5. Job Description and Qualifications - Head of O. A. Program

'J. L. Shepherd, Pre sident, General Manager and Head of Q. A.

Program. - Mr. J. L. Shepherd is responsible for the gene ral manage-

. ment of the company, specifically related to sales, contract 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 safety, before delivery to the cus tome r.

Mr. ' J. L. - Shephe rd has a B. S. from Loyola University of L es Angeles.

He did graduate wok at Notre Dame and University of California at Los Angele s, and has had Twenty-six_ years experience in product develop-ment, applic a tions, e nginee ring, s ale s, marketing and general management in the nuclear field. He specializes in the evaluation and selection of the optimum r.adiation sources and/or tracers and related equipment for nuclear applications, based upon the customer's total require me nts, including such parameters as licensing, radiation eafety, cost and reliability and proper shipping containers as required.

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I. Olt G A NI Z A TIO N Page 26 ry i

v G.. Statement of itesponsibility.

J. L. Shepherd, C. II. Prehoda. M. F. Shepherd, M. Irish. P. Wurstack, T. J. Shepherd,.l. S. Shepherd and 11. A. Iloward have the responsibility and authority to reject unsatisfactory materials, stop unsatisfactory work and.to supervise further processing after corrections have been made.

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13. A. Iloward 84 Md J. L. Shepherd,11. N. Donelson and C.11. Prehoda have the further responsibility and authority to stop the delivery and/or installation of non-conforming parts or materials.

This statement of itesponsibility is signed by each individual and posted

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in a visible location.

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,s-e II.JQuality Assuance Program -

Page 127 1

'l.' Statement of Verification of Assessment of Quality Assuance Program.

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The" Officers of the Quality Assurance Program'(QAP), in addition to daily Leommunication, hold weekly conferences in conjunction with appropriate departments,1to review the status of each job in regard to design, purchasing, work release, w'ork in progrese, corrective procedures,

. inspections, testing,. safety, storage or shipment,' proper documentation, eorrective actions (if necessary)' and shipment on whatever phase of T

pperation is pertinent to that job,. as well as overall views of work in progress. Ann ~ual audits to determine compliance, as well as for accounting and inventory purposes, are performed and review ed by officers 4,n

of the 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 made available for any employee to refer to.

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p (Each new employee is made familiar with the manual as part of the iTraining Program. ) M. F.. Shepherd is responsible for distributing approved revisions at all copies of the manual and advising the holders

thereof of the revisions, _ including facilities which keep the manual on file.

3. Statement of Verification that Quality Assuance Program llequirements 2

are Applicable to Outside Vendors.

'.I. L. Shepherd and Associates retains the right to supervise and inspect products at.a vendor's and/or' contractor's facility and/or to reject non-

- conforming materials and has agreements with vendors and contractors

'stitting such to maintain our Quality, Control mandatory requirements.

l4.. Safety-related Systems, Structures and Components Controlled by iQuality' Assurance Program,

, i All' mechanical, electrical and electronic components, as well as components

.and completed systems, are controlled and covered by the QAP by specification, drawing and/or operating manual where applicable.

T S Statement of Verification of itesolution of Disputes.

If,' and when, disputes arise concerning the quality of a product between the different departments, a review of the product's functions, specifications 4d compatability with the QA/QC Program, as well as NitC and DOT

.." Criteria is made by the QA Officers and the appropriate offices. It eviews are made at the weekly conferences or as needed when all pertinent data is

? gathered. Agreements are subject to review by.l. L. Shepherd for final approval.

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II. QUALITY! ASSURANCE PROGRAM

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16. ' Statement of Verification that Training Program is implimented J. L. Shepherd & Associates maintains a training program for all new employees and employees 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 delineated 'and how it is e ffe c -

tive, as well cs 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. IIence, in the training program, each indivi-dual is f. rained (and continuously monitored in the system of checks and balances maintained in the weekly review by the QA office rs to whom the employee is

..responsiC ) 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: Ifealth Physicists, welders,. machinists, for example, when applicable. All licenses und 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 c

program before continuing with their responsibilities or their.cmployment is w/

_ te rminated.

i 7. -Statement of Verification that Quality-Related Activities are Performed According to Predete rmined Measures

.J.'L.1 Shepherd & Associates performs all quality-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 t.nd document tha t all prerequisites have

' been satisfied before inspection and/or testing.

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' Page 29 L

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Statement of Verification of Responsible Design Procedures J.L. Shepherd & Associates has an established design procedure for its products.

f3ecause'of the nature of our business and products, ie: products involving radioactivity, all products are licensed by the proper licensing authority and all new products have licenses pending. The re fo re, in the initial design of a product, the first step is to provide licensing authorities with all pertinent

' drawing s.

LSales drawings, if applicable,- are made per customer requirements and lice nsing.c rite ria.

Engineering is t'o 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 use.. Approval by engineering and quality assurance is required prior to

' relea s e.

IChanges are to be documented through the use of Design Change Orders and

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Specification Change Orders. Changes require the approval of Enginee ring l

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 e Ve rification of Compliance with Regulatory Requirements in

' Drawings J. L. -Shepherd & A ssociate s Enginee ring Department and QA Department reviews all product d rawings, specifications for materials, procedures and instructions, with a final review by J. L. Shephe rd or R. N. Donelson on each job to verify that they meet all regulatory requirements and licensing criteria.

3.

Statement of Verification that Quality Standa rds are Maintained.

(J.L. Shepherd & Associates' Engineering Department maintains a complete list of specifications for each product. It issues a 13ill of Materials to the p

Purchasing Department with these specifications. Any changes from these U

. specifications by the. vendor or sub-contractor is subjected to review by the c-r g-

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III. ' DESIGN CONTROL Page 30 gb Engineering Department and QA Department before purchase is made. Any change or deviation on a particular product is noted on the specification documents for that particular. product.. All purchases are individually 4:hecked on delivery to verify that they do meet specifications before they l a re ' accepted. The Shop Foreman is directly responsible to the QA Officers for production lwhich is. inspected at various stages of completion.

-4.

Statement of Verification of Design Control

- J. L. -Shepherd & Associates Engineering Department and QA Department-revie'ws each product design with all revisions approved before release for-

. manufacture. 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 n:

J. L. Shepherd & Asso' iates QA Department and Engineering Department c

insures the proper. selection of components and design verification of each unit by means of prototypes from which licensing'is applied. The proto-

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Ltypes are thoroughly. tested and inspected in all stages to verify that they V'

f meet t11 licensing authority criteria and design specifications.. All inspec-tion an'd test crite ria are doc.tmented and made available to the QA Depart-ment,; wliich documents accep'ance 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

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

8. -Statement of Verification of Engineering and QA Responsibility and Authority

-J.'L. Shepherd & Associates maintains written agreerr mts delineatitig the areas of responsibilites and authority of each member of the Engineering

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. Department and the QA Department, wluth are agreed upon and unde rstood

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at the completion of the Training Program.

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.IV. ' PROCUREMENT DOCUMENT CONTROL

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.1. _ Statement of Verification of Purchasing Depa rtment Procedure J. L. Shepherd & Associates' Purchasing Department maintains a definite 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.

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Statement.of Purchase Orders-- Appendix E Criteria Verification-J.L. Shepherd & Associates' Purchasing ~ Department routiriely indentify

'10CFR,' Part 71, Appendix E criteria, as applicable and is described in the QA Program proper. ' Standard purchase orde r forms designate spaces

for this information.

~.b. Statement of Appropriate Reference of Specifo~.! ions on Pu rchase Orders

' J. L. Shepherd & Associates' Enginee ring Department provides appropriate references to technical requirements, ie: regulatory requirements, msterial and component identification requirements, drawings, specifications, codes and/or industrial standards, test and inspection requirements and special Fi procek--instructions,- on the Bill of Materials which is submitted to the

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- PD to be included on purchase orders, when applicable.

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Statement of Appropriate Reference of Documentation on Purchase Orders J. L. Shepherd &. Associates' Engineering Department provides appropriate refe rences of documenta tion,' ic:. d rawing s, specifications, procedures,

. inspection and fabrication plans, inspection and test records, personnel

- and procedures qualifications and chemical and test 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 Appropriate Documents Retained by Vendor

and Delivered to Purchaser J.-L. Shepherd L. 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' orde r if applicable.

6.

Statement of Verification of Purchase Order Containing Right of Access Clause s

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IV. - PROCUREMENT DOCUMENT CONTROL Page.32 d,m.

J. L. Shepherd L Associates. purchase orders contain an agreement clause covering the right to access lto the supplie r's facilities and records for a.

source inspection audit, when applicable. --

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Statement of Verification that Purchase Order Revision are Subject to Approval

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As ' stated in 111,1 #3, "Any changes from these specifications by the vendor

or subcontractor is, subjected to review ~by.the Engineering Department and

- QA Department before purchase is made. Any change o. deviation on a

. particular product is noted."

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V.. INSTRUCTIONS, PROCEDURES & ' DRAWINGS

'Page 337

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Statement of Verification that Activities Affecting Quality are Accom-plished in Accordance with Specifications -

J. L. Shepherd & Associates (JLS&A) has established eith the implemen ta-

. tion of the OA/QC program that activities affecting the quality of a prcduct

.are adhered to in all phases of operation according to prescribed documenta-

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tion of instructions, procedures and/or drawings.

2.. Statement of V'e rificationior Clear Sequence of Actions Concerning Instruc-tions, Procedures, and Drawings -

'JLS&A has established with the implimentation of the QA/QC Program that Tthere is a clear sequence of procedure in the preparation of, review,. appro-

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val, and control of instr uctions, procedures, and drawings.

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' 3.' : Statement of Ve rification of Quality Assu rance Department Re sponsibility.

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JLS&iA.QA Prog ram Department has the authority and responsibility to i review inspection plans; test calibration and special process procedures; drawings and specifications; and all: changes thereto and/or acceptable 7~V

-. alte rnatives,tunder the provisions of the QA Progre.m and does so.

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TVL'. s DOCUMENT. CONTROL Page.34 s.

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1. : Statement of Verification: that the Issue of Documents and Procedures

.thereof are Procedurally Controlled

-;JLS&A Engineering 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 Jrelease, Lon a-product, are satisfactory to quality requirements.

2.. Statement'of Verification that Changes to Documentation are Made by

.tlie 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.

Department, reviews and approves or rejects revisions to the original 3

document,- as needed.

3. - Statement of Verification that Revisions are Made on Appropriate Documents JLS&A Engineering Department is responsible for making all necessary revisions ~on all;related documents of a project, after approval thereof,

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. prior to' the implementation of these changes.

4.1 Statement of Verification that All Pertinent Documents are Available lat. Site' where They. a reito-be Implemented 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, 4 prior.to starting work. The Engineering Depa rtment is also responsible

' that the Purchasing Department has all pertinent documents to accompany t

the purchase orde r _(if applicable) to the supplie r before work begins on

' the project.

1 5.

Statement of Verification that Master Lists of Revisions are Current and

. Appear on Appropriate Documents 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.

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VII. = CONTROL of PURCIIASED MATERIAL, PARTS & COMPONENTS

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Statement of Verification'that Qualified Personnel Evaluate Suppliers

?-- (for.' Acceptabili,ty

'R. N. ; Donelson, Chief Engineer and QA Manager of JLSLA, is qualified and

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responsible for vendor selection and qualification of vendor QA Program

' to provide materials that meet specifications.

2. L Evaluation of Suppliers.

R;N. :Donelson, Chief Engineer and QA Manager of JLS&A, who is respon-

. sible for supplier selection uses the following criteria for approving a

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vendo r:

. The supplier's capability to comply with the elements of Appendix E to 10CFR Part.71 that are applicable to the type of material,

equipment, or;se rvice being procured.

lA-review of previous records and performances of suppliers who

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- have pr.ovided similar articles of the type being procured.

K l A> survey-of the. supplier's facilities and QA Programs to deter-il'

-mine his capability to supply a product which meets the design, manufacturing, and quality requirements.

3.. Statement of Verification that Supplier Evaluations are on File JLS&A maintains current files on the results of supplier evaluations made by 1R. N. Donelson, Chief Engineer and QA Manager, as well as current specifi-cations on products supplied.

4.

Statement of Verification that inspection and/or Supervision of Suppliers is Performed.

4 At the! weekly-meetings of the.QA Department and appropriate departments,

'it is determined if and when it is required that the Chief Inspector or appro-

.priate office r be present du ring fabritation, testing and shipment of a pro-

.' duct,- to assure accordance with purchase order specifications.

5.

Statement of Verification of Minimum Records supplied to Purchaser JLS&A requires as a' minimum from all vendors the follo. sing documentation:

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.Socumentation that identifies the purchased material or equip-1) ment and the specific procurement requirements (e.g., codes,

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- VII.1 CONTROL of PURCIIASED MATERIAL, PARTS & COMPONENTS, j:s.

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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 those 1

.nonconformances dispositioned " accept as is" or " repair."

Noie: ' Contingent upon acceptance by JLS&A, all nonconforming items must be repaired'or replaced and certification thereof.

1:' Statement of Receiving Inspectors Acceptability Criteria and Responsibilities The Chief Inspector for J T.S&A is responsible for, and will,not accept, products-

that do not meet the following criteria:

iThe; material ~ component or equipment is properly identified

- andjcorresponds with the identification on' receiving ~ documenta-tion'. :

. Material, components, couipments, and acceptance records are

' inspected-and ' judged acceptable in accordance with predetermined T

inspection instructions, prior to ins'tallation or use.

' Inhpection records or certificates of conformance attesting to-the ' acceptance of material and ' components a re.available prior to installation or use.

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~ Items accepted and released are identified as to their inspection

' status prior to forwarding lthem to a controlled storage area or releasing them for further work.

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s-VIII. IDENTIFICATION AND CONTROL OF MATERIALS, _ PARTS, &

~ COMPONENTS page-37 l ~. Statement of Verification of Established Procedures Used for Identifying and Omtrolling Materials

-Chief Inspector of JLSLA uses a standard procedure for identifying all pro-ducts received, as part of the QA/QC Program.

. 2. ' Statement of Verification that Products a re Identified Prope rly

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As-part of the standard receiving procedurer of the Chief Inspector of JLS&A, all products are identified and marked. This identification and marking is directly traceable to all pertinent records and this system precludes the use

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sof incorrect or defective items.

~ 3.' ' Statement of Verification that Safety-Related Mate rials a re Identified

- Prope rly :

TA s-stated'in LVIII, #2, all itmis are identified and marked, directly traceable

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to all pertinent records, ie., drawings, specifications, purchase orders, test reports, including'and especially the safety related items, which a re thoroughly inspected.

J 4.l Statement of Verification that the Location and Method for Identifving Products is not Harmful to Them

'JLS&A maintains-a receiving are'a where all products are identified and

' marked before allocation to proper inventory areas. The receiving area and method of identification (seve ral methods appropriate to item) ~do not in any way interfere with the fit, fun c tion, or quality of a product.

- 5. x Statement of Verification that Product Identification Numbers are Verified before Release -

JLS&A, -as part of the QA/QC Program, requires that any item from inventory be verified that.it is the proper item for that job before release for fabrica-tion, :a ssembly, o r in stalla tion.

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-q ilX.= CONTROL of SPECIAL PROCESSES l

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1.. Statement of Verification that Special-Proce sses are Procedurally Controlled The Shop'Forr. man at'JLS&A is directly responsible, 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 s

inspecting and controlling these processes at supplier's installations, as applicable.

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2. -Statement of Verification that Procedures, Equipment, and Personnel

.-Related to Special-Processes Meet Applicable Specifications, Codes, and

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i Standa rd s -

DLS&A Engineering Department and Shop Foreman, in conjunction with the QA. Department, are responsible' for maintaining appropriate procedures, equipment, and personnel connected with applicable codes, standards, and

'specifica tion s.

13. ! Statement of Verification that Qualification Records Conce rning Special

[.

Processee are Established and Current v

. 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 processes..In addition, copies of applicable records are

- filed in each job file.

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INSPECTION L pm Page 39

1.. lStatenient of Verification that Inspection Program Verifies Conformance of" Articles in'Accordance with Established Procedures A11Linspections p'erformed by JLS&A, which check conformance with quality associated areas, are performed in accordance with written and controlled procedures'and are ' ocumented.

d 12.

Statement of Verification that Inspection Personnel are Independent from Individuals Performing Activity Being Inspected EInspection" personnel'at JLS&A are independent from the personnel perform-ting the activity'being inspected, qualifications and independence determined iby;the QA' Department.

3. : Statement of Verification that Inspectors are Qualified and Qualifications

' 'are Recorded -

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The QA Department of JLSLA.is responsible for maintaining qualified in-

spectors (in accordance _with applicable codes,- standards, and training

. programs) and the certifications and qualifications thereof are on file and

ni kept current.

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14.

Statement of Verification that. Revisions a re Inspected in Accordance with the Original Specifications

~ Inspectors at JLS&A perform all inspections, including those on any modi-fications,s repairs, or replacements,. in accordance with the original design Especifications and procedures or acceptable alte rnatives; and all inspections

- a re documented.

- 5.

Statement of Verification that Inspection Points are Established and

-Observed The' Shop Foreman is-responsible for the supe rvision of work, including holding work prog ress until it has been inspected, at the appropriate phases.

The Shop. Foreman holdis work for inspection in accordance with predeter-

mined inspection specifications and for informing the QA Depa rtment of forthcoming inspections at weekly meetings and time of inspection.

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(XL TEST CONTROL i

Page : 40

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Statement:of: Verification that Test Programs are Established, Docu-mented,. and 'Pefo'rmed Accordingly Test Programs to. determine if an. item will perform satisfactorily are performed byfJLSLA Engineering and QA. Departments and are performed

. in'accordance.with established documented specifications, and are fully 5-

documente'd. -

2. :" Statement oflVerification that Revisions in Design are Tested in Accor-dance with Specifications..of the Original. Design

.JLS&U Engineering _ Department,' in conjunction with the QA Department,-

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L tests all modifications, repairs or replacements to the original design in i accordance~ withLoriginal specificatims or acceptable alternatives.

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3. ' Statement'of Verification that Test Results are Documented, Reviewed,

. and Accepted by Appropriate Department ar

- All' test pro' gram.results arc. fully documented. They are then evaluated and

. determined acceptable' by qualified Engineering and QA Department officers (l

. of tJLS&~A.

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XII.. CONTROL OF. MEASURING & TEST EQUIPMENT Page, 41~

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Statement of Verification that Measuring and Test Equipment are Pro-

- p'erly Calibrated JJLS&A maintains properly calibrated measuring and test equipment, based

upon required ' ccuracy, purpo'se, degree of usage, stability characteris-a

tics,3 or other' conditions affecting the measurement. Instruments used

. involving 1 the measurement of radioactivity are calibrated at three (3) month

' intervals: all'other instruments a re calibrated yearly.

t2.

Statement o'f Verification that Measuring'and. Test Equipment are -

Identified and-Traceable to' Calibration Te st Data

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JLS&A requires'and maintains serial numbers on all measuring and test equipment and requires all calibration test data to reference the instruments' serial numbe r.-

3. iStatement of LVerification that Measurements are Taken, Documented, and Validated against Previous Measurements if Instrtunent is found to be

--out of Calibration

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. JI SLA-performs new tests or measures (which are documented) to validate previous inspections in.the event that an instrument is found to be cu t of calibration,- 'and notifies app'ropriate pa rties, if applicable.

4.

Statement.of Verification that Calibration Meets Appropriate Standards a

JLSLA maintains National 13ureau of Standards traceable calibration records

-on all instruments which measure radioactivity, and these standards are referenced 'on all appropriate documentation. Other inspection instruments either meet nationally recognized standards or manufacturer's specifica-tions which are' documented and are on file at JLS& A.

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XIII... HANDLING, STORAGE, & SHIPPING Page 42

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.1. : Statement of Verification that Special Requirements are Accomplished by Qualified Individuals in Accordance with Work and Inspection Instructions

.'In: accordance with predetermined established work and inspection in struc-

'tions, qualified employees of J,LS&A perform 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 JLSLA pe rforms a. final inspection, before. shipment, on all items pertinent to NRC. and U. S. DOT specifications and conditions. Items must pass all criteria before shipment is made.

3.. Statement of Verification that Shipping Papers are Properly Prepared

' JLS&A prepares.(and keeps on file) all necessary shipping papers as required.

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~ Shipping papers on shipments containing radioactivity include the following

-- documentation:

.Date of shipment Custome r 1

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License of Customer 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

. Instrumen t Leak Test DOT class label Transport Index.

Truck placard requirement Shipping weight Freight Cla ssification Also included with shipments are External Radiation Level Certificate,

. Leak Test Certificate, Calibration Certificate, Attenuator Certificate, if applicable; 4.

Statement of Verification that Shipment Time is Consistant with Safe

Transportation Time JLSLA routinely cses motor freight for shipments because the weight inhibits fast-delivery and our products' mtura does not demand it.

Departure occurs 7

M afte r a package.has passed final inspection to meet NRC, DOT crite ria and

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XIIL IIANDLING, STORAGE & sIIIppING Page 43

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G the customer has necessary licensing (if applicable) and is ready to accept delivery. Shipments are monitored as applicable to the motor freight de-livery schedule and customer notification of a rrival.

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f XIV. - INSPECTION, ' TEST, & OPERATING STATUS

Page 44

11. Statement of Ve rification that Status of Packages is Known by Affected OrganizQions

. JLS&A 'QA Department, in conjunction with other appropriate departments

. (such as ship' ping, ' enginee ring, production, sec retarial), is re sponsible that

.the appropriate documentation and-identification of inspection, test, and f operating status.of packages is known and received by affected organizations, such as--inte r-depa rtmental, shipping agents, and/or customers.

2.. Statement of Verification that'llemoval 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 verification purposes) for records of "in-process" work. 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

- accordingly.

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3.- Statement of Verification that Bypassing of Inspection Tests or Other

- Critical Operations is Controlled

' The bypassing of inspections, tests, ~ or othe r c ritical ope rations is proce-durally controlled by documentation, work structure and procedure and daily communication,. as well as weekly meetings, between all departments and

. the QA Depa rtment.

~4.. Statement of Verification that Nonconforming' Items are Identified The Chief Inspector at JLSLA is responsible for identifying and inspecting in-coming m ste rials., Nonconforming items are so identified, not nlaced in inventory,L but returned to ' vendors If items are found to be defective or otherwise nonconforming during procedural inspections, the se items are

identified and either returned to vendor or placed in a special inventory for rework and retesting. These procedures are established to preclude the inadve rtant.~use of none'onfo rmine mate rials.

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' XV.- ; NONCONFORMING M ATERIALS

':Page: -451

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Statement of-Verification that Nonconforming Items are Procedurally

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, ' Controlled =

JLS&A has estaMidlied and enforced procedures during receiving inspection and for sub ;.:quent inspections to assure that the identification, riocumenta-tion,1r$gregation,' review disposition are implemented, affected orgpnizations

^are n6tified and that replacement and repair ~ are carried out.

f 2.

Statement of Verification that Nonconforming. item Documentation-is

' C omple te -'

4

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 appropriateLaction is taken.

.3.. Statement of Verification that Nonconforming Items are Segregated from

. Acceptable Items -

? JLS&A maintains a separate inventory location for nonconforming items,

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which are ' identified as such until t_ppropriate action is taken.

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i4.7 State' ment of Verification that Repaired or Reworked Items are Subjected

to Original Testing,

- JLS&Acinspectors subject all replaced, reworked, or repaired items to the

_.same documentation testing procedures per the original inspection, or by

~ acceptable alternative testing procedures.

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_ x-r XVI. CORRECTIVE ACTION

Page.40 p

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Statement of Verification that Evaluations are Conducted to Determine

.the:Ne'ed 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 the re is-a nonconformance, such as

failures, malfunctions, deficiences, or defectiveness, the Engineering and

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QA Departments jointly evaluate the need for corrective ' actions in accor-

' dance-with established procedures..

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2.. Statement of Verification that Corrective Action is Initiated, if Required In the event of nonconformance, -the Engineering and QA Departments of JLSLA 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.HStatement of Verification tlut Reviews cf Corrected Actions are Conducted T'(

The Engineering and QA Departments of JLS& A conduct inspections and V_

follow-up reviews of corrective actions to determine if they are acceptable, Land either close out required documentation and/or implement these actions

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as part of standard operations, whichever is needed.

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e lXVII.D ' QUALITY ASSURANCE RECORDS

' Page 47 ^

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Statement of Verification that Documentation is Maintained Concerning

Evidence of. Quality and Safety of Items and Activitics The Engineering Department of JLSLA maintains all documentation con-

-cerning the quality and safety of items and activities which affect quality and safety a reas, with revisiona and updates made annually, or as needed, or as required. -

12., Statement of Verification that Safety and Quality Related Documents Contain. Required Information IJLS&A QA records, maintained by the Engineering' Department include

operating logs; results' of reviews, inspections, tests, audits, and material

! analyses; qualification of personnel, procedures, and equipment; and other

-documentation'such a.s drawings, specifications, procurement documents, calibration procedures and reports;. nonconformance reports; and correc-tive action reports.

In addition, pertinent 6.

i nentation is included with each job file.

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3., Statement of Verification that Quality Assurance Documents are Identi-

' fiable and Retrievable

'JLS&A maintains a numerica1'and alphabetical system which cross references all QA-documentation, as well as all associated documentation, throughout

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 of Required Records and Storage Locations is Maintained JLSLA maintains a master list of where required records may be located, which includes the use of the e stablished numerical and alphabetical identi-fication system.

. S. ' Statemen t of Verification -that Required Records a re Kept on File

' JLS&A maintains complete file s, including design related records, inspec tion and related QA documents, since the company was established in 1967, and updates these files as regiired, ie., repairs or replacem ent pa rts, cor re s-pondence, etc. These files are identifiable and retrievable per the master list discussed in XVII. 3 & 4.

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-6.

Statement'of. Verification that Inspection and Test Records Contain

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' XVII. - QUALITY AS'SURANCE RECORDS -

Page 48 c-(:, -.

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~. A'ppropriate Information.

J'JLS8rA Engineering Department has' established and maintains inspectio >'and

~ test' records'which' include the following c rite ria:

(1) 'A description of the type of observation.

- (2) Evidence of completing and verifying a manufacturing,.

Jinspection, ' or te st operation.

(3) The date'and. results of the inspection' or. test.

.4.

'- (4)'lInformation related to conditions adverse to quality.

f (5) c Inspector or. data recorder identification. -

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

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, - X VIII. AUDITS Page : 49 M.

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11. ! Statement of Verification that Audits are Conducted in Prescribed Manner

JLSLA performs audits in accordance with prescribed procedures and check-lists.-; All audits are-performed by empl6yces who do not have direct responsi-bilities'for the area being audited. - Audits are performed interdepartmentally

- if those departments contain individuals who are qualified to 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 f Responsibility to Correct 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-

[Y audited Regularly.

=(f JLS&A, at the receipt of an order, makes total inventory and appropriate audits at that. time, ~ to determine the correct status of items. Special nota-tions and attention is made on items found previously deficient, or items frequently used.

5.

Statement of Verification that QA Program is Audited Annually Qualified 'JLS&A management personnel, in conjunction with the QA Depart-annually audits and review the entire QA Program and its implemen-me nt, Jtati_on with'special emphasis on the safety related features. Other audits and reviews are performed as necessary, if required.

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