ML20012D707

Forwards QA-RM-001-A,Rev 2, QA Manual, for Renewal.Fee Paid

ML20012D707
Person / Time
Site:	07100122
Issue date:	03/19/1990
From:	Shepherd M J.L. SHEPHERD & ASSOCIATES
To:	Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
References
NUDOCS 9003280267
Download: ML20012D707 (1)

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SiEpiERC diISSOCIATES 1010 ARROYO AE, $AN FERNANDQ CAUFORNIA 91340-1822 818-898-2361 FAX 818-361-8095 March 19, 1990 Charles E. MacDonald, Chief Transportation Certification Branch Division.of Fuel Cycle and Material Safety, NMSS U.S.N.R.C. Washington, D.C. 20555

Reference:

Quality Assurance Program Approval #0122, Revision 3. Expiration Date: April 30,~1990 Docket 171-0122 e Gentlemen: Enclosed are six copies of J.L. Shepherd and Associates' Quality Assurance Manual, QA-RM-001-A Revision #2, and Check # 38780 for the amount of $150.00, for renewal application of this package. ' Sincerely, J.L. SHEPHERD AND ASSOCIATES M 3. Mary F. Shepherd MFS/dfm l fh l l .g3 L1 % m3 y CA,b 9003260267 900319, ADOCK 0710 Q ,g, PDR kW

4 l l I r *;; ( QA-RM-001-A I Revision #2 QUALITY ASSURANCE MANUAL' i i 1 4 i APPROVED BY )

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i J YFM Shepherd, Tresi 'nt .L. January 20, 19 9 i l i i J.L. SHEPHERD & ASSOCIATES 1010 Arroyo Avenue San Fernando, CA 91340 (818) 898-2361 v^s ,l /Q CONTROL # (A-00052 1 l 461. Di nn f 37 mu

t i i U INTRODUCTION e J.L. Shepherd Associates manufactures shipping containers for radioactive materials in Type A, Type B and larger quantity categories, in both " Normal Form" and "Special form" for its own use and the use of others., J.L. Shepherd & Associates also uses its own and other manufacturer's containers for the transportation of radioactive materials as described above. The Quality Assurance Program, described in this manual, pertains to quality assurance in I r~3 design, manufacture and use of the above containers, including but not O limited to calibrators and irradiators which qualify as DOT Type 7A Containers, as called out in 10CFR71, Subpart H. Because of the specialized nature of its

business, i.e.,

products involving radioactivity, J.L. Shepherd & Associates maintains all necessary equipment for calibration and radiological control of its products. Members of the staff of J.L. Shepherd & Associates personally perform all test on equipment related to this aspect of operation. L /~'s V l'

t I i TABLE OF CONTENTS (') Introduction i V Revision Sheet 11 I. Organization 1. Statement of Responsibility 1 2. Quality Planning Manual 2 3. Organization Chart 18 4. Job Descriptions 19 5. Statement of Responsibility, 28 II. Quality Assurance Program Statements 1-2 29 Statements 3-5 30 Statement 6 31 Statements 6-7 32 III. Design Control, Statement 1 33 Statements 1-3 34 Statements 4-6 35 Statements 7-8 36 IV. Procurement Document Control Statements 1-3 37 em Statements 4-6 38 () Statement 7 39 V. Instructions, Procedures and Drawings Statements 1-3 40 VI. Document Control Statements 1-3 41 Statements 4-5 42 VII. Control of Purchased Materials, Parts & Components Statements 1-2 43 Statements 3-5 44 Statements 5-6 45 VIII. Identification and Control of Materials, Parts and Components Statements 1-3 46 Statements 4-5 47 IX. Control of Special Processes Statements 1-3 48 X. Inspection Statements 1-3 49 73 Statements 4-5 50

7: - 1 l' TABLE OF CONTENTS (continued) !s XI. Test Control Statements 1-3 51 i i XII. Control of Measuring and Test Equipment Statements 1-3 52 Statement 4 53 ) XIII. Handling, Storage and Shipping, Statements 1-3 54 ) Statements 3-4 55 Statement 4 56 XIV. Inspection, Test and Operating Status i Statements 1-2 57 ) Statements 3-4 58 XV. Nonconforming Naterials Statements 1-3 59 Statement 4 60 I j XVI. Corrective Action I Statements 1-2 61 Statement 3 62 rx. ( ' XVII. -Quality Assurance Records t Statements 1-2 63 Statements 3-5 64 Statement 6 65 i XVIII. Audits Statements'l-3 66 i Statements 4-5 67 ~ r ~

PCgo ist f REVISION SHEE r I x Revision Numbe r Date Summ ary Initials C ) Q A-R M-001 - A 11/16/79 Tietal revision per receipt of M FS 10CFR 71,.\\ppendix E g g' Acceptanco Criteria - Trans-portation Packages for Normal Form Ratlicactive Mate rial, f rom the U. S. N. lt. C. I Page 16 Rev.1 02/09/80 f rom *J. S.' Cohen Purchasing to /tt }.6 B. A. Howard - Purchasing and M FS from J. Doonnn-Chief, C. A. In-spector to M. Brandon, Chief, O. A. Inn nec to r Pgs.16 -rev. 2 08/21/R0 from Alatford Irish', Sliup l'or-MFS &20, Rev.1 man to Dunalil 13rewer. Shop g j Fnrman Pgs.16-Rev. 2 0'l/21/80 f enm Al. H enndon to.l.

Ferrec, MFS

& 22, llev. 1 Uhlef. Q. A. In: pector M 1 ] Pg s.16-Rev. 3 From D. H rewer, Shop Foreman Bl! l O./ L pgs. 20-22 3/29/S1 to P. Wustrack; from D. Howarrt Rev.2 purchasing to V. Towne: from J. Fe rrec, Chtof, Q. A. In spector to.vi. Irish Pg. 5 & Sa, Rev.1 04/23/31 Recordii sectiod revised to 2 pgs. .s1F3 4 Pgs.t 6, 1 0, 114, 06/08/31 Rewording an".1 namo chang;es MFS 15,16,19 (19A

erc, added), 2b & 27 Pgs. 16 26 08/10/31 Revision ni QA Organizational Phi chart, changes in personnel &

re-de finition of re ap<ansibilitie s O A-RM -001 - A 10/14/82 Total revision to reflect changes EM in pornonnel and sligh t changes 4 in procedurns due to introduc-tion of compute rizerl system. Pgs. 1, 18 thru 29 3/28/85 Name changes and rewording V.Tl of job descr Lptions [l cover pa9a. 4/1./66 Ad d r e s.1 c h a n ty

• / 7 Pg.

1, 18, & Personnal changes 20 ,!V Pages 9,18 6 28 8/6/86 Personnel changes V.T F

l 1 l('~h.^ ',. ( /. ;Page iv REVISION SHEET 1 p I Revisico Nunbar Data SumaY Initials I J s a Q4-3M-001-A. 1/20/89 Revisions to renect Rev. 2 personnel sanges d } i I l ,f i -i f t ? .t 4 t f i ( 1

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i i Page 1 (1.1) { , '] 10 CFR 71, Subpart H, Acceptance Criteria U' I. ORGANIZATION j 1. Statement of Responsibility ) 1 J.L. Shepherd Associates implements the Quality Control / Quality Assurance Program, as follows, as normal operation procedures in tho I design, manufacture and use to Type A, Type B.and large quantity categories of. both " Normal Form" and "Special Form" shipping containers for radioactive materials, for its own use and the use of others as well as for the use of containers made by other manufacturers. J.L. Shepherd Associates is responsible for the continued implementation of this program on future projects. J.L. Shepherd - General Manager J.S. Shepherd - Director, Business Development Q. Pho - Production Manager i O. Carandang - Quality Assurance Engineer O

I i l' 4 ') Page 2 (I.2.A) %d l A. ORGANIZATION L For each job undertaken by J.L. Shepherd Associates, prior to the time purchase orders are issued to subcontractors or vendors i for raw materials, a work plan is drawn up for the contract.' The work plan includes: 1. A complete work schedule including the purchase of long and short lead-time items; i 2. A Work Order Sheet which includes special ins ructions, job details and a drawing list. 3. A complete schedule for outside purchases and stock withdrawals (cutting list). 4. A complete quality assurance program including but not r~(_)s limited to contracted

parts, in-house manufactured components in process - inspection points, final assembly and final check-out subsequent to source loading.

This Quality Assurance Program takes into consideration the quality control procedures that will be necessary for satisfactory performance of the contract and outlines detailed specifications for raw materials subcontracted parts and in-house manufactured components. This program also specifically calls out quality assurance check points, t time of inspection and inspection instructions as well as equipment to be used for vendors, subcontractors and manufacturing personnel of J.L. Shepherd & Associates.

i Pag 3 3 (I.2.B,C) I B. COSTS 1 As part of the cost records for all

jobs, all direct costs as s

( ) attributed to quality assurance are included in a separate category and are available for purpose of evaluation and future planning. These costs include all pertinent information needed to identify the correction of nonconforming materials and' correction of defective workmanship. C. RECORDS Intermediate and final inspection forms ar..t records are permanently maintained at J. L. Shepherd & Associates, along with all'necessary radiological data such hs leak test certificates and any other records that pertain to the radiological aspect of the equipment as required by law and good quality assurance practice. Included in the Quality Assurance records which become a permanent l ~N file for each job, are the following forms: l (O Mechanical Components: Quality Control Certification Electrical Systems Check List Health Physics Check List - Subsequent to Loading Assembly Check List - Prior to Loading Shipping Check List QA/QC Operational Check List Materials Rejection Form Container /Overpack Inspection Check List (~ l (_-) I

w V Page 4 (I.2.C.) When Necessary, forms are also prepared and forwarded to subcontractors covering the various areas of quality control to bc checked by them, as outlined in Quality Planning, and then returned to J.L. Shepherd & Associates to be maintained in the permanent file. Prior to assembly, mechanical components and fabricated parts are checked for material and dimensions by the operator-or production manager and by the Quality Assurance Engineer. 'Also ' prior to assembly, all electrica) system components are checked for operation and/or function by the assembler. An operational check is performed by the assembler in conformity with the Quality Assurance Manager and/or Engineer with specific operation being determined by the Operation Manual for each unit. Criteria for these inspections is (9 l determined by individual drawing, per individual unit, as called out by Engineering and the QA/QC department. Prior to loading, assembled parts are inspected by the assembler or production manager and by the Quality Assurance

Engineer, with criteria being determined by the individual drawing for the individual unit.

The above mentioned Quality Assurance Forms are accompanied by Material Rejection Forms to be used if required. These forms become a part of the permanent file. See Corrective Procedures for details, t l

i-(~'T NJ Page 5 (I. 2. C, D) Subsequent to loading, Health Physics performs.a complete operational check on the unit (in accordance with the operating Manual for that j i unit) a minimum of 25 times. Instrument calibration, calibration of the unit, leak testing, external radiation level measurement for the I unit and for shipping purposes are also performed 'a t that-time. Health Physics also prepares radiological shipping information in the form of a " Shipping Document", inspects the shipment and certifies the Bill of Lading for that shipment. r~' o - (')sD. CORRECTIVE PROCEDURES A program for corrective procedures is maintained. This includes the following: 1. Monitoring and review of corrective procedures to assure their effectiveness. 2. Introduction of required improvements. 3. Analysis of scrapped products to determine reasons of nonconformity. 4. Analysis of methods and processes of work performed as indicated by actual labor vs. estimated labor. 5. Ra-inspections in the normal course of procedures of the corrected deficiencies and records thereof. l ./'T l \\-)

I l Q,) Page 6 (I. P.. E) i E. FACILITIES AND STANDARDS i i 1 Drawings and Specifications - Engineering is to maintain the central, current drawings and specification file. Individual job files including but not limited to all pertinent drawin'gs, ' correspondence, copies of contracts and/or customer's purchase

order, copy of customer's license (if applicable) copies of all purchasing records

-l 1 and copies of all Quality Assurance / Quality forms are to be maintained permanently by QA Records Maintenance Personnel. Prior to release for fabricatilon, 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 release. 1 Changes are to be documented on the drawings incorporating the current Design and/or Specifications. Changes require the approval of ,I Engineering and Quality Assurance. l l Engineering is responsible for transmitting change information to the customer, if required. Production Control and Engineering is also responsible for transmitting this information to the operations i Manager. \\

] Page 7 (I.2.E,F) Engineering is to be responsible for the removal of obsolete drawings and specifications from all issue points. The following sections of the Quality Assurance Program.may be broken into three categories: (1) Those shipping containers /overpacks made in conformance with specific DOT fabrication regul'ations as' called out in Department of Transportation regulations such as, but not limited to Paragraphs 179.104 and 178.194; (2) Shipping containers and overpacks made in conformance with DOT general packing performance criteria such as, but not limited to, Paragraph 178.350; and (3) gx shipping containers and overpacks designed to ship large quantities of ') 's_ i radioactivity for which U.S.N.R.C. Certificate of Compliance and licenses are required. i F. DRAWING CONTROL l 1. All drawings and design specifications must be checked for conformance with fabrication specifications as called out in the pertinent Department of Transportation specification and approved by the cognizant Quality Assurance Manager or General Manager before release for fabrication. 2. All drawings and fabrication specifications and all outside l purchase specifications for units out-purchased, must by checked and approved by the cognizant Quality Assurance Manager or A (_)

Page 8 (I. 2. F) General Manager prior to release for fabrication e.nd/or purchasing. For this equipment, a prototype of,each class of container-will either be tested or calculations will be made and approved by the cognizant Quality Assurance Manager or General Manager. A Work Process Sheet (release for fabrication) will net:be released until it can be shown that the, containers will meet pertinent transportation requirements. 3. All portinent data and calculations, including drawings, as called .out in 10 CFR Part 71, related to license applications and ~s ') Certification of Compliance applications for Type B and large quantity containers, will be checked and approved by the cognizant Quality Assurance Manager or General Manager prior to the submission of approval data to the U.S.N.R.C. After the Certificate of Compliance and license have been issued and prior i to the fabrication of the approved unit, all drawings and purchase specifications for material must be checked and approved by the cognizant Quality Assurance Manager or General Manager. !(

i i I V/ Page 9 (I.2.C) G. PURCHASING As noted in previous sections, J.L. Shepherd & Associates prepares a schedule of n.aterials to be purchased, as well as subcontracting, for each job prior to initiation of work on the contract. ' Purchase orders 1 which are let include, a complete description of the item to be purchased, as well as any qualifications which must be met on i Government and/or customer contracts and any certificationc which may be required. I (~ i' All pertinent drawings and manufacturing procedures are included as part of the purchase orders. J.L. Shepherd Associates purchase orders also require that all suppliers or subcontractors to notify J.L. Shepherd & Associates and obtain approval before any changes in design, materials and/or dimensions are undertakcn. In cases where shipment is made directly to the user, all instructions regarding shipment are included. J.L. Shepherd & Associates maintains a qualified vendor's list for which vendors are selected, based upon past performance as evaluated by the company's experienced responsible managing employees. O O

7 I J 1 .( ~} page 10 (I.2.G) V In cases where the subcontractor provides the materials on subcontracts let by J.L. Shepherd & Associates, these vendors are required to establish quality assurance procedures and records for raw materials received as well as material certification

required, including performance of fabricated parts purchased.

In case of subcontracts for manufacturing, J.L. Shepherd & Associates performs vendor surveys and evaluation prior to the letting of subcontracts. In cases where materials of a radiological nature are subcontracted, J.L. Shepherd Associates requires that these vendors submit information for permanent records relative to the quality of these , ')

products, i.e.,

leak test information on sealed sources, v The -following terms and conditions related to quality control will apply to all purchase orders for any type of radioactive sources purchased by J.L. Shepherd & Associates: A signed leak test certificate which calls out the following: 1. Source descriptions i 2. Source Serial Number 3. Date of Leak Test 4. Results of Leak Test i \\t,/ i

il[ g page 11 (I.2.G) will be included with each shipment as.a part of the operating manual. A-second copy will be sent via f,irst class ma,il at the time of shipment. Shields: All shipping containers will have the' following maximum-levels of remov,able contamination: 2 1. Beta-gamma 200dpm/100cm 2 2, Alpha 100dpm/100cm 'O Attached to each packing list prior to shipment will be a signed report form (Shipping Document) 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 all shi.oments 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 W will result in rejection of the shipment and-its immediate return., o m

n {j \\ -s. / L-Page 12 (I.2.H) H. MANUFACTURING CONTROL Materials Control - Quality Assurance, working with Inventory Control.' Personnel, will insure that all incoming materials.are inspected, tagged and segregated on job shelves as received.I = Nonconforming Materials and Parts - A Material Review Board (MRB) is to be established to determine the continuing disposition of non-conforming parts. The MRB will include representatives from gg Engineering, Quality Assurance, Inventory Control and the customer as required. Laboratory testing is to be employed as necessary and records of such test maintained by Quality Assurance. l. Processing Control - Engineering, Production Control and Operations will be responsible for establishing and maintaining detailed work instructions for processing operations. l l: l 1 ('b L (_/

l g i xi Page 13 (I.2.H, I, J) Engineering and Quality Assurance are responsible for establishing in-process inspection points. Such points are to be designated by by Quality Assurance. Quality Assurance is responsible for determining that -these inspections are performed and that parts are properly. identified and segregated. This also applies to subcontractors 'and vendors. I. INSPECTION STATUS Quality Assurance is to provide the mechanism for identifying the ] g-)- inspection status of parts and assemblies. This may include tago,- stamps or routing cards as appropriate, J. SOURCE TEST . Quality Control - Pre-inspection - material certification, helium leak test, dye penetrant. 1 s l >-- l.-

1 -[] Page 14 (I.2.J) ~ %/ Pre-weld test specimens one

liner, one capsule sectioned and checked for weld penetration; minimum penetration 75%

of wall-thickness. Leak test, liner - Helium leak test to 1 x '10~7 cc/sec. Leak test, capsule - Helium leak test to 1 x 10~7'cc/sec. Heat cycle test, source - 2 hours at 200 degrees C.,' repeated after -heat cycle. Contamination test, source - 0. 01uci/100cm-2 by wipe test; maximum per source less than.005uC'i. Storage test, source -7 days leak test and contamination test ' repeated after storage test, l Special Form Tests: (~( )j \\ 1. Free drop - a free drop through a distance of 30' onto a flat. essentially unyielding horizontal surface, striking the sur-face in such a position as to suffer maximum damage. 2.- Percussion Impact of the flat circular end of a 1" diameter steel rod ~ weighing three pounds, dropped through-a l distance of <40". The capsule or material is placed on a sheet of lead, of a hardness number 3.5 or 4.5 on the Vickers scale l l LO

~. Page'15 (I.2.J) and not more than one inch (1") thick, supported by a smooth, essentially unyielding surface. 3. Heating - Heating in air to a temperature of 1,475 degrees F., and remaining at that temperature for a period of ten' (10) minutes. 4. Immersion Immersion for 24 hours in water at room temperature. The water shall be pH6-pH8, with a maximum ~ conductivity of 10 micro-ohms /cm. Final Inspection - Fina'l inspection requirements are to be established by Engineering and Quality Assurance. Quality Assurance is responsible for assuring inspections are made and records of same maintained. Quality Assurance is also responsible for obtaining () Government approvals as required. 4 0 m

.[%- iu) Page 16 (I. 2. K, L) Quality Assurance is responsible for mainta,ining equipment in first class condition and establishing calibration requirements and frequency. Records of all calibrations are to be maintained. Quality Assurance will monitor all vendors to assure that vendor's test equipment is properly maintained and calibrated. ', l L. ' STORAGE, PACKAGING, DELIVERY Engineering and Health Physics is responsible for establishing-requirements for

storage, packaging and

delivery, including any l

\\ special requirements for radioactive materials. Attention is given j to Government regulations, such as the U.S.N.R.C. and ICC regulations, in addition to contractual specifications. Quality Assurance is responsible for assuring that these requirements are met and that records of such inspections are maintained. individual log sheet will be maintained for all Type B Certificate An of Compliance shipping containers /overpacks routinely used by J.L. Shepherd Associates in conjunction with transportation of radioactive materials, g-l l

10 'Page 17 (I.2.M) M. AUDITS On.an= annual basis, all log sheets covering containers, routinely used by J.L. Shepherd & Associates as well as all pertinent data sheets covering shipping containers manufactured by J.L. Shepherd Associates will be au,dited by Quality Assurance personnel and the Accounting Department. O O

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(~N. ~ :,/* 's ~ .\\ f ( f-Am,/ - ~ ~ ^ ,q r. a 'o- 'D. QUALITY l ASSURANCE PROGRAM-1.T -v ; - .(includes direct and': indirect lines of communication) O General' Manager-Radiological Safety Officer. I Operations Manager n -- 'Cww. Mz IH Manager: Engineering Production Control-Eo Manager '>:3' Radiological Safety Q.A. Records Q.A. Manager . Production Manager' [$! Maintenance Q.A. Engineer-g. wo.z-l' i . g M- --.I 'n[ w4 Inventory Control Inspector: Inspector": ~ Inspector: Material Inspector Purchasing Electrical Eng. & Rad.- Fab.~& Mech. Functions Functions' Functions-l 4 e g m. .-v,

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e P 7 _ -{v/ Page 19 (I.4) 4.0 JOB DESCRIPTION - GENERAL MANAGER General Manager / Radiological Safety Officer, responsibilities include general management of the

company, specifically related to

sales, contract management' engineering and quality l assurance..

General Manager / Radiological Safety Officer is personally responsible for the final inspection of-all products after completion, including those' 1 related to radiological safety and before delivery to the' customer.

Special qualifications include 25 years experience in product j

development and applications in the nuclear. field, evaluation and selection of optimum radiation sources and/or tracers and related equipment for nuclear applications, based upon the customer's total requirements. Including such-parameters as licensing, radiation safety, cost, reliability and proper shipping containers as required. '1 I O l.

l; O Page 20_(I.4.1) 4.1 JOB DESCRIPTION - CHIEF ENGINEER / RADIOLOGICAL-SAFETY ENGINEER The Chief Engineer is responsible'for all engineering and radiological safety functions of J.L. Shepherd Associates. Specific responsibilities. include vendor selection, qualification and quality assurance programs as a,ll vendor specifications relative-to the areas they encompass, including drawing change control. Chief Engineer / Radiological Safety Engineer is also responsible for quality assurance of the radiological aspects-of J.L. Shepherd & Associates products, includingL calibration, leak testing and certification, both on units-in which this work is performed at a vendor's facility and those units on which work is performed in the field. Special qualifications include being a certified Health Physicist with extensive experience in the nuclear field including

design, engineering and installation of all types of irradiation / calibration facilities and plants for handling radioactive materials as well as-production management.

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(KJ Page 21 (I.4.2)- 4.2 JOB DESCRIPTION - PRODUCTION CONTROL MANAGER -The Production control Manager works in conjunction with the General Manager toward production scheduling, expediting and records maintenance. With responsibilities including supervision of inventory . control and quality assprance records maintenance personnel,. acting as liaison between the Accounting / Computer Center, production manager and production personnel. Special'- qualifications include a minimum of 5 _ years previous experience in the manufacturing

field, including production scheduling, expediting, inventory control and personnel management.

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y jr w i Page 22 (I.4.3) a 4.3 JOB DESCRIPTION - QUALITY ASSURANCE MANAGER Under the direction of the General. Manager and Chief. Engineer, the . Quality Assurance Manager is responsible for in process. inspection and subassembly inspection at various vendor's$ and contractor's facilities as well as, work-in-process and final check out at-J.L. Shepherd & Associates Plant. Scope of responsibilities also include final approval of incoming materials to assure-that they meet I specifications as called out by purchase orders on which they are a V[~D obtained and for determining that these raw materials are properly tagged. .special qualifications include 10 years' -experience in all phases of fabrication including inspection of work-in-process and finished parts covering a wide variety of nuclear radiation equipment, including development of detailed processes for fabricating products requiring approved

drawings, procedures and practices for meeting nuclear quality requirements.

Qualifications also include radiographic ] r interpretation, liquid dye penetrant inspection, leak

testing, radiation and contamination

surveys, calibration, using radiation measuring systems.

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O Page 23 (I.4.4) '4.4 JOB DESCRIPTION - PRODUCTION MANAGER Under the direct. supervision of the General Manager,.the Production Manager has the responsibility for allocating proper materials to the respective jobs, assigning and supervising thel work-in-progress at J. L. Shepherd & Associ,ates. In this capacity, the Production Manager is also responsible for seeing that-production schedules are followed-and that all inspection points for work-in-process are maintained. ( Special qualifications include over 25 years experience in fabrication and metal

working, including expertise in operation of _ all shop machinery.

Experience includes machine shop supervision, purchasing, tool design, estimating and quality control. O I

' (# Page 24 (I.4.5) 4.5 JOB DESCRIPTION - PURCHASING AGENT 1 Assistant in. QA records maintenance, the purchasing . agent. is responsible for contacting vendors regarding material. rejection and seeing that the proper certifications accoinpany-all in-coming materials when required,. 4 5 f.

...m (y;. Page 25 (I.4.6) 4.6 JOB DESCRIPTION - INSPECTORt INVENTORY &, MATERIAL CONTROL, Working under the direct supervision of the production control

manager, the inventory control / material inspector has the responsibility _ for incoming raw material insp'ection and-material segregation as well as, inventory control, including material

cutting,

~ stock-out reports and maintenance of inventory records. l l l l' 1 ..]-

l'.- ] l y.' e e x l ?" i l l'w.) Page 26 (I.4.8) '4. 8 JOB DESCRIPTION - INSPECTOR: ENGINEERING, FUNCTIONS Under the direction of the Chief Engineer and the General Manager,-the-engineering inspector is responsible for the distribution.of drawings .and specifications to the appropriate departments after approval. In

addition, the-engineering inspector is responsible for executing

-engineering change order

forms, as needed, inspecting manufactured components,. work-in-process and final check out of units as pertains to engineering, rh

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[ l L A_/ l Page 27 (I.4.9) l.. 4.9 JOB DESCRIPTION - INSPECTOR: FABRICATION & MECHANICAL FUNCTIONS l Under the direct supervision of the QA Manager, the Fabrication and Mechanical Inspector is responsible for QA inspection of all component parts with respect to work-in-proces:s at-all. Inspection points during fabrication and final check-out as pertains to the '-fabrication.and mechanical functions of all units manufactured by J.L. Shepherd & Associates, l l O l L )g o 'l 4 l .O i \\m

l, l 0 Page-28 (I.6) 6. STATEMENT OF RESPONSIBILITY The General Manager, Operations Manager, Production Manager, Chief Engineer, Q.A. Engineer, Production Control Manager and Inspectors have-the responsibility and authority to reject unsatisfactory materials,- stop unsat,isfactory work and-to supervise further ' processing after corrections have been mada. The General Manager, Operations

Manager, Production Manager, Chief Engineer and Q.A.

Engineer have. the -further responsibility and authority to stop the delivery and/or installation of nonconforming parts or materials. This statement of responsibility is signed alone by each individual and a copy posted in a visible location. O l

Page 29 (II.1,2) 1 II. QUALITY ASSURANCE PROGRAM I 1. Statement of Verification of-Assessment of Quality-Assurance-,' Program. 1 The Officers of the Quality Assurance Program (QAP), ' in addition to_ daily communications,, hold scheduled conferences with appropriate i departments, to review the status of each job in regard to

design, 1

purchasing, work process sheet release, work-in-progress, corrective procedures, inspections, testing, safety, storage or shipment, proper-documentation, corrective actions _ (if necessary) and shipment on ) whatever phase of operation is pertinent to that job as well as overall views of work-in-progress. Annual audits to determine compliance as well as. for accounting and inventory purposes are performed and reviewed by officers of the QAP. 2. Distributica of Quality Assurance Program Manuals. Each officer of the QAP retains a copy of the QA/QC Program Manual. A master copy is kept and a copy is made available to.any employee, upon-request. (Each new employee is made familiar with the manual as a -part of the Training Program.) The Production Control Manager is responsible for distributing approved revisions to all copies of the manual and-advising the holders thereof of the revisions, including O) facilities which keep the manual on file. (

,m. '}. Page 30 (II.3,4,5) 3. Statement of Verification that-Qual,ity Assurance Program Requirements are Applicable to Outside. Vendors. J.L. Shepherd & Associates retains the right to supervise and inspect products at a vendor's and/or contractor's facility and/or to reject nonconforming materials and has agreements lwith vendors and ^ contractors stating such in order to maintain our Quality Control ' mandatory requirements. 4. Safety-related Systems, Structures and Components controlled by i Quality Assurance Program. 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. 5. Statement of Verification of Resolution 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 and compatibility with the QA/QC Program as well as NRC and DOT Criteria is made by the QA Officers and the appropriate offices. Reviews are made at the scheduled conferences or as needed when all pertinent data is gathered. Agreements are subject to review by J.L. Shepherd for final approval. t^J L l N 1

4 I. Page 31 (II.6) 6. Statement of Verification that Training Program is Implemented. J.L. Shepherd & Associates maintains

a. training., program for a~11 new employees and employees assuming additional responsibilities.. This program provides a thorough examination of the QA/QC Program and the Each QA of'icer's authority is purpose of maintaining this program.

f delineated and the effe,ct of that authority is demonstrated as well as an explanation of how the employee functions within the QA/QC Program. In as much as J.L. 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 individual 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 offective in the continuous effect functioning of the QAP.

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

l Page 32 (II.6,7) All Personnel are adequately. licensed or certified, i.e., Health Physicists, welders, machinists, when applicable. All licenses and-certifications are kept current. If an employee is not, performing to the specifications maintained by J.L. Shepherd & Associates, he/she is subject to a retraining program before continuing with his/her responsibilities. If this is not successful, employment is terminated 'after the appropriate notice has been given. 7. Statement of Verification that Quality-related Activities are O. Performed According to Predetermined Measures. J.L. Shepherd & Associates performs all quality-related procedures, i.e., inspections and

testing, in accordance with predetermined procedures which specify the equipment to be used, if necessary, and environmental conditions.

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

i f(~)N '\\_ .page 33 (III.1) III. DESIGN CONTROL l.- Statement of Verification of Responsible Design Procedures. J.L. Shepherd & Associates has an established design procedure for its products. Because of the nature of our business and products,- i.e., products involving radioactivity, all products are' licensed by' the proper licensing authority and all new products have licenses pending. Therefore, in the initial design of a product, the first step is to provide licensing authorities with all pertinent drawings. f3-Sales-drawings, if applicable, are made per customer requirements and U licensing criteria. Prior release for fabrication, all drawings and specifications are to .be reviewed for adequacy _in regard to standard design practice and end-product use. Approval by engineering and-quality assurance is required prior to release. Changes are to be documented through the use of revised drawings incorporating Specification Changes, if required. 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.

4 i LOL Page-34 (III.1,2,3)

Engineering is responsible for removing obsolete drawings and specifications from all issue 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 m'aterials, procedures ~ and instructions with,a final review by General Manager and/or Chief Engineer on each job to verify that they meet all regulatory and e licensing criteria. 3. Statement of Verification that Quality Standards are Maintained. J.L. Shepherd & Associates Engineering Department maintains a complete -list of specifications for each product. It issues a Bill of Materials to the Purchasing Department with these specifications. Any change from these specifications by the vendor or subcontractor. is subject for review by the Engineering Department and QA Department before purchase is made. Any change or deviation on a particular -product is noted on the specification documents of that 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.

(. Page 35 (III.4,5,6) 4. Statement of Verification of Design Control.. J.L. Shepherd Associates Engineering Department QA Department review 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. l Inspection and test criteria are identifieql and made available to the QA Department before release. 5. Statement of Verification of Adequacy of Design, f J.L. Shepherd & Associates QA Department and Engineering Department ( insure the proper selection of components and design verification of each unit by means of prototypes from which licensing is applied. The prototypes are thoroughly tested and inspected in all stages to verify that they meet all licensing authority criteria and design specifications. All inspection and test criteria are documented and made available to the QA Department, which documents acceptance or rejection and all pertinent data thereof. L 6. Statement of Verification of Design Department Controls i -The General Manager and Chief Engineer of J.L. Shepherd & Associates are responsible for the final design verification review after reviews by the Engineering Department and by the QA Department. 'pb l

-) l ,e~ A_/ Page 36 (III.7,8) J 7. Statement of V.'rification of Design Change, control s 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. ,,1

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

J.L. Shepherd & Associates maintains written agreements delineating j .i\\' the areas of responsibilities and authority of each member of the i Engineering Department and the QA Department, which are agreed upon and understood at the completion of the Training Program, j l L o l-1 .(~\\ ,g.

r n (~} Page 37 (IV.1,2,3) IV. PROCUREMENT DOCUMENT CONTROL 1. Statement of Verification of Purchasing Department Procedure J.L. Shepherd & Associates Purchasing'Departme'nt 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. 2. Statement of Purchase Orders - Subpart H Criteria Verification J.L. Shepherd & Associates Purchasing Department routinely identifies 10CFR, Part 71, Subpart H criteria as applicable and as described in 1 l the QA Program proper. Standard purchase order forms designate spaces () for this information. 3. Statement of Appropriate Referenco of Specifications on Purchase Orders. J.L. Shepherd Associates Engineering Department provides appropriate reference to technical requirements, i.e., 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 i orders when applicable. G L l

.{'y. .Page 38 (IV.4,5,6) V 4. Statement of Appropriate Reference of Documentation on Purchase Orders J.L. Shepherd & Associates Engineering Departme'nt' provides appropriate ^ references of documentation, 1: e.,.

drawings, speelfications, procedures, inspection and fabrication

plans, inspection and test

records, procedures qualifications and chemical,and t'est results of material, on the Bill of Materials which is. submitted to the PD to be included on purchase orders and provide to vendor, if applicable.

5. Statement of Verification of Appropriate Documents Retained by Vendor and Delivered to Purchaser. l t')s J.L. Shepherd Associates Engineering Department providas 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. Statement of Verification of Purchase Order Containing Right of Access Clause. J.L. Shepherd & Associates purchase orders contain an agreement clause. covering the right to access to the supplier's facilities and records for a source inspection audit when applicable. 1 l

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i { -(s Page 39 (IV.7) 7. Statement of Verification that Purchase Order Revision is Subject to Approval. As stated in III.3, "Any change 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 or deviation on a particular product is noted..." t., ' i .d l

Page 40 (V.1,2,3) V. INSTRUCTIONS, PROCEDURES AND DRAWINGS 1. Statement of Verification that Activities Affecting Quality are Accomplished in Accordance with Specifications.' J.L. Shepherd & Associates has established with the implementation of the QA/QC program that activities affecting the quality of a product are adhered to in all phases of operation acco,rding to prescribed documentation of instructions, procedures and/or drawings. 2. Statement of Verification of Clear Sequence of Actions Concerning Instructions, Procedures and Drawings. J.L. Shepherd & Associates has established with the implementation of the QA/QC Program that there is a clear sequence of procedure in the preparation, review, approval and control of instructions, procedures and drawings. 3. Statement of Verification of Quality Assurance Department Responsibility. J.L. Shepherd Associates QA Department has the authority and responsibility to review inspection

plans, test calibration and special process procedures, drawings and specifications, and all changes and/or acceptable alternatives thereto; under the provisions and authority of the QA

Program, the QA Department fulfills this responsibility.

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[") Page 41 (VI.1,2,3) v VI. DOCUMENT CONTROL 1. Statement of Verification that the Issuance of Document's and Procedures thereof are Procedurally cont' rolled', J.L. Shepherd & Associates Engineering Department, working with the QA Department and Purchasing Department, have , adequate procedural controls to check,

review, approve and issue documents and changes thereto, prior to release of a product.

2. Statement of Verification that changes to Documentation are Made by the Original Organization that Prepared Initial Document. ,m) J.L. Shepherd & Associates Engineering Department, when notified of s s_ 1 the nood for changes or modification by itself or other departments, in cooperation with the QA Department, reviews and approves or rejects revisions to the original documents, as needed. 3. Statement of Verification that Revisions are Made on Appropriate Documents. J.L. Shepherd & Associates Engineering Department is responsible for making all necessary revisions on all related documents of a project, after approval thereof, prior to the implementation of these changes. J

(~] Page 42 (VI.4,5) 'q,1 4. Statement of Verification that All Pertinent Documents are Available at Site where they are to be Implemented. J.L. Shepherd & Associates Engineering Department'is responsible for all pertinent documents related to a job to be available at the site where they are to be implemented, prior to s, tarting work. The Engineering Department is also responsible th'at. the Purchasing Department has all pertinent documents to accompany the purchase order (if applicable) to the supplier before work begins on the project, i 5. Statement of Verification that Master Lists of Revisions are l /-( ), Current and Appear on Appropriate Documents. J.L. Shepherd Associates Engineering Department keeps a current master listing of revisions on products so that revisions are identifiable and is also responsible that appropriate revisions are on I distributed documents. l l l ) t'~'T R) --m

(~} Page 43 (VII.1,2) \\/ VII. CONTROL OF PURCRASED MATERIAL, PARTS AND COMPONENTS 1. Statement of Verification that Qualified Personnel Evaluate Suppliers for Acceptability. The Chief Engineer, QA Manager and/or QA Engineer ~ of J.L. Shepherd Associates are qualified and responsible for vendor selection and qualification of vendor QA Program to provide, materials that meet specifications. 2. Evaluation of Suppliers The Chief Engineer, QA Manager and/or QA Engineer of J.L. Shepherd & Associates are responsible for supplier selection and use the (( ) following criteria for approving a vendor: The supplier's capability to comply with the elements of Subpart H to 10CFR Part 71 that are applicable to the type of material, equipment or service being procured. A review of previous records and performances of suppliers who have provided similar articles of the type being procured. A survey of the supplier's facilities and QA+ Programs to determine his capability to supply a product which meets the design, manufacturing and quality requirements. (J

/ 'T Page 44 (VII.3,4,5) \\_/ 3. Statement of Verification that Supplier Evaluations are on File J.L. Shepherd & Associates maintains current files on the results of l supplier evaluations made by the Chief Enginee'r and QA Manager and/or QA Engineer, as well as current specific ~tions on products supplied. a t i 4. Statement of Verification that Inspection a,nd/or Supervision of ] Suppliers is Performed. ,j At the scheduled meetings of the QA Department and appropriate departments, it is determined if and when it is required that the QA Engineer or appropriate officer be present during fabrication, testing and shipment of a product, to assure accordance with purchase (, ~) order specifications. 5. Statement of Verification of Minimum Records supplied to Purchaser. J.L. Shepherd & Associates requires as a minimum from all vendors the following documentation: Documentation that identifies the purchased material or equipment s andthespecificprocurementrequirements(e.g!hcodes, standards and specifications) are met by the items.

I' (~j Page 45 (VII.5,6) L \\_.- Documentation that identifies any procurement requirements which have not been met together with a description of those nonconformances dispositioned " accept as is" or " repair." Note: Contingent upon acceptance by

• J.L. Shepherd

& Associates, all nonconforming items must be repaired or replaced and' certification j thereof provided. 6. Statement of Recei'ving Inspectors Acceptability Criteria and Responsibilities. 1 The QA Engineer for J.L. Shepherd Associates is responsible for and will not accept products that do not meet the following criteria:

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i The material, component or equipment is properly identified and corresponds with the identification on receiving documentation. Inspection records of certificates of conformance attesting to the acceptance of material and components are available prior to installation or use. Items accepted and released are identified as to their inspection status prior to forwarding them to a controlled storage area or releasing them for further work. o L IU

1 .,r~w (_) I Page 46 (VIII.1,2,3) VIII. IDENTIFICATION AND CONTROL OF MATERIALS,, PARTS AND COMPONENTS 1. Statement of Verification of Established Procedures Used for Identifying and Controlling Materials. The QA Engineer of J.L. Shepherd Associates uses a standard procedure for identifying all products received as: part of the QA/QC .l Program. l i 2. Statement of Verification that Products are Identified Properly. ) As part of the standard receiving procedure of the QA Engineer at x J.L. Shepherd & Associates, all products are identified and marked. t ) This identification and marking is directly traceable to all pertinent records and this system precludes the use of incorrect or defective items. 3. Statement of Verification that Safety-related Materials are l Identified Properly. As stated in VIII.2, all items are identified and marked. directly traceable to all pertinent

records, i.e.,

drawings, specification, purchase orders, test reports, including and specifically the safety-related items which are thoroughly inspected.

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i i 1 g~)s (_ Page 47 (VIII.4,5) i i 4. Statement of Verification that.the. Location and Method. for 1 i Identifying Products is not Harmful to Them. i 1 J.L. Shepherd associates maintains a receiving area where all 1 products are identified and marked before alIlocation to proper i inventory areas. The receiving area and method of identification (one { of several methods appropriate to item) do not in any way interfere with the fit, function or quality of the product. l 1 f 5. Statement of Verification that Product Identification Numbers are ] i ! Verified before Release. J.L. Shepherd & Associates, as part of the QA/QC Program, requires that any item from inventory be verified that it is the proper item for a job before release for fabrication, assembly or installation of same job. l

l l 0 Page 48 (IX.1,2,3) IX. CONTROL OF SPECIAL PROCESSES 1. Statement of Verification that Special Process are Procedurally Controlled. The Shop Foreman at J.L. Shepheril Assoc:iates, is directly responsible, in conjunction with periodic QA Officer inspections, for the procedural control on each job of special' processes. such as

welding, heat treating, nondestructive testing and cleaning for items in-house.

The QA Engineer is responsible for inspecting and controlling these processes at suppliers installations, as applicable. 2. Statement of Verification that Procedures, Equipment and Personnel Related to Special Processes Meet Applicable Specifications, Codes and Standards. J.L. Shepherd & Associates Engineering Department and Shop Foreman, in cooperation with the QA Department, are responsible for maintaining appropriate procedures, equipment and personnel connected with applicable codes, standards and specifications. 3. Statement of Verification that Qualification Records Concerning Special Processes are Established and current. As an implementation of the QA Program, the Engineering Department at J. L. Shepherd & Associates maintains current qualification records of all areas associated with special processes. In addition, copics of applicable records are filed in each job file. O 1 1

Page 49 (X.1,2,3) X. INSPECTION 1. Statement of Verification that Inspection Program Verifies Conformity of Articles in Accordance with Established Procedures. All inspections performed by J.L. Shepherd & AsIsociates which check conformity with quality associated areas are performed in accordance ~with written and controlled procedures and are documented. 2. Statement of Verification that Inspection Personnel are Independent from Individuals Performing Activity being Inspected. Inspection personnel at J.L. Shepherd & Associates are independent from the personnel performing the activity being inspected; qualifications and independence are determined by the QA Department. 3. Statement of Verification that Inspectors are Qualified and Qualifications are Recorded. The QA Department of J.L. Shepherd Associates is responsible for maintaining qualified inspectors (in accordance with applicable codes, standards and training programs) and the certifications and qualifications thereof are on file and kept current. O + e- ~.

i (-. \\,) Page 50 (X.4,5) 4. Statement of Verification that Revisi,ons are Inspected in 'Accordance with the Original Specifications. Inspectors at J.L. Shepherd Associates perform all inspcetions, including those on any modifications, repairs or replacements, in accordance with the original design specifications and procedures or acceptable alternatives; and all inspections are documented. 5. Statement of Verification that Inspection Points are Established f and observed. t i The Shop Foreman is responsible for the supervision of work, including holding work progress until it has been inspected at the appropriate phases. The Shop Foreman holds work for inspection in accordance with l predetermined inspection specifications and for informing the QA l Department of the forthcoming inspections at weekly meetings and time I of inspection. i ) l ) r') R.

!vI Page 51 (XI.1,2,3) XI. TEST CONTROL 1 i 1. Statement of Verification that Test Programs are Established, Documented and Performed Accordingly. Test Programs to determine if an item will perform satisfactorily are I performed by J.L. Shepherd & Associates Engineering and'QA Departments i in accordance with estab,lished documented specifications and are fully documented. ) l 2. Statement of Verification that Revisions in Design are Tested in j Accordance with Specifications of the original Design. J.L. Shepherd & Associates Engineering Department, in conjunction with the QA Department, tests all modifications, repairs or replacements to the original design in accordance with original specifications or acceptable alternatives. 3. Statement of Verification that Test Results are Documented, Reviewed and Accepted by Appropriate Department. All Test program results are fully documented. They are then 9 evaluated and determined acceptable by qualified Engineering and QA Department Officers of J.L. Shepherd & Associates.

Page 52 (XII.1.2.3) XII. CONTROL OF MEASURE AND TEST EQUIPMENT 1. Statement of Verification that Measuring and Test Equipment are Properly Calibrated. J.L. Shepherd & Associates maintains properly calibrated' measuring and test equipment, based upon required accuracy,

purpose, degree of usage, stability characteristics or other conditions affecting the measurement of radioac'tivity are calibrated at three (3) month intervals; all other instruments are calibrated yearly.

2. Statement of Verification that Measuring and Test Equipment are Identified and Traceable to Calibration Test Data. g [ /N lV J.L. Snepherd & Associates 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. J.L. Shepherd & Associates performs new test or measures (which are documented) to validate previous inspections in the event that an instrument is found to be out of calibration and notifies appropriate parties, if applicable. O m

page 53 (XII.4) 4. Statement of Verification that Calibration Meets Appropriate Standards. J.L. Shepherd & Associates maintains National Bureau. 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 specifications which are documented and are on file at J.L. Shepherd & Associates. O l t l l I l i 0 l l I l

i L./ Page 54 (XIII.1,2,3) XIII. HANDLING, STORAGE AND SHIPPING 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 instructions, qualified, employees of J.L. Shepherd Associates perform work related to special

handling, preservation, storage, cleaning, packaging and shipping requirements.

2. Statement of Verification that Conditions of the NRC and U.S. DOT l Shipping Requirements are Satisfied before Shipment. em ' ' N_] ' J.L. Shepherd & Associates performs 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. J.L. Shepherd & Associates prepares and keeps on file all necessary shipping papers as required. Shipping papers on shipments containing radioactivity include the following documentation: I () l

l a. -i j Page 55 (XIII.3) 1 Date of Shipment l Customer l License of customer Source Information j 1 Shipping Container, Type and Device j Radiation Level at Surface of Shipping Container Radiation Level at three feet (3') from Surface of Container Surface Contamination l Instrument (q - ( ) i Leak Test 1 DOT Class Label ] Transport Index ) Truck Placard Requirement Shipping Weight Freight Classification j a Also included with shipments are External Radiation Level Certificate, Leak Test Certificate, Calibration Certificate, Attenuator certificate 1 as applicable. i l n i i 1

l ) 1 } jd '^ Page 56 (XIII.4) i 4. Statement of Verification that Shipment. Time is Consistent with Safe Transportation Time. H J.L. Shepherd & Associates routinely uses motor freight.for shipments because weight inhibits fast delivery and. the nature of our products does not demand it. Departure occurs after a packige has passed final inspection to meet NRC,, DOT criteria and th'e customer has necessary r licensing (if applicable) and is ready to accept delivery. Shipments are monitored as applicabic to the motor freight delivery schedule and customer notification of arrival. O V

t Page 57 (XIV.1,2) XIV. INSPECTION, TEST AND OPERATING STATUS 1. Statement of Verification that Status of Packages is Acknowledged by Affected organizations. J.L. Shepherd & Associates QA Department,. in conjunction with other appropriate departments such as shipping, enginee', ring, production or secretarial, is responsible for the appropriate ~ documentation and identification of inspection, test and operating status of packages being acknowledged and received by affected organizations, such as jnter-departmental, shipping agents and/or customer. j (J j 2. Statement of Verification that Removal of Inspection and Status Indicators are Procedurally Controlled. J.L. Shepherd & Associates requires that all inspection and welding stamps and/or status indicators 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 that gpplies to any item are done and after approval by the appropriate inspector be documented accordingly. L

Page 58 (XIV.3,4) ) 3. Statement of Verification that Bypassing of Inspection Tests or ) Other Critical Operations is Controlled. The by-passing of inspections, tests or other critical operations are procedurally controlled by docume*ntations, work structure and 1 procedure and daily communication. These documentations will be j discussed during the scheduled meetings of all departments concerning and the QA Department. 4. Statement of Verification that Nonconforming Items are Identified. The QA Engineer at J.L. Shepherd Associates is responsible for J identifying and inspecting incoming materials. Nonconforming items are identified and returned to vendor. If items are found to be defective or otherwise nonconforming during procedural inspections, these 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 inadvertent use of 1 l nonconforming materials. f3Q

~. t 'y !,,\\ l O Pago 59 (XV.1,2,3) XV. NONCONFORMING MATERIALS 1. Statement of Verification that Nonconforming, Items are Procedurally Cpntrolled. J.L. Shepherd Associates has established and ' enforced procedures during receiving inspect, ion and for subsequent inspections.to assure that the identification, documentation, segregation, review disposition are implemented. Affected organizations are notified and that replacements and repair are carried out. 2. Statement of Verification that Nonconforming Item Documentation is Complete. When a nonconforming item is found during inspection or testing, the QA Inspector of J.L. Shepherd & Associates is required to document the-reasons of nonconformance, identify the item and sign the report; l subsequent appropriate actions are taken. 3. Statement of Verification that Nonconforming Items are Segregated from Acceptable Items. J.L. Shepherd & Associates maintains a separate inventory location for nonconforming items, which are identified as such, until appropriate actions are taken. 1 p) L

\\ Page 60 (XV.5) 4. Statement of Verification that. Repaired or Reworked Items are subjected to original Testing. } J.L. Shepherd & Associates inspectors subject all replaced, reworked or repaired items to the same documentation, original inspection and testing procedures, or to acceptable alternate testing procedures. e 1 -O m

/' 4 4 - %.) Page 61 XVI.1,2) XVI. CORRECTIVE ACTION 1. Statement of Verification that Evaluations are . Conducted to Determine the Need for Corrective Action, if Required. J.L. Shepherd Associates does not accept o 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 such nonconformity, such as

failures, malfunctions, deficiencies, or defectiveness, the Engineering and QA I

(~h Departments jointly evaluste the need for corrective actions in A._J accordance with established procedures. 2. Statement of Verification that Corrective Action is Initiated, if Required. In the event of nonconformity, the Engineering and QA Departments of J.L. Shepherd & Associates evaluate all aspects of the discrepancy and determine the kind of corrective action to be taken to avert reoccurrence. This process is documented accordingly before the corrective action is taken and reinspected according to prescribed procedures. /m w 1

o Page 62 (XVI.3) 3. Statement of Verification that Reviews. of, Corrected Actions are Conducted. The Engineering and QA Departments of. J. L. Shepherd.&. Associates conduct inspections and follow-up reviews of cotrective actions to ~ determine if they are, acceptable and either close out required

• i documentation and/or implement these actions as part of standard operations, whichever is needed.

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1 -x I [J T Page 63 (XVII.1,2) i XVII. QUALITY ASSURANCE RECORDS I 1. Statement of Verification that' docuraentation is Maintained ) i Concerning Evidence of Quality and Safetp of Items'and Activities. The Engineering Department of J.L. Shepherd & Associates maintains all i documentation concerning the quality and safety of items and j i activities which affect quality and safety areas; revisions and updates them annually or'as required. I 2. Statement of Verification that Safety and Quality Related ) Documents Contain Required Information. (~h (_,) J.L. Shepherd Associates QA

records, maintained both by the Engineering Department and QA Department include operating logs, results of reviews, inspections, test, audits and material analysis, qualifications of personnel, procedures and equipment and other documentation such as drawings, specifications, procurement documents, calibration procedures and

reports, nonconformance reports and corrective action reports.

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

,c (w_ Page 64 (XVII.3,4,5) 3. Statement of Verification that Quality Assurance Documents are Identifiable and Retrievable. J.L. Shepherd & Associates maintains a numerical and alphabetical system which cross references all QA documentation as well as all associated documentation throughout all filing systems in all departments. Through the implementation of this $ystem, all r.ecords are identifiable and ret,rievable. i i 4. Statement of Verification that a List of Required Records and Storage Locations is Maintained. (~') J.L. Shepherd & Associates maintains a master list of where required j l i/ m records may be located, which includes the use of the established numerical and alphabetical identification system. l S. Statement of Verification that Required Records are Kept on File. J.L. Shepherd Associates has maintained complete files, including design-related records, inspection and related QA documents, since the company was established in 1967 and regularly updatas these files as

required, i.e.,

repairs or replacement parts, correspondence, etc. These files are identifiable and retrievable per the master list discussed in XVII.3,4. Q \\ v l-L

am (_-) 4 Page 65 (XVII.6) 6. Statement of Verification that Inspection and Test Records Contain Appropriate Information. J.L. Shepherd & Associates Engineering Department has established and maintains inspection and test records which include.the.following criterlat 1. A description of the type of observation 2. Evidence of completion and verification of a manufacturing f() inspection or test operation 3. The date and results of the inspection or test 4. Information related to conditions adverse to quality 5. Inspector or data recorder identification l 6. Evidence as to the acceptability of the results l l l

'l ,,m I w/ Page 66 (XVIII.1,2,3) XVIII. AUDITS Verification that Audits are conducted in Prescribed 1. Statement of Manner. J.L. Shepherd Associates performs audits in accordance with prescribed procedures and check lists. All Audits are performed by employees who do not have direct responsibilities for the area being audited. Audits are performed interdepartmentally if those departments contain individuals who are qualified to do so. t Statement of Verification that Audits are Reviewed by Management. L:() 2. J.L. Shepherd & Associates management personnel review all audits in l their areas affected by the audit. Employees compile all audits and a l complete report is made available' to management for a comprehensive i review. I. l 3. Statement of Verification that Management Reviewing Audits have i I the Responsibility to Correct Deficiencies. l The management personnel of J.L. Shepherd & Associates are responsible for correcting deficiencies as required after a review of the complete L auditing reports. /. (

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O Page 67-(XVIII.4,5) 4. Statement of Verification that Deficiencies Revealed by Audits are Re-audited Regularly. J.L. Shepherd & Associates, upon the receipt of;an order,.makes total inventory _ and appropriate audits to determine the correct. status of items. Special notation and attention are taken on' items previously =found deficient or'on-items frequently used. 5. Statement of Verification that QA Program is Audited Annually. IO Qualified J.L. Shepherd Associates management personnel, in cooperation with the QA Department, annually audit and review the-entire QA' Program and its implementation with special emphasis on~the < safety related

features, other audits and reviews are performed as.

necessary. ~ .}}