ML20058D621

From kanterella
Jump to navigation Jump to search
Rev 3 to QA Program Plan
ML20058D621
Person / Time
Site: 07100122
Issue date: 10/10/1990
From: James Shepherd
J.L. SHEPHERD & ASSOCIATES
To:
Shared Package
ML20058D616 List:
References
QA-RM-001-A, QA-RM-1-A, NUDOCS 9011060184
Download: ML20058D621 (78)
v • d • e


Text

4 s

c QA RM 001-A

t -

Revision #3 Revised in Entirety

[e

^

L QUAL 11YASSURANJ PROGRAM PLAN m

APPROVED BY:

N,-

,J.L Shepherd, President

=

October 10,1990 i

v J.L SHEPHERD & ASSOCIATES

'1010 Arroyo Avenue San Fernando, CA 91340

'(818) 898 2361 C

in i

TABLE OF CONTENTS f3 -

- Introduction i

Q

- Revision Sheet -

il 1.1 & 2.1 Organization 1

1. Statement of Responsibility 1

'i

2. Structure and Authority 1
3. Structure and Authority - Organization Chart 2
4. Job Descriptions 3

4.0 J.L Shepherd 3

4.1 D.F. She herd 3.1 4.2 M.F. Sh herd 3.2 4.3 D.C. She herd 3.3 4.4 - R.N. Do Ison 3.4 4.5 R.Jacobs 3.5 4.6 ' J.S. Shepherd -

3.6 4.7 O. Carandang 3.7 4.8 - Q.V. Pho 3.8 4.9 D. Haynes -

3.9 4.10 J.D. Fuzzell 3.10 o

4.11 A. Carwon 3.11 4.12 N. Pho 3.12 4.13 M. Irish 3.13 i

4.14 B. Peabody 3.14 L

4.15 L Weiss 3.15

l. 6 4.16 M. Pauls

.3.16 l j 4.17 V. Towne 3.17 i

4.18 P. Shepherd 3.18 t

4.19 J. Veilleux.

3.19 3

- 4.20 M. C. Shepherd 3.20 4.21 Minimum Job Qualifications 4

1.2 & 2.2 Quality Assurance Program 5

b 1.' Documentation - Master Index of QA Procedures

& Implementation 5

1.2 & 2.2 Scope & Applicability of QA Program-10 l'

1. Apphcability f Verification of Assessment of QAP 10 L

'1. Statement o 10 ll

2. Distribution of QAP Manuals 10
3. Statement of Verification that QAP Requirements are Applicable to Outside Vendors 10

~

4. Safety-related Systems, Structures & Components are Controlled by QAP -

10 7

5. Statement of Verification of Resolution of Disputes 11 L
6. Statement of Verification that Training Program is implemented 11
7. Statement of Verification that Quality related i

Activities are Performed According to Predetermined Measures 11 p 7-)

a.

v l

l l

l

2. Scope..

12

1. Procedures, Documentation & Records 12
2. Corrective Procedures 13
3. Facilities & Standards 14 l

.L

4. Drawing Control 14
5. Purchasing-15
6. Manufacturing Control 16
7. Inspection Status 17
8. Source Testing & Test Equipment 17
9. Measurement 18

'10.-Storage Packaging, Delivery 18

11. Audits 19 1;3 & 2.3 Design Control 20
1. Statement of Verification of Responsible Design Procedures 20
2. Statement of Verification of Compliance with Regulatory Requirements in Drawings 20
3. Statement of Verification that Quality Standards

-are Maintained 20

4. Statement of Verification of Design Control 21
5. Statement of Verification of Adequacy of Design 21
6. Statement of Verification of Design Department Controls 21
7. Statement of VeriGcation of Design Change Control 21

' 8. Statement of Verification of Engineering & QA Responsibility & Authority 22 1.4 & 2.4 Procurement Document Control 23

- 1. Statement of Verification of Purchasing Department Procedures 23

'1

~'

2. Statement of Verification that Appropriate Reference of Specifications Appear on Purchase Orders 23
3. Statement of VenGcation that Subpart h Criteria Appears on Purchase Orders 23

~ 4. Statement of Verification of Purchase Orders Containing

' Right of Access Clause 23 J

5. Statement of Verification that Appropriate Reference of Documentation Appears on Purchase Orders 23
6. Statement of Verification of A propriate Documents Retained F

by Vendor and Delivered to I urchasers 24

7. Statement of Verification that Purchase Order Revision is Subject to Approval 24 1.5 Instructions, Procedures & Drawings, Manufacturing 25
1. Statement of Verification that Activities Affecting Quality Are Accomplished in Accordance with Specifications 25
2. Statement of Verification of Clear Seq & Drawings uence of Actions Concerning Instructions, Procedures per 10CFR71, Subpart H Criteria 25

. 3. Statement of Verification that Activities important to SafLy are Satisfactoril,y Accomplished 25

4. Statement of Verification of QA Department Responsibility 25 b'

JO 1

1 I

2.5 Instructions, Procedures & Drawings,kages are Prepared for Use Packages 26 1; Statement of Veridcation that I ac 26

2. Statement of Veri 6 cation that Repair, Rework & Maintenance

,.)

Procedures are Established-26 V

3. Statement of Verification of Loading / Unloading Procedures 26
4. Statement of Veri 6 cation of Proper DOT Transport of Package 26 1.6 & 2.6 Document Control 27
1. Statement of Verification of Controlled Documents 27
2. Statement of Veri 6 cation that the Issuance of Documents

& Procedures are Procedurally Controlled 27

3. Statement of Verification that Changes to Documentation are Made by the Original Organization that Prepared Initial Document 27
4. Statement of Veri 6 cation that Revisions are Made on l

Appropriate Documents 27

5. Statement of Verification that all Pertinen! Documents are Available at Site Where They are to be implemented 28
6. Statement of Veri 6 cation that Master Lists of Revisions are Current & Appear on Appropriate Documents 28 1.7 & 2.7 Control of Purchased Materials, Parts, Components, Equipment & Services 29
1. Statement of Verification of Procurement Document Planning, t

That Qualified Personnel Evaluate Suppliers for Acceptability 29-

2. Statement of Verification of Evaluation of Suppliers 29
3. Statement of Verification of Contract Evaluation

& Award Procedures A

29

1. V
4. Statement of Veri 6 cation that inspection and/or Supervision of Supplier is Performed 30

' 5. Statement of Veri 6 cation of Minimum Records Supplied to 3

Purchaser 30

6. Statement of Verification of QA/QC Inspectors Acceptability '

f Criteria & Responsibility 30

7. Statement of Veri 6 cation of Purchased Materials, Parts, Components, Equipment or Services Records --

31 11.8 & 2.8 Identification & Control of Materials, Parts & Com ponents 32

1. Statement of Verification of Established Procedures L sed -

1 for identifying & Controlling Materials 32

2. Statement of Verification that Products are Identi6ed Properly 32
3. Statement of Veri 6 cation that Safety Related Materials are Identi6ed Properly

'32

4. Statement of Verification that the Location & Method of '

Identifying Products is not Harmful to Them 32

5. Statement of Verification that Product identi6 cation Numbers are Verified Before Release 32
6. Statement of Verification that Conditional Releases Are Controlled 33 m

c.

.1.9 & 2.9 Dantrol of Special Processes 34 1 Statement of Verification that Special Processes are Procedurally Controlled 34

2. Statement of Verification that Procedures, Equipment &

Personnel Related to Special Processes Meet Applicable Specifications, Codes & Standards H

(;

3. Statement of Verification that Qualification Records L

Concerning Special Processes are Established & Current 34 1.10 & 2.10 Inspection Control 35 1.~ Statement of Verification that inspection Program Verifies Conformity of Articles in Accordance with Established Procedures 35-

2. Statement of Verification that Receiving Instructions Verify Integrity of Important to Safety items 35
3. Statement of Verification that In Process inspections are Established 35
4. Statement of Verification that final Inspections Verify item Integrity 36 S. Statement of Veri 6 cation that inspection Personnel are independent from Individuals performing Activity

[

Being Inspected 36 6.' Statement of Verification that inspectors are Qualified

& Qualifications are Recorded 36

=

1.11 Test Control 37

1. Statement of Verification that Test Programs are Established, Documented & Performed Accordingly 37 o
2. Statement of Verification that Test Procedures Are Established 37

. '~

3. Statement of Verification that Test Results are Documented, Reviewed & Accepted by Appropriate Departments 37 2.11 Test Control, Packages 38
1. Statement of Verification that Packages Meet Acceptance Criteria Prior to Shipment 38
2. Statement of Verification that Maintenance Programs are Established 38

' 1.12 & 2.12 Control of Measure & Test Equipment 39

=

1. Statement of Verification that Measuring & Test

- Equipment are Properly Calibrated 39

2. Statement of Verification that Measuring & Test Equipment are Identified & Traceable to Calibration Data 39 3.' Statement of Verification that Calibration Meets Appropriate Standards 39 4rStatement of Verification that Measurements are Taken, Documented & Validated Against Previous Measurements, if Instrument is Found to be out of Calibration 39 O

l

1

~

1 1.13 & 1.14 Handling, Verification that Special Requirements &

Storage & Shipping 40

1. Statement of Preservation are Accomplished in Accordance with Work &

') '

Inspection Instructions 40

2. Statement of Verification that Conditiorc of NRC & DOT Shiaping Requirements are Satisfied Before Shipment 40
3. Stauement of Verification that Shipping Papers are Properly Pre aared 40
4. Statement o' Verification that shipment Time is Consistent 4

with Safe Transportation Time 41 l

S. Statement of Verification that 10CFR21.6 Posting

)

Requirements Have Been Established 41 1.14 &.2.14 Inspection, Test & Operating Status 42

1. Statement of Verification that Status of Packages is Acknowledged by Affected Organizations 42
2. Statement of VenGcation that Removal ofInspection &

Status indicators are Procedurally Controlled 42

3. Statement of Veri 6 cation that By-passing of inspection L

Tests or Other Critical Operations is Controlled 42

4. Statement of VeriGcation that Nonconforming items are IdentiGed 42 1.15 & 2.15 Nonconforming Materials 43
1. Statement of Verification that Nonconforming items are Procedurally Controlled -

43 i.

2. Statement of Verification that Nonconforming items are Segregated from Acceptable Items 43 O
3. Statement of Verification that Repaired or Reworked

.V Items are Subjected to original Testing 43 K

L

4. Statement of Verification that Nonconformance Reports are Evaluated 43
5. Statement of Verification that 10CFR21.6 Posting Requirements Have Been Established 43 1.16 & 2.16 Corrective Action

-44

1. Statement of Verification that Corrective Actions are Reported 44
2. Statement of Verification that Corrective Action Proceedings are Completed 44 1.17 & 2.17 Quality Assurance Records 45

- 1. Statement of VeriGcation that Documentadun Furnishes Evidence of Activities Affecting Safety 45

' 2. Statement of Verification that Records are Legible

& Completed 45

3. Statement of Verification that Required Records are Indexed & Classified 45
4. Statement of Verification that QA Documents are Identifiable & Retrievable 46 S. Statement of Verification that Records are Subject to Storage, Preservation & Safekeeping 46 p

e.

.% )

e

1.18 & 2.18 Audits 47

1. Statement of Verification that Audits are Conducted in a Prescribed Manner 47
2. Statement of VeriGcation that Audits are Scheduled 47 3.- Statement of Verification of Qualifications of Audit Personnel 47
4. Statement of Verification of Preaudit Conferences 47 S. Statement of Veri 6 cation of Post Audit Conferences 48
6. Statement of Verification of Audit Reaorting & Response 48
7. Statement of Verification of Audit fo! loup Action 48

!O e

O INTRODUCTION J.L Shepherd and Associates maintains a Quality Assurance Program, described in this-manual, combining both Annex 1 " Quality Assurance Proarams Applicable to Design, Fabrication, Assembly,"and Testing of Packaging Usedin the Transport of Radioactsve Material"and Annex 2 Quality Assurance Programs Applicable to Procurement, Use, Maintenance, and Repair of Packaging Used in Transport of Radioactive Material", of USNRC Regulatory Guide 7.10 Establishing" Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material, Revisson 1, June 198G, >er Section 71.10 \\

" Quality Assurance Requirements" of Subpart H of 10CFR Part 71. Adcitionally, in August 1989, the USDOE, Westinghouse Hanford, audited, evaluated and found jlS&A's Quality Assurance Program as meeting compliance criteria to ANSI /ASME NQA 1,1986 Edition, Basic Requirements 1-18, which meets all quality requirements as called out in 10CFR21.

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",

including but not limited to calibrators and irradiators which qualify as DOT Type 7A Containers, as called out in 10 CFR 71, Subpart H, for its own use and the use of others.

~

J.L. Shepherd & Associates also uses its own and other manufacturer's a 3 proved contain-ers and devices for the transportation of radioactive materials as descri aed above. This Program pertains to quality assurance in design, testing,, manufacture, procurement, use, maintenance and repair of the above referenced containers. 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 procucts.

Members of the Radiolomcal staff of J.L. Shepherd & Associates personally perform all

- Assurance /quipment re' lated to this aspect of operation, in addition to Quality _

tests on e Control responsibilities.

Type A quantity shipping containers, including but not limited to irradiators and calibra-tors, and sources therem, appear in the " Registry of Radioactive Scaled Sources and De-vices, Safety Evaluation of Device"of the U.S.N.R.C., when approval is applicable. All Type B shipping containers have U.S.N.R.C. issued "Certincate of Compliance for Radioactive Materials Packages" and, when applicable for international shipments a U.S.D.O.T.

" Competent Authority Certincation for Type B Radioactive Materials Package Design". All certifications are in accordance with 10CFR71.

- Page~il

. QAM REVISION SHEET -

[ ')-

= QA-RM 001 A, Revision #3, Revised in Entirety 10/10/90,.

M' 3er NRC Regulatory Guide 7.10," Establishing Quality Assurance Programs for

'ackaging Used in the Transport of Radioactive Material", Revision 1, June 1986.

Revision #

Date Summary Approval Page #

Initials i

!: g t

1

Page 1 AN NEX 1,1.1, and ANNEX 2, 2.1, COMBINED r5 il 1.1 & 2.1 ORGANIZATION

1. Statement of Responsibility J.LShep/ Quality Assurance Program, as follows, as normal operation pr Control design, testing, manufacture, procurement, use, maintenance and repair 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 use and the use of others as welf as for the use of containers made by other manufacturers. It is the policy of JLS&A to perform all important to-safety work in accordance with the quality assurance requirements specified -

-in 10 CFR 71, Subpart H, and as described in the QA Program plan and related imple-menting procedures.

line management of JLS&A is responsible for the continued implementation of this pro-i gram on future projects.

2. Structure and Authority

- JLS&A has an established organizational structure with procedures which ensures that (1) in all areas of quality assurance, the assignment and responsibility for each area, is achieved and maintained by appropriately qualified and trained personnel, (2) that con-A formance thereof is verifieJ by either individuals or groups not directly responsible for d

work performed or in the case of multiple functions, conformance is later verified by other mdividuals or groups in evaluations or inspections'and (3) that quality verification and reporting to management hierarchy precludes conflict ofinterest,i.e. interdependent i

from costing and scheduling,in management areas of responsibility. All personnelin-volved with Quality Assurance / Control have the authority ing mateiial, work, shipment, and responsibility, in writing, to stop at any time, the further process of any nonconform 1

delivery or installation with direct recourse to upper management. QA/QC Management personnel have the further authority and responsibility,in writing, to superviseTurther processing after corrections, for any procedural reason, have been made. This statement.

-is signed by each individual and posted in a visible location.

L L

1 1

V(3 1

~~

Page 2 ANNEX 1,1.1 and ANNEX 2,' 2.1 COMBINED n\\1 3.

Structure and Authority - Current Organizational Chart (including direct and indirect lines of communication)

M.F. SHEPHERD Vice President R.N. DONELSON R. JACOBS Special Projects & Lic I

Consulting Consulting Radiological lafe

'b --

QA/QC Inspection /Tet ti Certified Health Physicist Senior Radiological Safety Senior Engineer Field Operations & Safety Records Mainte unc Senior Auditor QA/QC Inspection / Testing Radiological Safety Records Maintenance QA/QC Inspection / Testing / Audits Records Maintenance

'I J.S. SH'EPHERO Q.V. PHO O. CARANDANG i-Dir. Business Development / Sales -.\\g Engineering Manager Production /0perations Manager Assistant Installation / Service Radiological Safety p

Shipping Managet pg Radiological Safety QA/QC Inspection / Testing / Audits Radiological Safety gjg QA/QC Inspection / Testing / Audits

.sf Records Maintenance QA/QC Inspection / Testing / Audit Records Maintenance Records Malntenance r it r_ nr s.s-r s

('

(

(

N. PHO Production / Operations Lead Man Radiological Safety db QA/QdInspection/ Testing / Audit

, Records Maintenance I

> r i

i

.J.

I J,

~

l,)J L. WEISS

)

)

M. PAULS V. TOWNE P.M a-A&inistrative Assist.

Engineering Assist.

P Contracts A &lnistrator QA/QC Audits QA/QC Audits.

Production Assist.

Radiol Records Maintenance Records Maintenance QA/QC Audits QA/QC Inspec Records Maintenance Assist. I-Record I

I Manufacturing Staff' Purchad office /Seles I Engineering Staff I[ Operations /ProductionStaff Administrative Staff,

J.L.

Df 5 MERD i

D.ncr Fresident m

Generat Manager H

Chief Radi ol ogic al Of f ic er Senior E ng i nce.

CA/QC Inspot t i on/Tes t ing/ A# t 6 D.F. $NEPHERD Owner President, Acting D.C. $4 PM RD i

Personnel Manager g.

g p

g g

. sing b

Electronics Manager Radiological Safety

'Audies

-p--

- y-CA/QC Inspection / Testing / Audits 4

c_

Records Maintenance i

l 7

.-.___a Q

)

I

-(, p

,,,..,,5,,

(' ( g g

~

r s

D. MAYhts

'y'h

(

J.D. FUZZELL A. CAWRON Wi s

,.i A A 4

w Head QA/QC Manager Dir. Radiological Saf ety Accounting Manager Head, Non Radiological Records Head, Radiological Recoros Maint.

-qi QA/QC Costing / Adits

~

Assistant Radiological Safety Head, Indu.trict safety

/vvs Records Maintenance Assistant Radiologicat Operations Blood Bank / Medical Sales QA/QC Inspection / Testing / Audits QA/QC Inspections / Testing / Audits Records Maintenance

~

d I (4 +

}{

M. IRISH B. PEABCDY

) ( Head, Non Rad. QA/QC Inspector Assistant Radiologicsl Operations i* Chief Receiving inspector Assist. Radiosogical Saf ety l QA/QC Inspection / Testing / Audits 1+ Assist. Tad. Shipping / Receiving ~ Records Maintenance Assist. Rad. Records Maintenance L QA/CA Inspection / Testing / Audits ~ r J 1 Records Maintenance a h $NEPHERD J. VEILLEUX ) ( M.C. SHEPHERD }j

rch
sing 9

shipping Electronics Assist. gical Safety QA/QC Audits Purchasing Assist. lon/isst ing/Audi t s Recor.'" Maintenance D-- Radiological Sa.ety J e ( CA/QC Inspection / Testing / Audits ketrial Safety Maint enance Records Maintenance 11 0 / r_ { Shipping / Receiving Staf f h._[ QA/QC Staf f Radiological Staf f_Ll Electronics Staf' hl Accourbo Stal.' l 9 0 RDb O )2' - 0\\

Pa ge 3 AN'NEX 1,1.1 and ANNEX 2,2.1 COMBINED 4 4.0 lob Descriptions - f.L Shepherd Owner Responsibilities: President / General Manager: supervision specifically related to sales, contract manage-ment, accounting, production / operations and quality assurance / quality control. Chici Radiological Safety Officer: responsible for the supervision of final inspection of all products, all areas of radiological and non radiological after completion, including but not limited operation, quality assurance / quality control, to calibration, leak test, external radiation levels, certifications and shipping documentation, before shipment from either plant, vendor's facility, customer's facility, or other field aaplications such as service or installation, in accordance with Radiological Safety Control Manual and State of California license. i Senior Engineer: responsible for the supervision of all engineering functions, from initial calculations and testing for package approvals through approval for engineering drawing and procurement packages prior to release for fabncation, including tiut not kmited to ventor selection, vendor qualifications and quality assurance programs, and drawing and/or procurement revision and/or change control, and service /mstallation proceed-ings. QA/QC Inspection / Testing //. adits: supervision and final decision in case of impasse, and final ap/ proval of resumption any item or procedure which has been stopped m process by QA QC personnel. Qualifications: Bachelor of Science, Chemistry, Loyola University. Owner, jlS&A 1959 to Present Research, development and desi n of custom hetion of the op'ti tions in the nuclear field, with emphasis on the evalbation and sel radiation source and equipment based upon customer requirements, U.S.N.R.C. and U.S.D.O.T. regulations radiation safety, device and shipping container reliability, arel uss efficiency, including field installation and servicing, i Named User on JLS&A State of California Radioactive Materials License. O

Pa( ANN;e 3.1 E EX 1,1.1 and ANNEX 2,2.1 COMBINED r i 4.1 lob Description. D.F. Shepherd Owner Responsibilities: Owner: as co-owner, responsibility and supervision of all JLS&A corporate and manage-ment policy changes, insurance policies, pension plan, and approvals of lease hold improvements and capital expenditures. Actin; President: in the absence of J.L. Shepherd, D.F. Shepherd assumes all [' and enfor/ General Manager responsibilities, with on site responsibilities for supervision Presic ent cement to be carried out by Vice Presidents, D.C. Shepherd and M.f. Shep-herd. Personnel Manager: responsibility and supervision of all employee related policies, employee / management arbitration of disputes and employee counseling. Qualifications: Bachelor of Science, Biolog Master of Arts, Psychology,y, Immaculate Heart CollegeLoyola Marymount Univers Registered American Art fherapy Association Registered Intern Marriage, Family & Child Counseling (License Eligible) l Owner,JLS&A -i i I i O

Y Page 3.2 ANNEX 1,1.1 and ANNEX 2,2.1 COMulNED q V 311ob Description - M.FuShepherd Responsibilities: Vice President: assistant to President / General Manager, including delegated special projects, assuming responsibilities therefore in absence, including but not limited to st )ervision of sales, contract management, accounting, production / operations and Q QC. Responsibilities include supervision of review, renewal, and maintenance of JLS A licenses and approvals and interface with authorities. Radiological Safety: in training Cognizant Radiological Personnel, with responsibilities, per JLS&A Radiological Safety Controf Manual and State of California Radioactive Matenals License, inclucfin logical records. g but not limited to QA/QC inspection and testing and auditing of R QA/QC Insplection/ Testing / Audits: performance of QA/QC ins pections, tests and lead auditor in al areas, including but not limited to design, assembly, final check out and ] calibration. Records Maintenance: supervision and responsibility for jlS&A licensing and approvals, general responsibility and authority for all QA/QC records. i (d ~'s Authority and responsibility to stop at any time the further process of any nonconformina material, work, shipment, delivery or installatlon until disposition thereof is ascertainell and to supervise further processing of corrections. Qualifications: 1-Bachelor of Arts, Fine Arts and Technical Theatre, immaculate ileart College. Continuing U.C.L.A Extension Program and community college classes. 1972-1978 JLS&A, part time office work, l.H.C. Work study program. 1979-1981 - JLS&A, Administrative Assistance, sales, licensing, production and operations, and QA/QC inspector and auditor. 19821987 - Co founder, Architect and / General Manager of H T Construction, working with insurance companies to provide disabled accessibility for clients. 1987 Present - JLS&A, Vice President, training CRP, QA/QC inspection and testing. (7 O

Pa ge 3.3 ANNEX 1,1.1 and ANNEX 2,2.1 COMBINED I 'd 4.3 lob Description D C. Shepherd Responsibilities: Vice President: assistant to President /Ceneral Manager, assuming responsibilities there. fore in absence, including but not limited to supervision of sales, contract management, accounting, production / operations and QA/QC. Electronics Manager: supervision of production, schematics and schematic changes in conjunction with engineering, electronics.QA/QC inspection and testing. Radiological Safety: Cognizant Radiological Personnel responsibilities, per jlS&A Radiolog-ical Safety Control Manual and State of California Radioactive Materials License, including but not limited to QA/QC inspection and testing. QA/QC Inspection / Testing / Audits: supervision and performance of electronics QA/QC inspection and testing. Performance of QA ing but not limited to assembly, final chec/QC inspection / testing in other areas non electronics areas. Records Maintenance: supervision and responsibility for electronics QA/QC records maintenance, with general responsibility and authority for all QA/QC records. 's) Authority and responsibility to stop at any time, the further process of any nonconforming material, work, shipment, delivery or installation until disposition thereof is ascertained and to supervise further processing of corrections. Qualifications: Bachelor of Science, Biology, U.C.L.A. Master of Science, Marine Biology, University of Hawaii Continuing U.C.L.A. Extension Program and community college classes. 1975 1984 - JLS&A, part time electronics engineer (6 years electronics experience with Certified Radiation), QA/QC inspector. 1984 Present JLS&A, Vice President, Cognizant Radiological Personnel, Electronics Manager and Engineer, QA/QC inspection and testing, field service engineer. n ,Y

Pame 3.4 ANNEX 1,1.1 and ANNEX 2,2.1 COMBINED 3 4 lob Description. R.N. Donelson Responsibilities: Consulting $enior Auditor, QA/QC Inspection / Testing and Records Maintenan and Independent Certified Health Physicist, Radiological Safety Officer, Senior

Engineer, Performs independent audits, pertaining to all radiological aspects as referenced above, supervision of special projects, enzineenng and calculations, including but not limited to special projects, device approvals and testing,ining programs for Cognizant Radio as well as provides radiolonic training 3rograms for new employees and certificated tra

[ 'essonnel, in accordance with JLS&A Radiological Safety Control Manual and State of Chlifornia Radioactive Materials License. Qualifications: Bachelor of Science, Chemical Engineering, University of Washington. 1948 1957 - General Electric Company, Hanford, Washington: Radiation Engineer and Supervisor, Process engineer, liaison Engineer, Radiation Monitoring Superintendent and

Manager, 1957 1967 - U. S. Nuclear: Chief Engineer, Design and Applied Health Physics, including 7

field installations and servicing. Certified Health Physicist,1960 through Present. Named User JLS&A State of California Radioactive Materials License. = L M' h O

.------.---------.--------.----__-----.us---,---_w

--J

Pa ge 3.5 AkNEX 1,1.1 and ANNEX 2,2.1 COMBINED h igj 4.5 lob Description - R. lacobs Responsibilities: Consultina and independent Senior Radiological Operations and Safety for field work, including but not limited to QA/QC inspection, test and records, Cognir:

  • Radiological Personnel field training, and field evaluations in accordance with JLS&A Radiological Safety Control Manual and State of California Raclioactive Materials !icense.

Qualification : 1957 US Navy, Naval Nuclear Power School 1957 - US Navy, Water Chemisty School 1959 - US Navy, Nuclear Power i rototype Training 1962 - US Navy, N.R.F Instructor's School 1964 - US Navy, NS Savannah, instrument / Electronics Officers Course 1964 - Univ, of Arkansas, Instrument and Control Theory 1957-1960 US Navy, Reactor Operator 1960 1963 - US Navy, Instructor N.R.f. Naval Reactor Prototype, Idaho falls, Reactor Op. 19631967 - N.S. Savannah Technical Staff, HP instrument repair & calibration, l~~') Nuclear Instrumentation & Safety System upgrade & redesign 1967-1970 - NUS Corp., technical associate N/ 1970-1975 - Neutron Products, Supervisor of irradiation processing, Mana_ger of instrument field services 19751982 RAD Services, Manager of Laurel facility, Manager of Instrument Services 1982 Present - Bartlett Nuclear, HP Consultant. Named User JLS&A State of California Radioactive Materials License ,L)

Pa ge 3.6 Ah NEX 1,1.1 and ANNEX 2,2.1 COMBINED !'v) 4.6 lob Description - 1.S. Shepherd a Responsibilities: Director of Business Development: Research and development coordinator in conjunc-tion with Engineering and Radiological Departments of new products or applications, supervising sales, contract administration, and assistant to Senior Engineer for installation and service areas working with Engineering and Radiological Departments. Radiological Safety: Cognizant Radiological Personnel responsibilities, per JLS&A's Radio-logical Safety Control Manual and State of California Radioactive Materials License, includ-ing but not limited to QA/QC inspecting and testing. QA/QC Inspection A/QC inspections and tests in all areas, including bu/ Testing / Audits: performance oft not limited to design, a Audits are performed outside of sales, contracts install tion and service areas. Records Maintenance: supervision and responsibility for Sales / Contracts QA/QC docu-mentation, general responsibility and authonty for all QA/QC records. Authority and responsibility to stop at any time, the further process of any nonconforming material, work, shipment, delivery or installation until disposition thereof has been ascer-tained, and to supervise further processing of corrections. mI,) u Qualifications: 1 Bachelor of Science, Engineering, Economics, U.C. Northridge 19741986 - jlS&A, En ;ineering Assistant 1986 Present -JLS&A, Director of Business Development, Sales and Service, CRP, Field Service Engineer. l 1 o

Pa ge 3.7 ANNEX 1,1.1 and ANNEX 2,2.1 COMBINED U) 4.7 lob Description O. CArandang Responsibilities: Engineering Manager: supervision and responsibility for drawings, drawing and ecifica-tion files current and archival, bills of materials with certi0 cations required, engineering change order execution, and inspecting manufactured components, work in arocess and final check out pertaining to engineenng,in conjunction with QA/QC and ladiological Safety. Radiological Safety: Cognizant Radiological Personnel responsibilities, per JLS&A Radiolog-ical Safety Control Manual and State of California Radioactive Materials License, including but not limited to QA/QC inspection and testing. QA/QC Inspection / Testing / Audits: performance of QA/QC inspections and testing in all areas, including but not limited to design, assembl Audits are performed outside of engineering areas.y, final check and calibration. Records Maintenance: supervision and responsibility for all engineering drawin cations and records, general responsibility and authority for all QA/QC records. gs Authority and res)onsibility to stop at any time, the further process on any nonconform-ing material, won shipment, delivery, or installation until (Jis ascertained, and to supervise further processing of corrections. position thereof has Qualifications: Bachelor of Science, Mechanical Engineering, Adamson University, Philippines 19751980 - Se atron Develo 1980-1981 AIT Industries,Ipment Corp., Project Engineer rocess Engineer 1981 1982 - Bachi Inc., Desi:tn Engineer 19821888 - Circuitron Inc., Design Engineer 1988 Presept JLS&A, Engineering Manager, CRP, QA/QC Inspection & Testing, Field Service Engineer. n ( L

3 Pa ge 3.8 AkNEX 1,1.1 and ANNEX 2,2.1 COMBINED 'd 4.8 lob Description - O.V. Pho r Responsibilities: all phases / Operations Manager and Shop Foreman: supervision and responsib Production of manufacturing and submittals to QA/QC for inspection processes, pro-curement of outside materials, stock withdrawals, pioduction scheduling. Supeivision of maintenance, handling, storage & repair of reusable shipping containers in conjunction with Engineering, QA/QC and Radiological. Head Shippin,g: supervision and responsibility for physical aspects of all outgoing ship-ments,in conjunction with QA/QC and Radiological. Radiological Safety: Cognizant Radiological Personnel responsibilities, per JLS&A Radiolog-ical Safety Control Manual and State of California Radioactive Materials license, including but not limited to QA/QC inspection and testing. QA/QC Inspection / Testing / Audits: performance of QA/QC inspections and testin areas, including but not hmited to design, assembly, final check and calibration.g Audit participation in non production / operations / shipping areas. Records Maintenance: supervision and responsibility for all production /o QA/QC records maintenance, with general responsibility for all QA/QC records.pera Authority and responsibility to stop at any time, the further process of nonconforming v material, work, shipment, delivery or installation until disposition thereof is ascertained and to supervise further processing of corrections. Qualifications: Bachelor of Science. Mechanical Engineering, Univ, of Saigon l l 19821984 - jl.S&A, Certified Welder, A.W.S.D1.181 19841987 JLS&A, Shop Supervisor, field service engineer. 1987 Present - JLS&A Production / Operations Manager, CRP, field service engineet. l l L l t Q me e

i Page 3.9 AkNEX 1,1.1 and ANNEX 2,2.1 COMBINED g I 4.9 lob Description D. Haynes Responsibilities: QA/QC Manager: supervision of all areas of QC/QC, responsibilities include in. process, subassembly, assembly and final check out ins acctions and all in coming matenals and components dispositions and allocations. With Production Manager and Radiological, responsibilities include QA/QC maintenance, handling storage and repair of reusable j shipping containers. Head Non radiological QA/QC Records: supervision and responsibility for records and maintenance. Radiological Safety Assistant: Cognizant Radiological Personnel responsibilities, per JLS&A's Radiological Safety Control Manual and State of California Radioactive Matenals License, including but not limited to QA/QC inspection and testing, assistant for radiolog-ical safety, shipping and records. QA/QC Inspection / Testing / Audits: supervision and responsibility for QA/QC inspections and testing, performance of radiological or other inspections which have other checks, and audit participation in areas other than QA/QC inspection and testing and records. Authority and responsibility to stop at any time, the further process of any nonconform /,L material, work, shipment, delivery or installation until disposition thereof is ascertaine( V and to supervise further processing of corrections. Qualifications: Military: Nuclear Power Sch,al, Nuclear Power Training Unit, Engineering Laboratory Technician, Machinir.; s Mate Class A, Quality insurance Inspector, Radiological Controls Maintenance, Maintenance & Materials management (3M), Gas free Engineering, Leadership & Management Training. 19841986 - US Navy, Radiac Chlibration Division & Radiological Controls, leading Petty OfGcer 1986-1988 - Radiological Control Shift Supervisor, Radiological Controls Monitor, Division Training Coordinator, Environmental Monitoring Petty Of6cer. 19881990 - Engineering Lab Technician, Gas free Engineer, Technical Publications Custodian, 1190 Present JLS&A, QA/QC Manager, CRP, etc., per above. V

Page 3.10 - AkNEX 1,1.1 and ANNEX 2,2.1 COMBINED 'd 4.10 lob Description 1.D. Furrell Responsibilities: Director of Radiological Safety: supervision and responsible for Radiological Safety, working under Chief Radiological Safety Officer and assuming responsibilities therefore in absence, aer JLS&A Radiological Safety Control Manual, State of California Radioactive Materials icense and QA/QC Program, including but not limited to procedures covered under QA/QC Program. Head Radiological Records Maintenance: supervision and responsibility for all radiological records, with general responsibility and authority for all QA/QC records. Head Radiological Shipping / Receiving:in conjunction with shipping and Q aspects of shipping receiving, working Head Industrial Safety:ing within the QA/Q and Radiological Safety Progra training programs, work QA/QC inspection / Testing / Audits: including but not limited to design, performance of inspections and testing in all area , performed outside Radiological QA/QC areas. y, Gnal check and calibration. Audi assembl O Authority and responsibility to stop at any time, the further process cf any nonconforming i V material, work, shipment, delivery or installation until disposition thereof has been ascer-tained, and to supervise further processing of corrections. QualiGcations: Pre Med, University of Kentucky, San Diego State, Univ. of Washington 2 yr. Physics, Chemistry, Biology L AEC Ind.yr. Math 3 isotope School l US Navy Radiation Defense Lab School Continuing Health Physics Education 19631967 Medcorp, Western Regional Manager,137-Cs sources, equipment and sales for afterloading techniques. 1970-1977 - Philips Medical Systems, Area manger for diagnostic equipment, sales, service and installation. 19771988 - Alpha Omega Services, Alternate Radiation Safely Officer, Operations, Manager 192-Ir manufacturing facility, Co Director Health Physics Programs, low level radioactive waste. L 1988 Present - JLS&A, Director of Radiological 0 3erations, Named User JLS&A State of l California Radioactive Materials License, 3tood Bank & Medical Sales 'O (

Paze 3.11 AkNEX 1,1.1 and ANNEX 2,2.1 COMBINED O 4.11 lob Description - A. Garwon Responsibilities: Accounting Manager: accounting, inclucfing but not limited to QA/QC functions of inventory review, phases of supervision and responsibility for bookkeeping and all review of work in process and closed jobs, and review of purchase orders and bills. QA/QC inspection / Testing / Audits: performance of QA/QC functions and audits listed above, with fine accounting audits performed by an outside C.P.A. and QA/QC by JLS&A Management. Records Maintenance: supervision and responsibility for accounting QA/QC records, with general responsibility for all QA/QC records. Authority and responsibility to stop at any time, the further process of nonconforming material, work, shipment, delivery or installation until disposition thereof has v=been ascertained, and to supervise further processing of corrections. Qualifications: Central Commercial High School Accounting Major ] Continuing Education, U.C. extension classes and seminars 1973-1986 R.S. Hughes Co.,Inc. / Saunders Corp: Head Bookkeeper, Regional finance Manager, General Accounting Manager. 1986 Present-jlS&A: Accounting Manager O

Pa ge 3.12 AkNEX 1,1.1 and ANNEX 2,2.1 COMBINED g V 4.12 lob Description N. Pho Responsibilities: Production / Operations lead Man: assistant to Production / Operations Manager and Shipping Head and assuming responsibilities therefore in absence, including but not limited to all phases of manufactunn procurement of outside materials, g and submittals to QA/QC for ins Section processes, stock withdrawals, production sc ieduling, QA/QC records maintenance and supervision of maintenance, handling,iological. storage & repair of reusable shipping containers in conjunction with Engineering and Rad Radiological Safety: Cognizant Radiological Personnel responsibilities, per JLS&A Radiolog-ical Safety Control Manual and State of California Radioactive Materials License, including but not limited to QA/QC inspection and testing. QA/QC Inspection / Testing / Audits: supervision and responsibility for QA/QC inspection and testing m all areas, including but not limited to design, assembly, and final check out. Audits are performed outside production / operations area, i Authority and responsibility to stop at any time, the further process of any nonconforming material, work, shipment, delivery of installation, until disposition thereof has been asce - tained, and to supervise further processing of corrections. g V Qualifications: l Certificate Program, Mechanical Machine Repair Ving Long College Certificate Program, Machine Technology, G endale Community College Certificate Program, Welding Technology, Blueprints, Welding Construction Codes, Valley Vocational School 1 19821982 - Edwards Welding, Heliarc & Arc Welder 19821983 - International Electronics Research Corp., Machinist 1983-1986 JLS&A, Welder, Machinist, Fabricator 1986 Present: JLS&A Production / Operations Lead Man, CRP, field Service Engineer 1 i L ln c

Page 3.13 AN NEX 1,1.1 and ANNEX 2, 2.1 COMUINED O 4.13 lob Description M. Irish Responsibilities: Head Non radiological QA/QC Inspector: supervision and responsibility for all QA/QC inspections and tests and drawing inspection prior to release for fabrication. Chief Receiving Inspector: supervision and responsibility for all non-radiological receiving procedures, inspections, testing, disposition antl dispersal. QA/QC Audits: audit participation in areas other than QC/QC inspection and testing. Records Maintenance: general responsibili'y for all QA/QC records. Authority and responsibility to stop at any time, the further process of any nonconforming material, work, shipment, delivery or installation until disposition thereof has been ascer-tained, and to supervise further processing of corrections. Qualifications: Education: 1971-1987 - Jt.S&A, Welder, Machinist, Fabricator, field Engineer 1987 Present - jlS&A, Head QA/QC Inspector O

Page 3.14 ANNEX 1,1.1 and ANNEX 2,2.1 COMBINED j \\ 4.14 lob Description - B. Peabody Responsibilities: Radiological Operations Assistant: assistant to Chief Radiological Safety Officer, in per-forming final inspections of radiological products after completion, including but not limited to calibration, leak test, external radiation levels and certifications. Radiological Safety Assistant: assistant to Director of Radiological Safety,in performing 3rocedures in conformance with JLS&A Radiological Safety Control Manual, State of Cali-Jornia Radioactive Materials License and QA/QC Program, including but not limited to procedures covered under the QA/QC Program. Radiological Shipping / Receiving: assistarn to Head Radiological Shipping / Receiving in performance and responsibility Tor all aspects thereof, working in conjunction with sh,ip-ping and QA/QC, Assistant Radiological Records Maintentace: assistant for all radiological secords mainte-nance, with general responsibility and a.ithority for all QA/QC records. QA/QC Inspection / Testing / Audits: performance of QA/QC inspection and testing,in-cluded but not limited to assembly, final check out, and calibration. Audit participation in non radiological areas. i 4 V Authority and responsibility to stop at any time, the further process of any nonconforming material, work, shipment, delivery or installation, until disposition thereof has been ascer-tained, and to supervise further processing of corrections. Qualifications: High School Diploma Various vendor equipment servicing courses. 19791990 - X Ray Equipment Company, service, installation and repair engineer for teletherapy and X Ray eguipment, source transfer assistant, authorized driver of - large quantity radioactive materials, radiation safety, radiation surveys, packaging and labeling of radioactive materials, and emergency notifications and procedures. l 1990 Present - JLS&A, Radiological Operations Assistant, CRP, l~ield Service 1:ngineer l l 1 l w

Pa te 3.15 AN'NEX 1,1.1 and ANNEX 2,2.1 COM10NED 4.15 lob Description - L Weiss Responsibilities: Contracts Administrator: responsibility for Contract Administration and approvals,includ ing but not limited to QA/QC functions of entering and initiating new contracts and modifications into the QA/qC system, and customer licensing and licensing authori-ty notifications ofimpending serv ce/mstallations as required. Records Maintenance: supervision and responsibility for entering and initiating QA/QC documentation papenvork into the system, from contracts as negotiated by Sales Dept., general responsibility and authority for all QA/QC records. QA/QC Audits: participation in audits performed outside of Sales / Contracts areas. Authority and responsibility to stop at any time the further process of any nonconforming material, work, shipment, delivery or installation until disposition thereof has been ascer-tained, and to supervise further processing of corrections. Qualifications: Central Commercial High School -/) Continuing Educational Classes v 1956-1966 - H.L Klebanow & Son, Secretary, Assistant Bookkeeper 19801984 - T.E.S.T., Inc, Secretary, Sales Coordinator 19841986 - Telescript Industries, Executive Secretary, Sales Coordinator 19861987 - JLS&A, Sales Secretary 1987 Present -JLS&A, Contracts Administrator F t !O r

Page 3.16 ANNEX 1,1.1 and ANNEX 2,2.1 COMBINED V 4.16 lob Description M. Pauls i Responsibilities. Administrative Assistant: management assistant,in areas of sales and contracts,installa tion and service, licenses and approvals, interface with authorities, QA/QC radiolo and non radiological records,inc uding but not limited to manuals and certitications. gica Records Maintenance: assistant to QA/QC and Radiological Records, with general re-sponsibility and authority for all QA/QC records. Authority and responsibility to stop at any time, the further process of any nonconforming material, work, shipment, delivery or installation, until disposition thereof has been ascer-tained, 'nd to supervise further processing of corrections. Qualifications: Bachelor of Science, Microbiology, Univ. of Michigan 1981 1983 - T harpe & Howell,p ale, legal Secretary to Sr. Partner _egal Secretary to Sr. 1978-1981 - Brawerman & Ko of civilliti ation documents. V(, 1983=1985 - Al Baker, et al, legal Secretary, and relate documents with Securities & preparation and Gling of public offerings i Exchange Commission. 19851988 - Owner, freelance Legal Secretarial Services, preparation and filing of civil litigation documents and documentation related to corporate, business tax and real estate law. 1988 Present JLS&A Administrative Assistant A 'N f

Page 3.17 ANNEX 1,1.1 and ANNEX 2,2.1 COMBINED O 4.17 lob Description V. Towne Responsibilities: Engineering / Production Assistant: assistant to en including but not limited to drawing reproduction,gineering and production with duti submittal of standard Bills of Matenal for review, inventory check of items from Bills of Materials, inventory analysis upkeep and review, and job package preparation for produc-tion. QA/QC Inspection / Audits: performance of review of job package review between enpi-those areas. production, and upkeep of open orders, with audit participation outside neering and Records Maintenance: sulaervision and resaonsibility for all proper engineering approvals on all documents before distribution and a location to production, with general responsi-bility and authority for all QA/QC records. Authority and responsibility to stop at.iny time, the further process of any nonconforming material, work, shipment, delivery or installation until disposition thereof has been astei-tained, and to supervise further processing of corrections. Qualifications: Schooling fillin 1981 1983 - jlS&A, inventory Control Clerk, Assembler 1983-1984 JLS&A, Welder 1984 Present JLS&A Production Control Planner / Assistant O h m-m_____i____ .mm ._mmm_-- - - - - - - - - - -

_------------------------------A

Pa ge 3.18 ANNEX 1,1.1 and ANNEX 2,2.1 COMBINED m ( ) 4.18 lob Description - P. Shepherd 'd Responsibilities: Purchasing: responsibility for placing of purchase orders in conformance with all specifi-cations as called out on Bills of Matenals, cost effectiveness by pricing comparisons on same items by qualified vendors, contacting vendors regarding material rejection, working with receiving popartment to check the proper certifications accompany shipment and initiating receivmg paperwork, and followup on late deliveries. Radiological Safety: Cognizant Radiological Personnel responsibilities, per JLS&A Radiolog-ital Safety Control Manual and State of California Radioactive Materials t.icense, including but not limited to QA/QC inspec' ion and testing. QA/QC Inspection / Testing / Audits: performance of QA including but not limited to de/QC inspections and testing in areas other than receiving, ion on non purchasing / reviewing areas. sign, assembly, Gnal check and calibration. Audit participat Assistant Industrial Safety: responsibility to assist in implementation of in plant industrial safety programs, woining with QA/QC and Radiological Safety Programs. Records Maintenance: su aervision and res general responsibility for al QA/QC records. ponsibility for all purchasing records, with Authority and responsibility to stop at any time, the further process of nonconforming C/ material, work, shipment, delivery or installation until disposition thereof has been ascer-tained, and to supervise further processing of corrections. Qualifications: Providence High School Continuing classes towards B.A., Glendale Community College 19851987 -JLS&A, Production / Operations Assistant 1987 Present -JLS&A Production / Operations Assistant, CRP, Geld service engineer, Assistant Purcbasing,1990 Purchasing 1 1

Paf Ah ,e 3.19 NEX 1,1.1 and ANNEX 2,2.1 COMBINED O 4.19 lob Description - 1. Veilleux Responsibilities: Shippi,ng: but not limited to Operatiresponsible for all shippin arrangements and docu including installation Manuals, Shipping Documents, Leak Test and External Radiation Level Cer cations and Overpack Log, working with QA/QC and Radiological. QA/QC Audits: participation in areas other than shipping. Records Maintenance: responsibility for all shipping records and documentation, with general responsibility for all Qa/QC records. Authority and responsibility to stop at any time, the further process on nonconforming material, work, shipment, delivery or installation until disposition thereof has been ascer-tained, and to supervise further processing of corrections. Qualifications: Hartford High School 1962-1980 Hewlitt Packard, office manager 1982-1984 - Cal Prop, general office 19851987 - IMI, general office 1987 Present - jlS&A, Shipping O

Page 3.20 ANNEX 1,1.1 and ANNEX 2,2.1 COMBINED 'U 4.20 lob Description - M. C. Shepherd Responsibilities: Electronics Assistant: Assistant to Electronics Manager, responsible for assembly, produc-tion, schematics and schematic changes in conjunction with engineering, production / operations and QA/QC, Purchasing Assistant: responsibility for placing purchase orders in conformance will all specifications as called out on Bills of Matenals, pricing comparisons from ciualified vendors, working with receiving department and initiating receiving paperwork, and followup on late deliveries. Radiological Safety: Cognizant Radiological Personnel responsibilities, per JLS&A Radiolog-ical Safety Control Manual and State of California License, including but not limited to QA/QC inspection and testing. QA/QC Inspection /Testin Audits: performance of electronics QA /QC insaection and testing in other area /QC inspection and testing. Performance of s, including but not limited to assembly, che out anc calibration. Audit participation in non-electronics areas. Records Maintenance: assistant to Electronics Manager for electronics QA/QC records (Vl maintenance, and for purchasing QA/QC records maintenance, with general responsibili-ty for all QA/QC records. Authority and responsibility to stop at any time, the further process of any nonconforming material, work, shipment, delivery or installation, until dis tained, and to supeivise further processing of corrections. position thereof has bee Qualifications: Providence High School Continuing education towards Bachelor of Science, Northridge University 1984 Present JLS&A, Electronics Assistant (4 years prior electronics experience with Certified Radiation), Purchasing Assistant, CRP, field service engineer l l

Pa te 4 i ANNEX ",,1.1 and ANNEX 2,2.1 COMBINED 4.21 Minimum lob Oualifications Accci'ntin Staff: Hi School Diploma or Equivalency Test Trade School or College or BA College Preferrr d or 510 years work expenence, or expenence wi hin JLS&A Engineerin; Staff: Hig1 School Di aloma or Equivalency Test 4 Year College Jegree in Engineering, additional science background preferred 4 years work experience, or experience within JLS&A Electronics Staff: High School Diploma or Equivalency Test AA trade School or College Degree or BA College Degree preferred or 410 years work experience, or experience with jlS&A except for entry level positions. Manufacturing Staff, Welders, Machinists, fabricators, Assemblers High School Diploma or Equivalency Test AA Trade School or College Degree and/or Certificates, journeyman Level, Blue Print Reading Ability 2-4 years work experience related to position offered, or experience within JLS&A Pass competency test administrated by JLS&A Note: entry level or starting positions only require High School Diploma or Equivalency Tests; F.e. shop helpers, delivery persons, etc. Office / Sales / Administrative Staff: High School Diploma or Equivalency Test 2 4 years related work experience to position offered, except for starting, clerical or temporary positions. Operations / Production Staff: High School Diploma or Equivalency Test AA Trade School or College or BA College Degree and/or workplace experience 2-4 years work experience, or experience wit iin JLS&A Purchasin Staff: Hi i School Diploma or Equivalency Test 2 years work experience, or experience within jlS&A QA/QC Staff: High School Diploma or Equivalency Test AA Trade school or College or BA College Degree and/or workplace experience Blueprint reading ability 2 4 years workplace experience or experience within jlS&A O

Pa ge 4.1 AhNEX 1,1.1 and ANNEX 2,2.1 COMBINED .,~, '~' 4.21 Minimum lob Oualifications continued Radiological Staff: Cognizant Radiological Personnel: High School Diploma or Equivalency Test, some c ilege or Health Physics classes or experience preferred Passed JLS&A 40 hour RadiologicalClass and Tc.and State of California Radioactive Materials License training qua ications Supervisory personnel: the above plus meeting State of California's evaluation to bet ome a Named User on JLS&A's Radioactive Materials License. Some college science or chemistry background preferred or 5-10 years related work experience. Shipping / Receiving Staff: High School Diploma or Equivalency Test some college or 2-5 years work experience preferred, or experience within JLS&A. ,,l (J I l

Page 5 ANNEX 1,1.2 and ANNEX 2,2.2 COMBINED r V 1.2 &,2 2 OUALITY ASSURANCE PROGRAM a

1. Documentation Master Index of OA Procedures and Implementation Implementing Title 10CRF71 Description Document
  • Subpart H Criteria QAM, QP 1.0 Organization 1.

Identifies JLS&A internal organization. Chart al structure and relationships in per. formance of activities affecting quality. Status: complete. QAM, QP 1.1 Job 1. Identifies individual QA/QC job functions Descriptions within oganization structure, responsibdities, authority and duties. Status: complete. QAM,QP2.0 Quality 2. Describes established procedures for Assurance Manual JLS&A's documented QA/QC program, originally implemented in 1979, under 10CFR71, Appendix E, currenuy Sub-art H. c( ) . tatus: complete. QAM, QP 3.0 Design Control 3. Describes established procedures for control of design process, input and verification directly related to NRC-issued " Certificate of Compliance for Radioactive Materials Package Design", and USDOT "CertiGcate of Competent Authority for Type B Qualities, and USNRC Issued Registry of Radioactive Scaled Sources & Devices"for Type A Quantity shipping containers, including but not limited to irradiators, calibra-tors and sources contained therein,in addition to 10CFR71, Subpart H. Status: complete. QAM, QP 4.0 Procurement 4. Describes established procedures for Document control of procurement document Control (purchase orders) preparatinn, reviews, concurrences, and approvals, including but not limited to technical require-ments, documentation, access to sup-pliers for audits, certi0 cations and changes. Cross reference to QAM, QP

6.1. Status

complete.

l Pa ge 6 AN NEX 1,1.2 and ANNEX 2,2.2 COMBINED

1. Documentation - Master Index of OA Procedures & Implementation, continued.

QAM, QP 5.0 Manufacturing 5. Describes established procedures for Control documented instructions, procedures, drawings, and acceptance criteria, with a clear sec uence of action, for important to sa'ety activities. Status: complete. QAM,QP6.0 Document 6. Describes established procedures for Control - Design document generation, issuance and changes, including but not limited to drawings and specifications, with a clear sequence of action. Status: complete. QAM, QP 6.1 Document 6. See QAM, QP 4.0. Control - Procurement Status: complete. QAM, QP 6.2 Document 6. Revision log,is part of the QA Manual & Manuals / oc/QC QC Sheets incorporate revision num-Control - uments bers, approvals and dates, with a clear sequence of action contained therein. Status: complete .O QAM, QP 6.3 Document 6. maintenance & modifica-Operating,dures incorporate revision Control-Operating tion proce Maintenance & Modi-number, approvals and dates, with a fications clear sequence of action contained there-in. Status: complete. QAM,QP6.4 Document 6. Inspection & test procedures, as called Control - Inpsec-out in pertinent regulatory guides, are tion & Test Docu-kept in permanent archives. Current ments status is determined b latest applicable regulatory guides and adioactive Materials License, and procedures are updated accordin , into QA/QC Pro-gram, Radiologica afety Control Manual, etc, with a clear sequence of action established. Status: complete. QAM,QP6.5 Document 6. Nonconformance Reports incorporate Control - Noncon-revision number, approvals and dates, formance Reports with an established clear sequence of sequence of action contained therein. Status: complete O

Page 7 ANNEX 1,1.2.1 and ANNEX 2,2.2.2 COMBINED

1. Documentation - Master Index of OA Procedures & Implementation, continued QAM,QP6.6 Document 6.

Design Change Requests incorporate Control Design revision number, approvals and dates, Changes with an established clear sequence of action contained therein. Status: complete. QAM, QP 7.0 Control of 7. Describes procedures for Procurement Purchased Material, Document planing, selection of pro-Equipment & Services curement sources, bid evaluation & award, supplier conformance control, verification activities, controlling nonconformances and records, with an established clear sequence of action contained therein. Status: complete. QAM,QP8.0 ID & Control of 8. Describes procedures for the identifica-Materials, Parts & tion, control and conditional releases of Components materials, parts and components, with an established clear sequence of ac-tion contained therein. Status: complete. QAM,QP9.0 Special 9. Describes procedures for the control of Processes special processes, including qualifica tions of procedures, equipment, per-sonnel, operations and records, with an established clear sequence of action contained therein. Status: complete. QAM, QP 10.0 Inspection 10. Describes procedures for inspection Control cations,g, inspections and their qualifi-plannin with an established clem se-quence of action contained thcrein. Status: complete. QAM, QP 11.0 Test Control 11. Describes requirements, p& evaluation. rocedures and result documentation of test control, with an established clear sequence of action contained therein. Status: complete. O 1 l

Pa ge 8 ANNEX 1,1.2 and ANNEX 2,2.2 COMBINED O ,1. Documentation Master index of OA Procedures & Implementation, continued. QAM, QP 12.0 Calibration 12. Describes procedures for calibration Equipment tion equipment, with an established clear sequence of action contained therein. Status: complete. QAM, QP 13.0

Handling, 13.

Describes procedures for handling, Storage & storage, shipping, including preserva-Shipping tion, preparation, release and delivery with an established clear sequence of action contained therein, in accordance with regulatory guidelines, licenses, approvals and Certi0 cates of Competent Authorities. Status: complete. QAM, QP.14.0 Inspection, 14. Describes established measures that Test & Operating that ensure identification of inspection, QC personnel,g status is known to QA/ Status test & operatin and that status indica-tors are procedurally controlled, with a clear sequence of action. Q Status: complete. QAM, QP 15.0 Control of 15. Describes established procedures for Nonconforming control of nonconforming materials, Material, Parts parts or components, including identiG-or Components cation, segregation, disposition and evaluation thereof, with a clear so-quence of action therefore. Status: complete. QAM, QP 16.0 Corrective 16. Describes established procedures for Action corrective action, including reporting, monitoring and closecut, with a clear sequence of action therefore. Status: complete. O

Pa ze 9 ' AN'NEX 1,1.2.1 and ANNEX 2,2.2.1 COMBINED 1.2.1 Documentation Master index of OA Procedures & implementajion. continued QAM, QP 17.0 QA Records 17. Describes established procedures con-cerning all aspects of QA records,in-cluding, design, procurement, manu-facturing, installation, evaluations, nonconformance reports, inspection results, tests, audits, analysis, as built drawings and speci6 cations, personnel quali0 cations, procedures, equipment, calibration procedures, training records, and corrective action reports, including records fication, generation, indexing and classi - receipt, retrieval, disposition, storage, preservations and safekeeping thereof. Status: complete. QAM, QP 18.0 Audits 18. Describes established procedures for a comprehensive audit program, includ-ing scheduling, team selection, audit documents, pre and post audit confer-ences, reporting and response and fol-lowup action, with a clear sequence of j. Status: complete. action. y 9 'i h A. m --A

Page 10 ANNEX 1,1.2 and ANNEX 2,2.2. COMBINED ~ 1,2 & 2.2 SCOPE & APPLICABILITY OF OA PROGRAM, INCLUDING PERSONNEL & CONTROLLED CONDITIONS

1. Applicability
1. Statement of Verification of Assessment of Quality Assurance Program.

The Officers of the Quality Assurance Program (QAP),in addition to daily communica-tions, hold scheduled conferences with appropriate departments, to review the status of - each job in regard to design, purchasing, work process releases, work in arogress, correc-tive actions (if necessary) and shipment on whatever phase of opera; ion is currently 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. Distribution 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 or auditor of JLS&A, upon request. (Each new employee is made familiar with the manual as a part of the Training Program.) . QA records personnel are responsible for distributing approved revisions to all internal .g. copies of the manual and advising the holders thereof of such revisions.

3. Statement of Verification that Quality Assurance Program Requirements are Are Applicable to Outside Vendors.

JLS&A retains the right to supervise und inspect products at a vendor's and/or contrac-tor's facilities and/or to reject nonconforming materials, jlS&A has agreements stating this requirement with vendors and subcontractors in order to maintain mandatory QA/QC requirements.

4. Safety related Systems, Structures and Components Controlled by Quality Assur-ance Program.

All mechanical, electrical and electronic components as well as components and com-pleted systems are controlled and covered by the QAP by specification, drawing and/or operating manual, where applicable. O

Page 11 AN'NEX 1,1.2 and ANNEX 2,2.2 COMBINED

5. Statement of Verification of Resolution of Disputes.

[ If and when disputes arise concernin the quality of a roduct between the different departments, a review of the product s functions,-speciffcations and compatibility with = the QA/,QC Program as well as NRC and DOT criteria is made by the QA olficers and the appropnate departments. Reviews are made at scheduled conferences or as needed when all pertinent data is gathered. Agreements are subject to review by President / ' General Manager for Gnal aoproval. In the event of unreachable absence of the Presi-dent / General Mana er, a review board has been established, with Snal resolution dis-pute to be arbitrated y Acting President. [

6. Statement of Verification that Training Program is implemented.

program for all new employees and employees assuming JLS&A maintains a training ~his pro ram provides a thorou h examination of the QA/QC additional. responsibilities. l Program and the purpose of mam aining this program, ach QA ofGcer's authority is L. delineated and the effect of that authority /QC Program.is demonstrated as well as an how the employee functions within the QA In as much as jlS&A is a small business, each employee is not only responsible to the QA ofGcers, but is directly responsible for his/her own work within the comp,any. Hence, -in the trainin program, each individual is trained (and continuousi monitored in the system of ch cks and balances maintained in the weekly review b the QA officers to

h_

whom the employee is responsible) to be effective in the continuous effect functioning of the QAP. Complete documentation of this program is on file at JLS&A. ~ All personnel are adequately licensed or certi6ed, i.e, Radiological, Cognizant Radiological Personnel, welders, machinists, when applicable. All licenses and certi0 cations are kept current. If an employee is not performing to the specifications maintained by JLS&A, he/she is sub ct to a retraining program F)efore continuiq with hi her responsibilities and duties.1 this is not successful, emp oyment is terminated a ter the appropriate -notice has been given and legal responsibilit es ful6tled.

7. Statement of Verification that Quality related Activities are Performed According to Predetermined Measures.

JLS&A performs all c uality related procedures,i.e., inspections and testing,d and environ. in accordance with predeterminec procedures whicn specify the equipment to be use mental conditions,if necessary. Inspectors are reguired to determine and document that all prerequisites have been satisfied before inspection and/or testing. O

Pa ge 12 ANNEX 1,1.2 and ANNEX 2,2.2 COMBINED f a'"

2. Scope For each job undertaken by JLS&A, prior to the time purchase orders are issued to subcontractors or vendors, a work plan is drawn up for that contract.

The work plan includes:

1. A complete work schedule including the purchase of long and short lead time items;
2. A work order sheet which includes specialinstructions, job details and a drawing list.
3. A complete schedule for outside purchases (Bill of Materials) and stock withdrawals (cutting list).
4. A complete quality assurance program including, but not limited to, contracted parts, in house manufactured components in process, with specific inspection points, final assembly and final check out subsequent to source loading, as well as maintenance, 4

handling, storage and cleaning for reusable shipping containers, as required. This Quality Assurance Program takes into consideration the quality control procedures that will be necessary f tr satisfactory performance of the contract and outlines detailed specifications for raw materials, subcontracted parts and in house manufactured compo, nents. This program also speci0cally calls out quality assurance inspection check points, time of inspection, inspection instructions and disposition of conforming or non-conforming parts, as well as e uipment to be used by vendors, subcontractors and manufactunng personnel of JLS&

1. Procedures, Documentatior and Records

) m - Intermediate and final inspection forms and records are permanently maintained at JLS&A, along with all necessary radiological data such as leak test certificates and any other records that pertain to the radiological aspect of the eregulatory authoritie Included in the Quality Assurance records, which become a permanent file for each job, are the following forms: .2. Work Orde/ Customer Purchase Order / Customer Licensing

1. Quotation r
3. Complete Drawing List -
4. Bill of Materials
5. Purchase Orders with Certifications
6. Engineering Change Orders
7. Materials Rejection Form
8. Mechanical Components: Quality Control Certification-
9. Electrical Systems Check List
10. Assembly Check List - Prior to loading
11. QA/QC Operation Check List
12. Health Physics Check List - Subsequent to Loading
13. Installation / Operation Manual and appropriate Certifications, i.e. l eak Test, Calibra tion, External Radiation Levels
14. Shipping Check List

'15. Container /Overpack Inspection Check List

16. Shipping Document anci Bill of Lading

Pa ge 13 Ah NEX 1,1.2 and ANNEX 2,2.2 COMBINED O

1. Procedures, Documentation and Records continued l

When necessary, forms are also prepared and fonvarded to subcontractors covering the various areas of c uality control to be checked by the, as outlined in Quality Planning, and then returned to LS&A to be maintained in the permanent file. Prior to tssembly, mechanical components and fabricated parts are checked for material and dimensions by the o3erator or Production / Operations Manager and the QA Engi-neer. Also prior to assem aly, all electrical system components are checked for operation and/or function by the assembler. An operational check is performed by the assembler in conformity with the QA Mananer and/or Engineer with specific operation being deter-mined by the Oaeration ManuaTfor each unit. Criteria for these mspections is deter-mined by indivic ual drawings, per individual unit, as called out by Engineering and the QA/QC department. Prior to radioactive materials loading, assembled 3 arts are inspected by the assembler or Production / Operations Manager and by the QA ingineer, with criteria being determined by the individual drawings and speci0 cations 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. Subsequent to radioactive materials loading,, h the Operating Manual for that unit) a QA performs a complete operational and .Q. safety check on the unit (in accordance wit complete operational and safety check (minimum of 25 times), gical performs anot minimum of 25 times. After the unit has been loaded, Radiolo mstrument calibration, unit calibration, leak test and external radiation level measurement are performed. Radio-logical also prepares radiological shipping information in the form of a " Shipping Docu-ment", inspects the shipment and certines the Bill of Lading for that shipment. As part of the costing records for all jobs, all direct costs as attributed to quality assur-ance, are included in a separate category and are available for purposes of evaluation and future planning. These costing records include all pertinent information needed to identi-fy the correction of nonconforming materials and/or correction of defective workmanship.

2. Corrective Procedures A program for corrective. procedures is maintained. This include the following:
1. A separate inventory location for non conforming parts or cessation of nonconforming procedures.
2. Re inspections of corrected parts or procedures in the normal course of procedures dures of the corrected deficiencies and records thereof.
3. Analysis of scra aped products to determine reasons of nonconformity.
4. Analysis of metlods and processes of work performed.
5. Introduction of required improvements.
6. Monitoring and review of corrective procedures to assure their effectiveness.

Page 14 ANNEX 1,1.2 and ANNEX 2,2.2 COMBINED. 'O

3. Facilities and Standards Drawings and Specifications - Engineering maintains the central, current drawings and specification files, as well as permanent files containing archival drawings and speciGca-tions. Individual job Gles are permanently maintained, including but not limited to all pertinent drawings, correspondence, copies of contracts and/or customer's purchase order, copy of customer's license (if applicable), copies of all purchasing records and copies of all Quality Assurance / Radiological records and forms which are maintained by QA Recoids maintenance personnel, h

Prior to re: case 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, QA and Radiological, when applicable,is required prior to release. Changes are to be documented on the drawings incorporating the current design and/or speciications. Changes require the approval of Engineering, QA and Radiological, when applicable. d Sales, Engineering or Radiological is responsible for transmitting change information to the customer,if required. Production Control and Engineering are also responsible for transmitting this information to the appropriate departments. Engineering is to be responsible for the removal of obsolete drawings and speciGcations from all issue points. The following sections of the Quality Assurance Program may be broken into three mtegories: (1) Those shipping containers /overpacks made in conformance with specific uOl fabrication regulations 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) shipping containers and overpacks de-signed to ship large quantities of radioactivity for which USNRC CertiGcate of Compliance are required.

4. Drawing Control Because of the nature of the products (products involving radioactivity and packages used to transport radioactive materials) products are a aproved by the proper licensm?

authorities. The initial deign of a product entails provicing licensing authorities with al pertinent drawings, and inTormation pertinent to approval criteria, i.e. prototype testing, design review, calculations, etc. - All drawings and design specifications must be checked for conformance with fabrication specifications as called out in the pertinent NRC or DOT specifications and approved by the cognizant Quality Assurance Manager, Senior Engineer, General Manager or Radiation Saft ty Officer, when applicable, before release for fabrication. O

Pa ge 15 - Ah NEX 1,1.1 and ANNEX 2,2.2 COMBINED ,3 L !4. Drawing Control, continued All drawings and fabrication specifications and all outside purchase speci6 cations for units out-purchased, must be checked and approved by the Quality Assurance Manager, General Manager, Senior Engineer or Radiation Safety Of6cer, when applicable, prior to of container will either be /or purchasing. For this equipment, a prototype of each class release for fabncation and tested or calculations will be made and approved by the cogni-zant Quality Assurance Manager, General Manager, Senior Engineer or Radiation Safety Of0cer, when applicable. A Work Order (release lor fabrication) will not be released until it can be shown that the containers will meet pertinent transportation requirements. All pertinent data and calculations, including drawings, as called out in 10 CFR Part 71, i related to license ap,plications and Certi6 cation of Compliance applications for Type B and large quantity containers, will be checked and approved by the cognizant Quahty Assur-ance Manager, General Manager, Senior Engineer or Radiation SaTety Office, when apf plicable, pnor to the submission of approval data to the USNRC. After the Certi6cate o Compliance and license have been issued and prior to the fabrication of the approved snit, all drawings and purchase specifications for material must be checked and approved oy the Quality Assurance Manager, General Manager, Senior Engineer or Radiation Safety i Of6cer, when applicable.

5. Purchasing As noted in previous sections, JLS&A l repares a schedule of materials to be purchased, d

as well as subcontracted, for each jo prior to initiation of work on the contract. Pur-chase orders which are issued inclu e a complete description of the item to be pur-chased, as well as any qualifications which must be met on Covernment or customer contracts and any certi0 cations which may be required. All pertinent drawings and manufacturing procedures are included as part of the pur-chase orders. JLS&A purchase orders also require that all suppliers or subcontractors to n,otify JLS&A and obtain approval before any changes in design, materials and/or dimen-sions are undertaken. in cases where shipment is made directly to the customer, all instructions regarding shipment are included. -JLS&A' maintains a qualified vendor's list for which vendors are selected, based upon past performance, as evaluated by the Jt.S&A, in surveys and audits, performed by the appro-pnate departments. In cases of subcontracts for manufacturing, JLS&A performs vendor surveys and evalua-tion prior to the letting of subcontracts. Where the cubcontractor provides the materials, these vendors are required to establish quality assurance procedures and records for raw materials received with material certi6 cation, if require.1, including performance of fabricated parts purchased. MSSD sheets required, when applicable O k.

Page 16 ANNEX 1,1.1 and ANNEX 2,2.1 COMBINED

5. Purchasing continued in cases where materials of a radiological nature are subcontracted, JLS&A requires that these vendors submit information for permanent record relative to the quality of these products, i.e. leak test information on sealed sources, source certiGcation, etc.

The following terms and conditions related to quality control will apply to all purchase orders for any type of radioactive sources purchased by JLS&A:

1. A signed leak test certificate (one which accompanies the shipment and one by Grst class mail) which calls out the following:
a. Source descriptions

-b, Source Serial Number

c. Date of Leak Test
d. Results of Leak Test
2. Source certiGcation including chemical form of nuclide, assay date and "Special" or

" Normal" form certiGcation.

3. Shields: All shipping containers will have the following maximum levels of removable contam,inat,on:

i 2

1. Beta gamma 200dpm/100cm 2
2. Alpha 100dpm/100cm Attached to each packing list for incoming shipments, a signed report form (Shipping Document) is required, showing that the container has been checked both for contami-nation and for external radiation levels and giving actual values of these tests.

E_ All shipments will be made to JLS&A in accordance with applicable DOT, NRC AND IAEA regulations and all shipments will be properly labeled with the necessary data. Failure to comply with any of the above quality control requirements will result in rejection of the shipment,'if immediately apparent, its immediate return, if return meets applicable ship-n e 11ations, and immediate notification to the proper regulatory agencies, per

6. Manufacturing Control Materials Control - Quality Assurance, waking with inventory Control Personnel, will insure that all non radiological incoming materials are inspected and tagged as received and segregated on job shelves or placed into inventory locations, as applicable. Radiolog-ical insures that all radiological incoming shipments are insaected, tagged and segregated a,s applicable, per jlS&A's Radiological Safety Control kanual and State of California License.

Nonconforming Materials and Parts - A Material Review Iloard (MRII) is established to determine the continuing disposition of non-conforming parts. The MRB includes repre-sentatives from Engineenng, Quality Assurance, Inventory Control and/or Radiological, as required. Laboratory testing is to be employed as necessary and permanent records of such tests is maintained by Quality Assurance, and/or in job Gles or other files, as applicable. O

Pa ge 17 . Ah NEX 1,1.1 and ANNEX 2,2.1 COMBINED

6. Manufacturing Control, continued Processing Control - Engineering, Production Control / Operations and Radiological, as applicable will be responsible for establishing and maintaining detailed work instructions for processing operations.

Engineering and Radiological, working in conjunction with QA, are responsible for estab-lisliing in arocess inspection points. Such points are to be designated by Quality Assur-ance and ladiological. QA and Radiological are responsible for determining that these inspections are performed and that parts are properly identined and segregated. This also applies to subcontractors and vendors.

7. Inspection Status Quality Assurance or Radiological provides the mechanism for identifying the inspection status of parts and assemblies. This may include tags, stamps or routing cards as appro-priate.
8. Source Testing All sources are manufactured to jl.S&A specifications, as approved by licensing authori-ties, meet "S )ecial Form" prototype testing, per 10 CFR 173.496 Special Tests and ANSI Standard Tes:ing, Classification and Performance Standard E35434, per Publication N542.

"Special form" prototype testing,h a distance of 30' onto a flat essentially unyielding per 10 CFR 173.496 Special Tests:

1. Free drop - a free drop throug face, striking the surface in such a position as to suffer maximum damage
2. Percussion - Impact of the Hat circular end of a 1" diameter steel rod weighing three pounds, dropped through a distance of 40" onto capsule. The capsule is placed on a sheet of lead, of a hardness number 3.5 or 4.5 on the Vickers scale 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 15 minutes, then allowed to cool.
4. Immersion - Immersion for 24 hours in water at room temp /cm.

erature. The water shall be aHG pH8, with a maximum conductivity of 10 micro-ohms S. eak Test - Bubble test, capsule heated to 240 degrees F. in glycol, no bubbles should emerge. O

i Page 18 ' ANNEX 1,1.1 and ANNEX 2,2.1 COMBINED q V

8. Source Testing continued ANSI Standards Testing, Classification and Performance Standard E53434, per Publication N542, includes:
1. Temperature / Thermal Shock
2. External Pressure
3. impact
4. Vibration
5. Puncture
6. Leak Test Sources manufactured by others to JLS&A specifications are required to meet "Special form" requirements for Type A Quantities and ANSI Standard L53434, per Publication 3

N542, witb documentation. Source capsules produced by llS&A for encapsulation by ollmrs am m(piired to meet "Special.1 orm" prototype testing.uul ANSI Stand.ud i 35434, per l'ublicalHin N542, with documentation. Nondestructive testing of liners and capsules also includes:

1. Preweld test specimen - capsule sectioned and checked for weld penetration, minimum penetration 75% of wall thickness.
2. Dimensional Check.
3. Helium' Leak Test, prior to encapsulation.

Final inspection - Final inspection requirements are to be established by Engineering, - O Radiological and Quality Assurance. Quality Assurance is responsible for assuring inspec-K.) tions are made and records of same maintained. Quality Assurance is also responsible for obtaining Government approvals as required. 1

9. Measuring and Test Equipment QA and/or Radiological, where applicable,is responsible for maintaining calibration equipment in first class condition, and establishing and maintaining calibration require-ments and frequency. Records of all calibrations are maintained. QA and/or Radiolop,ical will monitor all vendors to assure that vendor's test equipment is properly maintained and calibrated.
10. Storage, Packaging, Delivery Engineering and Radiological, working in conjunction with QA, are responsible for estab-lishing requirements for storage, packaging and delivery, including any special require-ments for radioactive materia s. Attention is given to government regulations, such as the USNRC and DOT regulations, in addition to contractual specifications.

QA and/or Radiological, where applicable, is responsible for assuring that these require-ments are met and that records of such inspections are maintained. ,m

Page 19 ANNEX 1,1.1 and ANNEX 2,2.1 COMBINED l'T. i / ~"

10. Storage, Packaging, Delivery, continued A,n individual log sheet will be maintained for all Type B Certificate of Compliance shipf ra}g containers /overpacks routinely used by JLS&A in conjunction with transportation o Pl ioactive matenals
11. Audits On an annual basis, JLS,&A conducts internal audits, covering all aspects of the QA/QC formed on a quarterly bas,on important to safety activities, Radiological audits are Program, with emphasis is, due to JLS&Ns State of California license requirements, i

f I U i

1 k '). Page 20 4 ANNEX 1j 1.3 and ANNEX 2,2.3 COMDINED 1.3 & '2.3 DESIGN CONTROL i '1. Statement of Verification of Responsible Design Procedures. JLS&A has an established design procedure for its products. Because of the nature of our 1 business and products (products involving radioactivity and packages used to transport radioactive materials), products are approved by the proper licensing authority and all new products have approvals pending. Therefore,in the mitial design of a product, the first step is to provide licensing authorities with all pertinent drawings and information pertinent to approval criteria, i.e. prototype testing, design review and calculations. - After licensing authority approval and prior to release for fabrication, all drawings and specifications are to be reviewed for adequac enci product use. Approval by Engineenng,y in regard to standard design prac reNired prior to release. Changes are to be documented through the use of revised drawings incorporating Speci-fication Changes, if required. Changes require the approval of Engineenng ancT Quali-ty Assurance and Radiological, when applicable. Licensing, Engineering and ing licensing agency appr/or Radiological, wbon applicable, is responsible fo w imormation to that agency, as requirca, i.e. additional prototype testing, drawings,- L : ). design review and/or calculations. u Engineering is responsible for permanent vellum archives, as built or in process drawings, 4 issuing current drawings and specifications and removing obsolete drawings and specifi- . cations from all issue points ancI placing them into permanent archives.

2. Statement of Verification of Compliance with Regulatory Requirements in Drawings.

Engineering, QA,' Licensing, Sales and Radiological Departments, as applicable, review all product drawings, specifications for materiaFs, procedures and instructions and design parameters'with a final review by General Manager, Radiological and/or Senior Engineer on each job to verify that they meet all regulatory and licensing criteria, including codes, standards,' maintenance, repair, inspection, handling, storage and cleaning requirements, as applicable, as incorporated into the product approval.

3. Statement of Verification that Quality Standards are Maintained.

Engineering maintains a complete list of specifications for each non radiological product. Radiological maintains a complete list of specifications for radiological products. They issue a Bill of Materials to Purchasing with these specifications. Any change from thase specifications by the vendor or subcontractor is subject for review by Engineering, QA or J Radiological, as applicable, before purchase is made. Any change or deviation on a par-ticular product is noted on the specification documents of that particular roduct. All . purchases are individually checke on delivery to verify that they meet speciti[ ations \\

5 Pa e;e 21 ANNEX 1,1.3 and ANNEX 2,2.3 COMBINED

3. Statement of Verification that Quality Standards are Maintained, continued before they are accepted. Any material from vendor or subcontractor found not to be in conformance,is immediately returned and further purchase of that item from that source is immediately put on suspension, until review and audit, if required, and either rein-statement or termination is determined by QA, En ineering and or Radiological and forwarded to Purchasing. The Shop Foreman,is direct responsible or routing oT produc-tion to QA for inspection at verhus designated stages of completion. If, at any time, a critical to safety related item, which has been called out in product approval by a regula-tory or licensing agency,is no longer available, an amendment to the will be applied for and item will not be used until amendment has been, product approval issued.
4. Statement of Verification of Design Control.

Engineering, QA and Radiological De aartments, review each approved product design with all approved revisions before re ease for manufacture. Any deviation from this is sub ect to a review by A for initial approval or re ide tified and made avai able to QA before release.jection. Inspection and test criteria are

5. Statement of Verification of Adequacy of Design.

QA, Engineering and Radiolo ical Departments-insure the proper selection of compo-h nonts and design verification o each package, by means of prototypes, testing of which is provided for licensing applications and approvals. The arototypes are thorougl y tested and inspected in all stages to verify that they meet a i licensing authority en eria and design cifications. Allinspection and test criteria are documented and made available to tlie A Department and Radiological, which documents acceptance or rejection and all pertinent data thereof. Additionally, each package design is reviewed to assure that the design characteristics are such that components can be readily inspected and tested, and that maintenance, handling, storage and cleaning requirements, as required, are specified.

6. Statement of Verification of Design Department Controls.

The President / General Manager and Senior Engineer is responsible for the final design verification review, prototype tests review and calculations review after reviews by t le Engineering, QA and Radiological Departments. ' 7. Statement of Verification of Design Change Control. -JLS&A maintains design specification change controls on the same basis as the origi-nal designs, See 1, 2, 3,4,5 & 6 above. 9

4 l. . l. - Pa ge 22 AhNEX 1,1.3 and ANNEX 2,2.3 COMBINED '[

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

JLS&A maintains written procedures delineating the areas of responsibilities and authority of the Engineering and QA Departments, which are agreed upon and under-stood at the completion o1 the Training Program. Radiological personnel are trained 4 in accordance with licensing agency approval programs in addition to QA Program. i I i 1 E(, l

Pa ge 23 ANNEX 1,1.4 and ANNEX 2,2.4 COMBINED 1.4 & 2.4 PROCUREMENT DOCUMENT CONTROL

1. Statement of Verification of Purchasing Department Procedure.

The Purchasing Department maintains a definite sequence of action in any purchasing operation, including but not limited to reviews, concurrences and/or approvals when designated and defined by other app,ropriate departments. A list of procedures is posted in the Purchasing Office and is explained in the employee training program. As noted in of Materials, all specifications, gineering and Radiological provide to Purchasing, via 1.3 and ~2.3 Design Control, En drawings, etc., pertinent to the scope of work to be per-formed by the supplier.

2. Statement of Verification that Appropriate Reference of Specifications Appear on Purchase Orders.

Engineering and/or Radiological Departments, when applicable, provide appropriate reference to technical requirements, i.e, regulatory requirements, material and compo-nent identification requirements, drawings, specifications, codes and/or industrial stand-ards, test and inspection requirements and special process instructions, on the Bill of Materials which is submitted to Purchasing to be included on purchase orders when applicable. MSSD sheets also required when applicable.

3. Statement of Verification that Subpart il Criteria Appears on Purchase Orders.

Purchasing identifies 10CFR71 Subpart H or 10CFR21.31 criteria, when ap!. above, for plicable, as provided by the appropriate de )artments, via Bills of Materials, etc., per. package components or compleLe packages. The following item will be required, when applicable, certification of model and serial number, NRC approved QA/QC program manufacturing practice certiGcate, use and maintenance verification programs, and certif-icates compliance, use and maintenance manuals, drawings, photographs or sketches. Replacement parts for important to safety package components are subject to the same requirements as called out in this program.

4. Statement of Verification of Purchase Order Containing Right of A cess Clause.

JLS&A's purchase orders contain an agreement clause covering JLS&A's right of access to the supplier's facilities and records for a source inspection audit when app icable.

5. Statement of Verification that Appropriate Reference of Documentation Appears on Purchase Orders.

Engineering and/or Radiological Departments, when applicable, provide appropriate references and/or documentation, i.e., drawings, specifications, procedures, inspection and fabrication plans, inspection and test records, arocedures qualifications, chemical, MSSD sheets and test results of material, on the Bil of Materials vhich is submitted to

Pa ge 24 Ah NEX 1,1.4 and ANNEX'2,2.4 COMBINED O .5. Statement of Verification that Appropriate Reference of Documentation Appears. on Purchase Orders, continued. Purchasing to be included on purchase orders and provided to vendor.

6. Statement of Verification of Appropriate Documents Retained by Vendor and Delivered to Purchaser.

Engineering and/or Radiological Departments, when applicable, provide the appropriate references of records, certTication or test reports to be retained, controlled and main-i

tained by the supplier and those which are to accompany delivery to Jt.S&A, on the Bill of l

. Materials which is submitted to Purchasing to be included with the purchase order. . 7. Statement of Verification that Purchase Order Revision is Subject to Approval. l As stated in 1.3 and 2.3,l"Any change from these specifications by the vendor or subcontractor is subjected to review ~by the Engineenng, QA or Radiological Depart - monts, as applicable, before purchase is made. Any change or deviation on a particu- 'lar product is noted on the specification documents of that particular product. All aurchases are individually checked on delivery to verify that they do meet specifica-lions before they are accepted. Any material from vendor or subcontractor found not a Lg be in conformance,is immediately returned and further purchase of that item from i G

that source is immediately put on suspension, until review and audit, if ret uired, and

~ ither reinstatement or termination is determined, by QA, Engmeenng ancfor Radio-e 3 logical and forwarded to Purchasing. The Shop Foreman is directly responsible to the L - QA Officers for routing production to QA for inspection at various designated states of completion. d i j

Page 25 i Ah NEX 1,1.5 - 1.5 INSTRUCTIONS, PROCEDURES AND DRAWINGS, MANUFACTURING

1. Statement of Verification that Activities Affecting Quality are Accomplished in Accordance with Specifications.

-JLS&A has established with the implementation of the QA/QC program that activities affecting the quality of a product and activities important to safety are adhered to in all phases of manufacture and operation according to prescribed documented instructions, procedures, inspections and/or drawings.

2. Statement of Verification of Clear Sequence of Actions Concerning instructions, Procedures and Drawings, per 10CFR71, Subpart H Criteria.

' JLS&A has established with the implementation of the QA/QC Program, a clear sequence of procedure in the 3 reparation, review, a aproval and control of instructions, procedures and drawin 'Subpart H,gs, inclucing all those applicab e sections of the 18 point criteria of 10CFR71,

3. Statement of Verification that Activities important to Safety are Satisfactorily Accomplished.

Q~ -

JLS&A has established QA/QC procedures which direct that instructions,' arocedures drawings and acceptance criteria of important to safety activities include cimensions, tolerances, operating limits, and workmanship be called out and that the inspection and acceptance criteria verify that these have been satisfactorily accomplished.
4. Statement of Verification of Quality Assurance Department Responsibility.

QA and Radiolo ical Departments have the authority and responsibility, under the provi-sions of the Q /QC program, to review inspection plans, test calibration and special 4 process proce ures, drawings and specifications, and all changes and/or acceptable alternatives thereto; and that the these departments fulfill this responsibility. Prior to release for fabrication, the-QC/QC program provides for inspection check points and inspection instructions, with times determined at scheduled conferences or as needed.

t 1 e' ' Pa ge 26 - AN NEX 2. 2.S'- i '( - 2.S INSTRUCTIONS, PROCEDURES AND DRAWINGS, PACKAGES

1. Statement of Verification that Packages are Prepared for Use.

I JLS&A has established procedures, which meet requirements of 10CFR71, 71.87, for placing packaging used in the transport of radioactive materials into use. These proce-dures are incorporated'into the initial regulatory approval applications and are subject to -the same QA/QC implementation program, including permanent current and archival . files a,

2. Statement of Verification that Repair, Rework and Maintenance Procedures are Established.

JLS&A has established provisions to ensure that repair, rework and maintenance i procedures for packages is prescribed before that work begins. These provisions are subject to'the established procedures for individual jobs undertaken by JLS&A, which are covered under this QA/QC Program. "3. Statement of Verification of Loading / Unloading Procedures. DJLS&A has an established Safety Control Manual anhjLhram, found in the State of California a proved Radiologi f'l &A's Radioactive Materials License cri eria,' to ensure that \\> loading / unloading of radioactive materials packaging. meets all regulatory requirements, Ki including but not limited to radiation surveys, contamination wipe tests, measurements of temperature and pressure, adequate. package venting, rigging and movement.- L

4. Statement of Verification of Proper DOT Transport of Package..

L ?JLS&A has established measures, per item 3 above, which ensure that the packages are in g'ed in item.3 above), identified per all pertinent DOT regulations, and 4 '(includ ' identified (including model and serial number). I M J

Pate 27 ' ANNEX 1,1.6 and ANNEX 2,2.6 COMBINED 1 1.6 & 2.6 DOCUMENT CONTROL.

1. Statement of Verification of Controlled Documents, 4

jlS&A has established procedures so that all documents and revisions thereto under the control of the QA/QC Program are subject to review and concurrences by the appropri-ate de aartments. Documents which fall under these procedures include, but are not limitec to all design documents and specifications, procurement documents, QA/QC 1 Manuals, operating and maintenance manuals, change order reports, inspection and test procedures, nonconformance reports, design change requests, and corrective action reports. ,2. Statement of Verification that the issuance of Documents and Procedures thereof are Procedurally Controlled.- Engineering,: working with the QA, Radiological, licensing and Purchasing Departments, -have adequate procedural controls to check, review, approve and/or change documents . and/or procedures prior to release.

3. Statement of Verification that Changes to Documentation are Made by the Original

. Organization that Prepared initial Document. o, Engineering and/or Radiological Departments, when notified of the need for changes or R modification by itself or other departments, in cooperation with QA and/or Radiological, . when applicable, reviews and approves or rejects revisions to the orip,inal documents, as. needed. Whenever any change or modification in any department is initiated, the de-partment.which initiated the change or modification has the responsibility and authority to supervise further processing, in conjunction with QA, Radiological and/or Licensing as appropnate. 4? Statement of Verification that Revisions are Made on Appropriate Documents. 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, or non radiologicalitems. Radiologicalis responsible for making all necessary revisions on all related documents of a project for radiologicalitems. 4

O

' Page 28 ANNEX 1,1.6 and ANNEX 2,2.6 COMBINED 1 ..p:: O

5. Statement of Verification that all Pertinent Documents are Available at Site Where They are to be implemented.

' Engineering and/or Radiological Department, when applicable, is responsible for all perti-nent documents related to a job to be available at the site where they are to be im ale-mented, prior to starting work. The Engineering and/or Radiological Department, w1en applicable,is also responsible for providing Purchasing with all pertinent documents to work beg,ny the purchase order (if applicable) to the supplier or subcontractor be accompa ins on the project. - 6. Statement of Verification that Master Lists of Revisions are Current and Appear on Appropriate Documents. i LJLS&A's established procedures provide that the appropriate department has the 4 responsibility and authority to keep a-current listing of revisions on specified docu-L ments, so that. revisions are identifiable, that appropriate revisions appear on current h documents and that revisions are distributed appropnately. h 1 'i I i i:

Page 29 Ah NEX 1,1.7 and ANNEX 2,2.7 COMBINED ."i 1.7 & 2.7 CONTROL OF PURCHASED MATERIALS, PARTS, COMPONENTS, EOUIP- -MENT AND SERVICES

1. Statement of Verification of Procurement Document Planning, that Qualified Personnel Evaluate Suppliers for Acceptability.

(Procurement Document Planning) The Senior Engineer, Radiological Manager, and/or QA Manager, as applicable, are quali-fled and responsible procurement 31anning for vendor selection, qualifying vendors' QA/,QC Programs, and to establish t1at materials, parts, components, equipment and/or services to be provided meet specifications for the procurement item.

2. Statement of Verification of Evaluation of Suppliers (Selection of Procurement Sources).

The Senior Engineer, Radiological Manager, and/or QA Manager are responsible for sup-plier selection and use the following criteria for approving a vendor: - The supplier's capability to comply with the elements of 10CFR71, Subpart H or 10CFR21 and/or _NRC aparoved QA part,componen:,equipmen/QC Program, which are applicable to the type of material t or service being procured. T '. A review of previous records and performances of suppliers who have provided similar i ' articles of the type being procured. - A survey or audit of the supplier's facility and NRC ap 3 roved QA Program, when applica-

ble, to determine capabilit and quality.requiremen's.y,to supply a product whic1 meets the design, manufacturing Note: audit results and approvals by other cognizant entities, along with a copy of the QA Manual and/or NRC or DOE approval,is acceptable in lieu of a formal jl.S&A audit.

3'. Statement of Verification of Contract Evaluation and' Award Procedures. J(Bid Evaluation and Award) 'JLS&A has established procedur'es that ensures that the appropriate departments evalu-ate prosaective suppliers, for purchased material, equipment or services which are - procuroc on the basis of bid solicitations. Criteria to be considered will include, when applicable, supplier's capability to comply w's facility and QA Program, per item 3 a ith 10CFR71, Subpart H, conformance to-QA requirements and survey results of suppher O

Page 30. LAN NEX Ii 1.7 and ANNEX 2, 2.7 COMBINED. J jg i M - 4. Statement of Verification that inspection and/or Supervision of Supplier is Per 4 formed. (Supplier Performance Control) ' At the scheduled meetings between the QA Department and other appropriate 1 departmentsj it is determined if and when it is required that the QA Engmeer or appropriate representative be present at supplier's site during fabrication, testing and/or. shipment of a roduct, to assure accordance with purchase order s pecifica-tions. Inspection an r supervision rec uirements are transmitted to JLS&A ?urchas- -ing Department (via Bi of Material) for inclusion in Purchase Order.

5. Statement of Verification of Minimum Records Supplied to Purchaser.
(Verification Activities)-

JLS&A requires as a minimum from all vendors the following documentation: l Documentation that identifies the purchased material, part, com services and that speciGc procurement requirements (e.g., codes,ponent, equipmen standards and speciG-i cations) are met by the items. 1 Documentation that identifies any procurement requirements which have not been ? met together with a description of those nonconformances. -l 1. Note: Contingent on' acceptance by JLS&A, all nonconforming items must be repaired / or. replaced and'certiGcation thereof provided. xj QA/QC insbection reports and documentation from vendor's facility, when applicable, subject to t1e same requirements as called out for in house QA/QC inspection proce- . dures. 4 i ,6. Statement'of Verification of QA/QC Inspectors Acceptability Criteria and Responsibility. - (Controlling Nonconformances). 3 The QA or Radiological Department, when applicable, is responsible for and will not. - accept products that do not meet the following criteria: 1 .The material, component or equipment is properly identified and corresponds with the 'identiGcation on receiving documentation. . Records of certificates of conformance attesting to the acceptance of material and. ~ 4 components, prior to disbursement, when applicable. L Any nonconformin~g item, categorized by the supplier, along with technical justiGcation, conditional' acceptance, until review and disposition has been ascertained by the appro-priate departments, using established procedures, in appropriate circumstances. Note: Items accepted and released are identi0ed as to their inspection status prior to forwarding them to a controlled storage area or releasing them for further work. 1 _ i)

Pa<ge 31 AhNEX 1,1.7 and ANNEX 2,2.7 COMBINED O

7. Statement of Verification of Purchased Material, Parts, Components, Equipment or Services Records.

Permanent records are maintained in job files'or other files as appropriate, which identi- .fies the material, component, part, equipment or service, the specific requirements as called out on the purchase document, the certifications which accompany that item, identification of specifications which have not been and disposition of nonconformances. JLS&A maintains files on the results of supplier evaluations made by the appropriate departments, as well as current specifications on products supplied. k

(;, Pa ge 32 AS NEX 1,1.8 and ANNEX 2, 2.8 COMBINED N M 1.8 & 2.8 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND COMPO. NENTS

1. Statement of Verificaticn of Established Procedures Used for Identifying and Controlling Matenals.

The QA or Radiolog,ical Departments, when applicable, use a standard procedure for identifying all matenals, parts and/or components received or fabricated as part of the QA/QC Program. . Z. Statement of Verification that Products are identified Properly, TAs part of the standard receiving procedure of the QA or Radiological Departments, i; when applicable, all products are inspected, identified and marked. This identifica-tion and marking is directly. traceable to all pertinent records and this system pre-cludes the use'of incorrect or defective items. Fabricated parts or components are inspected, identified and marked at applicable stages (before placements into inven- ~ tory and again when taken from inventory or reFeased into the assembly process. .Non conforming or non inspected parts or components are identified and marked 1 and held in a special inventory location separate from inventory for disposition. i "3. Statement of Verification that Safety Related Materials are identified Properly. g As stated in Vill.2, all items purchased or fabricated are inspected, identified and marked c directly traceable to all pertinent records, i.e., drawings, specification, purchase orders, L - test reports, including and sinspected, either as received,pecifically the safety reFa placed into inventory, taken out _of inventory or released into the assembly process.- L ' 4. Statement of Verification that the Location and Method of Identifying Products is Not Harmful to Them. -JLS&A maintains separate receiving, bricated,1are identi6ed and marked before a where all products, purchased or fa

to proper inventory areas.: The receiving area and method of identi6 cation (one of several.

J methods appropriate to item) do-riot in any way interfere with the 6t, function or qu'ality of the product. 1

5. Statement of Verification that Product identification Numbers are Verified Before

- Release. - JLS&A, as part of theQA/QC Program, requires that any item from inventory be veri 6ed that it is the proper item for the job before release for fabrication, assembly or installation. O v

i Pa ge 33 ~ ANNEX 1,1.8 and ANNEX 2,2.8 COMBINED n. 4,}- J - 6. Statement of Verification that Conditional Releases are Controlled. In the instance of a nonconforming or not ins aected or tested item, a conditional release of a partial sub assembly or component will be released to facilitate continued process-ing, when required inspections or test have not been completed. Physical control and [ ldentity of such items will be maintained. l i i ' [% - EN' t p.. s

i. i

\\ o l '. 4

.s . k,E ^ ? Page 34 Ah NEX 1,1;9 and ANNEX 2,.2.9 COMBINED ' 1.9 &'2.9 CONTROL OF SPECIAL PROCESSES -

1. Statement of Verification that Special Processes are Procedurally Controlled.

.The Shop Foreman is directly responsible,in conjunction with periodic QA inspections, ~ .for the procedural control on each job which requires special processes, such as welding, heat treating, nondestructive testing and cleaning of items. The QA Department is . responsible for inspecting and controlling these processes at suppliers' installations, as Lapplicable.

2. Statement of Verification that Procedures, Equipment and Personnel Related to Special Processes Meet Applicable Specifications, Codes and Standards.

The Engineering Department and Shop Foreman, in cooperation with the QA Depart-ment, are responsible for maintaining appropriate procedures, equipment and personnel -connected with applicable codes, standards and specifications, such as SNT,- ASME, AWS or ANSI standards, as appropriate for special processes or non destructive testing. 4

3. Statement of Verification that Qualification Records Concerning Special Processes are Established and Current.

The Engineering Department maintains current qualification records of all areas associat-ed with special processes, in addition, copies of applicable records are maintained in each job file. Personnel records are maintained by the QA Department. O

- Pa ge 35 Ah NEX 1,1.10 and ANNEX 2,'2.10 COMBINED 11 1.10 & 2.10 INSPECTION CONTROL

1. Statement of Verification that inspection Program Verifies Conformity of Articles in

- Accordance with Established Procedures. - All inspections performed by JLS&A which check conformity with quality associated areas are performed in accordance with written and controlled procedures, instructions or checklists and are documented. The Shop Foreman is responsible for the supervision of work, including holding work progress until it has been inspected at the appropriate phases. The S1op Foreman holds work for inspection in accordance with predetermined inspection specifications and for informing the QA Department of the forthcoming inspec-tions at scheduled meetings and time ofinspection.

2. Statement of Verification that Receiving Inspections Verify Integrity of important to Safety _ Items.

All receiving inspections performed by jlS&A on important to safety items, as previously discussed in Sections 1.4 & 2.4,1-7 Procurement Document Control,1.5,2 Instructions, . Procedures and Drawings,2.5,1-4 Instructions, Procedures and Drawings, Packages,1.7 l l & 2.7,1-7 Control of Purchased Materials, Parts and Components and 1.8 & 18,1-5 . Control'of Materials, Parts and Components. JLS&A's State-of California Radioactive-Materials License and approved Radiological Control Manual, have established safe radio-g active materials receiving procedures, including but not limited to CRP visual inspection on arrival, wipe test and survey of outer ca. miner, survey and wipe test of inner contain-1 er, if applicable, appropriate log entries, E .scument evaluation.- 'In the cases of reusable shipping packages, m inspection is performed, identifying main-tenance items. If replacement parts are required, a separate job-for that program is insti-tuted, with all the desgn, purc 1asing, inspections and acceptance criteria of the QA/QC : _ program applicable, belore that package is released for shipment. Both radiological and important to safety items are placed in separate receiving areas before dispersal to inventory locations.

3. Statement of Verification that in Process inspections Are Established.

r When applicable, jlS&A has established procedures to ensure that process specifications, with documentation, provides for indirect control by monitoring processing methods, equipment and personnel, if direct supervision is impractical. g

~ ~ ~ y Pa ge 36 - ~ AN NEX 1,1.10 and ANNEX 2,2.10 COMBINED - ' 4. Statement of Verification that Final Inspections Verify item Integrity. t - E Finalinspections are a cumulative result of Sections 1.1 & 2.1,6 Purchasing and 11 i Storage, Packaging and Delivery, 1.4&2.4,17 Procurement Control,1.5, 2 Inspections, Procedures and Drawings,2.5,1-4 Instructions, Procedures and Drawings, Packages,1.7 &~2.7 Control of Purchased Materials, Parts and Components, and 1.8 & 2.8,1-5 Control of Materials, Parts and Components. Final ins acctions include complete operational check oute supervisory reassessment of all identiiable and traceable records, documents and inspec tions,hysical and environmental damage, prior to shipment. inclu protected from p ~ lnspectors perform allinspections, including those on any modifications, repairs or re-placements,in accordance with the original design specifications and procedures or acceptable alternatives; and all inspections are documented. JLS&A's State of California Radio' ctive Materials License and approved Radiological Con-a trol Manual, have established safe radioactive materials storage and shipping including but not limited to CRP visual inspection, wipe test and survey of procedures, source and -container, survey and wipe test of outer contain.c, if applicable, appropriate log entries, and document evaluation.- Shipments include compliance will all applicable DOT or IAEA regulations,and shipping checklists which verify that the package is properly maintained, assembled .Establishecl conspicuously and durably marked, in accordance with DOT regulations. procedures ensure that only CRP's prepare radiological certifications and 7 shipping documentation, with reviews by supervisory personnel.

5. Statement of Verification that inspection Personnel are independent from Individ-uals Performing Activity Being inspected.

Inspection personnel at JLS&A are usually independent from the personnel performing the activity being inspected 'if not, supervisory personnel aerform verification. Qualifica- . tions and independence or; verifications are determined by the QA or Radiological De-partments, as applicable.

6. Statement of Verification that inspectors are Qualified and Qualifications are Recorded..

The QA Department is responsible for maintaining qualified inspectors (in accordance

with applicable codes, standards and training programs) and the certifications and qualiG-cations thereof are on file and kept current.

4 O x ---..--._I.

Pa ge 37 AkNEX 1,1.11 n. 4L') ?.11 TEST CONTROL

1. Statement of Verification that Test Programs are Established, Documss. led and Performed Accordingly.

All products are subject licensing authority approval which requires prototype testing, desi tion,gn review and calculation review. JLS&A test programs, including prototype, produc-proof and/or oaerational tests, which determine if an item will perform satisfactorily are performed by J. S&A's Engineering, QA and/or Radiological, when applicable, in accordance with established documented speci0 cations and are fully documented. Engineering,difications, repairs or replacements to the original design in ac tests all mo original specifications or acceptable alternatives.

2. Statement of Verification that Test Procedures are Established.

All test programs have established procedures, which identify the appropriate test crite- ' ria, including instrument calibration and condition, monitoring. hold points, environmen-1 tal conditions, methods of physical identification, records, documentation and acceptance

entena, n

i U

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

ed by Appropriate Departments. All test program results are fully documented. They/or Radiological Depa are then evaluated and determined acceptable by the appropriate Engineering, QA and when applicable, officers of jt.S&A. ' 'h

Pa!;e 38 'Ah NEX 2, 2.11 o. 2.11 TFST CONTROL PACKAGES

1. Statement of Verification that Packages Meet Acceptance Criteria Prior to Shipment.

JLS&A has an established shipment preparation program, with a clear sequence of action, in which QA, Radiological Engineenng, Licensin q, Production / Operations and Shipping Departments, when appficable, are responsibfe for package acceptance criteria and documentation, prior to shipment. Acceptance criteria is based upon applicable docu-mentation (certificate of com aliance and certification thereof, and operating and mainte-nance manuals) and physica inspections (structuralintegrity,leaktightness on contain-ment vessels, as well as auxiliary equipment and shield tanks, component performance of valves, gasket and fluid transport devices, shield integrity and thermal integrity).

2. Statement of Verification that Maintenance Test Programs are Established.

JLS&A has an established maintenance test programs in accordance with JLS&A's State of California Radioactive Materials License and a aproved Radiological Control Manual, which ensure that packages remain usable and 'ree of excessive radiation and contamination, through a controlled series of documented wipe tests. 7 !] C r r a ?

u u u u u l Pa e_ 39 Ak;NEX 1,1.12 and ANNEX 2,2.12 COMBINED 1.12 & 2.12 CONTROL OF MEASURE AND TEST EOUIPMENT

1. Statement of Verification that Measuring and Test Equipment are Properly Calibrated.

JLS&A maintains properly calibrated measuring and test equipment, based upon required accuracy, purpose, degree of usage, stability characteristics or other conditions affecting the measurement of the salient characteristics of a aarticular item. Survey instruments which measure radioactivity are calibrated at three L3) month intervals; all other instru-ments are calibrated yearly. Additional survey instrument calibration checks are called out in JLS&A's Radiological Safety Control Manual.

2. Statement of Verification that Measuring and Test Equipment are identified and Traceable to Calibration Test Data.

jlS&A requires and maintains serial numbers on all measuring and test equi) ment and requires all calibration test data to reference the instrument's serial num aer(s). All measuring and test equipment is labeled or tagged to indicate date of next calibra-tion.

3. Statement of Verification that Calibration Meets Appropriate Standards.

jlS&A maintains National Institute of Standards and Technology (NIST, formerly NBS) radiation source standards in house. Additionally, radiation measurement equi) ment is either re calibrated yearly to NIST traceable calibration or cross calibrated, wit i known valid relationships to NIST traceability, Radiation survey instruments are calibrated quar-terly to known valid relationships to NIST traceability. Non radiological measurement and test equipment is calibrated yearly to NIST or other nationally recognized standards. Other inspection instruments either meet nationally recognized standards or manufac-turer's specifications which are documented and are on fiTe at JLS&A. In the event that no known reco;nized standard is used for calibration, the parameters of that calibration procedure will ae documented. Records on all instruments which measure radioactivity are kept in current files or permanent archives and these standards are referenced on all appropriate documentation.

4. Statement of Verification that Measurements are Taken, Documented, and validat.

ed against Previous Measurements if Instrument is Found to be out of Calibration. Jt.S&A performs new test or measurements (which are documented) to validate arevious inspections in the event that an instrument is found to be out of calibration anc noti 6es appropriate parties, if applicable. Any measuring equipment which is consistently out of cahbration will be removed from service and repaireci or replaced. O u 1

i Pa ge 40 AN NEX 1,1.13 and ANNEX 2,2.13 COMBINED 3(d 1.13 & 2.13 HANDLING. STORAGE AND SHIPPING

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

In accordance with predetermined established procedural woik and inspection instruc. tions, qualificci employees of JLS&A perform work related to special handling, preserva-tion, storage, cleaning, environmental damage. packaging and shipping requirements, to preclude physica

2. Statement of Verification that Conditions of the NRC and US DOT Shipping Requirements are Satisfied Before Shipment.

JLS&A aerforms a final inspection before shipment on all items pertinent to NRC and DOT s lipping requirements for that shipment. Items must pass all criteria, cumula-tive results oFprevious section contained therein, which is documented, before shipment is made.

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

7(d JLS&A prepares and keeps on file all necessary shipping capers as required. Shippil.g papers on shipments containing radioactivity include the following documentation: Date of Shipment Customer License of Customer Source Information, Source Serial Number Shi) ping Container Type and Device and Serial Numbers . Rac iation Level at Surface of Shipping Container Radiation Level at three feet (3') from Surface of Device Surface Contamination t Instrument - Leak Test ~ DOT Class Label Transport Index Truck Placard Requirements Shipping Weight Freight Classincation ' Signature by radiologically cognizant personnel Also included with shipments are External RadiaSon Level Certificate, Leak Test Certifi-cate, Calibration Certificate, Attenuator Certificate and Operating and Maintenance i Manual, as appli aole. l .O L 1

Pa ge 41 AN'NEX 1,1.13 and ANNEX 2,2.13 COMBINED G

4. Statement of Verification that Shipment Time is Consistent with Safe Transportation Time.

JLS&A routinely uses motor freight for most shipments. Weight, end use, transport and/or diamond label, inhibits fast delivery by air or express company and the nature of our products does not demand it. Departure occurs after a package has passed final inspection to meet NRC and DOT criteria and the customer has necessary licensing (if applicable) and is ready to accept delivery. Shipments are monitored covering the motor freight delivery schedule and customer notification af arrival and installation scheduling, if applicable.

5. Statement of Verification that 10CFR21.6 Posting Requirements Have Been Established.

" Notification to Comply"or Existence of A Defect - Explanation of Noti 6 cation Procedures and Proper Authorities, along with Section 206 of the Energy Reduction Act of 1974, 1 Section 206, Noncompliance is posted in the prescribed manner according to 10Cf R21.6. O 1 k I l ,e

4 Pa ge 42 ANNEX 1,1.14 ad ANNEX 2,2.14 COMBINED g 1.14 & 2.14 INSPECh7N. TEST AND OPERATING STATUS

1. Statement of Verificatioa that Status of Packages is Acknowledged by Affected Organizations.

The QA and Radiological De,partments, in conjunction with other appropriate depart-ments such as Shipping, Engineering, Production / Operations, Licensmg, or Administra-tive,is responsible for the appropriate documentation and identification of inspections, tests and operating status o~ packa fected departments or organizations,ges, and that it is acknowledged and received b such as shipping agents and/or customer.

2. Statement of Verification that Removal of Inspection and Status Indicators are Procedurally Controlled.

JLS&A requires that all inspection and welding stamps and/or other status from an item for fabrication, be checked with the Shop foreman at the time of removal (for veri 6 cation purposes) for records of "in arocess" work, for inspection controlled items, any stamas or status indicators that app y to any item are removed and documented accordingly by the appropriate QA or Radiological inspector.

3. Statement of Verification that By passing of Inspection Tests or Other critical fT Operations is Controlled.

v The by passing of ins acctions, tests or other critical operations are procedurally con. I trolled by documenta1 ion, work structure, procedure and daily communication. These procedures re discussed during the scheduled meetings of the QA Department and all appropriate departments, as required.

4. State of Verification that Nonconforming items are Identified.

The QA Department is responsible for identifying and inspecting incoming materials. Nonconforming items are identified and return to vendor. On cases where return is delayed, items are identiGed and placed in a separate, special inventory location. If items are found to be defective or otherwise nonconforming during procedural inspections, these items are identined and either returned to vendor or placed in a special inventory in a separate location for rework and retesting. ' These clude the inadvertent use of nonconforming materials. procedures are established to O

Pate 43 ANNEX 1,1.15 and ANNEX 2,2.15 COMBINED 1.15 & 2.15 NONCONFORMING MATERIALS

1. Statement of Verification that Nonconforming items are Procedurally Controlled.

- JLS&A has established material rejection procedures for receiving and subsequent inspec-tions to assure that the identification, documentation, segregation, review disposition of non-conforming items is implemented. Affected deaartments are notified so that re-placement or repair procedures can be carried out. W1en a nonconforming item is found during nspection or testing, the QA or Radiological inspector, when applicable, is re-quired o document the reasons for nonconformance, identify the item, place item into s,pecial inventory, sign the report and notify the appropriate departments for item disposi-tion.

2. Statement of Verification that Nonconforming items are Segregated from Acceptable items.

jlS&A maintains a separate special inventory location for nonconforming items, which are identified as such, until appropriate actions are taken.

3. Statement of Verification that Repaired or Reworked items are Subjected to Original Testing.

O-QA or Radiological inspectors, when applicable, subject all r laced, reworked or repaired items to the same documentation, originalinspection proce urcs and testing procedures, or to acceptable alternate testing procedures.

4. Statement of Verification that Nonconformance Reports are Evaluated.

QA and Radiological Departments, when applicable, perform analysis of material rejection reports to determine quality trends and areas of problems for management review and assessment.

5. Statement of Verification that 10CFR21.6 Posting Requirements Have Been Established.

" Notification to Comply"or Existence of a Defect Exalanation of Notification Procedures and Proper Authorities,d in the prescribed manner according to 10CFR21.6.along w Noncompliance, is poste O

Page 44 ANNEX 1,1.16 and ANNEX 2,2.16 COMBINED (S 4 3 1.16 & 2.16 CORRECTION ACTION

1. Statement of Verification that Corrective Actions are Reported.

Jl.S&A does not unconditionally accept or use nonconforming materials for use in a product, as established by proceduralinspections at various pFmses of operation. See Sections 1.4 & 2.4,7 Procurement Document Control,1.5,4 Instructions, Procedures and Drawings,1.7 & 2.7,6 Control of Purchased Materials, etc., 1.8 & 2.8, 2,3,6 Identifi-cation and Control of Materials, etc., and 1.15 & 2.15,1 4 Nonconforming Materials in the event that an inspection determines there is such nonconformity, such as failure, malfunction, deficiency, or defectiveness, the QA De aartment documents and reports nonconformances to the appro riate departments. Ingineering, QA and Radiological Departments, when applicable, ointly evaluate the problem and establish the need for I corrective action in areas of ven r evaluation, engineering, purchasing, manufacturing or with establishe/or test procedures, etc. Corrective action procedures are in accordance inspection and d procedures. The item in question is also dispositioned in accordance with established procedures.

2. Statement of Verification that Corrective Action Proceedings are Completed.

in the event of a corrective action, the cognizant personnel of the Engineering, QA and Radiolop,ical Departments, when ap,plicable, evaluate all aspects of the discrepancy and n(/ determine the kind of correction action to be taken to avert reoccurrence. This process is . documented accordingly before the corrective action is taken and reinspected according to prescribed procedures. when applicable, conduct ins 3ections Engineering, QA and Radiological Departments, determine if they are acce ata ale and and follow up reviews of corrective actions to approariate within the procedures of the established program and either c ose out ie-quirec documentation or implement these actions as part of standard operations, which-ever is needed. l l

Page 46 Ah NEX 1,1.17 and ANNEX 2,2.17 COMBINED O

3. Statement of Verification that Required Records are Indexed and Classified, continued.

Nonpermanent records, which show evidence that an activity has been performed but do not meet criteria for lifetime status, are maintained on a 5 year basis.

4. Statement of Verification that Quality Assurance Documents are identifiable and Retrievable.

JLS&A has an established record receipt system which includes personnel routing of such records and the numerical and alphabetical systems which cross-reference all QA documentation as well as all associated documentation throughout all filing systems in all departments. Implementation of this system assures that all records are controlled, identifiable and retnevable.

5. Statement of Verification that Records are Subject to Storage, Preservation and Safekeeping, jlS&A uses record storage facilities which minimize risk of elemental, zoological or botan-ical damage. All current, permanent or temporary records are securely fastened within folders or binders and are placed in steel file cabinets. Measures are established for replacement,if possible, for lost or damaged records jlS&A has an on going program to duplicate records for storage at another location (s) and to place critical records (as de-Q fined b JLS&A) into fire proof file cabinets. Measures have been established to restrict entry o unauthorized personnelinto storage areas.

O

Pa ge 48 AN'NEX 1,1.18 and ANNEX 2,2.18 COMBINED ,,U

5. Statement of Verification of Post Audit Conferences.

Post audit conferences are held between management and audit team (s) to present and review audit results, implementation of changes and/or to clarify misunderstandings,if any.

6. Statement of Verification of Audit Reporting and Response.

Audit and/or corrective action reports are subject to time constraints, as determined at audit scheduling, or interim meetings. In the event that a corrective action cannot be im alemented immediately, a schedule for implementation and completion dates will be determined by management.

7. State:iisii; c.iVerification of Audit Followup Action.

Audit team leader (s) and management are responsible for verification of timely response and adequacy of audit reports, and that corrective actions have been accomplished. -eu m. -m. -}}

Retrieved from "https://kanterella.com/w/index.php?title=ML20058D621&oldid=4475132"