ML19351G505

QA Plan, Packaging & Transport of Licensed Radioactive Matls, Revision 1

ML19351G505
Person / Time
Site:	07100138
Issue date:	12/29/1980
From:	Imodia W, Nolan Battelle Memorial Institute, COLUMBUS LABORATORIES
To:
Shared Package
ML19351G503	List: ML19351G502 ML19351G505
References
BCL-NSP-2, BCL-NSP-2-R1, NUDOCS 8102240063
Download: ML19351G505 (48)

Text

'

BCL-NSP-2 O

QUALITY ASSURANCE PLMi PACKAGING AND TRANSPORT OF LICENSED RADI0 ACTIVE MATERIALS BATTELLE COLUMBUS LABORATORIES 505 KING AVENLT COLLMUS, OHIO 43201 w

4 8.', q e e Ako s

,)

81022400 0

BCL-NSP-2 PACKAGING AND TRANSPORT OF LICENSED RADIOACTIVE MATERIA'.

REVISION CONTROL SHEET Revision-Date Sect ion 1

2 l

3 l

4 Organization..............................

12-19-80 M.

Quality Assurance Program.................

12-19-80 Dasign Control............................

12-19-80

. Procurement Document Control..............

12-19-80 Instructions Procedures, and Drawings....

12-19-80

'. Document Control..........................

12-19-80 Control of Purchased Materials, Parts and Components............................

12-19-80 Identification and Control of Material, Parts and Components......................

12-19-80 Control of Special Processes..............

12-19-80 0.

Inspection................................

12-19-80 Te s t Co nt ro l..............................

12-19-80 2.

Control of Measuring and Test Equipment...

12-19-80 Handling, Storage and Shipping............

12-19-80 4.

Inspection Test and Operating Status.....

12-19-80 Nonconforming Material, Parts or Co mp o n e nt s................................

12-19-80

". Co r re c t ive Action.........................

12-19-80 Quality Assurance Records.................

12-19-80 r.

Audits....................................

12-14-80 Appendix A. Personnel. Assignments.........

12-19-80 Prepared by 7~

4

/ '2 - N - To

)

Q.A-Manager Date l

Approved by MM 12 [ '1 a l 9o Section Manager Nuclear Services Date g

Approved by M

l'E 'M Department Manager, Nuclear Technology

'Date and Physical Sciences l

t I

{

~

l l

l

PACKAGING AND TRANSPORT OF LICENSED RADIOACTIVE MATERIALS TABLE OF CONTENTS Page No.

0.1 Introduction.

1 0.2 Purpose.

1 0.3 Scope.

1 0.4 Authority.

1 0.5 Battelle Policy and Commitment 2

1.

Organization.

2 2.

Quality Assurance Program.

10 3.

Design Control........................

21 4.

Procurement Document Control...........

22 5.

Instructions, Procedures, and Drawings.

25 6.

Document Control.

26 7.

Control of Purchased Materials, Parts, and Components.

27 8.

Identification and Control of Material, Parts, and Components.

29 9.

Control of Special Processes.

30 i

10.

Inspection.

31 f

11.

Test Control...................

33 12.

Control of Measuring and Test Equipment..

34 l! _.

13.

Handling, Storage, and Shipping....

36 14 Inspection, Test, and Operating Status.

37 l

15.

Nonconforming Material, Parts, or Components.

38 e

39 16.

Corrective Action.

-17.

Quality Assurance Records.

40 1

(

18.

Audits.

41 i

r l

i l

I L

~

BCL-NSP-2 Revision 1 Page 1 of 42 PACKAGING AND TLCSPORT OF LICENSED RADIOACTIVE MATERIALS l

s 0.1 _ Int roduction This document is the Battelle-Columbus Division's Quality Assurance Plan that has been prepared to be responsive to the requirements of 10 CFR Part 71 Appendix E, Quality Assurance Criteria for Shipping Packages for Radioactive Material.

The Plan is designed to be responsive to the 18 criteria of quality assurance (see Sections 1.0 to 18.0) as applied to the packaging and transport of radioactive materials.

Each section describes the action or activities to be performed by Battelle-Columbus in assuring the quality of its buried radio-active wastes.

0.2 Purpose The purpose of this Plan is to describe the quality assurance program for packaging, transport, and shipping containers utilized by Battelle's Columbus Division for the transport of licensed radioactive materials.

0.3 Scope The scope of this plan includes design, fabrication, assembly, testing, use, maintenance, repair, and' modification of shipping containers utilized in the transportation of licensed nuclear fuel (irradiated and unirradiated) and licensed radioactive materials.

In cases where changes are being made to an existing licensed container, this. plan shall be limited to the design, procure-ment, fabrication, and assembly activities associated with the change being made and not the entire previously existing container design.

0.4 Aut hority Title 10 CFR Part 71, Appendix E.

a -..,

BCL-NSP-2 Revision 1 Page 2 of 4 2 0.5 Battelle Policy and Commitment It is the policy of BCD that the assurance of quality is an inter-disciplinary function involving all of our organizational components and is not the sole domain of our Quality Assurance personnel. Ultimately, the achievement of our quality objective is attained by each individual performing assigned work in strict compliance with approved applicable requirements and procedures.

This Plan for the packaging and transportation of licensed radioactive materials has the absolute and unqualified support of the Director of 3CD.

Battelle has a deep sense of responsibility for public safety and is committed to protecting the public, and personnel associated with the packaging and transport of radioactive materials by assuring quality in the plans and operations. The objective of this plan is to provide a quality program through controls and documentation which will assure compliance to the requirements and regulations controlling the packaging and transport of radioactive materials.

1.

Organization The Battelle-Columbus Division (BCD) organization provides for a quality assurance program in the Nuclear Technology and Services sections, as shown in Figure 1 for all BCD packaging and shipment of licensed radioactive materials. The operational responsibility and authority for this program rests with the BCD Section Manager responsible for nuclear materials management.

The Q.A. Manager administers the Q.A. program and reports to that Section Manager.

In this capacity the Q.A. Manager has the responsibility for:

(a) Conformance to The Q.A. Plan For The Transportation of Licensed

~

Radioactive Materials.

(b) Prompt notification to line management of all packaging or transportation irregularities.

(c) Conduct of Q.A. activities in a fiscally -sound and technically feasible manner.

(d) Administration of the Q.A. staff, budgets, and development activities.

l

BCL-NSP-2 Revision 1 Page 3 of 42 Figure 2 identifies the organizational units that function within the Battelle-Columbus Q. A. program. Table 1 briefly describes the responsibilities assigned to each of these units. Figure 3 shows the sixteen major quality elements within Battelle's Q.A. program and the management and operational responsibilities for each.

These three figures and one table clearly outline the authority and the duties of those responsible for the Q.A. program at Battelle-Columbus. This organization ensures the implementation of appropriate elements of Appendix E to 10 CFR Part 71 through the organizational units. This organization and the assignment of duties within it shall be implemented to provide the Q. A. Manager the necessary freedom to identify quality problems; to initiate, recommend, or provide solutions; and to verify implementation of solutions. All persons 1

administering the program shall fulfill qualification requirements spelled out j

by Battelle-Columbus job descriptions and by the Section Manager. These quali-fication requirements are in line with the competence needed to carry out the responsibilities of the various positions.

The Quality Assurance Manager holds the only principal QA/QC management position and should possess the following qualifications:

(a) Possess detailed knowledge of 'the quality requirements of 10 CFR 71 and the Q.A. criteria established in Part 71, Appendix E,10 CFR 50, Appendix B, ANSI Standards N 45.2-46.2 and 'RITF Standard F 2-2.

~

(b) Possess detailed knowledge of the BCD nuclear waste managemen't practices.

(c) Certification as a Lead Nuclear 0A Auditor in accordance with ANSI N 45.2.23.

(d) Capable of line management responsibility for the 0.A. staff, budgets, and development.

The inspection function shall operate independently of those actively performing the work. This is presented in Figure 2.

As shown there, the Q.A.

Manager and the Program Manager report to the same organizational level. This frees the Q. A. Manager from any direct responsibilities for schedules and costs

= - -.

BCL-NSP-2 Revision 1 Page 4 of 42 1

i i

for the purpose of directing the Q. A. program in a manner that ensures conformance to quality requirements.

i l

Responsibility for Battelle Q. A. policies, goals, and objectives rests with the Department Manager. The Department Manager is also responsible i

for regular 11v assessing the scope, status, implementation, and effectiveness of l

the Q. A. program to assure that the program is adequate and complies with 10 CFR 71 Appendix E criteria.

.i Quality assurance personnel shall have the authority to stop unsatis-factory work and control further processing or delivery of nonconforming material.

Battelle shall maintain responsibility for quality when outside con-tractors are involved by clearly defining specifications, Q.A. responsibilities, and inspection privilieges in the contracts and work statements. Lines of co=munication shall be established contractually to assure proper direction of the program and quick resolution of problems. The Progran Manager shall con-duct or be responsible for establishing liasion with all contractors to determine that functions delegated to contractors are being properly accomplished. The quality assurance organization shall monitor or audit the contractors as judged

~

necessary by the Program and Q.A. Managers.

i i

I l

l l

l l

BCL-NSP-2 Revison 1 Page 5 of 42 Director's Office Research Department Research Section J

a Quality Assurance Program Manager I

Retired Reactor Hot Plutonium Nuclear Materials ng Avenue i

JN-3 Laboratory Laboratory Management l

l l

l FIGURE 1.

BATTELLE-COLUMBUS DIVISION ORGANIZATION FOR l

PACKAGING AND SHIPPING OF RADI0 ACTIVE MATERIALS I

l l

l l

l

DCL-NSP-2 Revision 1 BCD Page 6 of 42 Director's Office Research Department Radiological l

Design Review Research Section.

Board Safety i

Program Manager QA Manager Technical QA Audit 1

Program Manager QA Surveillance Operations Training and Certification Container Inspection Transportation and Packaging QA Training and Material Handling and Accountability Central Files Coordination Shipping Laboratory Operations FIGURE 2.

ORGANIZATION CHART SHOWING Q.A. AND OPERATIONAL ACTIVITIES FOR PACKAGING AND TRANSPORTATION OF Container RADIOACTIVE MATERIALS Adminstration Container Design Fabrication and Repair

[

FICIIHE 3.

QUAI.ITY h!ATitlX hl ATEll!AI. PACNAGING, Sil!PPING & TR ANSPORTATION ACTIVITIES--OUTGOING O-1 0-2 0-3 O-4

' O-5 0-8 O-7 O-8 O-9 O-10 0-Il O-12 QUAI.lTY El.EAIENTS Containe r Container Container Procurement S!iipping Pack.ging On-Sate Storage lend &

Transfer Transport N..t s fy Design and Qu.lification Application Arrangements Transfer Tr.nsfer Accountaility Itr f Development Shapment Heceipt IMM ll\\ LENT HEVIEW a AP;*ltOVAI.

X X

X X

X X

X X

X X

' IX R'llMONT ItEl.E ASE

& CilANGE CONTitOI.

X X

X X

X X

X X

X X

\\ll: ASifillNG & TEST EQUIP, cal.!!titATION & CONTRO!.

X X

TESTING & EVAI.U ATION X

X INSPECTION X

X X

X DATA loCldlENTATION

a. CONTitol.

X X

X X

X X

X X

X X

CEltTIFICATION X

X X

X ltECONDS COI.B.ECflON.

STOR AGE & KIAINTENANCE X

X X

X X

X X

X

,X X

X

\\l ATEltl Al. IDENTIFICATION

& CONTHOt.

X X

X X

X X

X X

X X

OPEltATION AI CONT!tOL X

X X

X X

X X

X A

X X

PE f tSONNEl. TH A!NING

& Ql. AI.lFICATION X

X X

X X

X X

X

\\10Ni t'Olt!NG. It ADIATION X

X X

OA\\lil A & NEUTHON SCAN X

PHolti. Ell, Pall.llitE &

NONCONFOH \\l ANCE HEPOHTING ANI) AN AI. DIS X

X.

-X-X X

X X

X X

X X

X' CottHl:CTIVE ACTION CONTHOI. X X

X X

X X

X X

X X

X X

Al'DIT Pl.ANNING.

Pt:HColt\\ LANCE & REPOltTING X

X X

X X

X X

X X

X X

X mmw ra fD C3 UO <$ &

GH I G3 lic M W V)

O m OD I m

84 W

~

i BCL-NSP-2 Revision 1 Page 8 of 42 TABLE 1.

ORGANIZATIONAL UNIT RESPONSIBILITIES Unit Responsibilities Director's Of fice Establishes the laboratory policy and has the ultimate responsibility for the operations of the Laboratory.

Department Manager Responsible for conducting an annual independent audit of the licensed radioactive materials packaging and transportation QA system to evaluate the system and assure its adequacy to comply with 10 CFR 71, Appendix E.

Section Manager Acts as the Program Manager or appoints a Program Manager responsible to him/her.

Radiological Safety Health Physics activities, radiation monitoring, safety review of hazards.

Design Review Board Conduct reviews of plans and procedures for fabrication, examination or testing of trans-portation components.

4 Program Manager Administrative management of transportation operations.

Technical Program Manager Technical management of transportation operations.

..QA Manager Assure that need for, and extent of quality assurance program planning is established.

Training and Certification Provide for the technical training of _all personnel ~

(Operational) operating within QA-controlled activities.

Assure that personnel 'are qualified and initiate certifications.

Transportation and Packaging Responsible to the Technical Program Manager for establishing packaging and transportation in compliance with regulations and compliance with license conditions.,

-.. Material Handling and Accountability Responsible for regulatory control of all material designated for shipment or receipt.

Shipping Prepare all paperwork and documentation required by incoming or outgoing shipments.

Laboratory Operations Carry out physical operations required to identify, prepare, package, and handle incoming or outgoing materials.

. _ ~.

BCL-NSP-2 Revision 1 Page 9 of 42 TABLE 1.

(Continued)

Unit Responsibilities Container Administration Administer, manage, record, and control all operations relating to ownership, lease and use of shipping containers. Approve packing procedures.

Verify container condition as suitable for use.

Container Design, Fabrication and Initiate design and fabrication and implement Repair repaira or modifications to transportation containers.

QA Auditor Conduct periodic audits of the QA plan and operations as directed by the QA Manager.

QA Surveillance Perform surveillance on the package loading and critical operations associated with the packaging and transportation of licensed radioactive materials to assure accepted QA procedures are being followed.

Container Inspection Inspects containers prior to loading and prior to shipment. To assure they meet the required specifications for the shipment.

Training and Certification Provide for the training of all personnel con-(Quality Assurance) ducting QA operations and QA-controlled operations.

Assure that personnel certification is recorded and updated as required.

Central Files Coordinator Maintain a data files of all licensed radio-active materials packaging and shipments to document compliance to requirements.

y

BCL-NSP-2 Revision 1 Page 10 of 42 2.

Quality Assurance Program This plan describes the quality assurance program to be followed at

~

Battelle-Columbus Division for all safety-reiated structures, sy' stems and com-ponents associated with the packaging and transport of licensed radioactive materials. This shall include but not be limited to the primary and secondary containments of packages (i.e. design, f abrication and/or inspection of casks, canisters, drums, boxes, etc.), the identification and characterization of package contents, all data generating instruments and the qualification of personnel performing duties related to safety and compliance with transport regulations.

The plan is responsive to Title 10 CFR 71.51 and Battelle-Columbus Laboratories' Nuclear Technology Quality Assurance Manual. The manual provides the policy, authority, and guidelines for the operation of the nuclear quality assurance system at BCD.

Revision or amendments to the Q.A. Manual, this plan, or any implementation document shall require the same approval as the originating document.

Figure 4 contains the Q. A. Manual and implementing document references to the 18 criteria of 10 CFR 71, Appendix E.

The training of quality assurance personnel shall be conducted by the Quality Assurance Manager by classroom lecture, video and/or audio tapes, and on-the-job instruction to train and familiarize the Q. A. staff with the requirements of 10 CFR 71.51, this plan and the implementing procedures. The Q.A. personnel shall be certified for conducting their specific duties. The Personnel Certification Form is shown in Figure 5.

Operational personnel shall receive training in quality assurance related activities in an indoctrination class conducted by the Q.A. Manager for familiarization with the quality assurance system. This training will be continued on-the-job under the guidance of the Q.A. surveillance personnel.

The operational personnel will receive training by their supervisor on operational activities and' responsibilities and be certified as qualified to conduct their respective assignments as indicated on Forn HL-MQ-7.1 (Figure 5).

The packaging, shipping, and transportation requirements of_the Code of Federal Regulations being implemented through this Q.A. program are

..y..

BCL-NSP-2 Revision 1 Page 11 of 42 listed in Table 2 in relation to their respective activities. All BCL Department Managers and individuals responsible for licensed radioactive materials shall be notified in writing by The Nuclear Services Section Manager or Q. A. Manager of the BCL quality policy, Q.A. Manual and procedures, and mandatory requirements for implementation of the quality program.

The Q.A. Manager, in conjunction with the Program Manager shall be responsible for reviewing the Q. A. programs of principal contractors by on-site surveys or review of contractor-supplied documentation. The reviews shall document assurance or the adequacy of the contractors Q. A. program prior to letting the contract, and the implementation of the requirements of 10 CFR 71, Appendir E, in active programs.

Disputes involving quality arising frem a difference of opinion between Q.A. personnel and other personnel within the Nuclear Technology and Nuclear Services Section shall be resolved by the Section Manager.

Interdepartment or inter-section disputes with the Q.A. personnel involving quality shall be resolved by the BCL License Coordinator by authority of the BCL Director.

All quality-related activities shall be performed in accordance with approved procedures stating the equipment required and any special environmental conditions necessary for the activity.

Inspections and tests shall be conducted in accordance with an Inspection-Test Plan. This plan shall contain the required sequence of operations and hold points requiring approval of previous operations i

i before continuing. Any quality assurance surveillance reports' revealing a changing trend in quality shall be called to the attention of the Section Manager.

l l

l l

l e

,,,,. _- --_, -, -. - - _. -. ~.

. ~_

)

T BCL-NSP-2 i

Revision 1 l

FIGURE 4.

1. E" QUALITY ASSURANCE PLAN MATRIX l

10 CFR 71 Appendix E Criteria Requirement Manual BCL-QA-HC-1 Implementing Documents 1

Organization Sections M-1 thru -4 Q.A. Plan, Organization Charts, Q.A. Responsibility Matrix 2

Q.A. Program Sections M-1 thru -4 Q.A. Plan, (BCL-NSP-2) 2 Personnel Qualification Document HL-MQ-7.1 3

Design Control Sections D-1 thru -6 Design Review Boards, Q.A. Plan for Specific Item in Design 1

4 Procurement Sections B-1,

-2, -3 MN-3C-1, MN-EA-1, MN-EI-l Document Control E-1, I-10 5

Instructions, Sections W-1, I-2,

-3, Process flow chart Procedures, and T-2, D-1, X-1, S-1 Inspection-Test Plan Instruction & Procedural i

Drawings Documents 6

Document Control Sections C-3, R-2, Document Log N-2 Document Index Q. A. Surveillance 7

Control of Purchased Sections I-4, B-2, -3 MN-BC-2 Materials, Parts, Suppliers List Material Component and Components or Service Specification 8

Identification and Sections C-1, -2 Travelers, Tags Control of Materials, Parts and Components 9

Control of Special Section X Welding Procedures and Qualification as per ASME Processes B&PC. NDT qualifications as per SNT-TC-1A, HL-MQ-7.1 l

10 Inspection Sections I-l thru -10 Inspection procedures Inspection-Test Plan Q.A. Surveillance 11 Test Control Sections D-3, W Engineering Test Plan I-l thru -10 for Specifications Test Procedures r.,

,vv

-=..y,,

..,.v c.,

,...-,.~.e-

• y-...-,-,7.~,-

...,,.,,,y,~

,2y-

%~.4

. _. ~,

BCL-NSP-2 Revision 1 FIGURE 4.

Page 13 of 42 QUALITY ASSURANCE PLAN MATRIX (Continued) 10 CFR 71 Appendix E Criteria Requirement Manual BCL-0A-HC-1 Implementing Documents 12 Control of Measuring Sections T-1,'-2 Calibration Procedures and Test Equipment Calibration Schedule and Index Recall File NBS Standards Index and Recall File 13 Handling, Storage Section S Handling and Storage and Shipping Procedure Packaging and Shipping Procedures ANSI N 14.10.3 Advance Form and Shipping Data Sheet 14 Inspection, Test, and C-1, N-2 Travelers, Operating Status Status Tags Q.A. Surveillance 15 Nonconforming Material, N-1, -2 Nonconformance Parts or Components Reports, Inspection and Test Plan i

16 Corrective Action Section Z, F-3, -4 Nonconformance Report Failure Reports (MN-DF-1) 1 17 Records Section R Record Index, Procedures 18 Audits Section A Audit Checklists Audit Schedule l

l '

,n r-

-,,-,,,.,w, aw,res---~,

,c.-,

,,,,,-,---,,,~,,,,,--,.,-v

.>,,e

ECL-NSP-2 Revision 1 Page 14 of 42 FIGURE 5.

HL-MQ-7.1 BATTELLE-COLUMBUS L\\BORATORIES PERSONNEL CERTIFICATION 1.

This document certifies that has been instructed in the purpose, requirements, and implementation of the BCL Quality Assurance system as it relates to his/her program respon-sibilities and is qualified as stated to conduct the procedures and operations stated in this document.

2.

Procedures or operations certified to perform.

State certification levgl and attach additional certification documents where applicable.

3.

Basis for certification 3.1 High school yrs.

College yrs.

3.2 Formal training 3.3 Experience 3.4 Management evaluation 4.

Certification date Expiration date read and understood by Approved by Supervisor Approved by Section Manager Approved by Quality Assurance Manager

TABLE 2.

]

RADI0 ACTIVE MATERIAL PACKAGING, SillPPING. AND TRANSPORTATION REQUIREMENTS OF DOT AND NRC HATRIX AcrIVITY DESCRIPTION 49 CFR 10 CFR

..PPLICABILITY*

r Container Design, Definition 17 3. 389 (j, k) 0-1, 0-6 Type A and B Requirements for all packages 173.24 Requirements for general packaging 173.393 Container specifications Pt. 178 Container Testing, Test requirements for Type A and B 173.398(b) 71.34 0-1, 0-2 Type A Container Testing, Test requirements for Type A and B 173.398(b) 71.34 0-1, 0-2 x

Type B Special testing for Type B 71.35 Special testing for Type B 173.398(b) 71.36 Special Form Definition 173.398(g) 71.4(o) 0-1, 0-2, 0-6 Package requirements 173.394 Test requirements for special form 173.398(a)

Packaging, General packaging and shipping requirements 173.393 0-1, 0-6 Type A Packaging requirements for Type A 173. 396 (b)

Additional requirements for Type A 173.395(a)

Packaging, General packaging and shipping requirements 173.393 0-1, 0-6 Type B Packaging requirements for Type B 173.396 (c)

Additional requirements for Type B 173. 395 (b, c)

' Packaging, Exempt Materials and quantities exempt from 173.396 (a) 71.6-71.10 0-1, 0-6 packaging requirements

.Large Quantities Quantities exceed transport group limits 71.4 (f) 0-1, 0-2 Limited Quantitles Packaging exemption provisions, small 173.391 0-1, 0-6 Packaging Requirements quantities Iow Specific Activity Exemption provisions 173.392 71.4(g) 0-1, 0-6 gpg (LSA) Material Pack-g gy aging Requirements ag

.'S 7

• See Figure'3.

mw

TABLE 2. (Continued)

MATRIX ACTIVITY DESCRIPTION 49 CFR 10 CFR APPLICABILITY Fissile Classifications Definitions 173.389 71.4 (d,e) 0-1, 0-3 Type A and B Quantities Permissible limits in transport groups 173.389 0-1, 0-3 Transport Group Definitions, Assignment 173.389 0-1, 0-3 Transport index Definitions, Application 173.389 0-1, 0-3 Criticality Standards 173.396 71.33 0-1, U-3 173.393(1,j) 71.37-71.40 Docume n ta tion, Container design and development data 0-1 Container Design Container Design Approval Requirements, SARP 0-1 Safety Evaluation Report Preparation of container compliance report 0-1 Transport Quantity General Requirenents 173.26 0-3, 0-5, 0-6 Limitations Aircraft 173.27 Traf fic tbnagement Administrative, statutory compliance, 0-5 definitions Approved Means of 0-5 Shipment Request for Trans-Shipment planning, request preparation 0-5 portation Safeguards Shipping Papers Applicability, general requirements, Part 172-0-5 certification Subpart C y gs g

• <M 7E llazardous Materials Applicability, description of table Part 172-0-5 Table and Communica-column headings Subpart A

$o$

1. b

.tlons Regulations -

o* ""

Cene ra l N

TABLE 2.

(Continued)

MATRIX ACTIVITY DESCRIPTION 49 CFR 10 CFR APPLICABILITY Packagings Author-Conditions of permissible packaging 173.22(a) 0-5 ized Under Exemptions exemptions Packaging and General requirements 173.3 0-5, 0-6

. Exceptions Prohibited Packaging Unacceptable packaging practices 173.21 0-5, 0-9 Shippers' Responsibility Approved containers 173.22 71.55 0-5, 0-12 and Notification Notification of shipment; nonreceipt 73.36(c)

Packaging, Previously Prior authorization for packaging 173.23 0-6 j

Authorized Packaging. Assumed Unknown material properties 71.52 0-6 Properties (Notify Nuclear Safety)

Table of flazardous IIazardous materials listing -

Part 172-tb te rials Summary of Requirements Subpart B i

3.

Container Use Preliminary determination of condition 71.53 0-6 Container Reuse Reusable container inspection, test, and-173.28 71.54 0-6 cleaning requirements Shipping Empty Shipping conditions, label removal, 173.29 0-6 Containers

' empty' marking a

contamination Control Survey requirements, permissible levels 173.393(h) 0-6, 0-7, 0-9 173.397 Shipments by Air General Requirements 173.6 0-5, 0-6 Marking General and specific requirenents for Part 172-0-6 ypg marking containers Subpart D.

g 3, y mz Labeling Labels Part 172-0-5, 0-6

[1 { f Requirements, specifications and applications Subpart E o

N S

TABI.E 2.

(Continued)

MATRIX ACTIVITY DESCRIPTION 49 CFR 10 CFR APPI.ICABILITY Classified Fbterial Packaging, marking, sealing, notification, 0-6, 0-9, 0-11 Shipment Conditions surveillance

. Hall Transport Part 174

.Special Train' Service Administrative Procedures 0-5 General Parts Purpose, compliance, requirements, in-Subpart A 0-5 spections, restrictions Operating Requirements Shipping papers notices, incident re-Subpart B 0-5 porting; instructions, procedures, general information; customs clearance, import shipments i

llandling and Loading Cleaning and marking cars, material Subpart c 0-9 f

Requirements segregation llandling Placarded Cars Switching, separation, position Subpart D 0-9 Requirements for Radio-Special handling requiieaents, cleanliness Subpart K 0-9 Active tuterials

'of cars, leakage incidents Security Escort, communications requirements 73.33 0-11 Air Transport Part 175 General Regulatlocs Purpose, applicability compliance, Subpart A 0-5 acceptance, notification, shipping

. papers, incident reporting Special Requirements; Special. placement, additional incident 175.700 0-9, 0-11

' Radioactive Materials reporting requirements Special Requirements; Limitations, Fissile Class III 175.710 0-9, 0-11 Fissile Class III Security Quantity limitations 73.32 0-5, 0-9, 0-11 Limited Pu Shipments Conditions, approvals Pt. 871 0-5, 0-9, 0-11 E% ;E E i?

d$

a=s fM

4

,i TAllLE 2.

(Continued)

MATRIX ACTIVITY DESCRIPTION 49 CFR 10 CFR APPLICABILITY liighway Transport Part 177 General Information Purpose, scope applicability, container Subpart A 0-5 and Regulations acceptability, shipping papers Loading and Unloading Securing packages, safety practices, pre-Subpart B 0-9 1

cautions Loading and Storage Materials loading tables Subpart C 0-9 Chart Vehicles and Shipments Transportation and delivery, disabled Subpart D 0-11 Transit vehicles, accidents Security Transfer, communications escorts 73.31 Physical Futerial Access, storage, surveys, reports 0-8 Protection, Unclas-sified SNM loading and Unioading General regulations, lesding requirements 173.30 0-9 of Transport Vehicles 174 (rail) 175 (air) 177 (highway) 173.393(e) i Placarding Placards - requirements, specifications, Part 172-0-9 and application Subpart F Tiedowns Component or container securing on C-9, 0-11 transport vehicle 1'

Hecords, Shipping Container and material transfer records 71.62 0-9 required Security of Shipments Materials in transit 0-11 S$0 Transportation Security of classified and special nuclear Pt. 73 0-11 mg,3 Safeguards material in transit

,i ggg an O

N

%W N

-. =.-

TABLE 2.

(Continued)

MATRIX ACTIVITY DESCRIPTION 49 CFR 10 CFR APPLICABILITY Receipts Change-of-custody, classified material 0-11 Escorts Authorization, qualification, functions 0-11 SNM Ground Transport Conditions of transport, regulations 0-11 SNM Air Transport Conditions of transport, regulations 0-11 Reports, Damage Material protection compromised 71.61 0-12 Operating Procedures Assurance of compliance with statutory 71.51 Entire Program j

requirements Quality Assurance General quality assurance requirements 73.51 Entire Program Container QA requirements 71.51 Container QA, fabrication, maintenance, 71.51 and use requirements QA program requirements, containers, 71.51 and transport vehicles QA program requirements 71.51 Personnel Training Personnel qualification and certification 71.51 As Applicable 2

N:O cd

1. %9

• e M o %,

a O

N Pts H

+

BCL-NSP-2 Revision 1 Page 21 of 42 3.

Design control Plans and procedures shall be established for review and control of all packaging designs and design changes. The controls incorporated into these plans and procedures shall cover planning of the design effort; preparation of design criteria; specification of qualified materials, processes, codes, and standards; preparation of design descriptions; the use of engineering studies and development programs to validate dcsign features; and the controlled release of design docu-ment changes.

Design review and control procedures shall assure that:

Design activities are conducted in a planned, controlled, e

and orderly manner.

Applicable regulatory requirements and design bases are e

correctly translated into specifications, drawings, written procedures, and instructions, Design documents specify quality standards and deviations e

and changes from these standards are controlled. All design changes shall require the same review and approvals given the original design.

Suitable design controls are applied to stress, thermal, e

hydraulic, radiation, and accident analyses; material compatibility; and accessibility for inservice inspection, maintenance, and repair.

p Designs are reviewed to ensure that design characteristics can be controlled, inspected, and tested and that inspection and test criteria are identified.

Important elements in design and development planning will be identification of

~

test objectives and scheduling of testing programs. A Design Review Board, comprised of members not participating in the design but technically competent in the design, shall ensure that these elements are accomplished.

m

BCL-NSP-2 Revision 1 Page 22 of 42 Internal and external design interface controls are e

established. These controls will include the review, approval, release, distribution, and revision of docu-ments involving design interface with participating design organizations.

Design verification processes, to include qualification e

testing of a prototype unit when necessary, are properly identified and accomplished. Responsibility for design verifications shall not rest with the original designer's immediate supervisot. The Design Review Board shall ful-full this function and assure an independent verification.

Changes in design are made in accordance with controls and approvals equivalent to those for the orginal design.

Design errors and deficiencies are properly documented and e

corrective action to preclude repetition are initiated, o All materials, parts, and equipment will be reviewed for suitability before approval for a packaging design. This includes standard or off-the-shelf items, as well as those previously approved for a different application.

Those responsible for design review and verification are e

identified and controlled and that their authority and responsibility are also clearly' identified.

Suitable parts, materials, equipment, and processes for e

safety-related systems and components are selected.

Measures for selection shall include valid industry standards and specifications. This element will be a part of design and development planning.

4 Procurement Document Control Procurement control documents shall be tnplemented to assure that all purchased material, equipment, parts, items, and contracted services meet the design specifications. These documents shall ensure active participation of the Q. A. Manager in procurement control.

l BCL-NSP-2 Revision 1 Page 23 of 42 The procurement document control program shall include pre-procurement planning, purchase requisition review, inspection planning, and incoming in-spection. Procedures for preparing Q. A. procurement documents, shall clearly delineate steps in the preparation, review, approval, and control of the necessary documents. These procedures shall provide for review & i concurrence, by the Q.A.

Manager, of the adequacy of requirements stated in p:asorement documents. The review and approval shall be documented prior to release of a document and shall be available for verification.

The procurement documents shall identifv the applicable requirements from Appendix E of 10 CFR ? art 71 that must be complied with in the supplier's or contractor's Q. A. program. Major suppliers and contractors Q.A. prograns shall be reviewed and evaluated by the Q. A. and Prograu Manager before any activities affected by it are initiated.

The procurement documents shall contain, or shall reference, the design basis technical requirements, including applicable regulatory require-ments, material and component identification requirements, drawings, specifi-cations, codes and industrial standards, test and inspection requirements, and special process instructions. All drawings, specifications, procedures, inspection and fabrication plans, inspection and test records, personnel and procedure qualifications, and material test results needed for purchaser review and approval shall be identified in procurement documents.

The procurem2nt documents shall specify disposition of procurement records, i.e., whether they are to be retained and controlled by the supplier or delivered to Battelle. The documents shall also note whenever source inspection or surveillance of the supplier's facilities and records are re-quired.

All revisions of procurement documents, as well as all procurement documents for spare or replacement parts of safety-related items, must be reviewed by the Q.A. Manager before release.

The Q.A. review of procurement documents (requisitions) shall be

~

documented on Forms MN-BC-1 or EL-BC-1, as shown in Figure 6, and attached to che requisition.

BCL-NSP-2 Revision 1 Page 24 of 42 HL-8C-1 FIGURE 6.

Q. A. Purchase Requisition Control

1. Scope: Documentation for fulfilling requirements in initiating a quality assured purchase.

2. General 2.1 This document must be completed by the buyer (originator) and attached to the requisition. A copy will be filed in the section files with the requisition copy.

2.2 A copy well be filed by the Q. A. Manager.

3. Procedure 3.1 BCL buyer (originator)

. Date 3.2 Quality assured item to be purchased is 3.3 Established total cost of the purchase 3.4 The item or service will be procured from 3.4.1 Bids have been obtained and evaluated or sole-source justification prepared if necessary.

Initial 3.4.2 The supplier is listed on the Q. A. approved supplier list.

Initial 3.5 All specifications and drawings are included on or attached to the BCL requisition.

Initial 3.6 The source or receiving inspection of the requisition is as follows:

3.7 The requisition is w:itten to require the shipping papers to be attached to the outside of the shipping container.

3.8 The requisition is written to requires the shipping label to read:

This is a Quality Assured Item.

To Be Opened Only By 3.9 Requisition has been approved by C Principal investigator / Program Manager CDOE Project Administrator (if required)

C Section Manager or Associate Section Manager C Quality Assurance Manager

. -.. ~.

BCL-NSP-2 Revision 1 Page 25 of 42 5.

Instructions, Procedures, and Drawings There are many activities involved in packaging and shipping of radioactive materials that can affect quality. Written instructions, procedures,

~

and drawings shall be prepared as necessary to control these activities. Such control documents will include work instructions, inspection or test plans and instructions, instructions for control of measuring and test equipment, design and development plans, instructions on special processes, and preservation, handling, storage, and shipping instructions.

Both qualitative and quantitative acceptance criteria shall be in-cluded to provide means for verifying satisfactory completion of important activities. Workmanship sample would be an example of a qualitative criterion.

Quantitative criteria might include dimensions, tolerances, and operating limits.

All instructions, procedures, and dr:wf ags shall be reviewed and approved by the Q.A. Manager, the Section Manager, and the Author's Supervisor.

l l

l I

t 1

i i

I l

l

4 4

4&

1. +#

%*4>

. TEST TARGET (MT-3) 1.0 Py n 212 ylffIHE I

1.1 l m EM I

l '.8

"~

1.25 1.4 1.6 c

6"

1. 4

+4%

Nf+7777,b//?'

'4 4

%<y

++&

N k

' /)hk

$/fl~/

'%'+4

++

,..e.._ T -

T.ST TARG.T (MT-3) 1.0 l# EE UM

'M a

B=u m ru l,l h," bb

.g

~~

I.25 1.4 1.6 4

6" e'?p#'@ *f

'4 4

1. 4

'4, a 4%

4 ll///

cedures described in the Q.A. Manual chall be used to implement and document corrective action for these conditions. They also cover reporting-of adverse conditions, their cause, and the corrective action taken to appropria:e levels of management. This includes immediate reporting to cognizant NRC offices of defects and nontempliance that may result in a substantial safety hazard.

c

BCL-NSP-2 Revision 1 Page 40 of 42 17.

Quality Assurance Records A quality assurance records system shall be maintained to provide for completion, control, retention, retriotal, and final disposition of all quality recotds required by specified ASTM, ANSI, DOE, and CFR Q.A. guidelines.

Requirements for transmittal, retention, and maintenance shall be consistent with such guidelines and with procurement docunents. Records shall be main-tained with the objective of providing documentary evidence of the quality and safety of items and of activities affecting quality and safety.

Records to be retained shall be defined in Engineering Test Plans, Quality Assurance Program Plans, and similar doctaments. Additional records may be retained without reference to a specific plan or activity. - Q. A. records shall include radioactive material accountability, logs of operations, test and audit results, performance records, qualification documents, drawings, specifications, equipment descriptions, procurement documents, calibration reports, training, nonconformance reports, and corrective action reports, la large, records shall be grouped in a central location designed-to prevent environnental deterioration. However, established BCD record depositions will also be used where they meet necessary requirements.

In any case, a central file coordinator shall establish and maintain an index on the location of all documents associated with shipping, receiving, and storage of all containers used in the shipment of radioactive materials. All documents shall be assigned an alpha-numeric identification. This coding system will provide for coordination between activities where ince' face is required.

rne indexing system will assure that all records are readilf identifiable and retrievable.

The inspection and test records to be maintained will cover:

e Inspector and date recorder-e Type of observation e Date of completion e Results e Acceptability e Adverse conditions e Action to correct deficiencies Approvals.

e

a L BCL-NSP-2

~

Revision 1 Page 41 of 42

• s 18, Audits A system of planned and periodic audits of the implementation of Q. A.

procedures related to shipping packages shall be established by the Q.A. Manager.

These audits will provide a means of reviewing the operations and wi11 identify results of the prograr. They vill objectively evaluate quality-related practices, Procedures, and instructions and the effectiveness of implementation. Audits will caver the use, maintenance, and repair of shipping packages, including -

a review of doctanents and records.

A detailed checklist identifying elements or features to be verified shall be prepared for each audit. The checklists will emphasize. safety significance of the area being audited. The audits shall be performed by Q. A.

audit teams organized and trained by a lead auditor under direction of the Q.A.

Manager. Audit personnel shall tat have direct responsibilities Achin the area being audited.

i Results of all audits shall be do:umented in an audit report, which I

will record any spctific deficiencies found. A post-audit meeting shall then-be conducted with the Principal Investigator to review all findings. At'such

+

meetings, each noncompliance shall be discussed ano agreements shall be reached on corrective actions. Details of audit followup shall be documented on the audit or NCR Forms. Corrective actions shall be verified by reaudit and the documentation approved by The Q. A. Manager and the Principal Investigator.

i m

All audit documentation shall be forwarded' to the Section Manager for review and assessment.

Specific are. in which audits shall be performed include chose where the requirements of Appendix E to 10 CFR Part 71.are being implemented. - The audits shall be regularly scheduled on the basis of the status and safety importance of the activities being performed. They shall be initiated early_

enough to provide' effective quality assurance ' during-design, procurement,

f and contracting activities. Based on the foregoing', the schedule for the audit program on shipping packages shall be:

4

-n,

-. ~

e a a

n

t

• • 4 BCL-NSP-2 Revision 1 Page 42 of 42

' Audit Area Frequency Package unloading and loading Every 5 uses McIntenance Annually Decument control Annually Receiving inspections Annually Operational performance Annually Repairs and rework Each occurrence

)

Training and certification Annually I=plementation of use and test procedures Annually Calibration program Annually In addition to the specific audits, a general independent audit of the licensed radioactive materials packaging and transportation Q.A. system shall be conducted annua:1y at the direction of the Nuclear Technology Department Manager. This audit shall be a means for the Department Manager to assess the scope, status, implementation, and effectiveness of the Q. A. program to assure it is adequate and complies with 10 CFR 71 Appendix E.

d N

4

BCL-NSP-2 Revision 1 Page 1 of 1 APPENDIX A PERSONNEL ASSIGNMENTS

'1 4

Program k nager W. h dia Technical Program & nager H. Faust Transportation and Packaging T. Emswiler

&terial Handling and Accountability H. Faust Shipping T. Emswiler Laboratory Operations Hot Lab A.' Parsons Plutonium Lab C. Postle Other W. Gallagher Container Administration T. Emswiler -

QA M nager D. Lozier' QA Auditers and Surveillance D. Lnier B. White W. Bruce Container Insoection B. White Container Design, Fabrication and Repair E. Froma R. Burian Training and Certification

~

Hot Lab W. Gallagher Plutonium Lab D. Freas Quality Assurance D. Lozier Other H. Fat. t ':

Files B. White 1323-)

..