ML19339C656

QA Manual for Cask Use

ML19339C656
Person / Time
Site:	07100024
Issue date:	10/20/1980
From:	HITTMAN NUCLEAR & DEVELOPMENT CORP. (SUBS. OF HITTMAN
To:
Shared Package
ML19339C653	List: ML19339C652 ML19339C656
References
17812, HNDC-C-200, NUDOCS 8011180770
Download: ML19339C656 (91)

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QUALITY ASSURANCE MANUAL FOR CASK USE i

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Assigned to:

Name Company 4

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UNCONTROLLED COPY FOR INFORMATION ONLY 4

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Hittman Nuclear & Development Corp.

9190 Red Branch Road

~.v Columbia, Maryland 21045 4.

17812

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Document Number:

Rev:

Pev Date:

HITTMAN NUCLEAR &

ilhuC-C-200 0

10/20/80 D EVELOPMENT CORPORATION

Title:

Quality Assurance Program for the Use of tudwas te Shipping Packages

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Manager, Director utrector quattty vLee-rrea.

Admin.

Vice-Pres. Trans & Dis Marketing Assurance & Ger. era Rov.

Rev Date Services Engineerin g Services & Projects Manager Manager

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Title:

HNDC-C-200 0

LO/ 20/3 )

Quality Assurance Program for tne Use of Radwaste Shipping Packages FOREWORD In order to use a U.S. Nuclear Regulatory Commission (NRC) certified package (hereafter simply referred to as package) for shipments of greater than Type A quantities of radioactive material in accor-dance with the general license provided in 10 CFR Part 71.12, the user of the package must have a quality assurance (QA) program whose description has been submitted to and approved by the NRC as satis-fying the provisions of 10 CFR Part 71.51.

This requirement not-withstarding, users may delegate to others, such as Hittman Nuclear

& Develo> ment Corporation (HNDC), the work of establishing and executing the QA program, or any part thereof, but shall retain responsibility therefore.

HNDC recognizes the practical necessity for users of HNDC owned i

and certified packages to delegate most, if not all, of the work of establishing and executing the required QA program.

HNDC has, therefore, developed this "QA Program for the Use of Radwaste Sbip-ping Packages" in recognition of HNDC's delegated responsibilities for assuring that HNDC packages are used in such a manner as to provide for the safety of the public.

The importance of QA in con-tributing to this safety is also recognized.

In accordance with this philosphy this QA Program description has been prepared and by its issuance establishes the policies and practices for QA for the use of IINDC packages.

The approval, issuance, and control of this QA Program description shall be the responsibility of the Manager, Administrative Services, who has been assigned overall responsibility forf its development '

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and implementation.

Day to day responsibilities for QA, including preparation and review of additions, deletions, or modifications to this QA Program description shall rest with the QA Manager who reports directly to the Manager, Administrative Services.

H NDC-02(A)

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Title:

HNDC-C-200 0

10/20/8 Quality Assurance Program for the Use of Radwaste Shipping Packages Disagreements or dif ferences o'J cpinion on QA matters which orig-inate with or are brought to the attention of the -QA Managet are expected to be resolved by him and the affected department manager or group supervisor.

Where such resolution-is not achieved within a reasonable period of time, unre, solved differences shall first be referred to the Manager, Administrgtive Services, who shall then refer still unresolved matters to the Vice President & General Manager.

As directed by the Vice President & General Manager through the issuance of this Q4 Program description, the HNDC Manager, Admin-istrative Services, is hereby assigned the responsibility for all matters related to quality with authority as established in this QA Program.

All HNDC personnel with responsibility for activities related to HNDC package use have the additional responsibility for being fully knowledgeable of policies and procedures described _ in this QA Program description that are pertinent to their particular duties.

Conformance to the policies and practices described herein shall be required as of the date of approvai and issue of this procedure.

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HNDC-C-200 0

10/20/80 Quality Assurance Program for the Use of Radwaste Shipping Packages TABLE OF CONTENTS SECTION TITLE PAGE FOREWORD.

2 TABLE OF CONTENTS 4

1 ORGANIZATION.

5 2

QUALITY ASSURANCE PROGRAM 17 3

DESIGN CONTROL.

30 4

PROCUREMENT DOCUMENT CONTROL.

34 5

INSTRUCTIONS, PROCEDURES, AND DRAWINGS 37 6

DOCUMENT CONTROL,

39 7

CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES 44 8-IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS 50 9

CONTROL OF SPECIAL PROCESSES 57 10 INSPECTION.

59 11 TEST CONTROL.

63 12 CONTROL OF MEASURING AND TEST EQUIPMENT 65 13 HANDLING, STORAGE, AND SHIPPING 68 14 INSPECTION, TEST, AND OPERATING STATUS 70 15 110NCONFORM i NG MATER I Al.S,

l' ARTS, AND COMI'ONENTS 71 16 CORRECTIVE ACTION 75 17 QUALITY ASSURANCE RECORDS

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HNDC-02(A)

P,,,.. 4,, r F) _

No.

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Title:

HNDC-C-200 0

LO/20/80 Quality Assurance Program for tne Use of Radwaste Shipping Packages SECTION 1 ORGANIZATION 1.1 Scope and Applicability 1.1.1 This section includes a description of the organi-zational responsibilities normally assumed by HNDC for package handling, inspection, transportation, maintenance, repair, and modification.

These re-sponsibilities include both the performing func-tions involved in attaining quality objectives and the QA functions.

The QA functions are those of (a) assuring that an appropriate QA program is established and ef fectively executed and (b) veri-fying, such as by checking, auditing, and inspect-ing, that activities a f fecting sa fety-related functions have been correctly performed.

1.1.2 Users of HNDC packages may assume responsibi.lity for performing certain activities falling within the scope of this QA Program.

Examples include package inspection and handling and, in some cases, package maintenance and repai r, including parts replacement.

IINDC has no aut hori t y over user or-ganizations and, therefore, no direct control over the activities that may be carried out by user personneI not in comptiance with Ihe requ i remer.Ls o f this QA Program.

.I t is impo r t.dni, the re fo re,

that users adopt ing this QA Program as the means of meeting the requirements of 10 CFR Part 71.51 i

If(U)(U) u nn nMA >

No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages recognize that they have a responsibility to carry out safety-related activities in accordance with the requirements and procedures described herein.

1.2 Organization and Responsibilities 1.2.1 Figure 1-1 shows the organizational structure for HNDC.

Those individuals and groups having respon-sibility for activities falling within the scope of this QA Program are clearly identified in the figure.

The authority and specific responsibilities of these individuals and groups for such quality related activities are described in the following sections.

1.2.2 President 1.2.2.1 The President of HNDC has ultimate responsibility for t he company's activities related Lo the use of IINDC packages.

1.2.2.2 The President's day to day responsibilities for company activities, including responsibility for

. establishing the policies and practices set forth in this QA Program description, have been delegated to the Vice President & General Manager.

1.2.3 Vice President _& General Manager 1.2.3.1 The Vice President & General Manager has been designated by the' President of HNde as thd respon-sible corporate of f'icer for all QA matters related to the use-of HNDC packages.

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10/20/00 Quality Assurance Program for the Use of Radwas te Shipping Packages l

1.2.3.2 The Vice President & General Manager's day-to-day responsibilities for implementing the QA Program are delegated to t he QA Manager through the Manager, Administrative Services.

1.2.3.3 The Vice President & General Manager shall rettin responsibility for assuring the independence of the QA Manager from schedules and costs and for provid-ing the QA Manager, through the Manager, Administra-tive Services, the authority to direct and control the Qt. Program and to ensure conformance to quality requirements.

1.2.3.4 The Vice President & General Manager reserves the right to conduct, or order, the auditing of any activity at any time to determine the ef fectiveness of the policies and requirements set forth in this QA Program description and to determine compliance with the provisions of the QA Program and impiement-ing procedures.

1.2.4 Manager, Administrati.ve Services 1.2.4.1 The Manager, Administrative Services, is responsible for establishing QA policies and for managing the implementation of the QA Program.

This is accom-plished primarily through supervision of the QA Manager and assessments of the perl'ormance and rflectiveness of QA Depart ment personnel and the ef fectiveness of this QA Program.

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10/20/80 Quality Assurance Program Sr the Use of Radwaste Shipping Packages 1.2.4.2 The Manager, Administrative Services, is responsible for ensuring that the individual assigned the posi-tion of QA Manager satisfies the qualification and experience requirements discussed in Section 1.4 of this procedure.

1.2.4.3 The ~1anager, Administrative Services, has been given the authority by the Vice President & General Manager to stop unsatisfactory work or further processing of unsatisfactory material that is not in con formance with specified quality requirements and/or the provisions of the QA Program.

1.2.4.4 The Manager, Administrative Services, is responsible for conducting a formal review of the QA Program on an annual basis and reporting the results to the Vice President & General Manager.

1.2.5 QA Manager 1.2.5.1 The QA Manager reports to the Manager, Administra-tive Services, and is responsible for ensuring the implementation of the QA Program and for advising the Manager, Adminis trative Services, regarding its e f fec tiveness.

1.2.5.2 The QA Manager 'has been given t.he aut hority by the Viec President & General Manager to identit'y quality probiems and to initlate, recommend, or provide solutions to responsible individuals and groups through the Manager, Adm i n i s t ra t. i.ve. Se rv ic es.

The QA Manager verifies' implementation of these solutions.

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s tila H NDC-02(A)

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HNDC-C-200 0

10/20/3 )

Quality Assurance Program for the Use of Radwaste Shipping Packages l.2.5.3 The QA Manager is responsible for advising the Manager, Administrative Services, of the need to stop unsatisfactory work or further processing of unsatisfactory materials.

1.2.5.4 Specific duties of the QA Manager include the following:

(a)

Prenare and control the QA Program description including revisions and its distribution.

(b)

Formulate QA policies for use by HNDC.

(c)

Review the QA prcgrams of suppliers and con-tractors as appropriate.

(d)

Review specifications, drawings, and procedures for conformance to HNDC quali ty requi rements,

applicable industry standards, and regulatory requirements.

(e)

Manage the QA staf f in the performance of their activities.

(f)

Maintain current status of quality-related activit.ies as they pertain to the use o f IINDC packages.

(g)

Maintain communication with the QA organiza-t ions o f I he users of IINDC packages.

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HNDC-C-200 0

10/20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages (h)

Inform llNDC management of QA Department activi-ties through distribution of audit reports and other quality-related information.

(i)

Monitor the performance of quality related activities anu conduct periodic audits of the QA Program.

(j)

Provide assistance as appropriate with the preparation of quality related procedures controlling the activities of HNDC personnel.

1.2.6 Material Control Manager 1.2.6.1 The Material Control Manager reports to the Manager, Adminis trative Services.

1.2.6.2 The Material Control Manager is responsible for ma teria l purchasing, expediting, internal material control and developmer.t and implementation of mate-rial control procedures ano instructions.

1.2.6.3 The Material Control Manager provides supervision to the Expeditor who oversees the llNDC material store-room, including receipt and disposition of purchased material and items.

1.2.7 Vice President, l{ngineering 1.2.7.1 The Vice President, l{ng i n ee r i ng, report s di rectly to i

the Vice President & General Manage.c and is respon-J sible for managing the engineering group wi thin liNDC 1

and for the oversight of internal research and development.

l HNDC-02(A)

Poqe. lit o(..n2_.

No.

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Date

Title:

HNDC-C-200 0

10/20/80 Quality Assurance Program for the Use of Radwaste Shipping Packages 1.2.7.2 The Vice President, Engineering, is responsible for approving proposed modifications to llNDC packages and supervising engineering group activities related to preparation of package license amendments.

1.2.8 Manager, Systems & Equipment Design 1.2.8.1 The Manager, Systems & Equipment Design reports to the Vice President, Engineering.

1.2.8.2 Responsibilities of the Manager, Systems & Equipment Design include the following:

(a) supervision of engineering, design and design draf ting personnel; (b) preparation and review o f drawings, specifica-tions, calculations, and test p rocedu res ;

(c) preparation of license documents including sa fety analysis reports, topical reports and amendments thereto; (d) coordination of engineering reviews and ap-provals of reports of nonconforming materials and items, including the disposition of those materials and items; (e) reviews of special test results;

( f) development and implementati.<gn of engineering-procedures and instructions.

H NDC-02(A)

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10/20/83 Quality Assurance Program for the Use of Radwaste Shipping Packages l.2.9 Director, Transportation & Disposal Services 1.2.9.1 The Director, Transportation & Disposal Services, reports to the Vice President & General Manager.

1.2.9.2 The Director, Transportation & Disposal Services, has overall responsibility for the coordination and scheduling of HNDC package shipments including liaison with package users and the burial sites and transportation companies.

Day to day responsibility for these activities is delegated to the Eastern and Midwest Regional Operations Managers.

1.2.9.3 The Director, Transportation & Disposal Services, alsa is responsible for the preventive maintenance and repair of packages.

Day to day responsibility for package maintenance is delegated to the Main-tenance Supervi sor.

1.2.10 Regional Operations Managers, Eastern & Midwest 1.2.10.1 The Regional Operations Managers, Eastern & Midwest, report to the Director, Transportation & Disposal Services.

1.2.10.2 Specific dut ics of the Regional Operations Managers, include the following:

(a) coordination and scheduling of IINDC package shipments trom the eastern an(d midwes.t regions of the U.S. ;

(b) scheduling, in coordination with the Mainte-nance Supervisor, package preventive mainte-nance and repairs:

H NDC-02(A )

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LO/ 20/ SO Quality Assurance Prograta for the Use of Radwaste Shipping Packages (c) liaison with package users; 1.2.10.3 The Regional Operations Manager, Eastern, is also responsible for preparation and periodic review of package operation and use procedures and instruc-tions.

1.2.11 Maintenance Supervisor 1.2.11.1 The Maintenance Supervisor reports to the Director, Transportation & Disposal Services.

1.2.11.2 Responsibilities of the Maintenance Supervisor include the following:

(a) establishment of preventive maintenance plans, procedures, and schedules for !!NDC packages; (b) implementation of the preventive maintenance program including coordination and supervision of IINDC maintenance personnel at both head-quarters and field locations; (c) preparation of repair procedures and supervi-sion of repair activities for HNDC packages; (d) notification of and coordination with the Regional Operations Managers, Eastern & Midwest, when package maintenance must be scheduled;

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(e) order spare and replacement <narts and materi'als '

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for llNDC packages ;

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H NDC-02(A)

P~i L3 e r.19

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Title:

HNDC-C-200 0

10/ 20/30 Ouality Assurance Program for the Use of Radwaste Shipping Packages (f) training of maintenance personnel in the per-formance of maintenance activities.

1.3 HNDC-User interface Control 1.3.1 HNDC and the user share responsibility for estab-lishing and maintaining effective lines of communi-cation between them.

In this regard the primary communication line between the user and HNDC for matters related to the establishment and/or execu-tion of this QA Program shall be between the user's designated representative for such matters and HNDC's QA Manager.

1.4 QA Manager Position Qualifications 1.4.1 The QA Manager is responsible for ensuring imple-mentation of the QA Program.

The QA Manager shali satis fy the following minimum qualification require-ments:

(a)

Graduate of a four-year accredited college or university program in engineering or science; (b)

Minimum of two (2) years experience in QA, including testing or inspection (or both) of equivalent materials and siructures:

(c) in lieu o f a degree,

high school graduate a

plus five '(5) years of experience in general QA or engineering of equivalent.<m,aterials and structures; 1

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HNDC d-200 0

LO/ 20/ 8 )

Quality Assurance Program for tne Use of Radwaste Shipping Packages (d)

Individuals without any prior experience with radwaste shipping packages shall have training su f ficient to acquaint them with the safety aspects of IINDC packages.

4.

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L0/ 20/80 Quality Assurance Program for the Use of Radwaste Shipping Packages Figure 1-1 HNDC Organization PRESICENT A

VICE PRESICENT GENERAL MANAGEP,

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MANAGER ADMINISTRAfibE WICE PRESIDENT DIR. TRANS.

DIRECTCR ENGINEERING

& Ol$POSAL MARKEilNG &

SERVICE 5 A

SERVICES A

PRCEJCTS QUALITY MGR. SYSTEMS ASSURANCE 5 EQUlrMENT ny gg

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"ANELIINO MANAGER DL5iGN A

4 REGIONAL MANAGER HEALTH CON $ULilNG PHYSICS SERVICES OPERAfl0NS MGR.

PROJECT Sul'EltV650R MANAiA LASTERN gNGINEERING CONTRACT REGICNAL MANAGER

~' ADMIN 151RATOR OPERATIONS MGR.

FIELD PILOJ E CTS MlowEst a

MATERIAL CONTROL HITTMAN FIELD MANAGER TRANSPORY SERVICE 51 ItVICLS INC.

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NL*, PUN 5IOLE TOM ACllVlflLS SUUJttf 10 Tile RCOUIREMENTS OF THE QA PROGRAM.

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10/20/8 3 Quality Assurance Program for the Use of Radwaste Shipping Packages SECTION 2 QUALITY ASSURANCE PROGRAM 2.1 Program Objective 2.1.1 The quality objective of this QA Program is to insure that !!NDC packages used for the shipment of radioactive materials conform to the NRC approved design and are used in accordance with the terms and conditions set forth in each package approval.

2.2 Scope and Applicability 2.2.1 This QA Program satisfies the requirements of 10 CFR 71, Appendix E, applicable to the use, including loading and unloading, inspection, main-tenance, repair, and modification of IINDC packages.

QA requirement.s set forth in 10 CFR 71. Appendix E for package design, fabrication, assembly and testing are addressed separately in IINDC-C-100,

" Quality Assurance Program for the Engineering, Design, Procurement, Fabrication, and Initial Test-ing of Radwaste Systems and Equipment."

2.2.2 The structures, including appurtenances, components, pa rt s, and des inn cheirac t erist i cs, controlled by I h is QA Progr.im a r e those <leneribed in Ihe NRC package approval and sa fety evaluat ion.

2.2.3 Activities that shall be controllyd,by this QA

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Program include the following:

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10/ 20/80

' Quality Assurance Program for tne Use of Radwaste Sh.ipping Packages (a)

Activities specifically required to be per-formed as a condition of the package approval (e.g., certain inspections);

(b)

Activities that if performed improperly could cause the package to be used under conditions not in compliance with the conditions of the package approval; (c)

Activities in addition to those covered under (a) above that are determined necessary by the QA Manager and/or other qualified flNDC person-nel to verify periodically that package com-plies with the conditions of the package approval.

1 2.2.4 Activities not included within the scope of this QA Program established to implement the specific requirements of 10 CFR 71, Appendix E, are:

(a)

Activities specifically authorized and/ot required under a license to receive, possesc and transfer to authorized land burial facilt-ties packages containing solid waste by-product, source, and special nuclear materials.

These activities include, for example, radia-tion surveys and decontaminalion operations, and ot her act ivit ies prescribed and controlled generally in accordance with 10 CFR Parts 30, 40, and 70, and liNDC's RadSa fe Program;

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Qu lity Assurance Program for the HNDC-C-200 0

10/ 20/'30 Use of Radwaste Shipping Packages (b)

Operations at a radioactive material burial site including receipt, transfer, storage, i

repackaging, and disposal or bacial.

These activities are licensed in accordance with NRC and State regulations; (c)

Carrier activities 1egulated in accordance with the requirements of 49 CFR dealing with trans-portation of hazardous materials.

Such acti-vities include vehicle maintenance and inspec-tion, driver qualifications and training, and motor carrier recordkeeping and reporting.

2.2.5 The exclusions described in article 2.2.4 notwith-standing, it is recognized by llNDC that the appli-cation of QA principles and practices whenever practicable to the control of such activities is good policy.

To the extent that HNDC is involved in such activities, this will be the case.

It is emphasized, however, that the provisions of this QA Program are directed towards satisfying the specific requirements of 10 CFR 71, Appendix E, to ensure that HNDC packages conform to the NRC approved design and specifications for each individual pack-age.

2.2.6 The QA Manager shall be responsible for det ermining the specifie activitles to be controlled in accor-dance with the requ i rement.s o f th i s QA Program and i n for m i ng individuals and groups responsible for those activities.

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10/20/8 3 Quality Assurance Program for the Use of Radwaste Shipping Packages t

2.2.7 HNDC and contractor personnel performing activities within the scope of this QA Program shall adhere to the requirements of the program.

2.2.8 User personnel performing activities within the scope of this QA Program (e.g., package inspection, parts replacement, package handling), will be sub-ject to the requirements set forth herein if the user had adopted this QA Program as the means of meeting its responsibilities under 10 CFR Part 71.51.

Responsibility for veri fying satis f actory performance of such activities shall rest with the user.

2.3 Policy 2.3.1 This QA Program has been developed by IINDC and establishes the policies and practices for QA related to the use of !!NDC packages.

These poli-cies and practices are set forth in written proce-dures and instructions and shall be carried out in accordance with those procedures and instructions throughout the period during which the package is used.

2.3.2 The issuance and control of this QA Program descrip-tion shalI be the responsibiIit y of I he llNDC QA Manager.

AddiLions, deletions, or modifications to this document shall require t he approvals of the QA Manager, the Manager, Administrat ive Services,

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and the Vice Presiden.t & General Manager be fore such changes may be i nco'rpo ra ted.

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10/20/80 Quality Assurance Program for the Use of Radwaste Shipping Packages 2.3.3 Disagreements or dif ferences of opinion on QA matters which originate with or are brought to the attention of the QA Manager are expected to be re-solved jointly by him and the affected group or individual.

Where such resolution is not achieved within a reasonable period of time, unresolved differences shall be referred first to the Manager, Administrative Services, and, if necessary, to the Vice President & General Manager.

2.3.4 All ilNDC QA/QC personn't are responsible for being fully knowledgeable of all policies and practices described in this QA Program description.

2.3.5 All !!NDC personnel responsible for and/or performing activities covered under this QA Program are re-sponsible for knowing and implementing the portions of this program description pertinent to their respective responsibilities.

2.3.6 Con formance to the policies and pract ices described herein shall be required as of the date of approvai and issue shown on the title page.

2.3.7 Terms, abbreviations, and definitions used in this QA Program description are included in Table 2-1.

2.4 Program Description I.

2.4.1 This QA Program consist s of (1) a formal, docu-i

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mented system of admini st rative cop.t rols over ac t.ivi ties a f fec ting 'quali ty, and (2) quality verification through independent review, surveil-lance, and audit of those activities.

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HNDC-C-200 0

10/20/80 Quality Assurance Program for tne Use of Radwaste Shipping Packages 2.4.2 Administrative Controls The QA Program requires the preparation of appro-priate documents, including procedures, drawings, and specifications, which prescribe the measures which have been established to control activities affecting quality.

Compliance with this require-ment is the responsibility of each and every organi-zation or group with responsibility for activities related to the use of IINDC packages.

The measures which are established to control work must be de-tailed to the extent necessary to ensure that ade-quate controls have been incorporated.

2.4.3 Quality verification Quality is verified and assured through a system of planned reviews, surveillances, and audits of quality affecting activities by the QA Department which is independent of other organizations respon-sible for performing such activities.

2.4.4 The QA Program provides for control over activities affecting the quality of identified materials and components to an extent consistent with their im-portance to safety and as necessary to assure con-formance to t he approved design of each pacluige used f or t he shipment o f rad i oac t i ve.ma t.c r i a l s.

2.5 Respon.s_ i b i 1 i_t.. _i e.s 4.

2.5.1 IINDC's organization is described in Section 1.0.

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10/20/80 Quality Assurance Program for the Use of Radwaste Shipping Packages 2.5.2 IINDC has overall responsibility for ti,is QA Program.

Primary responsibility for establishing and imple-menting an integrated system of administrative con-trols over quality af fecting activities rests with the QA Manager, the Manager, Systcr.: & Equipment Design, the Regional Operations Manager, Eastern, and the Maintenance Supervisor.

These controls shall include provisions for quality verification appropriate to the activities being performed.

The QA Departmer.t is primarily responsible fo r quality assurance reviews, surveillances, and audits, including audits of HNDC contractors and suppliers.

2.5.3 Users of IINDC packages are responsible for estab-lishiag, maintaining, and executing a QA program satisfying the requirements of 10 CFR 71, Appendix E, and satisfying the speci fic provisions estab-

!ished in the NRC's approval for each package used.

Users may satisfy this responsibility by either adopting this QA Program or establishing an alter-native QA program.

In either case, each user is responsible for ensuring that activities performed by user personnel are in compliance with the govern-ing Ql. program.

2.6 Program Documentation 2.6.1 QA Program policies and practices are contained in various llNDC procedures that. comprise the ilNDC Procedures Manual.

A list o f p rodedu re s L'ha t de-H NDC-02(A)

Page 2.3_ of fi4

No.

Rev.

Date

Title:

HNDC-C-200 0

10/ 20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages scribe and implement this QA Program is included in Table 2.2.

This list includes a cross-reference of these procedures to the requirements of 10 CFR 71, Appendix E.

2.6.2 Various other documents, including instructions, NRC certificates ot compliance, and drawings that identify package requirements and delineate con-trols over activities are contained in separate Rad Services Manuals for each package model.

2.6.3 The QA Manager has the right to review and comment on all documents, including manuals, procedures, instructions, drawings, specifications, analyses, computations, and procurement documents that pre-scribe requirements for and controls over activi-ties related to the use of HNDC packages.

2.7 Personnel 2.7.1 It shall be the responsibility of the QA Manager to insure that !!NDC personnel responsible for per-forming quality related activities are instructed as to the purpose, scope, and implementation of this QA Program and implementing procedures.

2.7.2 The QA Manager or his designee shall periodically hold training meetings f or llNDC personnel perf orm-ing activities related to t he use of IINDC packages.

The frequency of these meet ings shall be at the discretion of the QA Manager but.$all not be less'

~

frequent than once ev'ery 12 months.

The scope of these meetings should include the following:

HNDC-02(A)

Poge lif. of_.J12

4 No, Rev.

Date

Title:

HNDC-C-200 0

10/ 20/8 ]

Quality Assurance Program for the Use of Radwaste Shipping Packages (a)

Review of audit results including any signifi-cant deficiencies or noncon formances.

(b)

Review of significant changes to the following documents:

(1)

Package certificates of compliance.

(2)

QA Program policies and practices con-tained in procedures listed in Table 2.2.

(3)

Rules and regr.lations related to package use.

The QA Manager shall oaintain a written record of such training and meetings includicg the date held, subjects discussed, and attendance.

2.7.3 It shall be the responsibility of individual llNDC departmental nicnagers to ensure that liNDC personnel responsible for parforming quality related activi-ties in each department are knowledgeable in the principles and techniques of the activity being pe rfo rmed.

2. 7.~ 4 IINDC departmental managers shall determine what t raining each individual shall be required to re-ceive in accordance with the individual's job re-sponsibilities and previous t raining and experience.

Training may include a combinal ion of reading assignments, such as portions of rdh.e package safetp analysis or text material, and special sessions with qualified individuals from, for example, other HNDC-02(A)

Page 21 of 89

I No.

Rev.

Date

Title:

HNDC-C-200 0

10/ 20/80 Quality Assurance Program for the Use of Radwas te S' ipping Packages n

functional units within HNDC.

Each departmental manager shal1 document for each individual the training received.

2.7.5 The QA Manager shall be responsible for the selec-tion and assignment of qualified auditors.

The QA Manager, whose minimum quali fication requirements are described in Section 1.4, shall establish the audit personnel qualifications appropriate to the nature and scope of the work to be performed and the importance of the activities being audited.

Personnel shall be selected for QA auditing assign-ment s based on experience or i raining which est ab-lishes that t heir quali fications are conunensurate l

with the compicxity or special nature of the activi-Lies to be audited.

2.7.6 The supplementary and nonmandatory guidance on the qualification, education, and experience of audi t personnel set forth in Supplement 2S-3 and Appendix 2A-3 respectively of ANSI /ASME NQA-1-1979, " Quality Assu rance Program Requirement a for Nuclear Power Plan ts," will be followed.

The QA Manage.r will maintain auditor qualification records as recom-mended in ANSL/ASME NQA-1-1979.

2.7.7 The QA Hananer or his desinnee shall mon i t or the perloimance of quality eclated activities within the scope of t his QA Program to verily that ilNDC person-t nel are aderpia t el y spral i f ied.

The QA Mananer should maintain a written record o f t hese soni toriiig activities.

..NDC -0NA)

Page _2.!2. of W3

No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages 8

4.8 Management Reviews 2.8.1 The Manager, Administrative Services, shall review the status and adequacy of the QA Program at least once every 12 months and report the results of that review to the Vice President & General Manager.

2.8.2 The Vice President & General Manager may equire the QA Manager and other departmental managers to make fo rma l recommendations with regard to the ade-quacy of QA Program policies and practices and HNDC's compliance with these policies ar.d practices.

t These recommendations shall becer.e part of the for-mal record of review of program ef fectiveness which shall be maintained by the Manager, Administrative Services.

2.8.3 The purpose of the management review is to assess the scope, implementation, and e f fectiveness of the QA Program to assure that the program is adequate and complies with the applicable requirements of 10 CFR 71, Appendix E.

4.

H NDC-02(A)

P,ae 2_Z nr89

No.

Rev.

Date

Title:

HNDC-C-200 0

LO/20/8 )

Quality Assuranct Program for the Use of Radwaste Si.pping Packages TABLE 2-1 DEFINITION OF TERMS certificate of complianc.e Form NRC-618 issued by the NRC for radioactive materials packages under 10 CFR Part 71 certificate of conformance See ANSI N45.2.13-1976, " Quality Assur-ance Requirements for the Control of Procurement of Items and Services for Nuclear Power Plants" package See 10 CFR 71.4 package approval A license or certificate of compliance issued by the NRC for packaging of type B, large quantity, and fissile radio-active material under 19 CFR Part 71 user Each person authorized by a specific j

license issued by the'NRC to recieve, possess, use, or transfer licensed ma-terials to a carrier for transport or transports such material oustdc the confines of his plant or other place of use should A recommendation shall A requirement that must be complied with as part of the QA program will An indication of an intention to carry out a particular action even though that action is not a requirement of the QA Program 4

H NDC-02(A )

Pogo.2d of80

No, Rev.

Date

Title:

HNDC-C-200 0

10/20/81)

Quality Assurance Program for the Use of Radwaste Shipping Packages Table 2-2 4

Matrix of HNDC Procedures uol2r2 ado 9 3uitpueH M1 3 200*W-3GNH 21eday 9 asueuasulew yse3 100-N-3GNH (8N33) sasf20N

/(sqq2) s2sanbay a3uey3' Su t, aauT3u3 100-3-3GNH me2302d,a00g.3;2, 5

5 2

(usisaq) 5 582302d YD 001-3-3GNH in suama3euew d

splosa3 Yb 900-3-3CNH 5

s2ap20/suoT21sinbay y

aseys2na jo to22uo3 9 uoisesede2d SCO-3-3CNH

.a -_

suoisesi;isads Jo Io22uo3 y

9 uo12ezeda2d 700-3-3CNH E

xapul sasoj 3GNH C00-3-3GNH sIenueH 3CNH Jo lo22uo3 g00-3-3cNH sa2npaso2d ant 2

.e22stuimpy 3cNH Jo to22uo3 9 uoiseavdaad 100-3*30NH 3'UIl 9 339WAN 33n03303d

/

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3 xIcN3ddy tar 01 H NDC-02(A)

Page.:;n of _ra.__

No.

Rev.

Date

Title:

HNDC-C-200 0

10/ 20/8 )

Quality Assurance Program for tne Use of Radwas te Shipping Packages SECTION 3 DESIGN CONTROL 3.1 Scope 3.1.1 The requirements of this section shall appiy to changes made to llNDC packages that have been de-signed in accordance with the provisions of IINDC's Quality Assurance Program for the Engineering, Design, Procurement, Fabrication, and initial Test-ing of Radwaste Shipping Packages or satisfy the provisions of 10 CFR 71.51(b) or (c).

3.1.2 This section establishes measures to insure that proposed changes to package structures, components, parts and/or design charact eristics are reviewed by qualified individuals, including QA personnel, prior to implementation to insure that the proposed change does not violate the conditions of the pack-age approval.

3.1.3 This section si so establishes measures to insure that proposed changes or amendments to the package approval are prepared, reviewed and approved in accordance wit h the applicable requi rement s of 10 CFR 71, Appendix E.

3.1.4 The requirement s of, this secticn db. not ap" ply to routine maintenance activities including replace-ment in kind of components and parts.

l H NDC-07(A)

Poae l!! of_di.__

No, Rev.

Date

Title:

HNDC-C-200 0

10/20/8 3 Quality Assurance Program for the Use of Radwaste Shipping Packages 3.1.5 Regardless of the type of package, component or part, or its function or the extent of the design change, every proposed package modification must be reviewed to determine whether the modificatior.

or the results of the modification will constitute a change to the package approval.

4 3.2 Responsibilities 3.2.1 HNDC, as owner of the approved package, shall review and approve all proposed modifications to HNDC packages.

3.2.2 Anyone, including user personnel, may propose a modification to ilNDC packages.

Such proposed modifications must, however, be processed in accordance with the t equirements of this section.

3.2.3 Proposed package modifications shall ine reviewed by the QA Manager or his designee prior to imple-l mentation.

1 3.3 Procedure j

3.3.1 An Engineering Change Request (ECR) form shall be used in accordance with the applicable requirements of Engineering Department procedures to document and cont rol t he processing of all package modi fica-tions.

~

3.3.2 Anyone, incimling IINDC or user pervionnel, may initiate an ECR.

Use'r personnel should contact the QA Manager who will assume responsibility for initiating an ECR as appropriate.

H NDC-02(A)

Page _11. of 89

No.

Rev.

Date iitle:

HNDC-C-200 0

10/20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages 3.3.4 The engineer performing the evaluation shall study the package license application and safety analysis and the NRC package approval to determine if implementation will require a change to the pack-age approval; in other words, the modification will change the package as designed and/or analyzed in the license application and described in the package approval.

3.3.5 The engineer shall prepare a written justification, including a list of factors he considered in his evaluation and any calculations, supporting his conclusion as to whether or not a license amendment is required.

This conclusion shall be indicated on the ECR.

Proposed package modi fications shall be

'sumed to require a license amendment unless it can be clearly justified that such an amendment is not required.

3.3.6

'the QA Manager and the Manager, Systems & Equipment Deaign shall review the engineer's conclusion prior to 1.iplementation of this change.

This review shall be documented on the ECR.

3.3.7 The Vice President, Engineering, shall approve proposed changes primarily for cost and impact on company operations.

3.3.8 Engineering and design activities required in order to implement approved ECRs shall be controlled in accordance with HNDC-C-100, "Qualjty Assurance Program for the Engineering, Design, Procurement, Fabrication, and Initial Testing of Radwaste Sys-tems and Equipment," so as to ensure that controls H NDC-07(A)

Pege _32 of 89

I No, Rev.

Date

Title:

HNDC-C-200 0

10/ 20/8 )

Qu lity Assurance Program for the Use of Radwaste Shipping Packages over design activities for package modifications are commensurate with those applied to the original 1

design.

f 3.3.9 The QA Manager shall be responsible for verifying that documents, including drawings, procedures,

)

manuals, etc., af fected by the package modi fication are changed in accordance with document control requirements described in Section 6.0 of this procedure.

3.3.10 Engineering documents that include technical infor-j mation related to the design change shall be main-tained as a quality record in accordance with the requirements described in Section 17.0 of this pro-cedure.

I

.i 1

l J

-(.

i H NDC-02(A)

Page.ll of 89

n No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages SECTION 4 PROCUREMENT DOCUMENT CONTROL 1

)

4.1 Scope and Applicability 4.1.1 This section delir. cates the sequence of actions to be accomplished in the preparation, review, approval j

and control of procurement documents used for the purchase of items and services for HNDC packages.

Purchased items consist principally of replacement parts, for example, studs, nuts, and gaskets.

Ser-vices may include, for example, repair welding or certain nondestructive examinations.

4.2 Procedure 4.2.1 Items and services shall be purchased in accordance with the requirements of this section and the applicable requirements of HNDC procurement procedures.

4.2.2 The requisitioner shall be responsible for review-ing the requirements of the package approval, in-ciuding drawings and speci ficat ions, and ident i fying Ihe speciiie requiremeuts ior ihe i t ems.md services to be procured.

4.2.3 The requisi t ioner sha.i t be respondible fo r' inco r-

~

porating and/or referencing the following in a pur-chase requisition:

H NDC-07(A)

Pona 3.{t. oL M9

No, Rev.

Date

Title:

HNDC-C-200 0

.0/ 20/ 8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages (a) a statement of work to be performed by the supplier; (b) technical requirements including applicable regulatory requirements, material and compo-nent identification requirements, drawings,

specifications, codes and indust. rial standards, test and inspection requirements, and special process instruction; (c)

QA requirements, specifically the requirements of 10 CFR 71 Appendix E, appropriate to the items or services being procured; (d) the documentation (e.g., d-awings, specifica-tions, procedures, inspection and fabrication plans, inspection and test records, personnel and procedure quali ficat ions, mat erial certifi-ca t. ions, e t.c. ) to be available f or review or submitted to llNDC for information, review cc approval; (e) a statement of IINDC's requirements for access to the supplier's facilities and records for source inspection and audit.

4.2.4 When the i t em's con formance to technical require-ments can he verified upon receipt by inspection, t est. or ut her suitable means, the re<pii remen t s o f 4.2.3(c), (d), and (c) may be waived by the QA Manager a f t er reviewing the procedp,res to be used

~

for such verification ~ activities.

H NDC-0?(A)

Page _31 of Ji9_._

l No.

Rev.

Date

Title:

HNDC-C-200 0

LO/ 20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages 4.2.5 When a Certificate of Conformance is used to accept an item or service the requi rements of 4.2.3(c),

(d), and (e) may be waived by the QA Manager af ter verifying and documenting that the supplier's cer-tification system is acceptable.

The purchase requisition shall include the requirement that a Certi ficate of Conformance be submitted by the supplier.

4.2.6 The QA Manager or his designee shall approve pur-chase requisitions for items and services subject to the requirements of this or Program.

4.2.7 Purchase requisitions, including attachments, and purchase orders requiring QA approval are quality records and shall be controlled in accordance with the requirements of Section 17 of this procedure.

t H NDC-02(A) -

Panelt. of 89

No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/8C Quality Assurance Program for tne Use of Radwaste Shipping Packages SECTION 5 INSTRUCTIONS, PROCEDURES, AND DRsWINGS 5.1 Policy 5.1.1 Activities subject to the requirements of this QA Program shall be prescribed by documented instruc-tions, procedures, or drawings of a type appropriate to the circumstances and accomplished in accordance with such documents.

5.1.2 These documents shall include, when necessary to ensure quality, appropriate quantitative and/or qualitative criteria for determining whether or not an activity has been satisfactorily accomplished.

5.2 Responsibilities 5.2.1 individuals or groups, including IINDC or user per-sonnel, responsible for performing quality related activities shali insure that written and approved instructions, procedures, and drawings appropriate to the circumst ance are available prior t o under-I a lc i n J', Ihe activiiy.

5.2.2 The QA Manager :;hal I veriIy by audit that ae ivities controlled by I h i:: QA l's one am a t e p c'.cribed by documented i nst ruct ions, p rocedu rds, and drawings, as required by this section.

n H NDC-02(A)

Page _11 of 59

f i4 Rev.

Date

Title:

hdDC-C-200 0

10/20/80 Quality Assurance Progran for the Use of Radwaste Shipping Packages

't 5.2.3 HNDC instructions, procedures, and drawings pre-scribing activities subject to the requirements of this QA Program shall be reviewed and approved in accordance with requirements described in Section 6.0 of this procedure.

5.2.4 Instructions, procedures, and drawings prepared by and prescribing user activities should be reviewed by the user's QA organization.

HNDC should, however, be informed of such activities.

5.2.5 A contractor or supplier responsible for an activity subject to the requirements of this QA Program shall be required in procurement documents to pro-vide the instructions, procedures and drawings ap-propriate to the activity being accomplished.

HNDC may require the submittal of such documents for re-view and acceptance prior to undertaking the activi-ty.

Such a requirement will be identified iri pro-curement documents.

H NDC-02(A)

Pacelli of 84

1 No.

Rev.

Date

Title:

HNDC-C-200 0

1.0/ 20/8 3 Quality Assurance Program for the Use of Radwaste Shipping Packages SECTION 6 DOCUMENT CONTROL 6.1 Policy 6.1.1 The review, approval and issue of document s, includ-ing changes thereto, which prescribe activities sub-q

.i ec t t o the requirement.s of this QA Program shall be controlled in accordance with written procedures or ins t ruc tions.

6.1.2 Changes to documents subject to the requirements of this section shall be reviewed and approved by the same organizations that performed the original re-view and approval.

This requirement. may be waived in writing by t.he QA Manager.

The writ ten waiver shall be maintained as part of the record of docu-ment revision.

6.1.3 Documents subject to the requirements of this sec-tion wtll be available for use at the location j

where the prescribed activities are performed.

(>. 2 General 6.2.1 Qualiiy related documents, ineluding instructions, i

procedu ren, d rawi ngs, and speci fical ions are con-l trolled by written procedures.

These proc'edures, along with many of the documents controlled by them, are incorporated into several !!NDC manuals, as il-l lustrated in Figure 6-1.

l H NDC-02(A)

Pagel2 or d9_

l

No.

Rev.

Date

Title:

HNDC-C-200 0

LO/ 20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages 6.2.2 The QA Manager shall be responsible for the issuance and control of the manuals illustrated in Figure 6-1.

6.3 IINDC Quality Assurance Manual 6.3.1 The !!NDC Quality Assurance Manual illustrated in Figure 6-1, includes controlled copies of the fol-lowing procedures:

(a)

IlNDC-C-100, " Quality Assurance Program for the Engineering, Design, Procurement, Fabrication, and Initial Testing of Radwaste Systems and Equipment."

(b)

IINDC-C-200, " Quality Assurance Program for the Use of Radwaste Shipping Packages."

(Note:

IINDC-C-200 may be omitted when not applicable t o t.he services being of fered or provided to an ilNDC eIient).

(c) other llNDC procedures from the IINDC Procedures Manual determined appropriate for inclusion in the Rad Services Manual - Quality Assurance by the QA Manager for purposes of information for the users of HNDC packages.

6.3.2 The llNI)C Qua l i l y A:, tu r nice Manua l is intcauled to ensure that l>ot h IINI)G and user personnel have ready access to a description of the QA policies and practices related to t he design and use of IINDC

~

packages.

d Gl:

fq a t

H NDC-02(A)

Pageltd. of M0 f

No.

Rev.

Date

Title:

HNDC-C-200 0

10/ 20/80 Qual.ity Assurance Program for the Use of Radwaste Shipping Packages 6.4 liNDC Procedures Manual 6.4.1 The ilNDC Procedures Manual contains a variety of technical and administrative procedures governing the operation of !!NDC.

A number of these proce-dures describe measures for control over activities subj ec t to the requirements of this QA Progrcm, in-cluding activities related to document control.

These procedures are ideptified in dection 2.0.

6.4.2 The QA Manager has the right to review and comment on any procedures that include measures for the control of quality related activities subject to the requirements of this QA Program.

6.5 Cask Manuals 6.5.1 Cask Manuals illustrated in Figure 6-1 include specific inLormation and data f or t he various IINDC packages.

6.5.2 Each manual will include, as a minimum, the following:

(a)

A copy of the latest revision of the NRC Certificar; of Compliance for the particular model shipping package including a copy of Ihe NRC transmitIal Ietier and ali enelosures thereto, a copy o f a l l drawings referenced in t he Cert i ficat e of Compliance, and a copy of all ot her re ferences identi f. ipsi in the Cert i fi-

~

cate with the exception of rules, regulations, and standard:4.

h

$&IW(d 1 H NDC-02(Ai Page 41 of 89

""D U h b

N r,.

Rey, Date

Title:

HNDC-C-200 0

l0/ 20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages (b)

Copies of procedures and/or checklists describ-ing requirements and methods for certain spe-cific activities, e.g.,

periodic maintenance, inspection, repair, handling, loading, and un-3 loading.

6.5.3 Cask Manuals may also include other informat ion of a general n.;ture regarding package design and use.

This informat ion shall be separated from the i n fo r-mation described in section 6.5.2 and shall be pre-faced with a written statement indicating that such data is for information purposes only and that it shall not be used as the basis for control over any quality related activities.

6.6 Rad Services Manual - General 6.6.1 Th. Rad Services Manual - General contains informa-

t. ion o f a gene ra l coimine rc i.il nature not subject to or controlled by this QA Program.

(.

HNDC-02(A)

Page 42 of 89

1 No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/8 0 Quality Assurancc Program for tne Use of Radwaste Shipping Packages Figure 6-1 HNDC Manuals r-e --

r--

g RAD

'f; HNDC fI HNOC

$ERVICES It!

CUAllTY 93 PR3(EDURES ll MANUAL

[

ASSURANCE MANUAL y

MANUAL

i h

I; h

9 CENERAL k

jil' hi l

r r------

~

r_

n :. :+.

HN 100 $

i HN 100 I

HN 100 HN 200 HN 600 g33g SERIES I i;

SERIE! 2 k

M

1. 'I

j. '

r, J

tl I

e CERTIFICATES OF COMPLIANCE e LICENSE APPilCATION ($AFETY ANALY$l$)

e DESCRIPTtyE DATA e SPECIAL INSTRUCTION $

e PACKAGE ORAWINGS l

?

4 e

H NDC-02(A)

Paces of d9

No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/8 3 Quality Assurance Program for the Use of Radwaste Shipping Packages SECTION 7 CONTROL OF PURCllASED MATERIAL, EQUIPMENT, AND SERVICES 7.1 Scope 7.1.1 This section describes the measures that have been established to ensure that replacement items purchasec for HNDC packages conform to the procurement docu-ments prepar4d in accordance with the requirements of Section

4. i.

7.1.2 The measures described in this section shall also apply to the acceptance of services, such as third party inspection, engineering and consulting ser-vices, and installation, repair, and overhaul or maintenance work associated with packages in use to the extent that such services involve activities subject to the requirements of this QA Program.

7.2 Reeiirements 7.2.1 The measures established by HNDC to ensure that purchased items and services for packages in use conform to procurement documents place re1innee on examinat. ion of product.s upon delivery and veri l ica-t ion. t hat document.iry evidence exists and is avail-

~

able prior to use showing that i t@ts con form to specific requ i reme n't s'.

These measures are con-sidered appropriate, sufficient, and consistent H NDC-02(A)

Pcae 44. of 0.9...

No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages with the importance, complexity, quantity, and cost impac t o f

'.he replacement items and services that may be purchased for packages in use.

7.2.2 The policy stated in section 7.2.1 notwithstanding, the QA Manager shall be responsible for evaluating on a case-by-case basis the need for supplementary measures to control purchased items and services, including evaluation and selection of procurement sources prior to award of contract and evaluation and verification of suppliers performance, including source surveillance and inspection.

These measures may be required when the quality of the item cannot be adequately verified through documentary evidence or inspections upon receipt.

7.2.3 The supplementary requirements and nonmandatory guidance for control of purchased items and services set forth in supplement 7S-L and Appendix 7A-1 res-pectively of ANSl/ASME NQA-1-1979, " Quality Assurance Program Requirements for Nuclear Power Plants," will be followed.

7.2.4 The QA Manager shall perform the ev-'uation de-scribed in section 7.2.2 prior to ap[ roving quality related purchase requisition for further processing.

i 7.2.5 1 t.em con formance to procurement requirements may be determined in accordance with section 7.2.1 by receivtag inspection only or by a combinat ion of receiving inspection and a supplidr" s Certi ficate of Conformance that specified requirements have been met.

HNDC 02(A)

Penell of 31

' I No.

Rev.

Date

Title:

HNDC-C-200 0

LO/ 20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages 7.2.6 Verification of item or service conformance to procurement requirements solely by receiving inspec-tion will only be considered when the items or services:

(a) are relatively simple or standard in design, manufacture, and test; (b) are adaptable to standard and easily verifiable inspections and/or tests o f the end product to verify quality characteristics af ter delivery; and (c) are such that receiving inspection does not require operations which could a f fect the in-tegrity. function, or cleanliness of the item.

7.2.7 Verification of item or service conformance to procurement requirements by a combinat ion of receivinf inspection and a supplier's Certificate of Confor-man _c shall be satisfactory when the item or service is of simple design and involves siandard materials, processes, and tests.

However, specific supplemental documentation such as material certificates or test reports shall be required as appropriate by procure-ment documents.

'lhe QA Manager shall be responsible for speci fying requirements for suppl ier Cert i ficates of Con f ormance and supp ' mentary document at ion in purchase requisitions.

7.2.8 When a suppl i er's Cert i ficate o f yo,n formance is required by the purchase requisition, the require-ments set forth in Section 8.2.l(a) through 8.2.1 (e) of Supplement 75-1 of ANSI /ASME NQA-1-1979 shall be communicated in writing to the supplier.

- H NDC-0?(A )

_ Page h.fi. of 89

No.

Rev.

I Date l

Title:

HNDC-C-200 0

10/20/8 3 Quality Assurance Program for tne Use of Radwaste Shipping Packages 7.2 9

'I Certi ficates of Con formance attest ing t o the acceptance of items or services shall be avail-able prior to install 'lon or use of the item or equipment.

7.2.10 The QA Manager shall be responsible for verifying the validity of supplier Certificates of Conformance and evaluating the ef fectiveness of the supplier's certi fications system.

Such verifications shall be conducted (e.g., during performance of audits of the supplier) at intervals commensurate with the supplier' s past quality performance and the importance and complexity of the purchased items.

Ve ri fica tion activities and results shall be documented, e.g., by written memoranda, and maintained in a file for the supplier.

7.2.11 The QA Manager shall maintain a list of suppliers whose certification systems have been evaluated and determined to be effective.

This list will be re-viewed at least annually by the QA Manager and determinations made regarding the need to reevaluate each supplier or remove any supplier from the list.

Ltems may be purchased from suppliers on this list witbout reevaluation of their certification system.

7.2.12 Receiving inspections shall be the responsibi l i t y o f the QA Department.

7.2.13 Receiving inspections shall be coordinated with the review of supplier documentation when procurement documents require such documentation to be furnished.

H NDC-ONA)

Peg,4 7_ nr 39..

i

No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages MosV replacement items purchased for packages in use

,7.2.14 are simple and standard in design (e.g.,

studs, nuts, washers, gaskets, etc.) and can be adequately inspect ed by QA Depart ment personneI without fo rma I wri t t en inspection checklists.

The need for written inspection checklists, however, shall be determined a case-by-case basis as part o f the QA Manager's review of purchase requisitions.

When it is deter-mined that special inspection checklists are necessary to ensure t he qual i t y of inspect ion activitles Ihe QA Mar.ager shall be responsible for having written checklists prepared, for reviewing and approving

t. hose checklists, and for havi ng

t. hose checklists available at the inspection location.

7.2.15 In certain cases involving procurement of services only, service may be accepted by any or all of the following methods:

(a) technical verification of the work performed and results; (b) surveillance and/or audit of the activity; (c) review of objective evidence for con formance to the procurement document requirements.

7.2.16 l' roc u remen t documents include st at ement s requiring suppliers to not i fy llNDC, speci ficaI1y t he QA Manager, of any deviat ions from the requirements ot' the procurement documents that the sppplier. intends to incorporate in the item or service to be of fered for H NDC-02(A)

Page13. of 89

No.

Rev.

Date T'de:

HNDC-C-200 0

LO/ 20/ 8 )

'uality Assurance Program for tne i

of Radwaste Shipping Packages i

i acceptance by HNDC.

The documentation and dis-position of such deviations shall be controlled in accordance with the requirements of Section 15.0 of this procedure.

i.

H NDC-07(A) -

Pc ce h_.9_ nr89

o No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages SECTION 8 LDENTLFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS 8.1 Applicability 8.1.1 The requirements of this section apply to the iden-tification and control of replacement items (e.g.,

studs, nuts, and gaskets) used in HNDC packages.

8.2 Policy 8.2.1 Replacement items shall be identified through all phases of receipt, storage, issue, and use or in-stallation to ensure that only correct and accepted items are used in llNDC packages.

8.2.2 The i<lenti ficat ion of replacement items for ilNDC packages shall be traceable to appropriate documen-tation such as drawings, specifications, purchase requisitions / orders, and manufacturing and inspec-tion documents that establish requirements'fer the item and document and how those requirements were sat is fied.

8.2.3 The identi f icat ion of replacement items shall be maintained either on the ilem or on records Lrace-s.

able to the item to preclude use df. incorrec t. or de fec t ive items.

H NDC-02(A)

Peqe.l.Q. of 89

No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/8 )

Quality Assurance Program for che Use of Radwaste Shipping Packages 8.2.4 When parts marking is used, it must be clear, unam-biguous, indelible and it must tot affect the fit, function or quality or the item.

8.2.5 The correct identification of replacement items shall be verified during receiving inspection and/or prior to installation or use.

8.2.6 Control and identification of replacement items shall be the responsibility of primarily the QA Manager and the Maintenance Supervisor.

8.3 Procedure 8.3.1 The QA Department shall maintain a segregated and controlled access storage area for replacement items for HNDC packages.

8.3.2 The QA Manager shall maintain a list of persons authorized access to the QA controlled storage area.

Access will be controlled by key lock.

8.3.3 Only replacement items issued by QA from the con-trolled storage area should be used on packages.

8.3.4 Use of replacement items other than those issued by QA must l>c approved l>y t he QA Hanager.

The require-ment s of sect ion 8.2 most lie sat is t ied prior io use oi'such items.

8.3.5 ldenti ficat ion of replacement i t en(s. c r.te red into,

~

main tained in, and 'is' sued f rom the QA controlled storage area as well as certain other items stored outside the controlled storage area with the approval H NDC-02 /A )

Page 31 of T2

No.

Rev.

Date

Title:

HNDC-C-200 0

LO/ 20/ 8')

Quality Assurance Program for tne Use of Radwaste Shipping Packages of the QA Manager is through the use of tags attached to each item or lot.

In addition, marking; may appear on an item as required by purchase specifi-cations which serve to identify certain character-istics (e.g., material) of the item.

These markings are verified during receiving inspection.

4 8.3.6 The tag used to identify replacement items is shown in Figure 8-1.

This tag comes in three colors;

namely, Yellow - Pending 4

Red - Hold / Reject Green - Acceptance 8.3.7 The QA Manager shall maintain a log of all tags used.

Tags may be applied and removed only by the QA Manager and other individuals designated by the QA Manager and identified in the Tag Log.

8.3.8 Replacement items received at the HNDC storeroom and awaiting receipt inspection and acceptance are identified by a yellow tag.

This tag must not be removed unless it is replaced with either a green or red tag as appropriate.

8.3.9 Yellow tagged items may be placed in the QA control-Led storage area but shall be separated as much as

~,,

possible from green tagged items.-(.

8.3.10 Receipt inspections shall be performed in accordance with the requirements of section 7.

Replacement items found acceptable may be green tagged.

H NDC-02(A)

Pane.51 or 49.__.

1 i

No.

Rev.

Date

Title:

HNDC-C-200 0

LO/ 20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages 8.3.11 Nonconforming items shall be red tagged and proces-sed in accordance with the requirements of Section 16.

Red tagged items may remain in the QA control-led storage area but shall be physically separated from green and yellow tagged items.

8.3.12 only green tagged replacement items shall be issued for use from the QA controlled storage area.

8.3.13 When one or more items are issued f rom a lot that has been green tagged the item or group of items shall be green tagged with a tag identical to the original lot tag with the following change:

under

" QUANT." identify the quantity of the items issued.

8.3.14 Green tagged items leaving the QA controlled storage area shall be logged on the Cask Materials Log sheet i

( form HNDC-08) shown as Figure 8-2.

This log shall be controlled by the QA Manager and maintained in the QA controlled storage area.

8.3.15 Only green tagged replacement items may be used with HNDC packages.

It shall be the responsibility of the Maintenance Supervisor to ensure that the tag number is entered on maintenance work requests orders related to package maintenance and repair.

8.3.16 linoned i i em:. retutned Io I he QA con t rol l ed ni o rar,e area shall be yellow tagged and visually reinspected prior to use.

A new green tag will be prepared for those items found acceptable fo r us e.

- t.

HNDC-02(A)

Page_11 of 89

_y

No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/8 )

Quality Assurance Program for tne Use of Radwaste Shipping Packages 8.3.17 Individuals issued replacement items from the QA controlled storage shall be responsible for ensuring that tags attached to the items are not lost, rais-placed and/or damaged.

Items not properly tagged shall be returned to the QA controlled storage area and yellow tagged.

-(.

H NDC- 07(A)

Page5.6.,_ or 89

l No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/80 Quality Assurance Program for tne Use of Radwaste Shipping Packages Figure 8-1 Inspection Status Tag HITT!!AI QA

@PROJ.

@.0.

. _ @ !O. _

@P/II __.

_. ___ ____.@AtA :T.

@SUPPLIEn._______

@in0P. n _._

____@I2 ULT 3

@ilanR.ctcars:

Each inspection tag will be completed as follows:

(l)

Project - Enter cask model number.

(2)

P.O.

- Enter HNDC purchase order number.

Additionally, on items procured for use as part of a certified trans-portation cask, the purchase order revision must be included (e.g., N3422d (2))

(3)

No. - Enter tag number as determined by the log main-taineu by the QA Manager.

(4)

P/N - Enter the purchase order item number.

(5)

Quantity - Self Explanatory.

(6)

Supplier - As noted on purchase order.

(7)

Inspected By - Enter initials of authorized QA repre-sentative.

(8)

Results - Enter as follows:

Green Tag

" ACCEPT,"

Yellow Tag "Il0LD," Red Tag "IIOLD" or " REJECT."

(9)

NGD Reports - List all applicable dispositioned CAM forms applicable to the item.

-(.

H NDC-02(A)

Page 55 or 89

No.

Rev.

Date

Title:

HNDC-C-200 0

LO/20/80 Quality Assurance Program for the Use of Radwaste Shipping Packages Figure 8-2 Cask Materials Log CASK MATERI AL,$ Lfr.

O Y

9 lssued to/

Checked out bv/

g j

Date Nteria Tescription

,g e,

Retur%d by Chacked in by Returned 1

mcc-tat A)

-i.

4 H NDC-02(A)

Pooe 16, or 89

j No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages SECTION 9 CONTROL OF SPECIAL PROCESSES 4

9.1 Requirements 9.1.1 Maintenance and repair of HNDC packages shall be controlled in accordance with documented instruc-tions, procedures or drawings of a type appropriate to the circumstances in accordance with the require-ments of Section 5.

9.1.2 Maintenance and repair activitie" may involve special processes, specifically welding, heat treating and/or nondestructive examinations.

9.1.3 The Maintenance Supervisor shall be responsible for developing written procedures, when required, fo r controlling welding operations and nondestructive examination and for qualifying such procedures as well.as equipment and personnel used in those activi-ties in accordance with applicable codes or standards as specified in the package Certificate of Compliance.

9.1.4 Welding and NDE procedures shall be reviewed by knowledgeable individuals wi t hin t he Engineering leepart ment s prior to use.

i he QA Manager sha l l verify that these reviews have been accomplished prior to authorizing use of specia(i, process procc

• dures.

Changes to welding and NDE procedures used for package maintenance and repair must be signed-of f by the QA Manager prior to use.

Additional

. H NDC-07 (A )

Pnoe J2 oFJ9

l i

No.

Rey, Date

Title:

HNDC-C-200 0

10/20/8 )

Quality Assurance Program for the Use of Radyaste Shipping Packages Engineering Department reviews may be required by the QA Manager.

9.1.5 The Maintenance Supervisor shall maintain control over welding procedures as well as qualification records of procedures, equipment, and personnel associated with those processes.

The Maintenance Supervisor shall ensure that those records are established, filed and kept current.

9.1.6 The QA Department shall be responsible for /erifying implementation of special process procedures to provide assurance the operators are qualified and that the approved procedures are being followed.

The QA Manager may define hold or witness points in special process procedures as appropriate.

v

-(.

i H NDC-02(A)

Pnc. 58 4 89

e No.

Rev.

Date

Title:

Quality Assurance Program for the HNDC-C-200 0

10/20/8 )

Use of Radwaste Shipping Packages SECTION 10 INSPECTION 10.1 Scope 10.1.1 inspection activities related to package use fall into the following three cat.gories:

(a).

inspections, including visual inspections and measurements, performed as part of normal periodic maintenance and as required by package Certificates of Compliance (e.g., seal inspec-tion prior to each shipment.)

(b) receiving inspections of replac'ement parts or materials prior to acceptance and use.

(c) independent verifications performed by QA Department personnel, including inspections and surveillance or monitoring of package use operations (e.g., maintenance, repair, package loading and unloading, etc.).

10.1.2 Inspect ions performed as a normal part of periodic maintenance and package shipment are controlled through the maintenance program and by package handling procedures.

Such inspections are not subject to the requirements of thQs section.

H NDC-02(A)

Page5_2 of 49

No.

Rev.

Date

Title:

HNDC-C-200 0

10/ 20/8 3 Quality Assurance Program for the Use of Radwaste Shipping Packages 10.1.3 Receiving inspections are performed by QA Department personnel in accordance with the requirements of Section 7 or this procedure.

10.1.4 The requirmaients of this section shall apply to verification of the quality of important activities related to the use of HNDC packages.

10...

Requirements 10.2.1 Quality verificntion may include, as appropriate, measurements and inspections, surveillance or monitoring, and reviews of the records or pe rform-ance of activities.

10.2.2 Responsibility for quality verification activities rests with the QA Manager.

10.2.3 The QA Manager shall determine when quality verifi-cation is required, the requirements for the veri-fication, the method (s) to be used, the schedule, and the personnel to be assigned.

10.2.4 Personnel assigned to perform quality verification activities shall be other than those who are per-forming or di rect ly supervising the activity being veri fied.

These individuals shalI not repo r t directly to the immeiliate supervisors, who ;i r e responsible for the activit'y being inspect

.l.

In general, individuals performing quali ty seri fication ac tivi ties wi ll be pa rt o f the QA.pppartmen t.

~

~.

H NDC-02(A)

Page 5!Q. of 89

No.

Rev.

Date

Title:

HNDC-C-200 0

LO/ 20/ 8 )

Quality Assurance Program for the Uce of Radwaste Shipping Packages 10.2.5 The QA Manager shall, by written memo, assign responsibility for performance of specific quality ve ri fica tions.

The memo should include, to the extent necessary, the foll2 wing in for: nation:

(a) identification of characteristics and activi-ties to be verified; (b) a description sf the method of verification; (c) identificat ion of the individual (s) responsible for performing the verification; (d) acceptance and rejection criteria as appro-priate; (e) identification of required procedures, drawings, and specifications and revision; (f) description of necessary measuring and test equipment including accuracy requirements.

10.2.6 Individuals assigned quality verification duties shall document the results of the verification on the memo and return it to the QA Manager.

10.2.7 The QA Manager shall m'intain a file of all quality veri ficat ion memos as a record of implement at ion of the quality verification program.

10.2.8 Provicions shall be established iq special process'

~

and repair procedures' for mandatory inspection hold points for witness by QA Department personnel.

l 1

H NDC-02(A)

Pec.j_L of.41

l

\\

i No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/80 Quality Assurance Program for the i

Use of Radwaste Shipping Packages These provisions provide for the review of such procedures by QA prior to use.

10.2.9 When quality verification activities are initiated by mandatory inspection hold points, a copy of the completed procedure with signoffs shall be placed in the quality verification file by the QA Manager.

10.2.10 QA hold and witness points in procedures shall be clearly marked in writing or by use of suitable stamps.

10.2.11 The QA Manager shall ensure that individuals assigned quality verification duties are knowledgeable in the activities to be verified and clearly under-stand the requirements of the quality verification The QA Manager may satisfy this responsibility memo.

by discussing the planned verification with the individual (s) to be assigned.

-(.

H NDC-07(A )

Pnc. 3 A 4 M G

No.

Rev.

Date

Title:

HNDC-C-200

-0 10/20/8 3 Quality Assurance Program for the Use of Radwaste Shipping Packages SECTION 11 TEST CONTROL 11.1 Scope and Applicability 11.1.1 Preoperational tests conducted during or upon com-pletion of package fabrication will be controlled in accordance with the requirements of IINDC-C-100,

" Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and initial Testing of Radwaste Systems and Equipment."

11.1.2 Tests conducted during package use other than non-destructive examinations controlled in accordance with Section 9 of this procedure shall be subject to the requirements of this section if those tests are required by the package approval to demonstrate that the package or part thereo f will perform satis fac-tority in service.

In general, such tests are not required.

I1.2 Regu i rem _en,ts 11.2.1 The QA Manager shall be responsible f or reviewing package approvals and identi f ying t he need for tests of packages and/or items used in packages.

Such testing may be required, fo r exami(1.e, fol1owing

~

pac kage mod i fi ca t io'ns', repairs, and/or part replace-l

' H NDC-07(A)

P,qe b_3, of 89 3

No.

Rev.

Date

Title:

HNDC-C-200 0

1.0/ 20/8 )

Quality Assurance Program for the Use of Radwas te Shipping Packages ments.

11.2.2 Testing required to demonstrate that items will per-form satisfactorily in service shall be performed in j

accordance with written test procedures which incor-po ra t e the requirements and acceptance limits con-tained in applicable design and licensing documents.

11.2.3 Test procedures shall include provisions for assuring that al1 prerequisites for the given test have been met, that adequate test instrumentation and equio-ment is available and used, and that the test i. s monitored and is performed uder suitable environ-mental conditions by competent personnel.

11.2.4 Test results shall be documented and evaluated to assure that test requirements have been satisfied, 11.2.5 The Engineering Department is responsible for pre-paration of test procedures and the review of test results.

11.2.6 The QA Manager shall review test procedures prior ' to use and incorporate hold or writers points as appro-priate.

I1.2.7 The Maintenance or Engineering Depart ment s wi i i generally be responsible for perf ormance of t est ing, when required, in accordance with documented and 1

approved procedures.

-(.

HNDC-02(A)

Page $ 1 of 8'4

No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages SECTION 12 CONTROL. Ol' MEASUR ING AND TEST EQUIP. MENT 12.1 Policy 12.1.1 Tools, gages, instruments, and other measuring and testing devices used in activit ies a f fect ing quality shall be properly controlled and calibrated and ad-justed to maintain accuracy within necessary limits.

12.1.2 Controlled measuring and test equipment may be cali-brated either at specified intervals or on a prior-to-use basis.

12.2 ResponsibiliLies 12.2.1 The organizarion (llNDC or package users) responsible for performing quality af fecting activities requir-ing the use of measuring and test equipment shall be responsible for establishing and documenting the mea-sures

• hat ensure that the requirements of this sec-tion are satis fied.

12.2.2 The QA Manager shall be responsible for reviewing IINDC activi t ies and ident il'ying the measuring and test equipment used by llNDC that must be controlled in accordance with the requirements of this section.

12.2.3 The Maintenance Department shall be responsible for control of measuring and test equipment used by liNDC personnel and subject to the requirements of this seetion.

H NDC-0?(A )

P-c:,h5. nr _ J9

i No.

Rev.

Date

Title:

HNDC-C-200 0

10/ 20/8 3

,uality Assurance Program for the Use of Radwaste Shipping Packages 12.3 Requirements 12.3.1 The method and interval of calibration of controlled measuring and test equipment should be based on the type of equipment, its stability characteristics, the required accuracy and other conditions affecting measurement control.

12.3.2 Controlled measucing and test equipment shall be cali-brated, adjusted and maintained against certified equipment having known valid relationships to nation-ally recognized standards.

If no national standard exists, the basis for calibration shall be documented.

if normal commercial practices provide adequate accuracy, special calibra?. ion and control measures are not required.

12.3.3 When controlled measuring and test equipment cali-brated at specified intervals are found to be out l

of calibration, the QA Manager may require that an evaluat ion be made and documented of the validity of l

previous measurements or tests performed wi th that equipment.

Such evaluations shall be required when the verification of the acceptability of items pre-viously measured, inspected or tested with that equipment is required to ensure that the package con-forms Io iis approv.il requirements.

12.3.4 Spec ial ca libral. ions sha t i be pe rt'ormed when ac-curacy of cont rolled measuring and t. cst. equipment is suspect.

Measuring and test equipment.consis-tently found to be ou't of calibration will be re-paired or replaced.

H NDC-02(A)

Page $5 of 89

No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/8 3 Quality Assurance Program for the Use of Radwaste Shipping Packages 12.3.5 Records shall be maintained and equipment suitable marked to indicate the calibration status for con-trolled measuring and test equipment.

1 s.

l HNDC-02(A) p,,n 67 nr 89

No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/80 Quality Assurance Program for the Use of Radwaste Shipping Packages SECTION 13 HANDLING, STORACE AND SillPPING 13.1 Applicability 13.1.1 The requirements of this section apply to purchased material and parts used as replacement items fo r llNDC packages.

13.1.2 The requirements of this section also apply to the handling, including loading and unloading, of HNDC packages.

13.2 Requirements and Responsibilities 13.2.1 Procurement documents shall include, as appropriate, requirements for handling, s t o rage, shipping, clean-ing, and preservation of purchased replacement parts and materials for ilNDC packages.

13.2.2 The QA Manager shall be responsible for reviewing the adequacy of handling, storage and shipping re-quirements speci fied in procurement documents for replacement iicms.

13.2.3 Weillen instructions for the handling, including loading, unloading and inspection prior to shipment of IINDC packages arc.inc1uded in dask Manu'ais as described in Section 6 of this procedure.

Use of these instructions ensures that. conditions o f the NRC package approval are satisfied prior to shir ment.

' HNDP -0?(A) c.... 6 3 t P4

j No.

Rev.

Date

Title:

HNDC-C-200 0

LO/ 20/8 3 Quality Assurance Program for the Use of Radwaste Shipping Packages 13.2.4 Responsibility for implementation of package handling instructions included in each Cask Manual rests with the package user.

-(.

HNDC-07(AI Pne,A2. or.._19_.

No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages SECTION 14 INSPECTION, TEST AND OPERATING STATUS 14.1 Requirements 14.1.1 The inspection status of replacement items purchased by llNDC and received, stored and issued through the HNDC storeroom and QA controlled storage area is maintained by the use of tags as described in Sec-tion 8 of this procedure.

14.1.2 The application and removal of tags used by llNDC is procedurally controlled in accordance with Section 8.

14.1.3

'The tagging system used by IINDC for replacement items provides for the identi fication of noncon forming items to prevent their inadvertent use.

14.1.4 The use of signs, labels, stamps, and other markings with packages shall adhere to the requirements of the package approval.

Provisions have been estab-lished for signs indicating the operating status of HNDC packages.

4.

H NDC-02(A)

P,ge _LQ of _d_,

No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages SECTION 15 i

i NONCONFORMING MATERIAL, PARTS OR COMPONENTS 15.1 Scope and Applicability 15.1.1 The requirements of this section apply to noncon-formances identified by suppliers of HNDC purchased replacement parts and materials and/or contractors providing quality related services to HNDC for HNDC packages.

i 15.1.2 Nonconformances identified by HNDC personnel during receiving inspection of replacement parts and ma-terials for llNDC packages shall be controlled as conditions adverse to quality in accordance with the requirements of Section 16.

15.1.3 Nonconformance of an HNDC package with the require-ments of the NRC package approval identified by HNDC personnel shall be controlled as a condition adverse to quality in accordance with the requirements of Section 16.

These requirements should also be ad-hered to by user personnel identifying such package nonconformances.

15.1.4 Procedural nonconformances and other conditions ad-g verse to quality that are not directly related to

~

package materials, pa.rts or compodents shdll also be controlled in accor'da'nce with the requirements of Section 16 of this procedure.

- H NDC-02(A)

Pace H. nf J2._

No.

Rev.

Date Utle:

HNDC-C-200 0

10/ 20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages 15.2 Requirements and Responsibilities 15.2.1 Suppliers furnishing replacement parts or materials for use in packages and contractors fabricating, erecting or installing materials or parts for pack-ages may be required in procurement documents to 4

establish procedures for the control of nonconform-ing items.

15.2.2 The responsibilty for specifying requirements in procurement documents for the control of nonconform-ing items by the supplier / contractor shall rest with the QA Manager.

15.2.3 When required by procurement documents, the supplier, upon identification of a nonconformance, shall be required to suspend the affected work until the nonconformance has been evaluated if:

(a) the continuance of the work would conceal the nonconformance and make corrective action dif-ficult or impossible, or (b) the nonconformance is due to the work procedure and continuing its use would increase the extent or severity of the nonconformance.

15.2.4 Suppliers and cont ract ors may be required in pro-curement documents to submit a description of noncon-forming conditions to llNDC using a Supplier Dis-position Request-(SDR) form ( form. fi,NDC-07 ).

' ~

. H NDC-02(A)

Page ZZ. nr.31.

)

NO.

Rev.

Date Title HNDC-C-200 0

10/20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages 15.2.5 The Supplier Disposition Request (SDR) form shall be processed as follows:

(a)

SDR's shall be forwarded initially to the QA Manager for evaluation.

(b)

The QA Manager shall assign a control number to the SDR and enter the number and date in an SDR log for followup control purposes.

(c)

The QA Manager shall determine if a technical review by the Engineering Department should be required.

l (d)

Wnen Engineering review is required both Engi-neering and QA shall approve the SDR dispo-sition action.

(e)

Upon completion of the SDR the QA Manager shall enter the close out date in the SDR log and forward the SDR to the Material Control Manager.

(f)

The Material Control Manager shall transmit the dispositioned SDR to the supplier or contractor and be responsible for legal / financial negoti-ations as required.

15.2.6 Noncon !'o rm i ng m.it c r i tii n, p.irts and componentn shalI be accepted, rejected, repaired or reworked as approprialc.

v 4.

15.2.7 Repaired and reworked items shall be reinspected to determine acceptability.

HNDC-02(A)

Pege _Z3. of 89

,g...._.

No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages 15.2.8 Engineering approval shall be required prior to re-pair of nonconforming materials, parts or components and prior to acceptance-as-is.

i 15.2.9 A description of the change, waiver, or deviation that has been accepted must be documented as a re-cord of the change and to denote the as-built con-dition.

i I

15.2.10 Control of nonconforming materials, parts and com-ponents shall include tagging, markitig, or other means of identification acceptable where physical segregation is not practical.

1 15.2.11 Nonconforming materials, parts and components shall not be used in packages if their use would con-stitute a nonconformance with the package approval.

1

.g.

~

4.

4

~ Hk tt,n?IA)

P..

-r'O'

No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages SECTION 16 CORRECTIVE ACTION 16.1 Requirements and Responsibilities 16.1.1 This QA Program has been established to provide adequate confidence that HNDC packages will perform satisfactorily in service.

Notwithstanding the program as instituted, conditions will occasionally occur which could cause a degradation of quality.

i Such conditions as failures, malfunctions, defici-encies (including design deficiencies and procedural deficiencies), deviations, defective material and equipment and nonconformances should be promptly identified and corrected.

16.1.2 In the case of significant conditions adverse to quality tne cause of the condition will be deter-mined if possible and species corrective action taken to preclude repetition.

In general, such special corrective action will be required where:

(a) noncon fo rmance report s indicate t rends due to inadequat e procedural cont rols ;

(b) exist.ing procedures cont rol iing i mpo rt a n t v

activities related to package 4,use are not be irig

~

properly implemented;

_ H NDC-02(A)

P,o,7.L 4 89

No.

Rev.

Date

Title:

HNDC-C-200 0

10/ 20/80 Quality Assurance Program for the Use of Radwaste Shipping Packages (d) recurring problems with nonconforming materials, parts or components are encountered; (d) conditions adverse to quality identified during audits or surveillance are not resolved to a satisfactory conclusion within a reasonable time.

16.1.3 The QA Manager shall be responsible for the control of conditions adverse to quality including perfor-mance of followup reviews to verify proper imple-mentation of corrective actions.

16.1.4 Significant conditions adverse to quality shall be reported to the Manager, Administrative Services, and the Vice President & General :.anager.

16.1.5 Package users should document and report conditions adverse to quality including nonconforming materials, parts and components, in accordance with the pro-cedure described in this section.

16.2 Procedure 16.2.1 Any individual encountering conditions adverse to quality shall notify the QA Manager by initiating or causing to be initiated a Corrective Action Memo (CAM) Form ( l'orm IINI)C-09 ) shown in Finure 16-1.

16.2.2 CAM control numbers shall be assigned by the QA s.

Manager or his designee.

The QA snager s'haii

~

maintain a log of a'11 CAM's.

1 l

H NDC-02(A)

N, 76 r M

No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/8 )

Quality Assurance Program for tne Use of Radwaste Shipping Packages 16.2.3 The CAM initiator shall identify the specific mate-rials, parts or components involved and/or procedures, drawi ngs, purchase orders, etc. that contain require-ments related to the adverse condition.

16.2.4 The CAM initiator shall list and describe the con-dition(s) adverse to quality and may provide recom-mendations as appropriate for resolution of the condition (s).

16.2.5 CAM's may be forwarded to the QA Manager directly or by mail, telex, or any other suitable means.

16.2.6 The CAM initiator shall sign and date the CAM.

16.2.7 The individual receiving the CAM for the QA Manager shall fo rwa rd it as soon as possible to the QA Manager or his designee.

16.2.8 The CAM initiator should retain a copy of the CAM transmitted to the QA Manager.

16.2.9 The QA Manager or his designee shall be responsible for designating one or more individuals within HNDC as an Action Designee.

The QA Manager shall sign and date the CAM and forward it to the Action Desig-nee (s) with appropriate i.ns t ruc t ions.

16.2.10 When more than one AcLion Designec is assigned separate copies of the CAM shall be forwarded to each Action Designee.

A s u f f i x l e,1,t e r ( i.e., A, B; j

C) shall be added to each CAM for identification purposes.

A notation shall be made in the CAM log.

H NDC-02(A)

Page ll of 8

No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages 16.2.11 The Action Designee shall be responsible for coor-dinating the resolution of the CAM including deter-mining cause and special corrective action to preclude repetition for significant conditions adverse to quality.

This responsibility includes obtaining the assistance as appropriate of other individuals or groups technically knowledgeable in Lne problem area.

16.2.12 The Action Designee shall describe the action taken or to be taken to resolve each condition adverse to quality.

Actual and planned close out dates shall be included.

16.2.13 The Action Designee shall sign and date the CAM when completed and return it to the QA Manager for review and acceptance.

16.2.14 A copy of the CAM shall be transmitted to the CAM initiator for review by him or his management as appropriate.

16.2.15 The QA Manager shall maintain a file of all CAM's and shall regularly. review the log of CAM's to en-sure that followup action is being taken in a timely manner.

16.2.16 The QA Manager shall be responsible for determining the distribution of completed CAM's.

The Vice President & General Manager shall receive a copy of all CAM's that docume.nt significan't. condit* ions ad-verse to quality.

H NDC-07(A)

N. 73 er 89 n

No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages Figure 16-1 Form HNDC-Q9 Corrective Action Memo Form

1. M **

HITTMAN NUCLEAR & JEVELOPMENT CORP.

CORRECTIVE ACTION MEMO Assigned by 11NDC QA Mgr.

Affected Eevioment Reference Documents

• [

p Description of Adverse Condition (s)/ Action Recommendatioes Dei e

0 Inifloted By (Nome /Componv)

Date QA Manager Review (Sign)

Date Action Description c,

',,,g

-(.

Action Designee (sign)

Date

' QA Monoger Review (sign)

Date H NDC-09(A)

H NDC-02(A)

Pone 79 f 89

No.

Rev.

Date

Title:

HNDC-C-200 0

10/ 20/8 )

Quality Assurance Program for tne Use of Radwaste Shipping Packages SECTION 17 QUALITY ASSURANCE RECORDS 17.1 Scope 17.1.1 The requirements of this section apply to records that furnish evidence of the quality of replacement parts and materials used in HNDC packages and of the quality of activities that fall within the scope of this QA Program.

17.1.2 Records related to the original design and fabri-cation of HNDC packages are controlled in accordance with IINDC-C-100, " Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and initial Testing of Radwaste Systems and Equipment.

17.1.3 Records subject to the requirements of this section include at least the following:

(a)

NRC Certificate of Compliance and all changes thereto including applications for license ammendments.

(b)

Copies of drawingn, specificalions, procedures, safety analyses and other documents reierenced in each package 1icense.

-(.

(c)

Procurement ret'o'rds incl ud ing purchase re-quisitions, purchase orders and specifications.

H NDC-02(A)

Page El of 49

No.

Rev.

Date

Title:

HNDC-C-200 0

LO/20/8 )

Quality Assurance Program for tne Use of Rad"aste Shipping Packages (d)

Supplier documentation including certificates of con formance, material certi fications, test reports, etc.

(e)

Personnel training and qualification records, as required, for ilNDC personnel performing activities within the scope of this QA Program.

(f)

Records of management reviews of QA Program e f fec tiveness.

(g)

Package design change records including com-pleted ECRs and supporting documentation.

(h)

Records of control of purchased items and ma-terial including receiving inspection reports, tag logs, and material issue logs.

(i)

Special process procedures and personnel certi-fication records.

(j)

Records of reviews of procedures, instructions and other documents as required by this QA Program.

(k)

Records of quality verification activities per-formed by QA Depart ment personnel, including witness and hold point inspections or waivers thereof.

(1)

Measuring and test equipment.gcalibration re-

~ v cords.

l

_ H NDC-02(A)

% dl 4 SL

>~

,,-ew---

No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/8 )

Quality Assurance Program for tne Use of Radwaste Shipping Packages (m)

Records of package inspections re quired to be performed by the package license.

(n)

Records of the identification and processing of nonconformances and other conditions adverse to quality including completed CAM's and sup-porting documentation.

(o)

Records of QA Department audits.

17.2 Requirements and Responsibilities 17.2.1 The QA Manager shall be responsible for preparation and maintenance of a Records System Index.

17.2.2 The Records System Index shall consist of a listing of document or record types (e.g., ECRs, CAM's purchase orders, certificates of conformance, etc) that contain information related to the quality of items and activities controlled by this QA Program.

17.2.3 The Records System index shall include the following in formation:

(a)

Record name and/or designation (b) filing or storage location (s)

(c) retention time requiremenLS

.v (d) records custodian, i.e., the hame o f 'the in-dividual responsible for the file H NDC-02(A)

Pan,02 er 89

e No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages (e) description of access control provisions, if any

( f) file verification frequency 17.2.4 Removal of records from files and from the immediate storage area shall be documented with record OUT cards.

These cards shall be placed in the storage location of the removed record and shall contain the following:

(a) identification of the record (b) name of individual removing the record (c) date of removal 17.2.5 Records pertaining to a particular HNDC package shall be retained for at least the lifetime of the package with the following exception:

only current records of certain maintenance, inspection, and parts replaccment activities performed on a repetitive basis are required to be maintained.

Records of the previous performance of such activities may be disposed of by the QA Manager af t er determination that they do not contain in formation pertinant to the enrrent condi t inn of I he pack.ine

• g.

H NDC-07(A)

P,,a 83 cr.J 9_.

8 0

No.

Rev.

Date

Title:

HNDC-C-200 0

10/ 20/80 Quality Assurance Program for tne Use of Radwas te Shipping Packages l

SECTION 18 AUDITS 18.1 Policy 18.1.1 Audits of this QA Program shall be performed:

(a)

To evalute compliance with the QA Program requirements, methods, and procedures (b)

To assess progress in assigned tasks (c)

To determine adequacy of performance (d)

To verify implementation of recommended corrective action.

18.1.2 Audits shall include evaluation of work areas, acti-vities, processes, and items and a review of docu-ments and records.

18.1.3 Audits shall be performed by competient individuals having no direct responsibility in the area being audited.

18.1.4 Audi ts shali be performed in accordance with pre-established written procedures or checklists.

.v i.

18.1.5 Audit results shall be documented and reviewed with management having responsibility in the area audited.

1 H NDC-02(A)

Pocad.h. M 89

No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/80 Quality Assurance Program for the j

Use of Radwaste Shipping Packages 18.1.6 Conditions adverse to quality revealed by the audit shall be documented and resolved in accordance with the requirements of Sect.on 16 of this procedure.

18.1.7 Deficient areas will be reaudited on a timely basis to verify implementation of correction actions.

18.1.8 All quality related functions are to be audited with-in a 12-month period or more frequently if appro-priate.

Documented customer audits may be counted in the implementation of this requirment.

18.2 Procedure 18.2.1 The QA Manager is responsible for planning, schedul-ing, conducting, evaluating, and documenting audits.

18.2.2 QA and non-QA Department personnel may assist the QA Manager with planning and implementing the ardit program.

These functions will be pe? formed, hov Jer,

'inder the direction of the QA Manager.

18.2.3 The QA Manager shall prepare and maintain an audit schedule.

The schedule shall include the following in formation :

(a)

A descript ion or list ing of t he major elements ol~ lhe QA l*rogram that must 13e tiud i l etl a t least annually (b)

The date and audit log numhec for the. last 4,

audit conducted for each element H NDC-02(A)

Pooe.$.1 ef 89

No.

Rev.

Date

Title:

HNDC-C-200 0

l0/20/8) quality Assurance Program for the

'ise of Radwaste Shipping Packages (c)

The planned date for the next audit for each program element.

18.2.4 The audit schedule shall be periodically reviewed and revised by the QA Manager as necessary to assure that coverage and schedule reflect current activities.

18.2.5 Unscheduled audits may be conducted by QA for one or more of the following conditions:

(a)

When it is necessary to determine the capabili-ty of a supplier's QA program prior to awarding of a contract or purchase order (b)

When significant changes are made in functional areas of the QA Program such as a significant reorganization or procedute change (c)

When there is evidence that the performance or reliability or package materials or parts is in jeopardy due to oeficiencies in this QA Program (d)

When a systematic, independent assessment of program effectiveness or item quality, or both, is necessary (c)

When it is necessary I o veri fy implementation of required corrective acLions.

18.2.6 Scheduled or unscheduled audits shall be conducted,

, y by using appropriately prepared ai/dit chec"klists.

The standard Audit Checklist form ( form HNDC-10) shown in Figure 18-1 may be used to prepare audit l

checklists.

l i

Hte C-07(A) p-,. 4 A

.c M

a No.

Rev.

Date

Title:

HNDC-C-200 0

LO/ 20/8 ]

Quality Assurance Program for the Use of Radwas te Shipping Packages 18.2.7 The auditor should review ' applicable portions of the QA Program description and other documents such as the package license, CAM's, previous audit checklists, procedures, specifications, codes, and standards to develop an audit checklist.

The checklist is intend-ed for use as a guide and should not restrict the audit investigation when findings raise further questions that are not specifically included in the checklist.

18.2.8 one or more individuals comprise an audit team.

The QA Manager shall select a leader for each audit team.

The team leader shall assure that the audit team is prepared prior to initiation of the audit.

18.2.9 Involved organizations shall be notified by the QA Manager of a scheduled audit reasonably in advance of the audit date.

This notification should be in writing and should inc.t.s' general information on the scope of the audit, schedule of meetings and method of audit.

Unannounced audits may be perform-ed.

18.2.10 A brief pre-audit conference should be scheduled with the cognizant orgnization management.

18.2.11 When any deficiency is found by an audi t further in-vestigation shall be conducted in an ef fort to iden-t i fy the basic cause of the de ficiency.

Elements found to be deficient should be acknowledged by a

~.

member o f the audited organizationg.,

H NDC-02(A)

Pace b.2_ of 59

4 e

No.

Rev.

Date

Title:

HNDC-C-200 0

10/20/8 )

Quality Assurance Program for the Use of Radwaste Shipping Packages 18.2.12 Deficiencies determind by the audit team leader to re-present conditions adverse to quality must be docu-mented on a CAM in accordance with the requirments of Section 16.

18.2.13 At the conclusion of the audit an exit interview should be held with management of the audited organi-zation.

An effort should be made to clarify misunder-standings and reach agreement on findings that consti-tute QA program deficiencies.

An ef fort should also be made to establish a tenatative course schedule for corrective action for each deficiency.

18.2.14 The audit team leader shall prepare an audit report listing the audit findings, items of understanding, and dates when corrective action is to be accomplish-ed and when response to the audit report is required.

The audit report shall be transmitted to the audited organization with a cover letter or memo signed by the QA Manager.

18.2.15 The Manager, Administrative Services shall receive a copy of all audit reports.

18.2.16 The QA Manager shall maintain an audit log to record entries of audits that were conducted.

The audit Iog number sluil I be assigned to andit checkIists used during the audit.

.v 4.

H NDC-02(A)

Page_!i6 of _89

w s

No.

Rev.

Date

Title:

H!iDC-C-200 0

LO/20/80 quality Assurance Program for the Use of Radwaste Shipping Packages Figure 18-1 Form HNDC-10 Standard Audit Checklist Form AU0!T CHECKL!$f Page or 5 0'98 " ' "'" 'ud ' * ;

'urco5' 5 5'30':

^ud Lo9 No :

R l:

Audit Date(s):

E Reference Coouieats:

Personnel contacted:

EftdRi a

Sureary Conclusiens:

1 Jtem Auctt Charactectstic Method of vertficatten

' Results l CA't 1

.?.

(PAR (D BY; CA MAf44GER APPROVAL:

4.

17812 H NDC-02(A)

Page E9_ of 89