ML20125D209

Working Paper Issue of Reg Guide 7.XX, Content of Description of QA Program for Use,Maint & Repair of Shipping Packages for Certain Special Form Radioactive Matl

ML20125D209
Person / Time
Issue date:	05/01/1978
From:	NRC OFFICE OF STANDARDS DEVELOPMENT
To:
Shared Package
ML20125D163	List: ML20125D160 ML20125D167 ML20125D173 ML20125D181 ML20125D189 ML20125D209 ML20125D508 ML20125D522
References
RULE-PRM-71-7, TASK-OS, TASK-TP-821-3 REGGD-07.XXX, REGGD-7.XXX, NUDOCS 8001140164
Download: ML20125D209 (13)

Text

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WORKIN , PAPER REGUI.ATORY GUIDE 7.XX CONTENT OF THE DESCRIPTION OF A QUALITY ASSURANCE PROGRAM FOR THE USE, MAINTENANCE AND REPAIR OF SHIPPING PACKAGES FOR CERTAIN SPECIAL FORM RADIOACTIVE MATERIAL A. INTRODUCTION

1. Scope Pursuant to Section 71.51, of 10 CFR Part 71, " Packaging of Radio-active Material for Transport and Transportation of Radioactive Material Under Certain Conditions," licensees must establish, execute and maintain a quality assurance program for shipping packages for transporting certain quantities of radioactive material.

The quality assurance program must satisfy each of the applicable criteria specified in Appendix E to 10 CFR Part 71,." Quality Assurance Criteria for Shipping Packages for Radioactive Material," and must also satisfy any specific provisions which are applicable to the licensee's activities concerning shipping packages. The general provisioca of the quality assurance program provide the administrative means of assuring

compliance with or completion of any specific provisions and must be -

based on the Appendix E criteria. It should emphasize features which are calated to radiological safety and performance of the package. The requirements of Appendix E should be applied in a graded approach, i.e.,

applied to an extent consistent with their importance to safety. The specific provisions, for the particular package under consideration, 90021188 7#

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including specific tests, operations, and a'eceptance criteria, are specified in Federal regulations and package approvals (see the following section of this guide, C. REGUI.ATORY POSITION, 2. Specific Provisions).

The purpose of this guide is to provide licensees, who are subject to the requirements of 10 CFR Part 71, with information on how to develop and describe a quality assurance program for the use, maintenance-and repair of shipping packages for certain special form radioactive material. It will also aid users of these packages in understanding and requiring quality assurance programs which are ad' equate to assure both safe and satisfactory service from each package.

2. Definition "Special form radioactive material" means that which, if released from a package, might present some direct radiation hazard but would present little hazard due to radiotoxicity and little possibility of contamination. This may be the result of inherent properties of the material (such as metals or alloys), or acquired characteristics, as through encapsulation (i.e., sealed source). The criteria for determining whether a material meets the definition of special fe m are contained in excerpts from 10 CFR Part 71 (See Appendix A of this guide). Plutonium (other than Pu-Be neutron sources), irradiated fuel and high level waste are excluded from this definition for the purpose of this guide.

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3. General Format The general format of the description of the QA program required by 10 CFR 6 71.51 is described below. Use of this'information will help ensure completeness in the proposed program and will assist }iRC staff in the review process.

An acceptable format for the description of the QA program required by 10 CFR S 71.51 follows:

3.1 Title Page. The title page should include the document title, and document number, and an identification of the licensee and his office location.

3.2 Revision Sheet. The revision sheet should contain a record of revisions of the document. Each revision should be dated and signed by a responsible management individual. (The revision number and signature may be located on the title page, if more convenient.)

3.3 Table of Contents. The table of contents should provide the major subject headings and their page locations.

3.4 Introduction. The introduction should contain any prefatory information desired- by the licensee; such as purpose, scope, authority, definitions, etc. '

1 3.5 Appendix E Criteria. The QA program should show how the pertinent I criteria of Appendix E are satisfied. Although not necessarily the only way, one method would be to, treat each criterion individually in a separate section. (See the following section of this guide, C. REGULATORY POSITION,

1. Description of QA Program (Applicable Appendix E Criteria).)

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l 3.6 Appendices. Appendices may be used for information such as,  !

organizational charts, matrices of accountability and responsibility, QA

. . 4 personnel qualifications, lists of reference documents or other pertinent information. .

1 B. DISCUSSION l

, 1. Pertinent Criteria i Section 71.51 of 10 CFR Part 71 requires a description of the quality assurance program to include a discussion of which requirements of Appen-dix E to 10 CFR Part 71 are applicable and how they will be satisfied.

J For the use, maintenance and repair of shipping packages for certain special form radioactive material, a description of a QA program should include, as a minimum, the following criteria form Appendix E to 10 CFR Part 71:

1.1 Organization 1.2 Quality Assurance Program 1.3 Document Control 1.4 Handling, Storage and Shipping 1.5 Inspecton, Test and Operating Status .

1.6 Quality Assurance Records 1.7 Audits

2. Graded Acoroach Section 71.51 of 10 CER Part 71 states that, "The pertinent require-ments of Appendix E should be applied in a graded approach, i.e., applied 9002: 1191 7.XX-4

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to an extent consistent with their importance to safety as described in Section 2 of Appendix E." The requirements in Appendix E should pr' ovide a graded control over each product or service and* the extent of this control should be in proportion to the degree of radiological safety that is required. This control should be sufficient to assure conformance to the asproved s design specifications of each individual package used for the shipment of radioactive material.

3. Responsibility .

The licensee who delivers a package to a carrier for transport'is responsible for determining that an adequate QA program for the particular package is in existence and that all quality assurance requirements have been met. The QA program must cover all aspects of the transportation package; design; manufacture, test, use, maintenance and repair. It is the licensee-user's responsibility to determine that all QA requirements for the package have been satisfied. Certifications that certain phases have been conducted in accordance with an NRC-approved QA program may be used. For example, a certification from a manufacturer that a QA program satisfying the criteria of Appendix E and satisfying the specific pro- ,

visions of the package design approval (which must be. applied in the manufacture of the particular package) may be used by the licensee-user.

However, it is the responsbility of the licensee-user to satisfy himself (and the NRC) that an acceptable program was in force during the manu-facture of the package.

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C. REGULATORY POSITION

1. Description of QA program (Applicable Appendix E Criteria)

The applicable Appendix E criteria for QA programs for the use, 5 maintenance and repair of shipping packages for certain special form radioactive material are: (1) Organization, (2) Quality Assurance Program, (3) Document Control, (4) Handling, Storage and Shipping, (5) Inspection, f

Test and Operating Status, (6) Quality Assurance Records, and (7) Audits.

These seven criteria represent a minimum cumber, for certain special form radioactive material. The licensee should determine if this minimum set is sufficient, and may use more criteria, other combinations of criteria or other equally-effective methods of addressing the Appendix E criteria for his QA program. -

1.1 Organization. The authority and duties of persons or organiza-tions performing quality assurance functions should be clearly established and delineated in writing. A statement that the licensee retains respon-sibility for the QA program should be included. The licensee's current organizational chart, which shows the interrelationship of the QA function to other management functions, should be provided. See Figure 1 for an ,

example chart. Each job function shown on the organization chart should be listed along with a concise statement of the QA responsibilities of that job function. A responsibility matrix may be provided in addition to this listing. See Figure 2 for an example responsibility matrix.

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PRESIDENT GDIERAL MANAGER QUALITY ASSURANCE MANAGER APPLICATIONS . FIELD OPERATIONS QUALITY ASSUR.GCE MANAGER MANAGER OPERATIONS FIELD, QUALITY ASSURANCE DIGINEER FIELD APPLICATIONS FIELD ASSIST.GT Figure 1. E::a=ple Organi:ational Chart

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PRESIDENT QA QA QA l MANAGER OPERATIONS FIELD QA FUNCTIONS: .

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1. ,QA Program A,C,D i

2. Training A,D,E

3. Certifications  ;

4.

Testing

5. Docu=ent Change

6. Shipping -

7. Specifications

8. Audits l

A - Approve ,

B - Accept C - Concur

. D - Initiate .

E - Perform 1

i Figure 2. Example Responsibility Matrix i

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. ,. L For small organizations, multiple QA functions may be performed by the same individual; however, such individuals should be aware of the actual controls which are defined by these functions and should retain the 5 independent nature of these functions for an effective operational QA program to exist.

1.2 Quality Assurance Program. Statements should be provided as follows: (1) management will establish and implement the QA program, (2) training and experience for all QA functions will be required according to established procedures, (3) QA program revisions will be made according to established procedures, (4) the QA program will ensure that all defined QC procedures, engineering procedures, and specific provisions of the package '

design approval are satisifed, (5) the QA program will emphasize control of the characteristics of the package which are critical to safety (note, the actual classification of characteristics need not be included in the i

description), and (6) other statements, as desired.  :

I 1.3 Document Control. Statements should be provided as follows:

(1) all documents related to a specific shipping package will be con-trolled through the use of established procedures (note, the actual j procedures need not be included in the description), (2) all document ,

l changes will be performed according to established procedures (no'e, t the actual procedures need not be included in the description), and (3) other i statements, as desired. Statements should be included that indicate what job positions are responsible for the document control procedures.

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9 1.4 Handling, Storage and Shipping. Statements should be provided

, as follows: (1) established safety restrictions concerning the handling,

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storage and shipping of packages for certain special form radioactive material will be followed, (2) shipments will not be made unless all tests, certifications, acceptances, and final inspections have been com-pleted, (3) work instructions will be provided for handling, storage, and shipping operations, and (4) other statements, as desired. State =ents should be included that indicate what job positions are responsible for the critical (i=portant to safety) handling, storage, and shipping operations.

1.5 Inspection, Test and Operating Status. Statements should be provided as follows: (1) inspection, test and operating status of packages for certain special form radioactive material vill be indicated and controlled by established procedures, (2) status will be indicated by tag, label, marking, or log entry, (3) status of nonconforming parts or packages will be positively maintained by established procedures, and (4) oth.er statements, as desired. Stater.ents should be included that indicate l l

what job positions are respon'sible for the critical inspecton, test and j operating activities. '

1.6 Quality Assurance Records. Statements should be provided as follows: (1) records will be maintained and include operating logs inspections, tests, and audit results, (2) other records to be maintained will include qualifications of personnel and descriptions of procedures and equipment, (3) records will be maintained ac:ording to established procedures (note, the actual procedures need not be included in the description),,(4)' records will be identifiable and retrievable, (5) a list 7.XX-10 910021197

of.the required records (e.g., records of shipments) and their storage locations will be maintained, and (6) other statements as desired.

1.7 -Audits". Statements should be provided' as follows: (1) established schedules of audits of the quality assurance program will be performed, (2) results of audits will be maintained and reported to management, (3) audit reports will be evaluated and deficient areas cor-rected, (4) the audits to be performed will be dependent on the safety significance of the activity being audited, (5) audit reports will be maintained as part of the quality control records, and (6) other state-ments, as desired.

2. Specific Provisions Section 71.51 of 10 CFR Past 71 requires the licensee to establish,

• maintain and execute a quality assurance program satisfying each of the applicable criteria in Appendix E and satisfying any specific provisions which are applicable to the licensee's activities. The QA program, then, is made up of general and specific provisions. The general provisions of the QA program must provide the controls to assure compliance with any specific provisions. Specific provisions are introduced in and specified by applicable DOT regulations, package approvals by NRC, package approvals

that have been revalidated by the Department of Transportation, and Subpart D of 10 CFR Part 71.

For example, an application for NRC package approval must contain specific provisions applicable to the prticular package design under i

l consideration (10 CFR s 71.24). These provisions became part of the i

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i Package approval and must be complied with by all users of that particular package.

D. IMPIIMENTATION The guidance contained herein may be used by any person establishing, maintaining, executing, and providing a description of a quality assurance Program pursuant to Section 71.51 of 10 CFR Part 71. Other effective means of conforming to the quality assurance requirements of Part 71 also may be used.

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APPENDLX A NUCLEAR REGULATORY COMMISSION (EXCERPTS FROM 10 CFR PART 71}

171.4 Definitions.

. cos -spectat form means any of the -

follostog physical forms of ;1 censed ma-ter!al of any trans ort group; (1) The mater:a! ts in so!!d form har-int no dimenston less tnan 0.5 mt!!! meter or at len.st one dimenston greater than Sre m!!!!metert; C0es not melt. sublime, or !gnite in air at a terr.;erature of 1.000*

P.; will not shatter or c.umble !! sub-

• jected to the percussion test descr. bed in AppendLt D of th:s part; and ts not dis-solved or converted into disperstble form to the extent of more than 0.003 percent by we!ght by im .ersion for 1 week in water at 63* T. or in air at E6' F.; or (2) The matettal is securely contatned in a capsule having no dimenston eas than 0.5 militmeter or at len.st one d: men-ston greater than .*.ve :ntiltmeters, which will retain its contea.ts tf sue;ected to the tests prescr!:ed in A;;:en::1.t D of this part: and 5:h:ch is constructed of mate.

rials which do not me t. sueltme. or it-nite In air at 1.4~5* T and do not d!s.

so!ve or convert into dispers:bie for n to Appendix D - Tests fer Special the. extent of more stan 0 005 percent br weithL by :ntners::n for 1 weet in <ater Form Licensed Material.

APPrwet* D--Trsts ron Segew, roen Ltccwer.o 2.targarat, 1; Tree Drop--A tree disp through a dts.

tance of *o teet onto a .1at essentta::y un.

ytelcing hor: fontal surface. str:R:ng the surface in such a ;csttion as to sufer ..tast. l mum dams gt.

2. Percussion-ff=1::s s of tne Cat :tr:uf ar end of a 1 inch diameter steel red we;tt:Ic4

. 3 pounds. dr:;;ed inr=ugu a sistar.:e et 4J .

11.ches. The capsule er matermi srtMI :s l p! aced on a sheet of fest. of Marc.*ess nuniner 3 $ to 4 3 on the V!cters ser.le, snu not more  !

than 1 tnen thic%. succorted Dy a a:no.am i essentinity untteletr\t snetsce. '

3. //#3 fine ==Hesting in Air 52 4 te*r#*P&.

Itfre of l.4*$' T and ??m A!*!PC at tr At te.".t*

perature f.ir a parted of In PFl* tut %

4. Immersioi immer' ten for 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> in water at room 'emr.**stt:re 7!.e wver shut tJ a* n!! -N! ' 4 :nr. ....r : t m. . e.

it v. t -f i 1: m., - ;cr cent..u-ter l

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