ML20062G788

QA Program Approval for Radioactive Matl package:0109 Rev 2

ML20062G788
Person / Time
Site:	07100109
Issue date:	11/15/1990
From:	Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
Shared Package
ML20062G787	List: ML20062G783 ML20062G788
References
NUDOCS 9011300322
Download: ML20062G788 (28)

Text

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g QUALITY ASSURANCE PROGRAM APPROVAL is m FOR RADIOACTIVE MATERIAL PACKACES n wSiofuustn i

h Pursuant to the Atomic Energy Act of 1954,as amended.the Energy Reorganization Act of 1974. as amended, and Title 10, Code of Federal Regulations. Chapter 1. Part 71, and in reliance on statements and representations heretof ore made in item 5 by the person named in item

h. -

2, the Quality Assurance Program identified in item 5 is hereby approved. This approvalis issued to satisfy the requirements of Section I

71.101 of 10 CFR Part 71. This approvelis subject to all applicable rules. re putations, and orders of the Nuclear Regulatory Commission g

now or hereaf ter in effect and to any conditions specified below.

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3. EXPIRATION DATE 2.NAME l

CINTICHEM, Inc.

December 31, 1990 i

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P.O. Box 816

( oOCxcf NvMecn M

CITY STATE ZlP COOL 4

Tuxedo NY 10987 71-0109 j

s ourtn v AssuliANCL PnOGnAM APPUCATION DATE(S) l October 17, 1985 y

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Activities conducted under applicable criteria of Subpart H of Il 4.

10 CFR Part 71 to be executed with regard to transportation

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FQR THE U.S. NUCLEAR REGULATORY COMMISSION

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hj Charles 1 MacDona d_

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}h DIVISION OF FUEL CYCLE AND MATERIAL SAFETY OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

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i RADIOACTIVE MATERI AL PACKAGING QUALITY ASSURANCE PROGRAM ClNTICHEM, INC.

Tuxedo, New York FQ-01-1 11/15/90

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TABLE OF CONTENTS b,

k' s-Page 3

iniroduct1on 4

I 1.

Organiza1 ton 5

2.

Quality Assuranco Program i:

7 3.

Design Control i

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4.

Procurement Document Control i

10 i

5.

Insirucilons, Proceduros, and Drawings 11 6.

Document Control l

7.

Control of Purchased Material, Equipment, and Sorvices 12 8.

Idenii f Ication and Control of Matorial s, Parts, and Components 13 14 j

-9.

Control of Special Processes I

l 15 10.

Inspection

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16 l

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Test Control jl 17 12.

Con 1rol of Measuring and Test Equipment u

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13.

Handling, Storago, and Shipping 20 5

14 Inspection, Test, and Operating Status 21 15.

Nonconforming Materials, Parts, or Components 22

.l 16.

Correctivo Action li 23 l

17.

Quali1y Assurance Records 24 l

18.

Audits 0

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19.

Figure 1 - Organization Chart a

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ll PQ-01-2 11/15/90 t

CINTICilEM, INC.

a RAD 10ACTTIVE MATERI AL PACKN3tlG QUAL STY ASSURANCE PROGRN4 lNTRODUCTION The Cinilchem, Inc.

operation at Tuxedo, New

York, is currently preparing to decommisslor, its Reactor and Radioachemical Production f acilities.

ThIs RedIcactive Mater 1ei Packaging QueIity Assurance Program appt ies to those packeges i

for which a QA program is required pursuant to 10CFR 71.12.

Typical r ad ioeci l ve maiorial packaging perf ormed at the f acility includes:

1.

Returnable steinless steel clad depleted urant o' containers for shipment of Type B quantitles of radiolsotopes.

2.

Stainless steel Type 2R containers f or Type B shipments.

3.

Steel clad wooden Jackets, Type 20 WC-2, to enclose returnable shipping containers.

Spec 17H steel drums f or disposal of radloactive waste.

4.

5.

Stainless steel clad, lead filled Model B3-1 shipping casks for radioactive waste shipments.

6.

Packeges approved for large quantity shipments for which the facility is a registered user.

7.

Shipment of irradiated MTR f uel elements (shipped pursuant to 10CFR 73.37) and low exposure fIssiIe terget material which has been de gassed and strlpped of other fission products (not subject to the requirements of 10CFR 73.37) in packages for which the facility is a registered user.

8.

Non-rout ine sh ipments package in compilance with existing NRC and DOT regulations (e.c. crated contaminated equipment destined f or burial or recovery).

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Polyethylene high integrity containers for disposal of radioactive waste.

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I PQ-01-3 11/15/90

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-le "'QRGANIZATION

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[Thof. qualityJI(assurcnce organizationican best L bo - understood-by1 ref err, lng-- toithe

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organization. chart:In-Figure 1.x

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. 0veral I-responsibility f orf the -packaging ~ que_Ilty_ assurance ' program wiiI? be. In tho" c

-hands l ofg the Project Manager,,

The person holding-thIs position wiiIn have.an

LoducailonalJ background 'in~ Science and Engincoring with a minimum 'of throe: years:.

expor tence with' the packaging for= shipment of radioactive < materials : under NRC and-DOT 'rogulatlons.

Depend!ng on the -type of material beIng; packaged (e g.,

e radioactive waste,, spent reactor f uel, or mixed wastes): there may be dif forent 11ndividuals responsible 'for; the packaging.

Level 1, with the. assistance of-the Health' Physics Supervisor,..wil'i' be directly. responsible - for Implementation _ of the program,, to Incl udo-. design _ and_ procurement eriterIa, inspection _ of _' material s, equipment, and f acilities _ as necessary, and such testing. as ls required to moet--the requirements of 10CFR Part 71, Subpart C.

The Wasio Manager 'will oversee: the:

? packaging.~and '~ shipment of radloactive materials, and will-assure that. routine

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inspectlon of outgoing parcols-and returned shipping containers are performed. :The-iWasio, Supervisor will-supervise the performance' of the. physical-packaging, y

shipping, and recolving activltles..

'The Hc,al th LPhysics Superv isor. - wl l_I have the authority to call f or any c ropelr,.

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modi f Icatlon,, or'. test Lof such packages that is deemed nocessary Junder,: 10CFR Parti

7_1, i and:. it. wI l 1 be the responsibil1ty, of Level :1. to_ ensure that such repairs,.

1 modi f Ications - orL testsc.are: promptly carr Md out, properly executed,; a'nd _ correctly-documented. :The Nuclear _ Saf eguards Commit 1ee.will-also have the: responsibility and-7 authority f to _ orovidel anf of f ectivel oversi ght of al l functions involved under this-Lqual Ity Eassurnace pr_ogram,1 - including the initiation of such actionsy as.may be <

i noeded tof onsve t orfimprovo _ compliance.

- This committee meets.regularlyf and ~

as noodod at the.s'lte to review those activities which have, or lmay. have,Lan impact on"

the~ !sa f e fporf ormance ;of al If operations, involving-radioactive-materlal.;

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As: a l servicef to : groups on " site who. handle. radioactive mater ial, the'; Waste

.Manegement Group will-accept: packaged waste material and-consolldate it:with other o wastes i sh'ipped ? 'f romlthe L sito.

Individual'. waste : pa.ckagers? wil l be: requi red to -

cortify;that-eachfcontainerils packaged properly.

Health. Phys Ics,-- w il:l;on a'_ random e

. basis / Lchockjsradioactive :wasto-containers.to - assure '.thah -propern packaging:

1 7tochnlques are uoing ' implemented.:

Qual ItyJ ControlT f unctions 1 relating yto' packages ~ of Ja --non-routinefor i potentially h6zardous naturojwll1_bo,directly.superv Isod'or-perf ormedLbyilndlv Idisals possessing.

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? specific competenco s to ! direct such ~ activities.1

.in_ ;most cases, these individuals Ewlllo be superylsory personnelL f rom-the_ Project Managers' Group,- with gul_ dance :f rom-the': Health Physics Department. Through -experience -and educational background, such y

people will p_ossess_ a thorough knowledge and ' understanding of _ regulations pertinent -

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d ito(sh ipment-of packages jcontaining. radioactive-material s"an_d: an. awareness _-of t any;

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potentialDhazards associated with a.speci f ic_ type'of

package.

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2 Ol)AL ETY SSURANCE PROGRAM

• 1 JSlnce theLProject Manager, wIll exercisei overal I sthor Ity regarding - the - Qual Ity 0

' 1 Assurance; program,i the; entireJ program-and any _ revisions to 1.t. must be+epproved by

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.hlm,'.-with the concurrence? of such other competent manager.lal' positions as he deems -

'_ appropriate for particular items.

The Q. A. program itself will be-~ disseminated and L!mp_lemented underlhis approval as an integral-part of the f acility.

Personnel will _ be quellf led to perform basic v isual Inspoction of standard packages.

4through on-the-j ob training and i nstruction regarding those sections.of the

-applicable regulations pertlnent to this type of-shipment.

Quality Control to non-routine items -or activitles wlll-be performed by f unctons = appl. icable individuals who have ' demonstrated competence In the area involved, either. by vir1ue-of, educational _ background or through acquired experience.

Training required for--

theJacouisition of such competence will be directed by Level 1-personnel with the aid of such.other quellfled Individuals as is appropriate or necessary.

All spersonnel'.whose work assignment may occasionally require the performance of -any instructed by the Health Physics Department _or

' packaging Q. AL f unction will be Level 1 or 2' personnel to the _ extent. that they-may perform -basic ~1nspectlon_s of__

l packages :suf ficient -to-detect obvious flaws.

Any personnel-assigned to work-

~t directly with packaging will be f urther int +ructed under -the direction of-Level.1

. personne_l-to t the point thei they ' wil1 have a demonstrated working knowledge of

appl _icable-regulations and safety criteria suf f icient' to ensure that no ' -

sub-stan_dard package w1Ii be roleased for sh f pment.

.The - Q. A. _ program w I 1 I be -_ promulgated by - management as an - Intcaral' part' of fthe d

facil~ity operating: procedures.

Al.I' revisions to the Q. A. program must therefore be.

h reduced to written' form and approved by the _ Project Manager,f with the concurrence of.' tho' Manager = _ Health Safety and Environmental Af fairs and the. Nuclear Safeguards Canmittee before any such.revIslon com take ef fect.

A' record. of these revisions q

Q wIII be maintained on-ffle.

'Speci fic : procedures f or each type of ; package wil _I be provided; f or 'the iuse of/those -

personnel prep.arIng such -pac _kages Ef or shipment... Means' 'f or-ensuring that-these; O

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be provided, - through; check-of fr 7 procedures have been satisfled.in each case 'wll,llogbook entr.les, etc., as.ls-b r

f procedures,- tagging, label l ing,

< parHeul ar-type of ' package.

Engineering _ procedures and package. design provisions.-

wil-l 1be; satisf ied :by7simi.lar means, ' under thoroversight of trained: supervisory J

person.neltwherelapproprlate.

Package characteristics which have any signi_ficant' bearing lon the safety of a given ship' ment wIi17 be cleariy a.id -spect f lealiy delIncated through the, Q. A.~ program, and each such:ltem wil_l - be subject to particular -control through this. program, iThe=

-Q.A.--program will prov'Ide that all significan.tisafety criteria portinentito each; Epackage'ere?satisfled prfor to the shipment of that_ package.-

tThis. Radioactive. Material Packaging Quality Assurance Program will. be. Included.asf a" discrete sectton of - the Procedures Manual, _ along wIth al 1. _ of f icial ~ revlsions.

Distribution of this manual and revisions <are controlled by the _ Issuance to each' il the'following:

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-Project Manager

. Secretary, Nuclear Safeguards Committee

= Nanager,. Health Safety and Environmental Af f airs Waste Manager

- PQ-01 11/15/90

Weste Supervisor Health Physics Suporvisor spec t f leally designated-portion of the of f iciat operating procedures, ihls

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As a p :.ckag i ng Q. A.

program and ali polIcles and proceduros described in it, are ma3datory requirements which must be followed and implemented by all personnel i n"ol ved.

Such adherence to all provlsions will be enforced in all casos by the Project Managor.

Any dispute involving the quality of packaging erising f rom di f forences of opinion bo1woon persons oxorcising QA/QC responsibill'y and any other group shal l be resolved f irst by the Hoelth Physics Supervisor.

If such a decision is not donned sailsf actory by olthor party, questions may be escalated to the ProJoct Manager, in concurrence with the Manager, Health saf ety and Environmental Affairs, acting if f urther resolution is required, the Nuclear Saf eguards Ccmmittee will provido a final end binding decision.

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3. DE' SIGN CONTROL I

l Approprlate design contrul measures must be exercised io assuro campilance with For those i

eppilcablo regulatory provisions and to ensure safety during transport. desig roesons, all aspects of Manager and Wasio Manager with the aid and concurrence of the Managor, Health Safety and Env ironment al Af f airs and the Nuclear Safoguards Committee.

Such ap proval will includo a review by the Waste Supervlsor and Health Physics Suporvisor to ensure (1) that all portinent inspection and test criteria are idenilflod and delineated in the appropriaio documentation and/or drawings, and (2) inspected, or tested.

that all design characteristics may be adoquately controlled, The job requiremonis of those two positions are such ihat a thorough understanding of the portinoni regulatory areas and of engincoring requirements for safety is

assured, inclusion of the Manager, Health Safety and Environmenial Af f airs and Supervisor in the review and approval process for package design Heali h Physicscasos provido design verification by an individual of authority in a will in all completely separato line of responsibility f rom that of iho designer.

In most casos where any major changes in package design or application are envisionod, design critoria will be verifled through testing of such packeges prior 10 Their uso.

All such design, appilcation, or specif ication changes are subject 1o iho samo design controls and approvals as woro applied to the original design of the liom.

Such testing will subject ihe package design under consideration to the and wIII be directed and approved by the Project adverso design condit lons, most Engineering studios or computational methods may be substliuted for such Manager.

testing in casos where the uso of those means is more approprlate.

Peckago or container designs will not be approved unless design critoria and parameters necessary to ensure regulatory compilance and safety are correctly and clon-ly tr an sl ated into specifications and drawings.

Specific proceduros and i nstructlons wIII be providod in writing where necessary to faciIItate such include select ion of suitable parts, materials, complianco.

Such instructions may or components, or such vihor information as accessary.

Where spec! fic regulatory critoria are portinent to a package design, such critoria will be included in packago design documents.

All package design drawings and documentatlon will be circulated to Individuals listed on the following checklist, a copy of which must accompany such drawings and documentation.

No fabrication of any type will be authorized without written approval on this checklist.

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PACKAGE DESIGN AND DOCUMENTATION ~ REYIEW.

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g AND APPROYAL CHECKLIST 7

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'l l Package Type and Description

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New Item-#:

or Revision #1 t'o item #:

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Test and Inspection Criteria:

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Designed.By =

Checked By ~

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= Review:

Waste: Supervisor >

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Comments:

He'elth PhysicsjSupervisort -

I Comrients:

k Verification ~and Approval

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. aste Managers:

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Approved:

.or) Changes Needed:'

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f Project: Manager:

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ce Approved:.

(or); Changes Needed: '

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-Manager,-; Health Safety and Environmental: Affairs ~.

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1(Secretary of Nuclear Safeguards Committee)=

Approved:-

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.(or) Changes-Needed:-

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-PQ-01.

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-g-i ;PROCUREEMT DOCUMENT CONTROL:

V ilniany case where. material, equipment, or servicer. whose Use :Is governed 1by 10CFR Part 71--are procured'f rom;an _outside supplier, the applicable requirements.of 10CFR Particular-will( be; clearlyJ i_ncluded-In the procurement documentation.1 Part 71 eitention w111; bo devoted to such,prov'Islons-as are related.to safety of-shipments,-

rend in suchs Instances'the suppller will' be required to document his' compliance.with 10CFR Part 71.

In addition, the suppller-w!! I _ be-Jthec approprlate --sect lons _ of

. required. to provido a quality - assurance program in compilance with the pertinent.

provlslons of. Part 71 whenever/ such e-program is deemed appropriate.

Preparat!on' of ' procurement documents and any changos or revisions thereto are under

-the : superv ision.of ' Level 1.

Such documents will either contain or reference-tho-y

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- necessary design _basisitochnical requirements for each 'ltem :or type of-item being 1

t purchased: as, to ensure compilanceJ with these requirements,- and wili : clearly-

ldentify cthe; documentation required f rom the supplier _for review and approval: by,

thel purchaser...This.IdontIfIcatton w11I al_so spectfy which documents and records g'

.are to beiprepared and retained by the supplier,.as well. as those which are to be =

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-: delivered to or'_ controlled by the purchaser, p

Al:1 l procurement _documeni s, changes, or revisions, will be: reviewed by. the Health;

--Physles-Supervisor or the Manager, Health Safety and Environmental Affairs prfor to.

approva'li-.to: ensure _ agreement-with all: appropriate design specifications. and-

compilenco LwIthTappl Iceble

regulatory requirements.

Finali approval = of - procurement -

--documentat ion 1 including.' changes and. revisions. wilI _ be! provided' by. : thel Project)

Also, no: procurement revlew-has been ' accompi.lshed. '

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= ManagorE ont y1 af ter.. +' is

'uniess the purchaser. s rIght'of access-to.the suppl ler's documenti w I i l' be' a,

, f acilities and records tu source inspection and audit Is clearly lspecif.ed, l

t Control :off procurement: documents will : be oxercised :by: the Wastc Sena'ger, who will-j soehto, itethat; they are properly maintained end - f i led in such a ; way. as to. be n

Ltraceablest Cli,e mpactfIc' item. _ Procedure-PQ provides /the procurement _ document-i preparer with the. Instructions and checks: necessary to meet above req 0lrements..

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h, INSTRUCTIONS, PROCEDURES, AND DRAWINGS

$cnoral Instructions meant to ensure a high level.of quellty and saf ety In the Deckeging of redloactive materials for transpc.t are included in this program, j

onder ihe headings of "lland l i ng,

Storago, and Shipping" (Section 13),

and "Inspecilon, Test, and Operating Status" (Tection 14).

Where appropr iate or necessary, specific I n si ruct lons, procedures, end dr aw l ngs wIII be provided to maintein or improve standards of quality and saio1y.

Includod in such instructions will be any quantit ative or qua l it at i ve acceptance criteria pertinent io iho perilcular package or shipment under consideration.

Means will be provided, through check-of f sheets, logbook entrios, or other applicable records, to document the saiisf actory accompiishment of such act1v1 ties.

I n st ruct ions, procedures, and drawings are subject to similar measures of control as are appilod to designs (Soct ion 3) and must be accompanlod at all times by approprlete rovlow and approval checklists.

No such documentatton wII1 be accepied as official until such checklists have boon completely filled out, Indl ating approval.

AlI such compiotod checklists wIII be filed w1th the original documentailon and all revisions in a master file for the liom mainiained by ihe Wasio Management group.

PQ-01-10 11/15/90

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DOCUMENT CONTROL All documents relative to any particular shipping package will be under the control in addition, documentation regarding non-routine packages or of iho Waste Manager, shipments which may pose particular saf ety or radiation hazards will be available to the Healih Physics Supervisor f or approval and confirmation that all applicable Q.C. and Q. A. provisions have been complies with.

document regarding the packaging and shipment of No changes will be made to any individual in a position radioactive material without 1ho approval of a competent of authorliy regarding the preparation and shipment of such a package.

The of course, depend on the particular type of involved wil l, specific Individual No changes in such documentation which are pertinent to package under discussion.

the-safety of a particular shipment will be made without the concurrence of the Hoelth Physics Department end ihe cognizant Level 2 manager.

m FQ-01-l!

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7,.

ChNTROL OF PUROlASED MATERI AL,_tiQUIPMENT AND SERVICES All purcheced mat e r i al,

equipment and services will be examined to ensure conformence wi4h procuremani cocuments.

The supplier of such items will be required io provido documented ev, e'ce of ihe quelliy of ihese items and their compliance with all portinent spe.if a11ons and reguletory requirements.

Such evidence will be provided by iho suppl.er bef ore any such purchased materit '

or equipmont is placed into service. This documentation, and any objective evidence of quelli'r, shalI cloerly referorco the speclfIc regul atory or quelity assurance prov;sloss met by the purchased items.

All such records shall be retained in a form irecoable io the specific item, or, If more appropr iate, group or type of times, whose quellty is under considere11on.

To f urther conirol the quell 1y of inspect such purchesod products, Clntichom representatives will, when eppropr iate, ihe supplier's facility, work in progress, and quality assurance program, in addlilon, Cinilchtm will, on occasion, perf orm such tesis on purchased liems as tre necessary to guaranico iho mainienance of high sienderds of quellty and safety, included in tho evaluation of pot ent i al suppliers will be their c pebility to comply wl1h ihe applicablo porilons of Subport H to 10 CFR Part 71 es demonstreied Inc. or other purchesers.

by pasi performer.ce !n supplying such 11 ems to Cintichem, If records of previous perf ormanco are not evalleble, iho. supplier's production f acilit ies and Q. A.

program will be studied by competent personnel to determine ihai iho capability is avallebit io moei iho requirements f or c.ompliance.

FQ-01-12 nm/sn

b, IDFNTIF1 CATION AND CONTROL OF MATERI ALS, PARTS, AND COWONENTS i

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[sspecif'cdund:r tha hoeding " Design Control" (Section 3), eppilc:ble rcgulefory r eq ui remoni s and q ura l i ty assurer.co crlierta will be clearly translated into

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l spec t f lecilons, d r ew i ng e.,

procedurcs, and i nst ruci lons.

Where eppropr lato, such i

i nst r uct ion s will call for the positive identification of maiorlal, ports, or componeni s throughout febrlecilon, Instelletion, or use of the Itom.

This l den t i f icai ion w I I I be rr.ade on 1he bar is of hoai nuniber, part number, or other such n,c an s as Is spectfIcelIy approprieie io the pleco under considera1 ion.

Such idonilfication will be traccable io a per+'

'pleted item, or type of item, either a1 iho It om 11self, or ihrough 61'on specific to that li cm.

l Parilcular core will be taks, to ensuo + at m

-h this procedure no incorreci or def ecilvo parts, meteriel, or compononts ero put

'o use.

The rnethod and loceflon of this identif ication will be individually determined by j

each liom under considoroflon to ensure that the 111, function, or quality of ihe tiem is in no way compromised by the IdentifItation systom.

No it em wili be accepied for use unless documentetion and vorifIcetIon ero providod estebIIshing iho correct Idont i f Icet lon of al I cr 11ical meier i al s, p!>ris, and component s.

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,9.j$NTR0l,0FSPECIAt.PROCFSSES Special processes, such es welding, heat ireailng, or non-destructive testing, will Pr!or to the start of such processes, an be performed only by qut:lfled personnol.

evaluation will be perf ormed by iho Pro, Ject Manager or his ciesignee to determine the opplicability of iho various codes, standards, speci f i cat ions, crlierta, or regulatory provisions which rney heve. a bearing on iho process under consideration.

A proceduro for performance of the process will then be est ab l i shed io ensure compilenco wiih such requirements and assure thet ine qualliy end safety charactoristIcs of the i tem under process are malntained.

Upon completion of such processing, iho li em will bo inspected by the Managor, Health Safety and Environmonial Af f air s io guaranico that all requirements have been met and the qualliy of the liom has not boon compromised.

As such special processes ero performed, a record of iho proceduros developed, the equipmoni utllized and ihe qual'ficailons of iho personnel involved will be osi eb i l shed, filed by 1bo Wacio Manager in such a wey as io be traceablo io the appropr leie tiems, end kopi curreni as changos occur.

PQ-01-14 1M15]OO--_

10.

Id4SPECilOli

.All ceilvit ies which could af f ect the quelliy of packeges conialning redloacilve mawr1al for shipment wlI i bo subject to inspecilon under the direciion of the Projeci Manager.

Such inspections w1il be conducted to sorify conf or,ance of 1he activity with documented

drewings, i nst ruct ion s, and procedures for its accomplishmoni, and to maintain high standards of quellty and safety.

In general, such inspecilons will be carried oui by individuals having l ine authority over those who perf orm the activliy.

In addit ion, such activ!tios may be inspected by oihor indivia-!; possessing special competenco to evaluete tho ecccep!!shment of ihr ouTivity.

These inspecilons will be carried out on a regular bests,1ho timing of which will be diciated by the safety signif icance of the activity in question and the need to mainialn a high Iovel of quality. Instructions for performance of manufecturing end producilon processos will includo provisions f or such inspection, including tests and examination, by mandating specific hold points beyond which work cannot progress without approval by a designa1ed Inspector, or by specif ying particular processes which musi be monliored by such an inspector or witness, or both, as necessary.

AlI modifIcailons, repairs, or rept acoments wiiI be subject 1o iho same mode of Inspectlon as requlrod by the original dosign, whero thIs Is practIcel.

If thIs is not foes!ble, inspection moihods will be required to establish that iho original lochnical cr110 8 are mot through alternato inspectlon techniques, in iho event tha1 spect fic codos or standerds are applicable to such inspections, specl-Ic inspectors will be trainod and cortiflod, where necessary, in the appropriato methods and techniques.

In other casos, company tralning programs will be utilized to develoo the nocessary exportiso to perform theso inspection f unci lons compoient ly.

Qualification, cortification, and training records of such inspeciors will be kept on file to provido ready roforence so that the appropriato individual may be assigned responsibility for each such inspecilon.

FQ-01-15 11/15/90

1'12 JEST CONTROL hocific t:r li t c n icst procc dur cs wlII be used io verify that elI packaging cupponents will perf orm sailsf actorily in service.

Such tests will be written in accordance with iho rcq u i ro:nent s of 10 CFR Part 71 enc 1he req u i reme nt s and

[

acceptence limits of the specific peckege approval.

Tnesc iests will be conducted under the direction of the Manager Health Sef ety end Environmental Af f airs, with the assistanco of such other compoient Individual as may be epproprieio in each case.

Test procedures will be written in such a ment o, thet all prerequi sites f or the icsi are mot, adequato test instrumentation is avelluale ano properly utilized, and ihe iest is perf ormed under suliable environmenial cond li t cas.

Tosi results will be clearly documented with part icular referenco to the specif ic items under evalua+lon and iho type of packago or component being tested.

These recults will be evaluated by the Menager Health Sefety and Environmental Affairs or other competent individual to assure that test requiroments have been met end that ell appi lcablo cr iteria have boon sati sf lod.

Such results shall be kept on file and ref erenced to the particular item or type of item which has been tested.

Where f easible, all modif ications, repairs, or replacemenis will be 1estod in the same manner as ihat required by the original design. Where this is not precilcal, alierncio methods will bo selected on the basis of their ability to sailsf y the semo criterie as specifled in the original design end testing er11eria.

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09-01-16 11/15/90 i

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'12, pNTROL OF MEASURING AND TEST EQUIPMDff All rc surem:nt and 10 sting d:viccs wh ich are used in activitics af fcciing the quellty of packages containing radioactive maierlei for trensport, or which ere used io evaluete the quality of such pockeges, wl!! be controlled.

Prior to the use of any such device 11 will be calibrated or adjusted es necessary to ensure its proper performance.

The accuracy of such devices will be verified by periodic calibration, and they will not be released for use unless they are accurate within 1he necessary Iimits.

Logs documenting such callbration or adjusiment will identify the measuring and test equipment and provide traceability to the cellbration test data for cach item.

Cal ibration of measuring and test equipment will be perf ormed and documented in such logs prior to its use to ensure that no inspecilons or tests are perf ormed witn equipment which is out of collbration.

Where possibl e, all stendards used wlil be traceable to nationally recognized standards.

Where this is not practical, the basis for cellbration will be selected and evaluated by the Maneger Healih Saf ety and Environmental Affairs, who will see to It that the needed verification and documentation are recorded along with the appropriate data.

FQ-01-17

'i1/15/90

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l13.t HANDL INGh ST6 RAG 6 AND SHIPPING' C

- Safety shall' be the. paramount consideration in the handling,- storage,; and shipping 4 of packegos f or radioactive meterial.

Upon: receipt of a returned package for such.

ma1ertal, the entire package will be visually ~1nspected by Level 3 personnel to i

deformine the extont of any damago which ' may have occurred during shipment.

. Typical items to be checked consist of (1) status of outer. 20 WC-2. Jacket. -

-secure fit of top and clinch ring; no puncture of outer steel drum or spiltting of r

. laminated pl ywood; no gross damage to threaded fasieners which would-hinder subsequent closure of package; (2) condiflon of stainless steel clad lead or depleted U. shipping pig - No significant radioactivo contamination; no damage to

.IIf ting rings or eyes which could causo a hazard when the pig is 'liffed; no damage

.10 threaded ' components which could-prevent _Ild f rom being securely f astened; (3) condit ion. of Innor Type 2R container - Level - of redloactivo cortamination and/or

-radiation readings below-haz ardous levels (100 mR/hr. ) ;

lifting ball in satisfactory condition; no damage io threaded closure; (4 ). type. B-3 and BMI-1 containers f or shipment-of radioactive waste - level of radioactive contaminatlon; gaskei condition; presenco of drain plugs; condition of lid bolts.

'Unless such packages are destined f or immodlate re-uso, they shal l bo stored in a:

designaiod area, saf e f rom - possible damage.

They should.bo stored in a closed condliion,- wlih all _ parts in placo, until they are to be used again An excepflon will be modo In the caso of _ any part which'is not ready for use by virtue of damage or : oxcossi vo coniemi nat ion.

Such parts may-be removed for-repair or-Edocontamination and subsequently stored separetely until ready to be re-used.

.No-shlpments wllI be made using any type of packago unless-all' appiIcable 1tosts, cortif icailons : and -Inspections. have been completed. -In general, - such tests will includes leak -- testing. undor: vacuum of primary containers (bottles) containing

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1suf f.lcloni 2 radioactive -maiorial in. IIqui) f orm. that spillage may _ be a hazard; iosiing of Typo-2R. containers Laf ter closure under vacuum to ensure that :they;are' soaled;' written cortif ication -'on the order / Invoice f rom' accompanying such shipments?

that!.thoso tests ihavo' been, porf ormed;_ certi f ication that tho contents of the

cylindors conta i ni ng gaseous radioactivity are packaged-at loss _ than E 1/2o atm, abso_l ute Lpr.ossurei' visual' Inspection of. al l -sh ippi ng contelnors to -onsure that al l, i

gaskots, l packing: material,. and f asteners. are _ properly llocated.and,.securc;.

4

'deiermination< that the 'levolf of-radiation emitted f rom any. singlo package or: array n

- - of such packages 'does-not exceed applIceblo Iimits through the use of: appropriate-O>

' monitor;lngi dovicos;. wipe;iosts.to _ensuro that no: signi.f Icant removable - radioactive

~

' coniaminailons is ~presentc.on any 'packageM to.-bo shipped: 'and a.- f Inali-v isual s

lnspecilon to. onsure ihet al I necessary u and ; appropr Iate(soal s, c I abe_I s,.

signs, or-tother;Identi f yIng _ devices are-properly and securely af f lxed-io each peckage.-

= in(orderL io Emin.imize. unnecessary. handl ing of r adioacilvoi mater loi s = and to ensurc = -

LthatialI :nocessarya tests, certi f Icatlons, and- ;lnspectlons have - been porf ormedj' iresponsibility is assignedias follows::

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CortifIcetlon-that Ieek tests on prImery conteiners have been perf ormed wIII be done by the technician dispenslag the motoriel. Pressure of geseous product cylinders will be similarly checked and cerilfled.

2.

Securo, leek tight closures on Type 2R coniainers will be corilflod by cither a member of the Hoelth Physics Dept. or by supervisory personnel f rom the Westo Management Dopertmoni.

3.

The Senior Technicien of the Wesio Management Dopertment will check that the above tesis and cortifications hevo boon performed bef ore accepting any such container f or f inet packegirg.

4.

V i t.uo l inspection of shipping contelnors, redletion monitoring, and wipe tests w1II be porf ormed by Weste Menegoment personnel under dIroctlon of by a Health Physics Technicien.

5.

Final visual inspection of each completed packago will be perf ormed by tho

[-

Wesio Supervisor or Manager.

Each packege will be so inspected prior to being loaded into a iransport vehicle, end will not be loaded unless all i deni t f y i ng

tags, labels,

seals, or signs ero properly afflxed and all shipping documenietion is completely and correctly f illed out.

The abovo procedures apply to elI shipments of redloacilvo products, and shotI be 7

perf ormed under tho d!rected supervision of iho Wesio Manager.

The Monager Hoolth

=

Saf ety and Environmental Af f elt s will also teko a dIroct role in certif ying that oil necessary, appropriate, and appilcable actions ero taken io ensure that iho shipreeni may be made saf 01y.

PQ-01-19 11/13/90

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14,, TNSPECTION, TESTi AND OPERATING STATUS a

r4 11 receipt 4 Inspectior. Indicates that upon. receipt ' alcontainer is acceptablo f or L4

Immediate re-use, tb9 package will be stored: In a designated-erea, and its presence inithis area will :ndicato its availability for shipment.:

n 11, however, any condition exists which indicates that such a packege mcy not be sui tab l e',f or immedleto use, it will bo segregated in another area and tagged to l

Indicato ihet _lt may: not be shipped, in~ such a case, a Level 3 Individual,. or-other individual In a _. higher positlon of authority wlil be notlfled, and this i

individual wIll personalIy inspect the package, datormine its proper dispositlon, and tabol it to indicate tho action to be taken, in addition, i f any 'such repairs j

or modif Icationr could poso e safety or. radiological hazard, the Health Physics Dept. will..bo called upon to Indicate any special procautions or actions which may.

have to be taken.

The. status of any package,_ or part thereof, awaiting any. such

i a'etion, or being worked on, will be clearly Indicated by: tag, label, or merking as:

1

_appropr a e, and ariy necessary. Information will be entered in the pertinent log, If -

it such 'onirlos.are appllcabio-to tho. type of packago under const deratlon.

f

-In any case 'whero Mh ropelrs are.necessary, or modif ication of a package nas -been periormod, - the ' packago _ wIIl : not be accepted for use..untIl the repal_rs' or' rnodi f icailons; have' been Inspected and certif lod by.the Waste Manager.

.Similar r

_ procodures wIli be f 01 lowed In the case of any package which Is undergoing iest to I

~

def ormino its suitabil_Ity. f or any.spocif ic packaging application.

Such containers undergoing test.will be clearly marked, end will nov be accepted for-use unti.l= test

_ results havo boon certIf1od by the proper authority.

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.in abo event _that any now or substantially changed packaging design is proposed-fo.r v

4 uso, er a now appilcation is proposed for an existing-package design, it wll1 be-J c

2 iho; recponsibility. of the - Manager. Health ' Saf ety and Environmental Affairs: to

,s doiermine' what type -of,tosts and inspections are necessary_.to :guarantoo that. all j

eppiIcable saf ety. and : regulatory eriterla.have been met. : The Project Manager wll'l l

oversee the porf ormance _ of. such f ests, and. wl*lh the - concurrence - of'-the Manager Health Safety and Environmenial. Af f airs, cortify 'that the package. design under 3

-consideration has boon adequately tested and is_ suitable for11ts proposed _use.

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l>.,f(0NCONf0RMitG MARRI AL S, PARTS, OR COMPONENTS 5s mentioned uner th heading " Inspection, Test and Operating Si etu s" (Section

, 14), In any case where a quesilon exists as to tio suHability of a particular packege, cont a i nor, or piece of equipmeni for uso, t he i t-:n will be segregated by locei jon if possible, and tagged to indicate its ron-operational sta1us, pending inspes n by a competent individual in a position of responsibility.

Such tags w1II s p., 'lealIy IdontIfy iho non-conforming item and br1ofIy describe the non-conf ormanco.

Af ter inspection, the liem will oliher be accepted f or use again, removed from service per manent l y, repaired, or reworked, as !s necessary and appropriaio.

Such disposiflon will be under iho direct control of iho Weste Manager, who will ensuro ihai the status of the liem is correcily stated, that iho pr oper ections are iakon in accordance with established procedures, and upon compleilon of iho required action, thet all necessary documentation is correct and complete.

Such documentation will include ihe iag described above, along with other pertineni information, and will clearly specify iho test or Inspection requirement s wh ich must bo mot to Jusilfy resiorailon of the item to operailonal status.

Upon l

completion of the necessary iosts or i nspeci lon s, a report will be appended to Tho 5

documeniatic a descr ibing 1 heir results, and dolineating the further disposition of iho liem.

Luch disposiiIon wiII noi be accomplished unt1I iho report Is app oved and signed by compeiont authorliy, generally the Manager Healih Safei, and Environmental Affairs.

3 1

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f9-01-21 11/15/90

l

16..QORRECTIVE ACTION All inspections, tests, and xcminoi tons conduct:d und:r this program, from thoso involving new v.aterial upon its receipt, to the, final inspection of cech package e

before shipmoni, are almed at mainialning 1he highest practical atendards of sefety and quality, and so are meant to pron.ptiy detect any condit ions adverse to the maintononce of such stenderds, if, through these inspections or through other

means, any defic!enclos, deviations, defective material and equipment, or nonconf r-mancos are discovered, immedlete action wi l l be taken to identify their source or cause, and to correct ihe problem.

In the event of any such discovery, the Wasic ManaDer will immediately be notliied, and he will promptly take such ection as necessary to maintain or achieve a condition of safety.

In the event that a significant condition adverse to quality, or a serious hazard potential exists, other individuals having specif le competenee io deal with the problem will be consulted, and remedial act ion will be underteken as soon as possible, j

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In the case of such a signif icant condition adverse to quellty, the Waste Manager will ihoroughly invastigate ihe situation, with such assistance as may be usef ul or necessary, to doth mine the casse of the conditlon.

He wiII then instituto correctivo acilon, subject to approval of tho ?roject Manager, to allevlaio the exi st i ng situation and provent recurrence of the condition.

He will also be j

responsibio for the generation of a clear and accurate report, documenting

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identif ication of the condition, its cause, and the correctivo action which was 1 eken.

This report shall be forwarded to such levels of management as may be appropricio.

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a.$ecords of f the Lperformance of : Padkaging. Quality : Assurance operations wiIll bei in- ' '

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designaied locations? providi ng security for such Lrecords, whl to stilI-allowing L m

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" ready - access when necessary.

The f orm. of such records wlI i - be epproprlate' to the-(M

tppe of packaging involved = and the : nature of' the informat'on to be recorded.

. hich. are speci f ic-to one ' particuler package, container, or piece of b

-Records: w

" equipment will 'be referenced to that; particular item through the use of logbooks,1 gb

-In which 'will be entered - the results of all inspections and tests, as well asia record of, alI. repelrs or modif Icatlons wl. ' ch have been performed.

. Records re. ferring to particular shipmenis will be kept in the f orm of completed check-of f

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shoois or completion _ notices Indicating thet all necessary Q. A. functions have been F-performed and identifying the responsible individuals.

Those records which are of a general nature, such as audit results or the results of tests appilcable to types-g of packages wllI be filed in-the same location.

y1. m Coples of:all current and past packaging procedure will also be maintained l'n this_.

F

area, along with a copy of the Quality Assura..::o 'progrom.. - In - addl1 f on,. el i M

personnel currently' involved in the packaging of radioactive materials oriengaged.:

g have coples'. of such documents available for their use.

6' in ; the. Q. A.

program will

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included wilI be nuclear. description of the _ tasks f or which each of. the var tous y,

positions' Involved In? the packaging or: shipment of _ radioactive _ mater f als is-responsible, as well as a Ilsting of what areas of authority regarding-the Q. A.

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~ program are tog beJexercised byLpersonnel _at difforent levels of responsiblIIty or

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-operating groups, bt

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. Al l. such records wi ll be mainteined~ on file in such - a manner that any specific U1 inf ormat.!on - required wil I be -readily accessible 1and traceable to a particular

conf alner or_ shjpment.; A 1Isting of the records on file and their location wiiI

be-y&

kept ?uplf o daio to_ ensure.that these i documents are identi f iable and retr ievable.'.

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'Itiwilll:be the responsibility of ihe individual completing. each record to forward Eit io the proper area _f or' f urther? dispositlon, and the Weste_. Manager w111 see.to--It rf e (ihat this. Is accomptIshed ~and that al1 such documents are properly recorded and/or b-

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-.Designi relatedn records wi l l 'be -maintained ' on 1.f l_le -- throughciut the enti re per iod2 L 6 "dur,Ing which the package, is kept-in use.1 All-otherfrocordsvrelating fo quality ofz 7

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such 1packagesLor shipments :wIII be kept available f or: Inspection for at--least twoi.

g years.;

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l Al? inspection fand test records will. describe. t's type;of observationiinvolved; and ;

t wll l-loclude-- ev Idence Lihat_ al l port inentmanuf actur ingp inspeci lon,E andy testing operations ~ have1 boon completed and verl<

j. This evidence will'Lincludeztheidete on-which Lsuch oper'utions ~ were perf ormed; mentif ication of. the -Individuals 11nvolved,;

t end. ihe( resul'ts of the test or -inspection...

InJaddition, : wherei nocessary,'

Minformation:will? benincluded describing any conditions which could adverselyiaf fect

_ ihe qual.1.' of theiltem or theJacceptability of the tests results.

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18 AUDITS

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, The packaging quality assurance program will be audited on'a' yocrly basis by a representative of the Nuclear Saf eguards Comnitice, and the restits of such audits will be reported to the Plani Manager. The primary concern in such audits will be iho hazard potential involved in all aspects of the packaging oporetlon, and eudits will bo intended to improve or maintain a high lovel of saf ety, f or employocs of the licensee, for the ultimato reciplent of packeges containing radioactive maiertal shipped by the licenseo, and f or members of the general public who may be in p, oximity to suv packages during their transoort.

The Plant Manager will evaluate the reports of all audits, wif

• tne assistance of such competent authority as he deoms necessary, and direct that areas of deficiency be corrected.

The Project Manager, shall direct such correctivo activity, and approve its completion.

Audit reports and reports of corrective actions shall be maintalned on file as part of the packaging quality control records, and will be e

f 1raceable to such other items in those records as are portinqnt.

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i f9-01-24

- 11/15/90

F""

FIGURE 1 ORGANIZATIONAL CHART i

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M.PE B PhCKAGE PROCUREMENTECHECKL15T PQ-02 s

PURPOSE:

To provide a summary and review of the procurement requirements of PQ-01, the Packaging QA plan, and offer a checklist that can be used to meet those requirements.

REQUIREMENTS:

Federal Regulations, 10CFR71.10 (b) (1), requires a OA plan for Radioactive Packaging if the package contains more than Type A quantities of radioactive material or greater than an exempt quantity of fissile material.

PROCEDURES:

Complete the checklist on page PO-02-03 in accordance with the following procedures:

Procurement requirements of our packaging OA Plan can be divided into four categories:

1) Selection of Suppliers, 2)

Contents of Procurement Documents, 3) Procurement Document Approval, an( 4) Acceptance and Use of Procurements.

1.

SELECTIOM JF SUPPLIERS:

An evaluation c :, supplier's capability to comply with regulations must be demonstrated by past performance in supply to Cintichem or other purchasers.

If records of a supplier's previous performance are not available, the supplier's facilities and QA program will be studied by competent personnel to determine that the capability is available to ineet requirements for compliance.

2.

CONTENTS OF PROCUREMENT DOCUMENTS:

Purchase documents will contain or reference:

1.

Necessary design basis' technical requirements for each item or type of item to ensure compliance.

2.

Clearly identify documentation required from the supplier for review and approval by the purchaser.

This documentation will also specify which documents and records are to prepared and retained by the supplier and those to be delivered to or controlled by the purchaser.

3.

No p r oc u r e; + nt docurr ant s will be approved unless the purchaser's right to access the supp]ier'n facilities and records for source inspection and audit is c3early specified.

PO-02-02 06/18/90 10/16/90 I

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PROCUREMENTLDOCUMENT APPROVAL:

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' 1'.

Preparation of documents and any changes or

'a revisions thereto are under the supervision of Level 1.-

(

2.

All procurement documents,, changes, or revisions (Q' * '.

~ o_r the will be reviewed by the Health Physics Supervisor Man. ge r Health Safety and Environmental a

control _s prior to approval to ensure agreement-with all appropriate design specifications and regulatory requirements.

j 3.m Final approval will-be provided by the Project Manager,- only after the above review has beeny accomplished.

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4,z ACCEPTANCE AND' USE OF PROCUREMENTS

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Al l--- purchased material, equipment,.and services

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'w111' be examined-to ensure conformance 'with fi 1

. procurement documents.

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2.

-Before any procured item is placed in service,.:the supplier - shall-have1 provided documented? evidence; L

of-the quality of these items.and their compliance'

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with all;; pertinent regulatory, requirements.-

Thist 7'

' documentation,.and anycother objective evidencelof 6 :;<,

[qualityE.'shall clearlyf: reference. the. specific

regulatory orc-quality assuran., provisions.. meta by-

.the-purchased.itemsE>

el-a L. -

S-Additionally,- Jour 1 PQ-plani-states:(

. Cintichem,:

will' wheni p

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appropriate,finspect; the ' supplier!sj f acility, work Jin progress,;

"andL OA; program 1 and: Cintichem willL,5 on eoccasion, perf orm 1such b

2:naintenance of.high qualityla_nd safety.,

^ Lto guarantee 1?the 3& ' ~ stiests ?ont purchasedL items Las' are nec<tssary r.

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Til>E B PACKAGE Pl<0Cl/I<EMENT CH ECKL3 ST PO-02 Item Being Purchased For Package (Package ID) h)

Selec. ion of Suppliers:

Suppliers capability to comply with regulations demonstrated by:

Past performance with Cintichem Past performance to other purchasers Other Purchasers Name:

OR Supplier's facilities and QA program studied by and determine 6 to have the capability to meet requT7ements for compliance.

/

B)

Procurement Document Contents:

Design basis technical requirements specified.

Required documentation and instructions for their distribution specified.

"Right to Access" supplier's facilities for source inspection and audit clearly specified.

M C)

Procurement Document Approval:

Document preparation supervised by Level 1.

Review by Health Physics Supervisor or Manager Health Saf ety and Environmental Controls.

Final approval obtained from Project Manager.

D)

Procurement Received and Accepted for Use:

Date procurement received.

Requested documentation received.

Procurement inspected and accepted for use.

PO-02-01 06/18/90 10/16/90