ML20209J506

Radioactive Matl Packaging QA Program

ML20209J506
Person / Time
Site:	07100109
Issue date:	10/14/1985
From:	CINTICHEM, INC.
To:
Shared Package
ML20209J501	List: ML20209J498 ML20209J506
References
NUDOCS 8511140043
Download: ML20209J506 (24)

Text

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RADI0 ACTIVE MATERIAL t

PACKAGING QUALITY

' ASSURANCE PROGRAM 1

CINTICHEM, INC.

Tuxedo, New York

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TARLE' 0F CONTENTS Page Introduction 3

1.. Organization 4

2..

Cuality Assurance Program 6

3. - Design Control 8

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4. - Procurement Document Control 10

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5 Instructions, Procedures, and Drawings 10 6

Document Control 11 7J: Control of Purchased Material ~ Equipment, and Services 12 8.

' Identification and Control of Materials, Parts, and Components 12 9.

Control of Special Processes' 13

10. Inspection 13

11. Test Control 14

12.. Control of Measuring and Test' Equipment 15 13L Handling, Storage,.and Shipping 15 14

-Inspection, Test, and Operating Status.

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15. -Nonconforming Materials,. Parts,- or Components 18 16 Corrective Action 19

17. Quality Assurance Records 19

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Audits 20'

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Figure 1 - Organization Chart 22 --

20.L Figure 2 - Responsibility Matrix 12 3 '

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CINTICHEM, INC.

RADI0 ACTIVE MATERIAL PACKAGING QUALITY ASSURANCE PROGRAM

. INTRODUCTION The Cintichem, Inc. operation. at-Tuxedo, -New York, is currently engaged-in the manufacture-.and. development of.various radiochemical and radiodiagnostic products for, sale on a commercial basis.

The-majority of-shipments of such products consist of-discrete packages, each containing only one relatively pure radionuclide,. destined :for

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use in the field of nuclea'r medicine.

Four radi.oisotopes (Mo-99, I-131, I-125, and P-32) contribute by far_.the largest portion of the shipments -at this, time.: Since most recipients of. these-products possess limited-facilities. for the-handling of radioactive; material, and most. shipments travel by means..of comercial transport, _ the packages are designed to :be. both simple and sturdy, _ facilitating maintenence and repeated useage.of each container.

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The radioisotopes 'are produced-in the reactor..at the facility tnd are separated;in the adjoining hot; cells.

Incident to the-production and separation of isotopes and other related site activities, both small and large quantity ? waste shipments must -be : packaged.

These con-tainers.must likewise be rugged and sturdy to meet restrictions by the transporter and receiver.

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.Due.to the simple -nature of the containers used for - packaging, and the routine nature of most. shipments, it is ; felt that the packaging-quality assurance program.should f also be - of a simple anc straight-forward nature.

In this manner,-it is believed that the intf rests of-safety and package integrity can best 'be; served _within the limited scope of activities by the small. staff available, while at_ thef same time minimizing confusion andl redundant ~ effort.

This Radioactive: Material. Packaging. 0uality -- Assurance < Program. applies i

to those packages for which Ja_ QA (progr'am is requirid : pursuant to

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10CFR 71.12;. Typical _ radioactive material. packaging -performed 3 at the facility _- includes:

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Glass and polyethylene bottles _ of various.si es.

2. - Disposable lead : shipping containers ranging' in wall thickness-

. from,1/8" toil i3/4" for shipment lof; Type A -quantities of radio-

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Sealed metal cans to enclose-lead shielded shipping containers for Type A quantities of radioisotopes.

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Corregated paperboard boxes for Type:A shipnents.

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Lead shielded gas _ cylinders for shipnent of radioactive gas-at less than atmospheric pressure.

6. : Returnable steel clad-lead containers _for shipment of Type A and Type B quantities of radioactive = material.

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Returnable stainless steel clad. depleted uranium containers for shipment of Type B quantities of radioisotopes.

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Stainless steel Type 2R containers for Type B shipments.

9t Steel clad wooden jackets, Type. 20 WC-2, to enclose returnable shipping containers.

10. ~ Spec _17H steel drums for disposal of' radioactive waste.

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

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

13. Shipment of irradiated LMTR 4 fue1 L elenents (shippe'd : pursuant to 10CFR 73.37) and low exposure' fissile-target _ material Lwhich has been de-gassed and. stripped of other fission - products- (not subject to the requirements of 10CFR 73.37) in packages for which the facility is a registered user.

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14. Non-routine shipments package in compliance with existing NRC and-DOT regulations (e.g. crated.Lcontaminated equipment. destined for burial)..

15 Polyethylene high integrity containers-for

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. radioactive waste.

1.1 Organization

-The: quality: assurance organization; ~ can best be understood' by; referring: to. the organization charti in Figure, _1.

The- _ responsi-if bilities. vested'in each position are defined by Figure 2.

^ Overall iresponsibility for the packaging -~ quality-assurance : program -

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will -'be in :the ihands ;of the Site Operations ; Manager.. The person ;

. holding 1this position will' have an educational.. background = in. Science' and Engineering with. an minimum Jof. three? years experience. with i

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g if the packaging for-shipment of radioactive materials under NRC and 00T regulations.

Depending on"the type of material being packaged- (e.g.

radiochemicals, spent reactor fuel,, or hot ~ cell wastes) there.may be

. numerous set of individuals : responsible for the various levels of responsibility of packaging.

In a ~ general fashion, each such set is

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composed of a. Level 1, 2, _ and ;3. representative, the levels being defined by the organization chart. ~ Level 1. with the: assistance of the Health Physics _ Supervisor, will be directly responsible-for implementation of the; program, to include. design.-and procurement

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equipment, and facilities as criteria, inspection of m

necessary, and such testing as is required - to meet the requirements of 10CFR Part '71, _ Subpart C.

Level '2 will oversee the packaging and shipment of radioactive materials, and will assure that routine inspection of outgoing parcels.and returned shipping containers are performed.

Level 3 will perform - the physical packaging, shipping, and receiving activities.

. The Health Physics Supervisor will haveL the_ authority to cal.1 for any repair, modification, 'or test of..such ~ packages that ~he deems neces-sary under'10CFR Part 71,.~andcit will be the responsibility of Level

'l to ensure-that such repairs; modifications or tests : are promptly carried out, properly. executed, and correctly documented.

The

' Nuclear Safeguards Conmittee will also have the. responsibility and authority to provide an. effective oversight of all f0nctions involved under this quality assurance. program,' including.the initiation of such actions _ as may be needed to ensure or improve: compliance.

This committee meets regularly and as needed ~ at the site to; review those activities which have, or may have, an impact on the safe performance of all operations involving" radioactive material.

As a service to groups on site' who handle 1 radioactive material, the Hot ' Lab Operations Group will accept -packaged wasteI material and consolidate.it with other wastes shipped from the. site... Those individual _ waste packagers -will'~ be required: to e certify that each

.. Health Physics..will' on a random container.pis '. packaged properly.

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basis check ' those : containers Lto. assure -that-proper ' packaging techniques are being implemented.-

Quality :Contro10 functions relating to packages of ? a: non-routine or.

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potentially hazardou'st nature-will(be. dire' tlyisupervised or performed c

-by individuals possessinglspecific competence to Edirect 'such activi-ties.- In most cases, these individuals;will be' supervisory personne1' from ' the - Reactor L0perations, (Radiochemical J; Production,C ore Hot Lab 10perations; Groups,nwith 9 guidance 1 fromi the - Heal th Physics J Department.

' Through?' experience Dand teducational' : background, -such. people ? will-

. possess a thorough, knowledge and; understanding of Tregulations perti -

. nent to shipment; of packages. containing radioactive : materials and Ean o:

f awareness - of; any t potential; hazards ? a'ssociated ;with t alspecific L type ; of -

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, 2.LQUALITY' ASSURANCE PRm RAM 2

Since ' the: Site : Operations Manager, will exercise. overall authority.

. regarding the Quality Assurance eprogrami. the entire program _ and any

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-_ revisions to'it must he_ approved by him, with the concurrence of such other - competent managerial positions -.as - he deems appropriate for-7-

. particular : items.

The Q.A.1 program itself will be. disseminated and

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implemented 'under his' approval as an integral part of the facility.

3 Due to theLsim'ple and routineinaturefof most shipments offradioactive material ~ from this -facility, ! personnel _ will be qualified to. perform basic ' visual inspection ';of. standard ' packages. through, on-the-iob

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training 'and instruction _ regarding those. sections of L the applicable regulations pertinent-to J.this type--of. shipment.

Quality? Control functons-applicable _ to non-routine. items or. activities will be 1

performed byLindividuals who:have demonstrated competencefin,the area involved, either _ by. virtue ; of_ educational-background: or- - through acquired -experience.

Training required. for. the-acquisition of such competence will be directed by level.1 personnel with the aid of such other qualified individuals as is' appropriate or necessary.

' All ipersonnel. wh'ose work assignment. may occasionally. require the-performance of any. packaging Q A._ function-will be instructed by the

-Health Physics Department-- or Level 1. or 2 person:lel' to ithe L extent that they may perform basic - i.nspections Tof packages _ sufficient to detect obvious flaws.. Any pert,onnel assigned to work directly -in the 4

packaging area will be c.further - instructed ounder! the. direction. of Level 1 personnel to the_ point that they will-have a1 demonstrated working knowledge of.._ applicable. regulations and safety; ; criteria sufficient to ensure _ that no rsub-standard Dpackage will be\\ released for shipment.

The Q.A. prog'ramLwill.be promulgatedt byimanagementyasf an: integral part of the. facility operation procedures. ?All revisions to the'Q A.

program must therefore-be-reduced to writteniform and : approved by sthe Site Operations Manager,- with;the concurrence; of the? Radiation Safety

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'.0fficer,; before. any.such revision.can take 'effect. < A record ;of these

revisions will be maintained ormfile;-

iSpecific:-procedures forieachI type of { package will1 tie 'provihed dor thef 8

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- ~use;of those.personne1' preparingisuch; packages for shipment. ~Means?

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for ensuring c thatl these procedures, have ;beenjsatisfied - in each ? case --

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willEbe Apr.ovided, through check-off procedures,1 taggings #1abelling,,

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!or:logbooki entries, as Lisibest; applicable? toi the particularitype of.; e t-package.' Engineering ? procedures)and lpackagesdesign' provisions will-H be:; satisfied. byi.similar 1means, oun'derithe f oversightfof-trained?

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. supervisory;personne1 { whee aopropriate.

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' Package. charac'teristics - which have any significant~ bearing on; the e

safety of a given shipment: : willz..be clearly and specifically i

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delineated through the 0.A.-_ program,. and, each such item will be subject..:to particular control through -this program. The-Q.A. program

. will provide. that' all significant safety criteria pertinent to each package are satisfied prior to the shipment of that package.

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_This Radioactive Material Packaging Quality Assurance.-Program will be included as a. discrete section ;of the Procedures. Manual,. 'along with all official revisions.

Distribution of this manual 'and revisions are: controlled by the' issuance to each the following:

1 Site Operations-Manager-Secretary, Nuclear Safeguards Committee.

Manager, Nuclear Operation Reactor Supervisor (2 copies)

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, Supervisor, Radiochemical Production.

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Radiation. Safety Officer I

As' - a specifically designated portion of the official operating-procedures, this packaging _~Q.A.-

program and all policies and 4

procedures described. in'it, a_re mandatory requirements which must _be followed and implemented by all - personnel involved. iSuch adherence 4

to all " provisions will be. enforced! :in all cases :by the Site

- Operations ' Manager.

Any_ dispute involving 'the quality of packaging arising from differ-n ences of. opinion between persons exercising-QA/QCL responsibility and' L

any other-: group shall be ; resolved -_- first.. by x the 1 Heal th Physics ~

Supervisor.

If such a~ decision ~ is not -deemed ; satisfactory by either party, ' questions may be escalated to the Site 10perations Manager,-

acting. in concurrence with thel Radiation -Safety \\0fficer. ?If.further.

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, Jesolution is required, the' Nuclear Safeguards Committee;will1 provide n

a final and binding; decision.

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3. ' DESIGN CONTROL Although the shipping containers currently used 'are relatively straightforward in design, being meant to provide-radiation shielding and accident protection for routine shipments, it is recognized that appropriate design control measures must be exercised to assure compliance with applicable regulatory provisions and to ensure safety during transport.

For this reasons, all aspects of design of such containers will be approved by the Site Operations Manager, with the aid and concurrence of the Radiation Safety Officer.. Such approval will include a review to ensure (1) that all pertinent inspection and test criteria are identified ' and delineated in the appropriate documentation and/or-

drawings,

.and (2) that all design characteristics may be adequately controlled, inspected, or tested.

Since the shipping containers under consideration are neither complex nor fragile, such centralized control will.be most effective in maintaining high standards of quality and guaranteeing compliance with regulatory requirements.

The job requirements of these two positions are such that a-thorough understanding of the pertinent regulatory areas and of engineering requirements for sa fety is assured.

Inclusion of the-Radiation Safety Officer in the review and approval process for package design will in all cases provide design verification by an individual ^ of authority in a completely separate line of responsibility from that of the designer.

In most cases where any major changes in package design or appli-cation are envisioned, design ' criteria will be verified through testing of such packages prior to_ their use.

All such design, application, or specification changes are subject to the same design controls and approvals _ as were applied to the original _ design of the item.

Such testing will _ subject the package design under consider-ation to the most adverse design conditions, and will be directed and approved by the Site Operations _ Manager.

Engineering ' studies or computational methods may be substituted ' for such testing in cases-where the use of *ese means is more appropriate.

Package or container designs twill not be approved unless design criteria and; parameters necessary to ensure regulatory compliance and safety are correctly and clearly translated into-specifications and drawings.

Specific procedures and instructions _will-be provided in writing where necessary to facilitate such compl iance.

Such instructions may include selection ~ of suitable: parts, materials, or components, or such other information as necessary.

Where specific regulatory criteria are pertinent to a package design, such-criteria will be included in package design documents.

All. package design drawings and documentation will-- be circulated to individuals : listed on the following checklist, fa/ 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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t PACKNGE DESIGN AND DOCUENTATION REVIEW AND APPROVAL CHECKLIST Package Type and Description.

hew Item' #:

or Revision #:

to Item #:

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Test and Inspection Criteria:

Designed By:

-. Checked By:

- Review:

Level 1: (Manager of Nuclear Operations or Manager of Radiochemical.

Production).

Comments:

Supervisor, Health Physics:

Comments:

. Verification and Approval:

Site Operations Manager Approved:-

(or) Changes Needed:

1 Radiation Safety Officer Approved:

(or) Changes Needed:

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4. PROCURETNT DOCUMENT CONTROL In - any case where material, equipment, or services whose use is governed by 10CFR Part 71 are procured from an outside supplier, the applicable requirements of 10CFR Part 71 will be clearly included in the procurement documentation.

Particular attention will be devoted to such provisions as are-related to safety of shipments, and in such instances the supplier will be required to document his compliance with the appropriate sections' of 10CFR Part 71.

In addition, the supplier will be required to provide a quality. assurance program in compliance. with the pertinent provisions of Part 71 whenever such a program is deemed appropriate.

Preparation of procurement documents and any changes or revisions thereto are under the supervision of Level 1.

Such documents will either contain or reference the necessary design basis technical requirements for each item or type of' item being purchased as to ensure compliance with these requirements, and will clearly identify the documentation required from the supplier for review and approval by the purchaser.

This identification will also specify which documents and records are to be prepared and retained by the supplier, as well as those which are to be delivered to or controlled by the purthaser.

All procurement documents, changes, or. revisions, will be reviewed _ by the Health Physics Supervisor or the Radiation Safety Officer prior to approval to ensure agreement _ with all appropriate design specifications and compliance with applicable regulatory requirements.

Final approval of procurement documentation including changes and revisions will be provided by the Site Operations fianager only after this review has been. accomplished.

Also, no procurement document will be approved unless the purthaser's right of access to the supplier's facilities and records for source' inspection and audit is -clearly specified.

Control of ' procurement ~ documents will be exercised by the Site Operations Manager, who will see to. it that they are properly:

' maintained and filed in such a way as to be traceable to the specific item.

5. INSTRUCTIONS, PROCEDURES, AND DRAWINGS General instructions : meant. to ensure' a high level of quality and safety in 'the packaging of ~ radioactive materials for transport are included in this program, under.the headings of " Handling, -Storage, and Shipping" ~ (Section.13), - and " Inspection, cTest, and Operating Status" (Section.14).

Where appropriate or necessary, specific I

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instructions, procedures, and drawings. will. be provided to maintain or improve standards of quality : and, safety.

Included in such instructions will be any quantitative.or qualitative acceptance criteria pertinent to the particular package or shipment under consideration..

Means will be - provided, through check-off sheets, logbook entries, or other : applicable records,. to document the p

. satisfactory accomplishment of such activities.~ -

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Instructions,-

procedures, and _ drawings are subject to similar

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measures of control as are applied.to designs (Section 3) and must.be accompanied at all times by appropriate _ review and approval check-

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lists. - Noisuch documentation will be-accepted as. official until such checklists-have.been completely filled out,' indicating approval.

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such completed checklists. will. be filed with - the original docu-mentation and-all revisions in a master file for the item maintained i-by the Radiochemicals group,

6. DOCUMENT CONTR0L-v.

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All documents relative to u any particularf shipping package will be p

under the control of the individual. responsible. for the shipment of t

- such a package.

In most cases, such cdocuments will be controlled by the Manager; of Radiochemical Production, as -most shipments made by t

the licensee consist of packages containing radiochemical products.

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Documents relevant to. other_. types of ~ packages, such ' as. shipments of i

radioactive waste materials for disposal, otservice _ irradiations, or h

spent reactor fuel will be under the control. of _ supervisory personnel from -the particular. group directly involved with such packaging.

In addition, documentation regarding non-routine packages or shipments which may' pose particular_ safety or. radiation' hazards will be i

available to the Health Physics Supervisor for. approval and confir-b mation that all applicable Q.C. c and.. Q.A.

provisions have been L.

complied with.

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' No changes will be made _ to lany document. regarding the ' packaging and F

- shipment of radioactive. material without the approval _ of a competent individual -in a position of authority regarding the preparation and

shipment. of such a package. _ The c sp~ cific 'individua11 involved will, e

~of : course, depend onL the. particular type. of L package under dis-cussion. -No changes in such; documentation which areJpertinent to the

- safety of a particular' shipment will bel made without the concurrence j

~.of the Health Physics Department.

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~ 7. CONTROL OF PURCHASED MATERIAL,'EOUIPENT AND SERVICES

All purchased material, equipment. and services will be examined to ensure conformance with procurement documents.

The supplier of such items will be. required to provide. documented evidence of;the quality of -these items and their compliance with all pertinent regulatory

-requirements.: _ Such evidence will be, provided by the supplier before any such ' purchased - material or equipment tis placed into service.

This ; documentation, and any 1 objective evidence of. quality, shall clearly reference the specific regulatory or quality assurance provisions.- met by the purchased items.

All such records shall be retained in a. form traceable >.to _ the specific item, Lor, if more appropriate,. group or. type of times,Lwhose quality is under consider-

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ation.. To~ further control the quality, of such purchased products, iCintichem representatives

will, when. appropriate, ' inspect the supplier's ' : facility, work. in progress,.and quality. assurance program ( In. addition, 'Cintichem will, on. occasion,- perform such tests on purchased. items ast are necessary to' guarantee the maintenance of high standards of ~ quality and-safety.

Included in the-evalu'ation of p' tential suppliers will be their o

capability to comply with the.' applicable portions of. Subpart H. to 10 CFR 'Part 71.as demonstrated = by past performance ip supplying such items to Cintichem, Inc. or other purchasers.

If, records-of previous performance are not available, the supplier'st production facilities Lan_d Q.A., program will be studied by competent personnel? to determine that the capability is available'- to meet the requirements for

- compliance.

8/ IDENTIFICATION AND-CONTROL.0F MATERIALS, PARTS, AND COWONENTS As specified under the heading ~ "Designi Control"' (Section 3 ),

- applicable : regulatory requirements ) and1 qualityJassurance criteria will' be clearly. translated into specifications,; drawings, procedures,-

.and instructions. Where appropriate,'.such instructions will' call for the Tpositive fidentification n of material,: Jparts, or components

'throughout J fabrication, c insta11ation, ore use: :of the item.

This identification wills be made.on the basis ~ of-heat-. number.'part number,

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orf other such means as -is

specifically-appropriate to the ' piece under:

consideration.- Such~ identification will.be ' traceable to: a.particularl M

- compl eted sitem,: L ori > type ofnitem, Leither c at ? the -- item c itsel f. c or )

ithrough l documentation : specific Jto thatEitem.i Particular.' care will ? be taken :to ensure.. thatothrough lthis tprocedure no t incorrectTor _ defective (parts, ; material',.or componentslare put into use.

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cThe ~ method -and elocation ' ofi this ridentification!will befindividually;

'determinediby :each item undericonsiderationito ensurea that' thel fit,.

ifunctionwor quality 1of 1the ? item 11s kin inof way" compromised by ' the :

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' identification t sys tem.. No fitemf willj bel accepted ; for J use Tunless i u:

r (documentation andf verification are _provided. establishing thevcorrect;

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Lidentification off all critical > materials { parts,:and conponents.=

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. 9. CONTROL OF SPECIAL PROCESSES I

Special processes, such as welding, heat treating, or non-destructive testing,.will be performed only by qualified personnel.

Prior to the l

start of such processes, an evaluation will _ be performed by the 1

. Supervisor, or such other competent individual as may be appropriate, i

S to determine the; applicability of the. various codes, standards, i

specifications, ~ criteria, or regulatory provisions which may have a

~ hearing >on-the process under consideration... A procedure for ' per-i formance-of the process willx then be established to ensure, compliance with such requirements - and assure.that the quality and safety characteristics of the item under process are maintained.

- Upon completion of. such processing, the item will be. inspected by the Health ~ Physics Supervisor. or another competent individual. to guarantee that all requirements have been. met and the quality-of_ the j

item has not been compromised.

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As such special ' processes are performed, a record of the procedures developed,- the equipment utilized and the qualifications of the personnel involved will be established,- filed in such a.way as to be traceabls to the appropriate items, and kept current as changes occur.

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10. INSPECTION ~

A11 activities which could affect the. quality of packages containing i.

. radioactive material for shipment willibe subject to inspection _ under

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the di_rection of the Site Operations Manager.

Such. inspections _ will be l conducted to verify conformance.- of' the activity with' documented drawings, instructions, and procedures for its accomplishment, --and to maintain high standards of - quality andi safety.. In: general, such inspecti.ons will be carried out by individuals having line authority over those who perform the activity. -In addition,' such activities 'may

- be' inspected ^by other ' individuals-posssssing special competence to e

evaluate the accomplishment of the activity.

. These inspections will be. carried out.on a regular basis, the timing of which will be dictated by the safety Lsignificance of the activity -

in~~ question - and the need to maintain.. a high level cof quality.

Instructions for _ performance -- of ' manufacturing and-production L

processes will include ~ provisions for such ' inspection, including Ltests 'and examination,. by mandating specific hold points beyond which work 2cannot-- progress without; approvul ; by a. designated-inspector, or-

'by,specifying particular processes which must be monitored.by such an

? inspector or witness, or both,--as necessary.

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s All modifications, repairs, or' replacements will be subject to the same mode of inspection as required. by the original design, where 4

this is practical.

If this is not feasible, inspection methods will be required to establish that the original technical criteria are met through alternate inspection techniques.

In the event that specific codes or standards are applicable to such inspections, specific inspectors will be trained and certified, where necessary, in the appropriate methods and techniques.

In other cases, company. training programs will be utilized to develop the necessary expertise to.perforn these inspection functions.compe-tently.

Qualification, certification, and training records of such inspectors will be kept on file to provide ready reference so that the appropriate individual may -be assigned responsibility for each such inspection.

11. TEST CONTROL Specific. written test procedures will be used to verify that all packaging components will perform satisfactorily in service.

Such tests will be written in accordance with the requirements of 10 CFR Part 71 and the requirements and acceptance. limits of the specific package approval.

These tests.will be conducted, under the direction of the Radiation Safety Officer, with the assistance of such other competent individual as.may-be appropriate in each case.

Test procedures will be written in such a manner that all prerequisites for' the test are met, adequate test instrumentation is available and properly utilized, and the test is perforned under. suitable environ-mental conditions.

Test results will be clearly documented with perticular reference to - the specific -items under evaluation and the type of package or component' being tested.

These results will be evaluated by the Radiation -Safety Officer or other - conpetent individual to assure that test requirements have been met and that all applicable criteria have been satisfied.

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

Where feasible, all modifications, repairs, or replacements will be tested in the same manner 'as that required by the original design.

Where this; is not practic'al, alternate rothods will be selected on.

the basis of their ability to satisfy the same criteria as specified E.in the original design and testing criteria.

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12. CONTROL OF KASURING AND TEST EQUIPENT

' All measurement and testing _ devices which are used in activities 5

affecting the quality of packages containing radioactive material for transport, or which are used to evaluate the quality of such packages, will be controlled.-. Prior to the use of'any.such device it 4

will be ' calibrated _or adjusted as necessary to ensure its proper-performance.

The accuracy of such. devices will _ be verified by t;

periodic calibration, and they will. not' be relea. sed for use unless they are accurate within the necessary limits.

LLogs documenting _..such - calibratio_ ~ or adjustment will identify the n

measuring and. test. equipment and provide traceability to. the

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calibration ? test - data for each item.

Calibration of measuring and test equipment w"1 be performed'and. documented in such logs prior to F

its; use to ' ensure that no' inspections 9 or tests are performed with

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equipment which is out of calibration. 'Where possible, all standards

'used will be traceable to nationally ' recognized standards.-

Where this is not practical, the basis;for calibration will be selected and j

evaluated'.by the Radiatio _n -Safety E0fficer,.who will see co it that

'the needed verification and documentation are recorded along with the 4

' appropriate data.

13. HANDLING, STORAGE, AND SHIPPING Safety shall be the paramount consideration in the handling, storage, f; _

and shipping. of packages for. radioactive material. Upon_-receipt of a returned package for such ' material, the' entire'. package will be

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visually inspected by Level 2_. personnel J to determine the extent of

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any damage which may have occurred 'during; shipment.. Typical items 1 o t

be. checked consist of:

(1)' status-of outer 20_ nC-2; jacket,- secure fit 'of top' and clinch ring;_ no-puncture 'ofn outer ' steelj drum or splitting of11aminated. plywood; no gross damage _ to threaded fasteners L

which would hinder 3subsequentfclosure of package; (2) condition of U

stainless steel-c1ad.. lead or; depleted _U - shipping ' pig.-? No significant t

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radioactive contamination;L nogdamage to lifting Lrings or' eyes which could cause a hazard when: the pigsis-lifted; no. damage J to threaded

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components.whichicould prevent 11d. from being securely 1 fastened; :(3) condition.of inner Type: 2R container - Level. of radioactive contami '

Lnatien:and/or radiation ' readings below haza"rdoustievels c(100 mR/hr.);

lifting ; bail-in. ~ satisfactory 7 con _dition;c ino; damage? to : threaded.

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closur.e; (4) type B-3 containers for; shipment 4of: radioactive waste --

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Ll evel : ? of i radioactive contami nation; gasket - condition;. presence lof; idrainl plugs;. condition of lid bolts."

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Unless such nackages are. destined' for -immediate re-use, they shall be stored in a, designated area,2 safe. from possible damage.

They should

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be~ stcred in a closed condition,_ with all-parts in place, until they are to be 'used again.

An exception will-be made.in the case of any part which is not ready for. use L by virtue-of damage or excessive contamination.

Such parts may -be removed for repair or decontami-nation and subsequently stored separately until ready to be re-used.

No shipments 1 will he made using. any : type of package unless _ all applicable tests, certifications.and inspections have been completed.

In - general,- such tests will include: ' leak-testing under vacuum of primary containers (bottlesF containing sufficient radioactive material in : liquid form.that spillage may-be a hazard;. testing of Type 2R' containers' after closure under vacuum tofensure that they-are sealed; written certificationion' the - order / invoice ~ from. accompanying-such shipments that these tests have; been. performed; certification that the contents of the -cylinders. containing gaseous radioactivity l'

are packaged atlless than 1/2.atm absolute pressure; visual. inspection of. all shipping containers to ensure that all

gaskets, packing i

material, and fasteners are properly located and secure;_ determination that the level of radiation emitted from any single package or array of_ such packages.does not; exceed applicable limits through the use of appropriate monitoring devices;~ wipe tests to ensure: that no signifi-j cant removable radioactive contamiaation 'is._ present on 'anyepackage to be= shipped; and a final visual inspection to ensure that all necessary ar.d appropriate seals, labels, signs, or other identifying. devices are t'

l-properly:and securely affix'ed to each package.

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In order to minimize unnecessary handling of-radioactive materials and 1

to ensure that all necessary tests. _ certifications,- _ and inspections have been performed, responsibility is assigned 'as follows:

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,1.

Certification that leak : t'ests on primary containers havet een b

performed will be done _by-ther technician dispensing. the material.

r Pressure of gaseous product cylinders will be? similarly} checked -

and certified.

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2.

Secure,, leak tight closuresi on Typel: 2R containers will be c

z certified by either a member of the _ Health. Physics Dept.f or by supervisory personnel from the-Radiochemical Production Department.

. 3.. The-Senior Technician of' the! Packaging $roup will check thatj the

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- above tests. ahd certifications: have= 'been ' performed before :

accepting. any.such container'for final packaging,.

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. Visual inspection-of shipping containers, radiation monitoring, and wipe tests will be performed by members of Level 3 personnel under direction of Level 2 ' per:,onnel or by a Health Physics

. Technician.

S.

Final visual inspection _ of each compl eted package will be performed by a Level 2 individual.

Each package will be so inspected prior to being. loaded into a transport vehicle, and will not be loaded unless all identifying tags, labels, seals, or signs are properly affixed and all shipping documentation is completely and correctly filled out.

4 The above procedures - apply to all routine shipments of radio-active products, and shall be performed under the directed supervision of Level 2.-personnel.

Shipments of a non-routine nature, or those processing particular characteristics which pose a potential safety hazard, will be prepared under the supervision of an individual ' knowledgeable of. such particular hazards and competent, through training or experience, to ensure that all safety requirements are properly. met.

In such instances, the Radiation Safety Officer will also take a direct role in certifying that all necessary, appropriate, and applicable actions are taken to ensure that the shipment may be made safely.

-14. INSPECTION, TEST, AND OPERATING STATUS If receipt inspection indicates that upon receipt a container is acceptable for imediate re-use, the package will be stored in a designated, area, and 'its presence in this area will indicate its availability for shipment.

If, however, any condition exists which indicates that such a package may -not be suitable for imediate use, 'it will be segregated in another area and tagged to indicate that it may not.be shipped.

In

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such a case, a Level 2 individual, or other individual.in a higher position of authority' will be_ notified,- and this individual will personally inspect the package, determine its ' proper _ disposition, and label it to indicate the action. to -be = taken.

In addition, if ' any such. repairs or modifications !could ' pose a safety or radiological hazard the Health P;.ysics Dept. will be called upon to indicate any special precautions or ' actions which may have to be tak en.'

The

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status of any package, or part 'thereof, awaiting any such action, or being worked on, will.be clearly indicated by tag, label, or! marking-

. as appropriate, and any necessary information wi'11be. entered in the :

- pertinent log, if such entries are applicable to the type of. package tunder consideration.

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In 'any case where such. repairs are necessary, or modification of a

.package:has been performed, the package will not be accepted for use until the repairs or modifications have been inspected and certified by :either. a.. Level 2 individual, or a member of the Health Physics

-Department, or. other responsible individual, if appropriate to the particulary type of package.

Similar procedures will be followed in

' the : case,of z anyrpackage which is undergoing test to determine its

- suitability for any specific packaging application.. Such containers undergoing test will be' clearly marked, and will not be accepted for luse until. test.results have been certified by the proper authority, sin the.. event that any.new orf substantially changed packaging ~ design is_ proposed for. use, or a new application is proposed for an existing package design,;it will :be the responsibility.of the Radiation _ Safety 0

0fficerlto: determine what' type of tests: and inspections are necessary to, guarantee that s ll applicable safety vand regulatory criteria have a

ibeen, ~ met. ' A Level :1 individual will oversee the performance.of such tests,- and with the concurrence of the Radiation Safety Officer and f

Lapproval f of the _ Site : Operations, Manager, certify that the package design under consideration has been adequately tested and is suitable

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for.its: proposed use..

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15. NONCONFORMING PATEPIALS, PARTS, OR COWONENTS l

' As ' mentioned under. the. heading " Inspection, Test. and Operating Status"L (Section 14), in any case where-a question exists as to the F

suitability of a particular package, container, or piece of equipment for use,ithe ' item will 'be segregated by location, Lif possible, and 3

itagged to indicate its non-operational ; status, pending inspection by a competente 1ndividual. in a' position _ of responsibility.. Such tags C

willi specifically' identify : the non-conforming' item rand briefly e

describe"the non-conformance. ; After inspection, the item;will either be ' accepted ifor -use again, removed ' from service' permanently, repaired,. or.. reworked, Las is necessary ' 'and. -appropriate.

Such disposition will be under.the direct control of a= level 1 - individual ~,

f who will ' ensure that the'. status 'of;the item is correctly stated, that

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the.i proper 1actionsf are taken in L accordance with ~ established : pro-

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cedures,_yaad upon completion: : of- - the requiredEaction, that-all 1 necessary; documentation is correct and complete.-.

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\\Such> documentation willtinclude the Etag described ab'ove, along. with -

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. otherjpertinentPinformation,1andLwillj clearlyEspecify' the _testeor sinspection (requirements which must: bejmet sto! justify restoration Jof ~

!thefitem toioperationalWstatu.- Upon:? compl etion ; of; the : necessary E

' tests; orf inspections,"a report willibeiappended ;to: theidocumentation

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describing (their results, and delineatin'gEthe1 further" disposition Lof '

the sitem.".Such tdisposttion willL not ~ be accomplished Luntil the report W, ',

zis -'approyectand isigned by s competent! authority, ; generally' the

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Radiation Safety'0fficer.

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$16. CORRECTIVE ACTION:

All: inspections, : tests, and examinations conducted under this a

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program, _ from those involving. new material upon its receipt, to the

-final inspection ~ of; each package,before: shipment, are aimed at maintaining the highest l practical; standards of safety and quality,

_and sonare meant to promptly detect any conditions adverse to the'

. maintenance ~ of. such i standards.

I f, through these inspections or

'through other means, any. deficiencies, deviations, defective material

' and equipment, 'or nonconformances are discovered, immediate. action

.will be taken to identify theirisource _ or cause, and to correct the

. problem.n,In the event of any-such discovery, the appropriate Level 1 individual will; i_mmediately be -notified, and he will promptly take Tsuch action as; necessary to maintain.or. achieve a' condition of safety.

In.the event that- 'a : significant condition Ladverse to i

1

quality, or. a Jserious hazard potential exists, other individuals havingl specific competence to deal with the problem will be consulted,~ and remedial action will be undertaken as soon as-possible.

Ini the case of such a significant condition adverse to quality, the-

,. Level.1 ? individual will thoroughly investigate the situation, with

such! assistance as may be useful. or necessary, :to -determine the cause of the condition. _He will then institute corrective action, subject to approval _ of th? Site Operations Manager, to alleviate the existing situation and prevent recurrence _ of the condition.

He will also be responsible for; the generation of a cleari and accurate report, documenting identification.of the condition, its cause, and the corrective action which was -taken.

Thi_s report shall. be forwarded to such levels of management as may be appropriate.

4

17. QUALITYL ASSURANCE RECORDS Records o_f the performance of, Packaging. Quality. Assurance-. operations will be in designated-locations): providing security. for asuch records, while'~still ' allowing ready.' access' when necessary.i The form of such records will be> appropriate:to theltype-of! packaging involved and the

" nature:of the information to be' recorded.1 Records which are specific to one particularf package, container,; or piece. of Lequipmentlwill' be-referenced.to thatiparticular item! through the use of logbooks :: in

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which -Jwill: be' entered the results-: of all inspections and tests,- as

,. ell. as La Trecord of.all > repairs; or modifications ' which have : been w

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2 performed.~ Records-referring to particular shipments will obe kept in -

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the. form -off completed Jcheck-off sheets f or completion: notices-' indi-

cating-that allr necessary LQ.AL.- functions _ - have-been X performed and

identifying' theJresponsible1 individuals.

JThoseirecords which : are of R

al general c nature,--- sucht aslaudit E resul tsD ori the

: resul ts / of " tests -

applicable _ to types of packalges'will;be filed'in the same, location;

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Cbpies1of all current and tpast. packaging procedures will also be maintained in this area,. along with a copy of the Quality Assurance

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program.

In' addition, all personnel currently involved in the ipackaging of ~ radioactive materials? or engaged in the Q A.

program will _have copies;of.such documents available for their use.

Included

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will o be a 1. clear ' description of 'the. tasks for which each of the L

variousf positions involved in = the_ : packaging or shipment of radio-active materialsJ is responsible, as well as a listing of what areas

~ ofiauthority :regarding the 1Q.A. _ program are to be exercised by I

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personnel at different-levels of responsibility or operating groups.

All such records will be maintained on file in such a manner that;any

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specific _ information. : required will be readily accessible and I

traceable 1to a particular container ~ or shipment.

A listing of the i

records on-file and their location will be kept up to date to ensure that thesen documents 'are identifiable and retrievable.

It - will be the responsibility of. the individual completing each record to forward.it E o Lthe proper area..for further disposi tion, and 'the t

~ appropriate ~ Level 1

individual will see to it that this is

accomp1ished and that.all such documents are properly recorded and/or filed.

' Design - related records will be' maintained on file throughout the

-entire' period during which shipping package, or typs of-package, is

_kept in. use.

All other records relating. to quality :of_ such packages t

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orLshipments will 'he kept available' for. inspection for _ at least two

-years.

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_ All. inspection 'and test records will detcribe the type of observation

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involved, and will include. evidence that all pertinent manufacturing,

-inspection, and testing operations? ha.ve been completed and verified.

Thisl evidence will1 include - the' date on which such l operations were

performed,. identification :'of- ' the : individual s. ' invol vEd, and : the results of the : test or Hinspection.. In ' addition, J where, necessary,-

'information will-be included _describingianyT conditions which ' could

' adversely affect.the cuality of-the item 1or the acceptabilityf of the

[

- tests - results.

18.EAUDITS LThe packaging _ quality; assurance programLwr,,; be audited on.a yearly.

' iba'si.s by1airepresentative of.- the Nuclearisafeguards / Committee, and nthe. resultsi of such Eaudits will be1 reported tofthe Plant.' Manager.

(The ? primary concern -in fsuch ? audits Ewill1be the: -hazard ipotentialc involvedjin Tall l aspdctsi ofJ the 1 packaging operation, and audits - willt

1. be? : intended f to l improveio.t ' maintain a-. high flevel~ of : safety,. for

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the ultimate recipient of packages containing radioactive ' material 1 shipped by the'. licensae, and; for-members of the general public who may be in proximity to such packages during their transport.

The Plant Manager will evaluate the. reports of all audits, with the assistance _ of such competent authority as he' deems necessary, and direct thattareas of deficiency be corrected.

The Site Operations Manager, shall direct such corrective activity, and approve i ts -

completion.

Audit reports' and reports of corrective actions shall be maintained on : file as part of the packaging quality control records,

and will be traceable to such other items in these records as.are-pertinent.

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FIGURE 1 ORGANIZATION CHART a

Plant Manager I

Radiation i

Safety Officer Site.

--~~---------

Operations I

Manager I

Health Physics Supervisor Manager Manager p

l Operation Production l

i Health Physics T6chnician

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l Hot Lab Reactor-Radiochemical Operations Supervisor Packaging LEVELL2 l

- l- ~~

Supervisor Supervisor

~~---

I.

I T----->l--

I Waste Packagers Packagers Packagers Packagers LEVEL 3 1.

Horizontal dashed lines indicate paths along which responsibility may be shared or concurrence achieved on items of con::ern.'

2. : Vertical. dashed lines indicate paths along which approval must be achieved or upon which an audit function is involved.

3.

A function or responsibility designated for a certain level individual may be assumed by a higher level individual provided the effectiveness of the program is not. decreased.

PQ-01 10/14/85

7 FIGURE 2

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RESPONSIBILITY MATRIX NUCLEAR

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RADIATION-l

. PHYSICS ' l SAFEGUARDS I ~

FUNCTIONS

'l-MANAGER l R EL 1*'l' LEVEL 2* l LEVEL 3*-ll _ __OFFIC,E_R_ ___ _ __l StPERVISOR I COMMITTEE l.

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• See Figure 'l for definition of, Levels 1, 2, and 3 A:. APPROVE B: ACCEPT C: CONCUR D:

INITIATE-E: PERFORM PQ-01 t 10/14/85 n

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