ML20006D595

Rev 1 to QA Program for Procurement,Use,Maint,Repair, Shipping & Transport of NRC Approved Packages for Radioactive Matls

ML20006D595
Person / Time
Site:	07100529
Issue date:	07/10/1986
From:	Fogle J THERAPY SERVICES, INC.
To:
Shared Package
ML20006D592	List: ML20006D591 ML20006D595 ML20006D597 ML20006D630
References
NUDOCS 9002140091
Download: ML20006D595 (14)

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Tl!ERAPY SERVICES INCORPORATED 3

QUALITY ASSURANCE PROGPAM for Procurement, Use, Maintenance, Repair, Shipping and Transport of NRC Approved Packanes for Radioactive Materials Original January 16, 1985 Revisions REV. 1 - July 10, 1986 t

6 Reviewed, approved, and implenented by QJkkL Sb-7- \\oN(o i

u L-Jerry L. Fogle Date Radiation Safety Officer l

l Quality Assurance Manager l

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p Paga 1 11IERAPY SERVICES INCORPORATED Quality Assurance Program for Procurement, Use, Maintenance, Repair, Shipping and Transport of NRC Approved Packages for Radioactive Materials 1.1 Organization 1.1.1. Authority By review and seal of acceptance of this Q. A. Program, the management of Therapy Services Incorporated acknowledges responsibility for implementation and performance of policy and procedures designed to assure that the :arocurement, use, maintenance, repair and shipping of NRC approved pac < ages are adequate for safety and consistent with Appendix E to 10 CFR Part 71.

1.1.2. Structure 7herapy Services Incorporated Quality Assurance organizational chart is shown in Figure 1. Positions and responsibilities are as follows:

Radiation Safety Officer /Q. A. Manager

a. approval of Quality Assurance program ano periodic review of records

b. approval or rejection of proposed revisions to the Q. A. program

c. recommending solutions to Q. A. Program deficiencies

d. impimenting procedures in case of emergency situations e conducting periodic audits to confirm compliance with all aspects of the Q. A. Program. A Teletherapy Shipping, Q. A. Audit Checklist is shown in Figure 2.

f. review of Q. A. records g identifying, reconniending, and providing solutions for Q. A.

program deficiencies, and verifying the implementation of solutions

h. assuring that Q. A. checks are appropriate, are adequate for the intended purpose, and are performed correctly.

Licensed Service Engineer

a. Shall perform shipping and receiving of containers and completion of shipping records and Q. A. Checklists

b. as'ume complete responsibility of the use of the transfer containers L

s at temporary job sites l

c. notifications to Q. A. Manager / Radiation Safety Officer of any l

damage to contbiners likely to result in reduced radiation shielding or safety of the package during shipping 1

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d. assist and consult with repair and maintenance personnel for container upkeep and maintenance Repair and maintenance personnel

a. repair and maintenance of shipping packages and transfer containers

b. document and record all repairs and maintenance performed in separate log books for each approved container

c. consult with package manufacturer and Q. A. Manager for any non-routine repairs or deficiencies found in containers Service Engineer

a. perform shipping and rocciving of containers under supervision of Licensed Service Engineer

b. notify' Licensed Service Engineer and/or Q. A. Manager of any damage or package deficiencies 1.1.3.

Qualifications The Radiation Safety Officer / Quality Assuratice Manager for Therapy Services Incorporated is Jerry L. Fogle. Mr. Fogle is named on four Radioactive Materials Licenses, in Agrement States, to transfer, ship, receive, and transport Cobalt-60 teletherapy sources. He served as a licensed engineer and teletherapy services manager for Neutron Products Inc., Dickerson, Maryland for 7 years, and has 10 years experience with overall responsibility for the implementation and performance of all of Therapy Services licensed activites and Q. A. programs. He has safely exchanged and shipped over 250 individual cobalt-60 teletherapy sources since 1973, throughout the United States and into other countries.

All shipnents of approved containers will be under the supervision of a licensed service engineer, familiar with the container design, intended ude, radiation safety, and shipping documentation.- All repair /mainten-ance personnel and service engineers will be selected according to appropriate qualifications by the Q. A. Manager or's licensed service engineer.

1.2 Procurement Document Control 1.2.1 Packaging Procurement For all containers used, certifications form the package manufacturer will be obtained before use, and will include Certificate of Compliance, package use and maintenance manuals, and information as required by the manufacturer in the Certificate of Compliance to include as built drawings, photographs, sketches, etc.

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Replacement Part Procurcment All maintenance and replacment parts used on the approved packages will be as specified in the manufacurer's fabrication drawings and approved for installation by the package manufacturer. Non-conforming parts will be approved by the manufacturer and recorded in the maint-enance log for that package.

1.3 Instructions, Procedures and Drawings 1.3.1 Preparation of Packaging for Use For all approved containers intended for use, a record will be main-tained by the Q. A. Manager. The record will include the date of package receipt, condition of package, verification of required certificates, and all information regarding safety and use of the specific package, as required by the manufacturer.

1.3.2.

Repair, rework and Maintenance Any repairs or maintenance of packages will be approved by.the manu-facturer and Q. A. Manager before the work begins. Aspects of safety and effectiveness of intended repairs will be reviewed and approved by the Q. A. Manager. All repair work will be logged in a separate book for each package.

1.3.3.

IoadingandUnloadingCbntents loading and unloading of radioactive material, to and from packages, will be performed according to a s weific procedure for each type of teletherapy unit. Procedures will x approved by the licensing agency (NRCorAgreementState).

1.3.4. Transport of Package All packages will be inspected before shipping to confirm good condition, adequate tie-down on transport vehicles, seals, DOT markings per regulations, and identification of model and registration ntabers. This informaiton will be recorded on the Radioactive Shipping Record, as shown in Figure 2.

1.4 Doctment Control All doctments related to use and shipping of approved containers will be filed by the Q. A. Manager. Documents will include:

1. Q. A. Program

2. Container use procedures

3. Dnergency procedures

4. Radioactive shipping records 4

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5. Package Receipt Checklist

6. Inspection and test procedures required by the manufacturer

7. Repair procMures as defined by the manufacturer

8. Maintenance logs The Q. A. Manager will make available to appropriate personnel, the most recent revisions to checklists, procedures, specifications, and drawings.

1.5 Inspection Control 1.5.1.

Receipt Inspection Visual inspection of each package will be made upon roccipt at temporary job sites and at the Company facilities. A Q. A. Package Receipt Check-list (rigure 3) will be used to doctrnent the package condition prior to use. Any visual damage will be recorded on the checklist and the Q. A.

Manager will be notified regarding necessary repairs. Any s'erious damage that has resulted in reduced radiation shielding or would keep the package from being used as specified in package use procedures, will be imediately reported to the A. A. Manager / Radiation Safety Officer. A corrective action plan will be considered and performed, if possible, to repair the damage. If the damage is considered unreaairable in the field, the R.S.O./Q. A. Manager will make plans to have t'ac pack-age taken to an appropriate facility (hot cell if necessary), for unloading and or repairs. A licensed service engineer will inspect any repaired package and report the condition as useable or not to the R.S.O./Q. A. Manager, before proceeding with normal use of the package.

1.6 Maintenance All maintenance on packages will be performed by the package manu-facturer'if possible. If package is in use by the Company when routine or repair maitenance is required, the manufacturer's specifications and guidelines will be followed.

1.7 Fi$alInspection After c6mpletion of a package for shipping, a Radioactive shipping Record will be prepared and signed by the individual that performed the work. A, Quality Assurance Shipping Checklist (Figure 4), will be then completed by a separate individual, if possible, to assure that the packagelis ready for shipment and that all NRC and DOT requirements nave been satisfied.

1.8 Test Control 4

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1.8.1 Use of Packages Acceptance checks and tests will be performed on all packages prior to shipping. Items specified on the manufacturer's Certificate of Compliance will be checked and documented on the Radioactive Shipping Record and/

or the Q. A. Shipping Checklist.

1.8.2.

Maintenance Tests All teletherapy sources to be loaded into containers will be checked by appropriate wipe test, for contamination, prior to the transfer. Should the presence of removable contamination in excess of 0.005 microcuries of Cobalt-60 be detected, the radioactive source shall not be trans-ferred into the container. Appropriate action, detailed in the Company teletherapy license, will be followed in this event. A wipe test will always be perfonned on containers loaded at a hot cell, before shipping.

Contamination above 0.005 microcuries will be removed from all accessible surfaces, before shipping from the hot cell. After use of an approved containeri the Licensed service engineer will orient the appropriate container components to minimize radiation output levels during shipping.

1.9 Control of Measuring and Test Equipnent 1.9.1.

Calibration Control Measurement and test equipment and devices used to measure radiation levels and leakage will be calibrated, adjusted, and maintained at least every 3 months, arxl no later than prior to use for shipping purposes.

The equipment will be labeled to indicate the date of the next calibra-tion. Calibrating standards will have known valid relationships to nationally recognized standards. If no recognized standard exists, the basis for calibration will be documented.

1.9.2.

Out-of-Calibration Equipent No equipment will be used for measuring and testing if out of calibration.

If equi p ent if found to be out of calibration, all measurements eated with calibrated equipment for tests or meas-possiblewillberepiuringtheout-of-calibrationperiod,andprevious urements performed c L

results modified and validated where applicable. Any equipment consist-ently,out-of-calibration will be repaired or replaced.

1.10 Inspection, Test, and Operating Status Packages and inner containers will be labeled at all times with either

. l' Radioactive Yellow II, Yellow III, or DPIY labels as required by the DOT,.to;cnsure current status of the package._In addition, packages being. serviced or repaired will be tagged by the Q. A. Manager in a conspicoous location. This tag will only be removed when service or repairs are complete and logged as such in the maintenance book for each contaliisr-.

1. 11. Quality Assurance Records a...

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1, 11. 1.

General All Quality Assurance records pertaining to shipping will be retained i

for the lifetime of the package, including evidence of delivery of packages to a carrier.

1. 11. 2.

Generating Records Q. A. records and checklists will be legible and completed to relfect the work accomplished. Q. A. Manager will review all records and check-lists and will take corrective action for individuals or groups not

, completing records. The Q. A. Manager will also file and maintain records on a prompt basis.

1. 11. 3.

Receipt, Retrieval, and Disposition of Records t

i All recofds will be forwarded to the Q. A. Manager for review and filing.

He will maintain files so that all' records are identifiable and retriev-able. No records will be destroyed or disposed of, during the lifetime of the package, j

1. 11, 4.

Storage, preservation, and Safekeeping Facilities to store records will be constructed to minimize the risk i

from damage or destruction. Records will be firmly attached in binders or placed in folders or envelepes for storage in steel file cabinets.

Record storage areas will be locked during nighttime hours to restrict entry of unauthorized personnel. lost or damaged records will be replaced, as soon as practical, by the Q. A. Manager.

1. 12. Audits l

An audit of the Q. A. Program, activities, and records, in the fom of a checklist (Figure 5), will be perfomed by the Radiation Safety Officer /Q. A. Manager on a random basis, no less often than once each year. The audit will include verification that all packages used were NRC approved. He will direct corrective actions resulting from findings

.i of audits, on a timely basis. Deficient areas will be reaudited in 30 days, or as soone ao practical, and documented by the Radiation Safety Officer /Q. A. Manager.

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Quality Assurance Manager b

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Licensed Service Eq.ineer Repair / maintenance personnel' f

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yt-Z.. Figure 1 - Quality Assurance Organizational Qart t

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Radioact5vo Shipmint Rscord l

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-Shipment Number Date Shipped Fmas Shipped tes i

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Consignee R.A.M. License No.. '

Issuing Agency Carrier (s)

Exclusive Use - Yes No Source Description Radioactive Material, special form, n. o. s., Radioactive Material.

Isotope Curies Date Scurce Model No.

Number of sources D.te Leak, tested and passed.

Transport Group Package Identification NRC Certificate No.

'Mfr.s/n Package Identification No.

IAFA Certificate Quantity - Type A B

-Large Package Type - A B

Cass weight lbs.

kilograms 1,

Package Leak Test dpm/100cm2 - initials date l

not required, clean facility 6, leak tight source i

I 3 feet from package '

Survey Dose rates - mr/hr - package con 6 feet from vehicle cab of vehicle Tro,nsport Index Radiation Survey Meter - Mfr.

Model No.

s/n Iabels and Security Yellow I II. -

" ' 'III

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EMPTY Placards - Radioactive EMPTY None requirel Tie down chains /b'inders secure Tamptir' seal sffixed s/n l

Certification - This is to certify that the above named materials are properly cla'ssified, i.

dcrcribed, packaged, marked,' and labeled, and are in proper condition for transportation r.ccording to. the applicable regulations of the Department of Transportation.

Signed Date Therapy Services Incorporated, Shipper Frederick, Maryland 21701 5

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Reviewed by Q. A. Manager:

,S16natu're Date Figure 2 Radioactive Shipment Record 18 2f

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t Therapy Services Incorporated Quality Assurance Shipment Receipt checklist s.

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Package Identification DOT Identification Nusber Mir.s/n Shipped from Received at

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s Inspection - Describe dama6e or deficiencies in space' below j

1 Structural integrity sound - Yes No Welds Ok

'Yes

'No c

closure flange mated properly - Yes No-

, Seal unbroken Labels in place - Yes No Package'I. 'D. visible 'Yes No'

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All bolts in place and secure - Yes No

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Description of, damage or deficiency

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Corrective action taken

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i Figure 3 Q. A. Shipment Receipt Checklist

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Therapy Services Incorporated e-Quality' Assurance i ',

Shipping Checklist-a

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t Package Identification

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- DOT Identification Number Mfr.s/n-s Inner Container Both lids secure Iabelsin.jlace Bolts in place label info complete; k

Gaskets.' n place i

Bolts tight-Outer Package.

' Flange oriented / mated -

Bolts in' place,_

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.. Bolts tight Wolds OK Lifting eyes covered Labels in place.

I. D. tags visible Label info complete Seal insti'lled Surface O.K.

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Date Shipment Number r

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Package Inspected by:

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'Ihgrapy Services Incorporated Quality Assurance Program Audit Checklict

. Audit performed at the following location Date of Audit Item Yes No NRC approved containers used for all shipments Certificates of Compliance on file,

Shipping records being maintained Q. ~ A. Checklists, Shipping / Receiving being maintained Measuring and Test equipment calibrated Repair / Maintenance logs'being maintained Storage of 29 cords is secure and safe Package manufacturers NRC. approved Q. A. Program --

on file and being used by manufacturer Detail deficiencies found above t

s Corrective action to be taken by 1:

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Audit completed by:

s Radiation Saf ety Officer Date i(

Reaudit N heduled:

Date by Figure 5.9. A. Program - Audit CheckIlst

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