ML20005D895

Application for Renewal of QA Program Approval for Radioactive Matl package:0238

ML20005D895
Person / Time
Site:	07100238
Issue date:	12/19/1989
From:	Howell T AGRICULTURE, DEPT. OF
To:	NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
References
26213, NUDOCS 9001020172
Download: ML20005D895 (5)

Text

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Washington, DC 20555 Gentlemen:

Enclosed is a description of the USDA Quality Assurance Program for Packaging of Radioective Materials for 1ransport which contains no change in substance from the Quality Assurance Program No. 0238 approved by KRC.

It is required that this QA Program be approved as required by 10 CFR Part 71.

If additional information is required, we will supply it upon request.

Sincerely,

( f d b) W 1 Thomas Howell Acting Director Enclosure

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USDA Quality Assurance Program for Packaging an Shipment i

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e of Radioactive Materials l

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General i

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The U.S. Department of Agriculture uses only packages that have been designed, fabricated, tested, and approved for use by other persons and m

f for which USDA has received a certification from the U.S. Department of Transportation or the U.S. Nuclear. Regulatory Commission.

Packages are i

used as originally furnished by the supplier and are not modified.. When.

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damaged they are restored to their original condition. The services of l

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.the package supplier are engaged as required.

Cartified-packages are r

used to transfer irradiators containing more than Type A quantities of 4

'special form ^ radioactive material from one laboratory to another, to i

--disposal sites, or to vendors foi reconditioning or reloading.

Such l

i shipments, however, are made infrequently. All shipments are made with t

.the prior approval and under the direction of the Radiological Safety r

Staff (RSS).

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Organization f

.The final responsibility for the Quality Assurance (QA) program for Part

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71 Requirements and auditing rest with the USDA's Radiological Safety Committ.ee (RSC). Design and fabrication, except repair, shall not be

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conducted under this QA program.

The Radiological Safety Officer (RS0) is responsible for overall implementation of the program, instructions, certification, and document control. The qualified responsible user approved by RSC is responsible for handling, packaging, shipping, storing, inspecting and furnishing records to the RSO. See last page for y

organizational chart, i

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Quality Assurance Program The Radiological Safety Committee establishes and the Radiological Safety Staff (RSS) implements the QA program. Training, in the form of written instructions, prior to engagement for all QA functions is required. QA program revisions will be made according to written procedures with RSS

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approve. The QA program will insure that all quality control procedures, engineering procedures, and specific provisions of the package design approval are satisfied. The QA program will emphasize control of the characteristics of the package which are critical to safety.

The Radiological Safety Staff will assure that $ radioactive material shipping packages are designed and manufactureC under a QA program approved by the NRC and/or DOT for all packagea designed or f abricated after the effective date of the QA program. This requirement will be satisfied by receiving a certification to this effect from the i

manufacturer.

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4 Document Control All documents related to a specific shipping package will be controlled through the use of written procedures. All document changes will be performed according to established written procedures.

The Radiological Safety Staff will ensure that all QA functions are conducted in accordance with the latest applicable changes to theso documents.

5.

Handling, Storage and Shipping Written safety procedures concerning the handling, loading, storage and shipping of packages for certain special form radioactive material will be followed.

Shipments will not be made unless all certifications, acceptance, and final inspection have been completed. Work instructions will be provided for handling, packaging, labeling, storage and shipping operations.

The Committee approved responsible user shall supervise and/or perform the critical handling, storage, and shipping operations.

6.

Inspection, Test, and Operation Status

-Inspection, test, and operating status of packages for certain special form radioactive material will be indicated and controlled by written procedures.

Status will be indicated by tag, label, marking or other suitable means. Only shipping packages as originally received (and restored if repairs are required) from supplier will be used.

The responsible user, as directed by the RSS, shall inspect the package prior to shipment to ensure that it is in proper condition for shipment in accordance with written procedures.

The RSS will ensure that these functions are performed.

7.

Quality Assurance Records Records of package approvals (including certifications by DOT or NRC),

procurement, inspections, written instructions, shipping papers, and records of shipments will be maintained. Descriptions of equipment and written procedures will also be maintained. The records will be identifiable and retrievable. The records will be maintained by the Radiological Safety Staff.

8.

Audits The Chairman, Radiological Saf ety Committee, or his designee on the committee will audit the QA program.

Such persons do not have day to day respoasibility in the QA program.

Copies of all reports and correspondence relative to our QA program will be directed to the person. The Radiological Cafety Of ficer's semiannual reports to the Radiological Safety Committee will include a full description of all activities conducted under the QA program for the period.

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"E-As mentioned ' previously, only_ packages _ designad, f abricated, tested' _; and g-

+ approved for use, by other persons and for which certifications from DOT i

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Interrelationship of QA Functions to Other Management Functions

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Secretary, U.S. Department of AEriculture t

Assistant Secretary, Science ard Education Administrator, Agricultural Research Service Radiological' Safety Committee.

(Establishes Radiological Safety Policies f

and Reviews Quality Assurance Program)

Radiological Safety Staff and Officer c

(Implements Radiological Safety Program Ancluding Quality Assurance Program)

Committee Approved Responsible User (Responsible for Packaging and Shipping) 4 k

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