ML19242D372
| ML19242D372 | |
| Person / Time | |
|---|---|
| Site: | 07100238 |
| Issue date: | 07/03/1979 |
| From: | AGRICULTURE, DEPT. OF |
| To: | |
| Shared Package | |
| ML19242D371 | List: |
| References | |
| NUDOCS 7908150030 | |
| Download: ML19242D372 (4) | |
Text
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USDA Quality Assurance Program for Packaging and Shioment of Radioactive Materials r
1.
General
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The Department of Agriculture only uses packages that have A
been designed, fabricated, tested and approved for use by other persons and f o.- which
't his received certifications
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from DOT.
Packages are retained as originally furnished by supplier and arc not modified, except when damaged in which y
P case they are restored to their original condition.
If necessary, the services of the supplier are engaged.
Ship-dk.
ments are made when it becomes necessary to transfer irradiators containing more than Type A quantities of radioactive material in the form of special form sealed sources from one laboratory to another.
Such shipments, however, are made infrequently--the average being once every three years.
All ship =ents are made with the prior approval and under the direction of the Radiological Saf ety Staff (RSS).
2.
Organization The final responsibility for the Quality Assurance (QA)
Program for Part 71 Requirements rests with the Radiological Safety Staff.
Design and fabrication, except repa.r, shall not be conducted under this QA Program.
The Radiological Safety Officer (RS0) is responsible for overall implementation of the program, instructions and certification, document control and auditing.
The qualified respoasible user approved by the Radiological Saf ety Committee is responsible for handling, packaging, shipping, storing, inspecting and furnishing records to the RSO, See lcou page for organizational chart.
3.
Quality Assurance Program The Radiological Saf ety Commit tee establish's and the 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 approval.
The QA Program will insure that all QC procedures, engineering procedures and specific provisions of the package design approval are satisfied.
The QA Program will emphasize control of the characteristi:s of the package which are critical to safety.
The Radiological Saf ety Staff will assure that all r ad io a c t iv e material shipp ing packages are designed and a QA Program approved by the NRC manufactured under and/or DOT for all packages designed or fabricated after l
the ef f ective date of the QA Program. This requ ement
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can be satisfied by receiving a certification to this effect from the manufacturer.
7 90815V C30 C
4.
Document Control All documents related cc a specific shipping package will be controlled through the use of wuitten procedures.
All document changes will be performed according to es t ab lished written procedures.
The Radiological Safety Staff will insure that all QA functions are conducted in i
acccrdance with the latest applicable changes to these documents.
5.
Handling, Storage and Shipping 8
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, acceptances, and final inspection have been completed.
Work instructi)ns will be provided for handling, packaging, labeling, storage and shipping operations.
The Committee approved r e s p o ns ib l e user shall supervise and / or perform the critical handling, storage and shipping operations.
6.
Inspection, Test and Operating Status inspection, test and operating status of packages for certain special form radioactive material will be indicated and controlled by written procedures.
Status wil2 be indicated by tag, label and marking.
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 package prior to shipment to e r.s u r e 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 ( inc lu d in g certifications by DOT), procurement, inspections, written instructi>ns, shipping papera and records of shipments vill be mai -
tained.
Descriptions of equipment and written procedures will also be maintained.
The records will be id e nt if iab le k
and retrievabic.
The records will be maintained by the 7
Radiological Saf ety Staff.
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8.
Audits Due to infrequency of shipments, the QA program will be audited prior to each shipment.
Resultr of audits will be maintained and reported to the Rad 121ogical S a f e t ;-
Committee.
Audit reports will be evaluated and deficient areas corrected where indicated.
Audit reports will be filed in the Radiological Safety Staff office as part of the quality assurance records and reviewed by a member of the Radiological Safety Ccamittee.
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9.
Specific Provisions As mentioned previously, only packages designed, fabricated, tested and approved for use by other persons and for which certifications from DOT have been received by the Department will be used.
More s p e c if ic a lly,
%i Certificate No, USA /6125/B(U)T for AECL Gammacell 220, t
expiration date May 31, 1980 and Certificate No.
I USA /5800/B(20WC-5) for Isomedix Gammator, expiration dated June 30, 1981 and held by the Radiological Safety Staff.
Our QA Program will apply to packages covered by these certificates plus any that may be obtained in the future.
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RSS July 3, 1979 4
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US6010
~4 Interrelationship of OA Functions to Other Mana ement Functions Pr I ;*
Secretary, U.S. Department of Agriculture l
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Director, Science and Education Adainistration t
I Deputy Director, Agricultural Research Badiological Safety Cc=mittee (Establishes Radiological Safety Policies)
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Radiological Safety Staff and Officer (Implements Radiological Saf ety Program includi 3 Quality Assurance Program)
Cocsittee Approved Rt pensible Usar (Responsible for Packaging and Shipping)
$>516'.lLf_
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