ML20045B727
| ML20045B727 | |
| Person / Time | |
|---|---|
| Site: | 07100238 |
| Issue date: | 06/11/1993 |
| From: | Jankovich J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Jensen J AGRICULTURE, DEPT. OF |
| References | |
| NUDOCS 9306180369 | |
| Download: ML20045B727 (2) | |
Text
1 SP -
INTB: TOM JUN 11 1f63 71-0238 U.S. Department of Agriculture Agricultural Research Service ATTN: Mr. John T. Jensen, Director Radiological Safety Staff 6303 Ivy Lane Greenbelt, Maryland 20770-1433
Dear Mr. Jensen:
This refers to your application dated January 29, 1993, requesting an amendment to your Quality Assurance (QA) Program Approval No. 0238 to include design and fabrication activities.
In connection with our review, we requested the additional information identified in our letter dated March 16, 1993.
Your response dated April 29, 1993, addressed most of the issues; however, several remain open.
To complete our review we need the information and clarification identified in the enclosure to this letter.
These issues were discussed with Mr. Jack Patterson of your staff on May 11, 1993. Mr. Patterson stated that we would receive a response by May 31, 1993. To date your response has not been received.
This information should be provided within 30 days from the date of this letter.
If you have any questions regarding this matter, you may contact Thomas Matula of my staff at (301) 504-2437.
Sincerely,
/S/
John P. Jankovich, Section Leader Quality Assurance Section Transportation Branch Division of Industrial and Medical Nuclear Safety, NMSS
Enclosure:
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71-0238 JUN 11 1993 Encl. to ltr. dtd.
Request For Additional Information Quality Assurance Program Approval No. 0238 General In our letter dated March 16, 1993, we asked you to describe, as a separate item, how quality assurance (QA) functions were performed to satisfy the requirements of 10 CFR Part 71 for the design and fabrication activities conducted on the irradiators that are partially fabricated without having an NRC-approved QA program.
In your letter dated April 29, 1993, you stated that "The USDA Radiological Safety Staff (RSS) will review the Isomedix QA procedures applied to the Model Husman irradiator for compliance with the NRC approved USDA QA Program prior to further construction activities by Isomedix."
I Expand the scope of your review of the Isomedix QA program to include the inspection and verification of QA records for the Model Husman irradiator in accordance with 10 CFR S 71.135.
Oraanization (Section I)
Provide management endorsement and commitment to the QA program through a written policy statement,, signed by a U.S. Department of Agriculture official, stating that it is your' policy to perform work on items important to safety in accordance with the requirements of 10 CFR 71 Subpart H as described in the QA Program and implemented by QA procedures.
In your letter dated April 29, 1993, you stated that a letter from E. E.
Finney, Acting Administrator, Agricultural Research Service, indicating management's support of the QA Program has been prepared, and a signed copy would be forwarded as soon as it was received.
To date this letter has not been received.
Quality Assurance Records (Section XVII)
In our letter dated March 16, 1993, we asked you to extend the retention time for QA records to three years beyond the date the activity ends, for which the QA Program was developed, as required by 10 CFR 5 71.135.
This request was not addressed in your response dated April 29, 1993, nor the enclosed QA Program for Radioactive Materials Packages, Revision No. O, dated April 1993.
Note: The date and revision number of the USDA QA Program should be updated when changes are made.
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