ML20237C096
| ML20237C096 | |
| Person / Time | |
|---|---|
| Site: | 07100420, 07100524 |
| Issue date: | 08/13/1998 |
| From: | Matthew Smith External (Affiliation Not Assigned) |
| To: | Eng P NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20237C097 | List: |
| References | |
| NUDOCS 9808200195 | |
| Download: ML20237C096 (1) | |
Text
7I- 0420 Q SteriGenics
, i-osz <-F lour Mtunn puhty samlauswn August 13,1998 Patricia L. Eng, Chief Transportation and Storage Inspection Section Spent Fuel Project Office Office of Nuclear Material Safety and Safeguards U. S. Nuclear Regulatory Commission Washington, DC 20555-0001
Reference:
Recent questions regarding Quality Assurance Program Approval No. 0420 and SteriGenics International Approval No. 0524
Dear Ms. Eng:
Yesterday, I spoke with a member of your staff regarding the questions and confusion surrounding the status of Quality Assurance Program Approval number 0420, which had been issued to RTI, Inc. The primary question deal with whether the SteriGenics International QA Program Appmval number 0524 was adequate to cover operations at the former RTI, Inc., facilities now operated by SteriGenics.
In our conversation, he mentioned that the most recent revision of the SteriGenics program approval available to you was from 1990. There have been revisions since that date, the most recent being revision 4 dated July 20,1995. I am enclosing a copy of the program approval as issued to our company.
In regard to questions as to whether the SteriGenics program encompasses operations at the former RTI, Inc., sites, I am enclosing a copy of procedure QP-01, revision 1 (March 1995), which describes the quality organization. This procedure defines the applicability of the QA program to all SteriGenics facilities without specifically naming individual sites. This was considered adequate to address operations at the former RTI, Inc.,
facilities, as well as new gamma irradiator facilities built and operated by SteriGenics within the past several years. All affected SteriGenics facilities have been provided with copies of the QA program documentation and are following it for operations involving shipping containers.
If this procedure does not address all of your questions or if you need copies of other procedures within the program, please let me know. (I have also included a copy of the j
Table of Contents for the uost recent QA program revision.)
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Sincerely,
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,,3 Mark A. Smith, CHP Director, Technical Services CC:
Don Currie, SteriGenics Pat Adarns, SteriGenics 9808200195 980813 PDR ADOCK 07100420-C PDR StenGenn internarninal.10811 Withers Owr l' ark ikm
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UNITED STATES s
j NUCLEAR REGULATORY COMMISSION 2
WASHINGTON, D.C. 20555 4001 y
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o July 20, 1995 SteriGenics International
' ATTN: Mr. Mark A. Smith, CHP Corporate Manager of Technical Services 10811 Withers Cove Park Drive Charlotte, NC 28273
Dear Mr. Smith:
Enclosed is Quality Assurance Program Approval for Radioactive Material Packages No. 0524, Revision No. 4.
This Approval satisfies the requirements of 10 CFR S 71.12(b) for a Quality Assurance Frogram approved by the Commission.
Please note the conditions in the Approval.
This Approval will remain in effect until the expiration date, indicated in Block No. 3.
Termination of your materials license does not cause this Approval to be automatically terminated.
If you wish to renew, amend, or terminate this Approval, please request it in writing.
This letter also serves as a reminder that if you are using or planning to use an NRC-approved packaging, you must be registered for use of that packaging with NRC.
Registration for use of NRC-approved packagings should be made pursuant to 10 CFR f 71.12(c)(3).
Sincerely,
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AWN ohn P.
nkovich, Section Leader Quality Assurance Section Source Containment and Devices Branch Division of Industrial and Medical Nuclear Safety, NMSS
. Docket No. 71-0524
Enclosure:
As stated i
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- 1. APPROV/iL NUMBER a
f OUALITY ASSURANCE PROGRAM APPROVAL 0524 g
FOR RADIOACTIVE MATERIAL PACKAGES
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h P rsuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and Title 10, Code of Federal l
Regulations, Chapter 1, Part 71, and in reliance on statements and representations heretofore made in item 5 by the person named in item 2, the Quality Assurance Program identified in item 5 is hereby approved. This approval is issued to satisfy the requirements of Section 71.101 of 10 CFR Part 71 This approval is subject to all applia,bie rules, regulations, and orders of the Nuclear flegulatory Commission now or hereaf ter in ef fect and to any conditions specified below.
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- 2. N AME
- 3. EXPIRATION DATE
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q SteriGenics International STREET ADDRESS July 31, 2000 4020 Clipper Court
- 4. DOCKET NUMBER CITY STATE ZIP CODE Fremont CA 94538-6540 71-0524 j
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- 5. QUALITY ASSURANCE PROGRAM APPLICATION DATC(S) l February 5. 1990. November 10, 1992, January 26, 1993, cod January 3, 1995 G, COWITIONS 1
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Activities authorized by this approval: procurement, maintenance, q
repair, and use to be executed with regard to transportation packagings.
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All other activities (i.e., design, fabrication, assembly, testing, and modification) shall be satisfied by obtaining certifications from l
packaging suppliers that these activities were conducted in accordance l
with an NRC-approved Quality Assurance Program.
It shall remain the
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responsibility of the Quality Assurance Program holder that all sj transportation activities meet the, requirements of 10 CFR 6 71.101.
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Records describing adt'ivities affecting quality shall be retained for i
9 three years, in accordance with 10CFR 571.91 and s71.135.
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FOR THE U.S. NUCLEAR REGULATORY COMMISSION f
ay so hn P. Ja vich, Ph.D.
July 20, 1995 l
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