IR 07100524/1992002

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Reviews 920701 & 23 Responses Re Notice of Nonconformances Noted in Insp Rept 71-0524/92-02.Corrective Actions Acceptable
ML20127D381
Person / Time
Site: 07100524
Issue date: 09/10/1992
From: Macdonald C
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To: Fairand B
STERIGENICS INTERNATIONAL (FORMERLY RADIATION STERILI
References
NUDOCS 9209140352
Download: ML20127D381 (2)


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SEP 10 tw SGTB:SCO 71-0524 SteriGenics International ATTN: Dr. Barry Fairand Vice President Technology /QA 15551 Redhill Avenue lustin, California 92680

Dear Dr. Fairand:

SUBJECT: NRC INSPECTION REPORT NO. 710524/92-02 NOTICE OF VIOLATION, NOTICE OF NONCONFORMANCE This refers to your responses dated July 1 and July 23, 1992, concerning the Notice of Violation and Notice of Nonconformance identified in the U.S.

Nuclear Regulatory Commission Inspection Report No. 710524/92-02, dated March 19, 1992.

The corrective actions which have been or will be taken regarding the Notice of Violation are acceptable.

The~ corrective: actions which have been or will be taken regarding the Notice of Nonconformance are acceptable to the extent that they are applied to future

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design, fabrication, maintenance, and use activities.

Concerning previous activities, please note that packagings fabricated after January 1,- 1979, are to be in full compliance with an approved Quality Assurance (QA) Program. We have reviewed "The Model No. 1500 Packaging Inspection and Refurbishment Plan" you- submitted in your July 1,1992, letter intended to provide information on fabrication quality comparable to a rackaging fabricated under an approved QA Program. The plan, if implemented, would not demonstrate that your packagingt were fabricated in accordance with -

.the measures of your QA program in effect at the time of manuf acture. In order to qualify the packagings for use, the plan should specify the standards (e.g. welding, NDE, materials, etc.) applicable to the packaging and how you intend to verify that each of these standards have been met.

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Should you have any questions, we will be pleased to discuss them with you.

Sincerely, Otiginal Signed by Charles E. MacDonald, Chief Transportath Branch Division of Safeguards and Transportation, HMSS G:\CCTB\ LETTER \STERIGEN.LTR

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- DTC: 1SGTB :SGTB :SGTB :SGTB :SGTB

___________ %________:SGTB ____f__ ______76 A ______________________________________

NAME:S0'Connor/jb :JJankov ch :CMacDona d :  :

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____________________ q _______________________________..__..__________________ l.

DATE: 9/I*/92  : lh_/92  : i/ t a92 -

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\ l 9209140352 920910 l 7 l DR ADOCK 0710 4 ' l.

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- John Massey 2

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Distribution:

RBurnett JJankovich S0'Connor GYlihas, RV ETen Eyck VMiller, OSP CMacDonald JLieberman, OE STreby, OGC NRC F/C NRC PDR NMSS/SGTB r/f RChappell HLee MRodriquez, OC l

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