IR 07100354/1993006
| ML20057A873 | |
| Person / Time | |
|---|---|
| Site: | 07100354 |
| Issue date: | 09/15/1993 |
| From: | Haughney C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Stein S ADVANCED MEDICAL SYSTEMS, INC. |
| References | |
| NUDOCS 9309160110 | |
| Download: ML20057A873 (3) | |
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SEP 151993
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SCDB:DGR 71-0354'
Advanced Medical Systems, Inc.
ATTN: Ms. Sherry Stein Director, Regulatory Affairs 121 North Eagle Street Geneva, Ohio 44041 l
Dear Ms. Stein:
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SUBJECT: NRC INSPECTION REPORT NO. 710354/93-06 I
NOTICE OF VIOLATION. NOTICE OF NONCONFORMANCE l
l This refers to your response dated July 8, 1993, concerning the Notice of
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Violation and Notice of Nonconformance identified in U.S. Nuclear Regulatory i
Commission Inspection Report No. 710354/93-06, dated June 18, 1993.
The corrective actions that have been or will be taken regarding Nonconformances A1, A3, A4, B1, B2, 83, B5, C1, C2, C3, C4, 02, El, E2, E3,'F, G and H are acceptable, contingent upon NRC approval of your recently
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submitted Quality Assurance (QA) Program, QA 2000 2.0.
Regarding Nonconformance B2, a typographical error was apparently made in referring to Procedure No. "QA 2000,1". We assume you intended to refer to Procedure No. "QA 2000 1.0".
Please let us know if our interpretation is inaccurate.
Concerning the Notice of Violation and Nonconformances A2, B4 and 01, please provide additional information as requested in the enclosure.
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The information requested should be provided within 30 days from'the date of
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this letter.
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Sinc g l
StevenLBaggett >
Charles J. Haughney, Acting Chief Source Containment and Devices Branch i
Division of Industrial and Medical Nuclear Safety, NMSS Nb Enclosure:
As stated
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Request for Additional Information
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Docket No. 71-0354 Enclosure to letter dated Violation Reauest 10 CFR 5 21.31 You state that Procedure No. QA 2000 2.0 now identifies which basic components require notification of the applicability of 10 CFR Part 21, and that these components include the sourcehead, rotor, C-Arm, yoke and source capsule.
Please verify that overpack components used as replacement parts for Model Nos. 181375 and 181361 overpacks (Certificate of Compliance (C0C) No. 5796}, and Model No. E-MEH-00-00004 overpack (C0C No. 9011) are also evaluated for their importance to safety, and are controlled in an appropriate manner.
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Nonconformance A2 You state that Procedure No. QA 1000 1.0 governs replacement parts that would be important to the safety of the overpacks.
As indicated above, please verify that components used as replacement parts for the NRC-certified overpacks are evaluated for their importance to safety, and that AMS procedurally controls these components in a manner suitable to their importance to safety.
B4 You state that suppliers are currently being informed as to which records must be retained by the supplier and which must be delivered to AMS.
However, the NRC Notice of Nonconformance states
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that you did not follow Section 4.3 of your QA Program, Procedure No. QA 1000 1.4, which
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requires that procurement documents will i
identify test and inspection requirements, and special process instructions.
Please identify what corrective actions will be taken to address the issue of your requirement
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for procurement documents to identify test and inspection requirements, and special process instructions.
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-2-Ddcket No. 71-0354 Nonconformance Reouest D1 You state that the Isotope Committee approves revisions to written procedures.
However, the NRC Notice of Nonconformance addresses the issue of conflicting information contained in two AMS procedures (QA 1000 3.1 and QA 1000 1.4, Section 2.1) in relation to the responsibilities of individuals in the approval of document revisions.
Please identify what corrective actions will be taken to rectify the conflicting information contained in these procedures.
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