ML20056D405
| ML20056D405 | |
| Person / Time | |
|---|---|
| Site: | 07100354 |
| Issue date: | 07/08/1993 |
| From: | Stein S ADVANCED MEDICAL TESTING SYSTEMS, ST. LOUIS, MO |
| To: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| NUDOCS 9308130168 | |
| Download: ML20056D405 (3) | |
Text
.
<Adv.anced Medical Systems,Inc.
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121 North' Eagle. Street. Geneva, Ohio 44041 (216)'466 4671 FAX (216) 466-0186 July 8, 1993 Mr. Charles E. MacDonald, Chief Transportation Branch Division of Industrial and Medical Safety, NMSS USNRC Washington, D.C.
20555 RE: Response to NRC Inspection Report 710354/93-06 Dated June 18, 1993
Dear Mr. MacDonald:
This letter is in response to the above-mentioned NRC Inspection Report. Please note that the enclosed quality assurance procedures are considered confidential, and we request that they not be released without prior notification.
Violation "10 CFR @21.31 "Procurements", requires the licensee to assure that each procurement document for a basic component issued by the licensee specify the provisions of 10 CFR Part 21 Apply."
ILessonse 10 CFR Part 21.31 requires that "Each.
corporation
. subject to the regulations of this part shall assure that each procurement document for a
... basic component issued by.
it on or af ter January 6,1978, specifies, when ann}Jeable, that the provisions of 10 CFR Part 21 apply."
QA 2000 2.0, which replaces QA 1000 1.4, governs compliance with 10 CFR Part 21 and now identifies which basic components require notification of the applicability of 10 CFR Part 21. These components include the sourcehead, rotor, C-Arm, yoke and source capsule. Procurement documents for these items will indicate that 10 CFR -
Part 21 applies.
Notice of Non-Comptiance Responses to each item of nonconformance are set forth below:
A1.
A new organizational chart has been prepared and made part of QA 2000 1.0 This procedure replaces QA 1000 1.4 in its entirety.
A2.
AMS does not presently design or fabricate overpacks.
Both QA 1000 Revision B and QA 2000 1.0 set forth procedures governing the procurement of components, inspections and control of measuring and test equipment as well as non-conforming material, parts or ccmponents. QA 10001.0 governs replacement parts that would be important to the safety of the overpacks.
All package components are inspected to insu' ? conformance with blueprint or technical specifications. The total package is inspected per QA 1014 prior to shipment, and bolts must be as specified to secure the device in a safe manner.
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i Page 2 Mr. Charles E. MacDonald, Chief l
Transportation Branch /USNRC July 8, 1993 A3.
AMS is in the process of documenting training of individuals performing duties related to 10 CFR Part 71 and Part 21.
A4.
AMS' QA program has recently been reviewed and revised.
A new audit checklist has also been developed following " Packaging Supplier Inspection Guide" NUREG/CR-5717.
A copy is attached.
Bl.
QA 2000 1.0 Section 4.8 addresses this.
B2.
Applicable 10 CFR Part 71 requirements will be added to procurement documents per QA 2000.1 Section 4.2.
Further, inventory and purchasing records have been marked to indicate which items require vendor conformance to 10 CFR Part 71, i
B3.
AMS does not presently design or fabricate overpacks. Purchase orders for replacement parts for overpack components specify, where applicable, that 3
the components must conform to AMS supplied blueprints or other technical-requirements as set forth by QA 2000 1.0 Section 4.3.
AMS requirements
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specify special process instructions, tests and inspection requirements.
B4.
Where applicable, suppliers are now being informed which records must be retained by the supplier and which must be delivered to AMS.
B5.
This is added to Procurement Documents, as necessary, as set forth in QA 2000 1.0 Section 4.6.
C1.
QA 1000 covers this, as does QA 2000 1.0 Section 4.8.
C2.
This list is in place.
C3.
As previously stated, the audit checklist has been revised utilizing
" Packaging Supplier Inspection Guide" NUREG/CR-5717, and a copy is attached.
C4.
The inspectors performing QA 1014 inspections have been advised of the importance of initialling QA 1014A checklists.
Dl.
The isotope Committee approves revisions to written procedures, as indicated, in the revised QA procedures.
D2.
This list is now in the file record room.
El.
AMS' key vendor for overpack components has supplied AMS with their QA program procedures pursuant to QA 2000 1.0 Section 7.2.
E2.
Suppliers of components for AMS overpacks are being evaluated pursuant to QA 2000 1.0 Part 7.2.
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Page 3 Mr. Charles E. MacDonald, Chief Transportation Branch /USNRC
' July 8, 1993 E3, Pursuant to QA 2000 1.0 Section 7.6C, inspection records are available.
F.
AMS does not design or fabricate overpacks at the present time.
AMS uses a first in first out procedure for inventory parts to permit traceability, as set forth in QA 2000 1.0 Section 8.2.1.
G.
AMS is now documenting calibration dates of equipment used to measure parts and components for the overpacks.
li.
As previously stated, a separate audit checklist, in addition to the quarterly audit, which does inspect QA 1014 documents, has been prepared.
Very truly yours,
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S..A/ Stein Director of Regulatory Affairs SJS:jmb g ygg Encl.,
QA 2000 2.0
[gg QA 2000 1.0 QA 2000 1.0 Annual Audit Form IM, U/
QA 1000 Revision B g
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