ML20147D396
| ML20147D396 | |
| Person / Time | |
|---|---|
| Site: | 07100212 |
| Issue date: | 12/08/1978 |
| From: | Engel J GENERAL ELECTRIC CO. |
| To: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| 7812508, NUDOCS 7812190240 | |
| Download: ML20147D396 (4) | |
Text
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GENER AL h ELECTRIC
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ii^ D C PUgDC Den, ENGINE pgg GENERAL ELECTRIC COMPANY b bW g g. p'glCliaCbNATI, OHIO 45215 GROUP 3
Phone (513) 243 2000 December 8, 1978
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Director Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Washington, D.C.
20555 REF: Quality Assurance Program (10CFR71) for Industrial Radiography Licenses We are submitting a copy of our Quality Assurance (QA) program per requirements of 10CFR7151 as published in the Federal Register 8/4/77 and ar. ended 6/23/78.
Our QA program covers our industrial radiography program under NRC license
- 34-00499-10.
The QA program is based on information supplied to us by the Technical Operations Company of Burlington, Massachusetts, vendor of our radiography equipment. Tech-nical Operations Company advises that the Model 650 source changer is a Type B package and wculd come under the QA directive.
They advise us that Model 414 source changer is a special package meeting DOT 55 requirements and is exempt from QA, and that Model 571 Cobalt-60 calibration unit (15 mC1) package is a Type A package exempt from QA.
Based on that advise, our QA program is designed to cover shipment of Model 650 cource changefs.
Technical Operations Company further advises that they have submitted information i
regarding design and QA for the Model 650 to the NRC under 100FR7151 (a) and i
vill send to us a certification of NRC approval for the 650 package. Our advisor at Technical Operations is John Munro (a.c. 617-272-2000 or 1-800-225-1383).
Sincerely yours, l
J.D. Engel, Radiation Protection Officer General Electric Company Mail Drop B-14 Cincinnati, Ohio 45215 a.c. 513-243-4040 JDE/jjd llan3 cm
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GENER AL h ELECTRIC
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ENGINE GENERAL ELECTRIC COMPANY.
.. CINCINNATI. OHIO 45215 GROUP Phone (513) 243-2000 December 8, 1978 General Electric Co., NRC License //34-00499-10 QUALITY ASSURANCE PROGR/d4 1.
Organization The final responsibility for the Quality Assurance Program for Part 71 Require-ments rests with the General Electric Company. Design and fabrication of ra-dioactive material shipping packages shall not be conducted under this Quality Assurance Program. The Quality Assurance Program is implemented using the following organization:
General Electric Company Aircraft Engine Group Fred MacFee, Vice President and Group Executive 4
Ray Letts, Vice President, Manufacturing Division f
Joe Wendelken, Section Manager, Employee Services t
Gordon Mindrum, M.D.,
Medical Director t
J.D. Engel, Manager of Industrial Hygiene and Radiation Protection A
Officer i
Radiographers J.D. Engel, Sc.D., the Radiation Protection Officer (RPO) is responsible for overall administration of the program, training, document control, and auditing.
The Radiographers are responsible for handling, storing, shipping, inspection, test, operating status and record keeping.
2.
Quality Assurance Program The management of General Electric Company establishes and implements this Quality Assurance Program. Training for all QA functions, prior to engagement in these functions, is required according to written procedures. QA Program revisions vill be made according to written procedures with management approval.
The QA Program vill ensure that all defined QC procedures, engineering procedures
O December 8, 1978 General Electric Co., QA Program (NRc 34-00499-10) and specific provisions of the package design approval are satisfied. The QA Program vill emphasize control of the characteristics of the package which are critical to safety.
The Radiation Safety Officer shall assure that all radioactive material ship-ping packages are designed and manufactured under a Quality Assurance Program approved by the Nuclear Regulatory Commission for all packages designed or fabricated after 1 July 1978.
3 Document Control All documents related to a specific shipping packcge vill be controlled through the use of written procedures. All document changes will be performed accord-ing to written procedures approved by management.
The Radiation Safety Officer shall insure that all QA functions are conducted in accordance with the latest applicable changes to these documents.
4.
Handling, Storage and Shipping Written safety procedures concerning the, handling, storage and shipping of packages for certain special form radioactive material vill be followed.
Ship-ments will not be made unless all tests, certifications, acceptances, and final inspections have been completed. Work instructions vill be provided for hand-ling, storage and shipping operations.
Radiographers shall perform the critical handling, storage and shipping oper-ations.
5 Inspection, Test and Operating Status Inspection, test and operating status of packages for certain special form radioactive material vill be indicated and controlled by written procedures.
Status vill be indicated by tag, label, marking, or log entry.
Status of nonconforming packages vill be positively maintained by written procedures.
Radiographers shall perform the regulatory required inspections and tests in accordance vill written procedures.
The Radiation Safety Officer shall ensure that these functions are performed.
6.
Quality Assurance Records Records of package approvals, inspections, tests, operating logs, audit results, personnel training and qualifications and records of shipments vill be main-tained. Descriptions of equipment and written procedures vill also be main-tained.
These records will be mainthined in accordance with written procedures. The records vill be identifiable and retrievable. A list of these records, with their sto. ace locations, vill be maintained by the Radiation Safety Officer.
1 Page 2
-December 8, 1978 General Electric Co., QA Program (imc 34-00499-10) 7 Audits Established schedules of audits of the Quality Assurance Program vill be per-formed using written checklists.
Results of audits vill be maintained and reported to management. Audit reports will be evaluated and, deficient areas corrected.
The audits vill be dependent on the safety significance of the activity being audited, but each activity vill be audited at least once per year. Audit reports vill be maintained as part of the quality assurance records. ' Members of the audit team shall have no responsibility in the ac-tivity being audited.
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