ML20129J525
| ML20129J525 | |
| Person / Time | |
|---|---|
| Site: | 07100431 |
| Issue date: | 10/28/1996 |
| From: | TRUTOM (U.S.), LTD. |
| To: | |
| Shared Package | |
| ML20129J518 | List: |
| References | |
| NUDOCS 9611060308 | |
| Download: ML20129J525 (4) | |
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TRUTOM (U.S.) LIMITED 16 Walker Way, Abany, New York 12205 Telephone: 518-464-9035 FAX: 518-464-9333 10CFR 71 OA PROGRAM FOR. INDUSTRIAL RADIOGRAPHY FOR TRUTOM (US) LTD.
1.
Oreanizati9n The final responsibility for the Quality Assurance Program for Part 71 requirements rest with TRUTOM (US) LTD. Design and fabrication shall not be conducted under this Quality Assurance Program. The Quality Assurance Program is implemented using the following organization:
RADIOLOGICAL CONTROL MANAGER RADIATION SAFETY OFFICER l
ASSISTANT RADIATION SAFETY OFFICER RADIOGRAPHER LEVEL I AND LEVEL II RADIOGRAPHER'S ASSISTANT Radiological Control Manager - The ultimate responsibility for Trutom's operation shall rest with the company's Radiological Controls Manager (RCM). Therefore, he shall act as the company's liaison officer with the NRC and the New York State Dept. Of Labor on all license matters. He shall be directly responsible for the control of the technical aspects of the operation. He or his delegate shall provide safety and technical training to the radiographic personnel. He shall be the supervisor of the RSO and the other radiographers and shall assure that employees under his supervision are complying with applicable NYS and NRC regulations and Trutom's " Operating and Emergency Procedures". He shall participate in the intemal audit system as specified in the
" Inspection System for the control of Radioisotopes", section of the license application.
9611060308 961028 PDR ADOCK 07100431 C
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LL TRUTOM (U.S.) LIMITED 16 Walker Way, Albany, New York 12205 Telephone: 518-464 9035 FAX: 518-464-9333 Cont'd Organization Pg. 2 of 4 The Radiation Safety Officer is responsible for overall administration of the program, and auditing. The RSO is also responsible for Part 71 Quality Assurance Requirements.
Assistant Radiation Safety Officer - shall assist the RSO in all areas of radiation safety and related paperwork. In the absence of the RSO, he may be appointed to assume the responsibilities of the RSO.
The radiographers are responsible for handling, shipping, inspection, test, operating status and record keeping.
Radiographer's Assistant - shall perform all work under the supervision of a radiographer.
2.
Ouality Assurance Program The management of Trutom (US) LTD establishes and implements this Quality Assurance Program. Training prior to engagement for all QA functions, is required according to written procedures. QA program revisions will be made according to written procedures with management approval. The QA program will ensure that all defined QC procedures, engineering procedures, and specific provisions of the package design approval are satisfied. The QA program will emphasize control of the characteristics of the package which are critical to safety.
The Radiation Safety Officer shall assure the radioactive material shipping packages are designed and manufactured under a Quality Assurance Program approved by the Nuclear Regulatory Commission for all packages designed or fabricated after 1 Jan. 79. This requirement can be satisfied by receiving a certification to this effect from the manufacturer.
3.
Document Control All documents related to specific shipping packages for certain special form radioactive material will be followed. Shipments will not be made unless all tests, certifications, acceptances and final inspections have been completed. Work instructions will be provided for handling, storage and shipping operations.
Radiography personnel shall perform the critical handling, storage and shipping operations.
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L TRUTOM (U.S.) LIMITED 16 Walker Way, Albany, New York 12205 Telephone: 518-464-9035 FAX: 518-464-9333 Cont'd Organization Pg. 3 of 4 Each new procedure or review of any procedure will be approved by the RCM. The RCM will make sure that the procedure used will always be the updated versions.
All the outdated versions will be thrown away except for the copies in the file of the RCM.
4.
Handling Storage and Shipping Written safety procedures conceming the handling, storage and shipping of packages for special form radioactive material will be followed. Shipments will not be made unless all tests, certifications, acceptances, and final inspections had been completed. Work l
instructions will be provided for handling, storage and shipping operations.
Radiography personnel shall perform the critical handling, storage and shipping operations.
5.
Inspection. Test and Operating Status Inspection, test and operating status of packages for certain special form radioactive material will be indicated and controlled by written procedures. Status will be indicated 4
by tag, label, marking or log entry. Status of non-conforming parts or packages wili be 3
positively maintained by writing procedures.
Radiography personnel shall perform the regulatory required inspections and test in accordance with written procedures. The Radiation Safety Officer shall ensure that these functions were performed.
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Ouality Assurance Records j
Records of package approvals (including references and drawings), procurement, inspections, tests, operating logs, audit results, persumel training and qualifications and i
records of shipments will be maintained for a retention period of three (3) years.
Descriptions of equipments and written procedures will also be maintained.
These records will be maintained in accordance with written procedures. The records will be identifiable and retrievable. A list of these records, with their storage locations, will be maintained by the Radiation Safety Officer.
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L EE TRUTOM (U.S.) LIMITED 16 Walker Way, Albany, New York 12205 Telephone: 518-464-9035 FAX: 518-464-9333 Cont'd Organization Pg. 4 of 4 7.
Audits Established schedules of audits of the Quality Assurance Program will be performed using written checklists. Results of audits will be maintained and reported to management. Audit reports will be evaluated and deficient areas corrected. The audits will be dependent on the safety significance of the activity being audited, but each activity will be audited at least once per year. Audit reports will be maintained as part of the quality assurance records. Members of the audit team shall have not responsibility in the activity audited.
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