ML20154M125
| ML20154M125 | |
| Person / Time | |
|---|---|
| Site: | 07100587 |
| Issue date: | 02/03/1986 |
| From: | Donovan L AIR FORCE, DEPT. OF |
| To: | Gordon L NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| 26513, NUDOCS 8603130327 | |
| Download: ML20154M125 (16) | |
Text
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RETURN TO 396-SS PbR
'7/' ##P7 DEPARTMENT OF THE AIR FORCE HEADQUARTERS UNITED STATES AIR FORCE DOLLING AFB DC 20332-6188
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FEB 1986
, Air Force Transportation Quality Assurance Program Mr Len Gordon USNRC Transportation Certification Branch 7915 Eastern Avenue Silver Spring MD 20014 1.
Reference our 16 Jan 1986 conversation concerning items needed to finalize the Air Forte Transportation Quality Assurance Program.
Based upon our conversation, we wish to modify our original applications dated 12 Sep 1985 and 7 Jan 1986 as follows:
a.
The USAF Radioisotope Comittee hereby makes a comitment to adopt the model program per Annex 3 of Regulatory Guide 7.10, dated January 1983.
b.
As the program in Annex 3 of Regulatory Guide 7.10 is general in nature, we wish to use the previously submitted " fill in the blanks" approach, modified per our conversation on 16 Ja..." (attached), which states in detail the requirements which users rust fol:ow, c.
The USAF Radioisotope Comittee will not forward a copy of requesting organization's USAF Radioactive Material ( RAMT7ermit.
(The Nuclear Materials and Material Safety branch has been provided and natntains a copy of all Air Forte issued RAM pemits).
2.
Please call me at comercial telephone number (512) 536-3331, to confirm that the preceding is what we need for appmval or if you need any additional infermation, h
N LAWRENCE DONOVAN, Capt, USAF, BSC 1 Atch
.g u USAF Radioisotope Comittee QA Program Office of the Surgeon General RECEIVED )
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CUALITY ASSURANCE PROGRAM FOR SEALED SOURCES Using Ortjanization J
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Introduction. Under the provisions of USAF Radioactive Material Pemit No.
, the (using organization) is authorized to receive, acquire, possess, deliver, or transfer sealed sources. Design and fabrication shall not be conducted under this Quality Assurance (QA) Program. Opening the sealed sources, maintenance and perfoming repairs is not covered under the I
j program and will be done by the manufacturers, relieving the user of the responsibility.
Users desiring repair and maintenance capability will obtain l
and follow the manufacturers' NRC approved QA program.
In this case, a pemit i
amendment is required.
Send amendment requirements.
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Licensed sealed sources and their corresponding Certificate of Compliance nuders are listed in Attachment 1.
l Activities perfomed relative to the sealed soun:es include:
j a.
Handling b.
Shipping 1
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c.
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d.
Operatirg r
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The purpose of this document is to outline the procedures which will be followed to comply with subpart H of 10 Code of Federal Register (CFR)71.
U.S. Nuclear Regulatory Commission Regulatory Guide 7.10. Estabitshing Quality Assurance Programs for Packaging Used in the Transport of Radiosctive Material, was used as a guide in developing this plan.
2.
Quality Assurance Organization. The final responsibility for the Quality Assurance (QA) program rests with the (using organization).
The QA Program is implemented using the organization outlined in Attachment 2.
3.
Quality Assurance Program. The (using organizaion) will implement the QA Program through the organization described in paragraph 2.
QA Program revisions will not be made without management approval.
The Program will insure that all activities involving sealed sources (see paragraph 1) are performed in accordance with applicable NRC, Department of Transportation (DOT), and U.S. Air Force regulations as well as USAF Radioactive Material Pemi t No.
and the specific provisions of the appropriate Certificate of Compliance.
The QA Program emphasizes control of the administrative and operational matters which are critical to safety.
Controls have been established to insure that activities involving sealed sources are conducted in accordance with the regulations, license and approvals mentioned above.
Prior to engaging in any activity important to safety, all personnel will have had indoctrination or training in that activity.
4 Design Control.
Not applicable. User of package only.
Sealed sourtes are designed, manufactured and maintained by the manufacturer under an NRC approved QA Program.
5.
Procurement Document Control. This organization is not involved in the manufacturing or maintenance of packaging. Procurement documents reflect that sealed sources are listed on Certificates of Compliance and have been manufactured under an NRC approved QA Program.
6.
Instructions, Procedures and Drawings, a.
Preparation of Packaging for Use: Prior to and after shipment, packages are visually inspected for damage, required leak tests and radiation surveys are perfonned, package security on pallet and pallet security on vehicle is verified if appi tcable, b.
Repairs, Rework and Maintenance: Not appi tcable. USAF RAM PERMIT does not authorize opening of sealed soun:es, c.
Loading and Unloading Contents: Not applicable. User does not load / unload radioactive material into or out of the sealed sources.
d.
Transport of Package: See paragraph 14
7.
Document Control. All documents related to a specific shipping package (e.g., Certificates of Compliance, Shipping and Receiving Procedures, etc.)
will be controlled and maintained by the Radiation Protection Officer.
All revisions and changes will be processed through him and he will insure that current versions of the documents are on file.
8.
Control of Purchased Material, Equipment, and Services. Design and fabrication not applicable.
Maintenance not applicable.
See paragraph 14 regarding shipping.
9.
Identification and Control of Materials, Parts, and Components. Not Applicabl e.
USAF Radioactive Material Pennit No, does not authorize opening of sealed sources.
- 10. Control of Special Processes. Not Applicable.
Package should require no major repairs necessitating use of special processes. USAF Radioactive Material Permit No.
does not authorize opening sealed sources, t
- 11. Insp'ection Control.
The Radiation Protection Officer shall use a checklist to insure that inspections are performed to verify that sealed sources have been marked and labeled and shipping papers completed in accordance with current requirements.
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- 12. Test Control. USAF Radioactive Material Permit No.
requires radiation surveys and leak tests.
Results will be documented.
- 13. Control of Measuring and Test Equipment. USAF Radioactive Material Permit No.
requires that all radiation survey equipment be in calibration during use.
a.
Calibration of Instruments is perfomed by:
(1) Base Precision Measurement Equipment Laboratory (PKL) under USAF Radioactive Material Pennit No, and/or (2) Manufacturer according to procedures approved by NRC b.
All instruments are calibrated at six month intervals. An AFT 0 Form 108, PME Certification, is affixed to all instruments indicating date calibrated, date due and calibrator's certification stamp. Air Force reference standards are certified by the National Bureau of Standards (NBS),
or the Air [orce Measurements Standards Laboratory. Air Force Base reference standards are certified at regu'arly prescribed intervals by the NBS, or the AF Measurements Standants Laboratory.
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- 14. Handling, Storage and Shipping Control. Written safety procedures concerning the handling, storage, and shipping of sealed sources will be followed. These procedures are perfomed in accordance with applicable NRC, Department of Transportation (DOT) and U.S. Air Force regulations, and the manufacturer's operation manual. Work instructions will be provided for handling, storage and shipping operations.
Shipments will not be made unless all tests, certifications, acceptances, and final inspections have been compl eted. The Manufacturer's Manual will be used as a guide to insure that the requirements of 10 CFR 71.85 and 71.87 are met and that packages are in good condition, adequately secured on the transport vehicle, marked and labeled per DOT regulations and identified by model and package identification nunber.
- 15. Inspection Test and Operating Status.
Inspection, test and operating status of sealed sourtes will be controlled and recorded in accordance with USAF Radioactive Material Pemit No.
This includes annual reports so long as the sealed source is in use concerning the status of the source, a.
Radiation surveys shall be made:
(1) Whenever a sealed sourte is received, but prior to offloading from the shipping vehicle.
(2) After the sealed source is initially placed in storage or use.
(3) After a sealed source is loaded on a shipping vehicle, but prior to shipment.
(4) Twice annually, while in storage or use, not to exceed six month l
interval s, b.
Sealed sourte surveys in storage or use will include:
(1) Sourte surface dose rates.
(2) A sketch showing the location of the sealed sources and dose rates at the boundary of the restricted area, c.
Shipping vehicles will be surveyed for contariination before a sealed source is onloaded and after a sealed sourte is offloaded.
(1) Leak tests will be performed:
(a) After a sealed source is initally placed in storage or use.
(b) Af ter a sealed source is loaded on a shipping vehicle, but prior to shipment.
(c) Twice annually, while in storage or use, not to exceed six month intervals.
(2) Permissible Levels for Leak Tests.
Sourtes will be considered to be leaking if more than 0.005 microcuries of activity are detected by leak testing the sealed source (0.05 microcuries for teletherapy scarces).
- 16. Non-confoming Materials, Parts, or Comonents. Not Applicable.
Pack age is used as is after required radiation surveys and leak test are performed.
USAF Radioactive Material Permit No, does not authorize opening of sealed sourtes for maintenance.
- 17. Corrective Action.
The Radiation Protection Officer (RPO) will provide annual staff assistance visits to all locations with licensed material.
The results of these visits will be provided to the parent unit. The report will note any deviations or discrepancies, office of primary responsibility (OPR) and abatement date, if applicable. Written response from the OPR is nomally mquired to provide details of abatement.
In addition, the RPO will report significant findings of staff assistance visits to the Unit or Base Radiation Safety Committee.
- 18. Quality Assurance Records. Records of package approvals (including mferences and drawings, relating to the use of the packaging) tests, audits, personnel training and qualifications, sealed source shipments, and compliance inspections will be maintailed.
Descriptions of sealed sourte(s),
manufacturer's operation manuals, and procedures pertinent to sealed source activities will also be maintained.
Records will be maintained, and kept in such a manner as to be identifiable and readily retrievable.
Record types and mtention times will be kept in accordance with Title 10, Code of Federal Regulations, part 71.91(a) and (c).
- 19. Audits.
Individual (s) perfoming the audits will have no responsibility in the activity being audited. Nomally, the Radiation Protection Officer will perform audits. Audits of the QA Program will be perfonned on an annual basis. Results of audits will be maintained and reported to the Radiation Safety Comittee. Audit reports will be evaluated and deficient areas corrected. Audit reports will be maintained as part of the QA records.
Audits will be conducted in accordance with checklist.
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SEALED SOURCE CERTIFICATE OF COWLI ANCE NUMBERS SEALED SOURCE CERTIFICATE OF COMPLIANCE NUMBER l
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QUALITY ASSURANCE PROGRAM ORGANIZATION 2.
Responsibilities Relative to the OA Program a.
The sealed source owner / user, is responsible for:
(1) The transport, storage and installation of sealed source while in his/her custody.
(2) Designates sealed source custodian for sourtes in storage while on base.
(3) Assuring compliance with the license and pertinent Federal and Air Force regulations relating to radiological safety while sealed sourtes are in his/her custody, b.
Radiation Protection Officer. The Radiation Protection Officer is approved by the USAF Radioisotope Comittee. The minimum qualifications of the RPO is that he/she be qualified by training and experience to use the material for the purpose requested, in such manner as to protect health and minimize danger to life or property. Further he/she will have received (1) a
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college degree at the bachelor level, or equivalent training and experience, in the physical or biological sciences, or in engineering and (2) at least 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of training and experience in the safe handling of radioactive materials, and in the characteristice of ionizing radiation, units of radiation dose and quantities, radiation detection instrumentation, and biological hazards of exposure to radiation appropriate to the type and foms of byproduct material to be used. The Radiation Protection Officer is responsible for:
(1) Assuring the implementation of the approved radiation safety program for the stated use of sealed sources.
(2) Reviewing plans for sealed source operation, handling, shipment and storage and providing reconinendation relative to radiation safety.
(3) Perfoming QA inspection & audits.
(4) Assessing the safeguards to be employed to limit radiation exposure of personnel during storage, transportation and operation.
(5) Assessing qualifications of individuals desiring to use the sealed sources to assure that they have sufficient education, training and/or experience to assure the safety of operations.
(6) Preparation, coordination, and administration of the radiation safety program.
(7) Provide safety staff assistance visits to all subordinate units.
(8) Monitors hazard reporting on related equipment and programs.
(9) Complying with the license for use of the sealed sources in his/her custody.
(10) The care and accountability of the sealed sources assigned him/her.
(11) Conducting and maintaining records of required inspections and test.
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