ML20211C512
| ML20211C512 | |
| Person / Time | |
|---|---|
| Site: | 07100626 |
| Issue date: | 01/20/1987 |
| From: | Steinmuller D TRANSPLANTATION SOCIETY OF MICHIGAN |
| To: | Gordon L NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| 27843, NUDOCS 8702200117 | |
| Download: ML20211C512 (3) | |
Text
7/-0424 RETURN IO 39~6-55 TRANSPLANTATION SOCIETY OF MICHIGAN S
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FEB Leonard Gordon TransportationCertificat[onBranch ( ~C) ggasttutATo(I E
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Dear Mr. Gordon:
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I would like to submit forfChpproddl under our byproduct materials license no.
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21-2048-01, the following Quality Assurance (QA) program applicable to procurement, use, maintenance, and repair of packages designed to transport radiographic exposure devices. At the same time, I would like to request approval for use of a USA /5800/B overpack to transport a Cs-137 Irradiator (AEtL GC10) source assembly from Ann Arbor, MI to Indianapolis, IN.
Enclosed is a check for $150 to cover the cost of review / approval of our QA program.
10CFR PART 71 QA PROGRAM
- 1. The final responsibility for the QA program for Part 71 requirements rests with the Transplantation Society of Michigan.
Design and fabrication will not be conducted under this QA program. The Radiation Protection Officer will be the responsible individual for the Part 71 QA requirements, including overall administration of the program, training and certification, document control, and auditing. The Radiation Protection Officer or his designee will be responsible for handling, storing, shipping, inspection, test and operating status and recordkeeping.
- 2. The management of The Transplantation Soci,ety of Michigan establishes and implements this QA 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 Protection Officer shall assure that all radioactive material shipping packeges are designed and manufactured under a QA Program approved by the Nuclear Regulatory Commission for all packages designed or fabricated after January 1, 1979. This requirement will be satisfied by receiving a certification to this effect from the manufacturer.
- 3. All documents related to a specific shipping package will be controlled through the use of written procedures. All document changes will be performed according to written procedures approved by management.
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liCCm FCC IDIorcu!I0n 8702200117 870120 cn Mh.
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PDR ADOCK 071*****
Ann Arbor, Michigan 48104 l
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s The Radiation Protection Officer shall ensure that all QA functions are conducted in accordance with the latest applicable changes to these documents.
- 4. Written safety-procedures concerning the handling, storage, and shipping of packages for certain special form radioactive material will be followed.
Shipments will not be made unless all tests, certifications, acceptances, and final inspection have been completed. Work instructions will be provided for handling, storage, and shipping operations.
The Radiation Protection Officer or his designee shall perform the critical handling, storage, and shipping operations.
- 5. Inspection, test, and operating status for certain special form radioactive material will be indicated and controlled by written procedures. Status will be indicated by tag, label, marking, or log entry. Status of nonconforming parts or packages will be positively maintained by written procedures.
The Radiation Protection Officer or his designee shall perform the regulatory required inspections and tests in accordance with written procedures. The Radiation Protection Officer shall ensure that these functions are performed.
- 6. Records of package approvals (including references and drawings),
procurement, inspections, tests, operating logs, audit results, personnel training and qualifications and records of shipments will be maintained.
Descriptions of equipment and written procedures will also be maintained.
These records will be maintained in accordance with written procedures.
The records wi)1 be identified and retrievable. A list of these records, with their storage locations, will be maintained by the Radiation Protection Officer.
- 7. Established schedules of audits of the QA Program will be performed using written check lists.
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 no responsibility in the activity being audited.
Sincerely yours,
- C David Steinsuller, Ph.D.
Radiation Protection Officer pc: Gerda H. Lipcaman, Executive Director, TSM LoE- -_h d i5' Re mitte r _ _ _N3_;9,Ld l _ _
Robert Anger, M.S.
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Radiation Safety Officer Methodist Hospital Amtunt
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