ML19250C372
| ML19250C372 | |
| Person / Time | |
|---|---|
| Site: | 07100273 |
| Issue date: | 11/08/1979 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | NAVY, DEPT. OF |
| Shared Package | |
| ML19250C370 | List: |
| References | |
| NUDOCS 7911230302 | |
| Download: ML19250C372 (3) | |
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Docket File APR 2 01979 Distribution:
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JSpraul JGilray FCTR: RHO y Waass 71-0273 DSkovholt RH0degaarden EBr'oyn II.S. Departrent of the !!avy NMSS R/F 11.S.3 !{oward tf. Gilmore (ASIS)
FCTR R/F ATTN: Mr. J. E. Allen FP0 ?:ew York, NY 09501 Centleren:
This refers to your application dated February 3,1979 requesting approval of your Quality Assurance (QA) progran as tr.eeting the QA program requirements of 10 CFR Q71.51.
In connection with our review, we have determined that your proposed QA program does not meet the require. cats of Appendix E to 10 CFR Part 71. To assist you in revising your application, we have enclosed a sample QA progran for industrial radiography licensees dated April 2, 1979.
Please submit seven copics of your revised application within 30 days of the date cf this letter.
If you have any questions regarding this request, please contact !:r. Jack Spraul at (301) 492-7741.
Sincerely, Original Signed by CH.85J.I5 2. !.'AC00:U.LD Charles E. MacDonald, Chief Transportation Cranch Division of Fuel Cycle and Material Safety,! MSS
Enclosure:
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April 2, 1979 (Revision 1) 10 CFR PART 71 OA PROGRAM i
FOR IllDUSTRIAL R DIOGRAPHY LICEtiSEES 1.
Organization The final responsibility for the Quality Assurance (QA) Program for Part 71 Requirements rests with (Ccepany Name).
Design and Fabrication shall not be conducted under this QA Program. The QA Program is implemented using the following organization:
No te:
The Organizational Chart as used in the license application should be presented.
It may be advisable to designate the Radiation Safety Officer as the responsible individual for the Part 71 QA Requirements.
The Radiation Safety Officer is responsible for overall administration of the program, training and certification, document control, and auditing.
The Radiographers are responsible for handling, storing, shipping, inspection, test and operating status and record keeping.
2.
Quality Assurance Program The management of (Company Program) 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 Safety Officer shall assure that all radioactive material shipping packages are designed and manufactured under a QA Program approved by Nuclear Regulatory Comnission fer all packages designed or fabricated after the effective date of the QA Program.
This requirement can be l
satisfied by receiving a certification to this effect from the manufacturer.
3.
Documer.t Control 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 nianagement.
The Radiation Safety Officer shall insure that all QA functions are conducted in accordance with the latest applicable changes to ti;ese documents.
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- 4. '!!cadling Storage and Shipping Written safety procedures concerning the handling, storage and shipping of packages for certain specia$ form radioactive material will be followed.
Shipments will not be made unles,s all tests, certifications, acceptances, and final inspections have been comp!ated.
Work instructions will be.
provided for handling, storage, and shipping c,perations.
Radiography personnel shall perform the critical handling, storage and shipping operations.
S.
Inspection, Test and Operating Status Ins'pection, test and operating status of packages for certain special form radioactive material will be indicated and controlled by written procedures.
Status will be indicated by tag, label, marking or log entr/.
Status of nenconfernir.g parts or packages will be positively maintained by written procedurcs.
Radiography personnel shall perform the regulatory required inspections and tests in accordance with written procedures.
ne Radiation Safety Officer shall ensure that these functions are performed.
6.
Quality Assurance Records Records of package approvals (including references snd drr. tings), procure-ment, inspections, tests, operating logs, audit rer.ults, personnel training and qualifications and records of shipments will te maintained.
Descriptions of equipment anB written procedures will also be maintained.
Rese records will be maintained in accordance with written procedures.
n e records will be identifiable and retrievable. A list of these records, with their storage locations, will be maintained by the Radiation Safety Officer.
7.
Audits Established schedules of audits of the QA Program will be performed using written check lists.
Results cf audits will be maintained and reported to management.
Audit reports will be evaluated and deficient areas corrected.
ne audits will be dependent on the safety significance of the activity being audited, but each activity will be audited at least once por 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.
13R7 337
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