ML19263E258
| ML19263E258 | |
| Person / Time | |
|---|---|
| Site: | 07100279 |
| Issue date: | 04/27/1979 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Mullikin M UNIVERSAL TESTING, INC. |
| References | |
| NUDOCS 7906050411 | |
| Download: ML19263E258 (3) | |
Text
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4 UNITED 3TATES
- 4 NUCLEAR REGULATORY COMMISSION vamy[j 3 f.I.(1 WASHINGTON, D. C. 20555
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APR 2 71979
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FCTR: RHO 71-0279 Universal Testing, Inc.
ATTN: Mr. M. S. !!ullikin 369 West Gregson Avenue Salt Lake City, UT 84115 Gentlemen:
This refers to your application dated March 8,1979 requesting approval of your Quality Assurance (QA) program as meeting the QA program requirements of 10 CFR 71.51.
In connection with our review, we have determined that'your proposed QA program does not meet the requirements of Appendix E to 10 CFR Part 71. To assist you in revising your application, we have enclosed a sample QA program for industrial radiography licensees dated April 2, 1979.
Please submit seven copies of your revisad application within 30 days of the date of this letter. If you have any questions regarding this request, please contact Mr. Jack Spraul at (301) 492-77'l.
Sincerely, I
k Charles E. MacDonald, Chief Transportation Branch Divigion of Fuel Cycle and Material Safety, NMSS
Enclosure:
Sample QA Program 2300 172 7906050411
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April 2, 1979 (Revision 1) 10 CFR PART 71 OA PROGRAM FOR INDUSTRIAL RADIOGRAPHY LICENSEES 1.
Organization The final responsibility for the Quality Assurance (QA) Program for Part 71 Requirements rests with (Company Name). Design and Fabrication shall not be conducted under this QA Program. The QA Program is implemented using the following o.ganization:
Note: The Organizational Chart as used in the license application should he presented.
It may be advisable to designate the Radiation Safety Officer as the responsible individual for the Part 71 QA Reysirements.
li l
The Radiation Safety Officer is responsible for overall administration of 3
the program, training and certification, document control, and auditing.
The Radiographers are responsible for handling, storing, shipping, inspection, test and operating status and record keepring.
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 cll defined OC procedures, engineering procedures, and specific provisions of the package design approval are satisfied. The QA program will onphasize 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 Comission for all packages designed or fabricated after the effective date of the QA Program. This requirement can be satisfied by receiving a certification,to this effect from the manufacturer.
3.
Document Control All documents related to a specific shipping package will be controlled through the use of written procedures. All document changes will be perfonned according 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.
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2.
- 4. ' Handling Storage and Shipping Written safety procedures concerning the handling, storage and shipping of packages fcr certain special form radioactive material will be followed.
Shipments will not be made unless all tests, certifications, acceptances, and final inspections have been completed.
h'ork instructions will be provided for handling, storage, and shipping operations.
Radiography personnel shall perforn the critical handling, storage and shipping operations.
5.
Inspection, Test and Operating Status
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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 entry.
Status of nonconforming part or packages will be positively maintained by written procedurcs.
Radiography personnel shall perform the regulatory required inspections and tests in accordance with written procedures.
The Radiation Safety Officer shall ensure that these functions are perfomed.
6.
Quality Assurance Records Records of package approvals (including references and drawings), procure-ment, 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.
nese records will be maintained in accordance with written procedures.
ne 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 sr-hedules of audits of.the QA Program will be perfomed using written check lists.
Results of audits will be maintained and reported to management. Audit reports will be evaluated and deficient areas. corrected.
Tne audits will be dependent on the sa'fety 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.
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