ML19207B136
| ML19207B136 | |
| Person / Time | |
|---|---|
| Site: | 07100117 |
| Issue date: | 08/03/1979 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Regina A MANIOR-ELECTRO ALLOYS, INC., A/K/A ELECTRO-ALLOYS |
| References | |
| NUDOCS 7908230432 | |
| Download: ML19207B136 (3) | |
Text
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UNITED STATES 8y NUCLEAR REGULATORY COMMISSION
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FCTR: RHO 71-0117 Abex Conoration ATTN: Mr. A. F. Regina, Jr.
Route 202 Mahwah, NJ 07430 Gentlemen:
This refers to your application dated June 30, 1978 requesting approval of your Quality Assurance (QA) program as meeting the requirements of 10 CFR 571.51.
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. Also, please delete Appendix B and attachments thereto. While there must be supporting written procedures to implement your QA program, these procedures and forms should not be submitted as part of your QA program plan.
Please submit seven copies of your revised application within 30 days following receipt of this letter.
If you have any questions regarding this request, please contact Mr. Fred Liederbi.i1 at (301) 492-7741.
Sincerely, h
-=h Charles E. MacDonald, Chief Transportatio:1 Branch Division of Fuel Cycle and Material Safety, NMSS
Enclosure:
Sample QA Program
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April 2, 1979 (Revision 1) 10 CFR PART 71 QA 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 organization:
Note:
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 P'rt 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 tc written procedures with management approval.
The QA Program will ensure ti.at all defined QC procedures, engineering procedures, and specific provisions of the package design approval are catisfied.
The QA program.,ill 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 Commission 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 frem 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 performed 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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April 2, 1979 (Revision 1) 10 CFR PART 71 QA PROGRAM FOR INDUSTRIAL RADIOGRAPHY LICENSEES 1.
Organization The final responsibility for the Quality fosurance (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 organization:
Note: 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 individust 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 (Ctmpany Program) establishes and implements this QA i
Program. Training, prior to engagement, for all QA functions is required according to written procedures. QA Program revisions will be made i
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 Commission 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 dccuments related to a specific shipping package will be controlled through the use of written procedures.
All document changes will be performed accordinc to written procedures apprcved by management.
The Radiation Safety Officer shall insure that all QA fur.ctions are conducted in accordance with the latest applicable changes to these documents.
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