ML19207C035
| ML19207C035 | |
| Person / Time | |
|---|---|
| Site: | 07100027 |
| Issue date: | 08/13/1979 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Stromer G BABCOCK & WILCOX CO. |
| References | |
| NUDOCS 7909060351 | |
| Download: ML19207C035 (3) | |
Text
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FCTE:FHO 71-C027 Pabcoc': & '.'ilcox Cercany ATTN:
Mr. G. R. Strorer High. ay 69 '..'est Mt. Vernon, IN 47620 Gentleren:
This refers to ycur undated application received June 20, 1978 requesting approval of your Quality Assurance (QA) program as meeting the requirerents of 10 CFR 91.51.
In connection with cur review, we have determined that your proposed QA prograr does not fully reet the requirerents of Appendix E to 10 CFR Part 71, especially in the areas of inspection, test and operating status, and audits. To assist you in revising yoJr application, we have enclosed a sarple OA progran for industri61 radiography licensees dated April 2,1979.
Please submit seven copies of your revised application within 30 days follo. in; receipt of this letter.
If you have eay questions regarding this request, please contact Mr. Fred Liederbach at (301) 492-7741.
Sincerely,
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Charles E. MacDonald, Chief Transportation Branch Division of Fuel Cycle and Material Safety, NMSS
Enclosure:
Sample QA Progren 316010
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April 2, 1979 (Revision 1) 10 CFR PART 71 QA PROGRAM FOR INDUSTRIAL RADIOGRAPHY LICENSEES Organization The final responsibility for the Quality Assurance (QA) Program for Part 71 Requirements rests with (Company Name).
Desian 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 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 rerJonsible for handling, storing, shipping, inspection, test and oper ting 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 OC 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 af ter 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 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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2.
- 4. 'llandling Storage and Shipping Written safety procedures concerning the handling, storage and shipping of packages for certain special form radioactive material will be follosed.
Shipments will not be made unless all tests, certifications, acceptances, and final inspections have been completed.
Work instructions will be provided for handling, storage, and shipping operations.
Radiography personnel shall perform the critical handling, storage and shipping operations.
5.
Inspection, Test and Operating Status Inspection, test and operating status of packages for certain special form radioactive material will be indicated and controlled by written procedu res.
Status will be indicated by tag, label, marking or log ento.
Status of nonconfermir.g parts or packages will be positively maintained by written procedurcs.
Radiography pcrsonnel shall perform the regulat;ry required inspections and tests in accordance with written procedures.
The Radiation Safety Officer siall ensure that these functions are performed.
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 recards 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 will be identifiabic and retrievable.
A list of these records, with their storage locations, will be maintained by the Radiation Safety Of ficer.
7.
Audits Established schedules of audits of the QA program will be perfonned 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 nu responsibility in the activity beit.g audited.
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