ML19207B905
| ML19207B905 | |
| Person / Time | |
|---|---|
| Site: | 07100160 |
| Issue date: | 08/13/1979 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Desiree Davis OMAHA TESTING LABORATORIES, INC. |
| References | |
| NUDOCS 7909060049 | |
| Download: ML19207B905 (4) | |
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UNITED STATES y 7) s,( 3 j, NUCLEAR REGULATORY COMMISSION E
WASHINGTON, D. C. 20S55
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AUG 131979 FCTC: RHO 71-0160 Omaha Testing Labcratories, Inc.
ATTN: Mr. Dale C. Davis 2917 Douglas Street Omaha, NB 68131 Gentlemen:
This refers to your application dated June E6,1978 requesting approval of your Quality Assurance (QA) program as meeting the QA program require-ments of 10 CFR 571.51.
In connection with our review, we have determined that your proposed QA program does not fully 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 note that while there must be supporting written procedures and fanns to implement your QA program, these procedures and forms should not be submitted as part of your QA program plan. Also note that the information requested in the enclosure to this letter should be provided.
If you have any questions regarding this request, please contact Mr. Fred Liederbach at (301) 492-7741.
Sincerely, Charles E. MacDonald, Chief Transportation Certification Branch Division of Fuel Cycle and Material Safety, NMSS
Enclosures:
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1.
Sample QA Frogram 2.
Request for Additional Information 7909060C49 c.
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OMAHA TESTING LABORATORIES, INC. (71-0160)
Recuest for Additional Information 1.
Ilease provide a copy of page 11/100.02, which is missing from tha copy of the submittal we received.
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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 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 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 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 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.
2.
- 4. ' Handling Storage and Shipping 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 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.
S.
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 procedures. Status will be indicated by tag, label, marking or log entry.
Status of nonconforming 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.
The Radiation Safety Officer shall 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 records of shipments will be maintained.
Descriptions of equipment and written procedures will also be maintained.
These records will be maintained in accordance wit 1. written procedures.
The 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 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.
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