ML19309E110
| ML19309E110 | |
| Person / Time | |
|---|---|
| Site: | 07100252 |
| Issue date: | 03/28/1980 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Sammons R DAYTON X-RAY CO. |
| References | |
| NUDOCS 8004180400 | |
| Download: ML19309E110 (3) | |
Text
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UNITED STATES J"
N NUCLEAR REGULATORY COMMISSION h,
a WASHINGTON, D. C. 20555
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/4 NAR 2 81930 FCTC: RHO 71-0252 Dayton X-Ray Company ATTN: Mr. R. J. Sammons 1150 W. Second Street Dayton, OH 45407 Gentlemen:
This refers to your application dated March 17, 1980 requesting approval of your Quality Assurance (QA) program as meeting the QA program requirements of 10 CFR 971.51. We are sorry about the apparent mix-up between your license renewal effort and your QA program submittal.
In connection with our review, we find the enclosure to your March 17, 1980 letter approximates what we require. However, the many references to attach-ments tend to detract from the submittal, since we are reviewing only the de-scription of the QA program. The QA program description should contain commit-ments which are met by following procedures which are documented elsewhere, such as in a QA manual. However, we do require an organization chart which shows, by position title, the reporting relationships of those involved in the QA program such as the Radiation Safety Officer and Radiographers.
An example of a commitment which we require but which is not made in the en-closure to your March 17, 1980 letter is a commitment that deficiencies found by audits will be corrected.
It may be that your procedures do, indeed, require this; but we cannot accept the descripticn of your QA program unless such a commitment is contained in it.
To assist you in revising the description of your QA program, we have enclosed a draft QA program description which contains the commitments we require.
Please prepare a QA program description which is responsive to the above and resubmit it within 60 days from the date of this letter.
If you have any questions, please call Jack Spraul on (301) 492-7741.
Sincerely, U
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Charles E. MacDonald, Chief Transportation Certification Branch Division of Fuel Cycle and Material Safety,'NMSS
Enclosure:
Draft QA Program Description 8004180 @
Draft March 27,1980 (Revision 2) 10 CFR PART 71 QA PROGRAfd 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 folicwing 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 managemant 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 the Nuclear Regulatory Commission for all packages designed or fabricated after January 1, 1979. This requirement will 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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' r 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.
Ship-ments will not be made unless all tests, certifications, acceptances, and final l
inspecticns have been completed. Work instructions will be provided for handling, j
storage, and shipping operations.
t Radiography personnel shall perform the critical handling, storage, and shipping j
operations.
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Inspection, Test, and Operating Status Inspection, test, and operating status of packages for certain special form f
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 procedures.
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 perfonned.
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6.
Quality Assurance Records Records of package approvals (including references and drawings), procurement, inspections, tests, operating logs, audit results, personnel training and quali-fications and records of shipments will be naintained. Descriptions of equip-ment and written procedures will also be maintained.
These records will be maintained in accordance with written procedures. The records will be identified 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 ev,aluated 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 main-tained as part of the quality assurance records. Members of the audit team shall have no responsibility in the activity being audited.