ML19323G050
| ML19323G050 | |
| Person / Time | |
|---|---|
| Site: | 07100387 |
| Issue date: | 05/14/1980 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Stewart M MASSACHUSETTS MATERIALS RESEARCH, INC. |
| References | |
| NUDOCS 8005300296 | |
| Download: ML19323G050 (3) | |
Text
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UNITED STATES
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NUCLEAR REGULATORY COMMISSION
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MAY 141980 FCTC: RHO 71-0387 Massachusetts Materials Research, Inc.
ATTN: Mr. Michael J. Stewart 241 West Boylston Street West Boylsten, MA 01583
' Gentlemen:
This refers to your application dated April 23, 1980, requesting approval of your Quality Assurance (QA) program as meeting the QA program requirements of 10 CFR 571.51.
In connection with our review, we find the enclosure to your April 23, 1980 letter approximates what we require. However, the many references to other docu-ments tend to detract from the submittal, since we are reviewing only the descrip-tion of the QA program. The QA program description should contain commitments which are met by following procedures and filling out forms which are documented elsewhere, such as in MMR's Administrative Manual or Operating and Emergency Procedurc Manual. Also, we require an organization chart.
An example of a comitment which we require but which is not made in the en-closure to your letter is a commitment that shipments will not be made unless all tests, certifications, acceptances, and final inspections have been completed.
It may be that your procedures do, indeed, require this; but we cannot accept the description of your QA program unless such a ccmitment 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 enclosure 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, Charles E. MacDonald, Chief Transportation Certification Branch Division of Fuel Cycle and Material Safety, NMSS
Enclosure:
Draft QA Program Gescription 8005300J.D C
T "ircn 27, U D (Revision 2) 10 CFR PART 71 CA PP.05 RAM FOR INDUSTRIAL RADIOSRAPHY 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,'is required according to
. implements this QA Program.
Training, prior to engagement, for all QA functions written procedures. QA Program revisicns 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 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 docu, ment 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.
l
_2-4 Handling, Storage, and Shipping b'ritten safety procedures concerning the handling, storage, and shipping of packages for certain special form radioactive material will be folicwed.
Ship-ments will not be made unless all tests, certifications, acce tances, and final r
inspections have been completed Work instructions will be provided for handling, storage, and shipping operati:
Radiography personnel shall perform the critical handling, storage, and shipping operations.
5.
Inspection, Test, and Operating Status Inspection, test, anc 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 procedures.
Radiography personnel shall perform the regulatory req 6 ired inspecticns 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), 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 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 main-tained as part of the quality assurance records. Members of the audit team shall have no responsibility in the activity being audited.