ML20003A242
| ML20003A242 | |
| Person / Time | |
|---|---|
| Site: | 07100402 |
| Issue date: | 01/21/1981 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Watson R C&R LABORATORIES, INC. |
| References | |
| NUDOCS 8102030194 | |
| Download: ML20003A242 (3) | |
Text
- "'44je UNITED STATES g
,3 o
NUCLEAR REGULATORY COMMISSION r,
a WASHINGTON, D. C. 20665 a
s., *... /
JAN 211981 FCTC: RHO 71-0402 mg Mr. Roland L. Watson C&R Laboratories 1534 Hooli Circle 5
Pearl City, HI 96782 Y
Dear Mr. Watson:
We have your letter of December 8,1980. Unfortunately, it does not meet our requirements for a quality assurance program description in accordance with 10 CFR Part 71. We require a self contained document which describes a quality assurance program meeting the regulations. While there can be flexibility in how the quality assurance program is presented, the letter of December 8,1980 misses the mark.
In order to assist you in preparing an acceptable submittal, we have enclosed a j
document titled "10 CFR Part 71 QA Program for Industrial Radiography Licensees" dated March 27, 1980. Many radiographer's organizations have used this enclosure to prepare an acceptable quality assurance program description. We suggest you follow its format in preparing your submittal. The procedures which you refer to in your December 8,1980 letter should not be submitted as part of your quality I
assurance program description. However, you should assure yourself that such pro-cedures are available and are followed to meet the comitments described in your submittal.
l If you have any questions on what we require, if you need further assistance in l
preparing an acceptable submittal, or if you wish to discuss the concepts involved, contact Mr. Jack Spraul of our Quality Assurance Branch at the letterhead address or by phone at (301) 492-7741.
I Sincerely,
[
Charles'E. MacDonald, Chief Transportation Certification Branch l
Division of Fuel Cycle and Material Safety, NMSS l
Enclosure:
10 CFR Part 71 QA Program for Industrial Radiography Licensees 1
81020306N c.,
l March 27,1980 (Revision 2) 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 imple-mented 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 recordkeeping.
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 the Nuclear Regulatory Commission for all packages designed or fabri-cated after January 1,1979. This requirement will be satisfied by receiving a certification to this effect from the manufacturer.
3.
Docment Control All documents related to a specific shipping package will be controlled l
through the use of written procedures. All document changes will be perfomed according to written procedures approved by management.
I 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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Handling, 5:Orage, anc Shi; ing Written safety orocedures concerning One nancling, storage, and sni;cing of packages for certain s:ecial f:r, radicactive caterial will be fellcwed.
Ship.ents will not te made unless all tests, certifica icns, acceptar.ces, and final ins;ections have been c::cleted. Werk instructicns will be
- rovided for nandling, st rage, and sni; ping
- eraticns.
Radiogra:hy cersonnel shall perfon :ne critical nancling, storaga, ano shipoing ocerations.
5.
Ins;ection, Test, and 0:erating Status
- ns:ecticn, test, anc ::erating status of :ackages for certain s:ecial for radicactive material will be incicatec and c:ntrollec ey writtan
- rececures. Status will be indicated by tag, latel..arting, er log entry. Status of nonconfoming : arts er ;ackages will be cositively maintained by written procedures.
Radiogracny ;ersonnel sna11 ;erform the regulatory recuired inspections and tests in ac:Ordance with written prececures. The Radiaticn Safety Officer shall ensure that these functions are perf:r 4d.
5.
Quality Assurance Records Records of package accrevals (including references and drawings),
precurement, inspections, tests, Operating legs, audit results, :erscnnel training and qualifications and records of shipeen*:. Jill be maintainec.
Cescriptions of equipment and written rocedures will also be =aintained.
Tnese records will be =aintrined in accordance with =ritten precedures.
The records will be identifi+d and retrievable. At list of these records, witn their s:crage locations, will be maintained by the Radiation Safety Officer.
7.
Aucits Established schedules of audits of the CA Prcgram will be perfemed using written check lists. Results of audits will :e maintained and reported to management. Audit reports will be evaluated and deficient areas corrected. The audits will be de:endent On the safety significance of the activity being audited, but each activity will be audited at least cnce per year. Audit reports will be maintained as ; art of tne quality assurance records. Nmeers of the audit team shall have no responsibility in the activity being audited.
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