ML19225C698
| ML19225C698 | |
| Person / Time | |
|---|---|
| Site: | 07100010 |
| Issue date: | 06/25/1979 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Richardson H GAMMA INDUSTRIES, INC. |
| References | |
| NUDOCS 7908020332 | |
| Download: ML19225C698 (3) | |
Text
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QB RECO UNITED STATES
'k P"JCLEAR REGULATORY COMMISSION WASHINGTON, D. C. 20555 g,
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J C 2 3 1973 FCTR: RHO 71-0310 Gamma Industries ATTN:
Mr. Harry D. Richardson P.O. Box 2543 Baton Rouge, LA 70821 Gen tlemen:
This refers to your letter dated June 11, 1979 which included six comments /
questions resulting from our letter of May 30, 1979. Our letter requested additional information relative to Gamma Industries' quality assurance program for transportation packages for radioactive material. Our response to each comment / question is given below.
1.
Your letter refers to " asterisked" items. Since no asterisks can be found in your letter, may it be assumed that your reference is to the "X" inserted in numerous places on a checklist which can be identified by a designation in the upper right corner - Docket No. 71-0013.
Response
Yes 2.
This leads us back to questions which were presented early last year and have been discussed with you on several occasions.
WHAT DC YOU WANT?
Response
We want what is required by 971.51 of 10 CFR.
That is, we want a description of Gamma Industries' quality assurance program applied to the design, fabrication, assembly, testing, maintenance, repair, modification, ana use of transportation packages for radioactive material. More specifi-cally, we want commitments from Gamma Industries that are responsive to the enclosure of our letter of May 30, 1979. Where the enclosure says, " Provide a statement that...," we want a statement, or commitment, from Gamma Industries, that....
We believe other items listed in the enclosure are self explanatory; but, if you have any questions, please contact Jack Spraul on (301) 492-7741.
To implement the quality assurance program described for us, you will require procedures, forms, drawings, specifications, check iists, etc. The status of your ongoing quality assurance program will determine how much work, if any, is required to develop the working documents to meet the commitments.
% ow 7908020 3 3 C
Mr. Harry D. Richardson JM 2 3 B79 3.
You will recall that the end result of QA documentation desired for radiography licensees was a " stereotyped" two page document.
This was determined ONLY after a very long and frustrating effort.
Response
The " stereotyped two page document" that you refer to has been found by the NRC to be an acceptable quality assurance program description for radiographers, i.e., organizations that use transportation packages for radioactive material but do not design or manufacture such packages.
We require an expanded quality assurance program from organizations like Gamma Industries that design and manufacture such packages.
4.
Is there a possibility that a very simple document is what you require in lieu of the eight page Quality Assurance program submitted on May 29, 1973?
Response
As noted above, a " stereotyped two page document" is inadequate.
The description of Gamma Industries' quality assurance program must address each of the acceptance criteria enclosed with our letter of May 30, 1979.
The reason that all of the items were not X'ed in the enclosure is that we felt your submittal of May 29, 1973 addressed the items not X'ed.
Before you resubmit the description of Gamma Industries' quality assurance program, yoc should assure that it is responsive to each item in the enclosure, whether X'ed or not.
5.
In the event that I prepare full documentation suggested by your check list, it is my estimate that the complete document will be numerous procedu'es which will fill several two inch three ring binders.
Preparing this will require several man-months of effort.
(I will also add my opinion that this would be wasted effort because in 25 years of manufacturing containers for shipping radioactive miteridia there is no evidence that the Gamma Industries Quality Assurance Program has not been acceptable.
This is based upon no transportation incidents resulting from poor QA or manufacturing during ten of thousands of shipments on a world wide basis.)
Response
In Gamma Industries' quality assurance program c :scription, we require that each of the items in the acceptance criteria be responded to.
We do not expect, nor will we review at this stage, detailed implementing procedures.
With the excellent record that you indicate Gamma Industries has in this area, we would expect implementing documentation to be in place and working.
However, some of the commitments we require may require modification of your present procedures or, perhaps, an additional procedure or two.
This should be accomplished on a timely basis.
6.
My last comment to your letter, please reconsider the mandatory 30 day response requirement while we determine precisely what is required and then give sufficient time to prepare the materials.
Response
In lieu of tne 30 day response request, and in light of the above information, please notify us within 10 days of receipt of this letter of when you will submit an acceptable description of Gamma Industries' quality 4/6 Ol'
M ' J ~/3 1r. Harry D. Richardson '
assurance program. We will then notify you if the date you propose is unacceptable.
I hope the above responses clarify our position to your satisfaction.
If not, please contact Jack Spraul on (301) 492-7741.
If you desire, a Gamma Industries-NRC meeting can be arranged to further dispel any misunderstandings.
Sincerely, Ibu
^'
Charles E. MacDonald, Chief Transportation Branch Division of Fuel Cycle and Meterial Safety, NMSS E cnu
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