ML19321A425
| ML19321A425 | |
| Person / Time | |
|---|---|
| Site: | 07100121 |
| Issue date: | 06/24/1980 |
| From: | Smedira C NEUTRON PRODUCTS, INC. |
| To: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML19321A426 | List: |
| References | |
| 16678, NUDOCS 8007230349 | |
| Download: ML19321A425 (3) | |
Text
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Mr. Charles E. MacDonald, Chief Transportation Certification Branch Division of Fuel Cycle and Material Safety, NMSS U. S. Nuclear Regulatory Commission
,,5 Washington, D. C.
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Dear Mr. MacDonald:
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S In accordance with your April 23, 1980 lecter, enclosed please find sevQ copies of Revision 3 of the Quality Assu7 ance Program for Nedtron'.Eroducus, Inc. {NPI).
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El P Attached to this letter is a summary that addresses item by item t$ request for additional information which you trar.smitted with your April 231ctter.
Items 2, 5, and 14 of the request for additional infomation were addressed by directly modifying the QA program. These changes are underlined.
If there are any questions regarding this submittal, please feel free to contact me at 301/428-9819.
Sincerely, NEUTRON PRODUCTS, INC.
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<hi Camine Smedira Quality Assurance Manager Enclosures CS/bms 8007230349
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NPI Response to Additional Information Requested by NRC With Respect to NPI QA 1.
The NPI QA program states that "The Quality Assurance Manager must have a sufficiently broad education and experience to be able to interpret the re-quirements of all regulatory agencies to all aspects of the company's opera-tions." The implementing criteria used by NPI management in the selection of QA managers are:
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(a) reasonably extensive nuclear project experience; (b) some experience in dealing with regulatory or safety require-ments; and, (c) demonstrated writing skills.
To date, NPI QA managers have been degreed engineers or scientists. While we do not intend to make a degree a requirement, most people who meet the above criteria are degreed.
The present QA Manager is a degreed nuclear engineer with 12 years of nuclear project experience. The majority of his time in the last year has been de-voted to trying to assure that company activities are in compliance with State of Maryland, Nuclear Regulatory Commission, Department of Transpor-tation, Food and Drug Administration, and other regulatory and safety re-quirements.
2.
See QA plan modification page 40.
3.
Safety related systems, structures and comp 6nents controlled by the QA program:
(a) All NPI shipping containers for radioactive materials (b) Customer teletherapy units serviced by NPI (c) Dickerson I and Dickerson II irradiators (d) Customer laminar flow equipment serviced by NPI 4.
Under the interpretation that a prototype unit is a full scale, full feature component of a system or structure to he put into service, NPI does~ not build prototype units.
Instead of prototype units, the acual system or struc ture has been built and proof tested before being placed a service.
S.
See QA plan nodification page la.
6.
NPI does not manufacture equipment. Consquently NPI identifies and controls materials, parts and components used in manufacturing through control of procurements (see Procurement Document Control, Control of Purchase and Material, Equipment, Services, Etc. in each subplan of the overall QA program).
7.
We believe this is covered in Section 17 of each subplan of the overall QA program.
l nOUTROn JRODUCTS inc
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NPI Response to Additional Information Requested by NRC With Respect to NPI QA Page Two 8.
In view of the re'lative simplicity of materials and parts important to the function of safety related systuas and components associated with NPI activ-ities, NPI does not maintain complete documentation of the actual materials and parts used in safety systems.
Instead, the, adequacy of the materials and parts used is usually readily ascertained while in service or under a routine inspection.
Documentation of the required functions of safety sys.tems is maintained.
For example, safety systems on NPI irradiators make extensive use of limit switches and relays whose performance is routinely checked. We do not verify the materials used in manufacturing the relays and switches.
We have documented the required performance of these systems.
9.
NPI management recognizes the role that good judgement of responsible em-ployees plays in making a QA program successful.
Consequently, we do not have a statement in our QA program to the effect that the method of ident-ifying an item should not affect the fit, function, or quality of the item.
To date, this has not been a problem.
10.
The comment we made with respect to item 6 above would appear to be appro-priate here also.
11, 12, 13.
Section 11 of each subplan of the overall QA plan covers special processes appropriate to that aspect of NPI operations. These subsections require procedural controls and personnel qualification as appropriate.
Section VI of the plan states that NPI shall maintain Personnel Qualifi-cation Approva) and Certification records.
14.
See QA plan modification page 41.
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