ML19339B837
| ML19339B837 | |
| Person / Time | |
|---|---|
| Site: | 07100121 |
| Issue date: | 10/17/1980 |
| From: | Smedira C NEUTRON PRODUCTS, INC. |
| To: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML19339B838 | List: |
| References | |
| 17647, NUDOCS 8011100245 | |
| Download: ML19339B837 (3) | |
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October 17, 198e yfs Y,$i,,.
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y Mr. Charles E. MacDonald, Chief Transoortation Certification Branch Divis' ion of Fuel Cycle and Material
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Safety, 5N. SS U. S. Nuclear Regulatory Commission y
Washington, D. C.
20555
Dear Mr. MacDonald:
On October 16, 1930, Neutron Products revised its current Quality Assurance Program. The present version, Revision 4 differs from the previously sub-sitted version, Revision I, as follows:
1.
The organi::stion chart in Figure 1 has been modified by deleting the nane of a secretary and by changing the name of the Manager for Laminar Flow Technology.
2.
On page 2, a paragraph has been added to acknowledge the fact that the company now plans to market a radiation therapy computer.
3.
As a result of the company's decision to terminate our plans to market simulators and to begin to market Biotest Air Samplers, the first full paragraph on Page 3 was changed to read:
" Bio-test Air Sampler - an air sampler which measures bacteria con-tent in the air in a specific location."
4.
On Page 4, a typographical error was corrected. The word "special" (in the heading for Part V) should have been " specific".
5.
On page 8, the entire first paragraph under 1.1.15, Handling, Storage, Distributing, Shipping and Installation, has been deleted in its entirety.
6.
On page 9, the word " labeled" has been changed to " identifiable" in Section 1.1.19.
7.
The word " sources" in the definition of Teletherapy Slugs on page 10 has -
' '-ted.
8.
Under Handhng, brorage, Distributing, Shipping and Installation on page 12, Procedures R 2003, General Procedure for In-Pool Source Operations; NR 2005, Procedure for Decanning Cobalt-60 Sources from Zircaloy Tubes; and NR 2008, Procedure for Placing and Unioading Casks in the Main Storage Pool have been incor-porated in the first paragraph.
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ihr. Charles E. MacDonald U. S. Nuclear Regulatory Commission Page Two The second paragraph has been revised to read: " Target rods shall be stored in the main storage pool."
9.
On page 12, the word " disposal" has been changed to " disposition" at the end of the paragraph on Nonconforming Parts.
10.
The word " labeled" has been changed to " identifiable" in the sentence under Packaging and Labeling on page 13.
11.
Under Special Processes on page 15, the NPI Specifications referred to are P-1, P-3, and P-4 instead of P-2, P-3, and P-4.
12.
On page 15, NPI Specification P-4, Procedure for Encajsulation of Teletherapy Sources has been incorporated in both 1.3.12 Inspection and 1.3.13 Test Control.
- 13. The paragraph under Control of Measuring and Test Equipment on page 15 has been changed to read: " Equipment for calibrating activity in industrial sources shall be in accordance with NPI Procedure R 2007.
14.
The Handling and Storage of Sources on page 15 now includes Pro-cedures NR 2002, R 2003, NR 2005, R 2006, R 2007, R.4000, R 5001, NR 5002, NR 5003, R 5004, R 5006, and NR 5007.
15.
The word " disposal" has been changed to " disposition" on page 15 under Nonconforming Materials.
- 16. The definition of " Quality" on page 25 now incorporstes the phrase
....under appropriate environmental conditions and..."
17.
On page 40, the following paragraph was added to the text:
"The NPI Quality Assurance Program (this document) will be revised as the need is determined. Changes (revisions) to this document must be approved by both the QA Manager and the President of the cca-pany. Any employee may propose a change by submitting his suggested revision to either the QA Manager or the company President."
- 13. The following paragraph was added at the end of page 43: "Inspec-tions and audits may be performed on as,ects of the company's oper-ations by regulatory authorities or custcmer epresentatives. When-ever this occurs, the President of the compan-and/or the Quality Assurance Manager shall have ar exit interview with the auditor and the QA Manager shall make sure a written record of the auditor's findings is made. Appropriate corrective actions shall be deter-mined and documented."
neuanon anooucrs inc
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Str. Charles E. MacDonald U. S. Nuclear Regulatory Comissien -
Page, Three 1
Attached to this letter are seven copies of the changed pages.
If there are any
- uestions or problems associated with this action, please do not hesitate to call se at 301/428-8919.
j Sincerely, NEUTRON PRODUCTS, INC.
($a.suu.'a b.-<-.k i
Carmine Smedira Quality Assurance Manager i
Enclosures CS/ bas 1
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