ML20035F236

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Forwards Request for Addl Info Re Amend to QA Program Approval for Radioactive Matl Package 0179.Info Should Be Provided 45 Days from Date of Ltr
ML20035F236
Person / Time
Site: 07100179
Issue date: 04/19/1993
From: Macdonald C
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To: Householder W
NUCLEAR CONTAINERS, INC.
References
NUDOCS 9304210068
Download: ML20035F236 (2)


Text

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APR 191993

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l IMTB: TOM 71-0179 Nuclear Containers, Inc.

ATIN: Mr. William R. Housholder President Route 9, Box 2237 Elizabethton, Tennessee 37643

Dear Mr. Housholder:

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This refers to your application dated March 24, 1993, requesting an amendment l

to your Quality Assurance (QA) Program Approval No. 0179.

In connection with l

our review, we need the information identified in the enclosure to this I

letter.

In my letter dated March 12, 1993, I requested an index by title / subject of your Standard Operating Procedures and a schedule for training of personnel on the applicable procedures to demonstrate that a documented QA program has been fully implemented. This information should also be provided.

This information should be provided within 45 days from the date of this letter.

If you have any questions regarding this matter, you may contact Thomas Matula of my staff at (301) 504-2437.

Sincerely, Original Signed by Charles E. MacDonald, Chief Transportation Branch Division of Industrial and Medical Nuclear Safety, NMSS

Enclosure:

As stated DISTRIBUTION:

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APR 191993 l

Encl. to ltr. dtd.

1 Quality Assurance Oroanization (Section 1.0)

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Quality Assurance (QA) should verify that all activities affecting quality and safety have been correctly performed.

Engineering activities are safety-i j

related and should be verified by QA. To give QA personnel direct access to i

the levels of management necessary to perform this function, it is suggested that the Organizational Chart (Figure 1) be changed to have QA on the same management level as Engineering and Operations.

It is also suggested that the l

Organizational Responsibilities (Section 1.2) be redefined to reflect this l

organizational change.

l Identify the qualification requirements for the principal QA management l

positions.

j Ouality Assurance Procram (Section 2.0)

State that personnel performing activities important to safety receive indoctrination and training commensurate with the skill levels needed, that the required training will be completed before the personnel engage in such activities, and that the proficiency of the personnel will be maintained by retraining, reexamining, and recertifying.

I Document Control (Section 6.0)

State that fabrication instructions, procedures, and drawings are distributed

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and used at the locations where the prescribed activities are performed (reference Sections 6.2.5 and 6.3.5).

Control of Purchased Materials. Eouioment & Services (Section 7.0) t g

Describe the measures established for evaluating and selecting procurement 4

sources including evaluating the supplier's capability to comply with applicable criteria of 10 CFR 71, Subpart H, the results of the survey of the supplier's facility and QA program, and the supplier's previous records and performance (reference Section 7.1.1).

Describe the role of QA in preparing, reviewing, and issuing Purchase Orders for material, equipment, and services (reference Section 7.1.1).

State that suppliers of parts and materials, as well as suppliers of fabricated products and services, will be audited at appropriate intervals (not to exceed 3 years) to assess their ability to meet the requirements imposed by Purchase Orders (reference Section 7.6.4).

Identification & Control of Materials. Parts & Components (Section 8.0)

Describe the measures which ensure that items whose shelf life or operation times have expired are identified and precluded from use.

l Corrective Action (Section 16.0) i Expand the scope of your corrective action program to include suppliers and to ensure that followup is documented to verify that corrective actions were implemented by the supplier and are effective.

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