ML19184A140: Difference between revisions

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Request for Additional Information
Request for Additional Information


ML19184A140 OFC:          DSFM              DSFM          DSFM      DSFM NAME:        TTerry        SFigueroa        JTapp    CAraguas DATE:      7/10/2019        7/10/2019      7/10/2019  7/10/2019
ML19184A140 OFC:          DSFM              DSFM          DSFM      DSFM NAME:        TTerry        SFigueroa        JTapp    CAraguas DATE:      7/10/2019        7/10/2019      7/10/2019  7/10/2019 Request for Additional Information Defense Threat Reduction Agency Docket No. 71-0958 Part 71 Quality Assurance Program By application dated April 22, 2019, the Defense Threat Reduction Agency requested approval of an amended Part 71 quality assurance (QA) program. This request for additional information (RAI) identifies information needed by the U.S. Nuclear Regulatory Commission (NRC) staff in connection with its review of the application. The requested information is listed by the section number in the quality assurance program application.
 
Request for Additional Information Defense Threat Reduction Agency Docket No. 71-0958 Part 71 Quality Assurance Program By application dated April 22, 2019, the Defense Threat Reduction Agency requested approval of an amended Part 71 quality assurance (QA) program. This request for additional information (RAI) identifies information needed by the U.S. Nuclear Regulatory Commission (NRC) staff in connection with its review of the application. The requested information is listed by the section number in the quality assurance program application.
Each individual RAI describes information needed by the staff for it to complete its review of the application and to determine whether the applicant has demonstrated compliance with the regulatory requirements.
Each individual RAI describes information needed by the staff for it to complete its review of the application and to determine whether the applicant has demonstrated compliance with the regulatory requirements.
Section 3.2 Quality Assurance Organization 3.2-1 Please include the organizational structure diagram as part of your DTRA Instruction 4540.01 Quality Assurance Program for Shipping Special Nuclear Material.
Section 3.2 Quality Assurance Organization 3.2-1 Please include the organizational structure diagram as part of your DTRA Instruction 4540.01 Quality Assurance Program for Shipping Special Nuclear Material.

Latest revision as of 08:00, 2 February 2020

Letter to S. Davis Request for Additional Information for Review of the Defense Threat Reduction Agency Amendment Request for Part 71 Quality Assurance Program for Packaging and Transportation of Fissile Material Approval
ML19184A140
Person / Time
Site: 07100958
Issue date: 07/10/2019
From: Christian Araguas
NRC/NMSS/DSFM/IOB
To: Davis S
US Dept of Defense (DOD)
Terry T
References
Download: ML19184A140 (4)


Text

July 10, 2019 Ms. Sherry J. Davis Director, ESOH Department Acquisition, Finance, & Logistics Defense Threat Reduction Agency 8725 John J. Kingman Road, Stop 6201 Fort Belvoir, VA 22060-6201

SUBJECT:

REQUEST FOR ADDITIONAL INFORMATION FOR REVIEW OF THE DEFENSE THREAT REDUCTION AGENCY AMENDMENT REQUEST FOR PART 71 QUALITY ASSURANCE PROGRAM FOR PACKAGING AND TRANSPORTATION OF FISSILE MATERIAL APPROVAL

Dear Ms. Davis:

By letter dated April 22, 2019, the Defense Threat Reduction Agency (DTRA) submitted an application for approval of an amended quality assurance (QA) program under Title 10, Code of Federal Regulations (10 CFR) Part 71. The request is for approval of DTRAs QA program to support shipping radioactive material under the 10 CFR Part 71 general license provisions.

In connection with the staffs review, we need the information identified in the enclosure to this letter. We request that you provide this information by August 30, 2019. Inform us at your earliest convenience, but no later August 2, 2019, if you are not able to provide the information by that date. To assist us in re-scheduling your review, you should include a new proposed submittal date and the reasons for the delay. Discussion of the RAIs and RAI response date occurred on July 12, 2019.

Please reference Docket No. 71-0958 in future correspondence related to this request. The staff is available to clarify these questions, and if necessary to meet and discuss your proposed responses. If you have any questions regarding this matter, please contact Tomeka Terry at 301-415-1488 or Jeremy Tapp at 301-415-8047.

Sincerely,

/RA/

Christian Araguas, Chief Inspections and Operations Branch Division of Spent Fuel Management Office of Nuclear Material Safety and Safeguards Docket No.: 71-0958

Enclosure:

Request for Additional Information

ML19184A140 OFC: DSFM DSFM DSFM DSFM NAME: TTerry SFigueroa JTapp CAraguas DATE: 7/10/2019 7/10/2019 7/10/2019 7/10/2019 Request for Additional Information Defense Threat Reduction Agency Docket No. 71-0958 Part 71 Quality Assurance Program By application dated April 22, 2019, the Defense Threat Reduction Agency requested approval of an amended Part 71 quality assurance (QA) program. This request for additional information (RAI) identifies information needed by the U.S. Nuclear Regulatory Commission (NRC) staff in connection with its review of the application. The requested information is listed by the section number in the quality assurance program application.

Each individual RAI describes information needed by the staff for it to complete its review of the application and to determine whether the applicant has demonstrated compliance with the regulatory requirements.

Section 3.2 Quality Assurance Organization 3.2-1 Please include the organizational structure diagram as part of your DTRA Instruction 4540.01 Quality Assurance Program for Shipping Special Nuclear Material.

This revision is required to verify the organizational freedom and independence from cost and schedule for the quality assurance organization and ensure this information is part of the QA program document.

This information is needed to determine compliance with 10 CFR 71.103.

Section 4.2 Control of Purchased Material, Equipment, and Services 4.2-1 Provide a description of how measures are established to assure the procured material, equipment, and services, as applicable conform to the procurement documents.

This information is required to verify, at a minimum, the adequacy of the procured transportation packaging and associated materials and equipment that is planned for use under 10 CFR Part 71. A description is also necessary for any required services, such as calibration of measuring and test equipment, that will be procured via current procedures.

This information is needed to ensure compliance with 10 CFR 71.115.

Section 4.3 Identification and Control of Materials, Parts, and Components 4.3-1 Provide a description of how measures are established to assure that quality materials, parts, and components are identified and controlled to prevent the use of incorrect of defective items.

Enclosure

This information is required to verify, at a minimum, the adequacy of the measures in place to ensure any items provided for 1) use of the packaging or 2) as replacement items are adequately identified and controlled.

This information is needed to ensure compliance with 10 CFR 71.117.

Section 4.5 Test Control 4.5-1 Provide a description of how measures are established to assure that applicable test programs are accomplished in accordance with written procedures.

This information is required to verify establishment of a test program necessary to demonstrate that the packaging will perform satisfactorily in use and follows the requirements of this part and the pertinent requirements and acceptance limits contained in the package approval.

This information is needed to ensure compliance with 10 CFR 71.123.