ML18270A082

Letter to P. Whaley Request for Additional Information for Review and Approval of the University of Texas at Austin Request for Part 71 Quality Assurance Program for Packaging and Transportation of Radioactive Material (W/Enclosure)

ML18270A082
Person / Time
Site:	University of Texas at Austin
Issue date:	09/26/2018
From:	Patricia Silva NRC/NMSS/DSFM/IOB
To:	Whaley P University of Texas at Austin
Roque-Cruz C
References
Download: ML18270A082 (5)

Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 September 26, 2018 Mr. Paul M. Whaley, Associate Director Nuclear Engineering Teaching Laboratory The University of Texas at Austin Austin, TX 78758

SUBJECT:

REQUEST FOR ADDITIONAL INFORMATION FOR REVIEW AND APPROVAL OF THE UNIVERSITY OF TEXAS AT AUSTIN REQUEST FOR PART 71 QUALITY ASSURANCE PROGRAM FOR PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL

Dear Mr. Whaley:

By letter dated February 5, 2018, the University of Texas at Austin submitted an application for approval of a new quality assurance (QA) program under Title 10 of the Code of Federal Regulations (10 CFR) Part 71. The request is for approval of the Nuclear Engineering Teaching Laboratory (NETLs) QA program to support shipping of TRIGA type fuel and other 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 November 30, 2018. Inform us at your earliest convenience, but no later than October 19, 2018, 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.

Please reference Docket No. 50-602 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 Ms. Carla Roque-Cruz at 301-415-1455 or email: Carla.Roque-Cruz@nrc.gov.

Sincerely,

/RA/

Patricia A. Silva, Chief Inspections and Operations Branch Division of Spent Fuel Management Office of Nuclear Material Safety and Safeguards Docket No.: 50-602

Enclosure:

Request for Additional Information

ML18270A082 *via email OFC DSFM *DSFM DSFM Name CRoque-Cruz SFigueroa PSilva Date 9/24/2018 9/24/2018 9/26/2018 Request for Additional Information The University of Texas at Austin Quality Assurance Program Facility License R-129, Docket 50-602 By letter dated February 5, 2018, the University of Texas at Austin submitted a request for approval for a Quality Assurance Program (QAP) for the Nuclear Engineering Teaching Laboratory (NETL) to support shipments of TRIGA type fuel and other radioactive material requiring a Type B package. The proposed program by the university is patterned from previously approved QAPs where shipment was accomplished utilizing the BEA Research Reactor Package [USA/9341/B(U)F-96].

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 draft NETL, QAP-T, Revision 1, dated January 22, 2018.

Section 3 Organization

1. Provide a description of how the current organization provides assurance that the required authority and organizational freedom, including sufficient independence from cost and schedule, when opposed to safety considerations, are provided.

Under the current organization chart and organization description it appears that the QAP and NETL daily operations will be performed within the operating organization. In addition, it appears that the staff performing the packaging, shipping and receiving inspections will also be responsible for implementing the QAP.

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

Section 5 Quality Assurance Program

1. Please explain the activities that will be covered by the Quality Assurance Program.

Your submittal states that this program will include activities that are important to safety for receiving, handling, loading and delivering to a carrier for transport. This submittal also states that specifically, this QAP will address the unloading of a package from a truck, receiving a loaded package and shipping an unloaded package from the NETL on a truck. This section does not mention that the QAP will address the loading of radioactive material into a package for later shipment. A 10 CFR Part 71 QAP is not required for unloading, receiving, or shipping unloaded packages.

2. Please explain how QAP procedures will be developed and who will be responsible for writing these procedures.

Section 3, Organization, states that the Reactor Oversight Committee will review and approve all written procedures. Section 5, Quality Assurance Program, states, in part, that quality assurance will be accomplished through the use of written procedures incorporating regulatory requirements, applicable portions of the NETL Health Physics Procedures, specific procedures developed by the manufacturer of the package and other procedures. Section 11, Instructions, Procedures, and Drawings, states that activities important to safety will be ensured by following manufacturers instructions, procedures, and limitations as they related to the safe use of packages. This QAP does not explain how QAP procedures will be developed.

Enclosure

2 This information is needed to determine compliance with 10 CFR 71.105.

Section 31 Nonconforming Materials, Parts, or Components

1. Please describe the program to address nonconforming material. Will nonconformance reports be developed to document the nonconformance in addition to identifying the nonconformance in the inspection report? Who will disposition the nonconforming item?

Section 31 states, in part, that any part that is damaged or unable to perform its intended function shall be identified in the inspection report. 10 CFR 71.131, Nonconforming Materials, Parts, or Components, states, in part, that procedures for identification, documentation, segregation, disposition, and notification to affected organizations must be included. Section 31 mentions the identification of the nonconformance in the inspection report for the receipt/shipping inspections but makes no mention of further documentation of the nonconformances.

2. Who will perform replacement activities for the package if a nonconformance is identified?

Section 31 states that replacement parts must be obtained from the package owner. However, Section 5, Quality Assurance Program, states that NETL does not intend to rework, repair maintain or modify the package. It is not clear if in the case of a nonconformance the package owner will provide the replacement part and NETL will be performing rework, repair or modification activities for the package.

This information is needed to determine compliance with 10 CFR 71.131.

Section 33 Corrective Actions

1. Please describe the process to correct any conditions adverse to quality identified by your QAP.

Section 33 states that conditions that are detrimental to quality will be promptly identified and reported to the NETL Associate Director (or designee). 10 CFR 71.133, Corrective Actions, states, in part, that measures shall be established to assure that conditions adverse to quality, such as deficiencies, deviations, defective material and equipment, and nonconformances, are promptly identified and corrected. Section 33 does not address how any conditions adverse to quality will be corrected.

This information is needed to determine compliance with 10 CFR 71.133.

3 Section 37 Audits

1. Please describe the training requirements for the individual chosen to perform audits.

Section 37.3, Team Selection, states in part that an independent individual will be chosen that has an understanding of the program and the requirements for compliance. 10 CFR 71.137, Audits, states that audits must be performed in accordance with written procedures or checklists by appropriately trained personnel not having direct responsibilities in the areas being audited.

This QAP does not address any training requirements or regulatory guidance to be used to assure that the audit leader and members (if necessary) are adequately trained.

This information is needed to determine compliance with 10 CFR 71.137