ML16237A439

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Texas A&M Engineering Experiment Station - Quality Assurance Program for the Model 9979 Type AF Shipping Package, Certificate Number 9979, Revision 0
ML16237A439
Person / Time
Site: Texas A&M University, 07109979
Issue date: 08/24/2016
From: Mcdeavitt S
Texas A&M Univ
To:
Document Control Desk, Office of Nuclear Material Safety and Safeguards
References
2016-0044
Download: ML16237A439 (14)
v • d • e


Text

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Dr. Sean

Director, Texas A&

Texas A&

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Mr. Marc L. Dapas, Office Director Office of Nuclear Material Safety and Safeguards United States Nuclear Reactor Commission Mr. Michael Young, President Texas A&M University 1246 TAMU College Station, TX 77843-1246 Dr. M. Katherine Banks, Vice Chancellor and Dean, Dwight Look College of Engineering 3126 TAMU College Station, TX 77843-3126 Dr. Yassin Hassan, Department Head Nuclear Engineering Texas A&M University Nuclear Engineering Department 3133 TAMU College Station, TX 77843-3133 Dr. John Hardy Reactor Safety Board Chairman Texas A&M University 3255 TAMU College Station, TX 77843-3255 Dr. Latha Vasudevan Radiological Safety Officer Texas A&M University Environmental Health and Safety 1111 Research Parkway College Station, TX 77843-4472 Mr. Jerry Newhouse, NSC Assistant Director Texas A&M Engineering Experiment Station 3575 TAMU College Station, TX 77843-3575 Mr. Scott Miller, NSC Manager of Reactor Operations Texas A&M Engineering Experiment Station 3575 TAMU College Station, TX 77843-3575 Mr. Jeremy Osborn AGN-201M Reactor Supervisor Texas A&M University Nuclear Engineering Department 3133 TAMU College Station, TX 77843-3133

Texas A&M University AGN-201M (Serial Number 106)

Facility License R-23 Facility Docket Number 50-59 Quality Assurance Program TAMU/TEES AGN-02 Revision 2 August 24, 2016

Contents

1. Introduction................................................................................................................................. 1
2. Definitions................................................................................................................................... 1 Management Organization.......................................................................................................... 1 Packages and Materials............................................................................................................... 2 Quality Assurance....................................................................................................................... 2
3. Scope and Graded Approach (U.S. NRC Regulatory Guide 7.10, Revision 3, Appendix A).... 2
4. Quality Assurance Organization (10 CFR 71.103)..................................................................... 3
5. Package Design Control (10 CFR 71.107)................................................................................. 5
6. Procurement Document Control (10 CFR 71.109)..................................................................... 5
7. Instructions, Procedures, and Drawings (10 CFR 71.111)......................................................... 5
8. Document Control (10 CFR 71.113).......................................................................................... 5
9. Control of Purchased Material, Equipment, and Services (10 CFR 71.115).............................. 6
10. Identification and Control of Materials, Parts, and Components (10 CFR 71.117)................. 6
11. Control of Special Processes (10 CFR 71.119)........................................................................ 6
12. Internal Inspection (10 CFR 71.121)........................................................................................ 7
13. Test Control (10 CFR 71.123).................................................................................................. 7
14. Control of Measuring and Test Equipment (10 CFR 71.125).................................................. 7
15. Handling, Storage, and Shipping Control (10 CFR 71.127)..................................................... 7
16. Inspection, Test, and Operating Status (10 CFR 71.129)......................................................... 8
17. Nonconforming Materials, Parts, or Components (10 CFR 71.131)........................................ 8
18. Corrective Action (10 CFR 71.133).......................................................................................... 9
19. Quality Assurance Records (10 CFR 71.135)........................................................................... 9
20. Audits (10 CFR 71.137).......................................................................................................... 10

Page 1 of 10

1. Introduction This document establishes the Texas A&M University AGN-201M Shipping Quality Assurance Program in accordance with 10 CFR 71, Subpart H. It ensures the safety of the general public during packaging and transportation of fissile materials by using 9979 Type A packages and U.S.

Department of Transportation approved Type A packages when used to meet the requirement of 10 CFR 71.

2. Definitions Notes on Definitions: Logical groupings of terms have been used rather than a strict alphabetical listing. Additional useful definitions may be found in 10 CFR 71.4, Definitions.

Management Organization Texas A&M University (TAMU) - TAMU is the organization that owns and operates the AGN-201M.

President, Texas A&M University (President) - The President is the Level 1 Manager and license holder of the TAMU AGN-201M.

Dean, College of Engineering, Texas A&M University (Dean) - The Dean shares Level 1 management responsibility with the President and is the typical Level 1 point of contact for the Department Head (Level 2 Manager).

Nuclear Engineering Department Head, Texas A&M University (Department Head) - The Department Head is the Level 2 Manager of the TAMU AGN-201M.

Director, Texas A&M Engineering Experiment Station Nuclear Science Center (Director) - The Director has been delegated the responsibilities and authority of the Level 2 Manager of the TAMU AGN-201M.

AGN-201M Reactor Supervisor, Texas A&M Engineering Experiment Station Nuclear Science Center (Reactor Supervisor) - The Reactor Supervisor is the Level 3 Manager of the TAMU AGN-201M.

Texas A&M University Reactor Safety Board (RSB)- The RSB fulfills the Technical Specification Review and Audit functions for the AGN-201M Texas A&M University System (TAMUS) - TAMUS is the governing organization over TAMU and TEES. Program compliance and records retention policies are established by TAMUS.

Page 2 of 10 Packages and Materials Licensed Material - Byproduct, source, or special nuclear material received, possessed, used, or transferred under a general or specific license issued by the Nuclear Regulatory Commission (NRC) pursuant to the regulations in Title 10, Chapter I, of the Code of Federal Regulations.

Packaging - The assembly of components necessary to ensure compliance with the packaging requirements of 10 CFR 71. It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system, and auxiliary equipment may be designated as part of the packaging.

Package - The packaging together with its radioactive contents as presented for transport.

Type A Quantity - A quantity of radioactive material, the aggregate radioactivity of which does not exceed A1 for special form radioactive material, or A2, for normal form radioactive material, where A1 and A2 are given in Table A-1 of 10 CFR 71, or may be determined by procedures described in Appendix A of 10 CFR 71.

Type A Package - A Type A packaging together with its radioactive contents. A Type A package is defined and must comply with the U.S. Department of Transportation regulations in 49 CFR 173.

Type AF Package - A fissile material packaging together with its fissile material contents.

Quality Assurance Certificate of Compliance - The certificate issued by the Nuclear Regulatory Commission under 10 CFR 71, Subpart D, which approves the design of a package for the transportation of radioactive material.

Quality Assurance - All planned and systematic actions necessary to provide adequate confidence that a system or component will perform satisfactorily in service. It includes quality control, which comprises quality assurance actions related to control of the physical characteristics and quality of the material or component to predetermined requirements.

Quality Assurance Program (QA Program) - A program that satisfies each of the applicable criteria of 10 CFR 71.101 through 71.137 and satisfies any specific provisions that are applicable to the licensees activities including procurement of packaging.

3. Scope and Graded Approach (U.S. NRC Regulatory Guide 7.10, Revision 3, Appendix A)

The TAMU QA Program establishes requirements applicable to the procurement, use, maintenance, and repair of packaging used to transport licensed material of Type A quantity.

The graded approach to safety described by U.S. NRC Regulatory Guide 7.10, Revision 3,

Page 3 of 10 Appendix A was used to develop the program. Based on this graded approach, all aspects of this program fall into Category B.

The program includes the organization, design, procurement, documentation, handling, storing, assembly, inspection, testing, operation, maintenance, repair, and shipping of packages. The TAMU QA Program applies to the activities that affect the packages and the package components that are significant to safety. Packages regulated by 10 CFR 71 may be released for shipping after the TAMU QA Program requirements have been met. U.S. Department of Transportation Type A packages used to fulfill the requirements of 10 CFR 71.23 are also subject to the TAMU QA Program.

TAMU does not design or fabricate Type A or Type AF packages or packaging. Therefore, the TAMU QA Program requires vendor-supplied Certificates of Compliance and supporting documentation for packaging provided by the supplier for transporting material of Type A quantity.

Training is provided by TAMU to the members of the quality assurance organization prior to performing quality assurance activities to ensure they are qualified to perform those activities.

Members of the quality assurance organization shall receive updated training as revisions to quality assurance procedures are implemented.

The TAMU Reactor Safety Board is responsible for reviewing the TAMU QA Program. The AGN-201M license holder, the President of TAMU, is responsible for the overall effectiveness of the TAMU QA Program. As noted in Section 4, the President shares Level 1 management jurisdiction with the Dean of the College of Engineering. The responsibility to implement this QA program is delegated to the the NSC Director (Level 2 management). All personnel involved in shipping licensed material shall follow the TAMU QA Program.

The document TAMU/TEES AGN-03 describes the QA work package that indicates how the QA program will be implemented.

All shipments of licensed material must be reviewed and approved by designated QA personnel from the TAMU Environmental Health & Safety Department.

4. Quality Assurance Organization (10 CFR 71.103)

The AGN-201M organization chart can be found in Figure 1 on the following page. Any TAMU QA Program trained TAMU Nuclear Engineering staff, Texas A&M Engineering Experiment Station Nuclear Science Center staff, or support contractors may perform functions under the TAMU QA Program. The President delegates the work of establishing and executing the TAMU QA Program to the Director, but shall retain responsibility for the program. The Director shall ensure that measures are established to provide adequate control over all quality-related activities.

The duties and qualifications of principal personnel performing quality assurance functions shall be established and documented in the QA records.

Individua work, de solutions level man als performin livery, or ins s; verify imp nagement, w ng QA funct stallation of lementation who can ensu Figure tions have th nonconform of solutions ure completio e 1: AGN-20 he responsib ming materia s; and have d on of quality 01M Organ ility and aut als; initiate, r direct access y-related act nization Cha thority to sto recommend, s to the Direc tivities.

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Page 5 of 10

5. Package Design Control (10 CFR 71.107)

TAMU is only a user of packaging and shall not perform design activities. However, TAMU shall ensure packaging design was accomplished in a way that satisfies the requirements of 10 CFR 71.107. This is accomplished by requiring the packaging supplier to submit documented proof (e.g., drawings, specifications) that the package design satisfies the requirements of 10 CFR 71.107. Deviation from the requirements of 10 CFR 71.107 shall be investigated and may be grounds for rejecting the package design. This documentation shall be kept in the QA records.

6. Procurement Document Control (10 CFR 71.109)

Procurement documents for material, equipment, and services shall include sufficient information to ensure adequate quality. This is done by ensuring the procurement documents identify applicable Subpart H requirements in the 10CFR 71 regulations. If procurement is performed by contractors or subcontractors, then they shall provide a QA Program consistent with the applicable provisions of 10 CFR 71.

If safety-related replacement parts are required to be procured for packaging, the Director shall designate QA personnel to ensure that appropriate technical and QA requirements are included in purchase orders and that the purchase orders are placed with suppliers qualified to supply the required parts. Procurement is made in consultation with the package owner. Any revisions or changes to procurement documents are subject to the same requirements as the original documents.

7. Instructions, Procedures, and Drawings (10 CFR 71.111)

The Director shall prescribe activities affecting quality by documented instructions, procedures, or drawings of a type appropriate to the circumstances and shall require that these instructions, procedures, and drawings be followed. The instructions, procedures, and drawings must include appropriate quantitative and/or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished.

If repair or maintenance is required to be performed on packaging, a written procedure shall be followed in coordination with the package owner and the repair or maintenance shall be performed by qualified personnel. This procedure shall incorporate appropriate inspection and test points. Any procedures for repair or maintenance shall be reviewed by designated QA personnel (both TAMU and supplier) to verify that the procedures address the characteristics important to safety.

8. Document Control (10 CFR 71.113)

All of the documents under the control of the TAMU QA Program shall be identified by a unique document number. Documents, including changes to documents, may only be issued by

Page 6 of 10 designated QA personnel. These personnel shall review the documents for adequacy, approve release of the documents, and distribute the documents at the location they are used.

9. Control of Purchased Material, Equipment, and Services (10 CFR 71.115)

Designated QA personnel shall take the necessary measures to ensure that purchased material, equipment, and services, whether purchased directly or through contractors and subcontractors, conform to the procurement requirements. Documentary evidence that the purchased material, equipment, or services conform to the procurement specifications shall be supplied with the packaging. This documentary evidence shall be retained and be sufficient to identify the specific requirements met by the purchased material, equipment, or services.

Packaging inspections shall be performed upon receipt by designated QA personnel to verify compliance with procurement documentation. The criteria for acceptance of each of these inspections, and actions to be taken if non-compliance is discovered, shall be determined in accordance with approved procedures.

Measures shall be established to control items until released for use, as well as measures for properly disposing rejected items.

10. Identification and Control of Materials, Parts, and Components (10 CFR 71.117)

Designated QA personnel shall ensure that materials, parts, and components used for Type A and Type AF packages, including those used for repair, are adequately identified and controlled to prevent use of incorrect or defective items. Where replacement of limited-life items is specified, measures shall be taken to ensure the shelf life or operation times of the replacement have not expired.

11. Control of Special Processes (10 CFR 71.119)

Special processes are not normally performed by the users of packaging. However, if packaging requires major repairs necessitating the use of these processes, designated QA personnel shall ensure that controls are followed for special processes subject to the following criteria:

1. procedures, equipment, and personnel are qualified in accordance with applicable codes, standards, and specifications;
2. the processes are performed by qualified personnel and accomplished in accordance with written procedures with recorded evidence of verification; and
3. qualification records of procedures, equipment, and personnel are established, filed, and kept current.

No special processes shall be undertaken without coordination between the packaging owner and TAMU QA personnel, and those processes shall be performed in accordance with QA procedures established by the packaging owner.

Page 7 of 10

12. Internal Inspection (10 CFR 71.121)

Conformance with the documented instructions, procedures, or drawings for accomplishing activities affecting quality shall be verified by designated QA personnel other than those who performed the activity being inspected. Activities expected to require internal inspection include:

1. package assembly;
2. shipping paperwork completion; and
3. package marking in accordance with U.S. Department of Transportation regulations.
13. Test Control (10 CFR 71.123)

A test program for packaging components comprised of written procedures shall be established to ensure they shall perform satisfactorily in service; this will be documented in the QA Work Package TAMU/TEES AGN-03. These written procedures shall incorporate the following:

1. the acceptance limits contained in the package approval;
2. provisions for assuring that all prerequisites for a given test have been met;
3. use of adequate test instrumentation; and
4. a requirement that the test be performed under suitable environmental conditions.

Test results shall be documented and evaluated by designated QA personnel to ensure that test requirements have been satisfied prior to delivering packages for transport to a carrier. Tests should consider the following, as applicable to the specific package design:

1. structural integrity; and
2. component performance (e.g. torque requirements, pressure relief device, and gaskets).
14. Control of Measuring and Test Equipment (10 CFR 71.125)

Designated QA personnel shall ensure that all instruments, gauges, and other measuring and testing devices used in activities affecting quality shall be properly controlled, calibrated (if necessary), and adjusted at specific times to maintain accuracy within necessary limits. This includes measuring and test equipment used for maintenance of safety-related items. Inspection and test equipment shall be tagged or labeled to indicate the date of the next planned calibration.

All calibration data shall be maintained with facility records or be readily traceable.

15. Handling, Storage, and Shipping Control (10 CFR 71.127)

Handling, storage, and shipping of Type A and Type AF packaging shall be controlled to ensure safety while minimizing degradation, damage, or loss.

The following measures shall be taken when handling or storing packages:

Page 8 of 10

1. if packaging requires special handling or lifting equipment, such equipment shall be used to move packaging from one location to another;
2. as required, special handling or storage provisions for packaging (e.g., closure assemblies in place, tags or markings to adequately protect and identify critical components) shall be specified and provided;
3. as required, special protective environments (e.g., climate controlled, air quality requirements) shall be specified and provided; and
4. all conditions specified in the certificate of compliance shall be adhered to when unloading packaging.

The following measures shall be taken when preparing a package for shipment:

1. cavities within the packaging are in the proper condition to receive licensed material;
2. specified operations, inspections, and tests are complete prior to delivery to a carrier;
3. U.S. NRC and U.S. Department of Transportation requirements are satisfied prior to delivery to a carrier; and
4. necessary shipping paperwork are prepared as required.
16. Inspection, Test, and Operating Status (10 CFR 71.129)

A tag, label, marking, log entry, or other documentation shall indicate the status of the Type A and Type AF shipping containers. The quality assurance records shall indicate when periodic surveillance tests have been performed. No deviation from the required inspections, tests, or other critical operations is authorized without the approval of the Director.

17. Nonconforming Materials, Parts, or Components (10 CFR 71.131)

Designated QA personnel shall ensure established measures are followed to control materials, parts, or components which do not conform to specified requirements in order to prevent their inadvertent use or installation. All materials, parts, or components for use by TAMU which must be quality controlled, shall be inspected upon receipt by designated QA personnel. The response procedure for nonconforming items shall include:

1. proper identification of the item and any nonconformance;
2. documentation of the incident of nonconformance;
3. segregation of the nonconforming item from other items;
4. disposition of the nonconforming item; and
5. notification to affected organizations.

All nonconforming items shall be placed in designated and controlled hold areas until proper disposition is completed. Nonconforming items shall be reviewed and either accepted, rejected, repaired, or reworked in accordance with documented procedures. The acceptability of nonconforming items as is, or after designated repair or rework has been completed shall be verified by designated QA personnel by re-inspecting or re-testing the item against the original requirements.

Page 9 of 10

18. Corrective Action (10 CFR 71.133)

For activities important to safety involving use, maintenance, or repair of Type A and Type AF packages, designated QA personnel shall ensure conditions adverse to quality (i.e., those resulting from failures, malfunctions, deficiencies, deviations, defective material or equipment, or other sources) are promptly identified and reported to the appropriate level of management. In the case of a significant condition adverse to quality, the root cause of the condition shall be determined and corrective actions taken to prevent recurrence.

19. Quality Assurance Records (10 CFR 71.135)

Written instructions shall be developed to establish a records retention program, and these instructions shall be included with the records. The records retention program shall include the following features:

1. the records shall be maintained at least three years after the last activity is complete for which the TAMU QA Program was developed and in compliance with the Texas A&M University System (TAMUS) Record Retention Policy;
2. a location where the records shall be stored and a storage method that ensures the records are retrievable;
3. an assignment of responsibility for the records; and
4. if any portion of the TAMU QA Program, written procedures, or instructions are superseded, the superseded material shall be retained for three years after it is superseded.

The following records shall be retained in accordance with 10 CFR 71.135:

1. the duties and qualifications of principal personnel performing quality related functions required by 10 CFR 71.103;
2. documentation of changes to the TAMU QA Program made under 10 CFR 71.106;
3. documented proof (e.g. drawings, specifications) from the packaging supplier that the packaging design satisfies the requirements of 10 CFR 71.107;
4. copies of procurement records required by 10 CFR 71.109;
5. the instructions, procedures, and drawings required by 10 CFR 71.111 to prescribe quality assurance activities, and closely related specifications;
6. documentary evidence from the supplier that material, equipment, and services meet the specifications of the procurement documents required by 10 CFR 71.115;
7. receipt inspection of materials required by 10 CFR 71.115;
8. identification records for materials, parts, and components used for Type A and Type AF packages required by 10 CFR 71.117;
9. qualification records of procedures, equipment, and personnel for special processes required by 10 CFR 71.119;
10. internal inspection records required by 10 CFR 71.121;
11. all calibration data for instruments, gauges, and other measuring and testing devices used in activities affecting quality required by 10 CFR 71.125;
12. handling, storage, and shipping records required by 10 CFR 71.127;
13. dates when periodic surveillance tests have been performed required by 10 CFR 71.129;

Page 10 of 10

14. nonconforming materials, parts or components incident, disposition, and review outcome records required by 10 CFR 71.131;
15. records of corrective actions required by 10 CFR 71.133; and
16. audit records required by 10 CFR 71.137.
20. Audits (10 CFR 71.137)

Audits of the TAMU QA Program shall be completed annually to verify compliance with all aspects of the program and to determine its effectiveness. The audits must be performed in accordance with written procedures or checklists by members or representatives of the Reactor Safety Board, but not by staff having direct responsibilities in the areas being audited. Audit results must be documented and reviewed by AGN management having responsibility in the area audited. Follow up action, including re-audit of deficient areas, must be taken where indicated.

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