ML26005A083
| ML26005A083 | |
| Person / Time | |
|---|---|
| Site: | 07100040 |
| Issue date: | 01/12/2026 |
| From: | Gerond George NRC/NMSS/DFM/IOB |
| To: | Hieber J QSA Global |
| References | |
| IR 2025201 | |
| Download: ML26005A083 (0) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 205550001 John Hieber Quality Assurance Manager QSA Global International, Inc.
40 North Avenue Burlington, MA 01803
SUBJECT:
QSA GLOBAL INTERNATIONAL, INC. - U.S. NUCLEAR REGULATORY COMMISSION INSPECTION REPORT NO. 71-0040/2025201
Dear Mr. John Hieber:
This letter refers to the U.S. Nuclear Regulatory Commission (NRC) team inspection conducted on September 8 to September 11, 2025, at the QSA Global International, Inc. (QSA) corporate office facility in Burlington, Massachusetts. The purpose of the inspection was to verify and assess the adequacy of your transportation packaging activities related to design, modification, fabrication, assembly, testing, procurement, repair, and maintenance and to determine whether QSA performed these activities in accordance with the requirements of Title 10 of the Code of Federal Regulations (10 CFR) Part 71, Packaging and Transportation of Radioactive Material, and 10 CFR Part 21, Reporting of Defects and Noncompliance. The enclosed report presents the results of this inspection as discussed during our final exit meeting on September 11, 2025.
This inspection examined activities conducted under your license as they relate to public health and safety, and to confirm compliance with the Commission's rules and regulations and with the conditions of your certificates of compliance. The inspection consisted of selected examinations of procedures and representative records, observations of activities, and interviews with personnel.
Based on the results of the inspection, the NRC inspection team determined that one Severity Level IV violation of NRC requirements occurred with multiple examples. The team evaluated the violation in accordance with the NRC Enforcement Policy. The current Enforcement Policy is included on the NRC's website at (https://www.nrc.gov/about-nrc/regulatory/enforcement). The violation is cited in the enclosed Notice of Violation (Notice) and the subject inspection report describes in detail the circumstances surrounding the violation. The team cited the violation in the Notice since the NRC identified the violation, and the violation was repetitive because of inadequate corrective actions from a previous NRC identified violation described in Inspection Report 71-0040/2019-201 (ADAMS Accession No. ML19338C286). This is consistent with criteria contained in Section 2.3.2 of the Enforcement Policy.
January 12, 2026
J. Hieber You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. If you have additional information that you believe the NRC should consider, you may provide it in your response to the Notice. The NRC review of your response to the Notice will also determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.
In accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding, a copy of this letter, its enclosure, and your response (if any), will be made available electronically for public inspection in the NRC Public Document Room (PDR) or from the NRC's Agencywide Documents Access and Management System (ADAMS). ADAMS is accessible from the NRC website at http://www.nrc.gov/reading-rm/adams.html. The PDR is open by appointment. To make an appointment to visit the PDR, please send an email to PDR.Resource@nrc.gov or call 1800-3974209 or 301415-4737, between 8 a.m. and 4 p.m. eastern time (ET), Monday through Friday, except Federal holidays.
Sincerely, Gerond George, Chief Inspection and Oversight Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards Docket No. 710040
Enclosures:
- 1. Inspection Report No. 710040/2025201
- 2. Notice of Violation Signed by George, Gerond on 01/12/26
ML26005A083 OFFICE NMSS/DFM NMSS/DFM NMSS/DFM NAME MDavis JGoodridge GGeorge DATE 1/5/2026 1/6/2026 1/12/2026 U.S. NUCLEAR REGULATORY COMMISSION Office of Nuclear Material Safety and Safeguards Division of Fuel Management Inspection Report Docket:
710040 Report:
71-0040/2025201 Enterprise Identifier: I-2025-201-0042 (QSA Global)
Certificate Holder:
QSA Global International, Inc.
Facility:
Corporate Office Location:
Burlington, MA Inspection Dates:
September 8, 2025, through September 11, 2025 Inspection Team:
Marlone Davis, Senior Transportation and Storage Safety Inspector, Team Leader Jeremy Tapp, Senior Transportation and Storage Safety Inspector Raju Patel, Transportation and Storage Safety Inspector Christian Murphy, Transportation and Storage Safety Inspector (Training)
Laine (Grace) Pennington, Nuclear Regulator Apprenticeship Network Approved by:
Gerond George, Chief Inspection and Oversight Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards
SUMMARY
QSA Global International, Inc.
NRC Inspection Report 710040/2025201 From September 8 to September 11, 2025, the U.S. Nuclear Regulatory Commission (NRC) conducted a planned inspection at the QSA Global International, Inc. (QSA) corporate office facility in Burlington, Massachusetts. The purpose of the inspection was to verify and assess the adequacy of QSA transportation packaging activities related to design, modification, fabrication, assembly, testing, procurement, repair, and maintenance. The NRC objective was to determine whether QSA performed these activities in accordance with the requirements of Title 10 of the Code of Federal Regulations (10 CFR) Part 71, Packaging and Transportation of Radioactive Material, and 10 CFR Part 21, Reporting of Defects and Noncompliance. The enclosed report presents the results of this inspection as discussed during a final exit meeting on September 11, 2025.
QSA, previously called Technical Operations, AEA Technology, and Amersham Corporation, received an initial NRC approval of their Quality Assurance Program Description (QAPD) in October 1974 under Docket No. 71-0040. QSA submitted updates to the QAPD on several application dates alone with name changes based on updated guidance and regulatory requirements. The NRC issued a new form 311, revision 21, dated August 6, 2015, as a part of the rule change to include 10 CFR 71.106(b) to request licensees to submit 24-month reports for changes to their QAPD. QSA submitted their latest QAPD Quality System Manual, QSM-1, Revision 15, dated August 3, 2025 (Agencywide Documents Access and Management System
[ADAMS] Accession No. ML25218A141) to the NRC. As of September of 2025, QSA maintains seven certificates of compliance (CoCs) for radioactive material transportation packages as shown in Table 1 below.
Table 1 - QSAs CoC Holder Transportation Packages Model #
Docket Number Package Identification#
Revision #
702 71-6613 USA/6613/B(U)F-96 22 865 71-9187 USA/9187/B(U)F-96 13 650L 71-9269 USA/9269/B(U)F-96 14 880 Series 71-9296 USA/9296/B(U)F-96 12 976 Series 71-9314 USA/9314/B(U)F-96 11 SENTRY 71-9357 USA/9357/B(U)F-96 7
360 71-9371 USA/9371/B(U)F-96 4
Based on the results of the inspection, the NRC inspection team determined that one Severity Level IV violation of NRC requirements occurred with multiple examples. The team evaluated the violation in accordance with the NRC Enforcement Policy. The violation is cited in the enclosed Notice of Violation (Notice), and the subject inspection report describes in detail the circumstances surrounding the violation and the scope of the inspection. The team cited the notice of violation (NOV) in the Notice since the violation was repetitive because of inadequate corrective action, and the NRC identified the violation. This is consistent with criteria contained in Section 2.3.2 of the Enforcement Policy.
List of Findings and Violations Additional Tracking Items None.
Failure to Promptly Identify and Correct Conditions Adverse to Quality Related to Procurement of Important to Safety Components and Services.
Report Section Severity Level IV NOV 07100040/2025201-01 OPEN 86001 The team identified a Severity Level IV Violation of 10 CFR 71.133 Corrective Action, because the certificate holder (QSA) did not establish measures to assure that conditions adverse to quality, such as deficiencies, deviations, defective material and equipment, and nonconformances, are promptly identified and corrected. Specifically, QSA did not identify, and correct QSAs program deficiencies related to their oversight of approved suppliers and procurement processes for commercial grade dedication (CGD) of important to safety items and services. The certificate holder failed to correct these similar issues that were previously identified as NRC violations in NRC inspection report 71-0040/2019-201 (ML19338C286).
INSPECTION SCOPES An NRC team of inspectors (team) conducted an inspection using applicable portions of inspection procedure (IP) 86001, Design, Fabrication, Testing, and Maintenance of Transportation Packaging, which is an approved IP located on the NRCs public website at http://www.nrc.gov/reading-rm/doc-collections/insp-manual/inspection-procedure/index.html.
This public website provides the locations for NRCs updated inspection procedures.
As part of this inspection, the team selected samples of QSAs procedures and records, observed activities, and interviewed personnel to assess QSAs performance and compliance with the Commission rules and regulations, license conditions, quality procedures, and applicable standards. The team completed the inspection when the objectives of the IP were met, which is consistent with the NRCs Inspection Manual Chapter (IMC) 2690, Inspection Program for Storage of Spent Reactor Fuel and Reactor-Related Greater-Than-Class C Waste at Independent Spent Fuel Storage Installations and for 10 CFR Part 71 Transportation Packagings.
Quality Assurance Program (IP Section 02.02)
The team reviewed QSAs Quality System Manual and associated implementing procedures to verify and evaluate the effectiveness of the Quality Assurance Program (QAP) implementation.
The team performed reviews of the quality program, policies, and procedures, and discussed portions of these documents with selected personnel to determine whether QSA adequately controlled and implemented activities subject to 10 CFR Part 71 regulations. The team also reviewed the previous revision of the QAP to determine if QSA made changes without prior NRC review and approval and to determine whether QSA performed the changes in accordance with the requirements of 10 CFR 71.106.
The team reviewed the QAP authorities and responsibilities to determine if these attributes were clearly defined and documented, and the quality assurance (QA) organization functioned as an independent group. In addition, the team reviewed the QAP to determine if commercial grade dedication activities are performed by QSA. The team reviewed QSAs graded approach to quality as documented in the QAP to verify QSA identified ITS components in its packaging designs in a graded approach and implemented, as applicable.
10 CFR Part 21 (IP Section 02.03)
The team reviewed QSAs implementing quality procedures to verify whether provisions were in place for reporting defects that could cause a substantial safety hazard from the nonconformances, and condition reports (CRs) identified. The team reviewed selected records and interviewed personnel to verify that QSA effectively implemented a nonconformance control program in accordance with their NRC-approved QAP and the requirements of 10 CFR Part 21.
The team requested a list of 10 CFR Part 21 evaluations and notifications associated with any transportation activities and interviewed personnel to verify if QSA was familiar with the implementing procedure. The team also reviewed postings within the facility to determine whether QSA complied with 10 CFR 21.6, "Posting requirements."
Design Control (IP Section 02.04)
The team interviewed personnel and reviewed selected design documentation to determine if QSA implemented adequate design controls. The team reviewed selected drawings, procedures, and records, and observed activities to determine if fabrication, test, and maintenance activities met design specifications identified in the safety analysis report (SAR) and CoCs.
The team conducted interviews with design engineering personnel to review the design change process, including the initiation, analysis, verification, and approval of engineering request form (ERF). The team reviewed a sample of ERFs and design documentation associated with the new Ecosystem Iridium Projector 1100 series, Model 880 Series, and Sentry including justification for safety classification of components. The team also reviewed QSAs design review process and associated documentation, including the sequence of internal design review meetings from design concept initiation to final design reviews to ensure conformance with quality procedures. This included the review of design controls that were in place for the transmittal and handling of design drawings transitioned from design to fabrication. The inspectors also evaluated the process for distributing the controlled engineering drawings.
Additionally, as a part of the design review, the team reviewed how QSA controlled software used in ITS applications.
Fabrication and Maintenance Activities (IP Section 02.05)
Fabrication The team reviewed selected drawings and records and interviewed personnel to verify that the procurement specifications for fabrication and maintenance materials, equipment, and services met applicable design requirements. The team evaluated the fabrication process to ensure that QSA controlled and verified the process from the onset of design through the completion of the manufacturing process. The team reviewed QSAs fabrication and maintenance controls to verify that QSA controlled and implemented all fabrication and maintenance activities for the transportation packagings in accordance with their NRC-approved QAP, SARs and CoCs.
The team reviewed the fabrication and maintenance controls for the 880 Series and SENTRY 330 models. This review included activities concerning fabrication travelers (route card), special processes including welding, assembly, cleaning, and storage, as applicable. The inspection included the review of inspection requirements, acceptance criteria, test conditions, test documentation, nondestructive examination controls, and QA hold points contained in the route cards.
Maintenance The inspectors observed maintenance activities performed on the Model 880 Series projector to verify that QSA personnel performed maintenance activities according to prescribed procedures and the acceptance criteria contained on the route card and in the SAR. The maintenance activity included a borescope inspection and assembly of a Model 880 projector.
The team also evaluated annual maintenance activities conducted at QSA for the previous five years. The team reviewed the maintenance requirements identified in the SAR, maintenance procedures, completed maintenance records, and personnel and qualification training records.
Assembly and Testing (IP Section 02.06)
The team observed activities affecting safety aspects of the packagings (i.e. fabrication, assembly, and testing) to verify that QSA performed these activities in accordance with approved methods, procedures, and specifications. The team observed QSA performing a mock sealed source welding and testing of a capsule. The team also observed the assembly and testing associated with the maintenance of the Model 880D Series projector to verify that QSA personnel followed the protocols and procedures associated with the demonstration.
Measuring and Test Equipment The team reviewed the control of measuring and test equipment (M&TE) control program to evaluate how QSA identified, specified, and controlled tools and equipment in accordance with applicable standards and regulatory requirements. The team selected a sample of M&TE such as a pressure gage, torque wrench, No-go ring gage, and micrometer. The team reviewed the calibration records to verify calibration dates, testing standards, and traceability of the associated M&TE.
Procurement (IP Section 02.07)
The team reviewed selected drawings and records, and interviewed selected personnel, to verify that the procurement specifications for the materials, equipment, and services met the design requirements and quality implementing procedures. Specifically, the team reviewed the procurement records, material traceability documents, drawings and procedures, shelf life of the components, and the receipt inspection program. The scope of the review included POs involving ITS Category A components associated with the Model 880 Series projector and the SENTRY 330 transportation packagings. The review included items such as the lock slide, selector ring retainer, socket head cap screw, end plate, security screw, and the hex-head stainless steel bolt. In addition to the items reviewed, the team confirmed that the vendors for were on QSAs approved suppliers list. The team interviewed QSA employees who authored POs and received quality related items contained in the documents reviewed.
The team also reviewed a sample of QSAs POs for calibration services.
Nonconformance and Corrective Action (IP Section 02.08)
The team reviewed selected records and interviewed selected personnel to verify that a nonconformance control program is effectively implemented, and that corrective actions for identified deficiencies are technically sound and completed in a timely manner. The review included an evaluation of how QSAs nonconformance control program and corrective action program addressed materials, parts, and components that do not conform to requirements and identified quality deficiencies. The team also reviewed provisions for reporting defects that could cause a substantial safety hazard within these programs.
Specifically, the team reviewed a sample of nonconformance reports (NCRs) and CRs since the last NRC inspection in 2019 (ML19338C286), including a CR generated because of a previous NRC identified violation to ensure adequate corrective actions were implemented to correct the issues.
The team focused the NCR review on use-asis and repair type dispositions to evaluate how QSA technically justified the approved dispositions. The CRs were reviewed to determine whether QSA completed corrective actions for identified deficiencies in a technically sound and timely manner, including assessment of reporting in accordance with 10 CFR Part 21 and 10 CFR Part 71 requirements. The team also reviewed two 10 CFR 71.95 reports initiated by QSA since the last inspection in 2019, to determine whether QSA had addressed and resolved the issues through the corrective action program (CAP) in a timely manner.
Personnel Training and Quality Assurance Oversight (IP Section 02.09)
The team reviewed selected records and procedures, interviewed selected personnel, and observed selected activities affecting the safety aspects of the packaging to verify that QSA properly trained and qualified individuals performing activities affecting quality and that the management and the quality assurance staff provided appropriate oversight. The team reviewed the records of two selected quality inspectors and one welder that performed maintenance and welding, respectively.
Audit Program (IP Section 02.10)
The team reviewed the QSA audit program to determine whether QSA scheduled, planned, and performed internal audits in accordance with applicable regulations and their QAP requirements.
The team reviewed a sample of internal audits conducted between 2021 and 2024 to determine if QSA audited all applicable QAP elements as required and in accordance with the established audit schedules.
The team reviewed a sample of external audits and supplier evaluations for the suppliers of procured components and services to determine if QSA audited each supplier and performed an annual assessment for continued placement on the QSAs qualified suppliers list.
Additionally, the team reviewed all audits for identified findings and whether QSA entered the findings into their CAP as required, and if QSA closed findings during the same audit or in the subsequent audits, as documented in the applicable audit report.
INSPECTION RESULTS Failure to Promptly Identify and Correct Conditions Adverse to Quality Related to Procurement of Important to Safety Components and Services.
Report Section Severity Level IV NOV 07200040/2025201-01 Open 86001 The team identified a Severity Level IV Violation of 10 CFR 71.133, Corrective action, which requires, in part, that the certificate holder (QSA) establish measures to assure that conditions adverse to quality, such as deficiencies, deviations, defective material and equipment, and nonconformances, are promptly identified and corrected. Specifically, QSA did not identify, and correct QSAs program deficiencies related to their oversight of approved suppliers and the procurement process for CGD of ITS items and services. The certificate holder failed to correct these similar issues that were previously identified as NRC violations in NRC inspection report 71-0040/2019-201 (ML19338C286).
==
Description:==
As part of the inspection, the team reviewed previously NRC identified violations (ML19338C286) to determine whether QSA had developed and implemented corrective actions associated with CR 2296. These actions were intended to resolve program deficiencies related to oversight of approved suppliers and the procurement process for CGD of ITS Category A components and services. QSA documented the corrective actions in CA 2442 and completed most of actions in June 2024approximately 5 years after the NRC initially identified the issues.
During the current review of the procurement process, the team identified several deficiencies that remain despite QSAs completion of the corrective actions. Specifically, the team noted the following deficiencies and deviations:
1.
QSA did not perform, or document annual supplier evaluations as required by its QA procedures and 10 CFR Part 71 requirements.
2.
There was no evidence that ITS Category A suppliers were audited to meet 10 CFR Part 71, Subpart H requirements; instead, suppliers operated under commercial or ISO 9001 quality programs.
3.
For the sample POs selected involving ITS Category A components, some lack required information per Section 5.3 of QSM-1, such as specific code revisions and applicable quality system requirements.
4.
CGD procedure WI-G-1410 did not define requirements for establishing a CGD plan for commercially procured items or calibrated M&TE services.
5.
QSA did not verify that M&TE calibration certificates received from vendors met procurement requirements.
6.
QSA did not perform receipt inspections on ITS Category A items prior to in-field use.
The team determined that QSA did not promptly identify and correct these conditions adverse to quality related to procurement of ITS components and services. The team also determined that this was repetitive because of inadequate corrective actions from a previous violation.
Corrective Actions: Response required in accordance with the information in the Notice.
Analysis: Using the NRC Enforcement Policy, the NRC determined that this Violation is a Severity Level IV because the violation was like one of the examples in the NRC Enforcement Policy. Specifically, Section 6.5.d.2 states in part that a licensee fails to establish, maintain, or implement adequate controls over the procurement process that are important to safety.
Enforcement:
Severity: The team determined that a Severity Level IV occurred using the NRC Enforcement Policy examples. Section 6.5.d.2 of the Enforcement Policy states, in part, that a licensee fails to establish, maintain, or implement adequate controls over the procurement process that are important to safety. Using the NRC Enforcement Policy, the NRC determined that this Violation is a Severity Level IV cited violation consistent with criteria in Section 2.3.2.a.
Violation: 10 CFR 71.133, Corrective Action, requires, in part, that the licensee, certificate holder, and applicant for a CoC shall establish measures to assure that conditions adverse to quality, such as deficiencies, deviations, defective material and equipment, and nonconformances, are promptly identified and corrected.
Contrary to the above, from October 2019 through the present, the certificate holder (QSA) did not establish measures to assure that conditions adverse to quality, such as deficiencies, deviations, defective material and equipment, and nonconformances, are promptly identified and corrected. QSA did not identify, or correct QSAs program deficiencies related to their oversight of approved suppliers and procurement processes for CGD of important to safety items and services. The program deficiencies included several issues with procurement of calibration and test services related to ITS Category A, supplier evaluations, and auditing suppliers that conform to 10 CFR Part 71, Subpart H requirements.
Enforcement Action: The team cited the violation since it was repetitive because of inadequate corrective action, and the NRC identified the deficiencies and deviations, consistent with criteria in Section 2.3.2. of the Enforcement Policy.
EXIT MEETING/DEBRIEFS On September 11, 2025, the team held an exit meeting at the end of the onsite inspection week with John Hieber, QSA Quality Assurance Manager and other members of the QSA team.
DOCUMENTS REVIEWED Type Designation Description or Title Revision or Date I-21-003 Internal Audit Report and Internal Audit Plan & Checklist for Sentinel Manufacturing, In-Lining & Service 11/18/2021 I-21-009 Internal Audit Report and Internal Audit Plan & Checklist for Procurement of Materials, Services &
Storage 10/28/2021 I-23-006 Internal Audit Report and Internal Audit Plan & Checklist for Quality Management Systems 4/28/2023 I-24-006 Internal Audit Report and Internal Audit Plan & Checklist for Quality Management Systems 4/18/2024 N/A External Audit Report for MSC 11/28/2023 Audits N/A External Audit Report for Ree Machine Works 6/18/2024 CR 2,295 N/A 10/24/2019 CR 2,296 N/A 10/24/2019 CR 2,350 N/A 2/18/2020 CR 2,368 N/A 2/24/2020 CR 2,375 N/A 3/12/2020 CR 2,381 N/A 4/10/2020 CR 2,437 N/A 11/18/2020 CR 2,440 N/A 11/18/2020 CR 2442 N/A 11/18/2020 CR 2,443 N/A 12/4/2020 CR 2,450 N/A 1/20/2021 CR 2,472 N/A 2/24/2021 CR 2,621 N/A 5//16/2022 CR 2,644 N/A 7/18/2022 CR 2,645 N/A 7/18/2022 CR 2,646 N/A 7/18/2022 CR 2,648 N/A 7/18/2022 CR 2,694 N/A 1/13/2023 CR 2,708 N/A 4/12/2023 CR 2,797 N/A 10/5/2023 CR 2,799 N/A 10/20/2023 Corrective Action Report CR 2,809 N/A 12/5/2023 ERF 4605 1100 Projector Release Product Line-Gamma Radiography Initial Release 2/8/2024 ERF ERF 4743 1100 Front Plate Tumbler Design Update 4/15/2025 Type Designation Description or Title Revision or Date ERF 4711 1100 Type A Label 4/15/2025 ERF 4729 1100 Lock Assembly Update 4/14/2025 ERF 4732 1100 Shell Update Request 4/10/2025 ERF 4735 Release of 1100 Ship Aids 8/27/2025 ERF 4739 1100 Jacket Revision (Manufacturing ability Improvement) 4/15/2025 ERF 4760 360 Torque Request Removal 6/25/2025 110000 Model 1100 Projector A
110010 1100 Jacket Assembly Class C D
110020 Model 1100 Body Weldment Class A A
110050-2 1100 Selector Retainer Class A A
8600-330 Projector Assembly Sentry 330 A
R8600 Sentry Transport Package V
86005 Weld Port Assembly Class A A
86010-110 Welded Body Assembly Sentry 110 Class A A
86015-330 Body Assembly Sentry 330, Cl. A A
BLT015 HH SS Bolt B
SCR002 Socket Head Cap Screw F
85701-5 Selector Ring Retainer F
SCR154 Security Screw G
88024 Lock Slide G
88004 Endplate E
88030 Front Plate Assembly L
88020 Rear Plate Assembly E
88010 Body Weldment P
88004 Endplate E
Drawings 88001 Shield 150 Ci P
N/A 2021 Internal Audit Plan & Schedule 1/24/2022 N/A 2022 Internal Audit Plan & Schedule 12/15/2022 N/A 2023 Internal Audit Plan & Schedule 12/4/2023 N/A 2024 Internal Audit Plan & Schedule 12/15/2025 N/A QSA Organization Chart 6/2025 N/A J.M. Test Systems Calibration Certificate for QSA Pressure Gage V-15 4/7/2025 N/A Cal-Tek Calibration Certificate No.
2025001862 3/14/2025 N/A Cal-Tek Calibration Certificate No.
2025002777 3/3/2025 Miscellaneous N/A Cal-Tek Calibration Certificate No.
2025000506 2/11/2025 Type Designation Description or Title Revision or Date N/A Glastonbury Southern Gage Calibration Certificate No. 4E22-1 5/9/2022 Form F-Q1401-1 Supplier Summary Evaluation of Glastonbury Southern Gage 1/31/2024 F-Q-1401-1 Supplier Summary Evaluation of J.M.
Test Systems, Inc.
8/8/2018 Test Plan 237 Model 1100 Type B Transport Package Tests 4/17/2024 Product Design Specification Form F-E-1211-1 PDS No. 33 model 1100 Series Ecosystem Iridium Projector 6/28/2023 Form FE-1205-1 Concept Design Review for Sentry Series 660 Projector and Source Changer 4/1/2008 F-E -1205-1 Sentry Series 660 Manufacturing Review meeting minutes 10/14/2008 F-E-1205-1 Sentry Test Program Design Review for Model 860 (projector) and Model 867 (charger) 2/4/2009 Design Review Checklist F-E-1205-1 Model 1100 Prototype, Manufacturing/Develop and Deployment 4/24/2024 F-R-1212-1 Initial Evaluation of ANSYS Version 5.6 through 16 5/31/2016 F-R-1212-2 SOLIDWORKS 2012/087 for Model 702 7/8/2025 F-R-1212-2 SOLIDWORKS Simulation 2012 SP 3.0 software Version 2025 used for Model 360 8/7/2025 F-R-1212-2 MIROSHIELD software Version 7.01 and 9.06 used for Model 360 12/13/2023 F-R-1212-2 MICROSHIELD software Version 5.05 used for Model 702 12/12/2023 F-R-1212-2 MICROSHIELD software Version 5.05 used for Model 976 12/10/2023 3rd Party Software Evaluation Form F-R-1212 F-R-1212-2 MONTE-CARLO N-Particle extended (MNPX) Version 26e used for Model 702 12/10/2023 QSM-1 Quality System Manual 15 SPS-M-1402-003.002 Supplier Product Certifications 02 F-P-2701-012.001 Route Card 1
QMP-1000 Management Review 08 QMP-1200 Design Control 06 QMP-1300 Control of Quality Documents 11 Procedures QMP-1400 Purchasing 05 Type Designation Description or Title Revision or Date QMP-1600 Product Identification and Traceability 02 QMP-2200 Corrective and Preventive Action 02 QMP-2500 Internal Quality Audits 04 QMP-2600 Training 05 QMP-3200 Contract Manufacturing 02 WI-E-1200 Engineering Request Form Process Overview 1
WI-E-1202 Design Development Plans 2
WI-E-1203 Quality Classification Determination 4
WI-E-1204 Design History Files 4
WI-E-1205 Design Review 4
WI-Q-1805 Product Quality Certificate Issuance and Control 8
WI-Q-1807 WI-M-1601 Lot/Serial Number Issuance 02 WI-Q-2501 Internal Audits 12 WI-Q-2602 Training and Qualification of Audit Personnel 03 WI-Q-3167 Baroscopic Inspection of S-Tubes 01 WI-R-1212 Review for 3rd Party Software Used to Demonstrate Type B Package Compliance 3
WI-R-3129 Part 21 Reporting 07 WI-G-1410 Use of Commercial Grade Items and Services in Safety-Related Application 4
WI-G-2201 Issue and Condition Management Process 24 WI-M-1401 Supplier Evaluation 13 WI-M-1402 Purchase Order Processing 17 WI-M-1404 Supplier Management 9
WI-M-1406 Procurement of Quality Related Services 3
WI-EQ-1901 Measuring and Test Equipment and Key Process Equipment Control 10 WI-M-1708 Engineering Request Form Change Evaluation and Implementation for New and Existing Projector Items 5
WI-L-1722 Data Entry into the Electronic Route Card System 0
SPS-E-1211-1 Product Design Specification 1
SPS-G-2201-2 Condition Report Investigation Process 4
SPS-L-1818-001 Annual Type B Package Inspection (Reference Information Only) 2 Type Designation Description or Title Revision or Date SPS-P-2701-5 Maintenance of Select QSA Global Inc Radiography Devices 4
P86169 JM Test Systems for Calibration Services of Pressure Gage V15 5/31/2024 P86670 Cal-Tek Company for Calibration Services 1/10/2025 P87573-01 Lock Slide Purchase Order 08/08/2025 P87132-00 Selector Ring Retainer Purchase Order 03/19/2025 P87017-00 Socket Head Cap Screw Purchase Order 02/11/2025 P87328 Cal-Tek Company for Calibration Services 6/6/2025 P87614-00 End Plate Purchase Order 08/21/2025 P87615 Cal-Tek Company for calibration services 8/21/2025 P87392-01 Security Screw Purchase Order 06/27/2025 Purchase Orders P85921-01 HH SS Bolt Purchase Order 02/21/2024 N/A 10 CFR 71.95(a)(3) Report for CoC number USA/6613/B(U)-96 Revision 20 (Model 702) 5/23/2022 N/A 10 CFR 71.95(a)(3) Report for CoC number USA/9296/B(U)-96 Rev. 12 (Model 880 Series) 6/8/2023 Reports/Records 237 Model 1100 Type B Transport Package Test Results 9/19/2024 NOTICE OF VIOLATION QSA Global International, Inc.
Docket No. 71-0040 Burlington, MA During an U.S. Nuclear Regulatory Commission (NRC) inspection, conducted from September 8 to September 11, 2025, the NRC identified one violation of NRC requirements. In accordance with the NRC Enforcement Policy, the violation is listed below:
Violation A:
Title 10 of the Code of Federal Regulations (10 CFR) 71.133, Corrective Action, requires, in part, that the licensee, certificate holder, and applicant for a CoC shall establish measures to assure that conditions adverse to quality, such as deficiencies, deviations, defective material and equipment, and nonconformances, are promptly identified and corrected.
Contrary to the above, from October 2019 through the present, the certificate holder (QSA) did not establish measures to assure that conditions adverse to quality, such as deficiencies, deviations, defective material and equipment, and nonconformances, are promptly identified and corrected. QSA did not identify, or correct QSAs program deficiencies related to their oversight of approved suppliers and procurement processes for commercial grade dedication (CGD) of important to safety items and services. The program deficiencies included several issues with procurement of calibration and test services related to ITS Category A, supplier evaluations, and auditing suppliers that conform to 10 CFR Part 71, Subpart H requirements.
This is a Severity Level IV Violation (NRC Enforcement Policy, Section 6.5.d.2)
Pursuant to the provisions of 10 CFR 2.201, QSA is hereby required to submit a written statement or explanation for this Notice of Violation (Notice or NOV) to the NRC, ATTN:
Document Control Desk, Washington, DC 20555-0001, with a copy to Shana Helton, Division Director, Division of Fuel Management, Office of Nuclear Material Safety and Safeguards, Two White Flint North, 11545 Rockville Pike, Rockville, MD 20852-2738, within 30 days of the date of the letter transmitting this Notice. This reply should be clearly marked as a "Reply to a Notice of Violation and should include for each violation: (1) the reason for the violation, or, if contested, the basis for disputing the violation or severity level; (2) the corrective steps that have been taken and the results achieved; (3) the corrective steps that will be taken; and (4) the date when full compliance will be achieved. Your response may reference or include previous docketed correspondence, if the correspondence adequately addresses the required response.
If an adequate reply is not received within the time specified in this Notice, an order or a Demand for Information may be issued requiring information as to why the license should not be modified, suspended, or revoked, or why such other action as may be proper should not be taken. Where good cause is shown, consideration will be given to extending the response time.
If you contest this enforcement action, you should also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.
Your response will be made available electronically for public inspection in the NRC Public Document Room or in the NRCs ADAMS, accessible from the NRC website at http://www.nrc.gov/reading-rm/adams.html. To the extent possible, your response should not include any personal privacy, proprietary [NOTE: For NOVs to be issued to gaseous diffusion plants or any other facility likely to hold classified material, insert: classified,], or safeguards information so that it can be made available to the public without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.390(b) to support a request for withholding confidential commercial or financial information). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21. If Classified Information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR Part 95.
Dated this 12th day of January 2026.