IR 07100040/2025201

QSA Global International - USNRC Inspection Report 71-00040/2025-201

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

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 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

Enclosure 1 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

- 2 -

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-96 865 71-9187 USA/9187/B(U)F-96 650L 71-9269 USA/9269/B(U)F-96 880 Series 71-9296 USA/9296/B(U)F-96 976 Series 71-9314 USA/9314/B(U)F-96

SENTRY 71-9357 USA/9357/B(U)F-96 360 71-9371 USA/9371/B(U)F-96

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.

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

2/4/2020

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

2/5/2023

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

- 11 -

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

21 Internal Audit Plan & Schedule

1/24/2022

N/A

22 Internal Audit Plan & Schedule

2/15/2022

N/A

23 Internal Audit Plan & Schedule

2/4/2023

N/A

24 Internal Audit Plan & Schedule

2/15/2025

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.

25001862

3/14/2025

N/A

Cal-Tek Calibration Certificate No.

25002777

3/3/2025

Miscellaneous

N/A

Cal-Tek Calibration Certificate No.

25000506

2/11/2025

- 12 -

Type

Designation

Description or Title

Revision or

Date

N/A

Glastonbury Southern Gage

Calibration Certificate No. 4E22-1

5/9/2022

Form F-Q1401-

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

2

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

2/13/2023

F-R-1212-2

MICROSHIELD software Version

5.05 used for Model 702

2/12/2023

F-R-1212-2

MICROSHIELD software Version

5.05 used for Model 976

2/10/2023

3rd Party

Software

Evaluation Form

F-R-1212

F-R-1212-2

MONTE-CARLO N-Particle extended

(MNPX) Version 26e used for Model

2

2/10/2023

QSM-1

Quality System Manual

SPS-M-1402-

003.002

Supplier Product Certifications

F-P-2701-012.001

Route Card

QMP-1000

Management Review

QMP-1200

Design Control

QMP-1300

Control of Quality Documents

Procedures

QMP-1400

Purchasing

- 13 -

Type

Designation

Description or Title

Revision or

Date

QMP-1600

Product Identification and

Traceability

QMP-2200

Corrective and Preventive Action

QMP-2500

Internal Quality Audits

QMP-2600

Training

QMP-3200

Contract Manufacturing

WI-E-1200

Engineering Request Form Process

Overview

WI-E-1202

Design Development Plans

WI-E-1203

Quality Classification Determination

WI-E-1204

Design History Files

WI-E-1205

Design Review

WI-Q-1805

Product Quality Certificate Issuance

and Control

WI-Q-1807

WI-M-1601

Lot/Serial Number Issuance

WI-Q-2501

Internal Audits

WI-Q-2602

Training and Qualification of Audit

Personnel

WI-Q-3167

Baroscopic Inspection of S-Tubes

WI-R-1212

Review for 3rd Party Software Used

to Demonstrate Type B Package

Compliance

WI-R-3129

Part 21 Reporting

WI-G-1410

Use of Commercial Grade Items and

Services in Safety-Related

Application

WI-G-2201

Issue and Condition Management

Process

WI-M-1401

Supplier Evaluation

WI-M-1402

Purchase Order Processing

WI-M-1404

Supplier Management

WI-M-1406

Procurement of Quality Related

Services

WI-EQ-1901

Measuring and Test Equipment and

Key Process Equipment Control

WI-M-1708

Engineering Request Form Change

Evaluation and Implementation for

New and Existing Projector Items

WI-L-1722

Data Entry into the Electronic Route

Card System

SPS-E-1211-1

Product Design Specification

SPS-G-2201-2

Condition Report Investigation

Process

SPS-L-1818-001

Annual Type B Package Inspection

(Reference Information Only)

- 14 -

Type

Designation

Description or Title

Revision or

Date

SPS-P-2701-5

Maintenance of Select QSA Global

Inc Radiography Devices

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

2/11/2025

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

2/21/2024

N/A

CFR 71.95(a)(3) Report for CoC

number USA/6613/B(U)-96 Revision

(Model 702)

5/23/2022

N/A

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

- 2 -

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.