ML24247A205
| ML24247A205 | |
| Person / Time | |
|---|---|
| Site: | 07100062 |
| Issue date: | 09/06/2024 |
| From: | Hector Rodriguez-Luccioni NRC/NMSS/DFM/IOB |
| To: | Bollinger C Industrial Nuclear Co |
| References | |
| EA-24-096 IR 2024201 | |
| Download: ML24247A205 (1) | |
See also: IR 07100062/2024201
Text
UNITED STATES
NUCLEAR REGULATORY COMMISSION
WASHINGTON, D.C. 205550001
EA24096
Charles Bollinger
Chief Operations Officer
Industrial Nuclear Co., Inc.
14320 Wicks Blvd
San Leandro, CA 94577
SUBJECT: INDUSTRIAL NUCLEAR CO., INC. - NRC INSPECTION REPORT
NO. 710062/2024201 AND NOTICE OF VIOLATION
Dear Charles Bollinger:
This letter refers to the inspection conducted on July 9 to 11, 2024, at the Industrial Nuclear Co.,
Inc. (INC) facility in San Leandro, California. The inspection team continued the inspection
activities with an inoffice review and held an exit meeting on July 26, 2024. The purpose of the
inspection was to verify and assess the adequacy of INCs activities associated with the
transportation of radioactive material to determine if they were performed 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 INCs U.S. Nuclear Regulatory Commission (NRC)
approved Certificates of Compliance (CoCs) and Quality Assurance Program (QAP). The
inspection scope included management, design, fabrication, and maintenance controls. The
enclosed report presents the results of this inspection.
The inspection examined activities conducted under your NRC approved QAP as they relate to
public health and safety, and to confirm compliance with the Commissions rules and regulations
and with the conditions of the applicable CoCs. Within these areas, the inspection consisted of
selected examination of procedures and representative records, observations of activities, and
interviews with personnel.
Based on the results of this inspection, the NRC has determined that one Severity Level IV
violation of NRC requirements occurred. The violation was evaluated in accordance with the
NRC Enforcement Policy. The current Enforcement Policy is included on the NRC's website at
(http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html). The violation is cited in
the enclosed Notice of Violation (Notice) and the circumstances surrounding it are described in
detail in the subject inspection report. The violation met the criteria for treatment as a non-cited
violation; however, because of INCs ongoing implementation of actions to address previously
identified programmatic issues within its corrective action program, the NRC determined the
issuance of a Notice is appropriate.
As documented in inspection report 710062/2022201, the NRC increased the routine
inspection frequency from 5 years to 3 years in accordance with Inspection Manual Chapter 2690, Inspection Program for Storage of Spent Reactor Fuel and Reactor-Related Greater than
September 6, 2024
C. Bollinger
-2-
Class C Waste at Independent Spent Fuel Storage Installations and for 10 CFR Part 71
Transportation Packagings. Based on the overall adequate implementation of the QAP and
identification of only one violation of very low safety significance that was an isolated incident
and not related to the previous issues identified, the NRC has returned the inspection frequency
to the routine interval of 5 years.
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 Part 2 of the NRCs Agency Rules of Practice and Procedure, a
copy of this letter, its enclosures, and your response, will be made available electronically for
public inspection in the NRC Public Document Room (PDR) or from the Publicly Available
Records component of the NRC's Agencywide Documents Access and Management System
(ADAMS), is accessible from the NRC website at http://www.nrc.gov/reading-rm/adams.html. To
make an appointment to visit the PDR, please send an email to PDR.Resource@nrc.gov or call
1-800-397-4209 or 301-415-4737, between 8 a.m. and 4 p.m. eastern time (ET), Monday
through Friday, except Federal holidays. To the extent possible, your response should not
include any personal privacy or proprietary information so that it can be made available to the
Public without redaction.
Sincerely,
Hector Rodriguez-Luccioni, Chief
Inspection and Oversight Branch
Division of Fuel Management
Office of Nuclear Material Safety
and Safeguards
Docket No. 710062
Enclosures:
1. Inspection Report No. 710062/2024201
cc w/Enclosures:
Mike Rose, Quality Assurance Manager & Assistant RSO
Signed by Rodriguez-Luccioni, Hector
on 09/06/24
OFFICE
DFM
E
DFM
E
E
DFM
E
NAME
JTapp
SFigueroa
DJones
HRodriguez-Luccioni
DATE
9/5/2024
9/6/2024
9/6/2024
9/6/2024
Enclosure 1
U.S. NUCLEAR REGULATORY COMMISSION
Office of Nuclear Material Safety and Safeguards
Division of Fuel Management
Inspection Report
Docket No.:
710062
Report No.:
710062/2024201
Enterprise Identifier:
I20242010016
Certificate Holder:
Industrial Nuclear Co., Inc.
Location:
San Leandro, CA
Inspection Dates:
July 9 - July 26, 2024
Inspectors:
Jeremy Tapp, Senior Transportation and Storage Safety Inspector, Team
Leader
Marlone Davis, Senior Transportation and Storage Safety Inspector
Azmi Djapari, Transportation and Storage Safety Inspector
Approved by:
Hector Rodriguez-Luccioni, Chief
Inspection and Oversight Branch
Division of Fuel Management
Office of Nuclear Material Safety
and Safeguards
2
EXECUTIVE SUMMARY
Industrial Nuclear Co., Inc.
NRC Inspection Report 710062/2024201
This routine inspection evaluated the ongoing activities at Industrial Nuclear Co., Inc.s (INCs)
facility in San Leandro, California related to transportation of radioactive material from July 9 to
11, with additional inoffice review through July 26, 2021. The purpose of the inspection was to
verify and assess the adequacy of INCs activities associated with the transportation of
radioactive material to determine if they were performed 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 INCs U.S. Nuclear Regulatory Commission (NRC) approved
Certificates of Compliance (CoCs) and Quality Assurance Program (QAP). The inspection
scope included management, design, fabrication, and maintenance controls.
Based on the results of this inspection, the NRC inspection team assessed that, overall,
implementation of INCs QAP was adequate. However, the team identified one violation of very
low safety significance where INC did not meet NRC requirements in measuring and test
equipment. The violation is summarized below and described in detail in the report details
section of this inspection report.
Quality Assurance Program
The team determined that the quality assurance (QA) controls at INC were generally
adequate. The team concluded that INC conducts its activities associated with QA
organization independence and QA responsibilities in accordance with their NRC
approved QAP. (section 1.1)
The team determined that the provisions of 10 CFR Part 21 were adequately
documented in quality procedures and INC complied with 10 CFR 21.6, "Posting
requirements." (section 1.2)
Design Control
The team determined that for the items selected for review that the fabrication
specifications were consistent with the design commitments and requirements
documented in the approved CoC and safety analysis report (SAR) for packagings, and
written procedures, as applicable. The team also determined that INC implemented a
design control program in accordance with their implementing procedures and NRC
approved QAP. (section 1.3)
3
Fabrication, Maintenance, and Testing
The team determined that INC is effectively implementing its fabrication controls,
including welding and nondestructive examination (NDE) processes, and has adequate
procedures in place to ensure compliance with the applicable regulations and QAP
requirements.
However, the team identified the control of measuring and testing equipment (M&TE) as
an area for improvement. A Severity Level IV violation was identified due to the failure to
use properly calibrated M&TE for verifying critical dimensions. (section 1.4)
Procurement
The team concluded that materials, components, and services received met the INC
procurement specifications, and the procurement specifications conform to the design
commitments and the requirements contained in the packaging SAR and CoC.
(section 1.5)
Nonconformance and Corrective Action
The team concluded that INC effectively implemented its nonconformance control
program and has adequate procedures in place to ensure compliance with the
applicable regulations and QAP requirements. The team concluded that INCs corrective
action program (CAP) is adequate to implement the requirements of INCs QAP and 10
CFR Part 71 but could not determine the effectiveness of the program as no corrective
action reports (CARs) were available to review. (section 1.6)
Personnel Training and Quality Assurance Oversight
The team determined that INC had trained and qualified individuals performing activities
affecting quality and that INC provided appropriate oversight of quality related activities,
as applicable. (section 1.7)
Audit Program
The team found that for the audits reviewed, INC conducted the audits with qualified
personnel and adequately evaluated the applicable functional areas of the QAP.
(section 1.8)
4
REPORT DETAILS
1.0
Applicable Portions of Inspection Procedure 86001-Design, Fabrication, Testing,
and Maintenance of Transportation Packagings
1.1
Quality Assurance Program
a.
Inspection Scope
The team reviewed the INC QAP, Design, Fabrication, Assembly and Testing of Type B
Shipping Containers and Source Assemblies, revision 15 and implementing quality
procedures (QPs) to assess the effectiveness of the QA program implementation. The
team conducted reviews of INCs quality program, policies, and procedures, to
determine whether activities subject to 10 CFR Part 71 were adequately controlled and
implemented under INCs NRC approved QAP. The team also reviewed procedures and
documents regarding the annual assessment of INCs QA program implementation and
biennial reports to the NRC regarding changes to the INC QAP.
b.
Observations and Findings
The team assessed that INC had a QA program and implementing procedures in place
that were generally effective in conducting activities in accordance with their
transportation package CoCs as well as their NRC approved QAP. The team verified
that the QA program authorities and responsibilities were clearly defined and
documented, and the QA organization functioned as an independent group. For the
annual assessment reviewed, it was performed as required and evaluated QA program
implementation to identify any trends and support improvement, as necessary. INC has
submitted biennial reports to the NRC regarding changes to the INC QAP as required by
No issues of significance were identified.
c.
Conclusions
The team determined that the QA controls at INC were generally adequate. The team
concluded that INC conducts its activities associated with QA organization
independence and QA responsibilities in accordance with their NRC approved QAP.
1.2
a.
Inspection Scope
The team verified that provisions are in place for reporting defects which could cause a
substantial safety hazard, as required by 10 CFR Part 21. The team reviewed the 10
CFR Part 21 procedure QP 19.1, Reporting of Defects and Noncompliance, revision 2
to verify if provisions were in place for reporting defects that could cause a substantial
safety hazard and whether INC would complete the required evaluation and notification
in a timely manner. The team requested a list of 10 CFR Part 21 evaluations and
5
notifications associated with INC quality activities. The team also verified if INC complied
with 10 CFR 21.6, Posting requirements.
b.
Observations and Findings
The team assessed that INC has provisions in place for evaluating deviations and
reporting defects that could cause a substantial safety hazard, as required by 10 CFR
Part 21. The team noted that for the 10 CFR Part 21 postings sampled at INCs San
Leandro, CA facility met the applicable requirements of 10 CFR Part 21. No Part 21
evaluations or notifications were performed since the last routine inspection in 2021.
No issues of significance were identified.
c.
Conclusions
The team determined that the provisions of 10 CFR Part 21 were adequately
documented in quality procedures and INC complied with 10 CFR 21.6, "Posting
requirements."
1.3
Design Control
a.
Inspection Scope
The team reviewed the design control section of the INC QAP and applicable
implementing quality procedures to verify that INC properly implemented a design
control program for their transportation packages. The team reviewed selected drawings,
dedication plans and interviewed INC personnel. The team reviewed design documents
to verify if INC had control of all phases of the design process from the onset of the
design through the fabrication activities. The team focused its review on the translation
of design information from the SAR to the fabrication drawings and the controls that
were in place and dedication plans met design requirements. The team reviewed the
INC implementing quality procedures specifically related to design control activities. The
team also reviewed the qualifications of selected engineering personnel and supplier
audits as applicable because INC contracts most of their design control activities to an
engineering contractor.
The team focused its review on INC design activities related to revision 0 of the CoC No.
9387 for the Part 71 packaging model Outer Package-Raw Material Shipping Container
(OPRMSC). Specifically, the team reviewed the following INC QPs and QAP section
associated with design control:
QAP, section 3.0, Design Control, revision 15, dated July 11, 2022,
QP 3.1, Design Control, revision 9, dated June 18, 2010,
QP 3.2, Commercial Grade Item Dedication, revision 7, dated August 22, 2022, and
QP 4.1, Procurement Document Control, revision 6, dated August 25, 2022.
The team reviewed the INC OPRMSC package SAR, revision 4, to ensure that INC
complied with the acceptable methods, drawings and engineering documentation
described in the NRC Safety Evaluation Report.
6
The team also reviewed fabrication drawings to verify that INC provided adequate
oversight of engineering services and that the engineering contractor had adequately
translated the design details of the model OPRMSC to the associated fabrication
drawings. Specifically, the team reviewed licensing drawings and compared the licensing
drawing to the related fabrication drawings.
SAR Licensing Drawings
OPRMSC-SAR-TA, sheets 14, revision 1
RMSC-SAR-TA, sheets 13, revision 2
RMSC-SPFH-SAR, sheet 1, revision 0
Fabrication Drawings
OPRMSC-ILA1, revision 0
OPRMSC-ILR1, revision 0
OPRMSC-IP1, revision 0
b.
Observations and Findings
The team assessed that overall, INC assigned design responsibilities appropriately and
the engineering service contractor was effectively implementing INCs design control
program. The team also assessed that implementing procedures were in place and
effective in controlling activities in accordance with the applicable regulations and
approved CoC.
No issues of significance were identified.
c.
Conclusions
The team determined that for the items selected for review and personnel interviewed
that INC implemented a design control program in accordance with their implementing
procedures and NRC approved QAP.
1.4
Fabrication, Maintenance, and Testing
1.2
Inspection Scope
The team reviewed procedures, drawings, and records, related to the model OPRMSC
to determine if fabrication, assembly, and testing activities met the SAR and design
commitments and requirements documented in the CoC. The team also reviewed
training records that include records of qualification and certification of welding and NDE
personnel. The team verified that welders were appropriately qualified according to
American Society of Mechanical Engineers Code Section IX requirements and that
welders met the current qualification requirements for the welding processes in use on
the shop floor. The team reviewed the following procedures, drawings, and records:
QP 8.5, Identification and Control of Materials, Parts, and Components for the
Manufacture of the OP-RMSC, revision 0
QP 9.1, Control of the Welding Process, revision 4
QP 10.1, Inspection
7
Attachment 8.5.A.1, Kitting and Manufacturing Traveler - OP-RMSC-CLA-1 Closure
Lid Assembly
Attachment 8.5.A.2, Kitting and Manufacturing Traveler - OP-RMSC-ILA-1 Inner Lid
Assembly
Attachment 8.5.A.3, Kitting and Manufacturing Traveler - OP-RMSC-BBPA-1 Body
Bottom Plate Assembly
Attachment 8.5.A.4, Kitting and Manufacturing Traveler - OP-RMSC-Body Inner
Cavity Assembly
Attachment 8.5.A.5, Kitting and Manufacturing Traveler - OP-RMSC-Body Inner
Cavity Assembly
Attachment 9.2B, Welding Procedure Specifications for Gas Tungsten Arc Welding
(GTAW)
Attachment 9.2C, Procedure Qualification Record for GTAW
Fabrication Drawings:
o
OPRMSC-OBA1, Outer Body Assembly, revision 1
o
OPRMSC-OB1, Outer Body, revision 0
o
OPRMSC-CR1, Closure Ring, revision 0
o
OPRMSC-ILA1, Inner Lid Assembly, revision 0
o
OPRMSC-ILR1, revision 0
o
RMSC-BTP1, revision 0
Personnel Training:
o
Attachment 9.2A, Welder Qualification Record
o
Certification of Visual Weld Examiner
The team reviewed selected M&TE used in the fabrication of the model OPRMSC,
along with the associated procedures and records, to ensure that the equipment used in
activities affecting quality, such as dimensional verification of critical characteristics,
were properly controlled and calibrated. The team reviewed the following:
QP 12.1, Control of Measuring and Test Equipment, revision 1
Calibration Due List 12.11, Measuring and Test Equipment
M&TE Sampled
o
6Inch Caliper (Digital)
o
12Inch Caliper (Dial)
o
Micrometer
The team reviewed calibration records to assess the control of M&TE, ensuring that
each piece of equipment is identifiable, traceable to the appropriate standards, and
within the current calibration period. Additionally, for the sample reviewed, the team
verified if any M&TE had been sent offsite for calibration and that the calibration service
providers were current on INCs approved suppliers list (ASL).
1.3
Observations and Findings
During the review of the M&TE used for dimensional verification of items receipt
inspected, the team identified that 5 out of 10 outer body pipes received for OPRMSC
8
fabrication were measured with improper M&TE. The outer body pipes were categorized
as important-tosafety (ITS) category B and the pipe diameter was identified as a critical
characteristic. INC measured the pipe diameters using a tape measure, which was
incapable of measuring to the required tolerance for the pipe dimensions in the drawing.
Additionally, the remaining five pipes lacked complete records of the M&TE used for
their measurements.
Title 10 CFR 71.125, Control of Measuring and Test Equipment, states, in part, the
licensee, certificate holder, and applicant for a CoC shall establish measures to assure
that tools, gauges, instruments, and other measuring and testing devices used in
activities affecting quality are properly controlled, calibrated, and adjusted at specified
times to maintain accuracy within necessary limits.
Contrary to the above, as of September 2021, INC used M&TE that was not properly
calibrated for activities impacting quality. Specifically, INC measured the diameters of
five outer body pipes with a tape measure that was incapable of measuring to the
required dimensional tolerance. In addition, another receipt inspection report did not list
the M&TE used to measure the critical dimension. The team noted that, after discussing
this issue, INC implemented corrective actions to achieve full compliance.
The team dispositioned the violation using the traditional enforcement process in
Section 2.3 of the NRC Enforcement Policy. The team determined the violation was of
more-than-minor safety significance in accordance with Inspection Manual Chapter 0617, Vendor and Quality Assurance Implementation Inspection Reports, Appendix E,
Minor Examples of Vendor and QA Implementation Findings, example 13b as the issue
resulted in measurements of indeterminate quality. The team characterized the violation
as a Severity Level IV violation in accordance with the NRC Enforcement Policy,
Section 6.5. INC entered the issue into its CAP under CAR 2402 and nonconformance
report (NCR) 2401. The violation met the criteria for treatment as a non-cited violation;
however, because of INCs ongoing implementation of actions to address previously
identified programmatic issues within its corrective action program, the NRC determined
the issuance of a Notice of Violation (Enclosure 2) is appropriate in this case.
(710062/2024201-01)
1.4
Conclusions
The team determined that overall, INC is effectively implementing its fabrication controls,
including welding and NDE processes, and has adequate procedures in place to ensure
compliance with the applicable regulations and QAP requirements. However, the team
identified the control of M&TE as an area for improvement. A Severity Level IV violation
was identified due to the failure to use properly calibrated M&TE for verifying critical
dimensions.
1.5
Procurement
a.
Inspection Scope
The team reviewed INCs procurement of ITS materials and services, including the
review of procurement documents, material traceability, drawings, and procedures, and
receipt inspection records. The team also reviewed the ASL to ensure that materials and
9
services were sourced from qualified suppliers and that these suppliers met the
necessary qualifications. The team reviewed the following documents:
QP 7.1, Control of Purchased Items, Materials, and Services, revision 7
Attachment 3.2B, Verification of Critical Characteristics - Welding Wire
Attachment 3.2B, Verification of Critical Characteristics - Outer Body
Receipt Inspection Reports for OPRMSC components
o
Outer Body Pipes
o
Inner Lid Ring
o
Closure Ring
o
Body Top Plate
o
Welding Wire for GTAW
Welding Wire for GTAW Heat No. 38LEE523B
Purchase Order (PO) No. 1484, OPRMSC-OB1 Outer Body
PO No. 602, Chemical Analysis of ER308/ER308L Weld Wire
Commercial grade survey report S2202 for Precision Measurements, Inc.
b.
Observations and Findings
The team observed that INC had adequate control of the procurement process for the
sample of ITS components and services selected and reviewed. The sample selected
included ITS category B components such as the outer body pipes, inner lid rings,
closure rings, and body top plates of the OPRMSC. The team also reviewed
procurement controls associated with ITS category A weld wire and reviewed a sample
of shop travelers for OPRMSC S/N 001, dated from September 2021 to December
2021. This review included INCs verification of conformance to the procurement
documents by receipt inspection and commercial grade dedication of the weld wire and
noted the critical characteristics for verification as chemical analysis. Using laboratory
testing services, INC verified that the weld wire met the standard specifications
according to American Welding Society A5.9, ER308/ER308L. The team determined that
INCs material traceability and procurement were adequate and specified the applicable
criteria and requirements including Part 21 based on the ITS category.
No issues of significance were identified.
c.
Conclusions
The team concluded that materials, components, and services received met the INC
procurement specifications, and the procurement specifications conform to the design
commitments and the requirements contained in the packaging SAR and CoC.
1.6
Nonconformance and Corrective Actions
a.
Inspection Scope
The team reviewed selected records and interviewed personnel to verify that INC
effectively implemented a nonconformance control program in accordance with their
NRC approved QAP and the requirements of 10 CFR Parts 21 and 71. Specifically, the
team reviewed INCs approved procedure, QP 15.1, Control of Nonconformances,
10
revision 3. The team reviewed the one NCR issued since the last routine inspection in
2021 to verify that the NCR was identifiable, traceable, and the disposition of the
nonconformance was adequate and properly closed out in accordance with QP 15.1.
The team reviewed selected records and interviewed personnel to verify that INC
effectively implemented a CAP in accordance with the NRC approved QAP and the
requirements of 10 CFR Part 71. Specifically, the team reviewed INCs approved
procedure QP 16.1, "Corrective Action, revision 4 to verify it was adequate to implement
the requirements of INCs QAP and 10 CFR Part 71. The team requested CARs since
the previous 2021 routine inspection, however, none had been written since that time.
b.
Observations and Findings
The team assessed that INC adequately dispositioned and closed the selected NCR in
accordance with the requirements of QP 15.1, as applicable. In addition, the team
assessed that QP 16.1 was adequate to implement the requirements of INCs QAP and
10 CFR Part 71. However, the team could not assess the improvements made to the
CAP since the last routine and follow-up inspections as no CARs have been written.
No issues of significance were identified.
c.
Conclusions
The team concluded that INC effectively implemented its nonconformance control
program and has adequate procedures in place to ensure compliance with the
applicable regulations and QAP requirements. The team concluded that INCs CAP is
adequate to implement the requirements of INCs QAP and 10 CFR Part 71 but could
not determine the effectiveness of the program as no CARs were available to review.
1.7
Personnel Training and Quality Assurance Oversight
a.
Inspection Scope
The team reviewed selected records and procedures, and interviewed selected
personnel to verify that individuals performing activities affecting quality were properly
trained and qualified, and that management and QA personnel were cognizant and
provide appropriate oversight. Specifically, the team reviewed training and qualification
records for selected engineering personnel and individuals that performed special
processes to verify their personnel qualifications were adequate and current.
b.
Observations and Findings
The team assessed that INC had trained and qualified individuals performing activities
affecting quality and in accordance with written quality procedures.
No issues of significance were identified.
11
c.
Conclusions
The team determined that INC had trained and qualified individuals performing activities
affecting quality and that INC provided appropriate oversight of quality related activities,
as applicable.
1.8
Audit Program
a.
Inspection Scope
The team reviewed selected records and interviewed personnel to verify that INC
effectively implemented an internal audit program in accordance with the NRC approved
QAP and the requirements of 10 CFR Part 71. Specifically, the team reviewed INCs
approved procedure QP 18.1, "Audits and Commercial Grade Surveys, revision 4.
The team reviewed selected internal audits since the previous 2021 routine inspection to
determine if they were performed in accordance with QP 18.1, if INC identified
deficiencies, and whether INC addressed these deficiencies within their CAP. The team
reviewed the 2022 and 2023 internal audits, including the audit plan, audit report, and
audit checklist. The team also reviewed the 2024 audit schedule to determine if all areas
of the QAP were planned to be audited.
b.
Observations and Findings
For the 2022 and 2023 internal audits reviewed, the team assessed that the audits were
adequately performed per QP 18.1, assessed current INC activities, and contained
appropriate objective evidence of the information and activities audited.
No issues of significance were identified.
c.
Conclusions
The team found that for the audits reviewed, INC conducted the audits with qualified
personnel and adequately evaluated the applicable functional areas of the QAP.
2.
Entrance and Exit Meeting
On July 9, 2024, the NRC inspection team discussed the scope of the inspection during
an entrance meeting with Mike Rose and other members of the INC staff. On July 11,
2024, the NRC inspection team presented the inspection results and observations during
an onsite preliminary exit meeting. On July 26, 2024, the NRC inspection team
conducted a final telephone conference exit with Mike Rose and other members of the
INC staff. Section 1 of the attachment to this report shows the attendance for the
entrance and exit meetings.
Attachment
ATTACHMENT
1.
ENTRANCE/EXIT MEETING ATTENDEES AND INDIVIDUALS INTERVIEWED
Name
Title
Affiliation
Entrance
Onsite
Exit
Exit
Inspection Team
Leader
NRC/DFM
X
X
X
Inspector
NRC/DFM
X
X
Azmi Djapari
Inspector
NRC/DFM
X
X
X
Mike Rose
QA Manager
INC
X
X
X
Ron Monteforte
Quality Management
Consultant
INC
X
X
X
2.
INSPECTION PROCEDURES USED
Design, Fabrication, Testing, and Maintenance of Transportation
Packagings
Classification of Transportation Packaging and Dry Spent Fuel Storage
System Components According to Importance to Safety
Quality Assurance Inspections for Shipping and Storage Containers
3.
LIST OF ITEMS OPENED, CLOSED, AND DISCUSSED
Item Number
Status
Type
Description
710062/2024201-01
Opened
Failure to use properly calibrated
M&TE to verify critical dimensions
4.
LIST OF ACRONYMS USED
Agencywide Documents Access and Management System
ASL
Approved Suppliers List
Corrective Action Program
Corrective Action Report
CFR
Code of Federal Regulations
Certificate of Compliance
DFM
Division of Fuel Management
Gas Tungsten Arc Welding
IP
Inspection Procedure
INC
Industrial Nuclear Company, Inc.
Important-toSafety
Measuring and Test Equipment
Nonconformance Report
NOV, Notice
NRC
U.S. Nuclear Regulatory Commission
OPRMSC
Outer Package-Raw Material Shipping Container
2
PO
Purchase Order
Quality Assurance
Quality Assurance Program
Quality Procedure
Safety Analysis Report
5.
DOCUMENTS REVIEWED
Certificate holder documents reviewed during the inspection were specifically identified in the
report details above.
Enclosure 2
Industrial Nuclear Co., Inc.
Docket No. 07100062
San Leandro, CA
EA24096
During an NRC inspection conducted on July 9 - 26, 2024 one violation of NRC requirements
was identified. In accordance with the NRC Enforcement Policy, the violations are listed below:
As required by 10 CFR 71.125, Control of Measuring and Test Equipment, in part, the
certificate holder shall establish measures to assure that tools, gauges, instruments, and
other measuring and testing devices used in activities affecting quality are properly
controlled, calibrated, and adjusted at specified times to maintain accuracy within
necessary limits.
Contrary to the above, as of September 2021, Industrial Nuclear Company, Inc. used
measuring and test equipment (M&TE) that was not properly calibrated for activities
impacting quality. Specifically, the receipt inspection reports for the outer body pipes of
the package, categorized as important-tosafety category B, did not document that the
pipe diameters were measured using properly controlled M&TE. The pipe diameters
were identified as a critical characteristic. One receipt inspection report, which involved
five outer body pipes, indicated that a tape measure was used which cannot be
accurately calibrated and was incapable of measuring to the required tolerance for the
pipe dimensions. In addition, another receipt inspection report did not list the M&TE used
to measure the critical dimension.
This is a Severity Level IV violation (Section 6.5).
Pursuant to the provisions of 10 CFR 2.201, Industrial Nuclear Co., Inc., is hereby required to
submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN:
Document Control Desk, Washington, DC 205550001, with a copy to Hector Rodriguez, Chief,
Inspection and Oversight Branch, Division of Fuel Management, Office of Nuclear Material
Safety and Safeguards, within 30 days of the date of the letter transmitting this Notice of
Violation (Notice). This reply should be clearly marked as a Reply to a Notice of Violation, EA-
24-096 and should include for the 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 previously 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 205550001.
Because your response will be made available electronically for public inspection in the NRC
Public Document Room or in the NRCs Agencywide Documents Access and Management
System (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,
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proprietary, 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 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.
In accordance with 10 CFR 19.11, you may be required to post this Notice within two working
days of receipt.
Dated this 6th day of September 2024.