ML23187A106
| ML23187A106 | |
| Person / Time | |
|---|---|
| Site: | 07100102 |
| Issue date: | 07/13/2023 |
| From: | Natreon Jordan, Jeremy Tapp NRC/NMSS/DFM/IOB |
| To: | Sanchez M Source Production & Equipment Co |
| References | |
| IR 2023201 | |
| Download: ML23187A106 (18) | |
See also: IR 07100102/2023201
Text
UNITED STATES
NUCLEAR REGULATORY COMMISSION
WASHINGTON, D.C. 205550001
July 13, 2023
Mike Sanchez, Vice President
& General Manager
Source Production & Equipment
Company, Inc.
113 Teal Street
St. Rose, LA 70087
SUBJECT: SOURCE PRODUCTION & EQUIPMENT COMPANY-U.S. NUCLEAR
REGULATORY COMMISSION INSPECTION REPORT NO. 710102/2023201
Dear Mike Sanchez:
This letter refers to the inspection conducted by the U.S. Nuclear Regulatory Commission
(NRC) on May 15-18, 2023, at the Source Production & Equipment Company (SPEC) facility in
St. Rose, LA. The inspection team continued the inspection activities with an inoffice review
and held an exit meeting on June 1, 2023, with you and other members of your staff. The
purpose of the inspection was to verify and assess the adequacy of SPECs activities
associated with the transportation of radioactive material and 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 SPECs NRC approved
Certificate of Compliances (CoC) and Quality Assurance Program (QAP). 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 two Severity Level IV
violations of NRC requirements occurred. Because SPEC initiated corrective actions to address
these issues, these violations are being treated as Non-Cited Violations (NCVs), consistent with
Section 2.3.2 of the Enforcement Policy. These NCVs are described in the subject inspection
report. If you contest the violations or significance of these NCVs, you should provide a
response within 30 days of the date of this inspection report, with the basis for your denial, to
the Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington DC
205550001, with copies to: (1) the Director, Office of Nuclear Material Safety and Safeguards;
and (2) the Director, Office of Enforcement, United States Nuclear Regulatory Commission,
Washington, DC 205550001.
As discussed with you and your staff on June 1, 2023, the NRC staff plans to perform at a
minimum, annual status calls to determine whether adequate and timely corrective actions are
being taken as a result of the inspection findings that were identified. If the NRC staff
determines that adequate or timely progress is not being made, the NRC will consider an
M. Sanchez -2-
increased routine inspection frequency and communicate to you the decision, along with the
basis. If the NRC decides to increase the routine inspection frequency, it will be performed in
accordance with Inspection Manual Chapter 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, which is consistent
with our inspection program policy.
In accordance with 10 CFR Part 2 of the NRCs Agency Rules of Practice and Procedure, a
copy of this letter, its enclosure, and your response, if you choose to provide one, will be made
available electronically for public inspection in the NRC Public Document Room (PDR) or from
Publicly Available Records component of the NRC's Agencywide Documents Access and
Management System (ADAMS). ADAMS 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 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,
Signed by Jordan, Natreon
on 07/13/23
Natreon Jordan, Acting Chief
Inspection and Oversight Branch
Division of Fuel Management
Office of Nuclear Material Safety
and Safeguards
Docket No. 710102
Enclosure:
Inspection Report No. 710102/2023201
cc w/Encl: Kristen Bonds, Regulatory
Manager & Assistant RSO
OFFICE: NMSS/DFM NMSS/DFM NMSS/DFM
NAME: JTapp JCurry NJordan
DATE: 7/12/2023 7/10/2023 7/13/2023
U.S. NUCLEAR REGULATORY COMMISSION
Office of Nuclear Material Safety and Safeguards
Division of Fuel Management
Inspection Report
Docket No.: 710102
Report No.: 710102/2023201
Enterprise Identifier: I2023201-0015
Certificate Holder: Source Production & Equipment Company, Inc.
Location: St. Rose, LA
Inspection Dates: May 15-18, 2023
Inspectors: Jeremy Tapp, Transportation and Storage Safety Inspector,
Team Leader
Marlone Davis , Senior Transportation and Storage Safety
Inspector
Azmi Djapari, Transportation and Storage Safety Inspector
(Trainee)
Andres Rowe, General Engineer NRAN (Observer)
Approved by: Natreon Jordan, Acting Chief
Inspection and Oversight Branch
Division of Fuel Management
Office of Nuclear Material Safety
and Safeguards
Enclosure
EXECUTIVE SUMMARY
Source Production & Equipment Company
NRC Inspection Report 710102/2023201
This routine inspection performed at Source Production & Equipment Companys (SPECs)
facility in St. Rose, LA from May 15-18, 2023, with additional inoffice review through June 1,
2023, evaluated the ongoing activities related to the design, fabrication, and maintenance of
transportation packages for radioactive materials. The purpose of the inspection was to verify
and assess the adequacy of SPECs 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, SPECs U.S. Nuclear Regulatory Commission (NRC) approved
Certificates of Compliance (CoCs) and associated Safety Analysis Reports (SARs), and SPECs
NRC approved Part 71 Quality Assurance Program (QAP).
Based on the results of this inspection, the NRC inspection team assessed that overall, the
implementation of SPECs QAP was adequate. However, two Severity Level IV violations of the
NRC requirements were identified by the team in the areas of package design control and
instructions, procedures, and drawings. The violations are summarized in the sections below
and described in detail in the Report Details section of this inspection report.
Management Controls
The team determined that overall, the quality assurance controls at SPEC, which primarily
includes the Quality System Procedures Manual (QSPM), were generally adequate and
implemented in a graded approach, as defined in the QAP.
The team concluded that SPEC effectively implemented its nonconformance control program
and corrective action program (CAP) and had adequate procedures in place to ensure
compliance with the applicable regulations and QAP requirements.
Overall, the team concluded that SPEC was adequately implementing its document control and
records program and has adequate procedures in place to meet the applicable regulations and
QA program requirements. However, the team identified this as an area for improvement. One
Severity Level IV violation was identified for failure to follow procedures to adequately store
quality records, so they were free from environmental threats.
The team concluded that SPEC had an adequate audit program in place to schedule, evaluate,
and document the results. The team determined that SPEC appropriately identified issues and
documented them in the CAP as required.
Design Controls
Although there were no design modifications that have been made, the team concluded that
SPEC has adequate procedures in place to initiate design and drawing changes through a
review process, and to digitally record signatures and approvals by responsible personnel in
their MQ1 system. Overall, the team concluded that SPEC adequately implemented its design
control program. However, the team identified this as an area for improvement. One Severity
Level IV violation was identified for failure to properly categorize the sealed source capsule as
an important-tosafety (ITS) Category A component as it performs the function of the primary
2
containment vessel, and instead, categorized it as ITS Category T, which is not equivalent to
ITS Category A in procurement controls, with no documented engineering justification.
Fabrication Controls
The team concluded that materials, components, and other equipment received met the SPEC
procurement specifications, and the procurement specifications conform to the design
commitments and requirements contained in the packaging SARs and CoCs.
The team concluded that SPEC personnel were familiar with the designated fabrication
techniques, testing requirements, and quality control associated with the fabrication, test, and
inspection of the SPEC300 packaging.
The team concluded that SPEC used suitable calibrated equipment to conduct fabrication and
maintenance activities. The team also noted that SPEC identified, specified, and controlled tools
and equipment in accordance with their quality implementing procedures and regulatory
requirements.
Maintenance Controls
The team concluded that SPEC personnel effectively implemented a maintenance control
program in accordance with their NRC approved QAP, work instructions, and requirements
contained in the packaging SAR and CoC for the SPEC150 and SPEC300.
3
REPORT DETAILS
1. Management Controls
1.1 Quality Assurance Policy
a. Inspection Scope
The team reviewed the SPEC part 71 QAP, Quality Assurance Program, Revision 5
and QSPM that contains SPECs implementing procedures to assess the adequacy and
effectiveness of SPECs QAP implementation. The team conducted reviews of SPECs
quality program, policies, and procedures, to determine whether activities subject to
10 CFR part 71 were adequately controlled and implemented under SPECs NRC
approved QAP. The team also reviewed the QAP to determine if changes were made
and if so, were performed in accordance with the requirements of 10 CFR 71.106, as
applicable.
The team reviewed the QAP authorities and responsibilities to determine if they were
clearly defined and documented, and the QA organization functioned as an independent
group. In addition, the team reviewed the QAP to determine if commercial grade
dedication activities are performed by SPEC.
The team reviewed SPECs graded approach to quality as documented in the QAP to
verify SPEC identified important-tosafety components in its packaging designs in a
graded approach as described.
b. Observations and Findings
The team assessed that SPEC had a QA program and implementing procedures in
place that were generally effective in conducting activities in accordance with SPECs
NRC-approved QAP and CoCs as well as part 71 requirements. The team verified that
the QA organization operated in a manner sufficiently independent from cost and
schedule, when opposed to safety considerations. The team determined that no
changes to the NRC-approved QAP occurred since the last NRC inspection in 2018.
The team found that SPEC used a graded approach to categorize components
important-tosafety in its packaging designs. The team reviewed the adequacy of the
categorizations as a part of the design control review documented in section 2 of this
report. The team noted that SPEC does not currently implement a commercial grade
dedication program for parts or services.
No issues of significance were identified.
c. Conclusions
The team determined that overall, the QA controls at SPEC, which primarily includes the
QSPM, were generally adequate and implemented in a graded approach, as defined in
the QAP.
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1.2 Nonconformance and Corrective Action Controls
a. Inspection Scope
The team reviewed a sample of SPEC's nonconformance reports (NCRs) and
corrective/preventive action reports (CPARs) and interviewed selected personnel to
verify that SPEC effectively implemented their nonconformance control program and
CAP. The review included an evaluation of how SPEC's nonconformance control
program and CAP 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. The team reviewed the
following SPEC quality procedures and work instructions:
QSPM section 15.0, Control of Nonconforming Product and Service, revision 9
QSPM section 16.0, Improvement, Corrective and Preventive Action,
revision 14
QSPM section 15.1, Reporting and Defect Notification, revision 14
Work Instruction No. QA51, Root Cause Analysis, revision 2
The team reviewed NCRs and CPARs since the last NRC inspection in 2018 and
reviewed two CPARs written because of issues identified during the 2018 inspection.
The team discussed the nonconformances and corrective actions with the SPEC staff to
understand the process. The team focused the NCR review on use-asis and repair type
dispositions to evaluate how SPEC technically justified the NCRs reviewed. The CPARs
were reviewed to determine whether SPEC completed corrective actions for identified
deficiencies in a technically sound and timely manner. The team also toured the SPEC
facility to review the controls in place for control of nonconforming items and verified
items with open NCRs were adequately controlled. In addition, the team requested a list
of part 21 evaluations and notifications associated with the SPEC transportation
packagings. The team also reviewed postings within the SPEC facility to determine if
SPEC complied with the 10 CFR 21.6, "Posting requirements."
b. Observations and Findings
The team found that SPEC had adequate procedures and controls in place for
identifying, writing, and dispositioning NCRs and for reporting defects that could cause a
substantial safety hazard. The team noted that there were no part 21 reports issued
since the previous inspection.
The team assessed that SPEC had adequate procedures and controls in place for
identifying and writing CPARs, documenting corrective action(s) taken, performing
causal analyses as necessary, documenting corrective actions and actions taken to
prevent recurrence as applicable, and performing CPAR closure verification.
No issues of significance were identified.
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c. Conclusions
The team concluded that SPEC effectively implemented its nonconformance control
program and CAP and had adequate procedures in place to ensure compliance with the
applicable regulations and QAP requirements.
1.3 Documentation Controls
a. Inspection Scope
The team reviewed SPECs documentation control program to assess the effectiveness
of controls established for the approval, issuance, revision, and use of quality
documents. The team reviewed SPECs instructions and procedures regarding the
control of documents and quality records, and interviewed responsible personnel to
verify that documents are retained and located in areas consistent with the instructions
and procedures. The team reviewed the following SPEC quality procedures and work
instructions:
QSPM Section 6.0, Document Control, revision 16
QSPM Section 17.0, Control of Quality Documents and Records (ISO 4.2 and
6.2), revision 13
Work Instruction No.: QA01, Document Control and Security System, revision 7
Form: QA01F1, List of Quality Records, revision 13
Work Instruction No. QA02, Lost Document or Record Instruction, revision 4
The team verified that document changes and approvals are properly signed, dated, and
recorded on the MQ1 system. The team also toured areas of the facility where quality
documents are stored to verify the documents are being stored as required by SPECs
quality procedures and instructions.
b. Observations and Findings
That team noted that due to the effects of Hurricane Ida in 2021, storage cabinets were
moved to temporary locations on site. SPEC is currently in the process of reorganizing
them and will update QA01F1, List of Quality Records, as appropriate.
SPEC also identified that external audits and approved supplier evaluation records were
lost to the storm and entered the issue into their CAP. However, the team identified that
prior to the storm, SPEC had not stored these records per QSPM section 17.0, which
resulted in the loss of records, and this specific issue was not documented in the CAP.
The filing and storage section of QSPM, section 17.0, states, in part, that quality records
shall be filed in storage devices/areas free from environmental threats such as water
leaks and open doors posing a threat from outside winds.
The team determined this was a violation of 10 CFR 71.111, Instructions, procedures,
and drawings, which requires, in part, that the certificate holder shall prescribe activities
affecting quality by documented instructions, procedures, or drawings of a type
appropriate to the circumstances and shall require that these instructions, procedures,
and drawings be followed.
6
Contrary to the above, in August 2021, the certificate holder (SPEC) did not follow the
filing and storage section of QSPM section 17.0 and quality records were lost due to
Hurricane Ida. Specifically, some quality records were not filed in storage devices/areas
free from environmental threats as required.
The team dispositioned the violation using the traditional enforcement process in
section 2.3 of the NRC Enforcement Policy. The team determined that the violation was
of more-than-minor safety significance in accordance with Inspection Manual Chapter
(IMC) 0617, Vendor and Quality Assurance Implementation Inspection Reports,
appendix E, Minor Examples of Vendor and QA Implementation Findings, Example
17a, because actual required records were lost or damaged, and SPEC could not easily
recreate the records with reasonable assurance of their accuracy. The team
characterized the violation as a Severity Level IV violation in accordance with the NRCs
Enforcement Policy, section 6.5. SPEC entered the issue into its CAP under CPAR
- 00172. Because this violation was of low safety significance, was entered into SPECs
CAP, and the issue was not repetitive or willful, this violation was treated as a NCV,
consistent with Section 2.3.2.a of the NRC Enforcement Policy. (710102/2023201-01)
c. Conclusions
Overall, the team concluded that SPEC was adequately implementing its document
control and records program and has adequate procedures in place to meet the
applicable regulations and QAP requirements. However, the team identified this as an
area for improvement. One Severity Level IV violation was identified for failure to follow
procedures to adequately store quality records, so they were free from environmental
threats.
1.4 Audit Program
a. Inspection Scope
The team reviewed SPECs audit program to determine if SPEC scheduled, planned,
and performed internal audits in accordance with the applicable regulations and QAP
requirements. The team also reviewed the qualification records to determine if they met
the QAP and procedure requirements. The team reviewed SPECs quality procedure
QSPM Section 18.0, Internal Quality Audits, revision 18.
The team reviewed a sample of audit schedules since 2018 to verify that all 18 QAP
criteria were planned to be audited, as applicable, each year. The team reviewed and
assessed a sample of the internal audits completed since the last inspection to
determine if they were performed in accordance with quality procedures, used qualified
lead auditors independent of the areas being reviewed, and if there were identified
deficiencies, whether SPEC adequately addressed these deficiencies within the CAP.
The team reviewed the current procedure for the qualification of audit personnel and
reviewed a sample of lead auditor qualification records to determine if they met the
applicable QAP requirements.
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b. Observations and Findings
Overall, the team assessed that for the audits sampled, SPEC conducted them with
qualified and certified personnel, were comprehensive in nature, and covered a
representative sample of SPECs activities in the area being audited.
No findings of significance were identified.
c. Conclusions
The team concluded that SPEC had an adequate audit program in place to schedule,
evaluate, and document the results. The team determined that SPEC appropriately
identified issues and documented them in the CAP as required.
2. Design Controls
a. Inspection Scope
The team interviewed responsible personnel and reviewed selected design
documentation to verify that SPEC is adequately implementing their design control
program. The team reviewed the following SPEC quality procedures and work
instructions:
QSPM section 3.0, Design Control & Product Realization, revision 16
QSPM section 3.1, Verification and Validation, revision 1
EG03, Change Requests for Engineering Documents, revision 15
EG05, Engineering Change Notice, revision 5
b. Observations and Findings
The team reviewed the ITS categories documented for structures, systems, and
components for both the SPEC150 and SPEC300 packagings that SPEC holds a CoC.
The team noted that the sealed source capsule, which is credited in the SAR as the
primary containment vessel for both the SPEC150 and SPEC300 packagings, was not
properly categorized as an ITS Category A component per NRCs guidance in
NUREG/CR6407, Classification of Transportation Packaging and Dry Spent Fuel
Storage System Components According to Importance to Safety. SPEC classified the
sealed source capsule as ITS Category T, which is an internal SPEC categorization and
is not equivalent to ITS Category A requirements, specifically in procurement controls. In
addition, the team noted that SPEC did not perform an engineering evaluation to support
the assignment of the sealed source capsule as ITS Category T.
The team determined that this was a violation of 10 CFR 71.107, Package design
control, which requires, in part, that the certificate holder shall establish measures to
assure that applicable regulatory requirements and the package design, as specified in
the CoC for those materials and components to which this section applies, are correctly
translated into specifications, drawings, procedures, and instructions. These measures
must include provisions to assure that appropriate quality standards are specified and
included in design documents and that deviations from standards are controlled.
Measures must be established for the selection and review for suitability of application of
8
materials, parts, equipment, and processes that are essential to the functions of the
materials, parts, and components of the packaging that are ITS.
Contrary to the above, since May 2023, SPEC failed to establish measures to assure
that appropriate quality standards were specified and included in design documents.
Measures were also not established for the selection and review for suitability of
application of materials, parts, equipment, and processes that are essential to the
functions of the materials, parts, and components of the packaging that are important-
tosafety. Specifically, SPEC did not perform an engineering evaluation and provide
sufficient justification to support the assignment of ITS Category T to the sealed source
capsule, which is defined as the primary containment vessel in the SPEC150 and
SPEC300 SARs. The sealed source capsule was not properly classified as ITS
Category A to ensure all required procurement controls are applied.
The team dispositioned the violation using the traditional enforcement process in section
2.3 of the NRC Enforcement Policy. The team determined that the violation was of
more-than-minor safety significance in accordance with IMC 0617, appendix E, Example
4a because the design change requires evaluation to determine whether the component
can perform its intended safety function or meet its original qualifications. The team
characterized the violation as a Severity Level IV violation in accordance with the NRCs
Enforcement Policy, section 6.5. SPEC entered the issue into its CAP under CPAR
- 00178. Because this violation was of low safety significance, was entered into SPECs
CAP, and the issue was not repetitive or willful, this violation was treated as an NCV,
consistent with section 2.3.2.a of the NRC Enforcement Policy. (710102/2023201-02)
c. Conclusions
Although there were no design modifications that have been made, the team concluded
that SPEC has adequate procedures in place to initiate design and drawing changes
through a review process, and to digitally record signatures and approvals by
responsible personnel in their MQ1 system. Overall, the team concluded that SPEC
adequately implemented its design control program. However, the team identified this as
an area for improvement. One Severity Level IV violation was identified for failure to
properly categorize the sealed source capsule as an ITS Category A component as it
performs the function of the primary containment vessel. Instead, it was categorized as
ITS Category T, which is not equivalent to ITS Category A in procurement controls, with
no documented engineering justification.
3. Fabrication Controls
3.1 Material Procurement
a. Inspection Scope
The team reviewed SPEC's processes that addressed procurement, including receipt
inspection, traceability of material, and commercial grade dedication, as applicable. The
team reviewed selected drawings and records and interviewed personnel to verify that
SPECs procurement specification for materials, fabrication, and inspection met design
commitments and requirements contained in the packaging SARs and CoCs. The team
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reviewed quality system procedures, receipt inspection records, and sampled Purchase
Orders (POs). The team reviewed the following documents:
QSPM section 4.0, Procurement Documents, revision 13
QSPM section 7.0, Control of Purchased Materials, revision 7
QSPM section 8.0, Product Identification, Traceability and Serialization,
revision 15
Drawing 15B002A, SPEC-150 Exposure Device, revision 9
Drawing 19B000, Sheets 18, General Arrangement SPEC-300, revision 5
Drawing B190700, Sheet 1, DU Shield - Co-60 SPEC-300, revision 5
Approved Suppliers List, revision 81
PO No. 000940-SPEC150 Source Capsule
PO No. 000925-Byers Precision Fabricators (Enclosure Base for SPEC300)
PO No. 000930-Aerojet (Depleted Uranium Shields)
PO No. 001029-Urethane Technology (Polyurethane Foam)
b. Observations and Findings
Overall, the team assessed that SPEC had adequate control of the procurement process
for the ITS components selected and reviewed. The team determined that SPEC
procured ITS components consistent with design requirements and their QA
implementing procedures and work instructions. SPECs material traceability,
procurement, and receipt inspection controls were adequate. The team assessed that
the POs were adequate and specified the applicable criteria and requirements including
Part 21, as applicable based on the ITS category. The material ordered and received at
the facility met the design requirements. Additionally, SPEC verified and maintained the
traceability throughout the procurement and receipt process. The team also determined
that SPEC purchased and applied controls based on SPECs approved suppliers list.
No issues of significance were identified.
c. Conclusions
The team concluded that materials, components, and other equipment received met the
SPEC procurement specifications, and the procurement specifications conform to the
design commitments and requirements contained in the packaging SARs and CoCs.
3.2 Fabrication and Assembly
a. Inspection Scope
The team reviewed selected drawings, procedures, and records, and observed selected
activities related to the SPEC300 fabrication and assembly to determine if the
fabrication, testing, and any maintenance activities met SAR design commitments and
the requirements documented in the CoC. The team selected the enclosure base and
cover assembly activity for the SPEC300 to observe because those fabrication activities
occurred during the onsite inspection. The team reviewed and observed the following
documents and activities:
10
QSPM section 5.0 Instructions, Procedures, and Engineering Documents,
revision 10
QSPM section 9.0, Control of Special Processes, revision 15
Drawing 19B000, Sheets 18, General Arrangement SPEC-300, revision 5
Manufacturing Traveler, Final Assembly, SPEC-300 (190601), revision 38
Gas Tungsten Arc Welding (GTAW) of the enclosure base to the enclosure cover
Liquid penetration and visual nondestructive examinations (NDEs) of the welding
activity
b. Observations and Findings
Based on the sample selected and observed, the team assessed that SPEC established
appropriate means to control the SPEC300 fabrication activities and special processes
that met the SAR design commitments and requirements documented in the CoC. The
team examined SPECs fabrication specification, design and fabrication drawings, work
control procedures, and travelers and confirmed that the fabrication and testing activities
were adequate. The team noted that the shop manufacturing travelers identified the
applicable drawings, part numbers, work instructions, and qualified personnel applicable
to the fabrication and assembly activities.
No issues of significance were identified.
c. Conclusions
The team concluded that SPEC personnel were familiar with the designated fabrication
techniques, testing requirements, and quality control associated with the fabrication of
the SPEC300 packaging.
3.3 Test and Inspection
a. Inspection Scope
The team observed activities for the test and inspection of the SPEC300 of the enclosure
base and cover to verify that SPEC performed these tasks in accordance with approved
methods, procedures, and specifications. The team reviewed the test and inspection
process through observations of welding, assembly, and NDEs, and personnel
interviews of the activities as described above. The team reviewed the following quality
procedures and work instructions:
QSPM section 9.0, Control of Special Processes, revision 15
QSPM section 11.0, Testing, revision 10
QA27, Visual Weld Inspection, revision 10
QA28, Liquid Penetrant Procedure for Solvent Removable Visible, revision 10
QA63, Written Practice for the Qualification and Certification of NDE Personnel,
revision 1
PR22, GTAW - Welding Procedure Specification, revision 7
11
b. Observations and Findings
The team assessed that the SPEC established appropriate means to control the
SPEC300 fabrication and special processes for test and inspection activities. The
team noted that SPEC implemented their QAP, quality procedures, and special
processes with qualified personnel, using approved procedures for assembly, welding,
and testing. The team also assessed that SPEC provided the appropriate information
on shop manufacturing travelers in accordance with approved quality procedures.
No issues of significance were identified.
c. Conclusions
The team concluded that SPEC personnel were familiar with the designated fabrication
techniques, testing requirements, and quality control associated with the test and
inspection of the SPEC300 packaging.
3.4 Tools and Equipment
a. Inspection Scope
The team reviewed the control of measuring and test equipment (M&TE) program to
evaluate how the SPEC identified, specified, and controlled tools and equipment in
accordance with their QAP, implementing standard procedures, and regulatory
requirements. Specifically, the team reviewed the following quality standard procedure:
QSPM section 12.0, Control of Inspection, Measuring, and Test Equipment,
revision 13
The team selected a sample of the M&TE used during the assembly and testing of the
SPEC300 packaging. The sample included a review of travelers that identified the use
of specific M&TE that the team selected such as a light meter, thread gauge, and
caliper. The team reviewed the calibration records to verify calibration dates, testing
standards, and traceability of the associated M&TE.
b. Observations and Findings
The team determined that there the M&TE being used was within the calibration dates
for use, and for the items selected the team noted that the M&TE were properly labeled
with calibration history recorded per quality procedures.
No issues of significance were identified.
c. Conclusions
The team concluded that SPEC used suitable calibrated equipment to conduct
fabrication and maintenance activities. The team also noted that SPEC identified,
specified, and controlled tools and equipment in accordance with their quality
implementing procedures and regulatory requirements.
12
Maintenance Controls
a. Inspection Scope
The team reviewed selected records and interviewed personnel to verify that SPEC
personnel effectively implemented a maintenance control program in accordance with
their NRC approved QAP and requirements contained in the packaging SAR and CoC
for the SPEC150 and SPEC300. The team performed a review of maintenance records
related to the packagings and observed an operational test of the lock cap and device
lock. The team reviewed the following quality implementing procedures and
maintenance instructions:
QSPM section 10.0, Inspection, revision 14
QA45, Model #7 Connector and G-60 Pigtail Inspections, revision 20
SH09, Returned or Reported Malfunctioning Equipment/Material, revision 18
b. Observations and Findings
Based on a review of the maintenance records and procedures, the team assessed that
SPEC used appropriate maintenance materials, tools, and equipment to conduct the
annual maintenance activities for the SPEC150. The team verified that the inspections
were comprehensive and met acceptance criteria for tests identified in the maintenance
records and procedures. The team verified that SPEC appropriately inspected attributes
of the lock cap and device lock. The team also verified that maintenance personnel and
technicians recorded the proper information on the applicable forms and data sheets as
defined and required in the SPEC quality and maintenance instructions. The team
assessed that the maintenance tests satisfied the requirements identified in the
No issues of significance were identified.
c. Conclusions
The team concluded that SPEC personnel effectively implemented a maintenance
control program in accordance with their NRC approved QAP, work instructions, and
requirements contained in the packaging SAR and CoC for the SPEC150 and
SPEC300.
4. Entrance and Exit Meeting
On May 15, 2023, the NRC inspection team discussed the scope of the inspection
during an entrance meeting with Mike Sanchez and other members of the SPEC staff.
On May 18, 2023, the NRC inspection team presented the inspection results and
observations during an onsite debrief. On June 1, 2023, the NRC inspection team
conducted a final telephone conference exit with Mike Sanchez and other members of
SPEC staff. Section 1 of the attachment to this report shows the attendance for the
entrance and exit meetings.
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ATTACHMENT
1. ENTRANCE/EXIT MEETING ATTENDEES AND INDIVIDUALS INTERVIEWED
Name Title Affiliation Entrance Onsite Exit
Debrief
Jeremy Tapp Inspection Team Leader NRC X X X
Marlone Davis Inspector NRC X X X
Azmi Djapari Inspector (Trainee) NRC X X X
Andres Rowe Observer NRC X
Mike Sanchez Vice President & General SPEC X X X
Manager
Kristen Bonds Regulatory Manager & SPEC X X X
Assistant RSO
2. INSPECTION PROCEDURES AND OTHER NRC DOCUMENTS USED
IP 86001 Design, Fabrication, Testing, and Maintenance of Transportation
Packagings
NUREG/CR6407 Classification of Transportation Packaging and Dry Spent Fuel Storage
System Components According to Importance to Safety
NUREG/CR6314 Quality Assurance Inspections for Shipping and Storage Containers
3. LIST OF ITEMS OPENED, CLOSED, AND DISCUSSED
Item Number Status Type Description
710102/2023201-01 Opened and Closed NCV Failure to adequately store
records per procedure
710102/2023201-02 Opened and Closed NCV Failure to properly classify
and justify sealed source
capsule quality category
4. LIST OF ACRONYMS USED
ADAMS Agencywide Documents Access and Management System
CAP Corrective Action Program
CFR Code of Federal Regulations
CoC Certificate of Compliance
CPAR Corrective/Preventive Action Report
DFM Division of Fuel Management
GTAW Gas Tungsten Arc Welding
IMC Inspection Manual Chapter
IP Inspection Procedure
ITS Important-toSafety
M&TE Measuring and Test Equipment
NCR Nonconformance Report
Attachment
NCV Non-Cited Violation
NDE Nondestructive Examination
NRC Nuclear Regulatory Commission
PDR Public Document Room
PO Purchase Order
QA Quality Assurance
QAP Quality Assurance Program
QSPM Quality System Procedure Manual
SAR Safety Analysis Report
SPEC Source Production & Equipment Company, Inc.
5. DOCUMENTS REVIEWED
Certificate holder documents reviewed during the inspection were specifically identified in the
report details above.
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