ML23187A106

Source Production and Equipment Company (Spec) Inspection Report 71-0102/2023-201

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

ML23187A106

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

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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.

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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

1. 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

1. 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

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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

SPEC150 SAR and CoC.

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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