ML22151A127

Enclosure 1: Orano - Inspection Report 07100947/2022201

ML22151A127
Person / Time
Site:	07100947
Issue date:	06/01/2022
From:	NRC/NMSS/DFM/IOB
To:	Orano TLI
J TAPP NMSS/DFM/IOB 3014158047
Shared Package
ML22151A125	List: ML22151A126 ML22151A127 ML22151A128
References
IR 2022201
Download: ML22151A127 (14)

See also: IR 07100947/2022201

Text

U.S. NUCLEAR REGULATORY COMMISSION

Office of Nuclear Material Safety and Safeguards

Division of Fuel Management

Inspection Report

Docket No.: 71-0947

Report No.: 71-0947/2022-201

Certificate Holder: Orano-Transport Logistics International, Inc.

8161 Maple Lawn Blvd, Suite 480

Fulton, MD 20759

Facility: Container Products

Corporation 112 North

College Road Wilmington,

NC 28406

Inspection Dates: February 22-May 20, 2022

Inspectors: Jeremy Tapp, Transportation and Storage Safety Inspector, Team

Leader Jon Woodfield, Transportation and Storage Safety Inspector

Aaron Thomlinson, Quality Assurance Engineer

Approved by: Hipolito Gonzalez, Acting Chief

Inspection and Oversight Branch

Division of Fuel Management

Office of Nuclear Material Safety

and Safeguards

Enclosure 1

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EXECUTIVE SUMMARY

Orano-Transport Logistics International, Inc.

NRC Inspection Report 71-0947/2022-201

On February 22 through 24, 2022, the U.S. Nuclear Regulatory Commission (NRC) staff

conducted an announced onsite inspection at the Container Products Corporation (CPC) facility

in Wilmington, NC. The CPC is under contract with Orano-Transport Logistics International, Inc.

(TLI) to fabricate important-to-safety (ITS) components of the Versa-Pac transportation

packaging under Certificate of Compliance (CoC) 71-9342.

The purpose of the inspection was to verify and assess the adequacy of TLIs compliance with

the NRC requirements for the design, modification, fabrication, assembly, testing, and

procurement of Versa-Pac components. TLI is the holder of the CoC and designer of the Versa-

Pac transportation packaging.

Management Controls

• The team determined that the quality assurance (QA) controls at CPC were generally

adequate. The team concluded that CPC conducts its activities associated with QA

organization independence and QA responsibilities in accordance with their Quality

Assurance Manual (QAM). (Section 1.1)

• The team concluded that CPC has an adequate nonconformance control program in

place to ensure compliance with the applicable regulations and quality assurance

program (QAP) requirements. (Section 1.2)

• The team identified CPCs corrective action program (CAP) as an area for improvement

as evidenced by the issue identified and described in this report. The team identified one

Severity Level IV violation of 10 CFR 71.133, Corrective action for CPCs failure to take

adequate corrective actions from an issue identified during the previous inspection to

ensure that suppliers on its Qualified Suppliers List (QSL) received a triennial inspection

as required by the QAM and that the QSL was maintained current with qualified vendors.

(Section 1.3)

• The team concluded that CPC was effectively implementing its document and records

control program and had adequate procedures in place to ensure compliance with the

applicable regulations and QAP requirements. (Section 1.4)

• The team found that for the audits reviewed, CPC conducted the audits with qualified

personnel independent of the areas being audited and evaluated the applicable

functional areas of the QAP. (Section 1.5)

Enclosure 1

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Design Controls

• The team concluded that CPC was effectively implementing their design control

program. (Section 2.1)

Fabrication Controls

• The team determined that the procurement controls were adequate, and CPC was

generally effective in implementing their procurement program. (Section 3.1)

• CPC's implementation of fabrication controls for fabrication and assembly, including

material storage, was assessed to be adequate. (Section 3.2)

• The team assessed that CPC had adequate controls for inspection of the Versa-Pac and

it was generally being inspected per approved QA procedures and fabrication

specifications by qualified personnel. (Section 3.3)

• The team concluded that the measuring and test equipment (M&TE) quality procedure

being implemented at CPC provided adequate guidance for M&TE calibration and use,

and CPC adequately implemented M&TE calibration, tracking, and use requirements.

(Section 3.4)

REPORT DETAILS

1. Management Controls

1.1 Quality Assurance Policy

a. Inspection Scope

The team reviewed the Container Products Corporation (CPC) Quality Assurance Manual

(QAM), Revision 24 and the associated Quality Control Operating Procedures (QCOPs)

and Department Procedures to assess the effectiveness of the quality assurance program

(QAP) implementation. The team conducted reviews of CPCs quality program, policies,

and procedures, to determine whether activities subject to 10 CFR Part 71 were

adequately controlled and implemented under CPCs QAM.

Specifically, the team reviewed the QAP authorities and responsibilities to determine if they

were clearly defined and documented, and the quality assurance (QA) organization

functioned as an independent group.

b. Observations and Findings

The team assessed that CPC had a QAP and implementing procedures in place that were

generally effective in conducting activities in accordance with their QAM. No issues of

significance were identified.

Enclosure 1

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c. Conclusions

The team determined that the QA controls at CPC were generally adequate. The team

concluded that CPC conducts its activities associated with QA organization independence

and QA responsibilities in accordance with their QAM.

1.2 Nonconformance Controls

a. Scope

The team reviewed selected records and interviewed personnel to verify that CPC

effectively implemented a nonconformance control program in accordance with the

requirements of 10 CFR Part 71 and CPCs nonconformance procedures. The team

requested the Discrepancy Report (DR), CPCs term for a nonconformance report, logbook

for the current batch of 25 Versa-Pacs being fabricated and found that no DRs had been

written. Therefore, the team assessed CPCs nonconformance controls process.

The team reviewed the following Section of the CPC QAM, Revision 24, and QCOPs:

• QAP-1015, Non-Conforming Items, Revision G

• QCOP-2030, Discrepancy Reports, Revision 8

• QCOP-2050, Supplier Discrepancy Report, Revision 1

b. Observations and Findings

The team assessed that CPC had adequate procedures and controls in place for

dispositioning and tracking DRs to closure. No issues of significance were identified.

c. Conclusions

The team concluded that CPC has an adequate nonconformance control program in place

to ensure compliance with the applicable regulations and QAP requirements.

1.3 Corrective Actions Controls

a. Scope

The team reviewed selected records and interviewed personnel to verify that CPC

effectively implemented a CAP in accordance with the requirements of 10 CFR Part 71 and

CPCs corrective action procedures. The team requested the CPC corrective action report

(CAR) logbook for the current batch of 25 Versa-Pacs being fabricated and found that no

CARs had been written. Therefore, the team assessed CPCs CAR control process.

The team reviewed the following Section of the CPC QAM, Revision 24, and QCOP:

Enclosure 1

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• QAP-1015, Corrective Action, Revision J

• QCOP-2031, Corrective Action Report, Revision 0

Additionally, the team included a review of CAR 2019-03 that was opened during the

previous 2019 NRC inspection to determine whether the corrective actions taken to

address the issues were appropriate and was closed out in a timely manner in accordance

with CPC procedures.

b. Observations and Findings

The team assessed that CPC had adequate procedures and controls in place for

identifying and writing CARs, documenting corrective action(s) taken, performing a root

cause evaluation for significant conditions adverse to quality, documenting actions taken to

prevent recurrence, performing CAR closure verification, and tracking CARs to closure.

During the review of the corrective actions taken to close CAR 2019-03, dated March 4,

2019, that was opened during the previous 2019 inspection to correct several issues

identified by the NRC, the team noted that corrective actions were taken with respect to

CPCs failure to perform two supplier audits at the three-year frequency established in CPC

procedures to keep the suppliers on CPCs QSL. The CAR stated that the corrective action

taken was to update the QSL to address this. For the action to prevent recurrence, the

CAR only states to see the revised QSL dated February 6, 2019. The team reviewed the

most recent QSL dated April 26, 2021, and the latest supplier audit schedule provided by

CPC. The team identified that Airgas Performance Plus Division had not been audited

since November 14, 2016, and Branham Corporation had not received an audit since being

added to the QSL on August 23, 2018. Both remained on the QSL and the QSL stated that

their qualification basis was by audit.

The team determined a violation of 10 CFR 71.133, Corrective action occurred in that

CPC took inadequate corrective actions during the previous inspection to ensure that

applicable suppliers on its QSL received a triennial audit as required by the CPC QAM

Section QAP-1007, and that the QSL was maintained current with qualified vendors. At the

time of the inspection, Airgas Performance Plus Division and Branham Corporation had not

been audited in the past three years and remained on the QSL. 10 CFR 71.133 Corrective

action states, in part, that the certificate holder (CPC represents the Certificate of

Compliance (CoC) holder TLI) shall establish measures to assure that conditions adverse

to quality, such as deficiencies, deviations, defective material and equipment, and

nonconformances, are promptly identified and corrected. In the case of a significant

condition adverse to quality, the measures must assure that the cause of the condition is

determined and corrective action taken to preclude repetition.

Contrary to the above, CPC took inadequate corrective action from the 2019 inspection as

documented in CAR 2019-03 to preclude repetition of suppliers not being audited triennially

in order to keep the supplier on the QSL. Specifically, Airgas Performance Plus Division

and Branham Corporation have not been audited in the past three years but remained on

the QSL.

Enclosure 1

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The team dispositioned the violation using the traditional enforcement process in

Section 2.3 of the Enforcement Policy. The team determined the violation was 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 16.a; because the

adverse condition recurred. The team characterized the violation as a Severity Level IV

violation in accordance with the NRCs Enforcement Policy, Section 6.8. CPC and TLI

entered the issue into their CAPs under CAR # 2022-08 and 1215, respectively. This

violation is being cited in the enclosed Notice of Violation (Notice). (71-0947/2022-201-01).

c. Conclusions

The team identified CPCs CAP as an area for improvement as evidenced by the issue

identified and described above. The team identified one violation of NRC requirements

concerning the failure by CPC to take adequate corrective actions from an issue identified

during the previous inspection to ensure that suppliers on its QSL received a triennial

inspection as required by the QAM and that the QSL was maintained current with qualified

vendors.

1.4 Documentation Controls

a. Scope

The team reviewed CPCs documentation and records control program and quality

procedures to assess the effectiveness of controls established for the approval, issuance,

use, and revisions of quality documents. The team also reviewed a sample of CPC

documents (instructions, procedures, records, drawings, and specifications) to verify how

CPC developed and controlled quality related documents. Specifically, the team reviewed a

sample of controlled QAMs and quality procedures, controlled copy distribution lists, receipt

records of updated quality manuals, and fabrication drawing hard copies distributed to

various CPC departments, among the sample of documents reviewed. The team reviewed

the following Sections of the CPC QAM, Revision 24, and Department Procedure:

• QAP-1006, Document Control, Revision J

• QAP-1017, Quality Assurance Records, Revision J

• 1002, Engineering Department Procedure, Revision 9

The team also interviewed QA personnel regarding document and record controls. The

team interviewed the QA Manager regarding responsibilities for 1) controlled quality

procedures including access, revisions, and distribution; and 2) final document package

development, among the interviews performed.

Enclosure 1

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b. Observations and Findings

The team assessed that CPC had adequate and effective controls established by their

implementing procedures for the approval, issuance, use, storage, and revision of quality

documents and records. No issues of significance were identified.

c. Conclusions

The team concluded that CPC was effectively implementing its document and records

control program and had adequate procedures in place to ensure compliance with the

applicable regulations and QAP requirements.

1.5 Audit Program

a. Scope

The team reviewed selected records and interviewed personnel to verify that CPC

effectively implemented an internal audit program in accordance with the QAM and the

applicable requirements of 10 CFR Part 71. The team reviewed the qualifications, training

records, and annual evaluations for CPCs Quality Assurance Manager and external

auditor to determine if they met the requirements stated in the QAM.

The team reviewed the audit schedule and internal audits performed since the previous

2019 initial inspection to determine if they were performed in accordance with the QAM, if

CPC identified deficiencies, and whether CPC addressed these deficiencies within their

CAP. The team reviewed the following Sections of the CPC QAM:

• QAP-1002, Quality Assurance Program, Revision O

• QAP-1018, Audits, Revision K

b. Observations and Findings

No issues of significance were identified.

c. Conclusions

The team found that for the audits reviewed, CPC conducted the audits with qualified

personnel independent of the areas being audited and evaluated the applicable functional

areas of the QAP.

Enclosure 1

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2. Design Controls

2.1 Design Development

a. Scope

The team reviewed the design control Section of the CPC QAM and applicable

implementing quality procedures to verify that CPC properly implemented their design

control program. Specifically, the team reviewed the design control process between the

CoC holder TLI and the fabricator CPC.

The team focused its review on the translation of the TLI design specification and licensing

drawings to the CPC fabrication drawings and the controls that were in place. The team

reviewed a sampling of CPC fabrication drawings for the Versa-Pac assembly and piece

parts. The team verified that the fabrication drawings developed by CPC had received the

proper CPC and TLI review and approvals.

The team reviewed the following sections of the CPC QAM, Revision 24, and Department

Procedure:

• QAP-1003, Design Control, Revision H

• QAP-1005, Instructions, Procedures & Drawings, Revision D

• 1002, Engineering Department Procedure, Revision 9

b. Observations and Findings

The team assessed that CPC was following its engineering procedures, as applicable, to

ensure that fabrication drawings and any associated specifications were consistent with the

TLI licensing drawings approved by the NRC, and design requirements/commitments as

documented in the Versa-Pac CoC. The team also determined that the design document

approvals were performed as required. No issues of significance were identified.

c. Conclusions

The team concluded that CPC was effectively implementing their design control program.

Enclosure 1

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3. Fabrication Controls

3.1 Procurement Controls

a. Scope

The team reviewed CPCs procurement of ITS materials and services, which included the

review of procurement documents, drawings and procedures, and receipt inspection

records. The team reviewed the following sections of the CPC QAM, QCOP and

Department Procedure associated with procurement:

• QAP-1004, Procurement Document Control, Revision J

• QAP-1007, Control of Purchased Items & Services, Revision M

• QCOP-1001, Material Receipt Inspection, Revision 22

• 1004, Purchasing Department Procedure, Revision 11

The procedures were reviewed to verify if they were being properly implemented. The team

also reviewed CPCs QSL, dated April 26, 2021, to determine if materials and services

were being procured from qualified suppliers and the suppliers were being acceptably

qualified.

The team selected a sample of qualified suppliers and ITS materials for review. The

sample included sheet steel, weld wire, hardware, gasket material, and nondestructive

examination (NDE) services.

b. Observations and Findings

No issues of significance were identified.

c. Conclusions

The team determined that the procurement controls were adequate, and CPC was

generally effective in implementing their procurement program.

Enclosure 1

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3.2 Fabrication and Assembly

a. Scope

The team reviewed records associated with fabrication of the Versa-Pac packagings as

well as material storage controls to verify that the fabrication and storage processes were

properly controlled and implemented. Although there was no ongoing fabrication or

assembly activities while the team was onsite, the facility was toured to assess material

storage controls and fabrication controls for those Versa-Pacs on the shop floor at the time

of the inspection. The team reviewed the following sections of the CPC QAM, QCOPs and

Department Procedure associated with procurement:

• QAP-1008, Identification and Control of Materials, Parts, and Components, Revision

E

• QAP-1013, Handling Storage and Shipping, Revision E

• QAP-1014, Inspection, Test, and Operating Status, Revision E

• QCOP-1010, Shelf Life Verification, Revision 9

• QCOP-2003, Tagging Procedure, Revision 5

• QCOP-2029, Shipping, Handling, and Storage, Revision 4

• 1001, Manufacturing Department Procedures, Revision 1

A sample of travelers for Versa-Pacs currently being fabricated and three that were

completed were reviewed to verify that fabrication and test activities were accomplished

and appropriately documented according to controlled drawings and quality procedures.

b. Observations and Findings

No issues of significance were identified.

c. Conclusions

CPC's implementation of fabrication controls for fabrication and assembly, including

material storage, was assessed to be adequate.

Enclosure 1

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3.3 Test and Inspection

a. Scope

The team reviewed CPC processes and procedures that address inspection of the Versa-

Pac packaging. The team focused on the magnetic particle inspection (MT) NDE that was

ongoing during the onsite inspection. The team observed MT being performed on Versa-

Pac welds and interviewed personnel involved in the activity. The team reviewed the

qualifications of the individual performing the MT NDE. The team also reviewed a sample

of completed MT records from previous inspection activities on the Versa-Pacs being

fabricated. The team reviewed the following sections of the CPC QAM and the NDE

service providers procedure:

• QAP-1009, Control of Special Processes, Revision G

• QAP-1010, Inspection, Revision E

• SSPC-ASME-MT1, Magnetic Particle Inspection Procedure, Revision 2

b. Observations and Findings

No issues of significance were identified.

c. Conclusions

The team assessed that CPC had adequate controls for inspection of the Versa-Pac and it

was generally being inspected per approved QA procedures and fabrication specifications

by qualified personnel.

3.4 Tools and Equipment

a. Scope

The team reviewed selected M&TE and reviewed records and procedures to assure that

equipment used in activities affecting quality were properly controlled and calibrated. The

team reviewed the following Section of the CPC QAM and QCOP:

• QAP-1012, Control of Measuring and Test Equipment, Revision H

• QCOP-2011, Control of Measuring and Test Equipment, Revision 1

Specifically, the team reviewed the calibration records with respect to the light meter used

to ensure the flashlight used during the MT inspections observed exceeded the minimum

footcandle requirement.

Enclosure 1

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b. Observations and Findings

No issues of significance were identified.

c. Conclusions

The team concluded that the M&TE quality procedure being implemented at CPC provided

adequate guidance for M&TE calibration and use, and CPC adequately implemented

M&TE calibration, tracking, and use requirements.

4. Entrance and Exit Meeting

On February 22, 2022, the NRC inspection team discussed the scope of the inspection

during an entrance meeting with Andrew Langston and other members of the TLI and CPC

staff. On February 24, 2022, the NRC inspection team presented the inspection results and

observations during an onsite preliminary exit meeting. On May 20, 2022, the NRC

inspection team conducted a final telephone conference exit with Andrew Langston and

other members of the TLI and CPC staff. Section 1 of the attachment to this report shows

the attendance for the entrance and exit meetings.

Enclosure 1

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ATTACHMENT

1. ENTRANCE/EXIT MEETING ATTENDEES AND INDIVIDUALS INTERVIEWED

Name Title Affiliation Entrance Exit

Jeremy Tapp Inspection Team NRC/DFM X X

Leader

Jon Woodfield Inspector NRC/DFM X X

Aaron QA Engineer NRC/DFM X

Thomlinson

Andrew Langston Director, Engineering TLI X X

and Packaging

Services

Alex Jones Chemical Engineer TLI X X

Tom Barron Designate, QA TLI X

Dwight Campbell President CPC X

Tammy Thurston QA Manager CPC X X

Brian Schave QC Supervisor CPC X

Katie Fletcher Sales CPC X

Alex Thomas Buyer CPC X

Rhonda Hahn Engineering CPC X

2. INSPECTION PROCEDURES USED

IP 86001 Design, Fabrication, Testing, and Maintenance of Transportation

Packagings

NUREG/CR-6407 Classification of Transportation Packaging and Dry Spent Fuel Storage

System Components According to Importance to Safety

NUREG/CR 6314 Quality Assurance Inspections for Shipping and Storage Containers

Enclosure 1

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3. LIST OF ITEMS OPENED, CLOSED, AND DISCUSSED

Item Number Status Type Description

71-0947/2022-201-01 Opened NOV Inadequate corrective actions to

prevent recurrence of failure to perform

triennial audits of suppliers

4. LIST OF ACRONYMS USED

ADAMS Agencywide Documents Access and Management System

ASME American Society of Mechanical Engineers

ASTM American Society for Testing and Materials

CAP Corrective Action Program

CAR Corrective Action Report

CFR Code of Federal Regulations

CoC Certificate of Compliance

CPC Container Products Corporation

DR Discrepancy Report

IP Inspection Procedure

ITS Important-to-Safety

M&TE Measuring and Test Equipment

MT Magnetic Particle Inspection

NDE Nondestructive Examination

Notice Notice of Violation

NRC Nuclear Regulatory Commission

QA Quality Assurance

QAM Quality Assurance Manual

QAP Quality Assurance Program

QCOP Quality Control Operating Procedure

QSL Qualified Suppliers List

TLI Orano-Transport Logistics International, Inc.

5. DOCUMENTS REVIEWED

Certificate holder and fabricator documents reviewed during the inspection were specifically

identified in the Report Details above.

Enclosure 1