IR 07100062/2022201
| ML23047A452 | |
| Person / Time | |
|---|---|
| Site: | 07100062 |
| Issue date: | 02/16/2023 |
| From: | Aida Rivera-Varona NRC/NMSS/DFM/IOB |
| To: | Bollinger C Industrial Nuclear Co |
| References | |
| EA-23-007 IR 2022201 | |
| Download: ML23047A452 (1) | |
Text
February 16, 2023
SUBJECT:
INDUSTRIAL NUCLEAR CO., INC. - NRC INSPECTION REPORT NO. 71-0062/2022-201 AND NOTICE OF VIOLATION
Dear Charles Bollinger:
This letter refers to the inspection conducted on November 30 to December 1, 2022, at the Industrial Nuclear Co., Inc. (INC) facility in San Leandro, CA. The inspection team continued the inspection activities with an in-office review and held an exit meeting on January 5, 2023. The purpose of the inspection was to verify and assess the adequacy of INCs activities associated with the transportation of radioactive material to determine if they were performed in accordance with the requirements of Title 10 of the Code of Federal Regulations (10 CFR) Part 71, Packaging and Transportation of Radioactive Material, and INCs U.S. Nuclear Regulatory Commission (NRC)-approved Certificates of Compliance (CoCs) and Quality Assurance Program (QAP). The inspection scope was limited to the review of corrective actions from the Severity Level IV Notices of Violation from a previous inspection conducted on May 25-27, 2021.
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 and interviews with personnel.
The enclosed report presents the results of this inspection.
Based on the results of this inspection, the NRC has determined that one Severity Level IV violation of NRC requirements occurred. The violation was evaluated in accordance with the NRC Enforcement Policy. The current Enforcement Policy is included on the NRC's website at https://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html The violation is cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding it are described in detail in the subject inspection report. The violation is being cited in the Notice because the certificate holder failed to restore compliance within a reasonable time after the violation was identified during the previous NRC inspection and the violation was continuing at the time of this inspection.
As discussed with you and your staff on February 15, 2023, the NRC staff has concerns about the violations that continue to be identified regarding your QAP implementation and has increased the routine inspection frequency from 5 years to 3 years in accordance with Inspection Manual Chapter 2690, Inspection Program for Storage of Spent Reactor Fuel and Reactor-Related Greater than 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.
The NRC has concluded that information regarding: (1) the reason for the violation(s); (2) the corrective actions that have been taken and the results achieved; and (3) the date when full compliance was achieved is already adequately addressed on the docket in the enclosed NRC Inspection Report No. 71-0062/2022-201. Therefore, you are not required to respond to this letter unless the description herein does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.
In accordance with 10 CFR 2.390 of the NRCs Rules of Practice, a copy of this letter, its enclosures, and your response if you choose to provide one, will be made available electronically for public inspection in the NRC Public Document Room or from the NRC's Agencywide Documents Access and Management System (ADAMS), accessible from the NRC website at http://www.nrc.gov/reading-rm/adams.html. To the extent possible, your response should not include any personal privacy or proprietary information so that it can be made available to the public without redaction.
Sincerely, Signed by Rivera-Varona, Aida on 02/16/23 Aida E. Rivera-Varona, Chief Inspection and Oversight Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards Docket No. 71-0062
Enclosures:
1. Inspection Report No. 71-0062/2022-201 2. Notice of Violation
Inspection Report
Docket No.: 71-0062 Report No.: 71-0062/2022-201 Certificate Holder: Industrial Nuclear Co., Inc.
14320 Wicks Blvd San Leandro, CA 94577 Inspection Dates: November 30-December 1, 2022 Inspectors: Jeremy Tapp, Transportation and Storage Safety Inspector, Team Leader Marlone Davis, Senior Transportation and Storage Safety Inspector Approved by: Aida E. Rivera-Varona, Chief Inspection and Oversight Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards
Enclosure 1
EXECUTIVE SUMMARY
Industrial Nuclear Co., Inc.
NRC Inspection Report 71-0062/2022-201 This limited scope follow-up inspection performed at Industrial Nuclear Co., Inc.s (INCs) facility in San Leandro, California from November 30-December 1, 2022, with additional in-office review through January 5, 2023, evaluated the corrective actions taken for the Severity Level IV Notices of Violation (NOVs) from a previous U.S. Nuclear Regulatory Commission (NRC)inspection conducted May 25-27, 2021. The focus of the inspection was to determine whether INC Title 10 of the Code of Federal Regulations (10 CFR) Part 71 corrective action activities were in accordance with commitments and requirements specified in their Certificates of Compliance (CoCs), Safety Analysis Report for Packaging, NRC-approved quality assurance program (QAP) for transportation of radioactive materials, and 10 CFR Part 71.
Based on the results of this inspection, the NRC inspection team assessed that the implementation of INCs QAP for corrective action continued to have issues in meeting NRC requirements and remains an area of improvement. The inspection resulted in a Severity Level IV violation of NRC requirements, which is summarized below and described in detail in the Report Details section of this inspection report. As stated in the cover letter to this inspection report, NRC staff held a management meeting on February 15, 2023, to discuss the issues that continue to be identified regarding your QAP implementation. In addition, the routine inspection frequency for INC has been put on an increased frequency.
Management Controls The team continued to identify INCs corrective action program (CAP) as an area for improvement as evidenced by the issue identified and described in the report. The team identified one violation of NRC requirements concerning the failure to promptly correct a condition adverse to quality when corrective actions regarding the issue described in corrective action report (CAR)21-005 were not taken within more than a one-year period since being opened. Due to the failure of INC to perform corrective actions and close issues in a timely manner in that an NRC identified issue from the previous inspection was still ongoing, the issue identified during this inspection is being cited in the enclosed Notice of Violation (Notice).
REPORT DETAILS
1. Management Controls
1.1 Corrective Actions Controls
a. Inspection Scope
The team reviewed selected records and interviewed personnel to verify that INC performed adequate corrective actions in accordance with the NRC-approved QAP and the requirements of 10 CFR Part 71. Specifically, the team reviewed INCs NRC-approved QAP, Design, Fabrication, Assembly and Testing of Type B Shipping Containers and Source Assemblies, Revision 15 and quality procedure (QP) 16.1, "Corrective Action, Revision 4. The team reviewed CARs21-001 through 21-005 that were written due to issues identified by the NRC during the 2021 routine NRC inspection along with INCs response to NRC Inspection Report No. 71-0062/2021-201 and Notice of Violation, dated October 27, 2021. The team reviewed these records and interviewed personnel to verify that INC completed corrective actions for identified deficiencies in a technically sound and timely manner.
b. Observations and Findings
During the review of CARs generated from the issues identified in the previous 2021 routine inspection, the team identified during the onsite inspection that CAR 21-005, dated 10/8/2021 was still open pending the implementation of corrective actions with an estimated completion date of 1/6/2022. INC opened CAR 21-005 because there was an allowance in QP 7.1, Step 10.0 for the addition of suppliers to INCs approved suppliers list (ASL) based solely on NRC approval of the QAP. The team found that QP 7.1 had not been updated as of the time of this inspection. The team noted that immediate corrective actions were taken to remove the one applicable supplier approved under this provision in QP 7.1 from the ASL. Since the violation issued by the NRC on 8/9/2021 was for QP 7.1 being an inadequate procedure, the team determined that the violation identified in August 2021 had not been corrected and was an ongoing issue. The CoC holder had failed to restore compliance within a reasonable time period. The team determined this was a violation of 10 CFR 71.133, Corrective action. In discussion with INC, the team determined that QP 7.1 was not revised in a timely manner because the one supplier approved for use using the inadequate supplier qualification method was removed from the ASL, and INC was in the process of determining how to best revise QP 7.1 without full recognition that revision of QP 7.1 was also necessary to achieve full compliance.
10 CFR 71.133, Corrective action states, in part, that the certificate holder (INC) shall establish measures to assure that conditions adverse to quality, such as deficiencies, deviations, defective material and equipment, and nonconformances, are promptly identified and corrected.
Contrary to the above, since January 2022, INC failed to assure that conditions adverse to quality were promptly corrected. Specifically, INC failed to promptly correct a condition adverse to quality when actions applicable to CAR 21-005 had not been performed to identify or implement corrective actions to bring QP 7.1 into compliance since August 2021.
The team assessed the significance of the violation using the NRC Enforcement Policy and Manual. The team determined that the violation was more than minor because of the potential for this issue to become more significant if left uncorrected. The team characterized the violation as a Severity Level IV violation in accordance with the NRCs Enforcement Policy, Section 6.8. This violation is being cited in the enclosed Notice.
The team noted that INC took corrective actions following discussion of this issue to come into full compliance. INC revised QP 7.1, effective 12/16/2022 to remove the inadequate supplier qualification Step 10.0. This corrective action was verified by the team and through INCs corrective action process and CAR 21-005 was closed to the actions taken on 12/19/2022.
c. Conclusions
The team continued to identify INCs 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 to promptly correct a condition adverse to quality when corrective actions regarding the issue described in CAR 21-005 were not taken within more than a one-year period since being opened. Due to the failure of INC to perform corrective actions and close issues in a timely manner in that an NRC identified issue from the previous inspection was still ongoing, the issue identified during this inspection is being cited in the enclosed Notice.
2. Entrance and Exit Meeting
On November 30, 2022, the NRC inspection team discussed the scope of the inspection during an entrance meeting with Mr. Mike Rose and other members of INC staff. On December 1, 2022, the NRC inspection team presented the inspection results and observations during an onsite preliminary exit meeting. On January 5, 2023, the NRC inspection team conducted a final telephone conference exit with Mr. Mike Rose and other members of INC staff. Section 1 of the attachment to this report shows the attendance for the entrance and exit meetings.
ATTACHMENT
1. ENTRANCE/EXIT MEETING ATTENDEES AND INDIVIDUALS INTERVIEWED
Name Title Affiliation Entrance Preliminary Exit Exit Jeremy Tapp Inspection Team NRC/DFM X X Leader Marlone Davis Inspector NRC/DFM X X X Mike Rose QA Manager INC X X X Ron Monteforte Quality Management INC X X X Consultant
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
3. LIST OF ITEMS OPENED, CLOSED, AND DISCUSSED
Item Number Status Type Description 71-0062/2022-201-01 Opened and NOV Failure to promptly correct Closed CAR 21-005 71-0062/2021-201-01 Closed NOV Failure to promptly correct CAR 2016-001 71-0062/2021-201-02 Closed NOV Failure to follow corrective action and audit procedures to enter a violation in the CAP and perform the 2016 internal audit 71-0062/2021-201-03 Closed NOV Failure to have adequate procedures in document control of quality records, material testing with an alloy analyzer, and allowable supplier qualification methods
4. LIST OF ACRONYMS USED
ADAMS Agencywide Documents Access and Management System ASL Approved Suppliers List CAP Corrective Action Program CAR Corrective Action Report CFR Code of Federal Regulations CoC Certificate of Compliance IMC Inspection Manual Chapter INC Industrial Nuclear Company, Inc.
IP Inspection Procedure ITS Important-to-Safety NOV Notice of Violation NRC Nuclear Regulatory Commission QAP Quality Assurance Program QP Quality Procedure
5.
DOCUMENTS REVIEWED
Certificate holder documents reviewed during the inspection were specifically identified in the
Report Details above.
NOTICE OF VIOLATION
Industrial Nuclear Co., Inc. Docket No. 07100062
San Leandro, CA EA-23-007
During a U.S. Nuclear Regulatory Commission (NRC) inspection conducted on
November 30, 2022, to January 5, 2023, one violation of NRC requirements was identified. In
accordance with the NRC Enforcement Policy, the violation is listed below:
CFR 71.133, Corrective action requires, in part, that the certificate holder shall
establish measures to assure that conditions adverse to quality, such as deficiencies,
deviations, defective material and equipment, and nonconformances, are promptly
identified and corrected.
Contrary to the above, since January 2022, INC failed to assure that conditions adverse
to quality were promptly corrected. Specifically, INC failed to promptly correct a condition
adverse to quality when actions applicable to CAR 21-005 had not been performed to
identify or implement corrective actions to bring QP 7.1 into compliance since August
21.
This is a Severity Level IV violation (Section 6.8).
The NRC has concluded that information regarding the reason for the violation, [if more than
one violation, specify which violation or violations] the corrective actions taken and planned to
correct the violation and prevent recurrence, and the date when full compliance will be (was)
achieved, is already adequately addressed on the docket in Inspection Report No.
71-0062/2022-201. However, you are required to submit a written statement or explanation
pursuant to 10 CFR 2.201 if the description therein does not accurately reflect your corrective
actions or your position. In that case, or if you choose to respond, clearly mark your response as
a "Reply to a Notice of Violation, (EA-23-007)," and send it to the U.S. Nuclear Regulatory
Commission, ATTN: Document Control Desk, Washington, DC 20555-0001 with a copy to Aida
Rivera-Varona, Chief, Inspection and Oversight Branch, Division of Fuel Management, Office of
Nuclear Material Safety and Safeguards, within 30 days of the date of the letter transmitting this
Notice of Violation (Notice).
If you choose to respond, your response will be made available electronically for public
inspection in the NRC Public Document Room or in the NRCs Agencywide Documents Access
and Management System (ADAMS), accessible from the NRC Website at
http://www.nrc.gov/reading-rm/adams.html. Therefore, to the extent possible, the response
should not include any personal privacy, proprietary, or safeguards information so that it can be
made available to the public without redaction.
In accordance with 10 CFR 19.11, you may be required to post this Notice within two working
days of receipt.
Dated this 16th day of February 2023.
Ltr ML23047A452 * via email
OFFICE NMSS/DFM/IOB* NSIR/DPR* NMSS/DFM/IOB
NAME JTapp JT JGoodridge JG ARivera-Varona AR
DATE Feb 16, 2023 Feb 16, 2023 Feb 16, 2023