IR 07100086/2021201
| ML21106A081 | |
| Person / Time | |
|---|---|
| Site: | 07100086 |
| Issue date: | 04/15/2021 |
| From: | Jeremy Tapp NRC/NMSS/DFM/IOB |
| To: | Hedger T Alpha-Omega Services |
| JETapp NMSS/DFM/IOB 301.415.8047 | |
| References | |
| IR 2021201 | |
| Download: ML21106A081 (10) | |
Text
U.S. NUCLEAR REGULATORY COMMISSION SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION NRC FORM 591S PART 1 (11-2020)
10 CFR 2.201 REPORT NUMBER(S) CERTIFICATE/QUALITY ASSURANCE PROGRAM (QAP) HOLDER:
2. NRC/REGIONAL OFFICE CERTIFICATE/QAP DOCKET NUMBER(S)
4. INSPECTION LOCATION 5. DATE(S) OF INSPECTION CERTIFICATE/QUALITY ASSURANCE PROGRAM HOLDER:
The inspection was an examination of the activities conducted under your QAP as they relate to compliance with the Nuclear Regulatory Commission (NRC) rules and regulations and the conditions of your QAP Approval and/or Certificate(s) of Compliance. The inspection consisted of selective examinations of procedures and representative records, interviews with personnel, and observations by the inspecto The inspection findings are as follows:
1.
Based on the inspection findings, no violations were identified.
2.
Previous violation(s) closed.
3.
The violations(s), specifically described to you by the inspector as non-cited violations, are not being cited because they were self-identified, non-repetitive, and corrective action was or is being taken, and the remaining criteria in the NRC Enforcement Policy, to exercise discretion, were satisfied.
4.
Non-cited violation(s) was/were discussed involving the following requirement(s) and Corrective Actions(s):
During this inspection, certain of your activities, as described below and/or attached, were in violation of NRC requirements and are being cited in accordance with NRC Enforcement Policy. This form is a NOTICE OF VIOLATION, which may be subject to posting in accordance with 10 CFR 19.11.
(Violations and Corrective Actions)
Statement of Corrective Actions I hereby state that, within 30 days, the actions described by me to the Inspector will be taken to correct the violations identifie This statement of corrective actions is made in accordance with the requirements of 10 CFR 2.201 (corrective steps already taken, corrective steps which will be taken, date when full compliance will be achieved). I understand that no further written response to NRC will be required, unless specifically requested.
TITLE PRINTED NAME SIGNATURE DATE CERTIFICATE/QAP REPRESENTATIVE NRC INSPECTOR NRC FORM 591S PART 1 (11-2020)
BRANCH CHIEF Alpha-Omega Services, In Rose Street Bellflower, CA 90706 71-0086/2021-201 71-0086 (QAP)
Bellflower, CA (Remote)
Troy Hedger Jeremy Tapp Leira Cuadrado Headquarters U. S. Nuclear Regulatory Commission Mail Stop TWFN 4A-60 Washington, DC 20555-0001 March 8-11, 2021 04/14/2021 Jeremy E. Tapp Digitally signed by Jeremy E. Tapp Date: 2021.04.15 09:02:18 -04'00'
Leira Y. Cuadrado-Caraballo Digitally signed by Leira Y. Cuadrado-Caraballo Date: 2021.04.15 09:48:38 -04'00'
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INSPECTOR NOTES COVER SHEET
Licensee/Certificate Holder (name and address)
Alpha-Omega Services, In Rose Street Bellflower, CA 90706 Licensee/Certificate Holder contact and phone number
Mr. Troy Hedger, CEO 562-804-0604 Docket N Inspection Report N /2021-201 Inspection Dates(s)
March 8-11, 2021 Inspection Location(s)
Bellflower, CA (Remote inspection)
Inspectors Jeremy Tapp, Team Leader, Safety Inspector Jon Woodfield, Safety Inspector Matthew Learn, Safety Inspector
Summary of Findings and Actions
The purpose of the inspection was to verify the adequacy of activities related to design, modification, procurement, repair, and maintenance of transportation packagings at Alpha-Omega Services, Inc. (AOS) facility in Bellflower, C The focus of the inspection was to determine whether AOS activities associated with transportation of radioactive material were executed in accordance with the requirements of 10 CFR Parts 21 and 71, Certificate of Compliance 71-9316 and associated Safety Analysis Report (SAR),
and AOS NRC-approved quality assurance (QA) progra The team determined that AOS implementation of its NRC-approved QA program was adequate based on an examination of selected design, maintenance, and QA activity records and procedures, and interviews with personne No issues of more than minor significance were identifie Lead Inspector Signature/Date
Jeremy Tapp Inspector Notes Approval Branch Chief Signature/Date
Jeremy E. Tapp Digitally signed by Jeremy E. Tapp Date: 2021.04.15 09:02:53 -04'00'
Leira Y. Cuadrado-Caraballo Digitally signed by Leira Cuadrado-Caraballo Date: 2021.04.15 09:49:15 -04'00'
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Inspection Background
Alpha-Omega Services, Inc. (AOS) corporate was last inspected in March 2016 and before that in February 201 The inspection in March 2016 was a full scope review of all aspects of AOS quality progra The inspection resulted in the identification of two violations of minor safety significance related to independent verification and classification of quality component Both issues were entered into AOS corrective action progra In addition, since the last inspection in March 2016, AOS has not fully completed fabrication of any packaging Inspection Purpose
The purpose of the full scope inspection was to assess AOS activities associated with transportation of radioactive material to determine if they were executed in accordance with the requirements of 10 CFR Parts 21 and 71, Certificate of Compliance (CoC) 9316 for the AOS-25/50/100 packagings and associated Safety Analysis Report (SAR), and AOS NRC-approved QA progra Overall, the team inspected AOS management, design, and maintenance control The team reviewed QA program implementing procedures and instructions, and selected documents, records, and drawing The team also reviewed various design and maintenance activities of the AOS-25/50/100 packagings approved by CoC 71-931 Because AOS has not fully completed fabrication of any packagings since the last inspection, the team focused on performance of maintenance activities for the current packagings in use, and on design activities related to a number of modifications performe Primary Inspection Procedures/Guidance Documents
- IP-86001, "Design, Fabrication, Testing, and Maintenance of Transportation Packagings"
NUREG/CR-6314, "Quality Assurance Inspections for Shipping and Storage Containers"
NUREG/CR-6407, "Classification of Transportation Packaging and Dry Spent Fuel Storage System Components According to Importance to Safety"
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INSPECTOR NOTES: APPLICABLE SECTIONS FROM IP 86001 WERE PERFORMED DURING THE INSPECTION WITH RESULTS DOCUMENTED BELOW UNDER THE BASIC HEADINGS OUTLINED IN NUREG-6314 Management Controls
Quality Assurance Policy
The team reviewed AOS Quality Assurance Program (QAP) PR9000 Revision H and implementing AOS Quality Procedures [Standard Operating Procedures (SOPs)] and assessed the effectiveness of the QA program implementation at AO The team conducted reviews of AOS quality program, policies, and procedures, and discussed portions of the reviewed documents with selected AOS staff to determine whether activities subject to 10 CFR Part 71 were adequately controlled and implemented under AOS NRC-approved QA progra In addition, the team reviewed the AOS quality organization chart and interviewed AOS QA personnel to assess their organizational independence from cost, schedule, and production activitie The team reviewed procedures and documents regarding training, qualification, and certification of personnel involved in quality activitie Specifically, the team reviewed the following SOPs:
PR9000.1, Quality Assurance Program and Implementing Procedures, Revision U PR9001.1, Organization and Responsibility, Revision F PR9002.1, Control of the Quality Assurance Program Revisions, Revision E PR9002.2, Indoctrination and Training of Personnel, Revision H
The team reviewed the qualifications and training for selected Quality Managers, Quality Engineers, and Service staff to determine if they met the requirements stated in the QA progra In addition, the team reviewed training records of a random selection of employees in quality related positions to determine if they received the required QA indoctrination and QAP revision trainin The team determined that for every AOS staff members records reviewed, each had completed the required training and attained the applicable qualifications to perform their dutie The team also reviewed the following AOS SOPs which address a graded approach to quality components and commercial grade dedication of packaging components when required:
PR9003.7, Identification of Quality Categories and Safety Classifications, Revision C PR9007.1, Control of Purchased Material, Equipment, and Services, Revision H PR9007.5, Dedication of Commercial Grade Items and Services, Revision F
The team verified that the material commercial grade dedication program/procedure included requirements for the identification, documentation, and implementation of important-to-safety levels in dedication plan The procedure provided significant guidance on the identification of critical characteristics needed during the dedication proces The dedication report must
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provide the acceptance criteria for each critical characteristic and identification of the method of verificatio Guidance on the associated audits or approvals of the supplier or testing company commensurate with the safety rating of the part or material being procured is also provided in the procedure Overall, the team determined that the quality assurance controls at AOS were adequate and in accordance with their NRC-approved QA No issues of more than minor significance were identifie Nonconformance and Corrective Action Controls
The team reviewed a sample of nonconformance reports (NCRs) and Corrective and Preventive Actions (CAPAs) generated since the previous NRC inspection and interviewed personnel to verify that AOS effectively implemented the nonconformance control and corrective action program The team also reviewed AOS SOPs PR9015.1, "Nonconforming Material, Parts, and Components," Revision E and PR9016.1, "Corrective Action," Revision E that govern the nonconformance and corrective action programs, respectivel The team reviewed the SOPs for compliance with the applicable regulations in 10 CFR Part 7 The team also specifically reviewed the five CAPAs written during the NRC 2016 AOS inspection to assess their corrective and preventive actions, as applicable, and resolution and closur The team determined that all five CAPAs adequately addressed the issues they were written for and were properly close The team discussed the nonconformance and CAPA program controls with the AOS staff and reviewed a sample of 12 NCRs and 12 CAPAs for appropriate dispositio The team also reviewed the AOS NCR log used to keep track of the status of nonconforming item The team focused on CAPAs that had cause analyses for a condition adverse to quality or a significant condition adverse to qualit The CAPA sample included a review of SOP compliance issues, audit findings, drawing issues, shipping issues, and nonconformances that needed a CAP The team verified that AOS completed CAPAs for identified deficiencies in a technically sound and timely manne The nonconformance sample reviewed by the team was focused on reports associated with accept-as-is and repair/rework disposition The team determined AOS dispositioned the NCRs in accordance with PR9015.1, as require AOS QA is responsible for evaluating quarterly, in conjunction with an NCR review, the effectiveness of the corrective action progra The quarterly report also provides trend analysis and identifies CAPA and NCR recurring issues and deficiencie After the report is prepared, it is reported to management for revie The team reviewed the latest CAPA and NCR trend analysis report and determined it was thorough in its evaluation for negative trends in quality area The team also verified that the CAPAs and NCRs reviewed and the standard forms they were written on had a connection to the 10 CFR Part 21 progra Page 5 of 9
The team reviewed the AOS program controls for 10 CFR Part 21, "Reporting of Defects and Noncompliances," and the associated SOP PR9015.2, "Regulatory Requirements Reportability,"
Revision The team verified that AOS' procedure adequately implemented the requirements of Part 2 Since this inspection was performed remotely, AOS provided electronic photographs of the 10 CFR Part 21 postings at their facilitie By reviewing the photographic evidence, the team verified that AOS was meeting the 10 CFR Part 21 posting requirements of both the regulations and PR901 The team determined that AOS posted the 10 CFR Part 21 regulations, Section 206 of the Energy Reorganization Act of 1974, Form 3, and PR9015.2 on boards where employees could easily see the No issues were identified by the team regarding 10 CFR Part 21 program controls or implementation at AO Overall, the team concluded that AOS had an adequate nonconformance control and corrective action program in place to identify, track, and resolve quality related deficiencies and deviation Documentation Controls
The team reviewed AOS documentation control program to assess the effectiveness of controls established for the approval, issuance, revision and use of quality document The team reviewed PR9006.1, Document Control, Revision The team assessed that the procedure provided adequate guidance for the processing of quality document approvals, issuance to internal and external organizations when necessary, and revision control for each documented organizatio For a sample of quality documents reviewed, the team verified that the documents were approved per procedure by appropriate personnel and the most current version was available for us The team observed AOS use of their document management and storage system for procedure control and use and noted it was controlled in accordance with the applicable requirements of PR900 The team interviewed personnel responsible for the program to ensure they were knowledgeable of the program requirements and were implementing the program as require The team also verified that a sample of procedure revisions were performed as required, including the associated forms required for the revision In addition, the team reviewed PR9017.1, Quality Assurance Records, Revision The team then discussed with document control and QA personnel how the applicable regulatory and procedural requirements for quality record control were being implemented by AOS QA program to ensure they were being performed as require Specifically, the team discussed where and how the quality documents were store The team noted that AOS stores multiple copies of electronic records on the company servers and on hard drives made regularly as permanent backup The company servers are located in different physical locations and the hard drives are stored at a different location than where the company servers are locate The team also verified that selected quality documents were filed and in the appropriate location on one of the quality record file server Page 6 of 9
Overall, the team determined that AOS was implementing its document control program, including quality record control, as required by the applicable regulatory and procedural requirement Audit Program
The team reviewed the AOS QAP and the following implementing procedures for performing external audits of AOS vendors on its Approved Suppliers List (ASL) and internal audits of AO PR9002.5, Qualification and Certification of Quality Assurance Audit Personnel, Revision E PR9018.1, Audits, Revision C
The team reviewed the qualifications and training records for AOS two Lead Auditors to determine if they met the requirements stated in PR900 The team found each had completed the required training and attained the applicable qualifications to perform their duties as lead audito The team reviewed the audits of two vendors on the AS The two vendors were on the ASL for: 1) Supplier of Important-To-Safety and Safety-Related Design and Engineering Services, and 2) Provider of Nondestructive Examination Methods (VT, PT, and LT).
The first audit reviewed by the team was a quality assurance program audit performed by AOS in August 2018 of a design and engineering services vendo The team found the audit package to contain the proper forms for audit summary, nuclear audit checklist, and audit pla The audit summary identified the product or service provided, activities audited, scope of the audit, summary of results, audit results, effectiveness of the quality system program, conclusion, and audit observation AOS in correspondence to the vendor identified six observations during the audi AOS requested a written response from the vendor when actions were completed to address the issue Overall, AOS found the vendor to be in compliance with its Quality Assurance Program and will be retained on the ASL, however with certain restriction These restrictions are shown on the ASL for this vendo AOS audit certification of this vendor will remain in effect for a period of three years until August 27, 202 The second audit reviewed by the team was a quality assurance program audit performed by AOS in April 2019 of a nondestructive examination vendo The team found the audit package to contain the proper forms for audit summary, nuclear audit checklist, and audit pla The audit summary identified the product or service provided, activities audited, scope of the audit, summary of results, follow-up, effectiveness of the quality system program, conclusion, audit observations, and recommendation AOS in correspondence to the vendor identified 12 observations and three recommendation findings during the audi AOS issued CAPAs to the vendor for the findings which required a written respons Overall, AOS found the vendor to be in compliance with its Quality Assurance Program and were retained on the ASL, however with certain restriction These restrictions are shown on the ASL for this vendo AOS audit certification of this vendor will remain in effect for a period of three years until April 22, 202 Page 7 of 9
The team found the sampled vendor audit results to be very detailed and well documented with the findings, audit checklists, supporting audit documentation reviewed, and vendor written responses all recorded and retrievabl All the requirements of procedure PR9018.1 were found to be me No concerns were identified by the team in the review of external audit The team reviewed the latest AOS internal audit report conducted in July and August 2020, which covered AOS implementation of their QAP and SOPs and verified compliance with the quality requirements stated in 10 CFR Part 71 Subpart H and 10 CFR Part 2 Internal audits are required to be performed by AOS on a yearly basis per PR901 However, the 2019 internal audit, which was to be performed in March and April of 2020, was delayed until July and August due to the COVID-19 public health emergency, which was past the timeframe allowed by PR901 The inability of AOS to perform the internal audit as required by PR9018.1 was documented in a CAPA to evaluate and track the issue, as require The audit was also conducted remotely due to the public health emergenc The 2019 audit team consisted of one auditor contracted to AO An audit plan, audit checklist, and audit summary were developed as required by PR901 The team reviewed the audit results in the 2019 repor The audit identified six comments and assigned a CAPA number to address the issues and internal discussions and track them to closur The 2019 Internal Audit Report also reviewed all the elements of the 2018 Internal Audit and any identified audit findings for completion and adherence to committed action The team found the audit results to be very detailed and the comments, audit checklists, and supporting audit documents reviewed well documented; along with a CAPA assigned to document the comments and discussions identifie The team determined that the internal audit was very effective in its structured approach for finding issues affecting quality at AOS and was performed in accordance with PR901 No concerns were identified by the team in the internal audit revie Overall, no concerns were identified with the performance of AOS ASL audits of external suppliers or internal audit.0 Design Controls
The team reviewed the AOS procedures specifically related to design development/control for modification activities and held discussions with AOS engineering and QA personne The team also reviewed the training and qualification for selected engineering personne The team focused its review on AOS design activities related to Revisions 7, 8, and 9 of CoC 9316 for the Part 71 AOS-025A/050A/100A/100B/100A-S packaging The team reviewed the following AOS SOPs associated with design control and training to verify they were being properly implemented:
- PR9003.1, "Design Control," Rev. D
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- PR9003.2, "Project Plan," Rev. B
- PR9003.3, Calculations, Rev. C
- PR9003.5, Design Review, Rev. D
- PR9002.6, Qualification of Engineering Personnel, Rev. C
The team reviewed the applicable design documentation for the modifications performed for Revisions 7, 8, and 9 of CoC 931 This included calculations, revised drawings and SAR pages, and design record file The team verified the applicable drawings were revised per PR9005.1, Drawings, Revision C, and calculations performed, as necessary, including proper review and acceptance of those performed by approved suppliers as required by quality procedure In addition, the team reviewed a selected licensing drawing to verify the design details were adequately translated to the associated fabrication drawing Specifically, the team reviewed licensing drawing 166D8137, Revision I and compared it to three related fabrication drawing For the design details reviewed, all were correctly translated to the fabrication drawing Overall, the team found the AOS design control program to be adequate and that implementing procedures were in place to control activities in accordance with the applicable regulations and approved Co No issues of more than minor significance were identifie.0 Maintenance Controls
Maintenance Activities
The team reviewed AOS' packaging maintenance program which requires a series of routine and periodic inspection The team specifically reviewed AOS SOP PR9110, "AOS Radioactive Material Transport Packaging System Generic Maintenance and Operating Procedure for Model AOS-025, AOS-050, and AOS-100 Transport Packages," Revision AOS stated that procedure PR9110 is provided to all the licensed users of its AOS series packaging The procedure covers the required actions to properly maintain the packaging, including pre-shipment inspection The team compared the instructions in the procedure for the various packaging activities against the approved operating procedures and maintenance requirements provided in Chapter 7 and 8 of the AOS packaging SAR and found them to be consistent as it relates to inspection and maintenanc AOS performs an annual inspection of the AOS packagings or prior to being used after a storage period of more than one yea The annual inspection is performed in accordance with PR9110.1, "Annual Maintenance Procedure for AOS Transport Packaging System," Revision The team reviewed AOS Form FM9110.4, "AOS Annual Inspection Plan Check Sheet," that is used to document the annual maintenance was performed on each packagin After the inspection, AOS generates a certificate of compliance for the packaging user certifying that the annual inspections and maintenance have been performe The team reviewed the CoC Annual Maintenance Certification for a sample of packaging The CoC contained detailed information that included an effective date and expiration date (period of one year). The team
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found the documentation for the packaging periodic and annual maintenance program at AOS to be complet Packaging annual inspections and tests could be outsourced to an AOS approved supplier or performed by AOS personnel who have been qualified and certified in accordance with SOP PR9002.3, "Qualification and Certification of Inspection & Test (I&T) Personnel," and SOP PR9002.4, "Qualification and Certification of Nondestructive Examination (NDE) Personnel."
The team reviewed a sample of training records for the individuals that performed annual maintenanc The team found the training records thorough and curren The team reviewed PR9007.4, "Receiving Inspection," Revision D, and PR9008.1,
"Identification and Control of Materials, Parts and Components," Revision C, which address receipt inspection and control of material The team reviewed a sample of procurement and receipt inspection of material Tools and Equipment
The team reviewed AOS SOP PR9012.1, Control of Measuring and Test Equipment, Revision G for the QA requirements for control of measuring and test equipment (M&TE) to verify that it was being properly implemente In general, at AOS the calibration of M&TE was subcontracted to and performed by approved supplier The team noted that AOS inspection/maintenance personnel are responsible to report on work travelers, or appropriate documentation, the M&TE serial number and calibration data used for all inspections and test They are also required prior to use to 1) ensure M&TE is identified with a serial number and a calibration label, 2) the M&TE has been calibrated and the calibration has not expired, and 3)
the M&TE is in good working orde AOS QA prepares and controls the M&TE Equipment Log in a databas The Equipment Log lists all M&TE used in activities affecting the quality of AOS packaging and includes calibration and preventive maintenance requirement Using the Equipment Log, inspection generates a report to identify the M&TE requiring calibratio The team reviewed the Equipment Log and current calibration documentation/record The team reviewed AOS' Acceptance of Calibration Services Form for a sample of calibrated equipmen The team also reviewed Calibration Certificates for a sample of calibrated equipment received from outside vendor Overall, the team found the AOS packaging maintenance and M&TE programs to be adequat No issues of more than minor significance were identified.