ML19324F291
| ML19324F291 | |
| Person / Time | |
|---|---|
| Issue date: | 12/31/2019 |
| From: | NRC/NRR/DRO/IQVB |
| To: | Chris Miller NRC/NRR/DRO |
| Park D | |
| References | |
| Download: ML19324F291 (9) | |
Text
THE VENDOR TIMES NRC/NRR/DRO The Vendor Times December 2019 The Directors Cut In fiscal year (FY) 2019, the U.S. Nuclear Regulatory Commissions (NRCs) vendor inspection program (VIP) completed its transition to the Division of Reactor Oversight (DRO) in the Office of Nuclear Reactor Regulation (NRR). We conducted a total of 20 inspections for both new and operating reactors, including vendor, quality assur-ance (QA) implementation, and aircraft impact assessment (AIA) inspections. Not counted in these 20 inspections were observations of Korea Institute of Nuclear Safety and Nuclear Procurement Issues Corporation (NUPIC) audits, and an Interna-tional Laboratory Accreditation Cooperation (ILAC) NUPIC observation.
The NRC has maintained a VIP focused on ensuring the integrity of the nuclear sup- Chris Miller, ply chain, an objective that is critical to ensuring the safety of the nations nuclear pow- Director, er fleet. Through direct inspection of suppliers of nuclear safety-related materials, com- Division of Reactor Oversight ponents, and services, the NRCs VIP provides the regulatory oversight necessary to ensure the integrity, quality, and performance of the materials, components, and ser-vices that are relied upon to maintain nuclear safety. Since the establishment of the VIP, the mission has not changed, and we continue to verify the effective implementation of the vendors QA programs, and that de-sign requirements contained in the licensing documents are correctly implemented during engineering, pro-curement, fabrication, and testing activities. Quality Assurance and Vendor Inspection Branch (IQVB) inspec-tors observed that licensees are providing effective oversight of their supply chain and that the quality of ma-terials, equipment, and services supplied by vendors are consistent with the regulations. Compliance to the applicable regulatory requirements is an essential part of the NRCs mission to protect public health and safe-ty. QA must be included from start to finish for the components provided to US Licensees.
The vendor inspection staff will continue to communicate with the nuclear supply chain stakeholders via the NRCs 2020 Workshop on Vendor Oversight. Our oversight consists of three primary activities: (1) direct in-spections of vendors providing safety-related components, materials, and services, (2) observation of joint utility audits of suppliers conducted via NUPIC, and (3) NRC participation on the American Society of Me-chanical Engineers (ASME) Committee on Nuclear Certification (CNC) and Committee on Authorized Inspec-tion Agencies (CAA) which oversees the accreditation of ASME certificate holders and the authorized inspec-tion agencies, respectively. We continue to engage industry organizations such as NUPIC, the Multinational Design Evaluation Program (MDEP) Vendor Inspection Cooperation Working Group (VICWG), the Electric Power Research Institute (EPRI) Joint Utility Task Group (JUTG), and the ASME Nuclear Quality Assurance-1 (NQA-1). The Vendor Workshop is scheduled for June 18, 2020 in Baltimore, MD. Based on stakeholder feedback, the Vendor Workshop topics are going back to the basics.
Our inspection reports are publicly available on the NRCs Vendor Quality Assurance Inspection Web site at https://www.nrc.gov/reactors/new-reactors/oversight/quality-assurance/vendor-insp.html.
In This Issue:
The Directors Cut 2019 Vendor Inspection Trends 2020 Vendor Workshop Quality Assurance and Inspection Public Web Pages Incorporation of Safety Conscious Work Environment (SCWE) in Vendor Inspections MDEP 3rd Multinational Inspection at ENSA Issues Identified with the Environmental Qualification Thermal Aging Analyses for Electric Equipment Important to Safety Oversight of the Strategic Alliance for FLEX Emergency Response (SAFER) Program Provisional Recognition of ISO/IEC 17025:2017
The Vendor Times December 2019 2 2019 Vendor Inspection Trends The Vendor Inspection Program Plan (VIPP) verifies that reactor applicants and licensees are fulfilling their regulatory obligations with respect to providing effec-tive oversight of the supply chain. It accomplishes this through a number of activities, including: perform-ing vendor inspections that will verify the effective im-plementation of the vendors QA program, establish-ing a strategy for vendor identification and selection, and ensuring vendor inspectors obtain the necessary knowledge and skills to perform inspections. In addi-tion, the VIPP addresses interactions with nuclear consensus standard organizations, industry and exter-nal stakeholders, and international constituents.
From October 1, 2018 to September 30, 2019, the vendor inspection staff completed a total of 23 activi-ties, which included 20 vendor inspections, one obser-vation of the Korean Institute of Nuclear Safety Vendor Inspections (KINS), and two NUPIC observations. These inspec-tions assessed vendor compliance to provisions of Appendix B, Quality Assurance Program Criteria for of Defects and Noncompliance. The NRC issued a Nuclear Power Plants and Fuel Reprocessing Plants, total of seven Notice of Nonconformances (NONs) to Title 10 of the Code of Federal Regulations (10 against vendors during FY 2019. The decrease in the CFR) Part 50, Domestic Licensing of Production and total number of NONs from FY 2018 to FY 2019 follows Utilization Facilities, and 10 CFR Part 21, Reporting a similar decrease from FY 2017 to FY 2018, during a time of a decreasing number of vendor inspections from both FY 2017 to FY 2018, and then again from FY 2018 to FY 2019. Regarding 10 CFR Part 21, no No-tice of Violations (NOVs) were issued to vendors during FY 2019, as was the case during FY 2018.
The balanced spread of one to two NONs each (among various different Appendix B criteria) demonstrates the continued need to distribute our inspection resources for maximum efficiency throughout the industrys supply chain. Although it is anticipated that the number of ven-dor inspections necessary for routine oversight, and inspection, tests, analyses and acceptance criteria (ITAAC) review associated with new reactor projects will continue to decline, there has been an increasing trend in the number of allegation related inspections. In addition to the inspections for new and operating reac-tors, it is also anticipated that we will need to continue to perform limited inspections of vendors safeguards information programs and inspections of National Stra-tegic Alliance for FLEX Emergency Response (SAFER)
Vendor Inspection Findings facilities.
The Vendor Times December 2019 3 Incorporation of Safety Conscious Work Environment in Vendor Inspections As the Agency transforms, the Office of New Reactors has been merged into the Office of Nuclear Reactor Regulation (NRR). With this merger, the IQVB is cur-rently reviewing and updating Inspection Manual Chapters, Inspection Procedures and staff guidance documents. One of the of the areas currently being updated is the inclusion of Safety Conscious Work En-2020 Vendor Workshop vironment (SCWE) observations and assessments into the VIP. Although SCWE observations and assess-ments have been performed at vendor facilities in the past, no documented guidance existed for the vendor inspection staff. In efforts to align with NRR, guidance has been included in an Inspection Manual Chapter.
2010 Vendor Workshop in New Orleans, LA The inclusion of SCWE in Inspection Manual Chapter 0617, Vendor Quality Assurance Implementation In-2020 Vendor Workshop spection Reports, does not change the expectations of past vendor SCWE practices. Identified strengths The Division of Reactor Oversight (DRO), Office of and weaknesses are documented in vendor inspection Nuclear Reactor Regulation, is planning their 2020 reports subsequent to review and approval by IQVBs Vendor Workshop scheduled for June 18, 2020 in Branch Chief.
Baltimore, Maryland. Since 2008, the vendor in- - Aaron Armstrong, Reactor Operations Engineer spection program has facilitated biennial public workshops related to vendor oversight. These ven- Quality Assurance and Vendor dor workshops generate an audience of approxi- Inspection Public Web Pages mately 500 individuals, comprised of industry repre- As an Agency that prides itself on openness, the NRC sentatives, licensees, vendors, and members of the has a long history of, and is committed to transparen-public. The past six vendor workshops have been cy, participation, and collaboration in our regulatory held in conjunction with the NUPIC Vendor Confer- activities. As such, in our effort to build on this, the ences in order to generate maximum participation, IQVB maintains a public Web site with information as-since both meetings share the same target audi- sociated with how the NRC implements the regulations ence. for new reactor licensing and vendor QA inspections.
This Web site contains information such as QA regula-Some of the proposed topics for the 2020 vendor tions, new reactor licensing and vendor inspection re-workshop include new Part 21 guidance ports, inspection procedures, industry interactions, reg-(Regulatory Guide 1.234), international vendor in-ulatory positions, past NRC meeting presentations, and spections, compliance with Appendix B to 10 CFR information on past and future Workshops on Vendor Part 50 through the use of code and quality stand-Oversight, etc. The Web site can be found on the fol-ards, commercial grade dedication, and controlling lowing address:
a commercial item under an Appendix B program.
https://www.nrc.gov/reactors/new-reactors/oversight/
For more information visit https://www.nrc.gov/
quality-assurance.html.
reactors/new-reactors/oversight/quality-assurance/
- Antoinette Sakadales, Vendor Inspection Program Analyst vendor-oversight.html
- Jonathan Ortega-Luciano, Reactor Operations Engineer
The Vendor Times December 2019 4 NRC Participation in MDEP/VICWG Inspection From October 21-25, 2019, NRC Vendor Inspectors led a team of inspectors representing France, the United Kingdom, and the Unit-ed States in performing the third MDEP inspection at Equipos Nu-cleares, S.A. S.M.E. (ENSA) in Cantabria, Spain.
The purpose of the multinational inspections is to foster internation-al cooperation amongst nuclear regulatory agencies to leverage the resources and talents of our regulatory peers in other countries.
To this end, we actively participate in bilateral and multilateral interac-tions with our international counter-parts to help enhance our vendor oversight capabilities, and to foster more effective and efficient mon-itoring of the nuclear industry supply chain.
The MDEP inspections are comprised of two different inspection types: multinational and joint inspec-tions. These inspection types are described in the MDEP protocol VICWG-01, Witnessed, Joint, and Multinational Vendor Inspection Protocol, Revision 2, dated March 20, 2014.
A multinational inspection (in the MDEP protocol, paragraph 4.3) is an inspection carried out by two or more regulators based on the MDEP Common QA requirements described in the MDEP VICWG Technical Report, TR-VICWG-03, QA/QM Criteria for Multinational Vendor Inspection, Revision 1, dated January 20, 2014. This type of inspection was conducted during the first MDEP inspection at Va-linox, in Montbard, France in 2014.
The second type of MDEP inspec-tion is a joint inspection activity (in the MDEP protocol, paragraph 4.2)
The Vendor Times December 2019 5 in which one regulator conducts an inspection according to its own regulatory framework with the par-ticipation of one or more other regulators inspectors. For the ENSA inspection, this was the protocol followed. The US lead the inspection and France and United Kingdom participated as inspectors. The inspection was performed in accordance with NRC inspection procedures and provided an opportunity for our regulatory counterparts to gain inspection experience using the NRCs inspection methodolo-gies.
During this inspection, the MDEP inspectors evaluated implementation of selected portions of ENSAs quality assurance program applicable to on-going and completed safety-related fabrication and testing activities to assess compliance with the provisions of Appendix B to 10 CFR Part 50 and 10 CFR Part 21.
The NRC is currently drafting a vendor inspection report docu-menting the MDEP inspection activities which will be available on the NRC public Web site and in the NRCs Agencywide Docu-ments Access and Manage-ment System (ADAMS).
The inspection was considered a valuable cooperative exercise by all of the member-nations in-volved and based on the suc-cess of the ENSA inspection; the VICWG will likely continue performing multinational inspections.
- Greg Galletti, Senior Reactor Operations Engineer Newsletter Staff Editor Dong Park Contributing Writers Jeffrey Jacobson, Greg Galletti, Jonathan Ortega-Luciano, Yamir Castillo-Diaz, Aaron Armstrong, Nicholas Savwoir, and Antoinette Sakadales
The Vendor Times December 2019 6 Issues Identified with the Environmental Qualification (EQ)
Thermal Aging Analyses for Electric Equipment Important to Safety
Background
The NRCs IQVB routinely performs inspections at vendor facilities that supply EQ components or at laboratories performing EQ testing. In addition, over the last two years, as part of its baseline inspec-tion program, the NRC has conducted focused inspections on the EQ of electric equipment important to safety. While the focus of these inspections was primarily on the licensees program for establishing and maintaining the EQ of electric equipment, the qualification basis for most electric equipment ties back to vendor provided data and information. This information includes the vendor and laboratory conducted testing programs, the test results, and supporting information. While much of the EQ test-ing of components was conducted many years ago, the test reports and the associated test data are still being utilized by licensees to support new analyses. The need for these new analyses are a con-sequence of licensees extending the life of EQ components to account for plant life extensions or re-vising previously determined accident profiles as a result of design changes (e.g., power uprates), or the discovery of new environmental hazards.
Since the cost of repeating EQ testing is high, to the extent possible, licensees try to justify the qualifi-cation of existing equipment by performing new analyses, using a combination of updated site-specific data, as well as original data taken from the original qualification testing program. One common ap-proach that we have seen is for licensees to revise thermal aging calculations using more realistic site
-specific temperature profile data taken from actual measurements at a components installed location.
Since the original qualification program generally utilized a conservative temperature profile that was designed to cover most plants, using site-specific data typically affords some margin that can be uti-lized to extend the qualified life of the installed equipment. Another important input into the thermal aging calculations, along with this site-specific temperature data is the activation energy of the affect-ed materials. Many of the inspection findings identified during recent NRC inspections involved inade-quate justification for the activation energies used.
Thermal Aging Analyses and the Arrhenius Equation The Arrhenius thermal aging equation that is used for EQ applications has only a few variables: (1) the temperature at which the component is aged (which may be different than the oven temperature); (2) the length of time the component is aged; (3) the temperature the component will actually experience during installation (can be an average); and (4) the activation energies of the non-metallic materials that contribute to the overall safety function of the component. Inputting these parameters into the Ar-rhenius equation will provide data to support a qualified life for a given component. The choice of the aging period and aging temperature are commercial decisions, designed to provide a reasonable qual-ified life for a given set of conditions.
The Vendor Times December 2019 7 Activation Energy and Temperature Selection EQ components are typically comprised of many different materials. When performing thermal aging calculations, all non-metallic materials that contribute to the various failure mechanisms should be considered and the most limiting combination of activation energies and temperatures for the materi-als in question should be selected. When determining the appropriate temperatures to input into the Arrhenius equation, consideration should be given for self-heating effects and thermal heat transfer, and any differences between the installed and laboratory aging environments (such as the use of forced air ovens). Choosing an appropriate activation energy for a given material is critical to estab-lishing a qualified life, as small changes in the activation energy can result in large changes in the qualified life of a component. The list below includes several examples of findings in this area that were identified during recent NRC inspections.
A verified reference was not provided for the activation energy used.
Not all materials in a given component were assessed to determine the most limiting activation en-ergy.
The activation energy chosen for a given material was for a material property that was unrelated to the safety function of the material or subcomponent.
Insufficient basis was given for using an activation energy derived from testing of non-identical ma-terials or just a material family type.
The testing method used to determine the activation energy was inappropriate for the application in question.
Not accounting for the heat transfer effects when using forced air ovens (when evaluating internal temperatures of normally energized components with significant self-heating effects).
Using non-conservative methods for determining internal heat rise due to self-heating effects The above represent some, but not all, of the many findings that the NRC has identified in this area during recent inspections. In all cases, these issues were entered into the licensees or the vendors corrective action programs, and for some findings, resulted in reduction in the qualified life of the af-fected components.
- Jeffrey Jacobson, Senior Reactor Operations Engineer Farewell - On a personal note, we say goodbye to our longtime friend and col-league Jeffrey Jacobson, who retires after almost 40 years of federal service, 34 years with the NRC. During his distinguished career, Jeff has spent most of his time either leading or managing a wide range of NRC inspections and inspection programs, including inspections at operating nuclear power plants, manufacturers, and service providers.
During his career at the NRC, Jeff has also worked extensively in the international arena, most notably during the period between 2006 and 2010, where he worked under NRC Chairman Nils Diaz on the development and launching of the Multina-tional Design Evaluation Program, currently administered by the OECDs Nuclear Energy Agency.
Jeff, we wish you the best.
The Vendor Times December 2019 8 Oversight of the Strategic Alliance for FLEX Emergency Response (SAFER) Program Following the 2011 Fukushima Daiichi Nuclear Power Plant accident, the NRC issued Order EA-12-049 which imposed additional requirements on licensees to increase the capability of nuclear power plants to mitigate beyond-design-basis external events. The nuclear industry responded to the order by Nucle-ar Energy Institute (NEI) 12-06 (ADAMS Accession No. ML12242A378). NEI 12-06 outlined a process for individual licensees to define and implement site-specific diverse and flexible mitigation strategies that reduce the risks associated with beyond-design-basis conditions. NEI also supplemented the re-sponse with a white paper (ADAMS Accession No. ML14259A223) which detailed the programmatic aspects and implementation plans for the SAFER program. On September 26, 2014, the NRC issued an assessment (ADAMS Accession No. ML14265A107) which evaluated and determined the above commitments were acceptable to meet Order EA-12-049. The Program Manager Organization (PMO)/
Pooled Inventory Management (PIM), as agent for Pooled Equipment Inventory Company (PEICo), is under contractual agreements to support the SAFER program and responsible for the storage, mainte-nance, and testing of SAFER FLEX equipment used by NRC licensees in the event of a beyond design basis accident. Given the provision to inspect contractual agreements to reasonably assure the capabil-ities to deploy the FLEX strategy to meet NRC Order EA-12-049; the IQVB conducted inspections at the two National SAFER Response Centers (NSRC) in Phoenix (ADAMS Accession No. ML17012A186) and Memphis (ADAMS Accession No. ML17117A576). No findings of significance were identified. The NRC continues to work with its licensees and NUPIC to ensure proper oversight of the SAFER facilities.
- Nicholas Savwoir, Reactor Operations Engineer
The Vendor Times December 2019 9 Provisional Recognition of ISO/IEC 17025:2017 In a letter dated October 1, 2018 (ADAMS Accession No. ML18275A121), NEI requested the NRC to recognize the 2017 Edition of the International Standard Organization (ISO)/International Electrotech-nical Commission (IEC) standard No. 17025, "General Requirements for the Competence of Testing and Calibration Laboratories," for use during a three-year transition period that began on November 30, 2017, and is set to expire on November 30, 2020. This time period was established by ISO to al-low accredited laboratories to transition from the 2005 to the 2017 Edition of ISO/IEC 17025. Subse-quently, in a letter responding to NEI's request dated April 16, 2019 (ADAMS Accession No. ML19056A451), the NRC concluded that ISO/IEC 17025:2017 maintains the same technical and quality requirements as ISO/IEC 17025:2005. The NRC staff reached this conclusion based on its independent review of ISO/IEC 17025:2017 and the performance of a gap analysis by both the NRC staff and NEI which demonstrated that ISO/IEC 17025:2017 did not decrease or remove any of the technical and quality requirements that provided the basis for the NRCs initial recognition of the ILAC accreditation process.
The NRC staffs gap analysis also confirmed that ISO/IEC 17025:2017 contains all of the relevant technical and quality requirements which provided the basis for the NRCs original recognition of the ILAC accreditation process. Specifically, ISO/IEC 17025:2017 incorporates all of the applicable criti-cal characteristics for the commercial-grade dedication of calibration services identified in the NUPIC Commercial Grade Calibration Services Checklist. While NUPIC does not have a standard survey checklist for testing services, the NRC staff confirmed that the applicable critical characteristics for testing services are also incorporated in ISO/IEC 17025:2017. The NRC staff has confirmed that the applicable critical characteristics for commercial calibration and testing services continue to be proper-ly controlled and verified in ISO/IEC 17025:2017 as part of the ILAC accreditation process.
The NRC staff is anticipating that NEI will submit, for NRC staff review, a revision to NEI 14-05A such that the staff may fully endorse the use of ISO/IEC 17025:2017, if applicable.
- Yamir Diaz-Castillo, Reactor Operations Engineer Would you like to be added to the newsletter distribution? Or suggest topics?
We welcome useful and informative feedback on the content of this newsletter. Please contact Dong Park, Reactor Operations Engineer, Quality Assurance and Vendor Inspection Branch, by telephone at 301-415-0001 or by email at Dong.Park@nrc.gov.