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{{#Wiki_filter:NRC UPDATEAugust 9 , 2018EPRI JUTGCharlotte , North CarolinaJonathan Ortega and Aaron ArmstrongQuality Assurance Vendor Inspection Branch, Office of New Reactors Topics 2Vendor Inspection Findings Part 21-RG 1.234Update -Regulatory Issue Summary on Supplier Oversight Issues Identified During NRC Vendor Inspections2018 NRC Workshop on Vendor Oversight NRC Vendor Inspection Findings 3
{{#Wiki_filter:NRC UPDATE August 9, 2018 EPRI JUTG Charlotte, North Carolina Jonathan Ortega and Aaron Armstrong Quality Assurance Vendor Inspection Branch, Office of New Reactors
Breakdown of Vendor Inspection Findings 415 inspections
 
-14 NOVs/NONsCriterion III 50%Criterion IV 7%Criterion X 7%Criterion XI 7%Criterion XII 14%Criterion XVI 7%Criterion XVII 7%FY2018 NOV AND NON (OCTOBER 1, 2018
Topics 2
-JULY  13, 2018)
Vendor Inspection Findings Part 21- RG 1.234 Update - Regulatory Issue Summary on Supplier Oversight Issues Identified During NRC Vendor Inspections 2018 NRC Workshop on Vendor Oversight
Vendor Inspection Trends Significant FindingsDesign and Test Control-Translation of Design Requirements and TestingCommercial
 
-Grade Dedication 5
3 NRC Vendor Inspection Findings Breakdown of Vendor Inspection 4
Design and Testing Requirements 6Inspection conducted in June 2018 to assess Gutor'squality activities associated with the design, fabrication, and testing of components that comprise the Uninterruptable Power Supply System for the Westinghouse AP1000 reactors being constructed at the Vogtle Units 3 and 4. Inspection ResultsGutor failed to ensure the suitability of materials, parts, equipment, and processes that are essential to the safety
Findings FY2018 NOV AND NON (OCTOBER 1, 2018 - JULY 13, 2018)
-related functions of the inverters being supplied to the Vogtle Units 3 and 4 nuclear power plantsGutor failed to develop acceptance criteria to ensure that the battery chargers acceptance tests meet the design requirements as stated in Westinghouse's purchase orderTake-away: Suppliers need to ensure that design and testing requirements are met and document these design and testing requirements for activities affecting quality. Gutor Electronic, Wettingen, Switzerland Design and Testing Requirements 7Inspection conducted in May 2018 to verify TR's design control and testing activities for the NuScale emergency core cooling system (ECCS) Inspection ResultsTR did not provide the information for the first
Criterion XVII 7%
-of-a-kind-engineering (FOAKE) ECCS proof of concept testing as required by NuScale purchase order Also during Safety
Criterion XVI 7%
-Related testing activities TR do not establish controls to ensure the measuring and testing instrumentation used during testing activities affecting quality were adequately controlled, calibrated and adjusted at specified periods to maintain accuracy within necessary limits   Target Rock (TR) at the East Farmingdale, NY facility Design and Testing Requirements 8Take-away: Suppliers need to meet the requirements for the design documents and the requirements for the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to the safety
Criterion XII 14%
-related functions of the structures, systems and components   Suppliers should be able to demonstrate the adequacy of the design, testing and dedication through retention of auditable records providing reasonable assurance of acceptable for M&TETarget Rock cont'd Commercial
Criterion III 50%
-Grade Dedication 9Inspection conducted in January 2018 to assess the design, fabrication, and testing of the Limitorque motor-operated valve actuatorsInspections Results Flowserve did not verify the validity of the Certificates of Conformance for hardness and tensile strengths of motor shafts materialFlowserve did not maintain sufficient records for the commercially
Criterion XI 7%
-dedicated fastenersFlowserve records lacked evidence that material testing on commercially
Criterion X 7%
-dedicated hardware and fasteners confirmed suitability of the partsFlowserve Corporation, Lynchburg , VA Commercial
Criterion IV 7%                    15 inspections - 14 NOVs/NONs
-Grade Dedication 10Take-away: Suppliers need to ensure that design requirements meet the procurement documents and prescribed dedication activitiesSuppliers should be able to demonstrate the adequacy of the design, testing and dedication through retention of auditable records providing reasonable assurance for   acceptability Flowserve cont'd Commercial
 
-Grade Dedication 11Inspection conducted in April 2018 to assess SEC's rewinding, repair, reverse engineering and supply of safety
Vendor Inspection Trends 5
-related motors to the nuclear industryInspection ResultsSEC did not establish and implement an acceptable method to verify the material composition of shafts used in AC motors provided by a commercial supplierSEC failed to provide objective evidence to support the verification of Critical Characteristics by source evaluation and selection, objective evidence of quality furnished by the supplier, inspection at the supplier source, and/or examination of products upon delivery suppliersTake-away: Suppliers need to ensure that technical requirements are met, and ensure that any changes to dedication activities of commercial grade items are documented Schulz Electric Company (SEC) New Haven, CT Part 21 Evaluation and Reporting 12 EVALUATING DEVIATIONS AND REPORTING DEFECTSAND NONCOMPLIANCE UNDER 10 CFR PART 21 13Endorses Revision 1 of NEI 14-09, "Guidelines for Implementation of 10 CFR Part 21 Reporting of Defects and Noncompliance" Provides clarification on Part 21 requirements for reporting and evaluating New Regulatory Guide
Significant Findings Design  and Test Control
-RG 1.234 issued April 2018 Regulatory Issue SummarySupplier Oversight 14 Update 15Currently in internal concurrence phaseNRC staff expects to issue this RIS in late Summer/Fall of 2018Inform our stakeholders of recent NRC inspection findings involving:Inadequate oversight of suppliers (domestic & international)Suppliers not adequately imposing the requirements of Appendix B to 10 CFR Part 50 and 10 CFR Part 21 to their sub-suppliers in the procurement documents 2018 NRC Workshop on Vendor Oversight 16 2018 NRC Workshop on Vendor Oversight 17The NRC held their Workshop on Vendor Oversight in Cleveland, Ohio on June 14. The Workshop included a plenary session on such issues as safety conscious work environment; reverse engineering; counterfeit, fraudulent, and suspect items; and recent supplier oversight issues. The workshop also included afternoon panel discussions regarding commercial
    - Translation of Design Requirements and Testing Commercial-Grade Dedication
-grade dedication topics and additive manufacturing Audience included approximately 400 attendees14 Countries For More Information-18The Quality Assurance for New Reactors Website offers a variety of information including:Vendor Inspection Program (VIP) Plan http://www.nrc.gov/reactors/new
 
-reactors/oversight/quality
Design and Testing Requirements 6
-assurance/vendor
Gutor Electronic, Wettingen, Switzerland Inspection conducted in June 2018 to assess Gutors quality activities associated with the design, fabrication, and testing of components that comprise the Uninterruptable Power Supply System for the Westinghouse AP1000 reactors being constructed at the Vogtle Units 3 and 4.
-insp/vendor
Inspection Results Gutor failed to ensure the suitability of materials, parts, equipment, and processes that are essential to the safety-related functions of the inverters being supplied to the Vogtle Units 3 and 4 nuclear power plants Gutor failed to develop acceptance criteria to ensure that the battery chargers acceptance tests meet the design requirements as stated in Westinghouse's purchase order Take-away: Suppliers need to ensure that design and testing requirements are met and document these design and testing requirements for activities affecting quality.
-insp-prog-plan.htmlVendor Quality Assurance (QA) Inspection Reports for New Reactorshttp://www.nrc.gov/reactors/new
 
-reactors/oversight/quality
Design and Testing Requirements 7
-assurance/vendor
Target Rock (TR) at the East Farmingdale, NY facility Inspection conducted in May 2018 to verify TRs design control and testing activities for the NuScale emergency core cooling system (ECCS)
-insp/insp-reports.htmlQuality Assurance (QA) Inspections for New Reactor Licensing http://www.nrc.gov/reactors/new
Inspection Results TR did not provide the information for the first-of-a-kind-engineering (FOAKE) ECCS proof of concept testing as required by NuScale purchase order Also during Safety-Related testing activities TR do not establish controls to ensure the measuring and testing instrumentation used during testing activities affecting quality were adequately controlled, calibrated and adjusted at specified periods to maintain accuracy within necessary limits
-reactors/oversight/quality
 
-assurance/qual
Design and Testing Requirements 8
-assure-license.htmlWorkshop on Vendor Oversight 2018 Conferencehttps://www.nrc.gov/reactors/new
Target Rock contd Take-away: Suppliers need to meet the requirements for the design documents and the requirements for the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to the safety-related functions of the structures, systems and components Suppliers should be able to demonstrate the adequacy of the design, testing and dedication through retention of auditable records providing reasonable assurance of acceptable for M&TE
-reactors/oversight/quality
 
-assurance/vendor
Commercial-Grade Dedication 9
-oversight/past/2018
Flowserve Corporation, Lynchburg, VA Inspection conducted in January 2018 to assess the design, fabrication, and testing of the Limitorque motor-operated valve actuators Inspections Results Flowserve did not verify the validity of the Certificates of Conformance for hardness and tensile strengths of motor shafts material Flowserve did not maintain sufficient records for the commercially-dedicated fasteners Flowserve records lacked evidence that material testing on commercially-dedicated hardware and fasteners confirmed suitability of the parts
/
 
Commercial-Grade Dedication 10 Flowserve contd Take-away: Suppliers need to ensure that design requirements meet the procurement documents and prescribed dedication activities Suppliers should be able to demonstrate the adequacy of the design, testing and dedication through retention of auditable records providing reasonable assurance for acceptability
 
Commercial-Grade Dedication 11 Schulz Electric Company (SEC) New Haven, CT Inspection conducted in April 2018 to assess SECs rewinding, repair, reverse engineering and supply of safety-related motors to the nuclear industry Inspection Results SEC did not establish and implement an acceptable method to verify the material composition of shafts used in AC motors provided by a commercial supplier SEC failed to provide objective evidence to support the verification of Critical Characteristics by source evaluation and selection, objective evidence of quality furnished by the supplier, inspection at the supplier source, and/or examination of products upon delivery suppliers Take-away: Suppliers need to ensure that technical requirements are met, and ensure that any changes to dedication activities of commercial grade items are documented
 
12 Part 21 Evaluation and Reporting EVALUATING DEVIATIONS AND REPORTING DEFECTS AND NONCOMPLIANCE UNDER 10 CFR PART 21 13 New Regulatory Guide - RG 1.234 issued April 2018 Endorses Revision 1 of NEI 14-09, Guidelines for Implementation of 10 CFR Part 21 Reporting of Defects and Noncompliance Provides clarification on Part 21 requirements for reporting and evaluating
 
Regulatory Issue Summary 14 Supplier Oversight
 
Update 15 Currently in internal concurrence phase NRC staff expects to issue this RIS in late Summer/Fall of 2018 Inform our stakeholders of recent NRC inspection findings involving:
Inadequate oversight of suppliers (domestic &
international)
Suppliers not adequately imposing the requirements of Appendix B to 10 CFR Part 50 and 10 CFR Part 21 to their sub-suppliers in the procurement documents
 
2018 NRC Workshop on Vendor 16 Oversight
 
2018 NRC Workshop on Vendor Oversight 17 The NRC held their Workshop on Vendor Oversight in Cleveland, Ohio on June 14. The Workshop included a plenary session on such issues as safety conscious work environment; reverse engineering; counterfeit, fraudulent, and suspect items; and recent supplier oversight issues. The workshop also included afternoon panel discussions regarding commercial-grade dedication topics and additive manufacturing Audience included approximately 400 attendees 14 Countries
 
For More Information 18 The Quality Assurance for New Reactors Website offers a variety of information including:
Vendor Inspection Program (VIP) Plan http://www.nrc.gov/reactors/new-reactors/oversight/quality-assurance/vendor-insp/vendor-insp-prog-plan.html Vendor Quality Assurance (QA) Inspection Reports for New Reactors http://www.nrc.gov/reactors/new-reactors/oversight/quality-assurance/vendor-insp/insp-reports.html Quality Assurance (QA) Inspections for New Reactor Licensing http://www.nrc.gov/reactors/new-reactors/oversight/quality-assurance/qual-assure-license.html Workshop on Vendor Oversight 2018 Conference https://www.nrc.gov/reactors/new-reactors/oversight/quality-assurance/vendor-oversight/past/2018/
 
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Latest revision as of 20:47, 20 October 2019

NRC Update EPRI JUTG Meeting, August 9, 2018
ML18206A446
Person / Time
Issue date: 07/25/2018
From: Aaron Armstrong, Ortega J
NRC/NRO/DCIP/QVIB1
To:
Armstrong A
References
Download: ML18206A446 (19)


Text

NRC UPDATE August 9, 2018 EPRI JUTG Charlotte, North Carolina Jonathan Ortega and Aaron Armstrong Quality Assurance Vendor Inspection Branch, Office of New Reactors

Topics 2

Vendor Inspection Findings Part 21- RG 1.234 Update - Regulatory Issue Summary on Supplier Oversight Issues Identified During NRC Vendor Inspections 2018 NRC Workshop on Vendor Oversight

3 NRC Vendor Inspection Findings Breakdown of Vendor Inspection 4

Findings FY2018 NOV AND NON (OCTOBER 1, 2018 - JULY 13, 2018)

Criterion XVII 7%

Criterion XVI 7%

Criterion XII 14%

Criterion III 50%

Criterion XI 7%

Criterion X 7%

Criterion IV 7% 15 inspections - 14 NOVs/NONs

Vendor Inspection Trends 5

Significant Findings Design and Test Control

- Translation of Design Requirements and Testing Commercial-Grade Dedication

Design and Testing Requirements 6

Gutor Electronic, Wettingen, Switzerland Inspection conducted in June 2018 to assess Gutors quality activities associated with the design, fabrication, and testing of components that comprise the Uninterruptable Power Supply System for the Westinghouse AP1000 reactors being constructed at the Vogtle Units 3 and 4.

Inspection Results Gutor failed to ensure the suitability of materials, parts, equipment, and processes that are essential to the safety-related functions of the inverters being supplied to the Vogtle Units 3 and 4 nuclear power plants Gutor failed to develop acceptance criteria to ensure that the battery chargers acceptance tests meet the design requirements as stated in Westinghouse's purchase order Take-away: Suppliers need to ensure that design and testing requirements are met and document these design and testing requirements for activities affecting quality.

Design and Testing Requirements 7

Target Rock (TR) at the East Farmingdale, NY facility Inspection conducted in May 2018 to verify TRs design control and testing activities for the NuScale emergency core cooling system (ECCS)

Inspection Results TR did not provide the information for the first-of-a-kind-engineering (FOAKE) ECCS proof of concept testing as required by NuScale purchase order Also during Safety-Related testing activities TR do not establish controls to ensure the measuring and testing instrumentation used during testing activities affecting quality were adequately controlled, calibrated and adjusted at specified periods to maintain accuracy within necessary limits

Design and Testing Requirements 8

Target Rock contd Take-away: Suppliers need to meet the requirements for the design documents and the requirements for the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to the safety-related functions of the structures, systems and components Suppliers should be able to demonstrate the adequacy of the design, testing and dedication through retention of auditable records providing reasonable assurance of acceptable for M&TE

Commercial-Grade Dedication 9

Flowserve Corporation, Lynchburg, VA Inspection conducted in January 2018 to assess the design, fabrication, and testing of the Limitorque motor-operated valve actuators Inspections Results Flowserve did not verify the validity of the Certificates of Conformance for hardness and tensile strengths of motor shafts material Flowserve did not maintain sufficient records for the commercially-dedicated fasteners Flowserve records lacked evidence that material testing on commercially-dedicated hardware and fasteners confirmed suitability of the parts

Commercial-Grade Dedication 10 Flowserve contd Take-away: Suppliers need to ensure that design requirements meet the procurement documents and prescribed dedication activities Suppliers should be able to demonstrate the adequacy of the design, testing and dedication through retention of auditable records providing reasonable assurance for acceptability

Commercial-Grade Dedication 11 Schulz Electric Company (SEC) New Haven, CT Inspection conducted in April 2018 to assess SECs rewinding, repair, reverse engineering and supply of safety-related motors to the nuclear industry Inspection Results SEC did not establish and implement an acceptable method to verify the material composition of shafts used in AC motors provided by a commercial supplier SEC failed to provide objective evidence to support the verification of Critical Characteristics by source evaluation and selection, objective evidence of quality furnished by the supplier, inspection at the supplier source, and/or examination of products upon delivery suppliers Take-away: Suppliers need to ensure that technical requirements are met, and ensure that any changes to dedication activities of commercial grade items are documented

12 Part 21 Evaluation and Reporting EVALUATING DEVIATIONS AND REPORTING DEFECTS AND NONCOMPLIANCE UNDER 10 CFR PART 21 13 New Regulatory Guide - RG 1.234 issued April 2018 Endorses Revision 1 of NEI 14-09, Guidelines for Implementation of 10 CFR Part 21 Reporting of Defects and Noncompliance Provides clarification on Part 21 requirements for reporting and evaluating

Regulatory Issue Summary 14 Supplier Oversight

Update 15 Currently in internal concurrence phase NRC staff expects to issue this RIS in late Summer/Fall of 2018 Inform our stakeholders of recent NRC inspection findings involving:

Inadequate oversight of suppliers (domestic &

international)

Suppliers not adequately imposing the requirements of Appendix B to 10 CFR Part 50 and 10 CFR Part 21 to their sub-suppliers in the procurement documents

2018 NRC Workshop on Vendor 16 Oversight

2018 NRC Workshop on Vendor Oversight 17 The NRC held their Workshop on Vendor Oversight in Cleveland, Ohio on June 14. The Workshop included a plenary session on such issues as safety conscious work environment; reverse engineering; counterfeit, fraudulent, and suspect items; and recent supplier oversight issues. The workshop also included afternoon panel discussions regarding commercial-grade dedication topics and additive manufacturing Audience included approximately 400 attendees 14 Countries

For More Information 18 The Quality Assurance for New Reactors Website offers a variety of information including:

Vendor Inspection Program (VIP) Plan http://www.nrc.gov/reactors/new-reactors/oversight/quality-assurance/vendor-insp/vendor-insp-prog-plan.html Vendor Quality Assurance (QA) Inspection Reports for New Reactors http://www.nrc.gov/reactors/new-reactors/oversight/quality-assurance/vendor-insp/insp-reports.html Quality Assurance (QA) Inspections for New Reactor Licensing http://www.nrc.gov/reactors/new-reactors/oversight/quality-assurance/qual-assure-license.html Workshop on Vendor Oversight 2018 Conference https://www.nrc.gov/reactors/new-reactors/oversight/quality-assurance/vendor-oversight/past/2018/

19