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{{#Wiki_filter:NRC UPDATEJanuary 30, 2018EPRI JUTGOrlando, FloridaKerri Kavanagh and Jonathan Ortega
{{#Wiki_filter:NRC UPDATE January 30, 2018 EPRI JUTG Orlando, Florida Kerri Kavanagh and Jonathan Ortega-Luciano Quality Assurance Vendor Inspection Branch-2, Office of New Reactors
-LucianoQuality Assurance Vendor Inspection Branch
 
-2, Office of New Reactors Topics 2Vendor Inspection Findings Quality Assurance Program Criteria  
Topics 2
-RG 1.28Part 21-Draft Guide 1291 (RG 1.234) Proposed Regulatory Issue Summary on Supplier Oversight Issues Identified During NRC Vendor InspectionsAdvanced Manufacturing (3
Vendor Inspection Findings Quality Assurance Program Criteria - RG 1.28 Part 21- Draft Guide 1291 (RG 1.234)
-D Printing)
Proposed Regulatory Issue Summary on Supplier Oversight Issues Identified During NRC Vendor Inspections Advanced Manufacturing (3-D Printing)
NRC Vendor Inspection Findings 3
 
Breakdown of Vendor Inspection Findings 4 37 inspections
3 NRC Vendor Inspection Findings Breakdown of Vendor Inspection 4
-47 NOVs/NONs7 inspections
Findings FY2017 NOVs and NONs                                  1ST-2ND QTR FY2018 NOVS AND NONS Part 21    Criterion I 7%          2%
-4NOVs/NONsCriterion III 75%Criterion XII 25%1ST-2ND QTR FY2018 NOVS AND NONSCriterion I 2%Criterion III 26%Criterion IV 2%Criterion V 4%Criterion VII 21%Criterion IX 4%Criterion X 2%Criterion XII 2%Criterion XIII 2%Criterion XVI 17%Criterion XVIII 7%AIA 4%Part 21 7%FY2017 NOVs and NONs Vendor Inspection Trends Significant FindingsDesign Control:
AIA Criterion 4%
-Translation of Design RequirementsInadequate Implementation of QA Program Requirements 5
XVIII 7%
Design Requirements 6Inspection conducted in October 2017 to assess design , fabrication, testing, and dedication of nuclear qualified pressure, differential pressure, vacuum, and temperature switches. Inspections Results: SOR qualification testing of prototype units failed to verify the adequacy of the design under the most adverse design conditions not analyzing the full temperature rise of the device due to energized parts; not accounting for the full operating range of the devices; not documenting the resolution of anomalies experienced during qualification testingStatic O-Ring (SOR) (Lenexa, KS)
Criterion XII Criterion III                              25%
Design Requirements 7Take-away:Suppliers need to ensure that design requirements are metSuppliers need to provide an adequate technical justification, including any communications between the customer and the supplier to any design changes or departures from the design requirementsSuppliers should be able to demonstrate the adequacy of the design under the most adverse conditions Anomalies that occur during qualification testing should be evaluated and documented in order to determine if the anomalies could invalidate the qualification SOR cont'd Design Requirements 8Inspection conducted in June 2017 to observe design, manufacturing, and testing activities associated with the AP1000 Ex-Core detectors nuclear instrumentationInspection Results Mirion IST did notestablish adequate measures to assure that the purchased material conform to the design requirements specified in the procurement documents. The material verification was performed using a Niton Alloy Analyzer (PMI), which can determine the family of material, in this case titanium, but lacks the ability to distinguish between the grades of titanium, as required by the design specifications.Take-away: Measures selected for material verification need to have the adequate sensitivity to assure that the material complies with the design requirements.Mirion IST Design Requirements 9Inspection conducted in August 2017 to assess Konecranes' design and testing of the containment building polar crane upgrade for Palo Verde Nuclear Generating StationInspection ResultsKonecranes did not verify the adequacy of the design and suitability of application of materials that are essential to the safety
26%
-related function of the main hoist lower blocks and the drum sheaves:Drum sheaves were manufactured from a proprietary polymer material instead of steel as required by ASME NOG
Criterion XVI 17%                                                                                   Criterion III 75%
-1.Konecranes did not demonstrate that the main hoist lower blocks and polymer drum sheaves did not exceed the maximum allowable stress values form ASME NOG
Criterion VII               Criterion 21%                         IV Criterion XIII                                                    2%
-1Take-away: Suppliers need to ensure that design requirements are met, or provide an adequate technical justification, including any communications between the customer and the supplier to any design changes or departures from the design requirements.Konecranes Nuclear Equipment & Services (New Berlin, WI)
2%
Inadequate Implementation of QA Program Requirements 10Reactive unannounced inspection conducted in January 2017 to verify implementation of corrective actions from previous inspections Inspection ResultsAs required by Criterion I of Appendix B CB&I Laurens did not assure that portions of the QA program were effectively executed, and failed to verify that activities affecting safety
Criterion XII                                         Criterion V 2%       Criterion X    Criterion IX                4%
-related functions have been correctly performedChicago Bridge & Iron (Laurens, SC)
2%             4%
Inadequate Implementation of QA Program Requirements 11Criterion I finding issued due to:3 rdinspection in a period of years with multiple findings (6 NONs, 1 NOV identified during this inspection)Self imposed stop work (during 2 ndNRC inspection in March 2015) identified a significant number of deficiencies in the QA program  
37 inspections - 47 NOVs/NONs                                        7 inspections - 4 NOVs/NONs
-13 of the 18 criteria had issuesActions taken in response to the stop work failed to address the deficiencies identified in the implementation of the QA programTake-away: Suppliers need to assure that their QA programs are being adequately implemented, including the CAP, and that there is management involvement at all levels to assure that the corrective actions are effectively implemented.Chicago Bridge & Iron cont'd QUALITY ASSURANCE PROGRAM CRITERIA 12 RegulatoryGuide 1.28 ,"QualityAssuranceProgramCriteria(DesignandConstruction)
 
"13Final RG issued October 2017 (ML17207A293)RG 1.28 endorses, with certain clarifications and regulatory positions, various versions of the ASME NQA-1 standard; the standards included are the NQA-1b-2011 Addenda to ASME NQA-1-2008, NQA-1-2012, and NQA-1-2015. The staff determined that the NQA
Vendor Inspection Trends 5
-1b-2011 Addenda to ASME NQA 2008, NQA-1-2012, and NQA-1-2015 provide the most current guidance for QA programs.
Significant Findings Design Control:
Part 21 Evaluation and Reporting 14 Draft Guide-1291, "Evaluating Deviations and Reporting Defects and Noncompliance "15Endorses Revision 1 of NEI 14-09, "Guidelines for Implementation of 10 CFR Part 21 Reporting of Defects and Noncompliance" (ML16054A825)Provides clarification on Part 21 requirements for reporting and evaluating Comment period closed on October 4, 2017 Staff evaluated industry and stakeholder comments received and plans to issue the regulatory guide as final by the end of March 2018.Proposed New Regulatory Guide
    - Translation of Design Requirements Inadequate Implementation of QA Program Requirements
-RG 1.234 Regulatory Issue SummarySupplier Oversight 16 RIS on Supplier Oversight:Issues Identified during NRC Vendor Inspections 17Inform 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 21to their sub-suppliers in the procurement documentsNRC staff expects to issue this RIS in Spring of 2018, and also plans to do a presentation on this topic at the 6 thNRC Workshop on Vendor Oversight, June 14, 2018 in Cleveland, OH ADVANCED MANUFACTURING 18 Additive Manufacturing (3
 
-D Printing) 19The staff is currently developing an Agency Action Plan:Staff from the Office of Research, Office of Nuclear Reactor Regulation, and Office of New Reactors, are participating in the development of this planSeveral interactions have taken place with other Federal Agencies and industry stake holdersOn November 28
Design Requirements 6
-29, 2017, NRC hosted a public meeting on Additive Manufacturing for reactive materials, with presentations from EPRI, FAA, GEH, ASME, WEC, NASA, NuScale, NAVSEA, NIST, ASTM, and others.
Static O-Ring (SOR) (Lenexa, KS)
For More Information-20The Quality Assurance for New Reactors Website offers a variety of information including:Vendor Inspection Program (VIP) Plan http://www.nrc.gov/reactors/new
Inspection conducted in October 2017 to assess design, fabrication, testing, and dedication of nuclear qualified pressure, differential pressure, vacuum, and temperature switches.
-reactors/oversight/quality
Inspections Results:
-assurance/vendor
SOR qualification testing of prototype units failed to verify the adequacy of the design under the most adverse design conditions not analyzing the full temperature rise of the device due to energized parts; not accounting for the full operating range of the devices; not documenting the resolution of anomalies experienced during qualification testing
-insp/vendor
 
-insp-prog-plan.htmlVendor Quality Assurance (QA) Inspection Reports for New Reactorshttp://www.nrc.gov/reactors/new
Design Requirements 7
-reactors/oversight/quality
SOR contd Take-away:
-assurance/vendor
Suppliers need to ensure that design requirements are met Suppliers need to provide an adequate technical justification, including any communications between the customer and the supplier to any design changes or departures from the design requirements Suppliers should be able to demonstrate the adequacy of the design under the most adverse conditions Anomalies that occur during qualification testing should be evaluated and documented in order to determine if the anomalies could invalidate the qualification
-insp/insp-reports.htmlQuality Assurance (QA) Inspections for New Reactor Licensing http://www.nrc.gov/reactors/new
 
-reactors/oversight/quality
Design Requirements 8
-assurance/qual
Mirion IST Inspection conducted in June 2017 to observe design, manufacturing, and testing activities associated with the AP1000 Ex-Core detectors nuclear instrumentation Inspection Results Mirion IST did not establish adequate measures to assure that the purchased material conform to the design requirements specified in the procurement documents.
-assure-license.html 21}}
The material verification was performed using a Niton Alloy Analyzer (PMI), which can determine the family of material, in this case titanium, but lacks the ability to distinguish between the grades of titanium, as required by the design specifications.
Take-away: Measures selected for material verification need to have the adequate sensitivity to assure that the material complies with the design requirements.
 
Design Requirements 9
Konecranes Nuclear Equipment & Services (New Berlin, WI)
Inspection conducted in August 2017 to assess Konecranes design and testing of the containment building polar crane upgrade for Palo Verde Nuclear Generating Station Inspection Results Konecranes did not verify the adequacy of the design and suitability of application of materials that are essential to the safety-related function of the main hoist lower blocks and the drum sheaves:
Drum sheaves were manufactured from a proprietary polymer material instead of steel as required by ASME NOG-1.
Konecranes did not demonstrate that the main hoist lower blocks and polymer drum sheaves did not exceed the maximum allowable stress values form ASME NOG-1 Take-away: Suppliers need to ensure that design requirements are met, or provide an adequate technical justification, including any communications between the customer and the supplier to any design changes or departures from the design requirements.
 
Inadequate Implementation of QA 10 Program Requirements Chicago Bridge & Iron (Laurens, SC)
Reactive unannounced inspection conducted in January 2017 to verify implementation of corrective actions from previous inspections Inspection Results As required by Criterion I of Appendix B CB&I Laurens did not assure that portions of the QA program were effectively executed, and failed to verify that activities affecting safety-related functions have been correctly performed
 
Inadequate Implementation of QA 11 Program Requirements Chicago Bridge & Iron contd Criterion I finding issued due to:
3rd inspection in a period of years with multiple findings (6 NONs, 1 NOV identified during this inspection)
Self imposed stop work (during 2nd NRC inspection in March 2015) identified a significant number of deficiencies in the QA program - 13 of the 18 criteria had issues Actions taken in response to the stop work failed to address the deficiencies identified in the implementation of the QA program Take-away: Suppliers need to assure that their QA programs are being adequately implemented, including the CAP, and that there is management involvement at all levels to assure that the corrective actions are effectively implemented.
 
12 QUALITY ASSURANCE PROGRAM CRITERIA
 
Regulatory Guide 1.28, Quality Assurance Program Criteria (Design and Construction) 13 Final RG issued October 2017 (ML17207A293)
RG 1.28 endorses, with certain clarifications and regulatory positions, various versions of the ASME NQA-1 standard; the standards included are the NQA-1b-2011 Addenda to ASME NQA-1-2008, NQA-1-2012, and NQA-1-2015.
The staff determined that the NQA-1b-2011 Addenda to ASME NQA-1-2008, NQA-1-2012, and NQA-1-2015 provide the most current guidance for QA programs.
 
14 Part 21 Evaluation and Reporting Draft Guide-1291, Evaluating Deviations and Reporting Defects and Noncompliance 15 Proposed New Regulatory Guide - RG 1.234 Endorses Revision 1 of NEI 14-09, Guidelines for Implementation of 10 CFR Part 21 Reporting of Defects and Noncompliance (ML16054A825)
Provides clarification on Part 21 requirements for reporting and evaluating Comment period closed on October 4, 2017 Staff evaluated industry and stakeholder comments received and plans to issue the regulatory guide as final by the end of March 2018.
 
Regulatory Issue Summary 16 Supplier Oversight
 
RIS on Supplier Oversight:
Issues Identified during NRC Vendor Inspections 17 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 21to their sub-suppliers in the procurement documents NRC staff expects to issue this RIS in Spring of 2018, and also plans to do a presentation on this topic at the 6th NRC Workshop on Vendor Oversight, June 14, 2018 in Cleveland, OH
 
18 ADVANCED MANUFACTURING Additive Manufacturing (3-D Printing) 19 The staff is currently developing an Agency Action Plan:
Staff from the Office of Research, Office of Nuclear Reactor Regulation, and Office of New Reactors, are participating in the development of this plan Several interactions have taken place with other Federal Agencies and industry stake holders On November 28-29, 2017, NRC hosted a public meeting on Additive Manufacturing for reactive materials, with presentations from EPRI, FAA, GEH, ASME, WEC, NASA, NuScale, NAVSEA, NIST, ASTM, and others.
 
For More Information 20 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
 
21}}

Revision as of 03:44, 22 October 2019

NRC and EPRI Joint Utility Task Group Procurement Form Held on January 30 - February 1, 2018, in Orlando, Florida
ML18018A546
Person / Time
Issue date: 01/30/2018
From:
Division of Construction Inspection and Operational Programs
To:
Ortega-Luciano J, NRO/DCIP
References
Download: ML18018A546 (21)


Text

NRC UPDATE January 30, 2018 EPRI JUTG Orlando, Florida Kerri Kavanagh and Jonathan Ortega-Luciano Quality Assurance Vendor Inspection Branch-2, Office of New Reactors

Topics 2

Vendor Inspection Findings Quality Assurance Program Criteria - RG 1.28 Part 21- Draft Guide 1291 (RG 1.234)

Proposed Regulatory Issue Summary on Supplier Oversight Issues Identified During NRC Vendor Inspections Advanced Manufacturing (3-D Printing)

3 NRC Vendor Inspection Findings Breakdown of Vendor Inspection 4

Findings FY2017 NOVs and NONs 1ST-2ND QTR FY2018 NOVS AND NONS Part 21 Criterion I 7% 2%

AIA Criterion 4%

XVIII 7%

Criterion XII Criterion III 25%

26%

Criterion XVI 17% Criterion III 75%

Criterion VII Criterion 21% IV Criterion XIII 2%

2%

Criterion XII Criterion V 2% Criterion X Criterion IX 4%

2% 4%

37 inspections - 47 NOVs/NONs 7 inspections - 4 NOVs/NONs

Vendor Inspection Trends 5

Significant Findings Design Control:

- Translation of Design Requirements Inadequate Implementation of QA Program Requirements

Design Requirements 6

Static O-Ring (SOR) (Lenexa, KS)

Inspection conducted in October 2017 to assess design, fabrication, testing, and dedication of nuclear qualified pressure, differential pressure, vacuum, and temperature switches.

Inspections Results:

SOR qualification testing of prototype units failed to verify the adequacy of the design under the most adverse design conditions not analyzing the full temperature rise of the device due to energized parts; not accounting for the full operating range of the devices; not documenting the resolution of anomalies experienced during qualification testing

Design Requirements 7

SOR contd Take-away:

Suppliers need to ensure that design requirements are met Suppliers need to provide an adequate technical justification, including any communications between the customer and the supplier to any design changes or departures from the design requirements Suppliers should be able to demonstrate the adequacy of the design under the most adverse conditions Anomalies that occur during qualification testing should be evaluated and documented in order to determine if the anomalies could invalidate the qualification

Design Requirements 8

Mirion IST Inspection conducted in June 2017 to observe design, manufacturing, and testing activities associated with the AP1000 Ex-Core detectors nuclear instrumentation Inspection Results Mirion IST did not establish adequate measures to assure that the purchased material conform to the design requirements specified in the procurement documents.

The material verification was performed using a Niton Alloy Analyzer (PMI), which can determine the family of material, in this case titanium, but lacks the ability to distinguish between the grades of titanium, as required by the design specifications.

Take-away: Measures selected for material verification need to have the adequate sensitivity to assure that the material complies with the design requirements.

Design Requirements 9

Konecranes Nuclear Equipment & Services (New Berlin, WI)

Inspection conducted in August 2017 to assess Konecranes design and testing of the containment building polar crane upgrade for Palo Verde Nuclear Generating Station Inspection Results Konecranes did not verify the adequacy of the design and suitability of application of materials that are essential to the safety-related function of the main hoist lower blocks and the drum sheaves:

Drum sheaves were manufactured from a proprietary polymer material instead of steel as required by ASME NOG-1.

Konecranes did not demonstrate that the main hoist lower blocks and polymer drum sheaves did not exceed the maximum allowable stress values form ASME NOG-1 Take-away: Suppliers need to ensure that design requirements are met, or provide an adequate technical justification, including any communications between the customer and the supplier to any design changes or departures from the design requirements.

Inadequate Implementation of QA 10 Program Requirements Chicago Bridge & Iron (Laurens, SC)

Reactive unannounced inspection conducted in January 2017 to verify implementation of corrective actions from previous inspections Inspection Results As required by Criterion I of Appendix B CB&I Laurens did not assure that portions of the QA program were effectively executed, and failed to verify that activities affecting safety-related functions have been correctly performed

Inadequate Implementation of QA 11 Program Requirements Chicago Bridge & Iron contd Criterion I finding issued due to:

3rd inspection in a period of years with multiple findings (6 NONs, 1 NOV identified during this inspection)

Self imposed stop work (during 2nd NRC inspection in March 2015) identified a significant number of deficiencies in the QA program - 13 of the 18 criteria had issues Actions taken in response to the stop work failed to address the deficiencies identified in the implementation of the QA program Take-away: Suppliers need to assure that their QA programs are being adequately implemented, including the CAP, and that there is management involvement at all levels to assure that the corrective actions are effectively implemented.

12 QUALITY ASSURANCE PROGRAM CRITERIA

Regulatory Guide 1.28, Quality Assurance Program Criteria (Design and Construction) 13 Final RG issued October 2017 (ML17207A293)

RG 1.28 endorses, with certain clarifications and regulatory positions, various versions of the ASME NQA-1 standard; the standards included are the NQA-1b-2011 Addenda to ASME NQA-1-2008, NQA-1-2012, and NQA-1-2015.

The staff determined that the NQA-1b-2011 Addenda to ASME NQA-1-2008, NQA-1-2012, and NQA-1-2015 provide the most current guidance for QA programs.

14 Part 21 Evaluation and Reporting Draft Guide-1291, Evaluating Deviations and Reporting Defects and Noncompliance 15 Proposed New Regulatory Guide - RG 1.234 Endorses Revision 1 of NEI 14-09, Guidelines for Implementation of 10 CFR Part 21 Reporting of Defects and Noncompliance (ML16054A825)

Provides clarification on Part 21 requirements for reporting and evaluating Comment period closed on October 4, 2017 Staff evaluated industry and stakeholder comments received and plans to issue the regulatory guide as final by the end of March 2018.

Regulatory Issue Summary 16 Supplier Oversight

RIS on Supplier Oversight:

Issues Identified during NRC Vendor Inspections 17 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 21to their sub-suppliers in the procurement documents NRC staff expects to issue this RIS in Spring of 2018, and also plans to do a presentation on this topic at the 6th NRC Workshop on Vendor Oversight, June 14, 2018 in Cleveland, OH

18 ADVANCED MANUFACTURING Additive Manufacturing (3-D Printing) 19 The staff is currently developing an Agency Action Plan:

Staff from the Office of Research, Office of Nuclear Reactor Regulation, and Office of New Reactors, are participating in the development of this plan Several interactions have taken place with other Federal Agencies and industry stake holders On November 28-29, 2017, NRC hosted a public meeting on Additive Manufacturing for reactive materials, with presentations from EPRI, FAA, GEH, ASME, WEC, NASA, NuScale, NAVSEA, NIST, ASTM, and others.

For More Information 20 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

21