ML18024A495
| ML18024A495 | |
| Person / Time | |
|---|---|
| Issue date: | 01/30/2018 |
| From: | Greg Galletti, Mcintyre R NRC/NRO/DCIP/QVIB1, NRC/NRO/DCIP/QVIB2 |
| To: | |
| McIntyre R, NRO/DCIP | |
| References | |
| Download: ML18024A495 (22) | |
Text
NRC UPDATE January 30, 2018 NUPIC General Membership Meeting Orlando, FloridaRich McIntyre and Greg GallettiQuality Assurance Vendor Inspection Branch, Office of New Reactors Topics 2Vendor Inspection Findings Quality Assurance Program Criteria -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-D Printing)Internal Auditor Independence NRC Vendor Inspection Findings 3 Breakdown of Vendor Inspection Findings 437 inspections -47 NOVs/NONs7 inspections -4NOVs/NONs Criterion III 75%Criterion XII 25%1ST-2ND QTR FY2018 NOVS AND NONS Criterion I 2%Criterion III 26%Criterio n IV 2%Criterion V 4%Criterion VII 21%Criterion IX 4%Criterion X 2%Criterion XII 2%Criterion XIII-Criterion XVI 17%Criterion XVIII 7%AIA 4%Part 21 7%FY2017 NOVs and NONs Vendor Inspection Trends Significant FindingsDesign Control:
-Translation of Design RequirementsInadequate Implementation of QA Program
Requirements 5
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 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 Static O-Ring (SOR) (Lenexa, KS)
Design Requirements 7Take-away:Suppliers need to assure 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 acti vities associated with the AP1000 Ex-Core detectors nuclear
instrumentationInspection Results MirionIST 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 NitonAlloy Analyzer (PMI), which can determine the family of material, but lacks the ability to distinguish between the grades of material, 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.MirionIST 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 ResultsKonecranesdid 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.Konecranesdid not demonstrate that the main hoist lower blocks and
polymer drum sheaves did not exceed the maximum allowable stress values form ASME NOG-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
an y desi g n chan g es or de partures from the desi g n Konecranes Nuclear Equipment & Services (New Berlin, WI)
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-related functions
have been correctly performedChicago Bridge & Iron (Laurens, SC)
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 -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 RegulatoryGuide1.28,"QualityAssuranceProgramCriteria(DesignandConstruction)"
13Revision 5 of 1.28 was issued final in 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.
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 -RG 1.234 Regulatory Issue Summary Supplier 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 28-29, 2017, NRC hosted a public meeting on Additive Manufacturing for Reactor Materials, with presentations from EPRI, FAA, GEH, ASME, WEC, NASA, NuScale, NAVSEA, NIST, ASTM, and others6 thNRC Workshop on Vendor Oversight to be held on June14, 2018, in Cleveland OH, will include a breakout session on Additive Manufacturing (3-D Printing)
Internal Auditor Independence 202017 NUPIC audit finding identified that the same lead auditor performed the internal audit
portion of the audit for the last 3 yearsIssue determined to have NO impact on the
engineering services provided by companyPart 50 Appendix B, Criterion18, "Audits"
requires:audits be performed by appropriately trained
personnel not having direct responsibilities in the areas being audited Audit results shall be documented and reviewed bymanagementhavingresponsibilityinthearea For More Information-21The 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.htmlVendor Quality Assurance (QA) Inspection Reports for New
Reactorshttp://www.nrc.gov/reactors/new-reactors/oversight/quality-assurance/vendor-insp/insp-reports.htmlQuality Assurance (QA) Inspections for New Reactor Licensing http://www.nrc.gov/reactors/new-reactors/oversight/quality-assurance/qual-assure-license.html 22