qa for an international nuclear program under us regulations -...
TRANSCRIPT
QA for an International Nuclear Program under US Regulations
Piet van der Heide
ASQ Energy & Environmental division – October 13, 2009
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Topics
• Company & Organization
• Status to Date – a Pictorial Update
• International Scene
• Quality Assurance Program
• Difference in QA Programs and Experience
• Implications for QA Programs and QA Practices
• Change in QA Approach due to ISA Change
• Commercial Grade Dedication of Cascade System
• Compliance with NRC Ruling
• Dedication Plans
• CGD Process
• Activities under Dedication Plans
• QA Approval of Requirements Determination
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Company & Organization (1)
• Site
- National Enrichment Facility (NEF)
• Company
- Louisiana Energy Services LLP (LES)
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Company & Organization (2)
Urenco Enrichment
Company Ltd
Urenco Investments
Inc
100 % 100 %
50 %50 %
Enrichment Technology
Company Ltd
Facilities in• United Kingdom• Germany• The Netherlands
Enrichment Technology US, Inc
Facilities in• United Kingdom• Germany• The Netherlands• France• US
supply of uranium enrichment technology
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Pictorial update – preparation December 2006
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International Scene
• LES as US licensee
• Wholly owned subsidiary of European company
• Classified centrifuge technology supplied by European company
• Technology controlled by three European governments
• Provided in license to US to operate under DOE/NRC ruling
• For “black box” and “core design” 10 – 15 European contractors
• US construction and utility contractors
• Infrastructure installed by US contractors
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Quality Assurance Program
• Licensee committed in QAPD to criteria of 10 CFR 50 appendix B
- QAPD = Quality Assurance Program Description
• To meet criteria Licensee committed to compliance with ASME NQA-1-1994 as revised by the ASME NQA-1a-1995 Addenda
• All QAPD requirements applied exclusively to QA Level 1 items, defined as IROFS and items that affect the function of the IROFS
• QA Level 1 controls applied to SSCs and activities identified as IROFS and items, SSCs, or administrative controls that affect the function of the IROFS
- SSCs = Structures, Systems and Components
• QA Level 2 designation for selected SSCs require application of owner-defined QA controls using NQA-1 as guidance
• An item, SSC, or activity not designated as QA Level 1 or 2 will have QA Level 3 controls applied, defined as standard commercial practice
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Difference in QA Programs and Experience
• Strong, power station related nuclear program at Licensee
• European partners with ISO-programs
• Construction companies operating under customer program
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• Comply with 10CFR50 appendix B by implementing NQA1
- Develop vendors to support project
- Develop personnel skill sets
• Align ISO based programs to comply with NQA1
- Integration and interfaces
- Acceptance of processes and equipment
• Foreign oversight
- Identify and enlist foreign support
Implications for QA Program and QA practices (1)
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• Attentiveness to differences in codes and standards
- Review of codes and standards: European versus US
- ‘Americanization’ of European designs, processes and equipment
• Interfaces with regulators (Federal and State)
- Unfamiliar with non-US standards
- Unfamiliar with non-nuclear standards
Implications for QA Program and QA practices (2)
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• Examples- NQA1 training for European vendors
- Auditor training at critical vendors
- Review of all European mechanical structures versus US requirements by independent nuclear contractor
- UL review of European electrical systems
- Multiple sessions to familiarize NRC with European design criteria
- Educate European personnel in use of US codes and standards
Implications for QA Program and QA practices (3)
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Change in QA Approach due to ISA Change (1)
• Initial ISA defined building as confinement boundary for potential chemical release
• A 2008 License Amendment redefined confinement boundary from building to UF6 process systems
• This license amendment changed required quality level of Cascade Hall components from QL3 and/or QL2 to QL1
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Change in QA Approach due to ISA Change (2)
• Pressure boundary and pressure boundary support systems assigned as QL1
• This includes the systems
- Machines (centrifuges)
- Piping
- Supporting steel structure
- Concrete base
• A QA level assignment resulted in a listing of agreed Key Attributes for these systems
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Commercial Grade Dedication of Cascade System
• As a result the cascade will be a Commercial Grade “Item”
• Not dedicated per individual item but as a complete system
• The system as a whole is designed and manufactured in Europe according to European specifications and standards
• The complete cascade system (concrete foundation, machines, header pipe-work and supporting steel) are assembled in the US
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• Validation and concurrence by NRC that item meets definition of CGI and is being purchased for use as basic component –individual components from ETC do not meet specific definition of a CGI per 10CFR21
• Licensee received an exception for these parts from NRC
Compliance with NRC Ruling (1)
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Compliance with NRC Ruling (2)
• Involvement of engineering staff, purchasing and QA of licensee
• Effective source inspection, receiving inspection as well as testing upon receipt in US
• Solid engineering based program for review, test, evaluation anddeclaration of critical characteristics
� Between Licensee (LES) and supplier (ETC) a comprehensive agreement on Key Attributes (Critical Characteristics) and the related Dedication Plan has been established
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Dedication Plans
• Post-Dedication
- Systems/components procured, manufactured and/or installed after approval of CGD Plan
• Pre-Dedication
- Systems/components procured, manufactured and/or installed prior to preparation of CGD Plan
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CGD Process
• Qualification requirements – environmental, seismic
• Listing of technical requirements and references
• FMEA
• Definition of key attributes for each of four elements
• Engineering evaluation
• Sampling plan
• Definition of acceptance criteria
• Survey by LES
• Definition of verifications by ETC and verifications by LES
• Agreement on methods of confirmation by ETC
• Definition of certificate of conformance
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Activities under Dedication Plans
• Dedication upon receipt on site of individual items
• Dedication after completion of installation but prior to introduction of hex
• Engineering evaluation of delivered/installed items
• Audits and surveillances to confirm adequate supplier controls are in place
• Independent verification of key attributes by licensee
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QA Approval of Requirements Determination
Supplier Verification
QA Inspection Verification
QA Audit Verification
Key Attribute
or
Critical Characteristic
Part / item
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Questions
?
Piet van der HeideCompliance Manager
Quality, Health, Safety, Environment and SecurityEnrichment Technology US, Inc
[email protected] 575 394 6258Cell 575 602 0449