ML16215A410
| ML16215A410 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 05/26/2016 |
| From: | NRC/NRR/DPR/PRLB |
| To: | |
| Lynch S, NRR/DPR, 301-415-1524 | |
| Shared Package | |
| ML16215A398 | List: |
| References | |
| Download: ML16215A410 (47) | |
Text
Non-Power Production and Utilization Facility (NPUF) Construction Inspection Program (CIP)
U.S. Nuclear Regulatory Commission May 26, 2016
Construction Inspection Program Overview Carl Weber Office of New Reactors
=
Background===
- Not all aspects will apply to every facility
- Sample based
- Focus on safety related systems, structures, and components (SSCs)
- Quality Assurance Program commitments
- Corrective Action Program 3
Licensing and Oversight Responsibility Construction Inspection Manual Chapter:
Region II QA Inspections SSC Inspections Operational Readiness Inspection report from Region II stating CIP complete Operation Inspection Manual Chapter:
NRR Startup Testing Licensing Actions: NRR Issue Operating License Issue Construction Permit Oversight Inspections 4
Inspection Manual Chapter (IMC) 2550
- NPUF-CIP: Single IMC
- Facility Specific Assessment and Review Group (FSARG)
- Inspection Report format
- Enforcement (Traditional)
- Overall Inspection Strategy
- Assessment
- Transition to Operations.
- Qualification and Training for Inspectors addressed in IMC 1245 5
Inspection Procedures (IPs)
- Facility Construction
- IP 69020, Inspections Of Structures, Systems And Components During Construction Of Non-Power Production and Utilization Facilities
- Quality of Construction
- IP 69021, Inspections Of Quality Assurance Program Implementation During Construction Of Non-Power Production and Utilization Facilities
- Operational Readiness
- IP 69022, Inspections Of Operational Readiness During Construction Of Non-Power Production and Utilization Facilities 6
Facility Construction Inspection Procedure Structures, systems and components (SSC) inspection procedure Sample selection will be based on safety significance (QL-1 systems)
Potential inspection areas:
- Foundations and buildings
- Structural concrete
- Structural steel and supports
- Piping systems
- Piping restraints and supports
- Mechanical components
- Electrical cable
- Electrical systems and components
- Ventilation and confinement systems
- I&C systems
- Nuclear welding
- Structural welding
- Fire protection systems Inspections include applicable aspects of QA Program implementation 7
Quality of Construction Inspection Procedure
- Quality Assurance (QA) Implementation IP
- Consists of 3 parts
- One Time QA Implementation Inspection.
- Periodic QA Inspections (at least annually):
- Corrective Action Program (CAP) Review.
- Design Control, Nonconformance Control, Audits.
- Other Criteria (as needed).
- Reactive Inspections (e.g., problem areas identified during SSC inspections, adverse trends, etc.)
- ANSI 15.8 requirements 8
Operational Readiness Inspection Procedure
- Operational Readiness Assessment Inspection
- One time inspection
- Conducted after licensee submits operating license application and near the end of construction activities
- Covers status of CIP completion, and may include programs needed for operations
- Inspection supports decision on operating license application determination 9
Construction Oversight and Inspections William Gloersen Region II
Oversight and Inspections:
Communication
- Establish and maintain frequent communications with NRC
- Establish point of contact for NRC RII construction project manager
- Conduct weekly teleconferences with the following participants:
- NRC licensing (HQ) and construction project management staff (RII)
- SHINE licensing and construction project management staff 11
Oversight and Inspections:
Communication Consider developing a construction status briefing sheet to facilitate the teleconference with the following information:
- Construction status and schedule
- Major milestones
- Major activities in the past week
- Major activities planned
- NRC inspection schedule
- Inspections completed
- Inspections planned
- Licensing Status
- Key licensing actions
- Meetings
- SHINE drop-in visits to NRC HQ or RII
- NRC management visits to SHINE
- Public meetings 12
Oversight and Inspections Establish and maintain a restricted access electronic reading room for use by both NRC inspection and licensing staff Types of information provided in the electronic reading room
- Licensing Documents
- Construction Authorization
- Quality Assurance Plan
- Safety Analysis Report
- Inspection Documents
- Construction Schedules
- Project Procedures
- Condition Reports
- Non-conformance Reports
- Engineering documents and drawings
- Construction photographs 13
Observations
- Develop strong partnerships with proven vendors
- Maintain critical oversight of work planning packages
- Perform intrusive and strategic inspections to confirm work is performed correctly prior to major undertakings and prior to NRC inspections 14
Observations
- Develop a robust corrective action program
- Identify, classify, and track conditions adverse to quality
- Ensure proper implementation and closure of corrective actions are completed
- Consider a Management Review Committee
- Safety Culture
- Keep the terms simple and usable for the construction staff
- Encourage staff to have a questioning attitude
- Demonstrate importance daily and reward behaviors
- SHINE Management Oversight
- Challenge the status quo
- Be seen in the field and model the correct behaviors and priorities - seek to understand 15
Construction Lessons Learned:
New Reactors Phil OBryan Office of New Reactors
Discussion Topics
- Design Control Lessons Learned
- Construction Lessons Learned
- Corrective Action Program Lessons Learned 17
Design Control Lessons Learned
- Unclear Licensing Basis
- New aspect of design that wasnt originally described or addressed in Construction Permit
- Misapplication of Codes/Standards in licensing basis
- Lack of awareness of licensing basis commitments
- Use of standard methodologies not in licensing basis
- Misinterpretation of Codes/Standards
- Use of wrong revision of Codes/Standards
- Incorrect, or lack of, vendor specifications
- Field changes poorly researched 18
Construction Lessons Learned
- Poor vendor quality, not identified by receipt inspection
- Poor Work Packages/Procedures
- Constructability & Field engineering
- Poor Supervision/QC oversight 19
Corrective Action Program (CAP)
Lessons Learned
- Safety Conscience Work Environment and workers new to nuclear industry
- Use of multiple CAPs/QAPs
- Use-as-is justifications
- Use of CAP to reconcile deviations and licensing basis 20
Construction Lessons Learned:
Fuel Cycle Facilities David Tiktinsky Office of Nuclear Material Safety and Safeguards
Topics
- Commitments in licensing documents
- Change process
- QA programs
- NRC observations 22
Commitments Made in Licensing Documents
- Clear commitments in licensing documents (e.g. codes, standard and exceptions)
- NRC inspects against licensing commitments
- Interpretations of code requirements
- Clear language
- Deviations and exceptions from codes and standards
- Descriptions versus commitments 23
Change Process During Construction
- Change requirements used for evaluating changes to site, structures, processes, systems, components, etc. (for ISA summary)
- Change process for license application
- NRC reviews and inspects process and results
- Reassess criteria based on actual experience 24
NRC Observations
- Design control
- Vendor oversight
- Inspection 25
Design Control Inspection Findings
- Translating design requirements (including codes and standards) into design and construction documents and properly implementing design documents
- Initiating, performing, verifying and documenting design changes and evaluating the impact of those changes on the design bases 26
Design Control Corrective Actions
- Training
- Surveillance activities at vendors
- Documentation of code deviations
- Procedure revisions 27
Supplier and Vendor Inspection Findings
- Compliance of inspection procedures with respect to ASME codes
- Oversight of vendors QA activities
- Documentation of weld repair procedures
- Vendor welder qualification program
- Inadequate documentation of weld repair/rework activities 28
Supplier and Vendor Corrective Actions
- Training related to preparing technical justifications
- Revised procedures to provide project personnel instructions on handling supplier issued non-conformance reports
- Additional oversight of vendors QA
- Clarification of procurement specifications 29
Lessons Learned from Industry Representative*
- Accepted Industry Practice does not necessarily affect the NRCs Position
- Emphasis on survey of the supply chain not realistic, unless accounted for when developing procurement strategy for how to establish a supply chain for a CGI
- The completeness of the evaluation, survey results, test results and the final acceptance records are important for CGI as any other nuclear component
- Presented by Rodney Whitney, MOX Services at NRC vendor oversight workshop in August 2012.
30
Challenges to Quality Construction (Industry)
- Ensuring vendors and construction contractors are implementing quality assurance requirements
- All organizations should be trained on and use similar corrective action programs
- Designing and redesigning as construction continues impacts inspection resources and scheduling
- Design control and verifications
- Does the field design match the approved design?
31
Vendor-Related Lessons Learned/Recommendations (Industry)
- Know your suppliers (and your suppliers supplier) fabrication and CGD processes
- Demand objective evidence that suppliers and sub-suppliers have appropriate QA programs & CGD Processes in-place to assure implementation is effective
- Otherwise you may see or get:
- Procedures not workable or developed but not followed
- Implementing procedures dont consistently address requirements
- Incapable of identifying critical characteristics
- Lack of experience with nuclear regulations and QA requirements
- Control of sub-suppliers by prime suppliers is poor 32
Vendor-Related Lessons Learned/Recommendations (Industry)
- Allow vendor flexibility in sampling plans due to their knowledge of particular circumstance of their supply chain knowledge
- Allow vendors to propose alternatives for your acceptance
- Experience has shown that QL-1 (IROFS) vendors vary dramatically in their knowledge of standard sampling plans and implementation of sampling plan methodology
- Example: Destructive/Non-destructive testing of raw materials 33
Vendor-Related Lessons Learned/Recommendations (Industry)
- Vendor Communication with project CGD group is very important.
- Placing CGD personnel in the vendor shop can be very beneficial.
- Train Subcontract Technical Representatives to understand project CGD positions, since they are the first line of technical oversight of the vendor.
- Understand foreign company quirks.
34
Vendor-Related Lessons Learned/Recommendations (Industry)
- Aggressive management and oversight of CGD programs is prudent
- Review all vendor Commercial Grade Dedication plans and procedures initially.
- Reviews may be stopped or lessened when confidence is gained with vendors program
- CGD acceptance process needs to be closely coordinated with receipt inspection capabilities 35
NRC Enforcement Program Tom Marenchin Office of Enforcement
Purpose of Enforcement Program:
Support NRC Mission
- Enforcement Action Should Be Used:
- As a deterrent to emphasize the importance of compliance with requirements, and
- To encourage prompt identification and prompt, comprehensive correction of violations 37
Enforcement Tools
- Formal Mechanisms (legally binding)
- Minor violation
- Non-cited violation (NCV)
- Civil penalty
- Order
- Demand for Information
- Administrative Actions (not legally binding)
- Notice of Deviation (failure to satisfy non-binding requirement)
- Notice of Nonconformance (contractor failure)
- Confirmatory Action Letter (licensee agreement to take specified actions) 38
NRC Enforcement Process
- Identify
- Assess
- Disposition 39
Identifying Noncompliances
- What requirement was violated?
- How was the requirement violated?
- When did the noncompliance occur?
- How long did it exist?
- Who identified it and when?
- What is significance
- What is the root cause? (if known)
- Corrective actions?
40
Significance
- NRC consider four issues:
- Actual safety consequences
- Potential safety consequences
- Potential for impacting the NRCs ability to perform its regulatory function
- Any willful aspects of the violation 41
Traditional Enforcement
- Each violation assigned a Severity Level (SL)
- SL I, II, III, IV, with SL I being the most significant and SL IV being the least significant on risk
- Enforcement Policy Provides violation examples for each of the four SLs
- Section 6.5 - Facility Construction (10 CFR Part 50 and 52 Licensees and Fuel Cycle Facilities)
- SL may be increased if violation determined to be willful 42
- A written notice setting forth one or more violations of a legally binding requirement
- NOV states:
- When violation occurred (date)
- Who violated requirement
- Time and/or number of times violation occurred
- Brief description of the violation (i.e., what actually happened resulting in the violation)
- A civil penalty may be issued in conjunction with NOV 43
Escalated Enforcement
- SL I, II, III violations Civil Penalties
- NOVs to individuals
- Orders to modify, suspend, or revoke NRC licensees or the authority to engage in NRC-licensed activities
- Orders to impose civil penalties 44
Enforcement Panel
- All proposed escalated enforcement reviewed by enforcement panel
- Panel considers:
- Facts of the violation and requirements
- SL and violations examples in Policy
- Whether Identification Credit is warranted
- Whether Enforcement Discretion is appropriate
- Whether a CP is appropriate
- Whether to hold a PEC 45
Predecisional Enforcement Conference (PEC)
- Held if needed by NRC or requested by licensee
- Normally open to public
- Purpose - to obtain information to assist enforcement decision:
- Facts, Root Causes, Missed Opportunities
- Corrective Actions taken or planned
- Significance 46
References
- NRC Enforcement Policy http://www.nrc.gov (select Electronic Reading Room, then Document Collections, then Enforcement Docs, then Enforcement Policy)
- NRC Enforcement Manual http://www.nrc.gov (select Electronic Reading Room, then Document Collections, then Enforcement Docs, then Enforcement Guidance, then Enforcement Manual)
- Issued Escalated Enforcement Actions http://www.nrc.gov/about-nrc/regulatory/enforcement/current.html 47