1. Regulatory project management
VN/RA/01 Task 1&2 Workshop
Hanoi, October 2012
Confidential
Ilari Aro
Ref. to Kirsi Alm-Lytz
STUK

2. Outline Regulatory oversight projects
Procedures developed at STUK
Typical oversight projects
Examples of regulatory project management in new build projects
OL3 - STUK’s role and organisation in licensing steps
Summary of STUK’s competences and resources needed for OL3 project oversight
Preparation for regulatory oversight of upcoming new build projects
PVM/NN

3. Regulatory oversight projects
Regulatory oversight is defined in the legislation and regulations
New plant projects and plant modifications are initiated by the licensees
-> STUK can’t decide whether the regulatory work should be done or not but choice can be made whether the oversight work is performed as projects or within line organisation

4. Projects office at STUK/NRR (Department of Nuclear Reactor Regulation)
Projects office (PMO) founded in 2002 for the oversight of the OL3 licensing
Co-ordinates the regulatory oversight in new NPP licensing process, in NPP operating license renewals and in some larger plant modifications
Develops the project management procedures for oversight projects
Supports the project managers in project planning and prepares quarterly collective report on projects’ progress
Provides resident inspectors for new NPPs under construction

5. Development of the project management procedures at STUK/NRR
After foundation of Projects unit in 2002 also other oversight works have been co-ordinated as projects
The detailed guidance for the regulatory project management was finalised in 2010
STUK/NRR project model is based on generic project management practices, references e.g.,
A guide to the project management body of knowledge (PMBOK guide), ANSI/PMI
ABC project model, Finnish Project Institute

6. STUK/NRR project model
Portfolio management G1 G0 PE
Project idea
Evaluation
phase
Preparation
phase
Planning
phase
Execution
phase
Closing
phase
Project management
Initiating
Project planning
Management and control
Closing
Project execution MS MS
End product
of project
Project documents
Project meeting memos
Assessment report
Project charter
Project management plan
Progress reports
List of follow-up items
PVM/NN

7. Regulatory oversight projects
Guidance for a single project
Decision of project start, G0 (criteria, project charter template)
Project organisation (steering group, project manager, project group, resident inspectors)
Project planning (project management plan templates)
Project management and control (meeting practices, communication with licensee and other stakeholders, resource management, progress reporting and template)
Closing project (closing meeting, assessment report and follow-up list templates)
Documentation (record keeping)
Project management in STUK/NRR
Project classification (ABC model, classification principles and procedures in different classes)
Project portfolio management (excel table used by PMO, quarterly project progress reports and portfolio reporting)
Engagement in the department’s yearly planning process (resource planning)

8. Typical oversight projects
New build projects
Operating licence renewals and periodic safety reviews
Extensive plant modifications involving
several technical areas
high safety significance
long time schedules (several years)
large resource need (several person-months of oversight work)

9. Oversight projects of nuclear facilities
new nuclear facilities
FIN5 ( , oversight of OL3 licensing and construction)
PAP ( , DiPs for new NPPs)
VALVE ( , preparations for FIN6/7 CL appl. review)
ONKALO (2005 ->, construction of research tunnels and final repository for spent fuel)
operating licence renewals/ periodic safety reviews
KLUPA (Loviisa licence renewal, ended 2007)
OLMATA (Olkiluoto periodic safety review, ended 2009)
FLUPA (Research reactor licence renewal, ended 2012)
large plant modifications
LARA (Loviisa I&C renewal, )
LOKIT (Loviisa liquid waste solidification plant construction, )
KOPLA (enlargement of Olkiluoto interim storage for spent fuel, )
LAMO (modernisation of Loviisa refueling machine, >)
DiGU (modernisation of Olkiluoto diesel generators, >)
LoPolar (modernisation of Loviisa Polar crane, >)

10. Estimated project progress (traffic lights)
Project portfolio
Name
Description
Class
Owner
Manager
Group
Schedule
Project phase
Estimated project progress (traffic lights)
e.g. FIN5
Olkiluoto 3 ... A
N.N.
N.N., …
Project initiated
– predicted end
Planning/
Execution/
Closing
-Resources available
-Use of resources compared
to the planned
-deviations in the submitting schedule
of documents for review
-deviations in the quality of submitted
documents for review
Excel table collecting information on different projects
Includes also links to the project charter, project management plan and the latest progress report
Project managers report quarterly on the progress of their projects
Office head of PMO updates the project portfolio and reports quarterly in the operative and management meetings on the progress of projects and possible resource problems

11. Example – Olkiluoto 3, resources for licensing and regulatory oversight

12. OL3 Project generally 1/2 OL3 is the first EPR being constructed
OL3 is a turn key project
Owner and operator (Licensee) is TVO
Constructed by Consortium of Areva and Siemens
Project is progressing but is more than five years behind the original schedule
Photos: TVO

13. OL3 Project generally 2/2
Main civil construction activities finished at the site
Current issues
Installation activities ongoing
Design of instrumentation and control system (independence, testing, qualification)
Operating licence application expected during 2013
Schedule for Commercial operation under elaboration

14. OL3, CL phase - organization, competences and resources 1/4
STUK started preparations for regulatory oversight of OL3 project in 2002 after DIP
Establishment of a
project office and project group to plan and coordinate work
project plan for the oversight (steps, goals, resources, risks, reporting)
Discussions with
the utility on the project schedule, content of documents for construction licence
Technical Support Organisations to establish analysis capabilities needed for independent comparison analyses
Regulators with recent licensing and construction experience
Regulators and TSO’s with knowledge on EPR design
Inspection Organisations possibly needed in the project
Resource planning
to plan the work of subprojects (technical disciplines)
to find out possible expertise gaps.
PVM/NN

15. OL3, CL phase - organization, competences and resources 2/4
Conclusions of the planning were
STUK mainly had a core competences to review technical issues presented in PSAR and other documents of CL application
on the other hand, resources to oversee existing plants was too small - recruiting was necessary.
Technical support of TSOs was needed
for new features like airplane crashes, severe accidents (melt retention in core catcher), digital I&C and primary system materials and components
to perform independent assessments and analyses of design to support STUK’s decision making.
co-operation with French regulatory body (ASN) to share experiences of EPR design.
PVM/NN

16. OL3, CL phase - organization, competences and resources 3/4
STUK´s project group
VALO
management
RETU
SÄVY
PISA
RAKE
LAKU
SATU
AUTO
MEKA
KATU
YDIN
LATE
Electrical systems
Automation systems
Layout, Auxiliary systems
Turbine systems
Nuclear materials
and Waste
Mechanical
equipment
Reactor, safety functions,
systems and analyses
Radiation safety and emergency
preparedness
Probabilistic risk
assessment
Civil construction, Structures,
Fire protection
Quality Management
and organisation
Commissioning and
operational safety
PVM/NN

17. OL3, CL phase - organization, competences and resources 4/4
OL 3 technical support areas in CL phase
PVM/NN

18. OL3, construction - STUK objectives 1/2
Review and approval of detailed design documentation for systems, structures and components (SSCs)
Before start of construction or manufacturing
Oversight of and inspections on manufacturing and construction to verify QA and QC activities of manufacturer, vendor and licensee
Resident inspectors on site (complemented with staff from HQ)
Regular visits at the component manufacturing sites
Assessment of licensee´s performance to verify the adequacy of project management, safety assessment, QA/QC programmes, etc.
Quality of the submitted regulatory documentation
Inspections within the construction inspection programme
Resident inspectors at site
Assessment of the performance of the parties responsible for design, construction and manufacturing
participation as an observer in audits, inspection visits, manufacturing and construction oversight, meetings
PVM/NN

19. OL3, construction - STUK objectives 2/2
Inspections during construction can be divided to two categories
Inspections during construction on structures and components
To verify QA and QC results and activities of manufacturer, vendor and licensee - product conformity
Defined in regulatory guides
Inspection organizations used in lower safety classes
Inspections on licensee’s performance within the Construction Inspection Program
To verify the adequacy of project management, safety assessment, QA/QC programmes, etc. - performance conformity
PVM/NN

20. OL3, Construction phase - organisation, competences and resources
Oversight during construction needs
same core competences than during CL phase but also
much new know-how (e.g. materials, concreting, welding, QA/QC inspections to manufacturers, site supervision...) and human resources when the amount of work is much larger.
STUK has continued recruiting as well as using of TSOs and IOs
technical experts recruited from expert organisations, utilities or from “conventional” industry - background from nuclear side not necessarily needed in all tasks
IOs are “extension” of STUK - they take STUK’s role as a regulator in lower safety classes.
TSOs participate more in STUK’s reviews than make independent analyses.
PVM/NN

21. Regulatory Oversight (man-years/NPP)

22. Oversight OL3 - mechanical engineering and manufacturing technology
Core competences for mechanical engineering, red colour indicates remarkable increase of resources
Nuclear fuel and control rods
Mechanical equipment
Nuclear power plant pressure vessels
Strength analysis
Manufacturing technology
Material technology and ageing
NDI
Ageing management
Assessment of QMS
Utilization of PRA in inspections
Maintenance
Assessment of inspection organisations.
PVM/NN

23. Oversight OL3 - reactor and safety systems
Core competences for reactor and safety systems
Safety Principles and Design Basis of NPP
Deterministic safety analysis
NPP Technology and system design, thermal hydraulics
Reactor technology and physics, criticality safety
Nuclear fuel technology
Containment functions
I&C functions
Severe accidents
Technical specifications
Emergency response
Operational safety
PVM/NN

24. Oversight OL3 - radiation protection
Core competences for radiation protection
Radiation protection - dose control
Radiation protection - dose calculations
Radioactive release (normal operation)
Emergency preparedness and rescue services at NPP
Dispersion of radioactive releases in accidents – source term
Meteorology - dispersion of radioactive releases
Monitoring environment of NPP
Research reactors
Nuclear waste management.
PVM/NN

25. Oversight OL3 - risk analysis
Core competences for risk analysis
PRA in risk informed regulation
Fire protection
Meteorological and environmental risks
Seismic risks
PRA-methods (level 1 and 2)
PRA software (user skills and development)
Operation, Maintenance
Reliability of human performance
Theoretical basis of risk analysis.
PVM/NN

26. Oversight OL3 - electrical and automation systems
Core competences for electrical and automation systems
Electrical systems and components
Embedded automation of electrical components
Protection automation
Accident instrumentation and accident management systems
Software based automation systems
QA & QC, verification and validation
Operational automation
Control room
Ageing of I&C components.
PVM/NN

27. Oversight OL3 - civil engineering
Core competences for civil engineering
Civil engineering
Construction technology
Strength analyses
Fire protection
Lay-out
Risk analysis.
PVM/NN

28. Oversight OL3 - project office
Core competences for project office
Handling of license applications
Regulatory control of plant projects
Project management
Management systems / QA & QA, safety culture issues
Modification projects
Interfaces between technical areas
Safety analysis
PRA
Oversight at site during construction (resident inspectors).
PVM/NN

29. Oversight OL3 - operational safety
Core competences for operational safety
Technical specification and basis
Operation
Maintenance
Operational experiences
Operating organisation
Safety culture
Management systems
Personnel resources, training
Emergency preparedness
Resident inspectors
PVM/NN

30. Annual costs of the technical support contracted for OL 3
Oversight OL3 - using of TSOs
Annual costs of the technical support contracted for OL 3
PVM/NN

31. YVL 1.1: Construction Inspection Programme

32. YVL 1.1: Construction Inspection Programme
The purpose of STUK’s Construction Inspection Programme is to verify that the operations of the construction licensee ensure high-quality construction and implementation in accordance with the approved designs while complying with the regulations and official decisions concerned. In particular, the Construction Inspection Programme assesses and controls the following issues:
the licensee’s general operations with a view to constructing the facility
detailed procedures in the various fields of technology implemented for constructing the facility
dealing with safety matters and consideration of safety in management procedures
the licensee’s expertise and use of expertise
quality management and quality control.

33. Construction Inspection Programme
The Construction Inspection Programme is divided into two main levels: the upper level assesses the licensee’s main operations, such as project management and resources management, project control, dealing with safety issues and project quality management.
The next level, known as the operation level, assesses, e.g., project quality assurance, training of the operating personnel, inspection procedures, utilization of the PSA, document management, radiation safety, and structure and component-specific inspections in the various fields of technology. Furthermore, the emergency response arrangements during construction, physical protection, fire protection and nuclear waste treatment are included in the Construction Inspection Programme within the scope STUK considers necessary.
In addition to the above-mentioned inspections, of which the licensee is informed in advance, STUK carries out inspections without prior notice at its discretion.

34. Inspections and regulatory control required by YVL Guides
STUK controls the construction project, quality management of the construction and the licensee’s safety work with the aid of inspections at its discretion. The inspections pertain, e.g., to the following issues:
project management and control
organization; training, competence and adequacy of the personnel
dealing with safety matters
implementation of quality management as a whole and in the different sectors
control exercised by the licensee concerning the implementation of quality management by the licensee itself, the facility contractor and their subcontractors.

35. Buildings and concrete and steel structures
STUK controls the design, manufacture and installation of the buildings and concrete and steel structures important to safety. The control includes
pre-inspection of structures
inspections at the construction site concerning the readiness to begin work
inspections concerning manufacture
construction inspections of steel structures
commissioning inspections.
The safety class of structures is taken into account when determining the scope of control and setting the requirements. The requirements for and control of concrete and steel structures have been described in Guides YVL 4.1 and YVL 4.2. Fire protection at nuclear facilities is discussed in Guide YVL 4.3.
Only organizations and persons in their employ that have been granted approval by STUK are allowed to carry out inspections and expert duties subject to licence relating to concrete and steel structures. Guides YVL 1.3 and YVL 4.1 deal with these duties and the approval procedures.

36. Components
STUK controls the design, manufacture and installation of pressure equipment and other mechanical components of nuclear facilities. The control includes
inspection of the construction plans for components
approval of the manufacturers and testing organizations
inspections concerning manufacture
construction inspections
installation inspections
commissioning inspections.
The safety class of components is taken into account when determining the scope of control and setting the requirements. On the licensee’s application, STUK may approve a separate testing organization to carry out specified control duties. The requirements for and control of mechanical components have been described in Guides YVL 1.3, YVL 1.14 and YVL 1.15 and in YVL Guides of series 3 and 5. Guide YVL 3.0 describes the principles of pressure equipment control. Guide YVL 3.4 presents the requirements for the approval of manufacturers. Guide YVL 1.3 deals with the duties and the approval procedure for inspection and testing duties subject to licence relating to mechanical components.

37. Components
STUK controls the design, manufacture and installation of electrical and instrumentation and control equipment of nuclear facilities. The control includes review of the suitability assessment, inspections concerning manufacture and installation to be conducted at STUK’s discretion, and commissioning inspections.
The safety significance of the component concerned is taken into account when determining the scope of control and setting the requirements. The requirements for and control of electrical and instrumentation and control equipment have been described in Guides YVL 5.2 and YVL 5.5. Guides YVL 7.9 and YVL 7.10 give the requirements for radiation protection of nuclear facility workers and monitoring of occupational exposure. Other requirements and control concerning the radiation protection and environmental monitoring of a nuclear facility are discussed in guides of the YVL 7 Guide series.

38. Nuclear fuel
In accordance with Sections 114 and 115 of the Nuclear Energy Decree, STUK controls that the nuclear fuel is designed, manufactured, transported, stored, handled and used in compliance with the valid regulations.
The nuclear fuel licensing procedure and STUK’s regulatory control measures for nuclear power plants have been described in Guide YVL 6.1.
Guides YVL 6.2, YVL 6.3, YVL 6.4, YVL 6.5, YVL 6.7 and YVL 6.8 give the requirements for the design, manufacture, transport, handling, storage and use of nuclear fuel.

39. Preparations for operation; organization and training
In accordance with Section 119 of the Nuclear Energy Decree, STUK controls that the organization operating the facility is appropriate and adequate and that the persons involved in the use of nuclear energy meet the competence requirements and that they are given proper training.
Development and training of the operating organization shall begin early enough during the construction of the nuclear power plant (YVL 2.5).
When reviewing the administrative rules and organization manual referred to in Section 4.2 above, STUK assesses the appropriateness and adequacy of the licence applicant’s organization and the qualifications required.
In accordance with Section 128 of the Nuclear Energy Decree, the operator of the facility systems in the main control room of a nuclear facility shall have STUK’s approval for this job. The requirements for the nuclear power plant operator licensing and the training of personnel have been defined in Guides YVL 1.6 and YVL 1.7.

40. Pre-operational testing
The purpose of the pre-operational testing of a nuclear facility is to demonstrate that the facility has been constructed and operates as designed. The testing consists of the following stages:
system performance tests
fuel loading and pre-criticality tests of the reactor systems
making the reactor critical and low-power tests
power tests.
STUK controls the testing of a nuclear facility by reviewing the general testing plans and programmes, by watching the tests at the nuclear facility and by reviewing the documents of test results.
The operation of a nuclear power plant is considered to begin when the loading of nuclear fuel into the reactor begins. The reactor loading requires that the Government has granted an operating licence and that STUK has approved the application concerning fuel loading and the reports on the reactor and fuel behaviour in the first operating cycle.

41. Pre-operational testing
To ensure that the nuclear facility complies with the regulations applied to it, STUK verifies, in accordance with Section 20 of the Nuclear Energy Act, before the fuel loading that
the documents linked with operation of the facility, referred to in Section 36 of the Nuclear Energy Decree, are acceptable in all respects
the instruction manuals concerning operation of the facility, including instructions for accidents and transients, are adequate
the organization operating the nuclear facility is appropriate and adequate
the persons involved in the use of nuclear energy meet the competence requirements
the persons designated as responsible manager for the facility operation and as his/her deputy have received STUK’s approval
there is a sufficient number of licensed operators at the facility
for operation of the facility, persons who have received STUK’s approval have been appointed to see to the emergency response arrangements, physical protection and safeguards of nuclear materials
the commissioning inspections of the facility systems, structures and components have been carried out with acceptable results
the results of system performance tests are acceptable insofar as it has been possible to perform the testing without the reactor
pre-service inspections of the structures and components have been completed
physical protection and emergency response arrangements are sufficient
the necessary control to prevent the proliferation of nuclear weapons has been arranged appropriately
the licensee of the nuclear facility has arranged indemnification regarding liability in the case of nuclear damage as prescribed.

42. Pre-operational testing
The reactor may be made critical and brought to a higher power level in accordance with the decisions taken by STUK.
When the testing has finished, the holder of the operating licence shall assess the results of the testing as a whole. The testing results shall be used to assess, for instance, whether any changes in the Final Safety Analysis Report and in the operational limits and conditions are needed. On the basis of this assessment, the licensee shall make the necessary changes in the operational limits and conditions and in the Final Safety Analysis Report, and submit them to STUK for approval.
Guide YVL 2.5 deals with regulatory control of the testing of nuclear power plants.

43. Preparation for regulatory oversight of upcoming new build projects

44. STUK’s preparation tasks for new projects (1/2)
Collecting and analysing OL3 experience and lessons learned
Collecting OL3 experience by interviewing project key persons
Collection, classification and analyse of OL3 lessons from different sources
Presenting targets for construction licence review according to the new STUK YVL guides
Influencing to licence applicants preparation activities and organisational preparedness
Possible meetings with licence applicants and vendors concerning plant design, design maturity and siting

45. STUK’s preparation tasks for new projects (2/2)
Coordinate possible applications, e.g. for material manufacturing before granting the construction license
Advancing STUK’s oversight activities
Producing specifications for project and requirement management tools
Planning competence and personnel resources for new oversight projects
Cooperate with national and international regulatory bodies and organisations

46. Summary, project management
Oversight of new build, licence renewals and plant modifications can be organised as projects, beneficial when includes
several technical areas
high safety significance
long time schedules (several years)
large amount of resources (several person-months)
Generic project management models are applicable for also regulatory oversight projects
Project management processes: initiating, planning, executing, monitoring and control, and closing
Cost management is reduced to human resource management
Good planning of use of inspection resources is important but sometimes it is difficult to predict the submitted documents and their schedule
-> licensing plan

47. Lessons to be learned for New Build
Regulator need to be well prepared for the project and licensing phases
regulations need to be up-to-date - requirements need to be managed
licensing steps, licensing documentation and regulatory hold points need to be commonly understood by project parties as well as project schedule and expectations to design completion
competences and human resources for safety evaluations need to be evaluated and ensured
TSO support was indispensable for STUK. It was profitable to:
use a limited number of experienced organisations
use organisations that were familiar with design of the plant - but independent from vendor
focus on the new features.
Co-operation with other regulators is a good possibility to benchmark requirements, findings and coverage of the review and inspection work.
PVM/NN