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

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

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

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

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 99-001-2008 ABC project model, Finnish Project Institute

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

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)

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)

Oversight projects of nuclear facilities new nuclear facilities FIN5 (2002-2014, oversight of OL3 licensing and construction) PAP (2008-2009, DiPs for new NPPs) VALVE (2010-2014, 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, 2004-2016) LOKIT (Loviisa liquid waste solidification plant construction, 2002-2013) KOPLA (enlargement of Olkiluoto interim storage for spent fuel, 2009-2013) LAMO (modernisation of Loviisa refueling machine, 2010 ->) DiGU (modernisation of Olkiluoto diesel generators, 2010 ->) LoPolar (modernisation of Loviisa Polar crane, 2010 ->)

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

Example – Olkiluoto 3, resources for licensing and regulatory oversight

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

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

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

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

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

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

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

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

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

Regulatory Oversight (man-years/NPP)

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

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

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

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

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

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

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

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

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

YVL 1.1: Construction Inspection Programme

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Preparation for regulatory oversight of upcoming new build projects

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

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

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

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