LEARNING OBJECTIVES FOR SECTION 4. Inspection and Enforcement by the Regulatory Body

Transcription

1 LEARNING OBJECTIVES FOR SECTION 4 Inspection and Enforcement by the Regulatory Body After following the lectures, studying the printed material, performing the exercises, studying the given IAEA references and after discussing with the tutor the application of the IAEA practices at the national level, the learner will be able to describe the following:?? IAEA guidance on inspection and enforcement function;?? IAEA guidance on inspection and enforcement methods;?? Some national good practices on inspection and enforcement;?? Typical inspection programmes and types of inspection;?? Inspection planning, implementation and reporting;?? Inspection of plant modifications;?? Inspection of operational events;?? National inspection and enforcement practices in the learner s own country;?? Comparison of the learner s inspection and enforcement practices with international practices. FUNDAMENTAL REFERENCE (TO BE READ THOROUGHLY)?? INTERNATIONAL ATOMIC ENERGY AGENCY, Regulatory Inspection of Nuclear Facilities and Enforcement by the Regulatory Body, Safety Series No. GS-G-1.3, IAEA, Vienna (2002). 1

2 4. INSPECTION AND ENFORCEMENT BY THE REGULATORY BODY 4.1. IAEA GUIDANCE ON INSPECTION AND ENFORCEMENT 1 Regulatory inspection and enforcement activities cover all areas of regulatory responsibility. Inspections allow the regulatory body to satisfy itself that the operator is in compliance with the conditions set out, for example, in the authorization or regulations. In addition, the regulatory body shall take into account, as necessary, the activities of suppliers of services and products to the operator. Enforcement actions are applied as necessary by the regulatory body in the event of deviations or non-compliance with conditions and requirements. The principal objectives of regulatory inspection and enforcement are to provide a high level of assurance that all activities performed by the operator during all the stages of the authorization process and during all stages of the lifetime of a nuclear facility (siting, design, construction, commissioning, operation and decommissioning or closure) are executed safely and meet the safety objectives and licence conditions. Inspection is performed to check independently the operator and the state of the facility, and to provide a high level of confidence that operators are complying with the safety objectives prescribed or approved by the regulatory body. This should be achieved by confirming that:?? All relevant laws, regulations and licence conditions, and all relevant codes, guides, specifications and practices are complied with;?? The operator has a strong and effective management, good safety culture and selfassessment systems for ensuring the safety of the facility and the protection of workers, the public and the environment;?? The required quality and performance are achieved and maintained in the safety related activities of the operator and in the structures, systems and components of the facility throughout its lifetime;?? Sufficient numbers of personnel, who have the necessary competences for the efficient and safe performance of their duties, are available at all times throughout all stages of the facility s lifetime;?? Deficiencies and abnormal conditions are identified and promptly evaluated and corrected by the operator and duly reported to the regulatory body as required; and?? Any other safety issue that is neither specified in the authorization nor contained in the regulation is identified and appropriately considered. Regulatory inspection includes a range of planned and reactive inspections over the lifetime of a nuclear facility and inspections of relevant parts of the operator s organization and contractors to ensure compliance with regulatory requirements. Regulatory enforcement actions are actions to deal with non-compliance by the operator with specified conditions and requirements. These actions are intended to modify or correct any aspect of an operator s procedures, and practices, or of a facility s structures, systems or components as necessary to ensure safety. Enforcement actions may also include the imposition or recommendation of civil penalties and other sanctions. 1 INTERNATIONAL ATOMIC ENERGY AGENCY, regulatory Inspection of Nuclear Facilities and Enforcement by the Regulatory Body, Safety Standards Series No. GS-G-1.3 (in press). 2

3 The regulatory body has legal authority for conducting and co-ordinating its inspection and enforcement responsibilities during the site evaluation, design, construction, commissioning, operation, decommissioning or closure of nuclear facilities under its authority. With regard to inspection, the regulatory body shall has the authority:?? To establish regulations and issue guidance which, among other things, serve as the basis for inspection;?? To enter the premises of any facility subject to the regulatory process at any time for the purposes of inspections;?? To require preparation of, access to, and submission of reports and documents from operators and their contractors when necessary;?? To seek the co-operation and support of other governmental bodies and consultants with inspection related competence or qualifications; and?? To communicate information, findings, recommendations and conclusions from inspections to other governmental bodies or interested parties, including high level officials, as deemed appropriate in view of the significance of the issue. With regard to enforcement, the regulatory body has the authority:?? To require the operator to take action to remedy deficiencies and prevent recurrence to curtail activities or to shut down the facility when the results of inspection or another regulatory assessments indicate that the protection of workers, the public and the environment might be inadequate; and?? To impose or recommend civil penalties and other sanctions for non-compliance with specified requirements. The regulatory body has adequate powers and authority to enforce compliance with its requirements and licence conditions, and has available a number of enforcement methods to provide sufficient flexibility to implement the method best suited to the seriousness of the violation and the urgency of corrective actions. The degree of authority of the regulatory inspectors is clearly defined, and clear administrative procedures are adopted and implemented. The regulatory body, including a dedicated support organization if appropriate, has staff capable of performing activities required by its inspection programme or, if outside consultants are used, staff capable of adequately supervising the consultants work and independently evaluating its quality and the results. It is neither necessary nor practicable for the regulatory body to be entirely selfsufficient in all technical areas relating to inspection. It may therefore be necessary to use consultants in specialized areas. It may occasionally be necessary owing to a heavy short term workload to augment the regulatory body s inspection staff with consultants having knowledge and experience equivalent to that of the regulatory body s inspection staff. 3

4 Regulatory inspection programme The regulatory body establishes a planned and systematic inspection programme. The extent to which inspection is performed in the regulatory process will depend upon the potential magnitude and nature of the hazard associated with the facility or activity. Specific responsibilities of the regulatory body in this regard include:?? Conducting planned inspections in all stages of the authorization process;?? Carrying out reactive inspections, if appropriate, in response to events, incidents or accidents;?? Identifying and recommending necessary changes to the safety requirements approved by the regulatory body, specified in the authorization or contained in the regulations;?? Preparing reports to document its inspection activities and findings;?? Verifying the operator s compliance with regulatory requirements and otherwise confirming continuous adherence to safety objectives;?? Ensuring that the operator has adequate, comprehensive and up-to-date information on the status of the facility and for the demonstrating its safety, and a procedure to maintain this information;?? Verifying that corrective actions have been undertaken by the operator to resolve safety issues identified previously;?? Tracking recurrent problems and non-compliance;?? Developing such procedures and directives as may be necessary for the effective conduct and administration of the inspection programme; and?? Determining and recommending suitable enforcement actions when non-conformance with requirements is identified. Regulatory inspection programmes are comprehensive and are developed within the overall regulatory strategy. These programmes are thorough enough to provide a high level of confidence that operators are in compliance with the regulatory requirements and are identifying and solving all actual and potential problems in ensuring safety. In order to establish or modify an inspection programme different methods may be used when selecting the inspection areas and establishing priorities for the inspection programme. The regulatory body should consider the following:?? The results of previous inspections;?? The safety analysis performed by the operator and the results of regulatory review and assessment;?? Performance indicator programmes or any other systematic method for the assessment of operator s performance;?? Operational experience and lessons learned from the facility and other similar facilities as well as results of research and development; and?? Inspection programmes of the regulatory bodies of other states. 4

5 The regulatory body has the capability to undertake inspection activities at any time as necessitated by the normal operation or by any fault conditions or operator s activities at the facility. The planning of the programme of inspections will also be influenced by the geographical location of the regulatory body in relation to the facility to be inspected. In particular it will depend on whether inspectors are permanently at the facility site (resident inspectors) during one or more stages of the facility s lifetime Types of inspections The regulatory body conducts two general types of inspection, namely planned inspections (including special inspections) and reactive inspections. Inspections may be conducted by individuals or teams and may be announced or unannounced, as part of a general programme or with specific aims. Planned inspections are those carried out in fulfilment of, and in conformance with, a structured and largely pre-arranged or baseline inspection programme developed by the regulatory body. They may be linked to operator schedules for the performance or completion of certain activities at all stages of the authorization process. They are scheduled in advance by the regulatory body. Special inspections may be carried out to consider specific issues that may be of interest to the regulatory body, such as new research and development findings and experience from other facilities. This type of inspection may range from a single inspector reviewing a specific inspection area, to a team inspection of several inspectors reviewing several different inspection areas. Team inspections, which may be multidisciplinary, provide an in-depth independent and balanced assessment of the operator s performance. Team inspections are of particular value once safety problems have been identified, since normal inspections cover only small samples of operator s activities in any particular area. Reactive inspections, by individuals or teams, are usually initiated by the regulatory body in response to an unexpected, unplanned or unusual situation or an incident, in order to assess its significance and implications and the adequacy of corrective actions. The regulatory body assumes the need for reactive inspections and plans its requirements for staff and consultants accordingly Provision of guidance to inspectors To ensure that all nuclear facilities in a country are inspected to a common standard and that the level of safety is consistent, the regulatory body provides written guidance in sufficient detail for its inspectors. The guidelines ensure a systematic and consistent approach to inspection, allowing sufficient flexibility for inspectors to take the initiative in identifying and addressing new concerns as they arise. Appropriate information and guidance are provided to the inspectors concerned and each inspector is given adequate training in following this guidance. 5

6 The authority vested in inspectors should oblige them to conduct themselves on-site in a manner that inspires confidence and respect concerning their competence and integrity Inspection areas Inspection by the regulatory body concentrates on areas of safety significance. The stages of inspection covers: site evaluation, design and construction, commissioning, operation and decommissioning. In the following key topics at each stage are covered. Table XIV presents areas of nuclear facilities that may be of particular interest for inspection at different stages of the authorization process Implementation of an inspection programme The regulatory body has an overall plan for the programme of inspections that it will undertake at a facility. In determining the intervals of inspections and the level of effort to be applied, the regulatory body takes into account the relative significance for the safety of the facility of each authorization stage and inspection area. Particular aspects that need to be considered in determining the intervals of inspection in the various areas and the level of inspection effort to be applied include:?? The safety significance of the issues;?? The inspection methods and approaches used (for example, the use of resident inspectors may affect the frequency and intensity of inspections);?? The qualified personnel and other resources available to the operator;?? The performance record of the operator and the facility, including the number of violations, deficiencies, incidents and problems encountered, and the number of reactive inspections required;?? Results of regulatory review and assessment;?? The type of facility;?? The personnel and other resources available to the regulatory body.?? Results of previous inspections. To facilitate management of the allocation of inspection resources, the regulatory body develops a site specific inspection plan that takes into account the factors presented in Table XIV. The inspection plans are recorded in such a way that can easily be modified to take into account continuing activities, and they are reviewed periodically and adjusted as necessary. The inspection plan is flexible enough to permit inspectors to respond to particular needs and situations. The regulatory body establishes a process of periodically evaluating inspection findings, identifying generic issues and making arrangements to enable inspectors from various plants, locations or projects to meet to exchange views and discuss the findings and issues. 6

7 7 TABLE XIV. INSPECTION AREAS FOR NUCLEAR FACILITIES The site evaluation stage Before construction of the nuclear facility begins, the regulatory body monitors as appropriate, through its inspection programme, site preparation activities undertaken by the operator, including verification of site characteristics and authorized excavation and earthwork. Specific inspection objectives in these areas include verification that the operator is undertaking siting activities in full conformity with existing regulatory requirements and assurance that the site preparation work does not proceed beyond that permitted by any authorization in force. During site preparation, the regulatory body is also concerned with confirming that the site characteristics remain consistent with the description presented by the operator in its application and in the subsequent supporting documentation submitted to the regulatory body. The design and construction stage The chief objectives of the regulatory inspection programme during the design and construction of the facility are to verify that:?? Safety related materials, SSCs meet the requirements established by the regulatory body and conform to good practices;?? Construction activities associated with manufacturing and installing SSC items are conducted in accordance with regulatory requirements and in conformity with general safety objectives.?? The as-built configuration of SSCs is in conformity with the assumptions made in the review and assessment; any deviation is analyzed and justified, and the documentation is updated;?? The operator s system and procedures for quality assurance and inspection are adequate to ensure the conformance of equipment to the technical specifications. The regulatory body inspects design and construction activities in a number of areas in order to attain these objectives. In particular, the following areas receive close attention in the construction stage:?? Mixing and placement of concrete and its reinforcement, especially in foundations, and safety related structures, particularly containment structures;?? Construction of cooling intake and discharge systems;?? Installation of safety related components, particularly containment and shielding boundaries, internals of vessels which will contain fissile and radioactive material, and equipment to be used in radioactive areas.?? Installation of safety related control, protection and power systems;?? Areas of the facility that are inaccessible after construction is completed, particularly systems and components embedded in the foundation or building structure;?? Housekeeping in respect of safety related SSCs; and?? The quality assurance systems of the designer, manufacturer and constructor. The commissioning stage Activities associated with commissioning will normally begin before construction is completed. Accordingly, the regulatory body prepares to inspect areas of commissioning activity in parallel with activities of the construction phase. In some countries the regulatory body approves the commissioning programme, and for advancing beyond certain hold points, the regulatory body s agreement has to be obtained. Inspection by the regulatory body during the commissioning stage focuses on four broad areas of the operator s activity:?? Testing before introduction of fissile and radioactive material;?? Initial introduction of fissile and radioactive material;?? Testing of operations involving fissile and radioactive material; and?? Other commissioning activities.

8 8 Testing before introduction of fissile and radioactive material encompasses those activities and tests performed before the introduction of fissile and radioactive material by the operator to demonstrate that SSCs and components function properly and conform to design requirements. The regulatory inspection programme includes:?? Examination of documented procedures to verify compliance with review and assessment conclusions;?? Review of the implementation of these procedures;?? Direct observation of the performance of key pre-operational tests;?? Examination of the results of selected tests; and?? Confirmation of the integrity of any engineered barriers. The number and the key tests examined and directly witnessed by the regulatory body will vary depending on the importance of the test for safety. This may involve the regulatory body in inspecting tests of:?? Safety related systems (e.g. instrumentation and control systems, shutdown systems and standby systems);?? The integrity of the containment and shielding boundaries (e.g. hydraulic tests of pressurized structures) as appropriate;?? The susceptibility of SSCs to vibration or to other design loads;?? Secondary containment integrity (e.g. leak rate tests);?? Emergency power systems as appropriate;?? Communication capabilities;?? Ventilation systems; and?? Integrated cold and hot functional tests. In relation to the initial introduction of fissile and radioactive material, regulatory inspection personnel are present at the facility site to observe:?? Tests of the main control room;?? Access control and radiation protection programme;?? Emergency preparedness and demonstration of the emergency plan;?? Systems for monitoring radioactive releases and meteorological conditions;?? Distribution of fissile and radioactive material and checks on process and/or criticality calculations; and?? Systems involved in the handling of radiation or fissile material. Testing of operations involving fissile and radioactive material encompasses operator activities up to nominal operating conditions:?? SSCs are tested to ensure that they have been constructed and installed properly and are capable of functioning in accordance with approved design requirements.?? Consideration is given to the performance of radiation surveys of facility shielding (e.g. concrete walls) during facility start-up.?? The operator is carrying out tests at increasing operational levels; this testing includes the recording; and analysis of data relating to temperatures, pressures, radiation levels, flows and variations in process parameters as well as other relevant parameters;?? The safety aspects of the operator s procedures of operational tests are examined and assessed as well as a sample of the test documentation and results of the tests. Regulatory inspection also involves monitoring and direct observation of several tests. Other areas requiring inspection by the regulatory body during the commissioning stage include:?? The ability of the operator s management to progress from construction to operation;?? Management s provisions for putting the emergency plan into effect;?? Training and qualification of the operators;?? Hold points during the operational testing phase and into the full operational phase are closely monitored.

9 9 The operation stage: Once the facility has attained the authorized operation stage, the regulatory body implements an inspection programme to verify systematically the operator s compliance with regulatory requirements and conformance to general safety objectives, and to detect potential safety problems. The area of operations should include the control and execution of activities directly related to operating a facility to the operating limits and conditions established by regulatory requirements or by procedures or specifications. Inspection personnel should perform safety verification of control room activities and the abilities of the operations staff to discharge their duties. To perform this safety verification, the following should be carried out:?? Operating procedures: a sampling review of operating procedures, including all those procedures for normal operations, abnormal or offnormal conditions, and emergency conditions, is performed. Inspection focus on the operating personnel s adherence to procedures including limits and conditions for operation and should also evaluate the usability and adequacy of the procedures.?? Operator s training programme including simulator training: the adequacy of the operator s staff training programme is assessed routinely to ensure that the training reflects actual facility conditions and operator responses to abnormal events and emergency conditions.?? Safety systems: a sampling review of safety systems is performed to evaluate: any identified degraded equipment; discrepancies between installed component/system hardware and the facility drawings; controls for performing maintenance on equipment; and the quality of performance of operations staff in log keeping and record keeping and in routine monitoring of equipment. whether the organizational structure is suitable, if there are adequate numbers of staff, how management and staff communicate, and how management that emphasizes the importance of safety encourages a good safety culture. Outages: Inspection covers outage activities. In addition to providing opportunities to observe modifications to the facility, outages provide opportunities to observe activities in areas that are not always accessible during normal operation. Before bringing back the facility to normal operation, it is usual for the regulatory body to perform a special inspection. Topics requiring specific attention include:?? Radiation protection;?? Maintenance, inspection and testing;?? Engineering;?? Modifications;?? Emergency preparedness;?? Security;?? Quality assurance programme;?? Effectiveness of management systems; The decommissioning stage: During the decommissioning stage of a nuclear facility, inspection activities, e.g. concentrate on: the adequacy of the operator s procedure for the control of each phase of decommissioning; the removal of radioactive material; the decontamination and dismantling activities; the waste management strategy for the treatment, conditioning, storage and disposal of all radioactive wastes; the physical condition of the facility especially the surveillance of the integrity and/or availability of relevant SSCs.?? Management: the management s involvement in the facility and its effectiveness in providing the appropriate attention to operational issues, including abnormal events, is evaluated. Inspections consider

10 The operator notifies the regulatory body of its schedules for carrying out activities and tests of regulatory interest and submits or makes available to the regulatory body the procedures for these activities in a timely manner. To facilitate this process, the regulatory body specifies well in advance to the operator which activities and tests it wishes to be informed of Preparation of an inspection Before an inspection is carried out the inspection personnel is thoroughly prepared for the task. The preparation will depend on the type and method of inspection to be used. Preparation may include a review of the following:?? Regulatory requirements relating to the inspection area;?? Past operating experience relating to the inspection area;?? Previous inspection findings and enforcement actions relating to the inspection area;?? Past correspondence between the regulator and the operator relating to the inspection area;?? The safety analysis report and operating limits and conditions;?? Documentation on operation and design for the facility;?? Operator s management procedures and quality assurance programme Methods of inspection The inspection programme of the regulatory body incorporates and utilizes a variety of methods as follows:?? Monitoring and direct observation, such as working practices and equipment;?? Discussions and interviews with the personnel of the operator and the contractor;?? Examination of procedures, records and documentation; or?? Tests and measurements Inspection reports and findings A report of each regulatory inspection is written by the inspector(s) who conducted it. The report is reviewed and approved according to established internal procedures. The purposes of inspection reports are:?? To record the results of all inspection activities relating to safety or of regulatory significance;?? To document and record an assessment of operator activities in relation to safety;?? To record relevant discussions held with facility staff, plant management and other concerned persons;?? To provide a basis for notifying the operator of the inspection findings and of any regulatory requirements, and to provide a record of any enforcement action taken;?? To record any findings or conclusions reached by inspectors;?? To record any recommendations by inspectors for future action by the operator or the regulatory body, and to record progress on recommendations from previous inspection; and?? To inform other members of the regulatory body;?? To contribute to maintaining institutional memory. 10

11 Inspection reports typically contain:?? The facility, purpose and date of inspection, inspectors names;?? The methods used in the inspection (interviews, observations, paper review etc.);?? Reference to applicable regulations;?? Criteria used in the assessment;?? Details of facility areas, activities, processes, systems or components which have been inspected, assessed or reviewed;?? A record of actual or potential problems relating to safety;?? A record of the results of any checks for compliance with the terms and conditions of the authorization for the facility and applicable national laws;?? A record of any deficiency or violation found during regulatory inspections, including a record of what has been contravened;?? A record of any regulatory action taken by inspectors and any consequent action taken by the operator in the period covered by the report;?? A record of discussions held with the facility s staff, the operator s managers and other persons, including a record of discussions with facility staff, the operator s managers about points of concern;?? A record of the inspectors opinion about the operator s or relevant facility manager s response to any matter of concern drawn to their attention after a regulatory inspection;?? A record of the findings or conclusions of the inspectors including corrective or enforcement actions that should be taken;?? A record of recommendations made by inspectors for future action, such as a need to advise other inspectors or operators about particular problems, proposals for further inspections or proposals for enforcement actions. Distribution of inspection reports should be according to established procedures Enforcement actions The regulatory body has statutory powers to enforce compliance with its requirements as specified in the applicable regulations and in license conditions, including the authority to require an operator to modify, correct or curtail any aspect of a facility's operation, procedures, practices, systems, structures or components as necessary to ensure the required level of safety. Within the legal framework under which it is established, the regulatory body may develop and issue enabling regulations, detailing procedures for determining and exercising enforcement actions as well as the rights and obligations of the operator. Enforcement actions are designed to respond to non-compliance with specified conditions and requirements. The action shall be commensurate with the seriousness of the non-compliance. Thus there are different kinds of enforcement actions, from written warnings to penalties and, ultimately, withdrawal of an authorization. In all cases the operator shall be required to remedy the non-compliance, to perform a thorough investigation in accordance with an agreed time-scale, and to take all necessary measures to prevent recurrence. The regulatory body shall ensure that the operator has effectively implemented any remedial actions. 11

12 The extent of the authority of the regulatory inspectors to take on the spot enforcement actions shall be determined by the regulatory body. The degree of authority given to an inspector may depend on the structure of the regulatory body and on the inspector' role and experience. Where on the spot enforcement authority is not granted to individual inspectors, the transmission of information to the regulatory body shall be suited to the urgency of the situation so that necessary actions are taken in a timely manner; information shall be transmitted immediately if the inspectors judge that the health and safety of workers or the public are at risk, or the environment is endangered. Enforcement actions on the spot by regulatory inspectors are appropriate only in unusual situations. In normal situations, decisions regarding enforcement actions, particularly those involving fines, curtailment of activity or suspension of authorization, should be approved by the regulatory body according to the procedures established in each state Factors determining enforcement actions A range of enforcement measures are available to the regulatory body, such as the issuing of written warnings or directives, or orders to curtail activities, the modification or revocation of licences or authorizations, and the imposition of penalties. The factors to be taken into account by the regulatory body in deciding which enforcement action is appropriate in each case include:?? The safety significance of the deficiency and the complexity of the correction that is needed;?? The seriousness of the violation;?? Whether a violation of a less serious nature has been repeated;?? Whether there has been a deliberate or wilful violation of the limits and conditions specified in the authorization or in regulations;?? Who identified and reported the non-conformance;?? The past performance of the operator and its related trend;?? The need for consistency and transparency in the treatment of operators Methods of enforcement The main methods of enforcement actions are:?? Written warnings or directives;?? Orders to curtail specific activities;?? Modification, suspension or revocation of the authorization;?? Penalties. The regulatory body has the authority to impose or recommend penalties, for example fines on the operator, as a corporate body or individuals, or to institute prosecution through the legal process, depending upon the legal system and authorization practices of the countries. The use of penalties is usually reserved for serious violations, for repeated violations of a less serious nature, or for deliberate and wilful non-compliance. Experience in some countries is that imposing penalties on the organization rather than individual workers is preferable and more likely to lead to improved safety performance. 12

13 The regulatory body has clear administrative procedures and guidelines governing the use and implementation of enforcement actions. All inspectors and other regulatory body staff should be trained in and knowledgeable about the procedures and guidelines. If there is no immediate risk to safety, the regulatory body allows reasonable periods of time for the operator to complete corrective action. These time periods reflect the seriousness of the issue and the complexity of the corrective action required. However, an integrated approach to safety considers the contribution to the total risk to the facility of each individual deficiency needing corrective action. All enforcement decisions shall be confirmed to the operator in writing. Internal records of decisions relating to enforcement actions and any supporting documentation is kept in such a way that can be easily accessible and retrieved when required. The regulatory body has a system to audit, review and monitor all aspects of its inspection and enforcement activities to ensure that they are being carried out in a suitable and effective manner. The system ensures that any changes due to improvements in techniques or otherwise, are implemented EXAMPLES OF SPECIFIC INSPECTIONS Regulatory inspection in Finland General arrangements for inspection In Finland all nuclear power plants (two sites, four units) are in the operating stage. This presentation concentrates on the regulatory inspections during operation. Radiation and Nuclear Safety Authority (STUK) acts as the regulatory body for nuclear power plants in Finland, i.e. as nuclear safety authority, radiation protection authority, pressure vessel authority and nuclear material and safeguards authority. Nuclear Energy and Radiation Protection Acts and Decrees define the regulatory framework in Finland. General safety requirements are given in the Decisions by the State Council (i.e. Cabinet of Ministers). A detailed technical and administrative instruction relative to the design, construction, commissioning and operation of nuclear power plants are given in the YVL guides published by the STUK. A detailed list of YVL guides is presented in Appendix V. These guides form a practical basis for the regulatory work. In addition to the YVL guides STUK has internal guides (YTV guides) which define inspection related practices. The organization chart of STUK is given in Fig. 8. The guide covering regulatory control of operating NPP s contains reviews and inspections which can be divided in three categories as follows:?? Periodic inspections as specified by STUK in plant specific programmes;?? Inspections of specific technical and other topics; and?? Safety re-assessment. Periodic inspection programme 13

14 Inspections contained in the periodic inspection programme are focused on the power company s activities important to safety. The control aims to ensure compliance with the regulations and the plans and programmes approved by STUK, and to assess the appropriateness of the power company s activities. In preparation for and in connection with each inspection, examples of the results of the activities in question are reviewed. Periodic inspection programme was renewed during STUK s inspection activities are focusing at licensee main working processes. The programme has three levels:?? Management of safety;?? Main working processes; and?? Inspections of the organizational units and specific technical areas. Because of the renewal of the programme the number of inspections was reduced but the scope of new inspections was enlarged. Inspections of specific technical and other topics Nuclear power plant operation includes activities which can be implemented only after STUK s approval of the activity has been granted. The approvals are tied to preceding inspections. It is also verified afterwards that the implementation complies with the plans and meets possible regulatory conditions. Requirements and obligations which apply to inspections of different topics are presented in the YVL guides. The inspections cover the following items: documents concerning operation; competence of personnel; outage planning and execution; refuelling of reactors in-service inspections done or contracted by the operating organization; in-service inspections as referred to in the Decree on pressure vessels; repairs, modifications and preventive maintenance; post-outage plant start-up; procurement of nuclear fuel; safeguards; exemption of nuclear waste from regulatory control. The important inspections which the operating organization is obliged to request are the inspections of repairs and modifications. For all the repairs of failed safety relevant components, as well as for all modifications of the safety systems the operating organization has to present their plans in advance for STUK approval. The plan has to include technical documentation as needed to verify the acceptability of the functional features, structure, and materials of the repaired or new equipment. Also the repair or installation method, quality control, and tests after the work have to be presented. When the work has been completed, the operating organization has to ask for construction and/or commissioning inspections. Safety re-assessment The safety level of the nuclear power plant is re-assessed after any abnormal event, and the need for corrective measures is considered. To ensure a systematic analysis of the event and its causes, an investigation team by STUK is nominated. The team has to find out root causes of equipment failures and human errors and weaknesses in the performance of the operating organization as a whole. At the end the team has to present a report including recommendations for corrective actions, intended to prevent re-occurrence of similar events. 14

15 A similar parallel activity is required from the operating organization, and it has to submit its special report for regulatory approval. A thorough evaluation of the situation at the Finnish plants is also done if an event reported from a foreign nuclear power plant is suspected to be of such a nature that it might as well occur in our country. Besides feedback from the operating experience, safety reassessment is done on the basis of PSA studies and in view of new information gained from safety research programmes Relationship between the regulatory body and operating organizations, enforcement actions In Finland it is emphasised that the licensee and in specific the manager of the operating organization has the full responsibility for the safety of his plant. The responsibility of the regulatory body is to define the safety requirements and to verify by inspections whether these requirements are fulfilled. An atmosphere of confidence and respect between the regulatory body and the operating organization is regarded as necessary to achieve adequate information transfer for inspection purposes. The regulatory inspectors may at any time require information they find necessary for their work, and they have access to all documents. They also have unhindered access to all installations, offices, workshops, and stores. As needed, they may carry out own measurements, take samples and install equipment necessary for supervision. If particular problems occur during operation, the regulatory body requests the solutions to be proposed by the operating organization. The regulatory body may indicate some constraints but it does not suggest solutions. All the inspection activities are channelled through the operating organization, and the regulatory body does not directly inspect suppliers (factories) and contractors who work for the operating organization. If needed, STUK has strong legal tools at its disposal. If the regulations or licence conditions have not been observed, or if the safety is otherwise endangered, STUK may order removal of the defect or the fault within the time specified. The order may be reinforced by a conditionally imposed fine, or a threat to interrupt or limit the operation. STUK may also have the deficiency fulfilled by some third organization at the expense of the operating organization. If a defect or fault causes an immediate danger or cannot be removed within given time, STUK may interrupt the operation or limit it in an appropriate manner. A police authority shall provide executive assistance if needed. Sanctions specified in the nuclear energy law for those who have deliberately or by negligence committed a nuclear energy crime are very strong. In such situations the persons would be prosecuted by a public prosecutor after having received the statement by STUK on the matter. The strong enforcement tools have not been used in practice. We think that for achievement of a high safety level it is better to motivate people to do good work, rather than to threaten them by fines or other penalties. Especially we want to avoid charges against individuals who have made mistakes or have been shown to have shortcomings in training 15

16 and information provided to them. It is also recognized that the use of legal or monetary penalties do not resolve the structural root causes of the problems. Experience has shown that a very effective means of enforcement is to give the public information about abnormal events at the nuclear power plants. If the plant safety is directly endangered because of some fault, or if some previously unknown safety hazard is observed, the STUK could demand plant shutdown on the basis of its own judgement. In practice, it is enough to have a serious discussion with the plant manager who is responsible for the safety of his plant. After such discussion the plant manager has always preferred making the shutdown decision himself. One reason is that a shutdown ordered by STUK would be negative for the public reputation of the operating organization Preparation for the inspections and reporting the results Inspection planning An annual inspection plan is made before the end of the year for the next year. Experience from previous inspections, needs for development, large modifications and needed settlements etc. may influence the inspection plan. In the annual plan a responsible unit is mentioned. This plan does not hinder the inspectors from doing extra inspections if they are needed. A specific annual focus area is presented by the management. The plan is submitted to the licensee for information. The inspections are performed according to the inspection procedures. The procedures are general enough so that they do not bind the inspector too much but give the inspector also some freedom to vary inspection topics and details. The procedures describe the area of inspection, background information needed and methods of inspection. Information is collected continuously for the planning of inspections such as:?? Regulatory requirements and international standards;?? Licensee QA manuals and instructions;?? Results from previous inspections and audits;?? Information from event investigations and root cause analyses;?? Information from resident inspectors and other regulatory work;?? Safety indicators;?? Other information (e.g. international experience). Through the analysis of information an initial assessment of the inspection area is made and specific inspection topics can be chosen. In this phase time and resource allocation is made. For each inspection a detailed plan is made. The plan is based on the procedure and specific topics to be covered in detail are mentioned. The plan also includes dates and times, participating NPP units and participating inspectors. The plan will be sent to the NPP 1 2 weeks before the inspection. Some topics can be inspected also without prior notice if that is considered necessary. 16

17 The group will be nominated according to chosen inspection area and expertise needed. The principle is that each person has an active role in the inspection. Each inspector has his or her own sub-topic in the inspection. The inspection begins with the start-up meeting with the licensee representatives. During the meeting the inspection topics, schedule and inspection methods are discussed. After the meeting the group will split up to review their own topics. During the inspection the group has meetings to discuss about findings and to build up a general view on the area. During the inspections that last for several days it is useful to have daily meetings with the licensee representatives. At the end the results are compared to the set criteria. Conclusions are written with justifications. The results of the findings and the general assessment of the inspection area are presented to the licensee in the exit meeting. Reporting the results Minutes of the inspection are written and signed by the inspector and NPP counterpart. Specific findings and remarks that need improvement and time schedule are mentioned if needed. For the minutes and remarks there are specific forms that are filled in. In addition to the minutes an inspection report is written. The report contains a summary part and justification part. In the summary part the following headings are included:?? Major findings which need corrective actions;?? Practices where there is potential for improvement;?? Development taken place since the previous inspection;?? Remarks concerning management of safety. In the justification part, findings and conclusions are justified and, in addition, inspectors have freedom to handle the topics which they consider necessary to write down for the future or for transferring information to colleagues. After the inspection report has been written a decision of STUK is prepared by the inspection group. The decision includes STUK s requirements based on the findings made during the inspection. It is presented to the management of the department of Nuclear Reactor Regulation for approval. The decision is submitted to the licensee one month after the inspection The structure of the periodic inspection programme The periodic inspection program is divided into three different levels:?? Management of safety (A level);?? Main working processes (B level);?? Inspections of the organizational units and specific technical areas (C level). The regulatory control aims to ensure compliance with the regulations and the plans and programmes approved by STUK, and to assess the appropriateness of the power company s activities. Each inspection area has it s own requirements that are set e.g. in the Nuclear Energy Act, Nuclear Eergy Decree, Decisions by the Council of State, YVL-guides and STUK s decisions. Furthermore licensee has it s own requirements set in the QA Manual and procedures. These requirements form the inspection criteria against which the licensee 17

18 activities are reviewed in the periodic inspections. In each inspection area also the functionality of QA system and competence and training of personnel as well as the adequacy of resources are assessed. Management of safety The inspection concentrates on the management activities at the plant from safety point of view. The aim is to find out the status of safety matters during decision making processes when dealing with real life situations, plant documentation and future planning. Also the capability to recognise safety matters will be assessed. The following issues are under this inspection:?? Management principles;?? Safety policy;?? Safety goals, safety expectations from the personnel procedures to commit the personnel to goals and plans;?? The position and activities of management support groups;?? Procedures to develop and maintain safety culture;?? Follow-up of the overall performance. The inspection will be carried out once every two years. Main working processes In these inspections attention will be paid on the main working processes at the plant. The assessment concentrates on the work performance of different organizational units and to the fulfilment of safety and quality related requirements. Special attention will be paid on:?? The appropriateness and performance of the methods and procedures used in the main working processes;?? The interface between different working phases;?? The feedback included into the main working processes and the use of feedback in the organization;?? The support functions for each main process (training, QA and documentation). The main working processes at the plant are divided into three groups: safety assessment and enhancement, operations and maintenance. Each group includes different parts that support the main process. For example: B1. Safety assessment and enhancement:?? Correspondence to the changes in safety requirements;?? Use of safety research results;?? Operational experience feedback in the safety assessment and development;?? Process of plant modifications. B2. Operations: 18