This chapter was published on “Inuitech – Intuitech Technologies for Sustainability” on November 13, 2012.
2. INSPECTION BY THE REGULATORY BODY:
2.1 IAEA Guidance on Inspection and Enforcement:
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 self-assessment 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.
The regulatory body has legal authority for conducting and coordinating 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 have 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 self-sufficient 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.
2.2 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.
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.
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.
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.
2.2.1 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 fulfillment 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.
2.2.2 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.
The authority vested in inspectors should oblige them to conduct themselves onsite in a manner that inspires confidence and respect concerning their competence and integrity.
2.3 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.
2.4 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; and
- Results of previous inspections.
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.
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 below. 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.
a) 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.
b) 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.
c) 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.
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.
2.4.1 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.
2.4.2 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.
2.4.3 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;
- To inform other members of the regulatory body; and
- To contribute to maintaining institutional memory.
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; and
- 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.
3. ENFORCEMENT BY THE REGULATORY BODY:
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.
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.
3.1 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 willful 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.
3.2 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; and
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 willful 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.
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.