Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December 2015 REGULATORY FRAMEWORK AND PRACTICES FOR THE OVERSIGHT OF HUMAN AND ORGANIZATIONAL FACTORS IN NUCLEAR INSTALLATIONS IN ROMANIA Madalina TRONEA, Coordinator of the Nuclear Regulations and Standards Unit within the Nuclear Fuel Cycle Division of CNCAN ROMANIA NATIONAL COMMISSION FOR NUCLEAR ACTIVITIES CONTROL

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December  The requirements on human factors in the nuclear regulations in Romania are fairly general, but they offer a framework sufficient for the regulatory oversight purposes. Guidance on the consideration of human factors in design and operation of nuclear installations is under consideration.  The regulatory oversight exercised by CNCAN (National Commission for Nuclear Activities Control) covers the following areas:  1) design – consideration of human factors in design is reviewed as part of the regulatory assessment of design modifications for the existing nuclear installations (or as part of the regulatory assessment of the overall design, in case of a new reactor);  for review, we use as guideline the standard IEEE Std Recommended Practice for the Application of Human Factors Engineering to Systems, Equipment, and Facilities of Nuclear Power Generating Stations and Other Nuclear Facilities Oversight of human factors

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December  The regulatory oversight exercised by CNCAN (National Commission for Nuclear Activities Control) covers the following areas:  2) safety analyses - considerations of human performance are reviewed as part of the regulatory assessment of deterministic and probabilistic safety analysis i.e. as regards  the assumptions made in the analyses regarding human actions,  the time when they are performed,  the probability of human error,  the conditions in which the actions are to be performed,  the “habitability” analyses, etc. Oversight of human factors

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December  The regulatory oversight exercised by CNCAN (National Commission for Nuclear Activities Control) covers the following areas (continued):  3) procedures - procedures for normal operation as well as emergency operating procedures are subject to regulatory review and human factors considerations are part of the assessment e.g.  format and style of the procedures,  place keeping,  compatibility with the number of staff and the environment in which they are to be used,  validation of operation and maintenance procedures,  validation of emergency operating procedures, including feasibility of various actions in different locations – Main Control Room, Secondary Control Area, local panels, etc., validation of minimum shift complement,  legibility of printed procedures, etc. Oversight of human factors

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December  The regulatory oversight exercised by CNCAN (National Commission for Nuclear Activities Control) covers the following areas (continued):  4) operational performance - human performance considerations are reviewed as part of the following activities:  the examination of control room and shift supervisors on the full-scope simulator, for licensing purposes;  the interview of plant managers, for licensing purposes;  the analysis of significant events which have human factors as a contributing cause;  the observation of various activities of the operating staff, such as shift- turnover, performance of testing and maintenance activities, training activities;  the assessment of training and qualification programs and procedures;  the assessment and inspection of human resources management (staffing, selection and recruitment, promotion, succession planning);  the assessment of organizational changes planning and implementation;  the implementation of fitness-for-duty Oversight of human factors

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December  The regulatory oversight exercised by CNCAN (National Commission for Nuclear Activities Control) covers the following areas (continued):  5) emergency planning and preparedness - considerations of human factors are reviewed as part of the regulatory assessment and inspection of emergency response plans, procedures and arrangements; this includes:  use of lessons learned from major nuclear and industrial accidents to improve emergency arrangements;  observation activities during emergency response exercises;  use of experience from exercises to improve emergency response plans and procedures and emergency preparedness training. Oversight of human factors

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December  The regulatory oversight exercised by CNCAN (National Commission for Nuclear Activities Control) covers the following areas (all supported by explicit regulatory requirements):  1) organizational structure and staffing of the licensee – the regulatory reviews focus on  the assessment of the staffing needs,  the procedures for recruitment and for training and qualification of staff,  licensees’ self-assessments on the sufficiency and adequacy of the staffing; succession planning is also reviewed;  changes to the organizational structure or resources require regulatory approval before implementation and monitoring after the implementation  2) management system and its processes – the management system manuals and procedures of the licensees, their management, core and support processes are reviewed, audited and inspected by CNCAN; the reviews cover the self-assessment and independent assessment processes, the use of operational experience feedback and the management of non-conformances and corrective actions. Oversight of organizational factors

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December  The regulatory oversight exercised by CNCAN (National Commission for Nuclear Activities Control) covers the following areas (continued):  3) safety conscious work environment – starting with September 2015, we have explicit regulatory requirements on the licensees’ obligation to encourage staff to report concerns without fear of repercussions/retaliation, to resolve such concerns and to provide feedback to the staff that raised the issues  4) implementation of the nuclear safety policy – we have new explicit regulatory requirements on the establishment, communication, display and implementation of the nuclear safety policy  5) implementation of the internal independent nuclear safety oversight - we have new requirements on the independent nuclear safety oversight within licensees’ organization (“internal regulator”)  6) nuclear safety culture – the regulatory oversight of safety culture has been formalized in a Safety Culture Oversight Process (SCOP), with detailed guidance for the assessors and inspectors, based on the 37 safety culture attributes in the IAEA safety guides Oversight of organizational factors

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December Safety Culture Oversight Process (SCOP)  The establishment of a SCOP started in 2010 following a recommendation from the 4 th Review Meeting of the CPs to the Convention on Nuclear Safety  The SCOP procedure has been reviewed and revised in 2015  SCOP is a structured process for the identification, collection and review of data relevant to the safety culture in licensees’ organisations  SCOP is applicable primarily in the regulatory assessment and inspection activities for organizations responsible for the construction, commissioning, operation or decommissioning of nuclear installations  The procedure supplements the current regulatory assessment and inspection procedures

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December Description of the Safety Culture Oversight Process (SCOP) WHY?

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December Safety Culture Oversight Process (SCOP)  General criteria for identifying data potentially relevant to safety culture:  issues which, in the opinion of the staff, are directly related to one of the safety culture attributes  all findings that constitute deliberate non-compliance with license conditions and / or regulations and / or requirements of the management system of the licensee  all findings that indicate a mismatch between the declared policies and organizational values (“espoused values”) and the current state of affairs, including procedures, behaviours, state of equipment, etc. (“artefacts”).

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December Safety Culture Oversight Process (SCOP)  IAEA GS-G-3.1 establishes a set of 37 attributes correspondign to the 5 safety culture characteristics ; SCOP uses these 37 attributes  All information gathered from inspection and assessment activities, from meetings with the licensees, can be relevant for safety culture  Generic data sources, examples  policy documents, procedures describe safety-related processes and activities;  self-assessment guidelines; self-assessment reports and safety performance indicators for various processes;  results of (quality) management system audits and reviews, reports from external reviews;  previous inspection reports; records of past events and corrective actions implemented;  interviews with licensee’s during the inspections; observations during common meetings;  observation of activities in the field

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December Safety Culture Oversight Process (SCOP)  SC Attributes can be assessed through: l Review of documentation l Interviews l Direct observation  Detailed guidelines are provided for the assessment of the safety culture attributes  For each safety culture attribute the detailed guidelines include, as applicable: regulatory expectations relevant to the attribute; documentation to be reviewed; questions to be asked; observations to be made; elements necessary for considering an attribute fulfilled; warning flags.

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December Safety Culture Oversight Process (SCOP) Identification number Unique identification number for the observed safety culture issue DateThe date when the safety culture issue was observed Nuclear installation The identification on the nuclear installation were the issue was observed AreaThe functional area in which the safety culture issue was observed FindingDescription of the finding Safety Culture Characteristic Safety Culture Attribute(s) (maximum 5, the most relevant) BasisBasis for considering the finding as a safety culture issue; any information needed during the assessment process Associated documents Inspection report, review report, minutes of the meeting, as applicable A safety culture oversight database is being put together, with this structure:

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December Regulatory Requirements on organizational aspects - examples §Regulation – NSN-20 “Norms regarding the nuclear safety policy and the independent oversight of nuclear safety” which has come into force in September 2015 §This new regulation introduces requirements on the development and implementation of a written nuclear safety policy by the licensees for nuclear installations: §“The nuclear safety policy shall clearly specify the principle according to which nuclear safety has priority in all activities related to nuclear installations and prevails over other requirements, as well as the fact that decision-making on safety related matter shall be made in accordance with this principle”

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December Regulatory Requirements on organizational aspects - examples continued: §“The nuclear safety policy shall specify the standards and requirements on the behaviour of the entire personnel that performs activities with impact or potential impact on nuclear installations. §The nuclear safety policy shall specifies the responsibilities of management personnel, as well as of all the other personnel, with regard to the development and maintenance of nuclear safety culture at the level of the entire organization of the license holder”

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December Regulatory Requirements on organizational aspects - examples continued: §“The nuclear safety policy shall include a declaration stating that the license holder commits to take measures for the continuous improvement of safety culture through: l Periodic evaluation of nuclear safety in an integral manner, taking account of operational experience feedback, the results of the research programs and te scientific and technological progress l Implementation, in due time, of all practicable safety improvements identified l Prompt implementation of corrective measures in case of non- conformances or of preventive measures in situations where new information becomes available that could indicate nuclear safety problems”

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December Regulatory Requirements on organizational aspects - examples continued: §“The license holder shall ensure that the nuclear safety policy is communicated to the entire personnel that performs activities with impact or potential impact on the nuclear safety of the nuclear installations. §The relevant provisions in the nuclear safety policy shall be communicated to the personnel of the contractors and suppliers of products and services, as the case may be, in such a manner that these understand them and apply them in their activities. §The license holder shall ensure that the nuclear safety policy is understood and applied by all personnel performing activities on the site of the nuclear installations. ”

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December Regulatory Requirements on organizational aspects - examples continued: §“The nuclear safety policy shall be visibly displayed in various work spaces on the site of the nuclear installations, such as control rooms, offices, training centers, meeting rooms. §The licensee shall include in the training program for all personnel, special modules dedicated to the development maintenance and improvement of the nuclear safety culture. Such modules shall be used as necessary also for the personnel of the contractors and suppliers of products and services important for nuclear safety, in particular for those working on the site of the nuclear installations.”

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December Regulatory Requirements on organizational aspects - examples continued: §“The license holder shall encourage all personnel in the operating organization, including the personnel of the contractors and of suppliers of products and services who work on the site of the nuclear installations, to identify and report any abnormal condition, in accordance with the procedures established for this purpose. §The licensee shall provide an environment conducive to the reporting of abnormal conditions and / or of non-conformances, so that the personnel is encouraged to identify and flag the potential problems relevant for nuclear safety without fear or repercussions from the employer.

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December Regulatory Requirements on organizational aspects - examples continued: §“The license holder shall provide the mechanisms through which the employees can express their opinions and bring to the attention of the management any deviations from the rules, concerns or any other aspects of interest, as well as proposals for improvement, with trust and in a safe manner (i.e. safe from any repercussions/retaliation). §The aspects reported by the personnel shall be evaluated promptly, with a priority proportional with their potential importance for nuclear safety, and resolved. The way in which the issues are resolved shall be communicated to the person who reported them, as well as to other members of the staff, depending of the relevance. §The license holder shall take measures to encourage all personnel to adopt a questioning attitude and an attitude of continuous learning.”

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December Regulatory Requirements on organizational aspects - examples continued: §“The license holder shall evaluate periodically the nuclear safety policy and its implementation. These evaluations can be performed as part of the periodic evaluation of the management system. §The license holder shall perform the periodic evaluation of the nuclear safety culture at the level of the entire organization, at least every 2 years. §The license holder shall take all the necessary measures for the performance of independent evaluations of nuclear safety culture, taking account of the international experience and good practices.”

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December Regulatory Requirements on organizational aspects - examples  The requirements on independent nuclear safety oversight have been established by CNCAN taking account of the international experience available in this area, including the information from various countries that have a long tradition in this practice (e.g. UK, France, Belgium, etc.), the conclusions in the Summary Report of the 6 th Review Meeting of the Contracting Parties to the Convention on Nuclear Safety ( summary-report-w-annexes-signed.pdf - paragraphs 21-22) and the publication „Independent Oversight - A Nuclear Industry Good Practice Guide” ( ernal%20Regulation/Independent_Oversight_GPG_Issue_1_2014.pdf). summary-report-w-annexes-signed.pdfhttp:// ernal%20Regulation/Independent_Oversight_GPG_Issue_1_2014.pdf  The requirements are aimed at establishing an organizational unit, inside each licensee’s organization, having as an exclusive and full-time job the independent oversight of nuclear safety.

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December Regulatory Requirements on organizational aspects - examples  The function of internal independent nuclear safety oversight is different / separate from the independent audit of the management system (which is nevertheless recognized as a form of internal independent oversight). It cannot be considered fulfilled by external independent oversight units / organizations (such as Nuclear Safety Review Boards) and external review missions.  The intent of the regulatory requirements is that the independent nuclear safety oversight function is performed on a continuous basis. In other jurisdictions, this function is referred to informally as an “internal regulator” function.  The implementation of the new requirements on independent nuclear safety oversight is not aimed to decrease the regulatory oversight effort but to provide additional assurance to the regulator that the licensee is taking all the reasonably practicable measures to find and correct any safety significant issues in a timely manner, taking account of the best practices in this area at international level.

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December Regulatory Requirements on organizational aspects - examples  The translation of the requirements on the internal independent nuclear safety oversight is available upon request; examples of such requirements are provided as follows.  For NPPs, the size of the organizational unit responsible for independent nuclear safety oversight shall have at least:  2 persons for single unit nuclear power plants;  3 persons for nuclear power plants with 2 nuclear reactor units;  6 persons for nuclear power plants with 3 or more nuclear reactor units.  For nuclear installations in the construction or commissioning phase, as well as for nuclear installations under refurbishment, CNCAN may require the licensee to supplement the number of persons with responsibilities for independent nuclear safety oversight.

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December Regulatory Requirements on organizational aspects - examples  The personnel responsible for the independent nuclear safety oversight shall:  have the necessary qualifications and technical competences in compliance with the requirements of this regulation;  have access to the nuclear installations and to the personnel, management and execution activities, documents and records necessary for performing the oversight;  have access to all the information necessary for maintaining and improving continuously their knowledge of the nuclear safety requirements, internal and external operating experience, good practices in the nuclear industry and the research activities relevant for nuclear safety;  be independent from cost and planning considerations;  not be involved in the performance or verification of the activities subject to evaluation;  have access to the highest level of management in the licensee’s organization, for communicating the results of the oversight work and of the recommendations arising from it.

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December Regulatory Requirements on organizational aspects - examples  The personnel responsible for the independent nuclear safety oversight shall be selected such as to fulfill the following requirements:  shall have adequate basic technical education;  shall have a minimum of 10 years of experience in the activities of the respective nuclear installation or of a similar nuclear installation, in operation, engineering and / or nuclear safety analyses; an experience of less than 10 years, but of more than 5 years, can be accepted on an exceptional basis, if compliance with the provisions in para. (2) is demonstrated;  shall have completed a specific training course or program on independent nuclear safety oversight, accepted by CNCAN.  The personnel responsible for the independent nuclear safety oversight shall be licensed by CNCAN. Permits will be issued for 5 years periods, with the possibility of being renewed.

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December Regulatory Requirements on organizational aspects - examples  The personnel designated to be part of the organizational unit responsible for the independent nuclear safety oversight shall meet the following competence requirements:  be knowledgeable of the design basis, nuclear safety analyses and the operational limits and conditions of the respective nuclear installations;  be knowledgeable of the operation modes and of the operating procedures of the nuclear installations, both procedures for normal operation and emergency operating procedures;  be knowledgeable of the processes, activities and documents of the organization that are important for nuclear safety;  be knowledgeable of the nuclear safety requirements established in the regulations and licenses issued by CNCAN and in the international codes and standards applicable, including the licensing basis for the respective nuclear installations;  be knowledgeable of the good practices in the nuclear industry at international level in the area of nuclear safety;  have interpersonal and communication skills, strategic thinking, skills for coordinating, planning and organizing work, observation skills, attention for details, questioning attitude and critical spirit.

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December Regulatory Requirements on organizational aspects - examples  The independent nuclear safety oversight shall cover all the aspects relevant for nuclear safety, including the following:  the compliance with the requirements in the applicable regulations, standards and codes;  the compliance with the operational limits and conditions;  the reliability and the performance of the systems, structures, components and equipment with nuclear safety functions;  the implementation of the dispositions from the inspection reports issued by CNCAN and of the recommendations resulting from self-assessments, internal audits, external reviews and from the root cause analyses for events;  the way in which the licensee uses the internal and external operating experience, results of the research activities and the good practices at international level for improving the nuclear safety performance of the nuclear installation and of its organization.

Technical Meeting on Regulatory Oversight of Human and Organizational Factors IAEA, Vienna, 14 – 18 December Regulatory Requirements on organizational aspects - examples  The independent nuclear safety oversight shall be implemented in a planned manner, through inspections, observation activities, document reviews, checks, tests, surveillance, interviews and other such methods.  The independent nuclear safety oversight shall identify the processes and activities that are not effective in preventing problems with impact on nuclear safety and shall support the formulation of recommendations for corrective and improvement actions.  The organizational unit responsible for the independent nuclear safety oversight shall elaborate periodic reports on the activities it has implemented and provide them for information to the licensee’s management. The reports hall described the activities performed, the findings, the resulting recommendations and the basis thereof.  The licensee’s management shall analyze the results of the independent nuclear safety oversight and shall direct the necessary corrective or improvement actions. These actions shall be justified, recorded and communicated and their implementation shall be monitored to confirm that their objectives are met.  Supplementary to the evaluations performed by the independent nuclear safety oversight unit, the licensee shall request periodically, at least every 2 years for nuclear power plants and at least every 5 years for other nuclear installations, international peer reviews for the evaluation of work processes and areas of activity important for nuclear safety.