Regulatory Experience

 

Principle 3 of the Fundamental Safety Principles states that effective leadership and management for safety must be established and sustained in organizations concerned with, and facilities and activities that give rise to, radiation risks [1]. The management system has to integrate all elements of management and also has to ensure the promotion of a safety culture, the regular assessment of safety performance and the application of lessons learned from experience.

Requirement 15 of General Safety Requirements Part 1 (IAEA GSR Part 1, Rev. 1) further states that the Regulatory Body shall make arrangements for analysis to be carried out to identify lessons to be learned from operating experience and regulatory experience, including experience in other States, and for the dissemination of the lessons learned and for their use by authorized parties, the Regulatory Body and other relevant authorities.

Regulatory Bodies are, therefore, expected to establish and sustain appropriate arrangements to collect regulatory experience, identify lessons to be learned from that experience and disseminate the lessons as necessary. The IAEA may, upon request, assist Member States in developing and putting in place appropriate arrangements for that end.

The President’s report of the third International Conference on Effective Nuclear Regulatory Systems, Transforming Experience into Regulatory Improvement, held in Ottawa, Canada, from 8 to 12 April 2013, notes that while Regulatory Bodies perform detailed assessments of regulatory requirements; systems and processes “do not routinely assess less significant events and issues, which could contribute to the continuous improvement of the regulatory process”. Action item number 2 of this report calls for assessing the need for a regulatory operating experience programme that is directed towards improving regulations as well as regulatory systems and processes.

The IAEA initiated in 2017 the preparation of TECDOC on the management of regulatory experience. Such document intended to provide Regulatory Bodies with information on how to build, establish and maintain effective and sustainable mechanisms to manage regulatory experience, enhance their regulatory frameworks and continuously improve safety of facilities and activities. The document is being elaborated by a set of experts after the assessment of lessons learned and practices taken from various Regulatory Bodies of Member States.

The IAEA Safety Glossary does not have a definition for the term “regulatory experience”. In June 2017 the IAEA sent out a feedback request to 42 Regulatory Bodies encompassing a wide array of sizes and characteristics to gain a good understanding of the use of the term “regulatory experience” and of the practices used by Regulatory Bodies to manage regulatory experience. The feedback request attached a questionnaire prepared by experts contributing to the elaboration of the TECDOC. The IAEA received 24 responses to the feedback request.

The experts analysed the responses to the questionnaire and reached the following general conclusions:

• The term “regulatory experience” does not have an official definition in any national regulatory framework. However, there is a general understanding that the term refers to the information and skills gained by the Regulatory Body from regulating facilities and activities and from external sources, national and international, relevant for regulating facilities and activities.
• Very few Regulatory Bodies have policies in place specifically addressing the management of regulatory experience. On the other hand, many Regulatory Bodies reported on processes and/or practices of their management system that address, to varying extends and degrees, the management of regulatory experience. Only in very few cases there are documented processes on the subject matter.
• The majority of the Regulatory Bodies scrutinize a wide range of internal and external sources in search of information and experience using different processes and approaches. They do not have in place an integrated framework towards managing regulatory experience.
• Lack of management commitment and necessary resources to establish and maintain a solid framework where highlighted as key obstacles for an effective and efficient management of regulatory experience. Other relevant causes include: absence of IT systems and documented processes, challenges to establish integrated processes in complex and large-scale organizations and organizations with limited maturity.
• Although all Regulatory Bodies share regulatory experience through local and international platforms, very few have in place a corporate approach to manage the dissemination of regulatory experience.