Regulatory document REGDOC-2.1.1, Management System, provides licensees and applicants with information on the CNSC’s “management system” safety and control area (SCA), along with supplemental information on various and emerging issues related to management systems.
The CNSC’s regulatory framework includes CNSC regulatory documents as well as national and international standards. Specifically, the Canadian Standards Association (CSA Group’s) N-Series of standards provides an interlinked set of regulatory requirements for the management of nuclear facilities and activities. CSA standard N286-12 Footnote 1 provides an overall management framework and direction to develop and implement sound management practices and controls for the licensing basis. This regulatory document does not duplicate the generic requirements of CSA N286-12. However, it provides more specific direction for those requirements.
Guidance contained in this document exists to inform the applicant, elaborate further on requirements or provide direction to licensees and applicants on how to meet requirements.
The Canadian Nuclear Safety Commission (CNSC) defines “management system” as “the framework of processes, procedures and practices used to ensure that an organization can fulfill all tasks required to achieve its objectives safely and consistently.” Footnote 1 Management system requirements provide overall direction to the licensee organization for developing and implementing sound management practices and controls for the organization. An effective and well-implemented management system helps to assure the CNSC that licensees will conduct their licensed activities safely.
Paragraph 3(d) of the Class I Nuclear Facilities Regulations states that an application for a licence to operate a Class I nuclear facility shall contain “the proposed management system for the activity to be licensed … ”.
Subparagraph 3(b)(v) of the Uranium Mines and Mills Regulations states that an application for a licence in respect of a uranium mine or mill shall contain “the proposed management system for the activity, including measures to promote and support safety culture … ”.
The General Nuclear Safety and Control Regulations, General Application Requirements (section 3) and Application for Licence to Abandon (section 4), contain requirements that form the basis of a management system.
The Nuclear Substances and Radiation Devices Regulations (sections 3 and 4) contain similar and more specific conditions that are fundamental to a management system.
For the construction of a Class II nuclear facility, paragraph 3(j) requires “the proposed quality assurance program for the design and construction of the nuclear facility”, and for the operation of such a facility, paragraph 4(h) requires “the proposed quality assurance program”.
For Class II prescribed equipment, “Licence to Service” (section 7) details the requirements that form the management system.
The Radiation Protection Regulations, paragraph 18(b) requires “the proposed quality assurance program” for a licence to operate a dosimetry service.
The Packaging and Transport of Nuclear Substances Regulations, 2015, paragraph 24(a), includes a requirement for a management system that is in accordance with IAEA regulations.
The CNSC expects licensees to adhere to all CSA N286-12 Footnote 1 principles as the basis of their management system and the corresponding core management processes. A management system implemented in accordance with these principles and requirements has features to assure safe operations. The requirements for a management system apply throughout the lifecycle of the licensed activity and extend to all safety and control areas (SCAs).
For nuclear facilities that do not have a licence condition for management system, the principles in CSA N286-12 can serve as guidance for establishing an effective management system. Further guidance on this matter is also found in other industry standards such as CAN/CSA-ISO 9001:16, Quality Management Systems – Requirements Footnote 2 and ISO 14001, Environmental management systems Footnote 3.
CSA N286-12 Footnote 1 integrates requirements from other management system standards for quality, health and safety, environment, economics and security. It therefore provides a basis upon which a single management system may be implemented.
CSA N286-12 is organized for ease of use for applicable facility types mentioned in the standard. The standard shows the generic requirements applicable to the facility types listed below, while each section thereafter applies to one or a group of facilities identified in the title. The table below shows the various facility types and corresponding sections containing CNSC management system requirements.
The CSA’s Commentary on CSA N286-12, Management system requirements for nuclear facilities (CSA N286.0.1-14) Footnote 4 provides background information concerning certain clauses and requirements in CSA N286-12. This background information can help the user clarify the context of CSA N286-12 requirements. Also, CSA N286.0.1-14 refers to research materials that were used during the formulation of some of the requirements in CSA N286-12. The clause headings and numbers used in CSA N286.0.1-14 correspond to those in CSA N286-12.
The role and behaviour of leaders in an organization are fundamental to achieving excellence in safety. Through the development and implementation of an effective management system, the organization can better understand and promote a healthy safety culture.
CSA N286-12 Footnote 1 recognizes leadership in its scope and through requirements specific to top management. CSA N286-12 applies to top management, as defined in the standard, with overall accountability for the nuclear facility. Top management defines, plans and controls the business (licensed activities) through processes that define expectations for the organization and the means to monitor performance. Expectations of top management include making use of effectiveness reviews to continuously assess and improve its management system, as well as utilizing the latter to understand and promote a healthy safety culture.
The CNSC fully supports the concept that an organization that actively fosters a healthy safety culture can have a powerful influence on employee attitudes and behaviours, and consequently, on individual and corporate safety performance.
The CSA N286-12 Footnote 1 safety culture requirement states the following: “Management shall use the management system to understand and promote a safety culture … .”Footnote 2 It is through the management system that organizations understand their prevailing culture. Top management communicates the vision and objectives of the organization while upholding the key principle that “safety is the paramount consideration guiding decisions and actions”. Safety culture is understood and improved through key management processes such as assessments and continuous improvement.
For further information on the CNSC’s approach to safety culture, refer to REGDOC-2.1.2, Safety Culture Footnote 6, which sets out specific requirements and guidance for assessing and fostering a healthy safety culture.
The specific requirements for a supply chain described in CSA N286-12 Footnote 1 apply to the supply of services as well as items. Licensees’ supply chain management processes implemented in accordance with CSA N286-12 are sufficiently robust to provide assurance that non-compliant items and services entering the supply chain are properly identified and dispositioned.
CSA standard N299, Quality assurance program requirements for the supply of items and services for nuclear power plants  was specifically developed for use by nuclear power plants for their suppliers. Therefore, this standard can also be used as guidance for the other classes of licensees with respect to the implementation of supply chain management processes and requirements for their suppliers.
It is important to note that it is not only the supply chain that is affected by CFSI. Organizational functions such as engineering, maintenance and operations also need to be cognizant of CFSI issues and able to deal with them.
Licensees are accountable for the work performed by contractors.
Adherence to a management system that meets the requirements of CSA N286-12 Footnote 1 will ensure that the configuration of a facility is maintained. However, there has been a recognized need for standardized processes and guidance to enhance the understanding of configuration management at high-energy reactor facilities. As a result, CSA standard N286.10-16, Configuration management for high energy reactor facilities Footnote 10, was issued to provide guidance on maintaining configuration throughout the full lifecycle of a facility.
CSA N286.10-16 provides information that may also be used by other nuclear facility licensees for maintenance and management of facility configuration.
CSA standard N286.7-16, Quality assurance of analytical, scientific, and design computer programs Footnote 11, applies to high energy reactor facilities as defined in CSA N286-12. The standard sets out the quality assurance requirements for software used in design, safety analysis, and supporting activities. CSA N286.7-16 provides guidance for other classes of licensees who use software programs for the purposes mentioned above, as well as for other operational needs.
Nuclear substance licensees, radiation device licensees, and Class II nuclear facility licensees have the primary responsibility for safety of the licensed activities. Licensees are expected to demonstrate that they are qualified to undertake the proposed activities and have made adequate provision for the health and safety of persons and protection of the environment. This includes demonstrating that they can manage and control the licensed activities. Licensees must provide effective management support, including both human and financial resources, to properly implement and maintain their radiation safety programs, meeting all of the programs’ regulatory obligations. This includes addressing the requirements of section 4 of the Radiation Protection Regulations.
When implementing safety and control measures, licensees should take into account the management system principles outlined in section 2 of this regulatory document, recognizing that measures should be appropriate to their unique structure and governance framework. Program oversight should be comprehensive and integrate the roles and responsibilities of the applicant authority, the radiation safety officer and the radiation safety committees, as applicable. Oversight activities include assessing the effectiveness of the safety and control measures, identifying opportunities for improvement and resolving any problems.
Licensees may have an existing system of controls and processes that govern their overall operations. In such cases, radiation safety programs should be integrated within the licensees’ existing management system.
The elements of leadership outlined in section 3.1 of this regulatory document should be employed by licensees’ top management. Furthermore, the principles underpinning a healthy safety culture, as described in section 3.2 of this document, should be considered by licensees when implementing their safety and control measures.
For definitions of terms used in this document, see REGDOC–3.6, Glossary of CNSC Terminology, which includes terms and definitions used in the Nuclear Safety and Control Act and the regulations made under it, and in CNSC regulatory documents and other publications. REGDOC–3.6 is provided for reference and information.
CSA Group, CSA N286-12, Management system requirements for nuclear facilities, Toronto, 2012.
CAN/CSA-ISO 9001:16, Quality Management Systems – Requirements, Toronto, 2015.
International Organization for Standardization, ISO 14001, Environmental management systems, Geneva, 2015.
CSA Group, CSA N286.0.1-14, Commentary on CSA N286-12, Management system requirements for nuclear facilities, Toronto, 2012.
IAEA GSR Part 2, Leadership and Management for Safety: General Safety Requirements, Vienna, 2016.
Canadian Nuclear Safety Commission, REGDOC-2.1.2, Safety Culture, Ottawa, 2018.
CSA N299 standard series, Quality assurance program requirements for the supply of items and services for nuclear power plants, Toronto, 2016.
International Atomic Energy Association, IAEA-TECDOC-1169, Managing suspect and counterfeit items in the nuclear industry, Vienna, 2000.
Electric Power Research Institute, Inc. (EPRI), 1019163, Plant Support Engineering: Counterfeit and Fraudulent Items - Mitigating the Increasing Risk, Palo Alto, 2014.
CSA Group, CSA N286.10-16, Configuration management for high energy reactor facilities, Toronto, 2016.
CSA Group, CSA N286.7-16, Quality assurance of analytical, scientific and design computer programs, Toronto, 2016.
The following documents contain additional information related to management systems.
Canadian Nuclear Safety Commission (CNSC), REGDOC-3.1.1, Reporting Requirements for Nuclear Power Plants, version 2, Ottawa, 2016.
CNSC, S-106, Technical and Quality Assurance Requirements for Dosimetry Services, Revision 1, Ottawa, 2006.
CSA Group, CSA N290.12, Human factors in design for nuclear power plants, Toronto, 2014.
IAEA TECDOC 1740, Use of a Graded Approach in the Application of the Management System Requirements for Facilities and Activities, Vienna, 2014.