ARPANSA-REG-LA-SUP-280B v6.1 September 2017 Page 22 of 31
ARPANSA-REG-LA-SUP-280B v6.1 September 2017 Page 22 of 31
REGULATORY GUIDE
Plans & arrangements for managing safety
REGULATORY SERVICES
REG-LA-SUP-280B
September 2017
ARPANSA-REG-LA-SUP-280B v6.1 September 2017 Page 22 of 31
Introduction
Under the Australian Radiation Protection and Nuclear Safety Act 1998 (the Act) and Australian Radiation Protection and Nuclear Safety Regulations 1998 (the Regulations), licence holders must develop and follow their own plans and arrangements to manage safety. This requirement is consistent with Principle 1 of the International Atomic Energy Agency’s Fundamental Safety Principles SF-1 which states that ‘the prime responsibility for safety is with the person or organisation responsible for facilities and activities that give rise to radiation risks.’
Parts 1 and 2 of Schedule 3 of the Regulations set out the information that may be required by the CEO in a licence application; this includes plans and arrangements that describe how the applicant proposes to manage the safety of the facility or source. The information that the CEO may require will vary depending on the type of application but may also include siting, design or construction plans, operating limits and conditions, preliminary or final safety analysis report, source identification and location details, etc.
The CEO must be satisfied that the information provided demonstrates that the proposed conduct (for a facility) or proposed dealing (for a source) can be carried out without undue risk to the health and safety of people and the environment. For facilities, this information will be collated in a safety case. The safety case is the collection of scientific, technical, administrative and managerial arguments and evidence in support of the safety of a facility, covering the suitability of the site and the design, construction and operation; the assessment of radiation risks and assurance of the adequacy and quality of all of the safety related work that is associated with the facility.
A major component of the safety case is the safety assessment, which includes the safety analysis. Important elements of the safety assessment are radiological impact on humans and the environment, site and engineering aspects, operational safety, non-radiological impacts and the management system. The safety analysis is the evaluation of the potential hazards associated with a facility or activity, documented in a safety analysis report (SAR). The safety case with its supporting safety assessment provides the basis for demonstrating safety for licensing purposes.
The arrangements in place to establish and manage a facility or activity, and the interdependencies between such arrangements, should be documented in a management system. A management system designed to support the object of the Act will integrate safety, health, environmental, security, quality, societal and economic elements.
The management system should foster and promote a culture of safety and security, which takes into account human factors such as attitudes and behaviour, as well as the general mindset by which all workers, including senior management, approach safety. These factors should interact with the technological and organisational factors in a way that promotes holistic safety (often referred to as systems safety), which is considered a best practice approach to safety management. A holistic approach to safety ensures the technology is safe to use; people perform tasks safely at work; and the organisation overall is managed safely.
Once a licence is issued and an applicant becomes a licence holder, Regulation 49 requires the licence holder to comply with their plans and arrangements. Changes to plans and arrangements that will have significant implications for safety can only be made after the licence holder has sought and obtained approval from the CEO under Regulation 51. Changes unlikely to have significant implications for safety do not need prior approval but must be reported to the CEO within three months under Regulation 52. Under Regulation 50, the licence holder must, at least every three years, review their plans and arrangements and keep and maintain records of any changes.
Scope and Purpose
This Guide is applicable to both sources and facilities. Its purpose is to outline those key aspects that should comprise an organisation’s plans and arrangements for managing safety. It should be applied to the extent practicable and commensurate with the degree of hazard associated with the conduct or dealing. For example, the plans and arrangements for a complex facility will be different to those for a low hazard source. A graded approach is important to ensure that efforts and resources are directed to the matters that are most significant for protection of health and safety of people and the environment.
This Guide may be useful to applicants or licence holders to draft, modify or review some or all of their plans and arrangements.
ARPANSA will take this Guide into consideration when:
· assessing an applicant’s plans and arrangements if submitted as part of a licence application
· assessing and monitoring licence holders’ compliance with the requirement to update any plans and arrangements for managing controlled facilities, controlled material or controlled apparatus under Regulation 50
· assessing Regulation 51 requests for a change with significant implications for safety
· overseeing general compliance as a result of inspections, site visits, meetings, etc.
ARPANSA has drawn on international best practice to prepare this Guide. Where appropriate, links to trusted international standards and additional guidance are provided; applicants are expected to take these into account when developing and reviewing their plans and arrangements.
It should be noted that this Guide is not prescriptive and ARPANSA may consider alternative means of achieving an equivalent level of safety or security provided this can be adequately demonstrated.
Structure
This Guide has eight chapters, based on Schedule 3, Item 4 of Parts 1 and 2 of the Regulations. Links to additional ARPANSA guidance and international standards are provided at the end of each chapter.
1. Effective Control
2. Safety Management
3. Radiation Protection
4. Radioactive Waste
5. Ultimate Disposal or Transfer (for source licences only)
6. Security
7. Emergency
8. Environment Protection
1. Effective Control
Statutory and regulatory compliance
Statutory and regulatory compliance underpin all operationsPlans and arrangements should demonstrate:
1.1 The processes or systems that will allow all relevant and applicable statutory and regulatory requirements to be identified.
1.2 How important statutory and regulatory compliance aspects will be shared and communicated to relevant personnel.
1.3 How all operations and functions will be in compliance with the identified requirements.
1.4 How the licence holder will ensure it stays up-to-date with applicable regulatory requirements.
Management commitment
Management is committed to maintaining safe and secure operations and work environmentPlans and arrangements should demonstrate:
1.5 Management’s support, promotion and endorsement of the P&A and their use throughout the organisation[1].
1.6 Management’s commitment to:
· ensuring compliance with statutory and regulatory obligations
· allocating adequate resources to safety and security
· maintaining control over the source or facility
1.7 Management’s commitment to the principles of holistic safety:
· human aspects and human performance
· organisational aspects including safety culture and organisational learning
· technological aspects
1.8 How management’s commitment to the aforementioned will be clearly understood by all staff and promulgated across the organisation.
Accountabilities and responsibilities
Accountabilities and responsibilities are identified for all key functions and operationsPlans and arrangements should demonstrate:
1.9 Accountabilities and responsibilities, including delegations, are clearly defined and described for:
· the overall management of the plans and arrangements are clearly defined[2]
· all conducts, dealings and operations and maintaining control over the source or facility
· safety and security
· statutory and regulatory compliance
· resources
· process implementation
1.10 Accountabilities and responsibilities are mapped out clearly for each section, branch and division.[3]
1.11 Systems are in place to ensure staff are fully aware of their own accountabilities and responsibilities and also those of other staff.
Resources
Resources are adequately allocated and controlledPlans and arrangements should demonstrate:
1.12 The systems in place to identify resource requirements.
1.13 How the organisation’s resources will be controlled.
1.14 How radiation protection and nuclear safety will be considered in allocation of resources.
1.15 The systems used to track and monitor resources.
1.16 The systems used to review resource allocations if circumstances change to ensure continued safety and security of operations.
Communication
Information is effectively communicated throughout the organisationPlans and arrangements should demonstrate:
1.17 Communication needs and requirements have been identified.
1.18 How communication processes and infrastructure will be maintained or put in place to address this need.
1.19 What modes of communication all staff, including contractors, are expected to use[4].
1.20 How all staff, including contractors, is able to communicate information with radiation protection and nuclear safety implications efficiently and effectively.
Process implementation
Operations, processes, functions and activities are adequately controlledPlans and arrangements should demonstrate:
1.21 There is a consistent method or approach to develop, approve and roll-out new processes and operations, or review existing ones.
1.22 The systems that will be used to encourage all staff, including contractors, to follow and adopt this method or approach.
1.23 How staff and stakeholder consultation will be included or involved in process development and implementation.
1.24 How process implementation will be monitored and controlled.
Documentation and document control
Documentation is organised and effectively managedPlans and arrangements should demonstrate:
1.25 All processes, both administrative and practical, with implications for safety or security, is carried out in accordance with written procedures.
1.26 All conducts, dealings and operations with implications for radiation protection and nuclear safety are adequately documented and periodically reviewed.
1.27 There are criteria, methods or manuals outlining what specific processes and operations need to be documented[5].
1.28 There are systems in place to ensure documents are integrated and consistent with one another[6].
1.29 The systems used to ensure documents are quickly and easily accessible staff (including contractors) who need them.
1.30 Documents are managed in an appropriate quality system (preferably accredited).
International Standards relevant to effective control:· GSR Part 1 Government, Legal and Regulatory Framework for Safety
· GS-G-1.1 Organization and Staffing of the Regulatory Body for Nuclear Facilities
· GS-G-1.2 Review and Assessment of Nuclear Facilities by the Regulatory Body
· GS-G-1.3 Regulatory Inspection of Nuclear Facilities and Enforcement by the Regulatory Body
· GS-G-1.4 Documentation for Use in Regulating Nuclear Facilities
· GS-G-1.5 Regulatory Control of Radiation Sources
· SSG-12 Licensing Process for Nuclear Installations
· SSG-16 Establishing the Safety Infrastructure for a Nuclear Power Programme
· WS-G-2.3 Regulatory Control of Radioactive Discharges to the Environment
· GSG-4 Use of External Experts by the Regulatory Body
2. Safety Management
Safety policy and objectives
Overarching policies and objectives for safety are clearly definedPlans and arrangements should demonstrate:
2.1 An adequate overarching safety policy exists related to all functions, operations, conducts and dealings.
2.2 Safety objectives are clearly outlined[7].
2.3 How all staff will be encouraged to fully adopt the safety policy and objectives and how the CEO (or management equivalent) will endorse their use.
2.4 The systems to ensure the safety policy and objectives will be communicated and understood by all staff[8].
2.5 The systems to ensure the policy will be monitored, reviewed and kept up-to-date. Monitoring and Measurement
Operations are tracked, monitored and measuredPlans and arrangements should demonstrate:
2.6 Processes used to collect safety data, including from incidents, accidents, exceedances, events, tests, walk-downs, assessments, observations, reports, audits, comments and suggestions.
2.7 Processes in place to observe, assess and promote a good safety culture.
2.8 The systems, processes or infrastructure that is used to report and communicate safety data.
2.9 What type of safety data that will be collected i.e. reactive and predictive data.
2.10 Clear systems or processes used to encourage reporting and communication of data.
2.11 How this data and other safety related data will be securely collected, stored and analysed (see Risk Assessment and Mitigation below regarding analysis of data).
2.12 How differences between how things are done versus how they are described will be identified[9].
2.13 How hazards throughout all operations, conducts and dealings will be identified.
Risk assessment and mitigation
Risks are reduced to acceptable levels by applying risk assessment and mitigation strategiesPlans and arrangements should demonstrate:
2.14 The process by which safety and security data collected from monitoring and measurement is assessed.
2.15 This assessment process enables safety and security data to be filtered and assessed according to the risk.
2.16 The systems to ensure staff designated to conduct this risk assessment have appropriate experience, knowledge and competence.
2.17 There is a threshold or criteria that determine when deviations from an expected outcome are investigated.
2.18 How investigations will take place and how they will be conducted. This should include investigations of breaches required under Regulation 45.
2.19 Methods are clearly outlined for conducting investigations and how personnel with sufficient knowledge, experience and competence will be involved.
2.20 Processes are in place to develop control measures for risks that warrant mitigation.
2.21 Implementation of risk mitigation measures according to change control and process implementation guidelines and procedures (see Managing Change below and also Process Implementation under Effective Control).
Managing change
Changes are safely managedPlans and arrangements should demonstrate:
2.22 A formal change management policy and process is in place.
2.23 How the need and objective for change will be identified or established.
2.24 The systems or processes used to develop options to meet this change objective.
2.25 How each option’s safety benefits, detriments and risks will be evaluated and compared.
2.26 How the preferred option(s) will be identified.