Changes are a normal part of operations, but some changes have significant implications for safety and need regulatory approval while others only require notification.
Significance is assessed based on the potential harm that may be caused by the change, including where the change may be inadequately planned or improperly carried out. When considering your request for approval, we assess the inherent risk and residual risk after any physical and administrative controls are in place. We have guidance to help you determine significance and understand the requirements of sections 63 and 64 of the Regulations.
Configuration control is active management of the physical configuration and operation of sources or facilities (see performance objectives and criteria) ensuring that safety margins are maintained. It is important to understand that configuration control includes the design and physical condition of what you have as well as how it is used and maintained. Good configuration control ensures you have an accurate picture of the state of your actual operation and that you identify the safety impact of any operational changes. For example, replacement of a device or component could change how tasks are done. Change is not always planned – e.g. it can happen due to breakdowns, changes in staffing, obsolescence/ageing.
ARPANSA inspectors have found that licence holders don’t always document or evaluate changes. They don’t always apply for prior approval or notify us that changes have occurred in accordance with the Regulations. In fact, configuration control was linked to more areas for improvement than any other factor over the past 3 years and several licence holders have been found in breach of the Act for such failures.
Why changes weren’t reported
In many cases, the change control process does not include an explicit assessment of the change’s safety significance and fails to capture the regulatory requirements. To be effective it needs to consider safety impact, internal review and approval procedures, and external regulatory approvals or notifications. In some cases, the change control procedure may not be well established/unknown to relevant staff, difficult to apply, or only followed in an ad hoc fashion. In other cases, changes are not recognised when they occur.
How you can improve change control
Your management system should assist you to identify when changes occur, when they need to be made and how to assess both the nature and consequence of the change. Differences between activities and procedures are a common scenario where necessary changes may not have been identified.
A method for determining the safety significance of proposed changes (i.e. whether section 63/64 applies) should be explicit in a procedure or in your change process. The regulatory guide When to seek approval to make a change with significant implications for safety (section 63) describes how to categorise changes and can be integrated into your procedures. The level of consideration and detail will depend on the overall risk to the facility, with higher risk facilities requiring greater defence in depth or safety controls. For less complex activities, a page long checklist highlighting the key considerations may be appropriate.
Involving or including expert radiation staff in your multidisciplinary team to manage a change will help you identify and flag radiation safety issues. Investigating any barriers and challenges associated with adherence to change control procedures and how to make it easier will also lead to improved performance in this area.