A safety case may be developed for different reasons. It may be that as an Air Operator you are applying to your Regulator to work outside specific elements of the Flight and Duty Time Limitations (FDTL) – such as for Ultra-Long Range (ULR) flights. Or it may be for an internal audience as part of a Management of Change risk assessment.
The size and nature of the safety case depends on the extent of the organisational change, derogation or alternative means of compliance being sought. It may involve detailed data collection taking objective and subjective measurements of sleep and fatigue, but may be more simple for a small change. A successful safety case must typically demonstrate that safety is improved compared to, or is equivalent to, operations done previously. The safety case should also be supported by an effective Fatigue Risk Management System (FRMS).
Our ServiceOur safety cases and scientific studies provide a high level of scientific integrity and ensure that the data collected enables specific operational questions to be answered – providing both you and your regulator with confidence. We have working knowledge of the regulatory application process, having been through it many times before, and can assist you to design and submit a successful case.
Our ApproachWe recommend that your safety case is developed in phases, to ensure that you have a robust FRMS to support it and an effective scientific study.
Our Fatigue Risk Management Performance Assessment is designed to establish the maturity of your existing fatigue risk management processes and procedures, identify any gaps that exist, and highlight potential fatigue hotspots in your operation. The Fatigue Risk Management Performance Assessment provides an improvement or implementation plan, to ensure that your FRMS is effective, and can be approved by your regulator. FRMS takes time to implement and mature, so it is essential to consider this within your timelines to ensure that there is sufficient time to implement and mature your FRMS before your application is submitted.
If you are looking to gain approval to work outside of current prescriptive limitations with your safety case, then your regulator will need to grant you permission for a trial period in order to undertake a scientific study.
Even if you are currently able to work the duty pattern or operation that you wish to study, early discussions with the regulator are key to success, so that they can support you on your FRM journey, and you can create confidence in the regulator through your ongoing communication.
We are able to support you with communication with the regulator throughout your safety case application process.
A scientific study usually forms the core of your safety case. The study must be specifically designed to examine the operation that you are submitting your safety case for, with sufficient data collection to ensure that all potential causes of fatigue can be identified and their impact measured. We will work with you to ensure that the scientific study is tailored to your application and proportionate to the level of potential risk associated with the safety case, and uses appropriate methodology.
Our Scientific Studies Include:
Our extensive experience of working with regulators enables us to assist you to build a submission to meet the standards and expectations of your regulator. We will support you through the submission process, whilst enabling you to show clear ownership and understanding of your own FRMS and how fatigue associated with your application will be monitored and managed following approval.
Baines Simmons’ FRM experts have over 15 years of experience in working with operators to assist them to manage fatigue risk. We have also been heavily involved with the development of regulations, international guidance material (including from EASA and the ICAO FRMS manuals), and safety cases for airlines in regulatory environments across the world. We have also undertaken safety cases for clients in:
We have also worked with regulators to assess submitted safety cases, giving us a clear understanding of the requirements of a safety case submission, and what the regulator is looking for to enable approval.
Undertaking a safety case and scientific study may be the reason why you are looking to significantly increase the maturity of your FRMS, or it may be the next logical step in your FRMS journey already supported by mature and effective fatigue risk management. Scientific studies and safety cases sit at the top of our pathway, supported by our Fatigue Risk Management Performance Assessment and Fatigue Risk Management System implementation support service.
