Fatigue Safety Cases and Scientific Studies

In many parts of the world, regulators have made a process available for Air Operators to apply to work outside the flight and duty time limitations. Airlines have followed this process to enable the operation of ultra-long range (ULR) flights for example, safely within the overall roster without causing excess fatigue levels.

Successful safety case applications must typically demonstrate that safety is improved compared to, or is equivalent to, operations undertaken within the published regulations. They should also be supported by an effective fatigue risk management system (FRMS), and usually require a scientific study. We have assisted many operators to take all the steps necessary to demonstrate that fatigue risk is effectively managed, and to submit successful applications to work outside the prescriptive flight and duty time limitations. 

Questions You May Have

  • Our regulations are changing, how can we demonstrate that our current operations control fatigue and are safe, so that we can continue to operate?
  • We have identified an opportunity to operate routes outside our current prescriptive limits (for example with longer duties, or reduced rest) in specific, limited parts of our operation – how can we get approval from our regulator?
  • We are changing our operations within legal limits, but want to demonstrate to our internal stakeholders and unions that this will not cause elevated fatigue – how can we do this?
  • Our Fatigue Safety Action Group (FSAG) has identified an area of the operation that requires greater examination to understand fatigue in detail, and is requesting an internal safety case, how do we do this? 

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. 

Phase 1 - Undertake a Fatigue Risk Management Diagnostic:

Our Fatigue Risk Management Diagnostic (FRMD) 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 FRMD 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. 

Phase 2 - Inform Your Regulator:

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. 

Phase 3 - Scientific Study:

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:

  • Working with you to identify an appropriate study question to ensure the study is appropriately focussed
  • Recruitment of sufficient participants working appropriate rosters to enable successful data collection and analysis
  • Briefing for all study participants explaining the intention of the study, how their data will be used, and how to collect good quality data
  • Provision of actigraphy devices for collection of objective sleep data
  • A specifically designed study app for use on participants’ mobile phones, which includes a sleep diary and appropriate subjective measures to be collected during duty (for example on sleepiness, fatigue, performance, workload, and recovery)
  • Monitoring of data collection to ensure as complete a database as possible
  • Use of bio-mathematical fatigue modelling, where appropriate
  • Appropriate statistical analysis of study results to answer the study question
  • A detailed report providing all study results and interpretation of what those results mean  

Phase 4 – Safety Case Submission

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.  

Our Experience

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: 

  • Helicopter air ambulance and search and rescue operations 
  • Air taxi operators
  • On-demand operators 

We have also worked for regulators to assess submitted safety cases, giving us a clear understanding of the requirements of a submission and what the regulator is looking for to enable an approval. 

Part Of Our FRM Pathway

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 Diagnostic and Fatigue Risk Management System implementation support service.