Building Your Drone Safety Case with SORA and FAA 8040.4

For advanced drone operations—like flying BVLOS or over populated areas—simply checking boxes on a prescriptive list of requirements is not enough. Regulators need assurance that you have thoroughly understood and mitigated all potential risks. This assurance is delivered through a "safety case." A safety case is not a single document, but a structured argument, supported by a body of evidence, that demonstrates your system is safe for a specific operation in a specific environment.

What is a Safety Case?

Think of it as the comprehensive story of your aircraft's safety. It answers the "what," "how," and "why":

● What are the potential hazards? (e.g., mid-air collision, loss of control, ground impact).

● How have you designed the system to mitigate those hazards? (e.g., redundancy, geofencing, DAA systems).

● Why do you believe these mitigations are effective? (e.g., test data, analysis, industry standards).

For global operations, two primary frameworks guide the development of a safety case: EASA's SORA and the FAA's SRM process.

EASA SORA: A Proportional Risk Assessment Methodology

The Specific Operations Risk Assessment (SORA) is a globally influential methodology developed by EASA and JARUS. Its genius lies in its proportional, risk-based approach. Instead of a one-size-fits-all rule, SORA tailors the safety requirements to the specific risk of the operation.

The process involves two key steps:

● Determining the SAIL (Specific Assurance and Integrity Level): You assess the intrinsic risk of your operation based on factors like the ground risk (what happens if it crashes?) and the air risk (likelihood of a mid-air collision). This results in a SAIL level from 1 (lowest risk) to 6 (highest risk).

● Identifying Operational Safety Objectives (OSOs): For your assigned SAIL level, SORA provides a list of OSOs—specific safety goals you must achieve. These relate to your technical systems, operational procedures, and organizational capabilities. The higher the SAIL, the more rigorous the OSOs.

FAA's Safety Risk Management Policy: Order 8040.4

The FAA's equivalent process is guided by Order 8040.4, which establishes a formal Safety Risk Management (SRM) policy. The FAA applies SRM to its own decision-making, but it requires applicants to provide the data that feeds this process. Your safety case must enable the FAA to complete its SRM assessment.

The FAA SRM process follows these steps:

● System Description: Describe your aircraft, operation, and environment.

● Hazard Identification: Identify what could go wrong.

● Risk Analysis: Determine the severity and likelihood of each hazard.

● Risk Assessment: Evaluate if the risk is acceptable.

● Risk Control: If not acceptable, define and implement mitigations.

● Bridging the Gap: Leveraging SORA for FAA Approval

● Here’s the strategic insight: The work you do for a SORA assessment is not wasted for the FAA. In fact, it provides a fantastic foundation. The core principles of hazard identification and risk mitigation are universal.

You can leverage your SORA work for the FAA in several ways:

● Hazard Log: The hazards you identify for SORA will be largely the same for the FAA. This becomes the starting point for your FAA SRM analysis.

● Mitigation Strategies: The technical and operational mitigations you develop to meet SORA's OSOs are directly relevant. You just need to present them in the context of the FAA's risk control process.

● Evidence Base: The test data, simulations, and analyses you gather to prove your mitigations for SORA (e.g., DAA performance validation) are the same evidence the FAA will require.

The key is translation. You must reframe your SORA-based argument into the specific terminology and format expected by the FAA. Instead of talking about SAIL levels, you'll discuss the likelihood and severity of hazards. Instead of OSOs, you'll demonstrate how your mitigations reduce risk to a level equivalent to that of accepted manned aviation operations.

Conclusion: One Safety Case, Multiple Frameworks

Building a strong safety case is the most critical technical and regulatory task for advanced drone operations. By starting with a robust methodology like SORA, you create a comprehensive, logical, and evidence-based foundation. Then, by working with experts who understand the nuances of the FAA's SRM process, you can efficiently adapt and translate this foundation into a compelling case for FAA approval. This dual-path approach not only saves time and resources but also ensures your operation is built on a bedrock of proven safety principles, ready for a global stage.