EASA Part 21J Safety Management System (SMS) General Introduction

Sofema Online (SOL) www.sassofia.com considers key features found in a typical Part 21 J Safety Management System

Introduction

In today’s aviation landscape, Safety Management Systems (SMS) play a vital role within Part 21J Design Organizations, ensuring that safety considerations are integrated into all aspects of design and development.

• The implementation of SMS is not merely a regulatory requirement but a strategic approach to proactively identify and mitigate potential risks associated with the design and production of aviation products.

Part 21J SMS and Compliance with ICAO Annex 19 and EASA Obligations

ICAO Annex 19 underscores the necessity of SMS for a globally harmonized approach to safety, promoting a risk-based, data-driven method to support modern aviation design's complexities.

• By fostering a safety culture of reporting, accountability, and continuous improvement, SMS allows organizations to address potential issues early in the design phase, where even small oversights can significantly impact downstream safety.

• Part 21 Subpart J organizations, also known as Design Organisation Approval (DOA) holders, are responsible for compliance with EASA Regulatory Requirements (Based on conformity with ICAO Annex 19)

• Mandating Safety Compliance with EASA regulations that incorporate these principles within the European regulatory framework.

Consider the following regarding how Part 21J organizations can ensure alignment with these obligations:

Establishment of a Design Management System (DMS)

The Design Management System (DMS), as mandated by 21.A.239, ensures compliance with applicable requirements, including safety management principles from ICAO Annex 19. This system structures safety management by integrating risk identification, safety performance monitoring, and continuous improvement into the organization’s processes.

Risk Management and Safety Reporting

Part 21 organizations are required to maintain a system for reporting occurrences of non-compliance or unsafe conditions, as per 21.A.3A.

• This aligns with Annex 19’s focus on safety data collection, analysis, and sharing, enabling organizations to identify and address risks proactively.

Safety Audits and Continuous Monitoring

Continuous monitoring and safety audits are integral to the DMS. These activities, guided by AMC1 21.A.139(d), enable organizations to verify compliance with EASA and ICAO standards, foster a culture of continuous improvement, and implement corrective actions as needed.

Training and Competency

Part 21J organizations must ensure that personnel have the necessary training and competencies to effectively execute SMS-related duties, as required by 21.A.245.

• This includes safety management training aligned with ICAO Annex 19 to enhance awareness of risks and encourage proactive safety behaviours.

Integration of SMS with Design Activities

The DMS requires SMS integration directly within design processes, ensuring that safety is embedded throughout the product lifecycle.

• This includes conducting safety risk assessments during design changes, repairs, or modifications to address any new risks.

Communication with Authorities

Coordination with EASA is essential for compliance, as outlined in AMC1 21.B.15. Part 21J organizations must report significant changes or safety concerns and share safety performance data, contributing to broader safety objectives.

Management of Safety Data

EASA’s occurrence reporting aligns with Annex 19’s emphasis on managing safety data.

• Collected data is used to identify trends, measure safety performance, and address potential risks, thereby supporting the State Safety Programme (SSP) and Safety Performance Indicators (SPI) objectives under Annex 19.

Adoption of Corrective Actions

Part 21J organizations must implement corrective actions to mitigate identified risks, as per AMC1 21.A.125B.

• These actions are tracked to ensure safety issues are effectively resolved, maintaining alignment with both EASA and ICAO standards.

Unique Challenges of SMS Integration in Part 21J

Implementing SMS in a Part 21J environment requires balancing safety with other key factors, including cost, performance, and innovation. Effective SMS integration demands a nuanced understanding of safety management and consistent communication across teams, alongside managing evolving regulatory compliance and a robust risk assessment process. This course will guide participants through embedding SMS within a design organization, promoting a proactive safety culture, and addressing the unique challenges associated with Part 21J compliance.

• Balancing Safety with Cost, Performance, and Innovation

>> Safety vs. Cost: Ensuring robust safety features can lead to increased costs due to additional testing, certification requirements, and the implementation of safety controls.

>> Safety vs. Performance: Achieving safety goals can sometimes limit performance characteristics, particularly in cases where lighter, high-performance materials may be less proven in terms of safety.

>> Safety vs. Innovation: Innovation drives competitive advantage, but in aviation, innovative approaches must be balanced with the need to adhere to strict safety protocols.

• Developing a Nuanced Understanding of Safety Management

>> Understanding SMS in Context: SMS requires more than a general understanding of safety; it demands that safety principles are applied specifically to design practices, with the entire product lifecycle in mind.

• Proactive Safety Analysis

>> Safety is not static, and in complex design environments, emerging risks can develop as designs evolve.

>> Part 21J organizations need to integrate proactive hazard identification, where risk assessments and safety impact analyses are embedded throughout the design process.

• Establishing a Robust Risk Assessment Process

>> Comprehensive Hazard Identification: Identifying hazards requires a proactive approach, where potential safety concerns are anticipated and evaluated at the early design stages.

>> Risk Mitigation Through Design: The goal of SMS in design is to prevent safety issues before they arise.

• This requires designing layers of safety redundancies, such as fail-safe mechanisms and fault-tolerant systems, and conducting design reviews to assess risk mitigations.

>> Risk Assessment for Design Changes: Design is often an iterative process, and each iteration brings potential new risks.

>> Part 21J organizations must be diligent in performing safety reviews for all design changes, particularly as regulatory requirements may also mandate additional compliance checks for design modifications.

Next Steps

Sofema Aviation Services and Sofema Online is pleased to provide the following training course. For further information please see the websites or email [email protected].