Sofema is pleased to announce an upcoming webinar aimed at supporting aviation professionals in navigating the requirements of EASA Part 21 Subpart G (Production) and Subpart J (Design).

Join us for an interactive live webinar workshop on Tuesday, 10 February, from 10:30 am to 13:00 (Sofia, Bulgaria time).

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In this article, you can read more about the key roles and responsibilities within an EASA Part 21 J organization, as outlined under Regulation (EU) 2022/201 reference – 21.A.239 Design Management System.

By adhering to these roles and responsibilities and addressing the issues of concern with proactive and structured approaches, EASA Part 21 J organizations can effectively manage safety and design assurance, thereby ensuring compliance with regulations and the safety of aviation products:

Head of the Design Organization (HDO)

>> Accountability: The HDO is ultimately accountable for establishing, implementing,
and maintaining the design management system.
>> Oversight: Ensure that the design management system corresponds to the
organization’s size, nature, and complexity, considering the inherent hazards and
risks.
>> Integration: If applicable, integrate the design management system with
additional organization certificates as per Regulation (EU) 2018/1139.

Safety Manager

>> Policy and Objectives: Establish, implement, and maintain the organization’s
safety policy and related safety objectives.
>> Safety Risk Management: Oversee the identification, evaluation, and
management of aviation safety hazards and associated risks.
>> Safety Assurance: Implement a safety assurance process, including monitoring
safety performance and managing changes.
>> Safety Promotion: Promote safety within the organization through training,
education, and communication.
>> Occurrence Reporting: Establish and maintain an occurrence reporting system to
contribute to the continuous improvement of safety.

Design Assurance Manager

>> Design Control: Establish a system for the control and supervision of design,
changes, and repairs, ensuring compliance with applicable certification bases
and environmental protection requirements.
>> Independent Verification: Maintain an independent verification function to
demonstrate compliance with airworthiness, operational suitability, and
environmental protection requirements.
>> Subcontractor Oversight: Ensure the acceptability of parts or tasks performed by
partners or subcontractors.

Key Safety Personnel
Appointed in accordance with point 21.A.245(b), these individuals support the safety
manager in implementing the safety management element of the design management
system.

Part 21 J SMS Introduction

Implementing a Safety Management System (SMS) is a strategic, data-driven approach that proactively identifies risks to ensure global harmony with ICAO Annex 19 and EASA regulations. By fostering a culture of accountability and reporting, Design Organisation Approval (DOA) holders can address minor oversights early in the design phase before they impact downstream safety.

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

>> Establishment of a Design Management System (DMS)

>> Risk Management and Safety Reporting

>> Safety Audits and Continuous Monitoring

>> Training and Competency

>> Integration of SMS with Design Activities

>> Communication with Authorities

>> Management of Safety Data

>> Adoption of Corrective Actions

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.

Theoretical Foundations of Hazard Identification in Part 21J

Hazard identification (HAZID) under Part 21J is anchored in theoretical safety concepts, primarily driven by a proactive risk management approach.
The main theories include:

>> Reason’s Swiss Cheese Model

>> Risk-Based Approach (RBA)

>> System-Theoretic Process Analysis (STPA)

>> The Structured What-If Technique (SWIFT)

Safety Training Programs Tailored to 21J Environments

>> Initial and Recurrent Training: Regularly updated training programs should cover
theoretical aspects of hazard identification, familiarizing employees with tools like
FMEA, PHA, and other HAZID methodologies.
>> Scenario-Based Training: Using real-life case scenarios in training allows
participants to apply hazard identification techniques in controlled, relevant
situations.
>> SMS Competency Assessments: Assessing employee competence in SMS
processes ensures they retain necessary hazard identification knowledge and
skills.

To learn more on the topic: Join Mr. Steven Bentley, CEO of Sofema, speaker, on Tuesday, 10th February, to clarify your path to approval and ensure your organisation is built on a solid, compliant foundation.

Register here

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