Sofema Online (SOL) considers the Relationship between Human Factors and Safety System Management (SMS) within an EASA Part 145, how this should impact human factors training and training best practices.

Introduction

In an EASA Part 145 organization, the integration of human factors and SMS is critical to enhancing safety and operational performance.

By understanding the relationship between human factors and SMS, organizations can develop targeted training programs and best practices that address the root causes of human error and promote a proactive safety culture.

This holistic approach ensures that human factors are considered in all aspects of safety management, leading to stronger safety

Human factors encompass a range of elements that affect human performance in the workplace, including psychological, physiological, and social influences. In the context of aviation maintenance, these factors can significantly impact safety and operational efficiency.

Introduction by Sofema Online (SOL) www.sofemaonline.com

Following 21.A.239 Design management system within a Part 21 Subpart J Design Organisation. The regulations require that the design organization shall establish, implement, and maintain a design management system that includes a safety management element and a design assurance element with clearly defined accountability and lines of responsibility throughout the organization.

Extending ICAO Annex 19 to include Type Design Organisations represents a significant step forward in enhancing aviation safety. It recognizes the integral role of design and manufacturing in the safety ecosystem and aims to integrate safety management principles across all stages of the aviation lifecycle. While there are challenges and considerations in implementation, the overall goal is to create a more proactive, performance-based approach to safety management, aligning with the industry's growth and technological advancements.

Sofema Online (SOL) www.sofemaonline.com considers the primary purpose of KPIs within an Aviation SMS.

Introduction

Introduction – Risk Assessment & Management KPI’s

KPIs typically measure how well your operation is doing at achieving its goals, for example, by reducing downtime or costs. KPIs can be used as a benchmark to understand your organisation’s current position as well as to facilitate the development of Key Performance goals.

Sofema Online (SOL) considers the various processes to best address Aviation Safety Data in an EASA-compliant SMS system.

Introduction

Both quantitative and qualitative data play vital roles in the safety assessment process within an aviation SMS compliant with EASA standards.

While quantitative data provides measurable and objective insights, qualitative data offers depth and context. Effective processing of both types of data involves systematic collection, rigorous analysis, and thoughtful integration to enhance overall safety management and performance.

Sofema Online (SOL) considers the best processes to ensure safety assurance within an EASA Safety Management System (SMS).

Introduction – What is SMS – Safety Assurance?

Establishing and maintaining an EASA-compliant Safety Management System (SMS) is essential for aviation safety. The European Union Aviation Safety Agency (EASA) sets rigorous standards to ensure airlines and other aviation organizations maintain high safety levels

• • EASA – Safety assurance – all planned and systematic actions necessary to afford adequate confidence that a product, a service, an organisation, or a functional system achieves acceptable or tolerable safety.
• • FAA – Safety assurance – Processes within the SMS that function systematically to ensure the performance and effectiveness of safety risk controls and that the organization meets or exceeds its safety objectives through the collection, analysis, and assessment of information.

Sofema Online (SOL) considers the key deliverables of an EASA - compliance CMO SMS

Introduction

Why it is important to deliver an effective integrated SMS recognizing the importance of the Continuing Airworthiness Management Organisation (CAMO) sitting between maintenance and operations.

Safety management plays a vital role in an EASA Continuing Airworthiness Management Organization (CAMO) to maintain compliance, ensure aircraft safety, and coordinate efficiently between maintenance and operations.

Presented by Sofema Online (SOL) 

Introduction - Typically refers to the continuous surveillance and inspection of organisational and operational practices to ensure they meet established regulatory and internal standards.

It's a critical component of SMS, (do you agree?) Ensuring that safety measures are not only designed but also effectively implemented and maintained over time.

Note - Safety Management Systems (SMS) are systematic approaches to managing safety, including the necessary organizational structures, accountabilities, policies, and procedures. The core components of an SMS include safety policy, safety risk management, safety assurance, and safety promotion.

EASA Aviation organizations can successfully integrate SMS and compliance monitoring within a single organisational function. This integration not only enhances safety and quality but also aligns with EASA's regulatory requirements, ultimately fostering an organizational culture that prioritizes safety without creating stakeholder conflicts.

Sofema Online (SOL) www.sofemaonline.com takes a deep dive into the subject to understand the merits of an effective safety survey process and the benefits for the organisation.

Introduction

EASA does not mandate a standard for surveys, this is in fact left to the discretion of the organisation to develop.

Unfortunately this creates a challenge for both the organisation as well as the competent authority

Sofema Online (SOL) www.sofemaonline.com considers the key elements of an effective Safety Audit.

Introduction

Performing safety management system (SMS) audits by EASA (European Union Aviation Safety Agency) and ICAO (International Civil Aviation Organization) Annex 19 requirements involves a thorough assessment of an organization's safety practices, focusing on risk and performance rather than mere compliance.

Sofema Online (SOL) www.sofemaonline.com considers the requirements to ensure compliance with  - GM1 ATM/ANS.OR.B.005 Management system (ED Decision 2020/008/R)

Definitions and Concept of a Management System

• ISO 9000 series of standards define a management system as a 'set of interrelated or interacting elements to establish policy and objectives and to achieve those objectives'.
• Another available definition of management system is the following: ‘The structure, processes and resources needed to establish an organisation's policy and objectives and to achieve those objectives.'
• Traditionally, separate management systems were developed to address issues such as safety, quality, environment, health and safety, finance, human resources, information technology and data protection. However, it is foreseen that more and more the services providers will establish integrated management systems following the harmonised set of requirements in this Regulation.

Sofema Online (SOL) www.sofemaonline.com considers the process by which to audit ATM/ANS Safety Management Systems - Regulation (EU) 2017/373

Why perform a compliance audit of SMS?

It is necessary to carry out compliance audits to ensure that the organisation remains in compliance with both EASA regulations for example - Regulation (EU) 2017/373 as well as internally documented processes & Procedures – The safety Management System like all other organisational elements should be “independently audited”.

Sofema Online (SOL) www.sofemaonline.com considers a brief summary of what each element of the required Safety Management System will be documented within the Maintenance Organisation MOE.

Introduction – Consider the following elements (required)

>> 3.1 Hazard identification and safety risk management schemes
>> 3.2 Internal safety reporting and investigations
>> 3.3 Safety action planning
>> 3.4 Safety performance monitoring
>> 3.5 Change management
>> 3.6 Safety training (including human factors) and promotion
>> 3.7 Immediate safety action and coordination with the operator’s emergency response plan (ERP)

Sofema Online (SOL) www.sofemaonline.com considers the key element related to understanding Safety Management for Flight & Cabin Crew.

Introduction – What is an SMS?

>> A safety management system (SMS) is defined as a systematic approach to managing safety, including the necessary

o Organizational structures,
o Accountabilities,
o Policies and procedures.

Sofema Online (SOL) www.sofemaonline.com considers the typical duties of an EASA Part 145 Workshop Maintenance Manager

Introduction Workshop MM - Responsible for

>> The satisfactory completion and certification of all work required by contracted operators/customers in accordance with the work specification (Work Order and approved MOE procedures);

ensuring that the organisation's procedures and standards are complied with when carrying out maintenance;

>> Ensuring the competency of all personnel engaged in maintenance;

Sofema Online (SOL) www.sofemaonline.com – considers the specific requirements driven by EU 2023/203 (Information Security and Cyber Risks)

Introduction & Background

» Continuing airworthiness management organisations and maintenance organisations are to implement and maintain a management system to manage safety risks. (ref Annex II, point 3.1(b), to Regulation (EU) 2018/1139)
» Pilot training organisations, cabin crew training organisations, aero-medical centres for aircrew and operators of flight simulation training devices are to implement and maintain a management system to manage safety risks. (ref Annex IV, point 3.3(b) and point 5(b), to Regulation (EU) 2018/1139
» Air Operators are to implement and maintain a management system to manage safety risks. (Ref Annex V, point 8.1(c), to Regulation (EU) 2018/1139, air operators are to implement and maintain a management system to manage safety risks.)

What functions are served by the following groups?

Sofema Online (SOL) www.sofemaonline.com takes a detailed look at the role & purpose of the Safety Groups within an EASA Compliant Part 145 Organisation.

» Safety Review Board (SRB)
» Safety Action Group (SAG)
» Safety Expert Group (SEG)

Sofema Online (www.sofemaonline.com) considers the role and purpose of Aviation Safety Management System (SMS) - Safety Performance Indicators (SPI) within an EASA Part 21 G Organisation.

Introduction – Key Performance Indicator (KPI)

Typically measures how well your operation is doing at achieving its maintenance goals, for example reducing downtime or costs. KPIs can be used as a benchmark to understand your organisations current position as well as to facilitate the development of Key Performance goals.

Sofema Online (SOL) www.sofemaonline.com reviews SMS objectives to comply with EASA Part 145 requirements.

Introduction

Point 145.A.200 introduces the following as key safety management processes; these are further specified in the related AMC and GM:

» Hazard identification

» Safety risk management

Sofema Online (SOL) www.sofemaonline.com looks at typical descriptors for Defenses that reduce or mitigate the risk related to a particular hazard.

Introduction

Consider the Term “As Low as Reasonably Practicable” (ALARP). Not all risks are manageable to the extent that they are either no longer a factor or they are economically impractical to mitigate means the cost outweighs the benefit.

Hazard Identification / Risk Assessment is carried out in order to identify the hazards in the organizational systems and operational environment. It also supports the risk assessment where we consider the probability of occurrence and the severity of the hazard effects are analyzed and where the magnitude of the risk and its acceptability are determined.

Sofema Online (SOL) (www.sofemaonline.com) considers the information issued by EASA concerning the various implementation deadlines for compliance with EASA Part 145 Safety Management System Requirements.

» When do I need to Implement SMS within my Part 145 Organisation?
» What are the SMS Deadlines Regarding EASA Part 145 Approval?
» Implementation of Safety Management System in Part-145 Maintenance Organisations in accordance with Regulation (EU) 2021/1963.