The Role of EASA 

EASA commenced operations on September 28, 2003. Under the regulation, EASA initially has responsibility for: 

a) All design approvals
b) Continued airworthiness
c) Design organization approvals
d) Environmental certification
e) Approving production
f) Maintenance (repair station), and
g) Maintenance training organizations

Industry Steering Committee (ISC) Role

A team composed of delegates from:

The proposed or actual operators

Manufacturers (does not “own” the process)

Regulators - typically chair the process

The activities of the ISC are to essentially follow Advisory Circular AC 121-22A , based on:

Use of ATA MSG 3 methodology to develop the scheduled maintenance program for a given aircraft systems structure and engines.

The U.S. government has a bilateral agreement in place with the European Union, rather than EASA.

The U.S./EU Agreement covers more areas than bilateral agreements the U.S. has with other countries.

It is a three tiered agreement.

a) The highest tier is the Executive Agreement, which provides the framework for all cooperation between the U.S. and the EU in the area of aviation safety.
b) The second tier is the Annexes.

- Annex 1 covers airworthiness and environmental certification, and
- Annex 2 covers maintenance.

Introduction

The Continuous Airworthiness Management Organization “CAMO” is essentially responsible for 4 primary functions - Planning, Technical Records, Engineering, and Reliability. These groups work together to ensure that the Aircraft remain fully compliant with all requirements concerning the aircraft maintenance management and associated oversight.

Within the CAMO the Maintenance Planning, Technical Records, Engineering & Reliability groups work together to ensure that the aircraft remain fully compliant with all requirements concerning the aircraft maintenance management and associated oversight.

Within the CAMO department the Maintenance Planning Group has a range of responsibilities including:

Steve Bentley MD of Sofema Aviation Services www.sassofia.com explains

It is very healthy within the organisation to ensure that the Post Holder is able to deliver Compliance Independently of the QM (CM) - Explain

Consider the Role of the Aviation Quality System within the European Aviation Safety Agency “EASA”

Consider the following role definitions and responsibilities:

- First, that the Accountable Manager is responsible for the Quality System which includes both elements of Quality Control and Quality Assurance;

Sofema Aviation Services (www.sassofia.com) considers the challenges to be found during the implementation & delivery of an effective Maintenance Error Management System (MEMS) within an EASA Part 145 Aircraft Maintenance Organisation (AMO)

Tensions between the desire to ensure safety behaviours and the organisations economic objectives (Production versus Protection) deliver real challenges which have a direct bearing on safety culture.

What is an Aviation Maintenance Safety Culture?

The Role of Maintenance Error Management Systems (MEMS)

The ability of the organisation to investigate Maintenance Error is a valuable tool to understand causal, contributory and root elements and to develop and provide appropriate mitigation's to reduce ongoing exposure.

If we wish to minimize re-occurrence we should address not only the root cause (or causes) of a given outcome, but to also consider all the contributing causes (and there could be many!) as this will have a significant positive impact on the lowering of the threat level (reduction in exposure).

Introduction

The Key to a successful delivery of “CAMO” Continuing Airworthiness is without doubt “Core Competency” across the key business elements of Continuing Airworthiness Manager (CAM), Maintenance Planning (MP), Engineering (Eng), Reliability (REL) and Tech Records (T/L).

Remember that the goal of EASA compliance is a step on the journey and not the destination – the focus of any effective Continuing Airworthiness Management Organisation (CAMO) should be to maximize the availability, reliability and safety of the fleet as well as focusing on a reduction in maintenance costs.

EASA Focus is shifting to a Performance Based Approach to Regulation

A “Performance Based Approach” brings to the fore two challenges:

What are we Trying to Verify?

An Audit will typically generate a number of findings, and whilst the first step is usually to take an immediate “short term” action, the important business is ensuring the fundamental cause or “root cause” is addressed – the challenge is that this is far from easy!

Essentially, we are seeking evidence that the cause or “causes” of the problem have either been removed or mitigated in an acceptable way. (It is not always possible to completely fix the issue and sometimes the best outcome we can hope for is a reduction of the causes.)

Essential Evidence for Verification

To deliver effective EASA compliance audits it is necessary to pay attention to a number of key areas which are identified below for discussion purposes.

a) Maintaining Objectivity
b) Sample Size
c) Value of Finding Raised
d) Operator’s Authority on Area of Audit

Maintaining Objectivity

Objectivity requires both perspective and balance on the part of the auditor. We should also pay attention to the fundamental reason we are carrying out the audit.

An essential element of any system is to be able measure the effectiveness of the various processes which are involved in delivering the overall product.

The Quality System consists of 2 distinct parts:

a) The Quality Control Processes – Embedded in all production areas
b) The Quality Audit Processes – An independent way of assessing point a) above

By measuring the effectiveness of both parts of the company’s quality system (QA & QC) we will be able to provide a detailed status of the strength of the Quality Management System (QMS) as well as to provide a detailed understanding which will facilitate management planning and development.

Step 1 - Organisation & Regulatory Review

All EASA Approvals typically provide an independent Quality Assurance Function (EASA Part 21J requires a design assurance system)

The next comment is to consider the EASA “take” on QA & QC (A Quality System Contains Both). QC is embedded in every aspect and element of the Production Process.

The primary objective of an EASA Compliant Quality Auditing is to ensure both external and internal compliance with regulatory and organisational procedures.

We have a number of secondary objectives which are typically organisationally driven rather than EASA driven. (Never the less such elements provide for an indication of the intent and effectiveness of the organisation.)

An example of a secondary objective would be a demonstration of continuous improvement – which would mean a reduction in findings over time for a consistent level of auditing activity.

So let’s take a look at how we could perform an Audit of the Internal Reporting System within an Operators Management System.

Consider First the Background Regulatory Obligations and to note that we need in this case to comply with both 965/2012 and 376/2014 (Proposed Audit Items are identified as AI-N)

AMC1 ORO.GEN.200(a)(2) Management system
COMPLEX OPERATORS - SAFETY POLICY

(a) The safety policy should:

(4) Include safety reporting principles. AI-1

(b) The safety policy should include a commitment:

(5) Not to blame someone for reporting something which would not have been otherwise detected. AI-2

Introduction

The essential purpose of an EASA compliance audit is to support the maintenance of the regulatory approval.

Quality Assurance Compliance Audits are a systematic and independent comparison of the way the system process or objective is met. Using the observations made during this audit, as “objective evidence” a comparison is thus made against the standard, generating non-conformities or corrective actions in the event of any discrepancy.

The audits should be documented with a checklist which shows the details of the audit standard or audit criteria which is being applied to the audit.

Note 1 Quality Assurance Audits are Prescriptive in as much as they are always referenced against a standard – means compliant.

A discussion paper by Steve Bentley MD of SAS (www.sassofia.com)

So what is the Fundamental Mistake?

Essentially it is to "believe" that there is a similarity between ISO & EASA – there is not! Sure, Quality is Quality but make no mistake – EASA is all about compliance.

Even the Quality Assurance Manager has received a name change "makeover" He or She, is now called the Compliance Manager (CM).

What Does EASA Expect?

There are actually two expectations:

Steven Bentley MD of SAS www.sassofia.com considers the potential for HF Error with an EASA/GCAA compliant CAMO

Introduction

The Primary Roles of the CAMO are Maintenance Planning, Technical Records, Reliability & Engineering. Each “Role” brings the challenges of how we can ensure enough attention to both personal and organisational responsibility, when we consider the potential for HF error.

HF Example – Stress Caused by Pressure from “Poor Planning”

We are not considering here that it could be the Maintenance Planning Worker who is stressed - however this is of course a possibility, and we should always make sure that our team members have the appropriate level of “Competence” for the role.

Comments by Steve Bentley MD Sofema Aviation Services www.sassofia.com

Introduction

As a precursor to the introduction of Regulation 376/2014 EASA identified shortcomings related to Aviation Occurrence Reporting and proposed in 2010 a new regulation which in compliance with ICAO objectives moved the focus from a ‘reactive’ system to a pro-active, risk and evidence based system.  It also acknowledges that safety occurrence data is vital to allow for the timely identification and management of potential safety hazards and acts upon this before these hazards turn into an actual accident. 

EASA introduced EU Regulation 376/2014, (repealing EU directive 2003/42/EC), which came into force on 15th Nov 2015. The regulation provides additional safeguards to address the lack of protection of the reporters, the lack of harmonisation in the occurrence data collection and integration (leading to low quality reports and incomplete information), as well as insufficient requirements regarding safety analysis and the resulting recommendations.

Sofema Aviation Service www.sassofia.com looks at SMS reporting from the EASA perspective

What do we mean by Safety Occurrence Reporting?

We use the term Safety Occurrence to identify as a collective term which is used to embrace all events which have, or could have significance in the context of aviation safety.

Events identified may in fact range from minor events which are deemed to have a potential for an impact on safety through to incidents or events that should be reported to more serious events including serious incidents and accidents.

Building a Reporting Culture

The willingness to report, safety related exposures is a significant measure when we are considering the effectiveness of Safety Management System.

Sofema Aviation Services www.sassofia.com  & www.sofemaonline.com looks at the bigger picture driven by the recent changes to the EASA Basic Regulation 1139/2018.

Introduction

On 11th September this year entered in force the new EASA Basic Regulation No 1139/2018 which repeals existing Regulation (EU) 216/2008.

The European Aviation Safety Agency (EASA) welcomes the adoption by the Council of the European Union of updated aviation safety rules for Europe which include a new mandate for EASA.

The so-called new Basic Regulation formalises EASA’s role in the domain of drones and urban air mobility, enabling the Agency to prepare rules for all sizes of civil drones and harmonize standards for the commercial market across Europe.

Within the workplace the consequences of human failure can be significant, unfortunately, we are all capable of error regardless of our training or motivation.

A human error is an action or decision which was not intended, however it is important to consider that human failure is not random. There are two main types of human failure: errors and violations.

Errors often occur highly trained procedures where the person carrying them out does not need to concentrate on what they are doing (Improved design can reduce their likelihood and provide a more error tolerant system).

Violations are rarely malicious (sabotage) and usually result from an intention to get the job done as efficiently as possible. Getting to the root cause of any violation is the key to understanding and hence preventing the violation.

Organisation Obligations

The potential for Human Error should be managed proactively and should be addressed as part of a wider risk assessment process.