Sofema Online (SOL) www.sofemaonline.com considers the requirements introduced following the release of Annex VI to ED Decision 2023/010/R ‘AMC and GM to Part-145 — Issue 2, Amendment 6’

Background

According to EASA  - The current European aviation safety regulatory framework contains a series of requirements which are aimed at reducing the likelihood of an accident happening.

Sofema Online (SOL) www.sofemaonline.com considers the fundamental elements related to an EASA compliant Quality Assurance (Compliance System)

Introduction

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;

» Second The Quality Assurance Manager (Compliance Manager CM) is responsible for the auditing of all Compliance related elements of the organization system.

 Sofema Online (SOL) www.sofemaonline.com Considers best-practice behaviours to improve the effectiveness of your Aviation Quality System.

 Introduction: Let’s start by considering the composition of an EASA/GCAA compliant Quality System.

       »  The first comment to make is that there are actually 2 distinct elements as shown below:

           o   Quality Control - In just a few words this measures the organisation's ability to comply with the rules and deliver the production process in an effective way involving process procedures, management, competence, training, and effective culture and behavior.
           o   Quality Assurance - Again, in a nutshell, the QA process is intended to “ensure’ the effectiveness of the QC process by means of independent assessment (means the assessor is not part of the delivery of the product)

Sofema Aviation Services (www.sassofia.com) considers the various factors associated with Root Cause Analysis (RCA) and how to embrace the opportunities presented to drive improvements and efficiencies.

Introduction

Q - What is Root Cause?

A - In essence, It is the process of understanding what went wrong & why it does not fix anything simply it aids understanding.

Thought Leadership by Steve Bentley CEO of Sofema Aviation Services (SAS) www.sassofia.com

–  What is the Role of EASA in my Organisational Decision Making?

–  Can I use an online training platform for the delivery of EASA Part 66 Module 9 & Module 10 for Component Workshop Certifying Staff?

Background – Organisation's view of the need for compliance.

Some Organisations – let's call them to tick the box organizations – focus on collecting all the necessary pieces of paper to show they are compliant.

Other Organisations – recognize the role of demonstrating compliance but focus on managing competence to ensure the organization is able to deliver to the highest & most profitable standard

Considerations for the availability of supporting EASA Part 145 Maintenance courses delivered online through our virtual aviation academy.

Introduction

EASA Part 145 and its forebear JAR 145 is a mature regulatory environment with nearly 30 years of development within the European Arena.

There is the increasing focus being brought to bear regarding the importance of managing competence within the workplace and it is for the reason that both EASA & European Regulatory Authorities are expecting that EASA Part 145 Organisations manage the competence of employees within the 145!

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.

www.sassofia.com considers the complexities of Root Cause Analysis (RCA)

To be effective in reducing negative events we need to understand how we can use various analytical techniques to first understand and then to mitigate the actual as well as potential exposure.

The root cause analysis (RCA) method uses a cause and effect approach by asking (For example) multiple "why" questions as an effective way to identify one or more low level elements which contributed in some way to a subsequent failure.

With sufficient information available we are able to develop a number of corrective actions which should directly impact the exposure and which if taken correctly should prevent failure in the future.

Direct cause is defined as “the cause that directly resulted in the occurrence.” This would be like the person who whilst following a standard operating procedure (SOP) makes an “error” which results in an adverse outcome.

So therefore we can say that the person’s error is the direct cause of the problem that occurred.