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.

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Sofema Online (SOL) www.sofemaonline.com takes a deep dive into how the two business areas of Quality & Safety relate to each other.

Introduction

There are many misconceptions and misunderstandings regarding aviation Safety Management Systems (SMS) and Quality Management Systems (QMS) (Also Known as Compliance Management – CM)

The following is intended hopefully to clear up this misunderstanding regarding QMS and SMS – together they offer many common methods and techniques, but provide different outcomes and objectives:

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26.50 Seats, berths, safety belts, and harnesses - Regulation (EU) 2015/640
Operators of large aeroplanes used in commercial air transport, type certified on or after 1 January 1958, shall ensure that each flight or cabin crew member seat and its restraint system are configured in order to provide an optimum level of protection in an emergency landing whilst allowing the occupant’s necessary functions and facilitating rapid egress.

Sofema Online (SOL) www.sofemaonline.com – considers the various techniques which can be employed to ensure an effective compliance audit

Introduction EASA OPS Regulation 965/2012 

The issue of OPS regulation 965/2012 moved the emphasis of EASA driven organizational systems further in the direction of assessing compliance related to performance. With adjustments to the audit schedule to include additional attention being given to the effectiveness of the business processes.

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

The following abbreviated notes provide a summary of the key events related to the EASA Type Certification Process.

Type Certification

 A type certificate is an approval made by a regulatory authority that an aircraft is manufactured according to an approved design, and that the design ensures compliance with airworthiness requirements.

• The type certificate (TC) implies that the aircraft is manufactured according to the approved design and can be issued an Airworthiness Certificate.
• To meet airworthiness requirements, the aircraft, related products (engine and propeller), parts, and appliances must be approved.
• Within the European Union (EU), implementation rules for type certification are laid down by the Commission Regulation (EU) No 748/2012 of 3 August 2012.

Note - A Type Certificate is not an Airworthiness Certificate.

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Introduction Role & Purpose of an STC

An STC attests the approval of a major change, classified in accordance with Article 21A.91 of Annex Part 21 to Commission Regulation (EC) No. 748/2012, to an approved type design where the designer of the major change is not the Type Certificate holder.

The supplemental type certification shall be performed in accordance with the provisions of Annex II of the Basic Regulation and Annex Part 21, Subpart E of Commission Regulation (EC) No. 748 /2012 laying down implementing rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances and the related Acceptable Means of Compliance (“AMC”) and Guidance Material (“GM”).

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Introduction The EU Aviation Oversight System

The basis of the EASA working relationship is one of both cooperation and partnership between EASA and its Member States

EASA Regulations are issued as

» Implementing Rules – Considered as “Hard” European Law which is applicable to both Industry as well as Regulatory Authorities in each Member State and
» Acceptable Means of Compliance & Guidance Material (AMC & GM) which are considered as “Soft” European Law for which the Member State Regulatory Authority may agree to deviations – Known as Alternate Means of Compliance (AMOC)

Sofema Online (SOL) www.sofemaonline.com considers roles & responsibilities of an AOC holder related to continuing airworthiness.

Introduction

An EASA Operator will have a management system that is compliant with the requirements of EASA Regulation 965/2012 - Annex III - ORO.GEN.200 and in addition will comply with the requirements of Part - CAMO & Part M.

An EU licensed air carrier hereafter referred to as ‘the operator’, needs to consider both the relevant Part-ORO and the applicable Part CAMO / Part-M requirements.

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Introduction

To comply with FSTD comply with Certification Specification CS-FSTD(A) the following terms and abbreviations are contained in AMC1 FSTD(A).200.

Flight simulation training device (FSTD) means a training device which is In the case of aeroplanes        

       »  A full-flight simulator (FFS)

       »  A flight training device (FTD),

       »  A flight navigation procedures trainer (FNPT),

       »  or A basic instrument training device (BITD).

Sharing a view - Steve Bentley CEO of Sofema offers his take on how we interpret the terms QA & QC

Introduction - Is there a difference between EASA/FAA & ISO? Interpretation of Quality Assurance & Quality Control?

Well yes but first let's start with this interpretation (not mine) - Quality Glossary Definition: Quality assurance/quality control (QA/QC)

      » Quality assurance and quality control are two aspects of quality management.
      » While some quality assurance and quality control activities are interrelated, the two are defined differently.
      » Typically, QA activities and responsibilities cover virtually all of the quality system in one fashion or another,
      » While QC is a subset of the QA activities.
      » Also, elements in the quality system might not be specifically covered by QA/QC activities and responsibilities but may involve QA and QC.

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EASA Background – Qualified Entities

With the introduction of Basic Regulation EC 216/2008, EASA defined a Qualified Entity in the following way: "qualified entity" shall mean a body which may be allocated a specific certification task by, and under the control and the responsibility of, the Agency or national aviation authority.

The role of Qualified Entity is therefore viewed in the context of the provision of support to EASA, specifically in the field of certification activities.

CAMO Considerations Related to the Issue of EASA Airworthiness Review Certificate (ARC)

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

Introduction

The issuance of the airworthiness review certificate (ARC) by the airworthiness review staff only certifies that the aircraft is considered airworthy in relation to the scope of the airworthiness review performed and the fact that the airworthiness review staff are not aware of instances of non-compliance which endanger flight safety. Furthermore, it only certifies that the aircraft is considered airworthy at the time of the review.

Review of Commission Implementing Regulation - 2020/1159 of 5 August 2020 amending Regulations (EU) No 1321/2014 and (EU) No 2015/640 as regards the introduction of new additional airworthiness requirements

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Introduction

An aircraft, the design of which has already been certified, is not required to comply with an updated version of CS when it is produced or while in service.

Therefore compliance of such aircraft with additional airworthiness requirements that were not included in the initial CS at the time of certification of design should be introduced.

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Introduction - CAMO.A.125 Terms of approval and privileges of the organization (EU) 2020/270 

An organization approved in accordance with this Annex may: 

      » Extend an airworthiness review certificate under the conditions of point M.A.901(f) of Annex I (Part-M) or point ML.A.901(c)of Annex Vb (Part-ML), as applicable.
      » Located within a Member State

o   May additionally be approved to carry out airworthiness reviews in accordance with point M.A.901 of Annex I (Part-M) or point ML.A.903 of Annex Vb (Part-ML) as applicable, and:

o   Issue the related airworthiness review certificate and extend it in due time under the conditions of point M.A.901(c)(2) and point M.A.901(e)(2) of Annex I (Part-M) or point ML.A.901(c) of Annex Vb (Part-ML), as applicable;

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      » Sofema delegates benefit from taking SOL Courses – because they tell us!
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2019 was a Real Turning Point for Sofema Aviation Services! It was the year where we achieved 25,000 satisfied customers.

With more than 550 Classroom www.sassofia.com & 220 Online Courses with www.sofemaonline.com, we are confident we can meet and usually exceed your expectations in a professional & cost-effective way. 

Sofema Aviation Services (SAS) www.sassofia.com Considers the practical issues associated with the requirement for regulatory compliance for Drone “OPS”

General Introduction

      » Non-Certified Drones do not require Registration
      » Owner / Operator must be registered with NAA of EU Country (Single Registration – Will require Renewal)

o   Once registered, you receive a ‘drone operator registration number’ To be displayed on all the drones including those privately built. You must also upload it into the ‘Drone’s remote identification system’.

o   The unique registration number is valid in all other EASA Member States