March 29, 2019

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Introduction

Within the EU Jurisdiction design activities on aeronautical products may only be carried out by EASA approved Design Organizations. All design specifications must be strictly controlled.

Moreover, the organisation must ensure that process procedure and staff qualification shall ensure that appropriate attention is paid to safety and reliability during the design phase. (Essentially means to provide sufficient organisational attention to the management of competence.)

Concerning the CVE

A CVE is an independent person in/of the Part 21 organisation responsible for the approval of demonstrated compliance with processes, technical designs and environmental protection requirements.

A CVE fulfils an important safety role in aircraft design, manufacturing, maintenance and ultimately operation, a role that should be well understood within any Part 21 organisation.

Regulatory Requirements

21A.239(b) The design assurance system shall include an independent checking function of the showings of compliance on the basis of which the organisation submits compliance statements and associated documentation to the Agency.
GM No. 1 to 21A.239(a) 3.1.3

a. Approval by signing of all compliance documents, including test programmes and data, necessary for the verification of compliance with the applicable Certification Specification (CS) and environmental protection requirements as defined in Type Investigation programme.

The EASA certification noise levels are approved by EASA as part of the aircraft certification process. These noise levels are established in compliance with the applicable noise standards as defined in ICAO Annex 16, Volume I

b. Approval of the technical content (completeness, technical accuracy…), including any subsequent revisions, of the manuals approved by the Agency (Aircraft Flight Manual, the Airworthiness Limitations section of the Instructions for Continued Airworthiness and the Certification Maintenance Requirements (CMR) document, where applicable).

CS 25-1309 – The specific objectives are to maintain high safety and regulatory harmonisation through definition of a standardised criterion for conducting aeroplane-level safety assessment of specific risks that encompasses all critical aeroplane systems on large aeroplanes

Maintaining Independence

AMC 21A.239(b)

1. The independent checking function of the showing of compliance should consist of the verification by a person not creating the compliance data. Such a person may work in conjunction with the individuals who prepare compliance data.
2. The verification should be shown by signing compliance documents, including test programmes and data.

EASA Oversight

General process carried out by the DOA team to judge if the Independent Verification Function of an organisation appropriately performs its intended tasks, and is successfully integrated in the design assurance system.
The results of the assessments of competence are used by the Design Organisation Approval Team (DOAT) to determine compliance or non-compliance of the organisation with 21A.243(d) and 21A.245(a), they do not constitute an approval or rejection of the individual.

Delivering Conformity

  • Ensuring the validity of procedures
  • Reviewing Role Descriptions considering tasks and responsibilities
  • Ensuring Independence of oversight -signatory flow -design engineer/ CVE ratio and quantity -availability provisions (effective management of workload).
  • Possible use of external CVEs

 

Concerning Training Requirements

  • Review of the following – Nomination and Training -minimum nomination/qualification criteria – scope of authorisation -provisions for records
  • CVE has accepted the role – Provisions to maintain the Approval as CVE.
  • Organisation -training policy (How managed and assessed for effectiveness)
  • External CVEs (note the need for managing and ensuring competence)
  • DO Interface Document or equivalent (Procedures to interface with Part 21G POE)

 

Procedures for assessment of Competence

  • Evidence-Based sampling size based on organisation size and scope identified
  • Maintaining Competence Records – Including the selection process records including scope of authorisation & training records
  • Competence interview of CVE and/or
  • Detailed technical project files review together with the CVE
  • Note acceptable to provide a credit for previous competence checks
  • Review of DOA CVE procedures
  • Role Description including review of tasks and responsibilities
  • Confirm Independence -signatory flow -design engineer/ CVE ratio and quantity -availability provisions -use of external CVEs
  • Sampling size based on large/small organisation, scope and level of activity
  • Records check selection process records including scope of authorisation
  • Technical project files review together with the CVE -interviews where necessary to check understanding

CVEs must have been properly authorised under the appropriate procedures prior to the competence assessment of the organisation.

CVE Organisation Managed Obligations

a) To properly define the CVE function (Independent Checking Functions) and associated responsibilities:

b) Approval by signing of all compliance documents, including test programmes and data, necessary for the verification of compliance with the applicable CS and environmental protection requirements as defined in Type Investigation programme;

c) Approval of the technical content (completeness, technical accuracy…), including any subsequent revisions, of the manuals approved by the Agency (Aircraft Flight Manual, the Airworthiness Limitations section of the Instructions for Continued Airworthiness and the Certification Maintenance Requirements (CMR) document, where applicable);

d) Ensure appropriate level of independency, meaning that the CVE must not be involved in the creation of the compliance data.

Notes:

CVE acceptance by EASA

During the Initial Investigation Process (before the Design Organisation Approval is granted) the CVEs must have been properly authorised internally under the appropriate procedures prior to the competence assessment by the Agency.

The results of the assessments of competence are used by the DOA Team to determine compliance or non-compliance of the Design Organisation with 21A.243(d) and 21A.245(a), they do not constitute an approval or rejection of the individual.

During the Surveillance process, the DOA is expected to nominate the CVEs, within the approved Scope of Approval, according to the appropriate procedures. Therefore the DOA is not requested to notify the Agency but to provide this information during regular surveillance activities.

In case of a Significant Change to extend the Scope of Approval, the DOA must notify the Agency and proceed according to the appropriate procedures.

Sofema Aviation ServicesĀ &Ā Sofema Online Ā provide classroom, webinar & online EASA Part 21 Training for details please see our websites or email team@sassofia.com

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Certification Specification, easa part 21, DOA, Design Assurance System, Certification Verification Engineer, CVE