EASA Part 21 Design Considerations Related to Proportionality & Level of Involvement – Sofema Aviation Services (SAS) www.sassofia.com considers the steps EASA is taking to make life a little easier for smaller organisations.
Let’s First Consider Proportionality
Early in 2019, EASA introduced additional Acceptable Means of Compliance (AMCs) for Part 21. (Ref Annex I to ED Decision 2019/003/R – AMC/GM to Part-21 — Issue 2 Amendment 8)
EASA’s objective was to provide a more proportionate approach for small, non-complex organisations
- That produce lower-risk products and
- The parts installed on these products.
The new AMCs focus on the output of the process and instead of detailed step-by-step documentation of the process, a more product-oriented approach is employed.
Reducing the administrative burden – It is intended that the AMC will be used by a small organisation that may both design & produce low-risk parts for general aviation (GA) aircraft within the current Part 21 environment.
So to Consider Level Of Involvement
EASA Implemented the following Reg (EU) 2019/897 amending Reg (EU) No 748/2012 as regards the inclusion of risk-based compliance verification (as well as the implementation of requirements for environmental protection.)
The main element of this Regulation is an amendment of the certification process in respect of what is commonly referred to as “Level of Involvement (LOI)”.
The new LOI concept
Affected applicants will have to propose a break-down of the certification programme into meaningful groups of compliance demonstration activities and data (ref to point 21.A.15(b)(5) and similar provisions).
For each identified group of compliance demonstration activities and data,
- The affected applicants will have to perform a risk assessment considering
o The likelihood of an unidentified non-compliance with the type-certification basis,
o Operational suitability data certification basis or
o Environmental protection requirements and
o The potential impact of that non-compliance on product safety or Environmental protection.
Based on this assessment, the applicant shall make a proposal for the Agency’s involvement in the verification of the compliance demonstration activities and data.
EASA will determine its LOI considering the proposals submitted by the affected applicants.
The process allows for the determination as well as the depth of the investigation during the certification process for each Compliance Demonstration Item (CDI).
This concept of LOI introduced 4 criteria for the purpose of risk class determination:
- For each CDI, the level of novelty: novel or not novel
- For each CDI, the level of complexity: complex or not complex
- At organisation level, the DOA holder performance: low, medium, high
- Criticality: critical or non-critical
These 4 criteria are used for the determination of EASA LOI, as shown in the next 2 steps:
Step 1: enables to identify the likelihood of an unidentified non-compliance;
Step 2: determines the class of risk.
The approach is done at CDI level and enables to refine the awareness of the projects.
Step 1: The likelihood of an unidentified non-compliance identification
- The likelihood of an unidentified non-compliance should not be confused with the likelihood of occurrence of an unsafe condition as per AMC 21A.3B(b).
- The likelihood of an unidentified non-compliance expresses the confidence level that the applicant addresses all the details of the certification basis for the CDI concerned, and that a non-compliance will not occur.
Step 2: Class of Risk Identification
The second step enables to determine the risk class of a CDI – The risk class is the result of a combination between the level of the potential impact of unidentified noncompliance and the likelihood of the unidentified non-compliance.
The potential impact of a non-compliance with part of the certification basis is considered either critical or non-critical on product safety or in the environment.
Next Steps
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Acceptable Means of Compliance, AMC, Annex I, CDI, Certification Programme, Compliance, Design Considerations, Design Organisation Approval (DOA), DOA, EASA, EASA LOI, easa part 21, ED Decision 2019/003/R, Environmental Protection, GA, General Aviation, Level of Involvement, LOI, Lower-risk Products, Part 21 environment, POA, Product Safety, Production Organisation Approval (POA), Risk Identification, SAS blogs
