21.A.14 Demonstration of capability
Regulation (EU) 2019/897
(a) An applicant for a type-certificate or restricted type-certificate shall demonstrate its capability by holding a design organisation approval, issued by the Agency in accordance with Subpart J.
(b) By way of derogation from point (a), as an alternative procedure to demonstrate its capability, an applicant may seek the agreement of the Agency for the use of procedures setting out the specific design practices, resources and sequence of activities necessary to comply with this Annex I (Part 21), when the product is one of the following:
1. an ELA2 aircraft;
2. an engine or propeller installed in ELA2 aircraft;
3. a piston engine;
4. a fixed or adjustable pitch propeller.
(c) By way of derogation from point (a), an applicant may demonstrate its capability by obtaining the Agency's acceptance of its certification programme established in accordance with point 21.A.15(b), where the product to be certified is:
1. an ELA1 aircraft; or
2. an engine or propeller installed in ELA1 aircraft.
AMC1 21.A.14(b) Demonstration of capability
ED Decision 2021/001/R
ALTERNATIVE PROCEDURES FOR THE DEMONSTRATION OF DESIGN CAPABILITY
The availability of procedures that state the specific design practices, resources and sequence of activities is an acceptable means to demonstrate design capability in the cases described in points 21.A.14(b), 21.A.112B(b) or 21.A.432B(b). This concept is that the implementation, in the context of specific projects, of the procedures required for a Subpart J DOA, will ensure that the applicant performs the relevant activities, but without the requirements on the organisation itself. The setting up of those procedures may be seen as a starting phase for a design organization to develop into a Subpart J DOA by the addition of the missing elements.
1. Scope
1.1 A manual of procedures should be provided that sets out the specific design practices, resources and the sequence of activities that are relevant for the specific projects, taking the Part 21 requirements into account.
1.2 These procedures should be concise and limited to the information that is needed for the quality and proper control of activities by the applicant/holder, and by EASA.
2. Management of the (supplemental) type-certification process
2.1 Certification programme: see AMC 21.A.15(b) for type certification and AMC 21.A.93(b) for supplemental type certification.
2.2 Compliance demonstration: see GM 21.A.20.
2.3 Reporting: see GM 21.A.20(b).
2.4 Compliance documentation: see AMC 21.A.20(c).
2.5 Declaration of compliance: see GM 21.A.20(d).
3. Management of changes to type certificates, repair designs and production deviations
3.1 Management of changes to a type certificate or supplemental type certificate (hereinafter referred to as ‘changes’), repair designs and production deviations from the approved design data.
The applicant should provide procedures that are acceptable to EASA for the classification and approval of changes (see paragraphs 3.2 and 3.3), repair designs and production deviations from the approved design data.
3.2 Classification
3.2.1 Content
The procedure should address the following points:
— the identification of the product configuration(s) to which the change is to be made,
— the identification of the areas of the product that are changed or affected by the change,
— the identification of any reinvestigations that are necessary (see point 21.A.93(b)(2)), including the identification of the applicable certification specifications or environmental protection requirements and means of compliance,
— changes initiated by subcontractors,
— documents to justify the classification,
— authorised signatories,
— the criteria used for classification must be in compliance with 21.A.91 and the corresponding interpretations.
3.2.2 Identification of changes
The procedure should indicate how the following are identified:
— major changes,
— those minor changes where additional work is necessary to demonstrate compliance with the certification specifications,
— other minor changes that require no further demonstration of compliance.
3.2.3 Considerations of effects of the change
The procedure should show how the effects on airworthiness, operational suitability or environmental protection are analysed, from the very beginning, by reference to the applicable certification specifications.
If no specific certification specifications are applicable to the change, the above review should be carried out at the level of the part or system where the change is integrated and where specific certification specifications are applicable.
3.2.4 Control of changes initiated by subcontractors
The procedure should indicate, directly or by cross reference to written procedures, how changes initiated by subcontractors are controlled.
3.2.5 Documents to justify the classification
All decisions of classification of changes should be documented and approved by EASA. The document may be in the format of meeting notes or a register.
3.2.6 Authorised signatories
The procedure should identify the persons authorised to sign the proposed classification before release to EASA for approval.
3.3 Approval of changes
3.3.1 Content
The procedure should address the following points:
— compliance documentation,
— the internal approval process,
— authorised signatories.
3.3.2 Compliance documentation
For major changes and those minor changes where additional work to demonstrate compliance with the applicable type-certification basis, operational suitability data certification basis, and environmental protection requirements (hereinafter referred to as the ‘certification basis’) is necessary, compliance documentation should be established in accordance with AMC 21.A.20(c).
3.3.3 Approval process
A) For the approval of major changes, a certification programme as defined in AMC 21.A.93(b) must be established.
B) For major changes and those minor changes where additional work to demonstrate compliance with the applicable certification basis is necessary, the procedure should define a document to support the approval process.
This document should include at least:
— identification and a brief description of the change and its classification,
— references to the applicable certification basis,
— reference to the compliance documents,
— effects, if any, on limitations and on the approved design data,
— the name of the authorised signatory.
C) For the other minor changes, the procedure should define a means:
— to identify the change,
— to present the change to EASA for approval.
3.3.4 Authorised signatories
The procedure should identify the persons authorised to sign the change before release to EASA for approval.
3.4 Repair designs and production deviations from the approved design data
A procedure following the principles of paragraphs 3.2 and 3.3 should be established for the classification and approval of repair designs and unintentional deviations from the approved design data occurring in production (concessions or non-conformances). For repair designs, the procedure should be established in accordance with Part 21, Section A, Subpart M and the associated acceptable means of compliance (AMC) or guidance material (GM).
4. Issue of data and information (including instructions) to owners, operators or others required to use the data and information
4.1 General
Data and information include the operational suitability data.
4.2 Data related to changes
The data and information (including instructions) issued by the holder of a design approval (a TC, STC, approval of a change, approval of a repair design) are intended to provide the owners of a product with all the necessary data and information to embody a change or a repair on the product, or to inspect it.
The data and information (including instructions) may be issued in a format of a service bulletin as defined in ATA 100 system, or in structural repair manuals, maintenance manuals, engine and propeller manuals, etc.
The preparation of this data involves design, production and inspection. The three aspects should be properly addressed and a procedure should exist.
4.3 Procedure
The procedure should address the following points:
— Preparation;
— verification of technical consistency with corresponding approved change(s), repair design(s) or approved data, including effectivity, description, effects on airworthiness or operational suitability, especially when limitations are changed;
— verification of the feasibility in practical applications; and
— approval for the release of data and information.
The procedure should include the information (including instructions) prepared by subcontractors or vendors, and declared applicable to its products by the holder of the TC, STC, approval of changes or approval of repair designs.
4.4 Statement
The data and information should include a statement:
— confirming that the documentation has been produced by the design approval holder in accordance with the associated procedures accepted by EASA; and
— containing a reference to EASA approvals of related changes or repairs, when applicable12EASA does not directly approve information or instructions. These are approved as part of the TC, STC, change approval or repair design approval. When stand-alone changes (i.e. not related to a TC change or repair design) to the issued information or instructions (e.g. to take in-service experience into account) are needed, these should be prepared, verified and approved according to the agreed procedures (see above)..
5. Obligations addressed in 21.A.44 (TC holder), 21.A.118A (STC holder) or 21.A.451 (major repair design approval holder)
The applicant for alternative procedures to demonstrate their design capabilities should establish the necessary procedures to show to EASA how it will fulfil the obligations that are required under 21.A.44, 21.A.118A or 21.A.451, as appropriate.
6. Control of design subcontractors
The applicant for alternative procedures to demonstrate their design capabilities should establish the necessary procedures to show to EASA how it will control design subcontractors and ensure the acceptability of the parts or appliances that are designed, or the design tasks that are performed.