AMC-ELA No 2 to 21.A.239(a) Design assurance system – Ensuring compliance    

CAA ORS9 Decision No. 1

An acceptable design assurance system (DAS) contains the elements of the DAS that are described in AMC-ELA No 1 to 21.A.239(a), and which are further broken down below into the following activities:

1. The generation, iteration, CAA acceptance and maintenance of the certification programme:

— ensure that adequate product, change or repair specifications have been generated and are available to support a meaningful certification programme;

— generate a certification programme that is tailored to the product, or change, or repair specified, and that identifies:

— the product and the kinds of operations envisaged, or the changes to them;

— the proposed certification basis;

— a description of how compliance will be demonstrated, with the proposed means of compliance and any selected guidance material, if this is not clearly visible from the compliance/means of compliance (MOC) checklist;

— a compliance checklist, together with the means of compliance that is intended to be used, and any guidance material;

— the relevant CVE to be used on the project;

— the programme milestones for interaction with the CAA;

— iteration of the certification programme, until the CAA acceptance is reached;

— monitoring of the workflow in line with the certification programme:

— updating the certification programme and seeking a new acceptance by the CAA, if necessary;

— ensuring that the relevant staff members adhere to the certification programme when they conduct certification activities;

— structured methods for the classification of changes, repairs or deviations by using an adequate process flow, or by following adequate decision forms (matrices) if there are major changes that directly support the change-related certification programme.

2. Demonstration of compliance and its verification within the design organisation:

— ensure that a complete set of data has been developed in order to form a complete and concise definition of the type design;

— ensure that the selected method for defining the type design allows for adequate configuration management, for the purposes of design and design variant management, and for the later management of production;

— ensure that the handling of changes within the type investigation process and post-TC/- STC is controlled, coordinated and repeatable;

— ensure that analyses and tests have been conducted by using methods that are adequate to support the means of compliance that was defined, and that they are documented to allow their use for showing compliance;

— ensure that the formal demonstration of compliance for the intended type design, change design or repair design, including the generation of compliance statements with respect to any relevant certification requirement, is provided;

— conduct the formal verification of compliance for the intended type design, change design or repair design, including the verification of compliance statements with respect to any relevant certification requirement by an independent person nominated within the design organisation (i.e. a compliance verification engineer (CVE));

— ensure that the applicable product-relevant documentation, such as the AFM, ICA or MMEL, is established and provided;

— ensure that prototypes or test specimens, produced by a connected production organisation, or by any prototyping facilities of the design organisation itself, are used on the basis of an adequate configuration verification against the design definitions specified for the relevant test;

— ensure that coordinated flight test activities with adequate risk mitigations are performed.

3. Monitoring functions to ensure the continued airworthiness of the certified product:

— conduct monitoring of any significant events;

— ensure that all reported occurrences and events are investigated and classified;

— ensure that there is occurrence reporting for events that are classified as ‘safety-critical’ and that constitute unsafe or potentially unsafe conditions;

— ensure that information and instructions are generated and published, as applicable, and that information or instructions and any related design activity are verified by following the same principles as for any type design, change design or repair design activity/documentation.

4. Declaration of compliance by the design organisation to the CAA:

— verification of the completeness of the compliance verification and type design documentation as defined within the certification programme by the head of airworthiness (HoA);

— issuing of the declaration of compliance by the head of the design organisation (HDO) to the CAA, subsequent to the satisfactory completion of the verification of compliance against all the applicable certification requirements.