AMC-ELA No 1 to 21.A.243 Data – Design organisation handbook

CAA ORS9 Decision No. 1

The organisation is responsible for ensuring that the type design complies with the applicable type- certification basis, the applicable operational suitability data certification basis and the environmental protection requirements. This includes components that are part of the product, but are designed by external parties, and that are not covered by the applicable and individual parts-related (UKTSO) approvals or (type) certificates.

To discharge this responsibility, the DOA implements practised methods to ensure that there are adequate means to positively establish and verify the compliance of the design and the associated documentation that is generated. The completeness of those methods is documented within the design organisation handbook (DOH), together with the required supporting and company-specific definitions.

The extent of the documentation, and the associated training, is mandated only to the extent that is required to be able to demonstrate that the generated type designs, design changes or repair designs comply with the applicable type-certification basis, the applicable operational suitability data certification basis and the environmental protection requirements, and that the continued airworthiness activities are properly conducted. If evidence is found that the system described is not effective, then enhanced documentation may be one of the means, but not the only possible means, to rectify that situation.

The documentation of the elements within the DOH may be limited to workflow definitions (e.g. flow charts, process cards, or similar items) or to forms that are sufficiently process-oriented. If ERP systems or other IT systems that manage workflows are used, separate workflow documentation is not necessary, as long as the workflow can be demonstrated during surveillance activities on the basis of the IT system that is applied.

The ‘practising of methods’ is confirmed by observing that the methods are practised in an organised and repeatable manner on several examples. Those methods do not automatically require detailed documentation if they are otherwise defined. Nevertheless, ‘practised methods’ should be at least identified with a declarative statement.

The documentation at least covers the relevant items in the list below:

1. A unique identifier for the DOH, and a means to identify and record its revision status.

2. The name of the organisation and the address of its major place of activity, including any side offices where DAS functions as per AMC-ELA No 2 to 21.A.239(a) are performed under the DOA. If this location differs from the legal place of business, both addresses should be provided. Floor plans, or similar data, are not required.

3. A statement signed by the head of the design organisation (HDO) confirming that the DOH will be complied with at all times, and that it is used as a basic working document (i.e. a binding declaration).

4. A statement of the scope of the DOA (refer to GM-ELA No 1 to 21.A.251), which lists the key technologies used for airframe design and propulsion concepts on the projects in that scope.

5. The title and the name of the HDO, HoA and ISM, with statements of their accountability per AMC-ELA No 1 to 21.A.239(a). The delegation of tasks without responsibility does not affect accountability, and it is not required to be mentioned within the DOH.

6. The identification of the formal position and the reporting lines of the HDO, HoA and ISM within the company, possibly, but not necessarily, by means of an organisational chart.

7. A statement that the HDO assumes all the duties and responsibilities associated with the DOA, unless delegation of responsibility, beyond the delegation of tasks, is applied. In such a case, the allocation of responsibilities should be shown along with this statement.

8. A statement that the HoA is the formal point of contact for the CAA.

9. Definitions of the required competences and qualifications that are necessary for the HDO and the HoA (which may be consolidated if both functions are provided by one person), and for design engineers, CVEs and ISMs.

10. A listing of the CVEs, either directly in the DOH or in a separate source (a document, listing, the intranet, etc.) that is linked to the DOH, and this data should be easily accessible to everyone concerned within the company. This list should be made available to the CAA in its current version.

11. The approximate size of the company in full-time equivalent staff members, accurate enough to determine the related fees and charges that are laid down in Commission Regulation (EU) No 319/2014 (the Fees and Charges Regulation). This should include a declaration that the company ensures that the numbers and the qualifications of the staff involved in the design activities are adequate, that the company monitors these aspects, and that it takes action if necessary.

12. A confirmation that any significant changes to the DO, and any changes to the organisation that affect the contents of the DOH, will be notified to the CAA in a timely manner by the responsible person defined in the DOH.

13. A confirmation that, when changes to the organisation occur that affect the documentation required here, the DOH is kept up to date by the responsible person defined in the DOH, but under the responsibility of the HDO, or their delegate. Amendments to the DOH should be released by the HDO, or by their delegate, and distributed according to the implemented method for the control of documented information, to locations that are identified in a generic or document-specific distribution list, including the responsible design organisation approval team leader (DOATL).

14. A definition of the methods that are practised to verify the effectiveness of the elements of the DAS that are stated in this listing. The main targets of Subpart J are to ensure that the type design of the product complies with the applicable type-certification basis, the applicable operational suitability data certification basis and the environmental protection requirements, and that the continued airworthiness activities are properly conducted. The surveillance mechanisms that are used may include structured experience exchanges, regular quality meetings, brainstorming or lessons learned sessions, project reviews at appropriate phases of the development, planned and unplanned audits, or other similar means. Corrective actions that are identified should be followed up, and the means of resolution should be recorded. The DOH should define how this is accomplished.

15. A declaration that control methods are practised, and that the general principles of the applied document revision and access management processes ensure the use of current information.

16. A general identification of the documentation that is the result of all the design functions in relation to the airworthiness, operational suitability and environmental protection approvals, and continued airworthiness, each one of which should be commensurate with the complexity of the product and the risk level in terms of its content, style and format, including:

a. a listing of the document types that form the type design, such as, for example, specifications, drawings, bills of materials, instructions, and other documents;

b. a listing of the document types that form the compliance documentation, such as, for example, compliance reports, compliance summary documents, compliance checklists, means of compliance checklists, manuals, instructions for continued airworthiness (ICAs), master minimum equipment lists (MMELs) (if required), and others;

c. a listing of the document types that form the change and repair design-specific documentation, such as classification matrices and approvals of minor changes, repairs, or production deviations;

d. a listing of the documents related to continued airworthiness activities (information and instructions such as, for example, service bulletins/service instructions), if not already listed to address point a.

17. A declaration and a definition of the principles that are applied, and the accepted related duties, of the key elements of the DAS, as defined in AMC-ELA No 2 to 21.A.239(a). The definition of the elements can be provided by various means, such as precise forms that guide the user through the process, workflow modelling in IT-based design or document management systems, process charts, flow diagrams, classical process definition documents, or other comparable means that are commensurate with the complexity and the criticality of the products. If references are made to other documents that are outside the DOH, the DOH should contain a listing of those documents.

18. A confirmation that methods are practised that enable adequate airworthiness coordination with the applicant for, or the holder of, the production approval. Dedicated procedures and/or DO–PO agreements for the purpose of airworthiness coordination with the production approval holder are not required if the design and the production entities work within one consolidated team, or if the control of airworthiness-related information is conducted by the same group of persons for both design and production. However, it should be described how any occurrences, and any unintentional deviations from the approved design data that occur in production (i.e. concessions or non-conformances) are handled within the design organisation, and when a concession process or a direct approval of such non conformities under the DOA is sought, for example by using the change process. In addition, the methods/processes that are required by other AMC-ELA and GM-ELA should be defined, either directly in the DOH or in a document that is linked to it.

19. A declaration and a definition of the method applied to accept design work that is conducted by external parties, in line with AMC-ELA No 1 to 21.A.239(c).

20. The identification of the design subcontractors and satellite locations that operate under the DAS of the design organisation, and that fulfil functions required by the DAS, or are directly involved in critical aspects of compliance demonstration, such as, for example, flutter investigations and analyses. This identification may be an integral part of the DOH, or it may be provided in a separate listing that is only identified from within the DOH.

21. A reference to a flight test operations manual (FTOM) that is adequate for the flight test activities of the design organisation. If both the design and the manufacturing entities work within one consolidated team, it is sufficient to have FTOM procedures defined for only one of the entities. The FTOM shall then identify the workflow that defines how to issue flight conditions and PtFs for the purpose of conducting factory acceptance test flights.