21.B.120 Initial certification procedure

INVESTIGATION TEAM AND PROCEDURES

(a)The competent authority should appoint a team for each applicant for, or holder of, a letter of agreement. This team is responsible for conducting all the relevant tasks related to the issuance of the letter of agreement. The team should consist of a team leader to manage and lead the team, and, if needed, one or more team members. The team leader should report to the manager who is responsible for the activities of the competent authority as defined in point 21.B.25(b).

(b)The competent authority should perform sufficient investigation activities for an applicant for, or holder of, a letter of agreement, to justify the recommendations for the issuance, maintenance, amendment, suspension, limitation or revocation of the letter of agreement.

(c)The competent authority should prepare procedures for the investigation of applicant for, or a holder of, a letter of agreement, as part of the documented procedures that cover at least the following elements:

(1)evaluation of the application received;

(2)appointment of the investigation team;

(3)preparation and planning of the investigation;

(4)evaluation of the documentation (manual, procedures, etc.);

(5)auditing;

(6)follow-up of corrective actions; and

(7)recommendations for the issuance, amendment, suspension, limitation or revocation of a letter of agreement; and

(8)oversight.

The competent authority should ensure that the team leader and team members have received appropriate training in the relevant Subparts of Part 21 and in the related competent authority documentation before performing investigations in accordance with AMC1 21.B.25(a)(3). They should also have knowledge and experience at the appropriate level in aviation production and inspection activities related to the particular application for a letter of agreement.

EVALUATION OF APPLICATIONS

(a)General When applying Part 21 Section A, Subpart F and Section B, Subpart F, the competent authority should consider that these Subparts are only alternatives for production to Part 21 Section A, Subpart G and Section B, Subpart G. To meet the ICAO airworthiness obligations and to issue a certificate of airworthiness for an individual aircraft in a practical and efficient way, the competent authority should use a system of approval of production organisations (POA) under Part 21 Section A, Subpart G and Section B, Subpart G, providing to the competent authority the necessary confidence in the technical standards. The consistent standards of these approvals will also support the standardisation efforts by EASA. Nevertheless, it is recognised that it is not always practical, economical and/or advisable to use the POA. Considering the ICAO airworthiness obligations as well, Part 21 Section A, Subpart F and Section B, Subpart F are provided for such a case on the basis of the following principles:

(1)Subpart F should be considered as an alternative option for particular cases.

(2)Its adoption should be done on an individual basis, as a consequence of an assessment by the competent authority (see point 21.A.121, and its associated AMC and GM).

(b)Application The competent authority should receive an application for a letter of agreement on an EASA Form 60 (see AMC1 21.A.124) completed by the applicant. The eligibility of the application should be verified in relation to the competent authority procedures, based on point 21.A.121 and its associated AMC and GM. The applicant should be advised accordingly about the acceptance or rejection of the application. An application may be accepted from: an individual applying on his or her own behalf; or in the case of an organisation, an individual with the authority to make agreements on behalf of the organisation.

(c)Location of the applicant The location of the applicant seeking acceptance for production under Part 21 Section A, Subpart F determines which competent authority is responsible for issuing the letter of agreement.

INVESTIGATION PREPARATION AND PLANNING Following acceptance of an application for a letter of agreement and before commencing an investigation, the competent authority should:

(a)identify the site locations that they need to investigate;

(b)liaise with the competent authority of a Member State where the investigation of the organisation should include a facility in that Member State for one of the following reasons:

(1)where a production organisation has contracted part of the production to another organisation holding a POA and a need arises to ensure that the contract has the same meaning for all the parties to the contract, and the local competent authority of the Member State agrees;

(2)to inspect a product (or part or appliance) under production where the subcontractor does not hold a POA.

(c)coordinate with the competent authority of a third country and/or EASA where the investigation of the organisation should include a facility in that country for one of the following reasons:

(1)where a production organisation has contracted part of the production to another organisation holding a POA issued by EASA or accepted through a recognition agreement in accordance with Article 68 of Regulation (EU) 2018/1139, and a need arises to ensure that the contract has the same meaning for all the parties to the contract, and EASA and/or the competent authority agrees;

(2)to inspect a product (or part or appliance) under production where the subcontractor does not hold a POA.

During its investigation process, the competent authority may raise findings which should then be recorded. These may be non-conformities to the requirements, the manual as supplied by the production organisation describing its inspection procedures or non-conformities related to the items under inspection. The manner in which the findings will be handled by the competent authority before and during the validity of the letter of agreement, should be detailed in its procedures.

ISSUE OF THE LETTER OF AGREEMENT

(a)Unless otherwise agreed by the competent authority, no production before the issue of the letter of agreement may be accepted under Part 21 Section A, Subpart F.

(b)The agreement should include or reference a predefined plan of inspection points established as part of the production inspection system and agreed with the competent authority to be used as a basis for the inspections described in points 21.A.129 and 21.B.120(a) and their associated AMC and GM. The plan should clearly identify the inspection points, places, inspection subjects (materials, processes, tooling documentation, human resources, etc.), as well as the focal points and the method of communication between the production organisation and the competent authority.

(c)The competent authority should detail the method by which it will assure itself that the production organisation is working in accordance with the manual and the agreed inspection procedures during the validity period of the agreement. For a renewal of this validity period, the procedure as defined in point 21.B.140 should be used.

(d)Any conditions under which the agreement will expire (such as the termination date and/or number of units to produce) should be clearly stated in the letter of agreement.