21.A.121 Scope

Regulation (EU) No 748/2012

(a) This Subpart establishes the procedure for demonstrating the conformity with the applicable design data of a product, part and appliance that is intended to be manufactured without a production organisation approval under Subpart G.

(b) This Subpart establishes the rules governing the obligations of the manufacturer of a product, part, or appliance being manufactured under this Subpart.

GM No 1 to 21.A.121 Applicability – Individual product, part or appliance

ED Decision 2012/020/R

In this context, ‘demonstrating the conformity with the applicable design data of a product, part and appliance’ means that conformity with the applicable design data has to be established and shown for each and every product, part or appliance.

GM No 2 to 21.A.121 Applicability – Applicable design data

ED Decision 2019/018/R

Applicable design data is defined as all the necessary drawings, specifications and other technical information provided by the applicant for, or holder of a design organisation approval, TC, STC, approval of repair or minor change design, or ETSO authorisation (or equivalent when Part 21 Section A Subpart F is used for production of products, parts or appliances, the design of which has been approved other than according to Part 21), and released in a controlled manner to the manufacturer that produces under Part 21 Subpart F. This should be sufficient for the development of production data to enable manufacture in conformity with the design data.

Prior to the issue of the TC, STC, approval of repair or minor change design or ETSO authorisation, or equivalent, design data is defined as ‘not approved’, but parts and appliances may be released with an EASA Form 1 as a certificate of conformity.

After the issue of the TC, STC, approval of repair or minor change or ETSO authorisation, or equivalent, this design data is defined as ‘approved’ and items manufactured in conformity are eligible for release on an EASA Form 1 for airworthiness purposes.

For the purpose of Subpart F of Part 21, the term ‘applicable design data’ includes the information related to the applicable engine exhaust emissions and aeroplane CO₂ emissions production cut-off requirements.

21.A.122 Eligibility

Regulation (EU) No 748/2012

Any natural or legal person may apply to show conformity of individual products, parts or appliances under this Subpart, if:

(a) it holds or has applied for an approval covering the design of that product, part or appliance; or

(b) it has ensured satisfactory coordination between production and design, through an appropriate arrangement with the applicant for, or holder of, an approval of such a design.

AMC1 21.A.122 Eligibility

ED Decision 2023/014/R

LINK BETWEEN DESIGN AND PRODUCTION

An ‘arrangement’ is considered suitable if it is documented and satisfies the competent authority that coordination is satisfactory.

To achieve satisfactory coordination, the documented arrangements must at least define the following aspects, irrespective of whether the design organisation (DO) and the organisation producing or intending to produce under Part 21, Subpart F are separate legal entities or not:

(a) the responsibilities of a DO, which assure correct and timely transfer of up-to-date applicable design data (e.g. drawings, material specifications, dimensional data, processes, surface treatments, shipping conditions, quality requirements, etc.);

(b) the responsibilities and procedures of the production organisation (PO) for receiving, managing, and using the applicable design data provided by the DO;

(c) the responsibilities and procedures of the PO for developing, where applicable, its own manufacturing data in compliance with the applicable design data package;

(d) the responsibilities of the PO to assist the DO in dealing with continuing airworthiness matters and for required actions (e.g. traceability of parts in case of direct delivery to users, retrofitting of modifications, traceability of processes’ outputs and approved deviations for individual parts as applicable, technical information and assistance, etc.);

(e) the scope of the arrangements covering Subpart F requirements, in particular, points 21.A.126(a)(4) and 21.A.129(d) and 21.A.3A and any associated GM or AMC;

(f) the responsibilities of the PO, in the case of products prior to type certification to assist a DO in demonstrating compliance with the CS (access and suitability of production and test facilities for manufacturing and testing of prototype models and test specimen);

(g) the procedures to deal adequately with production deviations and non-conforming parts;

(h) the means to achieve adequate configuration control of manufactured parts, to enable the PO to make the final determination and identification for conformity or airworthiness release and eligibility status;

(i) the identification of responsible persons that control the above; and

(j) the acknowledgment by the holder of the TC/STC/repair or change approval/ETSO authorisation that the approved design data that is provided, controlled and modified in accordance with the arrangement is recognised as approved.

In many cases, the person producing or intending to produce under Part 21, Subpart F may receive the approved design data through an intermediate PO. This is acceptable, provided that an effective link between the design approval holder (DAH) and the PO can be maintained to satisfy the intent of point 21.A.122.

When the DO and the PO are two separate legal entities, a direct delivery authorisation should be available for direct delivery to end users in order to guarantee continued airworthiness control of the released parts and appliances.

Where there is no general agreement for direct delivery authorisation, specific permissions may be granted (see AMC 21.A.4).

AMC2 21.A.122 Eligibility

ED Decision 2023/014/R

LINK BETWEEN DESIGN AND PRODUCTION

In accordance with AMC1 21.A.122 the person producing or intending to produce under Part 21 Subpart F should demonstrate to the authority that it has entered into an arrangement with the design organisation. The arrangement must be documented irrespective of whether the two organisations are separate legal entities or not.

The documented arrangement must facilitate the person producing or intending to produce under Part 21 Subpart F to demonstrate compliance with the requirement of 21.A.122 by means of written documents agreed.

In the case where the design organisation and the person producing or intending to produce under Part 21 Subpart F are part of the same legal entity these interfaces may be demonstrated by company procedures accepted by the competent authority.

In all other cases to define such a design/production interface the following sample format is offered:

Arrangement Sample Form

Instructions for completion:

Title: The title of the relevant document must clearly indicate that it serves the purpose of a design/production interface arrangement in accordance with 21.A.122.

Commitment: The document must include the basic commitments between the design organisation and the manufacturer producing under Part 21 Subpart F as addressed in AMC 21.A.4 and AMC1 21.A.122.

Relevant Procedures: Identify an entry point into the documentary system of the organisations with respect to the implementation of the arrangement (for example a contract, quality plan, handbooks, common applicable procedures, working plans etc.).

Scope of arrangement: The scope of arrangement must state by means of a list or reference to relevant documents those products, parts or appliances that are covered by the arrangement.

Transfer of approved design data: Identify the relevant procedures for the transfer of the applicable design data required by 21.A.122 and AMC1 21.A.122 from the design organisation to the person producing under Part 21 Subpart F. The means by which the design organisation advises the person producing under Part 21 Subpart F whether such data is approved or not approved must also be identified (ref. 21.A.4 / AMC 21.A.4).

Direct Delivery Authorisation: Where the design organisation and the person producing under Part 21 Subpart F are separate legal entities the arrangement must clearly identify whether authorisation for direct delivery to end users is permitted or not.

Where any intermediate production/design organisation is involved in the chain between the original design organisation and the person producing under Part 21 Subpart F, evidence must be available that this intermediate organisation has received authority from the design organisation to grant Direct Delivery Authorisation.

Signature: AMC1 21.A.122 requests the identification of the responsible persons/offices who control the commitments laid down in the arrangement. Therefore the basic document must be signed mutually by the authorised representatives of the design organisation and the manufacturer producing under Part 21 Subpart F in this regard.

21.A.124 Application

Regulation (EU) No 748/2012

(a) Each application for an agreement to the showing of conformity of individual products, parts and appliances under this Subpart shall be made in a form and manner established by the competent authority.

(b) Such application shall contain:

1. evidence which demonstrates, where applicable, that:

(i) the issuance of a production organisation approval under Subpart G would be inappropriate; or

(ii) the certification or approval of a product, part or appliance under this Subpart is needed pending the issuance of a production organisation approval under Subpart G;

2. an outline of the information required in point 21.A.125A(b).

AMC1 21.A.124 Application

ED Decision 2022/021/R

An applicant should submit to the competent authority a fully completed EASA Form 60 (see below):

EASA Form 60 Issue 3

Block 1:The name of the applicant should be entered. For legal entities, the name should be as stated in the register of the National Companies Registration Office. In this case, a copy of the entry in the register of the National Companies Registration Office should be provided to the competent authority.

Block 2: State the trade name by which the applicant is known to the public if it is different from the information given in Block 1. The use of a logo may be indicated in this block.

Block 3: State all the locations of the manufacturing activities that are covered by the application. Only those locations should be stated that are directly under the control of the applicant that is stated in Block 1.

Block 4: This block should include further details of the manufacturing activities under approval for the addresses that are indicated in Block 3. The ‘Identification’ block should indicate the products, parts, or appliances that are intended to be produced, while the ‘Termination’ block should address any information on the limitation of the activity, e.g. by stating the intended number of units to be manufactured or the expected date of completion of the manufacturing activities.

Block 5: This block should state the evidence that supports the determination of applicability as stated in point 21.A.121. In addition, an outline of the manual that is required by point 21.A.125A(b) should be provided with the application.

Block 6: The information entered here is essential for the evaluation of the eligibility of the application. Therefore, special attention should be given concerning the completion of this block, either directly, or by reference to supporting documentation in relation to the requirements of point 21.A.122 and to AMC1 21.A.122.

Block 7: The information to be entered here should reflect the number of staff or in the case of an initial approval, the intended number of staff for the manufacturing activities under this application, and therefore, it should also include any associated administrative staff.

Block 8: State the name of the person that is authorised to sign the application.

GM 21.A.124(b)(1)(i) Applicability – Inappropriate approval under Subpart G

ED Decision 2012/020/R

The issue of a letter of agreement of production under Part 21 Subpart F may be agreed by the competent authority when:

1. The applicant produces or intends to produce aeronautical products, parts and/or appliances intended for airborne use as part of a type-certificated product (this excludes simulators, ground equipment and tools), and

2. The competent authority determines that Part 21 Section A Subpart G would be inappropriate, and consequently Part 21 Section A Subpart F applies. The main difference between Part 21 Section A Subparts G and F is that Subpart G requires the existence of a Quality System which provides the competent authority with the necessary confidence to grant to the manufacturer the privileges of certifying its own production. There are situations where a Quality System, including independent monitoring and continuous internal evaluation functions, is not justified and /or feasible. In making the determination that Subpart F may apply, the competent authority may take into account one or a combination of parameters such as the following:

—      no flow production (infrequent or low volume of production).

—      simple technology (enabling effective inspection phases during the manufacturing process).

—      very small organisation.

GM 21.A.124(b)(1)(ii) Certification or approval needed in advance of the issue of a POA

ED Decision 2012/020/R

In cases where Part 21 Section A Subpart G is applicable, but when some time is needed for the organisation to achieve compliance with Subpart G, i.e., to establish the necessary documented quality system, the competent authority may agree to use Part 21 Section A Subpart F for a limited period (transient phase).

In cases where Part 21 Section A Subpart G is applicable, such as to produce ETSO articles, a letter of agreement to produce under Part 21 Subpart F should not be given unless an application has been made for organisation approval under Subpart G, and reasonable progress is being made towards compliance with Subpart G. Long-term production under Part 21 Subpart F will not be permitted.

GM 21.A.124(b)(2) Application – Minimum information to include with the application

ED Decision 2012/020/R

At this early stage, provision of the complete manual is not necessary, but at least the following items should be covered:

1. Table of Contents of the Manual (including list of existing inspection system documents or procedures)

2. Description of items to be manufactured (including intended quantities /deliveries)

3. List of possible suppliers

4. General description of facilities

5. General description of production means

6. Human resources

21.A.124A Means of compliance

Regulation (EU) 2022/201

(a) An organisation may use any alternative means of compliance to establish compliance with this Regulation.

(b) If an organisation wishes to use an alternative means of compliance, it shall, prior to using it, provide the competent authority with a full description. The description shall include any revisions to manuals or procedures that may be relevant, as well as an explanation indicating how compliance with this Regulation is achieved.

The organisation may use those alternative means of compliance subject to prior approval from the competent authority.

GM1 21.A.124A and 21.A.134A Means of compliance

ED Decision 2022/021/R

GENERAL

(a) Acceptable means of compliance (AMC), as referred to in Article 76(3) of Regulation (EU) 2018/1139²⁸, are a tool to standardise the demonstration of compliance with, and facilitate the verification activities of the competent authorities in relation to, that Regulation and its delegated and implementing acts. AMC are published by EASA to achieve those objectives. While competent authorities and regulated entities are not legally bound to use the AMC, applying them is recommended.

(b) If an organisation wishes to use other means to comply with Regulation (EU) 2018/1139 and its delegated and implementing acts, which are different from the AMC that are published by EASA, that organisation may need to demonstrate compliance by using alternative means of compliance (AltMoC) that are established:

(1) by its competent authority (see GM1 21.B.115 and GM1 21.B.215); or

(2) by that organisation and approved by its competent authority (see point (c)).

An AltMoC does not allow deviation from Regulation (EU) 2018/1139 and its delegated or implementing acts.

(c) AltMoC that are established by an organisation and approved by its competent authority

An organisation that wishes to use a different MoC than the one published by EASA can propose an AltMoC to the competent authority and use it only once the competent authority approves it. In that case, the organisation is responsible for demonstrating how that AltMoC establishes compliance with the regulation.

The approval of an AltMoC is granted to the organisation by its competent authority on an individual basis and is restricted to that specific organisation. Other organisations that wish to use the same AltMoC should go through the AltMoC process (i.e. demonstrate how that AltMoC establishes compliance with the regulation) and obtain individual approval from their competent authority.

GM2 21.A.124A and 21.A.134A Means of compliance

ED Decision 2022/021/R

WHEN AN ALTERNATIVE MEANS OF COMPLIANCE IS NEEDED

When there is no EASA AMC to a certain point of a regulation, the means of compliance (MoC) that are proposed by the organisation to that point do not need to go through the AltMoC process. It is the responsibility of the competent authority to verify that compliance with the regulation is achieved. However, in certain cases, the organisation may propose, and the competent authority may agree, to have such MoC go through the AltMoC process.

When there is an EASA AMC, the AltMoC process is needed in the following cases (non-exhaustive list):

—      an AltMoC to the regulation is technically different to the AMC that is published by EASA; and

—      a Form is significantly different from the one that is included in the EASA AMC.

Note: a Form that is required by a delegated or implementing act cannot be modified.

Examples of issues that are not considered to require the AltMoC process include, but are not limited to:

—      editorial changes to an EASA AMC, as long as they do not change the intent of the AMC; and

—      incorporating an EASA AMC into the organisational structure, organisational processes, or standard operating procedures of an organisation with different wording and terminology that are customised to the organisation’s environment if it does not change the intent of the AMC and its associated level of safety.

AMC1 21.A.124A(b) and 21.A.134A(b) Means of compliance

ED Decision 2022/021/R

DESCRIPTION SUPPORTING THE ALTERNATIVE MEANS OF COMPLIANCE

(a) The description of the alternative means of compliance (AltMoC) should include:

(1) a summary of the AltMoC;

(2) the content of the AltMoC;

(3) a statement that compliance with the regulation is achieved; and

(4) in support of that statement, an assessment that demonstrates that the AltMoC reaches an acceptable level of safety, taking into account the level of safety that is achieved by the corresponding EASA AMC.

(b) All these elements that describe the AltMoC are an integral part of the management system records, in accordance with point 21.A.5.

21.A.125A Issuance of a letter of agreement

Regulation (EU) 2022/201

The applicant shall be entitled to have a letter of agreement issued by the competent authority agreeing to the showing of conformity of individual products, parts and appliances under this Subpart, after:

(a) having established a production inspection system that ensures that each product, part or appliance conforms to the applicable design data and is in condition for safe operation;

(b) having provided a manual that contains:

1. a description of the production inspection system required under point (a);

2. a description of the means for making the determination of the production inspection system;

3. a description of the tests required in points 21.A.127 and 21.A.128, and the names of persons authorised for the purpose of point 21.A.130(a);

(c) demonstrating that it is able to provide assistance in accordance with points 21.A.3A and 21.A.129(d).

GM No 1 to 21.A.125A Letter of agreement – Meaning of individual

ED Decision 2012/020/R

‘Individual’ means that each part number or type of item (i.e., product, part or appliance) to be produced should be specifically referenced, either directly or through a referenced capability list, in the letter of agreement from the competent authority. The letter may also specify any limitation in the production rate.

GM No 1 to 21.A.125A(b) Letter of agreement – Contents of the Manual

ED Decision 2012/020/R

The manual referred in 21.A.125A(b) should include, at least the following information:

1. Declaration by the applicant of undertaking in respect of

1.1 the requirements defined in Part 21 Section A Subpart F

1.2 the procedures contained in the manual and in the documentation mentioned herein

1.3 every legal provision laid down for the carrying on of the business activities (statutory declaration).

2. Declaration by the applicant certifying the conformity of the manual to the requirements defined in Part 21 Section A Subpart F

3. Jobs, power and responsibilities of the accountable personnel

4. Organisation chart, if required by the competent authority

5. Description of the resources, including human resources, with an indication of the personnel qualification criteria

6. Description of location and equipment

7. Description of the scope of work, the production processes and techniques, and reference to the ‘capability list’

8. Communications with the competent authority, and specifically those required by 21.A.125A(c)

9. Assistance and communication with the design approval holder, and the means of compliance with 21.A.125A(c)

10. Amendments to the Manual

11. Description of the Inspection System (including test, see GM No 2 to 21.A.125A(b), and 21.A.127 and 21.A.128), and the procedures to meet 21.A.126 and associated GM

12. List of suppliers

13. Issuing of the Statement of Conformity and competent authority inspection for validation

If the information is listed in the Manual in a different order a cross-reference to the above list should be made available in the Manual.

GM No 2 to 21.A.125A(b) Letter of agreement – Production Inspection System: Functional Tests

ED Decision 2012/020/R

All items produced should be subject to inspection to be carried out at suitable phases which permit an effective verification of conformity with the design data.

These inspections may provide for the execution of tests to measure performances as set out in the applicable design data.

Considerations of complexity of the item and/or its integration in the next level of production will largely determine the nature and time for these tests, for example:

—      appliances - will require full functional testing to the specifications

—      parts - will at least require basic testing to establish conformity, but due allowance may be made for further testing carried out at the next level of production

—      material - will require verification of its stated properties.

GM 21.A.125A(c) Letter of agreement – Assistance

ED Decision 2012/020/R

The competent authority should be provided with material which defines the means of providing assistance as required by 21.A.125A(c). Suitable descriptive material should be included in the Manual, as described in GM No 1 to 21.A.125A(b).

21.A.125B Findings and observations

Regulation (EU) 2022/201

(a) After receipt of the notification of findings in accordance with point 21.B.125, the holder of a letter of agreement shall:

1. identify the root cause(s) of, and contributing factor(s) to, the non-compliance;

2. define a corrective action plan;

3. demonstrate the implementation of the corrective action to the satisfaction of the competent authority.

(b) The actions referred to in point (a) shall be performed within the period agreed with that competent authority in accordance with point 21.B.125.

(c) The observations received in accordance with point 21.B.125(e) shall be given due consideration by the holder of the letter of agreement. The organisation shall record the decisions taken in respect of those observations.

GM No 1 to 21.A.125B(a) Uncontrolled non-compliance with applicable design data

ED Decision 2012/020/R

An uncontrolled non-compliance with applicable design data is a non-compliance:

a) that cannot be discovered through systematic analysis or

b) that prevents identification of affected products, parts, appliances, or material.

GM No 2 to 21.A.125B(a) Examples for level one findings

ED Decision 2012/020/R

Examples for level 1 findings are non-compliances with any of the following points, that could affect the safety of the aircraft:

         21.A.126         , 21.A.127, 21.A.128, 21.A.129.

It should be anticipated that a non-compliance with these points is only considered a level one finding when objective evidence has been found that this finding is an uncontrolled non-compliance that could affect the safety of the aircraft.

GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings and observations

ED Decision 2022/021/R

ROOT CAUSE ANALYSIS

(a) It is important that the analysis does not primarily focus on establishing who or what caused the non-compliance, but on why it was caused. Establishing the root cause(s) of non‑compliance often requires an overarching view of the events and circumstances that led to it, to identify all the possible systemic and contributing factors (human factors (HF), regulatory, organisational, technical factors, etc.) in addition to the direct factors.

(b) A narrow focus on single events or failures, or the use of a simple, linear model, such as a fault tree, to identify the chain of events that led to the non-compliance, may not properly reflect the complexity of the issue, and therefore, there is a risk that important factors that must be considered to prevent reoccurrence will be ignored.

Such an inappropriate or partial root cause analysis often leads to applying ‘quick fixes’ that only address the symptoms of the non-compliance. A peer review of the results of the root cause analysis may increase its reliability and objectivity.

AMC1 21.A.125B(a)(3), 21.A.158(a)(3) and 21.A.258(a)(3) Findings and observations

ED Decision 2022/021/R

FINDING-RELATED CORRECTIVE-ACTION PLAN AND IMPLEMENTATION

After receipt of notification of findings, the organisation should identify and define the action for all findings, to address the effects of the non-compliance, as well as its root cause(s) and contributing factor(s).

Depending on the issues identified, the organisation may need to take immediate corrective action.

The corrective action plan should:

—      include the correction of the issue, corrective and preventive action, as well as the planning to implement them; and

—      be timely submitted to the competent authority for acceptance before it is effectively implemented.

After receiving the competent authority’s acceptance of the corrective action plan, the organisation should implement the associated action.

Within the agreed period, the organisation should inform the competent authority that the corrective action plan has been implemented and should send the associated pieces of evidence, on request from the competent authority.

AMC1 21.A.125B(c), 21.A.158(c), 21.A.258(c) Findings and observations

ED Decision 2022/021/R

DUE CONSIDERATION TO OBSERVATIONS

For each observation that is notified by the competent authority, the organisation should analyse the related issues and determine when action is needed.

The handling of the observations may follow a process similar to the handling of the findings by the organisation.

The organisation should record the analysis and the related outputs, such as action taken, or the reasons why no action was taken.

21.A.125C Duration and continued validity

Regulation (EU) 2022/201

(a) The letter of agreement shall be issued for a limited period of time that in any case shall not exceed 1 year. It shall remain valid subject to the organisation’s compliance with all the following conditions:

1. the production organisation continues to comply with the applicable requirements of this Annex;

2. the production organisation or any of its partners, suppliers or subcontractors acknowledges that the competent authority may carry out investigations in accordance with point 21.A.9;

3. the production organisation is able to provide the competent authority with evidence showing that it maintains satisfactory control of the manufacture of products, parts and appliances under the letter of agreement;

4. the letter of agreement has not been revoked by the competent authority under point 21.B.65, has not been surrendered by the production organisation, and its duration has not expired.

(b) Upon surrender, revocation or expiry, the letter of agreement shall be returned to the competent authority.

21.A.126 Production inspection system

Regulation (EU) 2022/201

(a) The production inspection system required under point 21.A.125A(a) shall provide a means for determining that:

1. incoming materials, and bought or subcontracted parts, used in the finished product are as specified in the applicable design data;

2. incoming materials, and bought or subcontracted parts, are properly identified;

3. processes, manufacturing techniques and methods of assembly affecting the quality and safety of the finished product are accomplished in accordance with specifications accepted by the competent authority;

4. design changes, including material substitutions, have been approved under Subpart D or E and controlled before being incorporated in the finished product.

(b) The production inspection system required by point 21.A.125A(a), shall also be such as to ensure that:

1. parts in process are inspected for conformity with the applicable design data at points in production where accurate determinations can be made;

2. materials subject to damage and deterioration are suitably stored and adequately protected;

3. current design drawings are readily available to manufacturing and inspection personnel, and used when necessary;

4. rejected materials and parts are segregated and identified in a manner that precludes installation in the finished product;

5. materials and parts that are withheld because of deviations from type design or production specifications, and that are to be considered for installation in the finished product, are subjected to an approved engineering and manufacturing review procedure. Those materials and parts that have been found in that procedure to be serviceable shall be properly identified and reinspected if it is necessary to be reworked or repaired. Materials and parts rejected in that procedure shall be marked and disposed of to ensure that they are not incorporated in the final product.

GM 21.A.126 Production inspection system

ED Decision 2012/020/R

GM 21.A.126(a) and (b) have been developed for persons producing under Part 21 Section A Subpart F on the long term basis as defined in 21.A.124(b)(1)(i).

For those persons producing under Part 21 Section A Subpart F as a transient phase under 21.A.124(b)(1)(ii), compliance with 21.A.126 may also be demonstrated to the satisfaction of the competent authority by using the equivalent Part 21 Section A Subpart G AMC/GM.

GM 21.A.126(a)(1) Production inspection system – Conformity of supplied parts, appliances and material

ED Decision 2012/020/R

1. The person producing under Subpart F is responsible for determining and applying acceptance standards for physical condition, configuration status and conformity, as appropriate, of raw materials, subcontracted works, and supplied products, parts, appliances or material, whether to be used in production or delivered to customers as spare parts. This responsibility also includes BFE (Buyer Furnished Equipment) items.

2. Control may be based upon use of the following techniques, as appropriate:

2.1 first article inspection, including destruction if necessary, to verify that the article conforms to the applicable data for new production line or new supplier,

2.2 incoming inspections and tests of supplied parts or appliances that can be satisfactorily inspected on receipt,

2.3 identification of incoming documentation and data relevant to the showing of conformity to be included in the certification documents,

2.4 any additional work, tests or inspection which may be needed for parts or appliances which are to be delivered as spare parts and which are not subject to the checks normally provided by subsequent production or inspection stages.

3. The person producing under Part 21 Subpart F may rely upon an EASA Form 1 issued in accordance with Part 21 if provided as evidence of conformity with applicable design data

For suppliers not holding a POA the inspection system of the person producing under Part 21 Subpart F should establish a system for control of incoming materials and bought or subcontracted items which provides for inspections and tests of such items by the person producing under Part 21 Subpart F at the supplier’s facility, if the item cannot or will not be completely inspected upon receipt.

GM 21.A.126(a)(2) Production inspection system – Identification of incoming materials and parts

ED Decision 2012/020/R

All parts and materials coming from external parties should be identified and inspected to ascertain that they have not been damaged during transport or unpacking, that the incoming parts and materials have the appropriate and correct accompanying documentation and that the configuration and condition of the parts or materials is as laid down in that documentation.

Only on completion of these checks and of any incoming further verifications laid down in the procurement specification, may the part or material be accepted for warehousing and used in production.

This acceptance should be certified by an inspection statement.

A suitable recording system should allow reconstruction at any time of the history of every material or part.

The areas where the incoming checks are carried out and the materials or parts are stored pending completion of the checks should be physically segregated from other departments.

GM No 1 to 21.A.126(a)(3) Production inspection system – List of specifications

ED Decision 2012/020/R

It is the responsibility of:

1. The designer, to define all necessary processes, techniques and methods to be followed during manufacture (21.A.31) and this information will be provided as part of the applicable design data.

2. The manufacturer, to ensure that all processes are carried out strictly in accordance with the specifications provided as part of the applicable design data.

GM No 2 to 21.A.126(a)(3) Production inspection system – Means of checking of the production processes

ED Decision 2012/020/R

The Production Inspection System should be provided with appropriate means of checking that production processes, whether performed by the person producing under Part 21 Subpart F or by sub-contractors under its control, are carried out in accordance with applicable data, including:

1. A system for the control and authorised amendment of data provided for the production, inspection and test to ensure that it is complete and up-to-date at the point of use

2. Availability of personnel with suitable qualification, experience, and training for each required production, inspection, and test task. Special attention should be paid to tasks requiring specialised knowledge and skill, e.g., NDT/NDI, welding...

3. A working area where the working conditions and environment are controlled as appropriate in respect of: cleanliness, temperature, humidity, ventilation, lighting, space/access, protection against noise and pollution

4. Equipment and tools sufficient to enable all specified tasks to be accomplished in a safe and effective manner without detrimental effect on the items under production. Calibration control of equipment and tools which affect critical dimensions and values must demonstrate compliance with, and be traceable to, recognised national or international standards.

GM 21.A.126(a)(4) Production inspection system – Applicable design/production data procedures

ED Decision 2012/020/R

1. When a person producing under Part 21 Subpart F is developing its own manufacturing data from the design data package delivered by a Design holder, procedures should demonstrate the correct transcription of the original design data.

2. Procedures should define the manner in which applicable design data is used to issue and update the production/inspection data, which determines the conformity of products, parts, appliances and materials. The procedure should also define the traceability of such data to each individual product, part, appliance or material for the purpose of stating the condition for safe operation and for issuing a Statement of Conformity.

3. During execution, all works should be accompanied by documentation giving either directly or by means of appropriate references, the description of the works as well as the identification of the personnel in charge of inspection and execution tasks for each of the different work phases.

GM 21.A.126(b)(1) Production inspection system – Inspection of parts in process

ED Decision 2012/020/R

The purpose of the Production Inspection System is to check at suitable points during production and provide objective evidence that the correct specifications are used, and that processes are carried out strictly in accordance with the specification.

During the manufacturing process, each article should be inspected in accordance with a plan which identifies the nature of all inspections required and the production stages at which they occur. The plan should also identify any particular skills or qualification required of person(s) carrying out the inspections (e.g., NDT personnel). A copy of the plan should be included in, or referenced by, the manual required by 21.A.125A(b).

If the parts are such that, if damaged, they could compromise the safety of the aircraft, additional inspections for such damage should be performed at the completion of each production stage.

GM 21.A.126(b)(2) Production inspection system – Suitable storage and protection

ED Decision 2012/020/R

1. Storage areas should be protected from dust, dirt, or debris, and adequate blanking and packaging of stored items should be practised.

2. All parts should be protected from extremes of temperatures and humidity and, where needed, temperature-controlled or full air-conditioned facilities should be provided.

3. Racking and handling equipment should be provided such as to allow storage, handling and movement of parts without damage.

4. Lighting should be such as to allow safe and effective access and handling, but should also cater for items which are sensitive to light e.g., rubber items.

5. Care should be taken to segregate and shield items which can emit fumes (e.g., wet batteries), substances or radiation (e.g., magnetic items) which are potentially damaging to other stored items.

6. Procedures should be in place to maintain and record stored parts identities and batch information.

7. Access to storage areas should be restricted to authorised personnel who are fully trained to understand and maintain the storage control arrangements and procedures.

8. Provisions should be made for segregated storage of non-conforming items pending their disposition (see GM 21.A.126(b)(4)).

GM 21.A.126(b)(3) Production inspection system – Use of derived data instead of original design data

ED Decision 2012/020/R

Where derived data, e.g., worksheets, process sheets, fabrication/inspection instructions, etc., is used instead of original design drawings, documents identification and control procedures should be used to ensure that the documentation in use is always accurate and current.

GM 21.A.126(b)(4) Production inspection system – Segregation of rejected material

ED Decision 2012/020/R

All materials and parts which have been identified at any stage in the manufacturing process as not conforming to the specific working and inspection instructions must be suitably identified by clearly marking or labelling, to indicate their non-conforming status.

All such non-conforming material or parts should be removed from the production area and held in a restricted access segregated area until an appropriate disposition is determined in accordance with 21.A.126(b)(5).

GM1 21.A.126(b)(5) Production inspection system — Engineering and manufacturing review procedure

ED Decision 2022/021/R

(a) The procedure should permit to record the deviation, to present it to the design approval holder (DAH) under the provisions of point 21.A.122, and to record the results of the review and action taken consequently as regards the part/product.

(b) Any unintentional deviation from the manufacturing/inspection data should be recorded and handled in accordance with Part 21, Section A, Subpart D or E as changes to the approved design.

21.A.127 Tests: aircraft

Regulation (EU) No 748/2012

(a) Each manufacturer of an aircraft manufactured under this Subpart shall establish an approved production ground and flight test procedure and check-off forms, and in accordance with those forms, test each aircraft produced, as a means of establishing relevant aspects of compliance with point 21.A.125A(a).

(b) Each production test procedure shall include at least the following:

1. a check on handling qualities;

2. a check on flight performance (using normal aircraft instrumentation);

3. a check on the proper functioning of all aircraft equipment and systems;

4. a determination that all instruments are properly marked, and that all placards and required flight manuals are installed after flight test;

5. a check of the operational characteristics of the aircraft on the ground;

6. a check on any other items peculiar to the aircraft being tested.

GM 21.A.127 Approved production ground and flight tests

ED Decision 2012/020/R

The production ground and flight tests for new aircraft will be specified by the aircraft design organisation.

21.A.128 Tests: engines and propellers

Regulation (EU) No 748/2012

Each manufacturer of engines, or propellers manufactured under this Subpart shall subject each engine, or variable pitch propeller, to an acceptable functional test as specified in the type-certificate holder's documentation, to determine if it operates properly throughout the range of operation for which it is type-certificated, as a means of establishing relevant aspects of compliance with point 21.A.125A(a).

GM No 1 to 21.A.128 Acceptable functional test – Engines

ED Decision 2012/020/R

The functional test required for a new engine will be specified by the engine design organisation and will normally include at least the following:

1. Break-in runs that include a determination of fuel and oil consumption and a determination of power characteristics at rated maximum continuous power or thrust and, if applicable, at rated take-off power or thrust.

2. A period of operation at rated maximum continuous power or thrust. For engines having a rated take-off power or - thrust, part of that period should be at rated take-off power or - thrust.

The test equipment used for the test run should be capable of output determination of accuracy sufficient to assure that the engine output delivered complies with the specified rating and operation limitations.

GM No 2 to 21.A.128 Acceptable functional test – Variable pitch propellers

ED Decision 2012/020/R

The functional tests required for a new propeller will be specified by the propeller design organisation and should normally include a number of complete cycles of control throughout the propeller pitch and rotational speed ranges. In addition, for feathering and/or reversing propellers, several cycles of feathering operation and reversing operation from the lowest normal pitch to the maximum reverse pitch, should normally be required.

GM No 3 to 21.A.128 Acceptable functional test – Engines and Propellers

ED Decision 2012/020/R

After functional test, each engine or propeller should be inspected to determine that the engine or propeller is in condition for safe operation. Such inspection will be specified by the design organisation and should normally include internal inspection and examination. The degree of internal inspections will normally be determined on the basis of the positive results of previous inspections conducted on the first production engines, and on the basis of service experience.

21.A.129 Obligations of the production organisation

Regulation (EU) 2022/201

Each manufacturer of a product, part or appliance being manufactured under this Subpart shall:

(a) make each product, part or appliance available for inspection by the competent authority;

(b) maintain at the place of manufacture the technical data and drawings necessary to determine whether the product conforms to the applicable design data;

(c) maintain the production inspection system that ensures that each product conforms to the applicable design data and is in condition for safe operation;

(d) provide assistance to the holder of the type-certificate, restricted type-certificate or design approval in dealing with any continuing airworthiness actions that are related to the products, parts or appliances that have been produced;

(e) comply with Subpart A of this Section.

GM 21.A.129(a) Availability for inspection by the competent authority

ED Decision 2012/020/R

Each product, part or appliance should be made available for inspection at any time at the request of the competent authority.

It is recommended that a pre-defined plan of inspection points be established and agreed with the competent authority to be used as a basis for such inspections.

The manufacturer should provide such documentation, tools, personnel, access equipment etc. as necessary to enable the competent authority to perform the inspections.

AMC No 1 to 21.A.129(c) Obligations of the manufacturer – Conformity of prototype models and test specimens

ED Decision 2012/020/R

         21.A.33 requires determination of conformity of prototype models and test specimens to the applicable design data. For a complete aircraft a ‘conformity document’, that has to be validated by the competent authority, should be provided as part of the assistance to the design approval applicant. For products other than a complete aircraft, and for parts and appliances, an EASA Form 1 validated by the competent authority may be used as a conformity document as part of the assistance to the design approval applicant.

AMC No 2 to 21.A.129(c) Obligations of the manufacturer – Conformity with Applicable Design Data

ED Decision 2012/020/R

Individual configurations are often based on the needs of the customer and improvements or changes which may be introduced by the type-certificate holder. There are also likely to be unintentional divergences (concessions or non-conformances) during the manufacturing process. All these changes are required to have been approved by the design approval applicant/holder, or when necessary by the Agency.

AMC No 3 to 21.A.129(c) Obligations of the manufacturer – Condition for safe operation

ED Decision 2012/020/R

Before issue of the Statement of Conformity to the competent authority the manufacturer under this Subpart should make an investigation so as to be satisfied in respect to each of the items listed below. The documented results of this investigation should be kept on file by the manufacturer. Certain of these items may be required to be provided (or made available) to the operator or owner of the aircraft, and, for validation of the statement of conformity, to the competent authority.

1. Equipment or modifications which do not meet the requirements of the state of manufacture but have been accepted by the competent authority of the importing country.

2. Identification of products, parts or appliances which:

2.1 Are not new

2.2 Are furnished by the buyer or future operator (including those identified in 21.A.801 and 805).

3. Technical records which identify the location and serial numbers of components that have traceability requirements for continued airworthiness purposes including those identified in 21.A.801 and 21.A.805.

4. Log book and a modification record book for the aircraft as required by the Agency.

5. Log books for products identified in 21.A.801 installed as part of the type design as required by the Agency.

6. A weight and balance report for the completed aircraft.

7. A record of missing items or defects which do not affect airworthiness these for example could be furnishing or BFE (Items may be recorded in a technical log or other suitable arrangement such that the operator and Agency are formally aware).

8. Product support information required by other associated implementing rules and CS or GM, such as a Maintenance Manual, a Parts Catalogue, or MMEL all of which are to reflect the actual build standard of the particular aircraft. Also an Electrical load analysis and a wiring diagram.

9. Records which demonstrate completion of maintenance tasks appropriate to the test flight flying hours recorded by the aircraft. These records should show the relationship of the maintenance status of the particular aircraft to the manufacturers recommended maintenance task list and the Maintenance Review Board (MRB) document/report.

10. Details of the serviceability state of the aircraft in respect of, a) the fuel and oil contents, b) provision of operationally required emergency equipment such as life rafts, etc.

11. Details of the approved interior configuration if different from that approved as part of the type design.

12. An approved Flight Manual which conforms to the build standard and modification state of the particular aircraft should be available.

13. Show that inspections for foreign objects at all appropriate stages of manufacture have been satisfactorily performed.

14. The registration has been marked on the exterior of the aircraft as required by national legislation. Where required by national legislation fix a fireproof owners nameplate.

15. Where applicable, there should be a certificate for noise and, for the aircraft radio station.

16. The installed compass and or compass systems have been adjusted and compensated and a deviation card displayed in the aircraft.

17. Software criticality list.

18. A record of rigging and control surface movement measurements.

19. Details of installations which will be removed before starting commercial air transport operations (e.g., ferry kits for fuel, radio or navigation).

20. List of all applicable Service Bulletins and airworthiness directives that have been implemented.

21.A.130 Statement of conformity

Regulation (EU) 2021/1088

(a) Each manufacturer of a product, part or appliance manufactured under this Subpart shall raise a statement of conformity, an EASA Form 52 (see Appendix VIII), for complete aircraft, or EASA Form 1 (see Appendix I), for other products, parts or appliances. This statement shall be signed by an authorised person who holds a responsible position in the manufacturing organisation.

(b) A statement of conformity shall include all of the below:

1. for each product, part or appliance, a statement that the product, part or appliance conforms to the approved design data and is in condition for safe operation;

2. for each aircraft, a statement that the aircraft has been ground- and flight-checked in accordance with point 21.A.127(a);

3. for each engine, or variable pitch propeller, a statement that the engine or variable pitch propeller has been subjected by the manufacturer to a final functional test in accordance with point 21.A.128;

4. additionally, in the case of environmental protection requirements:

(i) a statement that the completed engine is in compliance with the applicable engine exhaust emissions requirements on the date of manufacture of the engine, and

(ii) a statement that the completed aeroplane is in compliance with the applicable CO₂ emissions requirements on the date its first certificate of airworthiness is issued.

(c) Each manufacturer of such a product, part or appliance shall:

1. upon the initial transfer by it of the ownership of such a product, part or appliance; or

2. upon application for the original issue of an aircraft certificate of airworthiness; or

3. upon application for the original issue of an airworthiness release document for an engine, a propeller, a part or appliance,

present a current statement of conformity, for validation by the competent authority.

(d) The competent authority shall validate by counter-signature the statement of conformity if it finds after inspection that the product, part or appliance conforms to the applicable design data and is in condition for safe operation.

GM1 21.A.130, 21.A.163 and 21.A.165 Performance of tasks in real time for the issuance of an ‘EASA Form 1’ for prototype and new parts, appliances and products other than complete aircraft, using information and communication technologies (ICT)

ED Decision 2021/007/R

This GM provides technical guidance on the use of remote ICT to support the issuance of an ‘EASA Form 1’ for prototype and newly produced parts, appliances and products other than complete aircraft.

It is the responsibility of the production organisation to assess whether the use of remote ICT constitutes a suitable alternative to the physical inspection of the part, appliance or product in accordance with the applicable requirements. The production organisation that intends to use the remote ICT for such purposes should first discuss the feasibility aspects with its competent authority.

(a) Terminology

In the context of this GM, the following terminology is used:

—      ‘issue of an EASA Form 1’ means the issuance of an EASA Form 1 under Part 21 Subpart G by a certifying staff, raise an EASA Form 1 under Part 21 Subpart F by an authorised person, and the validation of an EASA Form 1 under Part 21 Subpart F by a competent authority inspector, except in the case of issuance of an EASA Form 1 for the correction of error(s) on a previously issued certificate and for the recertification of an item from ‘prototype’ to ‘new’ provided that the design data has not changed;

—      ‘authorised staff’ means certifying staff as defined in Part 21 Subpart G, and ‘authorised person’ and ‘competent authority inspector’ as defined in Part 21 Subpart F;

—      ‘item’ means any part, appliance or product other than a complete aircraft;

—      ‘applicable design data’ means non-approved design data for a prototype item and approved design data for a newly produced item;

—      ‘task’ means any inspection, test and/or verification, as described in a documented procedure, which is needed to be performed by an authorised staff before signing an EASA Form 1;

—      ‘remote ICT’ means any real-time video and audio communication tools using information and communication technologies (ICT) whose aim is to enable the performance of the task(s) by the authorised staff from a location different from that where the item is located (on-site).

(b) Regulatory context

The following entities may issue an EASA Form 1 for produced items in order to certify their conformity to the applicable design data and, for new items, their condition for safe operation:

—      the holder of a letter of agreement (LoA) that is issued in accordance with Part 21 Subpart F (refer to point 21.A.130(a));

—      the competent authority in the context of Part 21 Subpart F (refer to point 21.A.130(d));

—      the holder of a production organisation approval (POA) in accordance with Part 21 Subpart G (refer to point 21.A.163(c)).

An EASA Form 1 has to be issued by appropriately qualified authorised staff. Part 21 does not require authorised staff to be on-site when issuing an EASA Form 1, nor how the production organisation and the competent authority shall determine whether the part/appliance/product other than a complete aircraft conforms to the applicable design data and, for a new item, is in a condition for safe operation. These should be detailed in a documented procedure accepted by the competent authority.

Part 21 requires:

—      in point 21.A.130(d) that the competent authority validate the EASA Form 1 following inspections performed in accordance with 21.B.135(b) if it finds after the inspection that the product, part or appliance conforms to the applicable design data and is in condition for safe operation;

—      in point 21.A.165(c) that the POA holder has to determine that:

—      other products, parts or appliances are complete and conform to the approved design data and are in a condition for safe operation before issuing an EASA Form 1;

—      other products, parts or appliances conform to the applicable data before issuing an EASA Form 1.

Typically, compliance with these requirements is ensured through the on-site presence of the authorised staff in order to guarantee they have appropriate access to the item, as needed.

However, compliance with these requirements may be also ensured in certain circumstances, determined as per the considerations described in point (c) below, by remotely conducting the tasks which are needed before the issuance of an EASA Form 1 by the use of remote ICT. The following considerations should be used as guidelines when the on-site presence of the authorised staff is to be replaced by virtual presence, using remote ICT.

(c) The use of remote ICT to support the issuance of an EASA Form 1

Remote ICT may have limitations that could render it unsuitable for some applications. Accordingly, careful consideration and risk management should be applied when determining when to use remote ICT. These considerations, listed below, are however not exhaustive and should not be treated as a checklist.

(1) General considerations

—      As an overarching principle, it needs to be determined whether the nature of the tasks to be performed by the authorised staff allows the use of remote ICT.

—      The facility where the item is located:

—      should be referred to in EASA Form 65 or EASA Form 55, directly or indirectly by reference to the corresponding section of the manual or production organisation exposition (POE); or

—      for a POA, should be a facility from where a POE procedure related to point 21.A.139(b)(1)(xv) authorises the issuance of an EASA Form 1.

—      The complexity, novelty and safety criticality of the item to be released with the EASA Form 1 should be taken into account.

—      The level of competence and experience of the personnel in the use of the particular procedures and equipment that will be used to perform the tasks before issuing EASA Form 1.

—      Previous experience of the organisation / confidence in the organisation’s inspection system / quality system / management system.

—      The appropriateness of the inspection and test instruments and/or equipment, especially if used to evaluate qualitative aspects of a product, part or appliance.

(2) Equipment and set-up considerations

—      The suitability of video resolution, fidelity, and field of view for the task being performed.

—      The need for multiple cameras, imaging systems or microphones, and whether the person that performs or witnesses the tasks can switch between them, or direct them to be switched, and has the possibility to stop the process, ask a question, move the equipment, etc.

—      The controllability of viewing direction, zoom, and lighting.

—      The appropriateness of audio fidelity for the evaluation being conducted.

—      Whether real-time, uninterrupted communication between the person(s) authorised to remotely witness the activity (authorised staff) and the personnel performing it exists at the location where the item is located.

—      The need for unique testing devices or equipment (for example, fast-frame cameras, special lighting conditions, sensitive listening devices, mobile phones with cameras for HD video calls).

—      Whether personnel have been adequately trained in the proper set-up, validation and use of the technology, tools and/or equipment to be used.

—      The need for the recording of audio and video data, as well for its retention or for the retention of other information.

(3) Cybersecurity considerations

There are cases where the facilities where the tasks have to be performed are subject to strict security limitations. When using remote ICT for the tasks needed before issuing an EASA Form 1, it is the responsibility of the organisation to provide an equivalent level of security, therefore the person that is responsible for IT security within the organisation should concur to the ICT technology before proceeding.

(4) Documenting the use of the remote ICT

The documented processes (procedures) developed by the holder of a letter of agreement (LoA) or a POA should be accepted by the competent authority, and should describe the following:

—      the risk assessment process required to determine the appropriateness of the remote ICT taking into account the above-mentioned considerations;

—      the tasks to be performed, including preparation activities, inspections, tests, verifications to be done, personnel involved in the remote ICT activities and their level of competence;

—      that it is necessary to guarantee that authorised staff have access to all necessary data (e.g. drawings, schematics, datasheets, etc.) they require in order to determine that the item conforms to the applicable design data, and how this can be ensured;

—      how remote ICT will be used in real time (not pre-recorded) so that authorised staff may direct the performance of the tasks as if it were conducted in-person, on-site, with the aid of the equipment or the personnel supporting the activity at the remote location;

—      the procedures for conducting a reinspection in case the equipment malfunctions or the process fails to yield acceptable results; a reinspection using remote ICT may be accomplished after correcting the malfunction or process, or by an actual on‑site inspection;

—      how authorised staff should record and communicate any difficulties or concerns regarding the process so that the organisation can improve its programme;

—      how the use of the remote ICT will be documented in the required records; and

—      how the organisation’s IT security is ensured throughout the remote ICT process (data protection and intellectual property of the organisation also need to be safeguarded).

AMC No 1 to 21.A.130(b) Statement of conformity for complete aircraft

ED Decision 2019/018/R

1. PURPOSE AND SCOPE

The description under this AMC refers only to the use of the aircraft Statement of Conformity issued under Part 21 Section A Subpart F. Statement of Conformity under Part 21 Subpart F for products other than complete aircraft, and for parts and appliances is described in AMC No 2 to 21.A.130(b).

Use of the aircraft Statement of Conformity issued by an approved production organisation is described in 21.A.163(b) under Part 21 Section A Subpart G and the completion instructions are to be found in the Appendices to Part 21.

The purpose of the aircraft Statement of Conformity (EASA Form 52) issued under Part 21 Section A Subpart F is to present to the competent authority a complete aircraft. The competent authority only validates the Statement of Conformity if it finds, as described in 21.A.130 and its associated GM, that the aircraft conforms with the type design and is in condition for safe operation.

2. GENERAL

The Statement of Conformity must comply with the format attached including block numbers and the location of each Block. The size of each Block may however be varied to suit the individual application, but not to the extent that would make the Statement of Conformity unrecognisable. If in doubt consult the competent authority.

The Statement of Conformity must either be pre-printed or computer generated but in either case the printing of lines and characters must be clear and legible. Pre-printed wording is permitted in accordance with the attached model but no other certification statements are permitted.

Statements of Conformity must be issued in one or more of the official language(s) of the issuing competent authority with translations in English shown below, if required. Completion may be either machine/computer printed or hand-written using block letters to permit easy reading.

A copy of the Statement of Conformity and all referenced attachments are to be retained by the manufacturer. A copy of the validated Statement of Conformity is to be retained by the competent authority.

3. COMPLETION OF THE AIRCRAFT STATEMENT OF CONFORMITY BY THE ORIGINATOR

There must be an entry in all Blocks to make the document a valid Statement.

A Statement of Conformity must not be issued for validation by the competent authority, unless the design of the aircraft and its installed products are approved.

The information required in Blocks 9, 10, 11, 12, 13 and 14 may be by reference to separate identified documents held on file by the manufacturer, unless the competent authority agrees otherwise.

This Statement of Conformity is not intended to provide for the complete equipment fit required by the applicable operational rules. However, some of these individual items may be included in Block 10 or in the approved type design. Operators are therefore reminded of their responsibility to ensure compliance with the applicable operational rules for their own particular operation.

Block 1 Enter name of the State of manufacture.

Block 2 The competent authority under which authority the Statement of Conformity is issued.

Block 3 A unique serial number should be pre-printed in this Block for Statement control and traceability purposes. Except that in the case of a computer generated document the number need not be pre-printed where the computer is programmed to produce and print a unique number.

Block 4 The full name and location address of the manufacturer issuing the statement. This Block may be pre-printed. Logos, etc., are permitted if the logo can be contained within the Block.

Block 5 The aircraft type in full as defined in the type-certificate and its associated data sheet.

Block 6 The type-certificate reference numbers and issue for the subject aircraft.

Block 7 If the aircraft is registered then this mark will be the registration mark. If the aircraft is not registered then this will be such a mark that is accepted by the competent authority of the Member State and, if applicable, by the competent authority of a third country.

Block 8 The identification number assigned by the manufacturer for control and traceability and product support. This is sometimes referred to as a Manufacturers Serial No or Constructors No.

Block 9 The engine and propeller type(s) in full as defined in the relevant type-certificate and its associated data sheet. Their manufacturer identification No and associated location should also be shown.

Block 10 Approved design changes to the Aircraft Definition.

Block 11 A listing of all applicable airworthiness directives (or equivalent) and a declaration of compliance, together with a description of the method of compliance on the subject individual aircraft including products and installed parts, appliances and equipment. Any future compliance requirement time should be shown.

Block 12 Approved unintentional deviation to the approved type design sometimes referred to as concessions, divergences, or non-conformances.

Block 13 Only agreed exemptions, waivers or derogations may be included here..

Block 14 Remarks: Any statement, information, particular data or limitation which may affect the airworthiness of the aircraft. If there is no such information or data, state: ‘NONE’. If the competent authority has endorsed a CO₂ emissions production cut-off exemption, make the following record: ‘Aeroplane exempted from the applicability of paragraph 2.1.1 [x] as referenced in the 1st Edition of Annex 16, Volume III, Part II, Chapter 2 (July 2017).’

Block 15 Enter ‘Certificate of Airworthiness’ or ‘Restricted Certificate of Airworthiness’ for the Certificate of Airworthiness requested.

Block 16 Additional requirements such as those notified by an importing country should be noted in this Block.

Block 17 Validity of the Statement of Conformity is dependent on full completion of all Blocks on the form. A copy of the flight test report together with any recorded defects and rectification details should be kept on file by the manufacturer. The report should be signed as satisfactory by the appropriate certifying staff and a flight crew member, e.g., test pilot or flight test engineer. The flight tests performed are those required by 21.A.127 and GM 21.A.127, to ensure that the aircraft conforms to the applicable design data and is in condition for safe operation.

The listing of items provided (or made available) to satisfy the safe operation aspects of this statement should be kept on file by the manufacturer.

Block 18 The Statement of Conformity may be signed by the person authorised to do so by the manufacturer in accordance with 21.A.130(a). A rubber stamp signature should not be used.

Block 19 The name of the person signing the certificate should be typed or printed in a legible form.

Block 20 The date the Statement of Conformity is signed must be given.

Block 21 For production under Part 21 Subpart F, state ‘NOT APPLICABLE’

Additionally, for production under Part 21 Section A Subpart F, this Block must include validation by the competent authority. For this purpose, the validation statement below should be included in the Block 21 itself, and not referred in a separate document. The statement can be pre-printed, computer generated or stamped, and should be followed by the signature of the representative of the competent authority validating the certificate, the name and the position/identification of such representative of the competent authority, and the date of such validation by the competent authority.

VALIDATION STATEMENT:

‘After due inspection the identify the issuing competent authority is satisfied that this document constitutes an accurate and valid Statement of Conformity in accordance with Part 21 Section A Subpart F.’

AMC2 21.A.130(b) Statement of Conformity for Products (other than complete aircraft), parts, appliances and materials — The Authorised Release Certificate (EASA Form 1)

ED Decision 2021/011/R

A. INTRODUCTION

This AMC relates specifically to the use of the EASA Form 1 for manufacturing purposes under Part 21 Subpart F. It can be used as a supplement to the completion instructions in Part 21, Appendix I which covers the use of the EASA Form 1.

1. PURPOSE AND USE

The EASA Form 1 is prepared and signed by the manufacturer. For production under Part 21 Subpart F it is presented for validation by the competent authority.

Under Subpart F the certificate may only be issued by the competent authority.

A mixture of items released under Subpart G and under Subpart F of Part 21 is not permitted on the same certificate.

2. GENERAL FORMAT

Refer to Part 21 Appendix I.

3. COPIES

Refer to Part 21 Appendix I.

The Part 21 Subpart F originator must retain a copy of the certificate in a form that allows verification of original data.

4. ERROR(S) ON THE CERTIFICATE

If an end user finds an error(s) on a certificate, they must identify it/them in writing to the originator. The originator may prepare and sign a new certificate for validation by the competent authority if they can verify and correct the error(s).

The new certificate must have a new tracking number, signature and date.

The request for a new certificate may be honoured without re-verification of the item(s) condition. The new certificate is not a statement of current condition and should refer to the previous certificate in block 12 by the following statement: ‘This certificate corrects the error(s) in block(s) [enter block(s) corrected] of the certificate [enter original tracking number] dated [enter original issuance date] and does not cover conformity/condition/release to service.’ Both certificates should be retained according to the retention period associated with the first.

5. COMPLETION OF THE CERTIFICATE BY THE ORIGINATOR

Refer to Part 21 Appendix I for completion of the certificate. Specific Part 21 Subpart F instructions that differ from the Part 21 Appendix I are provided below.

Block 1   – Approving competent authority/Country

State the name and country of the competent authority under whose jurisdiction this certificate is issued. When the competent authority is the Agency, ‘EASA’ must be stated.

Block 12  – Remarks

Examples of conditions which would necessitate statements in Block 12 are:

a) When the certificate is used for prototype purposes, the following statement must be entered at the beginning of Block 12:

 ‘NOT ELIGIBLE FOR INSTALLATION ON IN-SERVICE TYPE-CERTIFICATED AIRCRAFT’.

b) Re-certification of items from ‘prototype’ (conformity only to non-approved data) to ‘new’ (conformity to approved data and in a condition for safe operation) once the applicable design data is approved.

 The following statement must be entered in Block 12:

 RE-CERTIFICATION OF ITEMS FROM ‘PROTOTYPE’ TO ‘NEW’:

 THIS DOCUMENT CERTIFIES THE APPROVAL OF THE DESIGN DATA [insert TC/STC number, revision level], DATED [insert date if necessary for identification of revision status], TO WHICH THIS ITEM (THESE ITEMS) WAS (WERE) MANUFACTURED.

c) When a new certificate is issued to correct error(s), the following statement must be entered in Block 12:

 ‘THIS CERTIFICATE CORRECTS THE ERROR(S) IN BLOCK(S) [enter block(s) corrected] OF THE CERTIFICATE [enter original tracking number] DATED [enter original issuance date] AND DOES NOT COVER CONFORMITY/CONDITION/RELEASE TO SERVICE’.

d) In case of an engine, when the competent authority has granted an exemption from the environmental protection requirements, the following statement must be entered in block 12:

‘ENGINE EXEMPTED FROM [REFERENCE TO THE TYPE OF EMISSION] EMISSIONS ENVIRONMENTAL PROTECTION REQUIREMENT’

Additionally, for production under Subpart F, this block must include the Statement of Conformity by the manufacturer under 21.A.130. For this purpose, the appropriate Block 13a statement must be included in the block 12 and not referenced in a separate document. The statement may be pre-printed, computer generated or stamped, and must be followed by the signature of the manufacturer’s authorised person under 21.A.130(a), the name and the position/identification of such person and the date of the signature.

Block 13b – Authorised Signature

This space shall be completed with the signature of the competent authority representative validating the Block 12 manufacturer Statement of Conformity, under 21.A.130(d). To aid recognition, a unique number identifying the representative may be added.

Block 13c – Approval/Authorisation Number

Enter the authorisation number reference. This number or reference is given by the competent authority to the manufacturer working under Part 21 Subpart F.

AMC1 21.A.130(b)(4)(i) Applicable engine exhaust emissions requirements

ED Decision 2021/011/R

This determination is made according to the data provided by the engine type-certificate holder. It should be noted that the competent authority has the possibility to grant exemptions from these requirements as noted in Chapter 2, paragraph 2.1.1 and Chapter 4, paragraph 4.1.1 of Part III of Volume II of Annex 16 to the Chicago Convention.

When such an exemption is granted, the competent authority:

—      takes into account the number of exempted engines that will be produced and their impact on the environment;

—      considers imposing a time limit on the production of such engines; and

—      issues an exemption document.

The Agency establishes and maintains a register, containing at least the engine serial number, and makes it publicly available.

ICAO Doc 9501 ‘Environmental Technical Manual’ Volume II provides guidance on the issuing of exemptions.

GM1 21.A.130(b)(4)(i) Definitions of engine type certification date and production date

ED Decision 2021/011/R

Volume II of Annex 16 to the Chicago Convention contains three different references to applicability dates:

1. the ‘date of manufacture for the first individual production model’, which refers to the date when the type certificate is issued for the engine type or model;

2. the ‘date of application for a type certificate’, which refers to the application date to the certificating authority of the State of Design of the engine type certification; and

3. the ‘date of manufacture for the individual engine’, which refers to the production date of a specific engine serial number (date of EASA Form 1).

The third reference refers to the date of the first engine EASA Form 1 issued after the completion of the engine production pass-off test.

The third reference is used in the application of the engine emissions production cut-off requirement, which specifies a date after which all in-production engine models must meet a certain emissions standard.

21.A.130(b)(4)(i) includes the production requirements for engine exhaust emissions.

ICAO Doc 9501 ‘Environmental Technical Manual’ Volume II provides guidance on these applicability dates.

AMC1 21.A.130(b)(4)(ii) Applicable aeroplane CO2 emissions requirements

ED Decision 2021/011/R

This determination is made according to the data provided by the aeroplane type-certificate holder. This data should allow the determination of whether the aeroplane complies with the CO₂ emissions applicability requirements in Chapter 2, paragraph 2.1.1 of Part II of Volume III of Annex 16 to the Chicago Convention.

It should be noted that the competent authority has the possibility to grant exemptions as noted in Chapter 1, paragraph 1.11 and Chapter 2, paragraph 2.1.3 of Part II of Volume III of Annex 16 to the Chicago Convention,.

When such an exemption is granted, the competent authority:

—      takes into account the number of exempted aeroplanes that will be produced and their impact on the environment; and

—      issues an exemption document.

The Agency establishes and maintains a register, containing at least the aeroplane serial number, and makes it publicly available.

ICAO Doc 9501 ‘Environmental Technical Manual’ Volume III provides guidance on the issuing of exemptions.

AMC 21.A.130(c) Validation of the Statement of Conformity

ED Decision 2012/020/R

It is the responsibility of the applicant to ensure that each and every product, part and appliance conforms to the applicable design data and is in condition for safe operation before issuing and signing the relevant statement of conformity. During manufacture, the applicant is expected to use such facilities, systems, processes and procedures as are described in the Manual and have been previously agreed with the competent authority.

The competent authority must then make such inspection and investigation of records and product, part or appliance as are necessary to determine that the agreed facilities, systems, processes and procedures have been used, and that the statement of conformity may be regarded as a valid document.

To enable timely inspection and investigation by the competent authority, the statement of conformity must be prepared and submitted to the competent authority immediately upon satisfactory completion of final production inspection and test.

AMC 21.A.130(c)(1) Initial transfer of ownership

ED Decision 2012/020/R

Upon transfer of ownership:

a) For a complete aircraft, whether or not an application for a certificate of airworthiness is to be made, an EASA Form 52 must be completed and submitted to the competent authority for validation.

b) For anything other than a complete aircraft an EASA Form 52 is inappropriate, and an EASA Form 1 must be completed and submitted to the competent authority for validation.

NOTE:  If there is any significant delay between the last production task and presentation of the EASA Form 52 or EASA Form 1 to the competent authority, then additional evidence relating to the storage, preservation and maintenance of the item since its production must be presented to the competent authority.