21L.A.121 Scope

Regulation (EU) 2022/1358

(a) This Subpart establishes:

1. the procedures for declaring the production capability of natural and legal persons showing the conformity of products and parts with the applicable design data;

2. the rights and obligations of the natural and legal persons making a declaration of production capability referred to in point (1).

(b) The following categories of products and parts may be produced by organisations which have made a declaration of production capability in accordance with this Subpart:

1. products and parts the design of which has been certified in accordance with this Annex;

2. aircraft the design of which is covered by a declaration made in accordance with this Annex, and their engines, propellers and parts.

GM1 21L.A.121(a) Scope

ED Decision 2023/013/R

APPLICABLE DESIGN DATA

Applicable design data is defined as all necessary drawings, specifications and other technical information provided by the applicant for, or holder of, a design approval to be issued in accordance with this Annex or by a natural or legal person that has declared or intends to declare the compliance of the aircraft design in accordance with this Annex, and has released it in a controlled manner to a declared production organisation. This should be sufficient for the development of production data to enable repeatable manufacture to take place in conformity with the applicable design data.

Prior to the issuance of the type certificate (TC), supplemental type certificate (STC), approval of the changes to the TC/STC or approval of the repair design, design data is defined as ‘non- approved’ but parts may be released with an EASA Form 1 as a certificate of conformity.

After the issuance of the TC, STC, approval of the changes to the TC/STC or approval of the repair design, the design data is defined as ‘approved’ and items manufactured in conformity with this data are eligible for release on an EASA Form 1 for airworthiness purposes.

When the compliance of the aircraft design and any subsequent compliance of any changes to the design or the repair design are subject to a declaration according to the requirements of Subparts C, F or N respectively of Annex Ib (Part 21 Light) to Regulation (EU) No 748/2012, the design data is considered ‘non-approved’. However, a distinction can be made between the status of the data before the issuance of the declaration and after. This will be indicated in Block 12 ‘Remarks’ of the EASA Form 1.

Note: For the EASA Form 1 layout, contents and instructions for completion, please refer to Appendix I to Annex I (Part 21) to Regulation (EU) No 748/2012.

For the purpose of Subpart G of Part 21 Light, the term ‘applicable design data’ includes the information related to the applicable environmental protection requirements.

21L.A.122 Eligibility

Regulation (EU) 2022/1358

Any natural or legal person (‘organisation’) may declare their production capability under this Subpart, if that person:

(a) has applied or intends to apply for the approval of the design of the product or part in accordance with this Annex; or

(b) has declared or intends to declare the compliance of an aircraft design in accordance with this Annex; or

(c) is collaborating with the applicant for, or holder of, an approval of the design of the product to be issued or issued in accordance with this Annex, or with the organisation that has declared or intends to declare the compliance of that aircraft design in accordance with this Annex, in order to ensure that the manufactured product or part is in conformity to that design, and to ensure the continued airworthiness of the product or part.

GM1 21L.A.122(a);(b) Eligibility

ED Decision 2023/013/R

INTERFACE BETWEEN DESIGN AND PRODUCTION

In the natural or legal person that declares the production capability there is a need for an interface between staff responsible for design and staff responsible for production. This interface may be achieved through common design and production procedures.

Other ways to document this interface may be also used. For example, by defining simple flow charts supported by self‑explanatory forms, or by task descriptions of the responsible functions in the organisation. IT-based enterprise resource planning (ERP) systems may be used to ensure and to demonstrate that there is a correct flow of information on the basis of defined and visible workflows with assigned roles and release gates.

Such interface normally covers the following aspects:

—      the transfer of applicable design data from design to production (including their status:
approved / non-approved);

—      the development of own manufacturing data;

—      the management of continued airworthiness matters and required actions;

—      the cooperation in compliance-demonstration activities (e.g. manufacturing and testing prototype models and test specimens);

—      the management of production deviations and non-conforming parts; and

—      the configuration control of manufactured parts.

AMC1 21L.A.122(c) Eligibility

ED Decision 2023/013/R

ARRANGEMENTS BETWEEN DESIGN AND PRODUCTION ORGANISATIONS

In accordance with point 21L.A.122(c), the natural or legal person that declares their production capability (referred to as ‘declared production organisation’ in this AMC and in GM1 21L.A.122(c)) must collaborate with the applicant for, or holder of, an approval of the design of the product, or with the organisation that has declared or intends to declare the compliance of that aircraft design (referred to as ‘design organisation’ in this AMC and in GM1 21L.A.122(c)) to ensure that the manufactured product or part is in conformity to that design, and to ensure the continued airworthiness of the product or part.

An acceptable means of compliance with point 21L.A.122(c) is an arrangement documented between the declared production organisation and the design organisation that are separate legal entities.

GM1 21L.A.122(c) Eligibility

ED Decision 2023/013/R

ARRANGEMENT BETWEEN DESIGN AND PRODUCTION ORGANISATIONS — FORMAT

To define such a design–production interface, the following sample form is offered:

ARRANGEMENT SAMPLE FORM

21L.A.123 Declaration of production capability

Regulation (EU) 2022/1358

(a) Prior to producing any products or parts, an organisation intending to show the conformity of those products or parts with the applicable design data shall declare its production capability.

(b) The declaration, and any subsequent changes thereto, shall be made in a form and manner established by the competent authority.

(c) The declaration shall include the information necessary for the competent authority to become familiar with the organisation and the intended scope of work, and shall include at least the following:

1. the registered name of the organisation;

2. the contact details of the organisation’s registered address of their principal place of business and, where applicable, the contact and the operating sites of the organisation;

3. the names and contact details of the accountable manager of the organisation nominated in accordance with point (c)(1) of point 21L.A.125;

4. the intended scope of work;

5. the date of the intended commencement of production;

6. a statement confirming that the organisation:

(i) has a management system for production in accordance with point (a) of point 21L.A.124; and

(ii) will maintain the management system for production in compliance with this Subpart;

7. a statement confirming that the organisation will adhere to the processes and procedures established in accordance with point (d) of point 21L.A.124;

8. a statement that the organisation agrees to undertake the obligations of a declared production organisation in accordance with point 21L.A.127.

(d) The declaration of production capability shall be submitted to the competent authority.

AMC1 21L.A.123(c) Declaration of production capability

ED Decision 2023/013/R

DECLARATION FORM

The natural or legal person that declares their production capability should provide the information required by point 21L.A.123(c) in the declaration form defined below.

EASA Form 203

Instructions: If the DPO, for the purpose of compliance with point 21L.A.124(d), has produced a declared production organisation exposition (DPOE), then the DPOE sections should be referenced in the right-hand column of the form.

21L.A.124 Management system for production

Regulation (EU) 2022/1358

(a) The declared production organisation shall establish, implement, and maintain a management system for production with clear accountability and lines of responsibility throughout the organisation that:

1. corresponds to the nature and complexity of its activities and the size of the organisation, and takes into account the hazards and associated risks inherent in these activities;

2. is established under the accountability of an accountable manager nominated according to point (c)(1) of point 21L.A.125.

(b) The management system for production shall include a means to manage quality by maintaining a quality system that shall:

1. ensure that each product or part produced by the declared production organisation or by its partners, or supplied from or subcontracted to outside parties, conforms to the applicable design data and is in a condition for safe operation;

2. establish, implement, and maintain, as appropriate, within the scope of their activities, control procedures for:

(i) document issue, approval, or change;

(ii) vendor and subcontractor assessment, audit and control;

(iii) verification that incoming products, parts, materials, and equipment, including items supplied new or used by buyers of products, are as specified in the applicable design data;

(iv) identification and traceability;

(v) manufacturing processes;

(vi) inspection and testing, including production flight tests;

(vii) calibration of tools, jigs, and test equipment;

(viii) non-conforming item control;

(ix) the collaboration with the applicant for, or holder of, the design approval or the declarant of a declaration of design compliance;

(x) the completion and retention of records;

(xi) ensuring the competence and qualifications of personnel;

(xii) the issue of airworthiness release documents;

(xiii) handling, storage and packing;

(xiv) internal quality audits and the resulting corrective actions;

(xv) work performed at any location other than the operating sites included in the declaration;

(xvi) work carried out after the completion of production but prior to delivery, to maintain the aircraft in a condition for safe operation;

(xvii) the request for the issuance of permits to fly and the approval of associated flight conditions;

3. include specific provisions in the control procedures for any critical parts.

(c) The declared production organisation shall establish, as part of their management system for production, an independent function to monitor the compliance of the organisation with the relevant requirements, and compliance with, and the adequacy of, the production management system. This monitoring shall include a system to provide feedback to the person or group of persons referred to in points (c)(1) and (2) of point 21L.A.125 to ensure, as necessary, corrective action.

(d) The declared production organisation shall establish, maintain and keep updated, as part of their management system for production, processes and procedures that ensure the compliance of products that are produced with the applicable design data. The declared production organisation shall make documentary evidence of these processes and procedures available to the competent authority upon request.

(e) The declared production organisation shall have procedures in place to ensure that newly manufactured aircraft are maintained in accordance with the applicable maintenance instructions and are kept in an airworthy condition and, if applicable, that a certificate of release to service is issued for any maintenance that has been completed.

(f) If the declared production organisation holds (an)other organisation certificate(s) issued on the basis of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof, the production organisation may integrate the production management system with the management system that is required for the issuance of the other certificate(s).

GM1 21L.A.124(b) Management system for production

ED Decision 2023/013/R

QUALITY SYSTEM DOCUMENTATION

The quality system is an organisational structure, included in the management system for production, with responsibilities, procedures, processes, and resources, which implements a management function to determine and enforce quality principles.

The quality system should be documented in such a way that the documentation can be made easily available to personnel that need to use the material for performing their normal duties, in particular:

—      the procedures, instructions and data to cover the issues of point 21L.A.124(b)(2) are available in a written form;

—      the distribution of relevant procedures to offices/staff is made in a controlled manner;

—      the job descriptions (or equivalent) providing staff with a clear list of their tasks and responsibilities; and

—      the updating process is clearly described.

The person or group of persons responsible for ensuring that the quality system is implemented and maintained should be identified.

Other methods to document the quality system may be used if they ensure that members of the organisation can obtain the actual and relevant information in a reasonable way. Such other methods may include the provision of such information by electronic means, for example, on the intranet of the organisation, by the use of an electronic database such as document management system (DMS), on paper, by illustration, by using workflow definitions within IT-based enterprise resource planning (ERP) systems, etc.

GM2 21L.A.124(b) Management system for production

ED Decision 2023/013/R

USE OF RECOGNISED STANDARDS

An organisation that has a quality system designed to meet a recognised standard such as ISO 9001,
EN 9100, or ASTM F2972 (relevant to the scope of work of the declared production organisation), should ensure that the existing quality system covers all the aspects defined in point 21L.A.124(b).

For example, if the standard that is used is ISO 9001, the quality system should be expanded to include at least the following additional topics, as appropriate, in order to demonstrate compliance with the requirements of this Annex:

—      mandatory and voluntary reporting system as required by point 21L.A.3;

—      control of work occasionally performed outside the operating sites included in the declaration;

—      collaboration with the applicant for, or holder of, an approved design, or with the organisation that has declared or intends to declare the compliance of a particular aircraft design as required by point 21L.A.122(c);

—      issue certificates within the scope of work of point 21L.A.126;

—      incorporation of airworthiness data in production and inspection data as required by point 21L.A.125(b);

—      when applicable, ground test and/or production flight test of products in accordance with the procedures defined by the applicant for, or holder of, the design approval or the declarant of a declaration of design compliance;

—      procedures for traceability including the definition of clear criteria of which items require such traceability; traceability is defined as a means of establishing the origin of an article by reference to historical records for the purpose of providing evidence of conformity; and

—      personnel training and qualification procedures especially for certifying staff as required by point 21L.A.125(d).

GM1 21L.A.124(b)(1);(b)(2)(iii) Management system for production

ED Decision 2023/013/R

QUALITY SYSTEM — CONFORMITY OF SUPPLIED ITEMS

The declared production organisation is responsible for determining and applying acceptance standards for the physical condition, configuration status and conformity of supplied products, parts, materials or equipment, whether to be used in production or delivered to customers as spare parts. This responsibility also includes items of buyer-furnished equipment (BFE).

To discharge this responsibility, the quality system needs an organisational structure and procedures to adequately verify the supplied items.

The below list provides examples of verification techniques to be used as appropriate to ensure conformity of the product or part:

—      qualification and auditing (desktop and on-site audits) of the supplier’s quality system;

—      evaluation of the supplier’s capability in performing all the manufacturing activities, inspections and tests necessary to establish the conformity of parts, materials or equipment to the applicable design data;

—      first-article inspections of supplied parts, including destruction, if necessary, to verify that the article conforms to the applicable data for a new production line or a new supplier;

—      incoming inspections and tests of supplied parts, materials or equipment that can be satisfactorily inspected on receipt;

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

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

The declared production organisation could for example rely on the results of inspections/tests performed by the supplier, if the supplier can establish that:

—      the personnel responsible for these tasks satisfy the competency standards of the declared production organisation quality system;

—      quality measurements are clearly identified; and

—      the records or reports showing evidence of conformity are available for review.

For the purpose of showing conformity, a declared production organisation could for example rely upon an EASA Form 1 issued by the supplier.

If the items are not delivered with an EASA Form 1, the supplier is considered a subcontractor under the direct control of the quality system of the declared production organisation.

Since the declared production organisation is responsible for the verification of the supplied items, it retains direct responsibility for inspections/tests carried out either at its own facilities or at the supplier’s facilities.

GM1 21L.A.124(b)(2)(vi) Management system for production

ED Decision 2023/013/R

INSPECTION OF PARTS IN PROCESS

The purpose of the inspection 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 those specifications.

During the manufacturing process, each part should be inspected in accordance with a plan that 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). This plan should be considered part of the documentation required by point 21L.A.124(d).

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.

GM1 21L.A.124(b)(2)(vi) Management system for production

ED Decision 2023/013/R

TESTS

If relevant, the declared production organisation will have to perform functional, ground and flight tests for the manufactured products.

The production ground and flight tests for new aircraft are specified by the aircraft design organisation. These tests typically include:

—      a check on handling qualities;

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

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

—      a determination that all instruments are properly marked, and that all placards and required flight manuals are installed before flight test;

—      a check of the operational characteristics of the aircraft on the ground;

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

The functional test required for a new engine will be specified by the engine design organisation and are normally including the following:

—      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.

—      A period of operation at rated maximum continuous power or thrust. For engines that have 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 a level of accuracy sufficient to assure that the engine output delivered complies with the specified rating and operation limitations.

The functional tests required for a new propeller will be specified by the propeller design organisation and are normally including several 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.

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

GM1 21L.A.124(b)(2)(viii) Management system for production

ED Decision 2023/013/R

NON-CONFORMING ITEM CONTROL

All parts, materials and equipment that have been identified at any stage in the manufacturing process as not conforming to the specific design data should 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 segregated area with restricted access until their appropriate disposition is determined.

The non-conformities, which cannot be solved by restoring full conformity with the design data, should be recorded and presented to the relevant design organisation for review and disposition.
The results of the review and actions taken consequently as regards the part/product should be recorded as well.

GM1 21L.A.124(b)(2)(xiii) Management system for production

ED Decision 2023/013/R

HANDLING, STORAGE AND PACKING

Storage areas should be protected from dust, dirt or debris, and adequate blanking and packaging of stored items should be practised. All parts should be protected from extremes of temperatures and humidity and, where needed, environment-controlled facilities should be provided.

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

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).

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.

Particular attention should be paid to shelf life-limited items (e.g. sealants, adhesives) to ensure the storage conditions and monitor the expiry date.

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

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

Provisions should be made for segregated storage of non-conforming items pending their disposition (see AMC1 21L.A.124(b)(2)(viii)).

GM1 21L.A.124(c) Management system for production

ED Decision 2023/013/R

INDEPENDENT MONITORING FUNCTION

The purpose of the independent monitoring function is to ensure that:

—      the management system for production remains compliant with the applicable requirements of the Part 21 Light and with any additional requirements as established by the production organisation;

—      the staff of the production organisation follow the documented procedures of the management system when performing their tasks; and

—      the management system for production is adequate and enables the organisation through the use of its procedures to meet the conformity objectives identified in point 21L.A.124.

An objective review of the complete set of production-management-related activities is provided through independent monitoring activities, such as audits, inspections and reviews. The independence of the monitoring activities is established by always ensuring that those activities are performed by staff that are not involved in the function, procedure or products that they monitor and that are independent from the operating managers of the function(s) being monitored; however, this should not exclude support by domain experts during monitoring.

The monitoring is usually performed based on a monitoring plan. This plan is established to show when and how often the activities required by this Subpart will be audited. This plan normally includes, in a defined period of time, all the elements of the management system, including all workshops and subcontractors. The defined period of time for the audit planning is typically not exceeding 24 months.

When a non-compliance is found, the root cause(s) and contributing factor(s) should be identified and corrective actions should be defined and followed up. When providing feedback, the compliance-monitoring function should define who is required to address any non-compliance in each particular case, and the procedure to be followed if the corrective action is not completed within the defined time frame.

Also, as required in point 21L.A.124(c), feedback has to be regularly provided to the accountable manager on the overall status of the compliance and adequacy of the management system for production, including main issues identified and cases where corrective actions have not been satisfactorily implemented.

The staff that perform an independent monitoring function should have access to all the parts of the production organisation and, as necessary, to any subcontracted organisations.

GM1 21L.A.124(d) Management system for production

ED Decision 2023/013/R

DOCUMENTATION

Point 21L.A.124 (d) requires the declared production organisation to document its processes and procedures.

In order to do so, the declared production organisation may consider to establish a declared production organisation exposition (DPOE). The purpose of a DPOE is to set forth in a concise document format the organisational relationships, responsibilities, terms of reference, and the associated authority, procedures, means and methods of the organisation.

If utilised, the DPOE typically contains the following:

(a) a statement signed by the accountable manager confirming that the DPOE and any associated manuals/procedures/instructions which define the organisation’s compliance with this Subpart will be complied with at all times;

(b) the title(s) and name(s) of the person(s) nominated in accordance with point 21L.A.125(c)(2);

(c) the duties and responsibilities of the accountable manager and the persons as specified by points 21L.A.125(c)(1) and (2), including matters on which they may deal directly with the competent authority on behalf of the organisation;

(d) an organisational chart showing associated chains of responsibility of the managers as required by point 21L.A.125(c)(4);

(e) the list of certifying staff as referred to in point 21L.A.125(d)(2);

(f) a general description of manpower;

(g) a general description of the facilities located at each address specified in the declaration of production capability;

(h) a general description of the declared production organisation’s scope of work as defined in the declaration of production capability (see also point 21L.A.126);

(i) the procedure for the notification of changes to the competent authority according to point 21L.A.128;

(j) the amendment procedure for the DPOE;

(k) a procedure to develop, where applicable, the production organisation’s own manufacturing data in compliance with the airworthiness and environmental compatibility data package;

(l) a description of the quality system and the procedures as required by point 21L.A.124(b);

(m) a list of those outside parties referred to in point 21L.A.124(b)(1); and

(n) if flight tests are to be conducted, a flight test operations manual (FTOM) defining the organisation’s policies and procedures in relation to flight testing; for the contents of the FTOM, refer to AMC1 21L.A.127(b).

If this information is documented and integrated in manuals, procedures and instructions, the DPOE may provide a summary of the information and an appropriate cross reference.

When changes to the organisation occur, the DPOE should be kept up to date. Changes to the organisation shall be notified to the competent authority as required by point 21L.A.128.

If the organisation holds one or more additional organisation certificates (DOA, MOA, POA, etc.) within the scope of Regulation (EU) 2018/1139 and the delegated and implementing acts that are adopted on the basis thereof, so that the organisation is required to establish another exposition, the organisation may combine the documents by producing a separate manual or supplement that covers the differences between the DPOE and the other exposition. In that case, the separate manual or supplement should identify where in the other exposition the remaining information on the declared production organisation is covered. That remaining information then formally becomes part of the exposition.

GM1 21L.A.124(e) Management system for production and 21L.A.126(e) Scope of work

ED Decision 2023/013/R

MAINTENANCE ACTIVITIES

Point 21L.A.124(e) requires the declared production organisation to have procedures that cover maintenance activities for new aircraft it has manufactured, as necessary to keep them in an airworthy condition. The declared production organisation shall not maintain newly manufactured aircraft beyond the point at which the applicable operational rules require maintenance to be performed by an approved maintenance organisation (point 21L.A.126(e)). If the declared production organisation intends to maintain aircraft beyond that point, it would have to apply for and obtain an appropriate maintenance approval (see Articles 3 and 4 of Regulation (EU) No 1321/2014).

MAINTENANCE OF AIRCRAFT

Examples of maintenance activities within the scope of work of a declared production organisation are:

—      preservation, periodic inspection visits, etc.;

—      embodiment of a service bulletin (SB);

—      application of airworthiness directives;

—      repairs;

—      maintenance tasks resulting from special flights; and

—      maintenance tasks to maintain airworthiness during flight training, demo flights and other non-revenue flights.

Any package of maintenance activities should be recorded in the aircraft logbook. It should be signed by certifying staff for attesting the conformity of the maintenance work with the applicable airworthiness data.

If the aircraft logbook is not available or if the production organisation prefers to use a separate form (for instance, for a large work package or for delivery of the aircraft to the customer), the production organisation should use EASA Form 53B which should subsequently become part of the aircraft maintenance records.

MAINTENANCE OF COMPONENTS OUTSIDE THE DPO CAPABILITY

Such a maintenance activity outside the capability of the aircraft declared production organisation may still be accomplished under the original release organisation. In such circumstances, the engine(s), propeller(s), parts and appliances will require re-release in accordance with point 21.A.163(c) or point 21L.A.126(c) (EASA Form 1).

21L.A.125 Resources of the declared production organisation

Regulation (EU) 2022/1358

The declared production organisation shall ensure that:

(a) the facilities, working conditions, equipment and tools, processes and associated materials, the number and competence of staff, and the general organisation are adequate to discharge its obligations under point 21L.A.127;

(b) with regard to all necessary airworthiness and environmental protection data:

1. it is in receipt of such data from the Agency, and from the declarant of design compliance or the holder of, or the applicant for, the type certificate, or design approval, to determine its conformity with the applicable design data;

2. it has established a procedure to ensure that airworthiness and environmental compatibility data is correctly incorporated into its production data;

3. such data is kept up to date and made available to all personnel who need access to such data to perform their duties;

(c) with regard to management and staff:

1. an accountable manager has been nominated by the declared production organisation with authority to ensure that, within the organisation, all production is performed to the required standards and that the declared production organisation is continuously in compliance with the requirements of the management system for production referred to in point (a) of point 21L.A.124, and the processes and the procedures identified in point (d) of point 21L.A.124;

2. a person or group of persons has or have been nominated by the accountable manager to ensure that the organisation is in compliance with the requirements of this Subpart, and is (are) identified, together with the extent of their authority. Such a person or group of persons shall be responsible to the accountable manager and have direct access to them. They shall have the appropriate knowledge, background and experience to discharge their responsibilities;

3. staff at all levels have been given appropriate authority to be able to discharge their allocated responsibilities and that there is full and effective coordination within the declared production organisation in respect of airworthiness and environmental compatibility data matters;

4. the organisational structure of the organisation along with the key personnel who are responsible for ensuring that the organisation is in compliance with this Subpart is documented and kept updated;

(d) with regard to certifying staff, authorised by the declared production organisation to sign the documents issued under point 21L.A.126 within the scope of declared production activities:

1. the knowledge, background (including other functions in the organisation), and experience of the certifying staff are appropriate to discharge their allocated responsibilities;

2. certifying staff are provided with evidence of the scope of their authorisation. A list of certifying staff shall be maintained by the declared production organisation.

GM1 21L.A.125(a) Resources of the declared production organisation

ED Decision 2023/013/R

GENERAL

1. FACILITIES AND WORKING CONDITIONS

A facility is a working area where the working conditions and the environment are controlled as appropriate in respect of cleanliness, temperature, humidity, ventilation, lighting, space/access, noise, and air pollution.

2. EQUIPMENT AND TOOLS

The organisation’s equipment and tools enables all the specified tasks to be accomplished in a repeatable manner without any detrimental effects. The calibration control of the equipment and tools that affect the dimensions and values of products makes it possible for the organisation to demonstrate compliance with, and be traceable to, national or international standards.

3. NUMBER OF STAFF

Sufficient staff means that, for each function, according to the nature of the work and the production rate, the organisation has a sufficient number of qualified staff to accomplish all the specified manufacturing tasks and to attest the conformity of such task. The number of staff should be such that the relevant airworthiness considerations may be applied in all areas without any undue pressure.

4. COMPETENCE OF STAFF

An evaluation of the competence of the staff is performed as part of the quality system. This should include, where appropriate, verification that specific qualification standards have been implemented, for example, for NDT, welding, etc.

Adequate initial and recurrent training should be provided in relation to the job function to ensure that staff remain competent. That training should be adapted based on experience that is gained within the organisation.

GM1 21L.A.125(b) Resources of the declared production organisation

ED Decision 2023/013/R

MANUFACTURING DATA

When a declared production organisation develops its own manufacturing data, such as computer-based data, from the design data package that is delivered by a design organisation, procedures are required to ensure the correct transcription of the original design data.

Procedures are required to define the manner in which airworthiness and environmental compatibility data is used to issue and update the production/quality data, which determines the conformity of products and parts. The procedure should also define the traceability of such data to each individual product or part for the purpose of certifying their condition for safe operation and issuing a statement of conformity or an EASA Form 1.

AMC1 21L.A.125(c)(1) Resources of the declared production organisation

ED Decision 2023/013/R

ACCOUNTABLE MANAGER

The term ‘accountable manager’ refers to the manager that is responsible and has corporate authority for ensuring that all production work is carried out to the required standards. This function may be performed by the chief executive officer or by another person in the organisation, nominated by the chief executive officer to fulfil the function, provided that the position and authority of that person in the organisation allows that person to discharge the associated responsibilities.

The accountable manager should:

(a) have sufficient knowledge and authority to be able to respond to the competent authority regarding major issues concerning the declared production organisation, and to implement any necessary improvements;

(b) have an understanding of this Annex, sufficient to discharge the relevant responsibilities.

AMC1 21L.A.125(c)(2) Resources of the declared production organisation

ED Decision 2023/013/R

NOMINATED MANAGERS

The person or group of persons nominated in accordance with point 21L.A.125(c)(2) should represent the management structure of the organisation and be responsible for all the functions specified in Subpart G. Depending on the size of the declared production organisation, the functions may be subdivided among individual managers (and, in fact, may be further subdivided) or combined in a variety of ways.

The responsibilities and the duties of each individual manager should be clearly defined in such a way that all the responsibilities are covered.

Where a declared production organisation chooses to appoint managers for all or for any combination of the functions identified in Part 21 Light because of the size of the undertaking, those managers should ultimately report to the accountable manager nominated in accordance with point 21L.A.125(c)(1). Where a manager does not directly report to the accountable manager, that manager should have direct access to the accountable manager formally established.

One such manager, normally known as the ‘quality manager’, should be responsible for the independent monitoring function as defined in point 21L.A.124(c). The independent monitoring function should be independent from other functions. As such, the quality manager should not be at the same time one of the other persons that are referred to in point 21.A.125(c)(2). The role of the quality manager should be to ensure that:

(a) the activities of the organisation are monitored for compliance with the applicable requirements and any additional requirements as established by the organisation, and that those activities are performed properly under the supervision of the nominated persons that are referred to in point 21L.A.125(c)(2);

(b) an audit plan is properly implemented, maintained, and continually reviewed and improved; and

(c) corrective actions are requested, as necessary, and their implementation is followed up.

GM1 21L.A.125(c)(4) Resources of the declared production organisation

ED Decision 2023/013/R

DOCUMENTATION OF ORGANISATIONAL STRUCTURE AND KEY PERSONNEL

Point 21L.A.125(c)(4) requires that the organisational structure together with the key personnel are documented. The key personnel are those managers nominated according to point 21L.A.125(c)(1) and (c)(2).

This could be achieved through the information included in the declared production organisation exposition (DPOE) (see AMC1 21L.A.124(d)).

The above information should be kept updated to reflect changes made within the organisation.

AMC1 21L.A.125(d)(1) Resources of the declared production organisation

ED Decision 2023/013/R

CERTIFYING STAFF

(a) Certifying staff should be nominated by the declared production organisation to ensure that each of the products and/or parts that are produced within the organisation’s scope of work, qualifies for a statement of conformity or a release certificate. The position and number of certifying staff should be appropriate to the complexity of the product and the production rate.

(b) The qualifications of certifying staff should be based on their knowledge, background and experience and on specific training (or testing) that is established by the organisation appropriate to the product or part to be released.

(c) Training should be given to develop a satisfactory level of knowledge of product/part specifications, the organisation’s procedures, the management system for production (including compliance monitoring), aviation legislation, and the associated regulations, AMC and GM that are relevant to their particular role. Training should include on-the-job training, as relevant.

(d) For that purpose, in addition to the general training policy, the organisation should define its own standards for training, including pre-qualification standards, for personnel to be identified as certifying staff.

(e) The training policy is part of the quality system.

(f) The training should be updated in response to experience gained and changes in technology.

(g) A feedback system to ascertain that the required standards are being maintained should be put in place to ensure the continuing compliance of personnel with authorisation requirements.

(h) For the release of products or parts, the responsibilities to issue statements of conformity or authorised release certificates (EASA Form 1) are allocated to the certifying staff that is identified in point 21L.A.125(d)(2).

AMC1 21L.A.125(d)(2) Resources of the declared production organisation

ED Decision 2023/013/R

EVIDENCE OF AUTHORISATION

(a) Certifying staff should be provided with evidence of their authorisation. This should be done through an internal authorisation document. That document should be in a style that makes its scope clear to the certifying staff and any entitled person that may require to examine the authorisation. It should include the privileges that are granted to the certifying staff and the category of products upon which they may exercise those privileges. Where codes are used to define the scope, an interpretation document should be readily available.

(2) Certifying staff are not required to carry the authorisation document at all times, but they should be able to make it available within a reasonable time following a request from an entitled person, which includes the competent authority.

(3) The list of certifying staff should be included in the declared production organisation exposition (DPOE) (see AMC 21L.A.124(d)), if utilised, or in equivalent processes and procedures.

21L.A.126 Scope of work

Regulation (EU) 2022/1358

(a) A declared production organisation is entitled to show the conformity of the products and parts that are within the scope of this Section and that it has produced within the declared scope of work, with the applicable design data.

(b) A declared production organisation is entitled, for a complete aircraft, after presentation of an aircraft statement of conformity (EASA Form 52B), to apply:

1. for an aircraft that conforms to a type design approved in accordance with Subpart B of Section B of this Annex, for a certificate of airworthiness and a noise certificate;

2. for an aircraft that conforms to a design for which compliance has been declared in accordance with Subpart C of this Annex, for a restricted certificate of airworthiness and a restricted noise certificate.

(c) A declared production organisation is entitled to issue authorised release certificates (EASA Form 1) for engines, propellers and parts that either conform to:

1. approved design data issued in accordance with Subparts B, D, E or M of Section B of this Annex;

2. declared design data for which design compliance has been declared in accordance with Subparts C, F or N of this Annex;

3. production data based upon all the necessary approved design data as provided by a repair design approval holder.

(d) A declared production organisation is entitled to recommend the conditions for an aircraft that it has produced and for which it has attested conformity with the applicable design data, under which a permit to fly can be issued by the competent authority under Subpart P of Annex I (Part 21).

(e) A declared production organisation is entitled to maintain a new aircraft that it has produced, as necessary to keep it in an airworthy condition, unless Regulation (EU) No 1321/2014 requires the maintenance to be performed under such rules, and to issue a certificate of release to service (EASA Form 53B) in respect of that maintenance.

GM1 21L.A.126(a) Scope of work

ED Decision 2023/013/R

CONFORMITY OF PROTOTYPE MODELS AND TEST SPECIMENS

Points 21L.A.25(c) and 21L.A.44(d) require the determination of conformity of prototype models and test specimens to the applicable design data.

The EASA Form 1 may be used as a conformity certificate as part of the assistance that a declared production organisation provides to a design approval holder/applicant or a declarant of a declaration of design compliance.

The EASA Form 1 should only be used for conformity release purposes when it is possible to indicate (in Block 12) the reason that prevents its issuance for airworthiness release purposes.

GM1 21L.A.126(d) Scope of work

ED Decision 2023/013/R

FLIGHT CONDITIONS

The need to recommend flight conditions for an aircraft is related to the performance of the production flight tests.

Production flight tests of a newly manufactured aircraft should be performed under the conditions specified in point 21L.A.241 and under Subpart P of Annex I (Part 21) to this Regulation.

For this purpose, the declared production organisation should apply for a permit to fly to the competent authority. EASA Form 21 (see AMC 21.B.520(b)) should be obtained from the competent authority.

Where the flight conditions are not approved at the time of application for a permit to fly, the declared production organisation should also apply for approval of the flight conditions (refer to point 21L.A.241(a) (and by inference to point 21.A.709 of Annex I (Part 21))).

GM1 21L.A.124(e) Management system for production and 21L.A.126(e) Scope of work

ED Decision 2023/013/R

MAINTENANCE ACTIVITIES

Point 21L.A.124(e) requires the declared production organisation to have procedures that cover maintenance activities for new aircraft it has manufactured, as necessary to keep them in an airworthy condition. The declared production organisation shall not maintain newly manufactured aircraft beyond the point at which the applicable operational rules require maintenance to be performed by an approved maintenance organisation (point 21L.A.126(e)). If the declared production organisation intends to maintain aircraft beyond that point, it would have to apply for and obtain an appropriate maintenance approval (see Articles 3 and 4 of Regulation (EU) No 1321/2014).

MAINTENANCE OF AIRCRAFT

Examples of maintenance activities within the scope of work of a declared production organisation are:

—      preservation, periodic inspection visits, etc.;

—      embodiment of a service bulletin (SB);

—      application of airworthiness directives;

—      repairs;

—      maintenance tasks resulting from special flights; and

—      maintenance tasks to maintain airworthiness during flight training, demo flights and other non-revenue flights.

Any package of maintenance activities should be recorded in the aircraft logbook. It should be signed by certifying staff for attesting the conformity of the maintenance work with the applicable airworthiness data.

If the aircraft logbook is not available or if the production organisation prefers to use a separate form (for instance, for a large work package or for delivery of the aircraft to the customer), the production organisation should use EASA Form 53B which should subsequently become part of the aircraft maintenance records.

MAINTENANCE OF COMPONENTS OUTSIDE THE DPO CAPABILITY

Such a maintenance activity outside the capability of the aircraft declared production organisation may still be accomplished under the original release organisation. In such circumstances, the engine(s), propeller(s), parts and appliances will require re-release in accordance with point 21.A.163(c) or point 21L.A.126(c) (EASA Form 1).

21L.A.127 Obligations of the declared production organisation

Regulation (EU) 2022/1358

(a) The declared production organisation shall work in accordance with clearly defined procedures, practices and processes.

(b) If the declared production organisation intends to conduct flight tests, then it shall prepare, maintain and keep updated an operations manual that includes a description of the organisation’s policies and processes for flight testing. The declared production organisation shall make this manual available to the competent authority upon request.

(c) For completed aircraft, prior to submitting an aircraft statement of conformity (EASA Form 52B) to the competent authority, the declared production organisation shall ensure that the aircraft is in a condition for safe operation and conforms to:

1. the approved type design of a type-certified product issued in accordance with Subpart B of Section B of this Annex, or

2. the design data of an aircraft for which design compliance has been declared in accordance with Subpart C of this Annex.

(d) For products (other than complete aircraft) and parts, the declared production organisation shall ensure prior to issuing an authorised release certificate (EASA Form 1) that the product or part is in a condition for safe operation and conforms to the approved type design of a type-certified product issued in accordance with Subpart B, D, E or M of Section B of this Annex or conforms to the design data of an aircraft for which design compliance has been declared in accordance with Subpart C, F or M of this Annex.

(e) For engines, the declared production organisation shall ensure that the completed engine is in compliance with the applicable engine exhaust emissions requirements applicable on the date of production of the engine.

(f) The declared production organisation shall include, in any authorised release certificates (EASA Form 1) that are issued by it, the reference number issued by the competent authority in accordance with point 21L.B.142 for this declared production organisation.

(g) The declared production organisation shall ensure that the organisation records the details of any work that is completed.

(h) The declared production organisation shall provide, to the design holder or the declarant of a declaration of design compliance, continuing airworthiness support for any products or parts that they have produced.

(i) The declared production organisation shall have an archiving system that records the requirements that have been placed on other organisations, such as suppliers and subcontractors. The declared production organisation shall make the archived data available to the competent authority for continuing airworthiness purposes.

(j) For the production of new aircraft, the declared production organisation shall ensure that the aircraft is kept in an airworthy condition and that maintenance is performed, including any necessary repairs in accordance with the applicable design data, prior to the issuance of an aircraft statement of conformity (EASA Form 52B).

(k) Where the declared production organisation issues a certificate of release to service after such maintenance, it shall determine that each completed aircraft has been subjected to the necessary maintenance and is in a condition for safe operation, prior to issuing that certificate.

(l) The declared production organisation shall comply with the requirements in Subpart A of this Annex applicable to a declared production organisation.

GM1 21L.A.127(a) Obligations of the declared production organisation

ED Decision 2023/013/R

WORK CARRIED OUT IN ACCORDANCE WITH DEFINED PROCEDURES, PRACTICES AND PROCESSES

The establishment of a declared production organisation exposition (DPOE) (if chosen to be utilised by the organisation (see AMC1 21L.A.124(d))) or the equivalent processes and procedures are a prerequisite for the registration of a declaration for production capability and for maintaining such registration.

The declared production organisation should make the DPOE or the equivalent processes and procedures available to its personnel, where necessary, for the performance of their duties. A distribution list should, therefore, be established. If utilised, and if the DPOE mainly refers to separate manuals or procedures, the distribution of the DPOE could be limited.

The declared production organisation should ensure that personnel have access to and are familiar with that part of the content of the DPOE or the referenced documents, at the latest revision level, which covers their activities.

Monitoring of compliance with the DPOE or the equivalent processes and procedures is normally the responsibility of the independent monitoring function.

AMC1 21L.A.127(b) Obligations of the declared production organisation and AMC1 21L.A.177(b) Obligations of the declared design organisation

ED Decision 2023/013/R

FLIGHT TEST OPERATIONS MANUAL (FTOM)

(a) General

(1) Scope: The FTOM covers flight-test operations.

The FTOM complexity should be proportionate to the organisation complexity’s as well as to the complexity of a particular aircraft.

(2) Format

The FTOM may:

be included in the declared production organisation’s (DPO) / declared design organisation’s (DDO) documents; or

be a separate manual.

The FTOM may make reference to other documents to cover the contents listed in point (b) below (e.g. for record-keeping).

(3) Use by subcontractors

When flight tests are performed by subcontractors, they should comply with the FTOM of the declared production or design organisations, unless they have established an FTOM in compliance with Part 21 or Part 21 Light, the use of which has been agreed between the two organisations.

(b) The FTOM should contain the following elements:

(1) Exposition

If the FTOM is presented as a separate document, it should include a chart indicating the structure of the organisation and, more specifically, the functional links of the staff in charge of flight-test activities. It should also mention the coordination between all departments affecting flight test, e.g. design office, production and maintenance, in particular the coordination for the establishment and update of flight-test programmes.

(2) Risk and safety management

The FTOM should describe the organisation’s policy in relation to risk and safety assessment, mitigation, and associated methodologies.

(e.g. see additional guidance on the EASA webpage at https://www.easa.europa.eu/en/domains/general-aviation/documents-guidance-and-examples)

(3) Crew members

According to the flight-test category, the FTOM should describe the organisation’s policy on the composition of the crew and the competence and currency of its flight-test pilots, including procedures for appointing crew members for each specific flight.

Note: For flight tests performed for demonstration-of-compliance activities required by points 21L.A.25 and 21L.A.44, the flight crew conditions or restrictions are part of the flight conditions approved by EASA. As part of the investigations required under point 21L.B.242, EASA will also check the flight crew qualifications to ensure that the flight testing can be conducted safely.

All crew members should be listed in the FTOM.

A flight time limitation policy should be established.

(4) Carriage of persons other than crew members

According to the flight-test category, the FTOM should describe the organisation’s policy in relation to the presence and safety onboard of people other than crew members (i.e. with no flying duties).

People other than crew members should not be allowed on board for Category 1 flight tests (for the definition of the flight categories, refer to Appendix XII to Annex I (Part 21) to this Regulation).

(5) Instruments and equipment

The FTOM should list, depending on the nature of the flight, the specific safety-related instruments and equipment that should be available on the aircraft or carried by people on board.

The FTOM should contain provisions to allow flights to take place in case of defective or missing instruments or equipment.

(6) Documents

The FTOM should list the documents to be produced for flight testing, and include (or refer to) the procedures for their issuance, update and follow-up to ensure the documents’ configuration control:

(i) documents associated with a flight-test programme:

—      flight order for a given flight, which should include:

—      a list of the tests to be performed and associated conditions;

—      safety considerations relevant to the flight;

—      category of the flight (e.g. certification flight, production flight);

—      composition of the crew;

—      names of persons other than crew members;

—      aircraft configuration items relevant to the test to be highlighted to the crew;

—      loading of the aircraft;

—      reference to approved flight conditions; and

—      restrictions relevant to the flight to be highlighted to the crew;

—      flight crew report;

(ii) documentation and information to be carried on board the aircraft during flight test;

(iii) record-keeping: the FTOM should describe the policy relative to record-keeping.

(7) Permit to fly

The FTOM should describe the involvement of the flight-test organisation or flight-test team (as appropriate) in the process for the approval of flight conditions and the issuance of permits to fly in accordance with Part 21 Light Subpart P (and by reference to Part 21 Subpart P).

(8) Currency and training

The FTOM should describe how training for flight test is organised.

Currency of the flight-test crew may be ensured either through recent experience or refresher training.

The FTOM should specify the requirements for a refresher training in order to ensure that crew members are sufficiently current to perform the required flight-test activity.

A system should be established to record the currency of the flight test crew’s training.

A valid national document (i.e. licence), issued by an EASA Member State under its national regulations and ensuring compliance with the agreed currency requirements, may be an acceptable means of compliance to demonstrate currency for a pilot that holds a flight-test rating.

GM1 to 21L.A.127(c) Obligations of the declared production organisation

ED Decision 2023/013/R

CONFORMITY WITH APPROVED OR DECLARED DESIGN DATA

Individual configurations are often based on the needs of the customer and improvements or changes which may be introduced by the type-certificate holder or the declarant of a declaration of design compliance. There are also likely to be unintentional deviations (concessions or non-conformances) during the manufacturing process. All these changes should be subject to approval by the design approval holder or the declarant, as relevant, or, when necessary, by EASA.

GM2 21L.A.127(c) Obligations of the declared production organisation

ED Decision 2023/013/R

AIRCRAFT — CONDITION FOR SAFE OPERATION

Before submitting the aircraft statement of conformity (EASA Form 52B) to the competent authority of the Member State of registry, the declared production organisation should make an investigation so as to be satisfied in respect of items listed below (as applicable for the respective type of aircraft). The documented results of this investigation should be kept on file by the declared production organisation. Some of these items may be required to be provided (or made available) to the operator or owner of the aircraft (and in some cases the competent authority of the Member State of registry):

1. Equipment or design changes that 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 or parts that:

(a) are not new;

(b) are furnished by the buyer or future operator (including those identified in point 21L.A.252(b)(1)).

3. Technical records which identify the location and serial numbers of components for which special traceability requirements apply for continued-airworthiness purposes, including those identified in point 21L.A.252(b)

4. Logbook and a modification record book for the aircraft as required by EASA.

5. Logbooks for products identified in point 21L.A.252(b)(1) installed as part of the type design as required by EASA.

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 furnishings or buyer-furnished equipment (BFE) (items of equipment may be recorded in a technical log or other suitable arrangement such that the operator and EASA are formally aware of).

8. Product support information required by other implementing rules and associated CSs or GM, such as a maintenance manual, a parts catalogue, all of which should 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 a particular aircraft to the manufacturer’s recommended maintenance task.

10. Details of the serviceability state of a particular aircraft in respect of:

(a)  the fuel and oil contents;

(b)  provision of operationally required emergency equipment.

11. An approved flight manual which conforms to the build standard and modification state of a particular aircraft shall be available.

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

13. The registration has been marked on the exterior of the aircraft as required by national legislation. Where required by national legislation, affix a fireproof owner’s nameplate.

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

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

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

17. Where maintenance work has been performed under point 21L.A.126(e), issue a release to service that includes a statement that the particular aircraft is in a condition for safe operation.

18. List of all applicable service bulletins (SBs) and airworthiness directives (ADs) that have been implemented.

GM1 21L.A.127(l) Obligations of the declared production organisation

ED Decision 2023/013/R

APPLICABLE SUBPART A REQUIREMENTS

The following requirements in Subpart A are applicable to declared production organisations:

—      points 21L.A.3(b), (c), (d), (e) and (f) Reporting system

—      point 21L.A.5 Collaboration between design and production

—      point 21L.A.6(b) Marking

—      points 21L.A.7(b), (c) and (d) Record-keeping

—      point 21L.A.10 Access and investigation

—      point 21L.A.11 Findings and observations

—      point 21L.A.12 Means of compliance

21L.A.128 Notification of changes and cessation of activities

Regulation (EU) 2022/1358

The declared production organisation shall notify the competent authority without undue delay of the following:

(a) any changes to the information that has been declared in accordance with point (c) of point 21L.A.123;

(b) any changes to the management system for production that are significant to the showing of conformity or to the airworthiness and environmental compatibility characteristics of the product or part;

(c) the cessation of some of or all the activities covered by the declaration.

AMC1 21L.A.128 Notification of changes and cessation of activities

ED Decision 2023/013/R

CHANGES AND THEIR TIMELY NOTIFICATION

The declared production organisation should notify the competent authority of the following changes:

(a) Changes to the information that has been declared in accordance with point (c) of point 21L.A.123v (according to point 21L.A.128(a)):

—       change of the registered name of the organisation;

—       change of the registered address of the organisation’s principal place of business and, where applicable, change of the operating sites and/or their addresses;

—       change of the accountable manager and/or their contact details; and

—       change of the scope of work.

These changes are notified to the competent authority by submitting a revised declaration of production capability.

(b) Significant changes to the management system for production (according to point 21L.A.128(b)):

—       significant changes to production capacity;

—       change to the manufacturing methods;

—       changes in the organisation structure, especially to those parts of the organisation in charge of quality;

—       change of the managers nominated according to point 21L.A.125(c)(2);

—       changes in the management system for production or quality system that may have an important impact on the conformity/airworthiness of each product or part; and

—       changes in the placement or control of significant subcontracted work or supplied parts.

—       These changes are notified without revising the declaration of production capability.

Timely notification: The declared production organisation should notify the change(s) as soon as it has taken the decision to introduce the respective change(s) but no later than 10 working days after the change(s) became effective.