21L.A.124 Management system for production

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.

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).

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.

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.

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.

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.

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)).

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.

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.

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).

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).