identifier: AMC & GM to Part-ORA

beslut: ED Decision 2012/007/R

nummer: part-ora

title: AMC & GM to Part-ORA

text: Annex to ED Decision 2012/007/R

text: European Aviation Safety Agency

text: Acceptable Means of Compliance (AMC) and Guidance Material (GM) to Part-ORA

text: Initial issue 19 April 2012

text: Annex to ED Decision 2012/007/R

text: AMC and GM to Annex VII ORGANISATION REQUIREMENTS FOR AIRCREW (PART-ORA) SUBPART GEN – GENERAL REQUIREMENTS SECTION I - GENERAL GM1 ORA.GEN.005 The following provides a list of acronyms used throughout this Annex: (A) aeroplane (H) helicopter ACAS airborne collision avoidance system AD airworthiness directive AIS aeronautical information service AM accountable manager AMC Acceptable Means of Compliance ARA authority requirements for aircrew ATA Air Transport Association ATC air traffic control ATO approved training organisation ATPL airline transport pilot licence BITD basic instrument training device BPL balloon pilot licence CBT computer-based training CFI chief flying instructor CM compliance monitoring CMP compliance monitoring programme CMS compliance monitoring system COP code of practice CRM crew resource management CS-FSTD(A) Certification Specifications for aeroplane flight simulation training devices CS-FSTD(H) Certification Specifications for helicopter flight simulation training devices CTKI chief theoretical knowledge instructor DG dangerous goods EC European Community ERP emergency response plan ETOPS extended range operations with twin-engined aeroplanes FATO final approach and take-off area

text: Annex to ED Decision 2012/007/R

text: FFS full flight simulator FMGC flight management and guidance computer FMS flight management system FNPT flight navigation and procedures trainer FSTD flight simulation training device FTD flight training device FTE full-time equivalent FTI flight test instructor GM Guidance Material GMP general medical practitioner HEMS helicopter emergency medical service HHO helicopter hoist operation HT head of training IFR instrument flight rules IMC instrument meteorological conditions IOS instructor operation station IR Implementing Rule LAPL light aircraft pilot licence LIFUS line flying under supervision LVO low visibility operation MCC multi-crew cooperation MMEL master minimum equipment list MPA multi-pilot aeroplane MPL multi-crew pilot licence NVIS night vision imaging system OPC operator proficiency check ORA organisation requirements for aircrew OSD operational suitability data OTD other training device PBN performance-based navigation PF pilot flying PIC pilot-in-command PPL private pilot licence QTG qualification test guide SMM safety management manual SOP standard operating procedure SPL sailplane pilot licence TAWS terrain awareness warning system TRE type rating examiner TRI type rating instructor

text: Annex to ED Decision 2012/007/R

text: VDR validation data roadmap ZFTT zero flight-time training AMC1 ORA.GEN.120(a) Means of compliance DEMONSTRATION OF COMPLIANCE In order to demonstrate that the Implementing Rules are met, a risk assessment should be completed and documented. The result of this risk assessment should demonstrate that an equivalent level of safety to that established by the Acceptable Means of Compliance (AMC) adopted by the Agency is reached. AMC1 ORA.GEN.125 Terms of approval and privileges of an organisation MANAGEMENT SYSTEM DOCUMENTATION The management system documentation should contain the privileges and detailed scope of activities for which the organisation is certified, as relevant to the applicable requirements. The scope of activities defined in the management system documentation should be consistent with the terms of approval. AMC1 ORA.GEN.130 Changes to organisations APPLICATION TIME FRAMES (a) The application for the amendment of an organisation certificate should be submitted at least 30 days before the date of the intended changes. (b) In the case of a planned change of a nominated person, the organisation should inform the competent authority at least 10 days before the date of the proposed change. (c) Unforeseen changes should be notified at the earliest opportunity, in order to enable the competent authority to determine continued compliance with the applicable requirements and to amend, if necessary, the organisation certificate and related terms of approval. GM1 ORA.GEN.130(a) Changes to organisations GENERAL (a) Typical examples of changes that may affect the certificate or the terms of approval are listed below: (1) the name of the organisation; (2) the organisation’s principal place of business; (3) the organisation’s scope of activities; (4) additional locations of the organisation; (5) the accountable manager; (6) any of the persons referred to in ORA.GEN.210 (a) and (b); (7) the organisation’s documentation as required by this Part, safety policy and procedures; (8) the facilities.

text: Annex to ED Decision 2012/007/R

text: (b) Prior approval by the competent authority is required for any changes to the organisation’s procedure describing how changes not requiring prior approval will be managed and notified to the competent authority. (c) Changes requiring prior approval may only be implemented upon receipt of formal approval by the competent authority. GM2 ORA.GEN.130(a) Changes to organisations CHANGE OF NAME OF THE ORGANISATION A change of name requires the organisation to submit a new application as a matter of urgency. Where this is the only change to report, the new application can be accompanied by a copy of the documentation previously submitted to the competent authority under the previous name, as a means of demonstrating how the organisation complies with the applicable requirements. AMC1 ORA.GEN.150(b) Findings GENERAL The corrective action plan defined by the organisation should address the effects of the nonconformity, as well as its root-cause. GM1 ORA.GEN.150 Findings GENERAL (a) Corrective action is the action to eliminate or mitigate the root cause(s) and prevent recurrence of an existing detected non-compliance or other undesirable condition or situation. (b) Proper determination of the root cause is crucial for defining effective corrective actions. AMC1 ORA.GEN.160 Occurrence reporting GENERAL (a) The organisation should report all occurrences defined in AMC 20-8, and as required by the applicable national rules implementing Directive

text: on occurrence reporting in civil aviation. (b) In addition to the reports required by AMC 20-8 and Directive

text: , the organisation should report volcanic ash clouds encountered during flight.

text: Directive

text: of the European Parliament and of the Council of 13 June 2003 on occurrence reporting in civil aviation OJ L 167, 4.7.2003, p. 23–36.

text: Annex to ED Decision 2012/007/R

text: SECTION II –MANAGEMENT AMC1 ORA.GEN.200(a)(1);(2);(3);(5) Management system NON-COMPLEX ORGANISATIONS - GENERAL (a) Safety risk management may be performed using hazard checklists or similar risk management tools or processes, which are integrated into the activities of the organisation. (b) The organisation should manage safety risks related to a change. The management of change should be a documented process to identify external and internal change that may have an adverse effect on safety. It should make use of the organisation’s existing hazard identification, risk assessment and mitigation processes. (c) The organisation should identify a person who fulfils the role of safety manager and who is responsible for coordinating the safety management system. This person may be the accountable manager or a person with an operational role in the organisation. (d) Within the organisation, responsibilities should be identified for hazard identification, risk assessment and mitigation. (e) The safety policy should include a commitment to improve towards the highest safety standards, comply with all applicable legal requirements, meet all applicable standards, consider best practices and provide appropriate resources. (f) The organisation should, in cooperation with other stakeholders, develop, coordinate and maintain an emergency response plan (ERP) that ensures orderly and safe transition from normal to emergency operations and return to normal operations. The ERP should provide the actions to be taken by the organisation or specified individuals in an emergency and reflect the size, nature and complexity of the activities performed by the organisation. AMC1 ORA.GEN.200(a)(1) Management system COMPLEX ORGANISATIONS - ORGANISATION AND ACCOUNTABILITIES The management system of an organisation should encompass safety by including a safety manager and a safety review board in the organisational structure. (a) Safety manager (1) The safety manager should act as the focal point and be responsible for the development, administration and maintenance of an effective safety management system. (2) The functions of the safety manager should be to: (i) facilitate hazard identification, risk analysis and management; (ii) monitor the implementation of actions taken to mitigate risks, as listed in the safety action plan; (iii) provide periodic reports on safety performance; (iv) ensure maintenance of safety management documentation; (v) ensure that there is safety management training available and that it meets acceptable standards; (vi) provide advice on safety matters; and

text: Annex to ED Decision 2012/007/R

text: (vii) ensure initiation and follow-up of internal occurrence / accident investigations. (b) Safety review board (1) The Safety review board should be a high level committee that considers matters of strategic safety in support of the accountable manager’s safety accountability. (2) The board should be chaired by the accountable manager and be composed of heads of functional areas. (3) The safety review board should monitor: (i) safety performance against the safety policy and objectives; (ii) that any safety action is taken in a timely manner; and (iii) the effectiveness of the organisation’s safety management processes. (c) The safety review board should ensure that appropriate resources are allocated to achieve the established safety performance. (d) The safety manager or any other relevant person may attend, as appropriate, safety review board meetings. He/she may communicate to the accountable manager all information, as necessary, to allow decision making based on safety data. GM1 ORA.GEN.200(a)(1) Management system SAFETY MANAGER (a) Depending on the size of the organisation and the nature and complexity of its activities, the safety manager may be assisted by additional safety personnel for the performance of all safety management related tasks. (b) Regardless of the organisational set-up it is important that the safety manager remains the unique focal point as regards the development, administration and maintenance of the organisation’s safety management system. GM2 ORA.GEN.200(a)(1) Management system COMPLEX ORGANISATIONS - SAFETY ACTION GROUP (a) A safety action group may be established as a standing group or as an ad-hoc group to assist or act on behalf of the safety review board. (b) More than one safety action group may be established depending on the scope of the task and specific expertise required. (c) The safety action group should report to and take strategic direction from the safety review board and should be comprised of managers, supervisors and personnel from operational areas. (d) The safety action group should: (1) monitor operational safety; (2) resolve identified risks; (3) assess the impact on safety of operational changes; and (4) ensure that safety actions are implemented within agreed timescales. (e) The safety action group should review the effectiveness of previous safety recommendations and safety promotion.

text: Annex to ED Decision 2012/007/R

text: AMC1 ORA.GEN.200(a)(2) Management system COMPLEX ORGANISATIONS - SAFETY POLICY (a) The safety policy should: (1) be endorsed by the accountable manager; (2) reflect organisational commitments regarding safety and its proactive and systematic management; (3) be communicated, with visible endorsement, throughout the organisation; and (4) include safety reporting principles. (b) The safety policy should include a commitment: (1) to improve towards the highest safety standards; (2) to comply with all applicable legislation, meet all applicable standards and consider best practices; (3) to provide appropriate resources; (4) to enforce safety as one primary responsibility of all managers; and (5) not to blame someone for reporting something which would not have been otherwise detected. (c) Senior management should: (1) continually promote the safety policy to all personnel and demonstrate their commitment to it; (2) provide necessary human and financial resources for its implementation; and (3) establish safety objectives and performance standards. GM1 ORA.GEN.200(a)(2) Management system SAFETY POLICY The safety policy is the means whereby the organisation states its intention to maintain and, where practicable, improve safety levels in all its activities and to minimise its contribution to the risk of an aircraft accident as far as is reasonably practicable. The safety policy should state that the purpose of safety reporting and internal investigations is to improve safety, not to apportion blame to individuals. AMC1 ORA.GEN.200(a)(3) Management system COMPLEX ORGANISATIONS - SAFETY RISK MANAGEMENT (a) Hazard identification processes (1) Reactive and proactive schemes for hazard identification should be the formal means of collecting, recording, analysing, acting on and generating feedback about hazards and the associated risks that affect the safety of the operational activities of the organisation. (2) All reporting systems, including confidential reporting schemes, should include an effective feedback process. (b) Risk assessment and mitigation processes (1) A formal risk management process should be developed and maintained that ensures analysis (in terms of likelihood and severity of occurrence), assessment

text: Annex to ED Decision 2012/007/R

text: (in terms of tolerability) and control (in terms of mitigation) of risks to an acceptable level. (2) The levels of management who have the authority to make decisions regarding the tolerability of safety risks, in accordance with (b)(1), should be specified. (c) Internal safety investigation (1) The scope of internal safety investigations should extend beyond the scope of occurrences required to be reported to the competent authority. (d) Safety performance monitoring and measurement (1) Safety performance monitoring and measurement should be the process by which the safety performance of the organisation is verified in comparison to the safety policy and objectives. (2) This process should include: (i) safety reporting; (ii) safety studies, that is, rather large analyses encompassing broad safety concerns; (iii) safety reviews including trends reviews, which would be conducted during introduction and deployment of new technologies, change or implementation of procedures, or in situations of structural change in operations; (iv) safety audits focussing on the integrity of the organisation’s management system, and periodically assessing the status of safety risk controls; and (v) safety surveys, examining particular elements or procedures of a specific operation, such as problem areas or bottlenecks in daily operations, perceptions and opinions of operational personnel and areas of dissent or confusion. (e) The management of change The organisation should manage safety risks related to a change. The management of change should be a documented process to identify external and internal change that may have an adverse effect on safety. It should make use of the organisation’s existing hazard identification, risk assessment and mitigation processes. (f) Continuous improvement The organisation should continuously seek to improve its safety performance. Continuous improvement should be achieved through: (1) proactive and reactive evaluations of facilities, equipment, documentation and procedures through safety audits and surveys; (2) proactive evaluation of individuals’ performance to verify the fulfilment of their safety responsibilities; and (3) reactive evaluations in order to verify the effectiveness of the system for control and mitigation of risk. (g) The emergency response plan (ERP) (1) An ERP should be established that provides the actions to be taken by the organisation or specified individuals in an emergency. The ERP should reflect the size, nature and complexity of the activities performed by the organisation. (2) The ERP should ensure: (i) an orderly and safe transition from normal to emergency operations;

text: Annex to ED Decision 2012/007/R

text: (ii) safe continuation of operations or return to normal operations as soon as practicable; and (iii) coordination with the emergency response plans of other organisations, where appropriate. GM1 ORA.GEN.200(a)(3) Management system INTERNAL OCCURRENCE REPORTING SCHEME (a) The overall purpose of the scheme is to use reported information to improve the level of safety performance of the organisation and not to attribute blame. (b) The objectives of the scheme are to: (1) enable an assessment to be made of the safety implications of each relevant incident and accident, including previous similar occurrences, so that any necessary action can be initiated; and (2) ensure that knowledge of relevant incidents and accidents is disseminated, so that other persons and organisations may learn from them. (c) The scheme is an essential part of the overall monitoring function and it is complementary to the normal day-to-day procedures and ‘control’ systems and is not intended to duplicate or supersede any of them. The scheme is a tool to identify those instances where routine procedures have failed. (d) All occurrence reports judged reportable by the person submitting the report should be retained as the significance of such reports may only become obvious at a later date. AMC1 ORA.GEN.200(a)(4) Management system TRAINING AND COMMUNICATION ON SAFETY (a) Training (1) All personnel should receive safety training as appropriate for their safety responsibilities. (2) Adequate records of all safety training provided should be kept. (b) Communication (1) The organisation should establish communication about safety matters that: (i) ensures that all personnel are aware of the safety management activities as appropriate for their safety responsibilities; (ii) conveys safety critical information, especially relating to assessed risks and analysed hazards; (iii) explains why particular actions are taken; and (iv) explains why safety procedures are introduced or changed. (2) Regular meetings with personnel where information, actions and procedures are discussed may be used to communicate safety matters.

text: Annex to ED Decision 2012/007/R

text: GM1 ORA.GEN.200(a)(4) Management system TRAINING AND COMMUNICATION ON SAFETY The safety training programme may consist of self-instruction via a media (newsletters, flight safety magazines), class-room training, e-learning or similar training provided by training service providers. AMC1 ORA.GEN.200(a)(5) Management system ORGANISATION’S MANAGEMENT SYSTEM DOCUMENTATION (a) The organisation’s management system documentation should at least include the following information: (1) a statement signed by the accountable manager to confirm that the organisation will continuously work in accordance with the applicable requirements and the organisation’s documentation as required by this Part; (2) the organisation's scope of activities; (3) the titles and names of persons referred to in ORA.GEN.210 (a) and (b); (4) an organisation chart showing the lines of responsibility between the persons referred to in ORA.GEN.210; (5) a general description and location of the facilities referred to in ORA.GEN.215; (6) procedures specifying how the organisation ensures compliance with the applicable requirements; (7) the amendment procedure for the organisation’s management system documentation. (b) The organisation’s management system documentation may be included in a separate manual or in (one of) the manual(s) as required by the applicable Subpart(s). A cross reference should be included. GM1 ORA.GEN.200(a)(5) Management system ORGANISATION’S MANAGEMENT SYSTEM DOCUMENTATION (a) It is not required to duplicate information in several manuals. The information may be contained in any of the organisation manuals (e.g. operations manual, training manual), which may also be combined. (b) The organisation may also choose to document some of the information required to be documented in separate documents (e.g. procedures). In this case, it should ensure that manuals contain adequate references to any document kept separately. Any such documents are then to be considered an integral part of the organisation’s management system documentation.

text: Annex to ED Decision 2012/007/R

text: AMC1 ORA.GEN.200(a)(5) Management system COMPLEX ORGANISATIONS – ORGANISATION’S SAFETY MANAGEMENT MANUAL (a) The safety management manual (SMM) should be the key instrument for communicating the approach to safety for the whole of the organisation. The SMM should document all aspects of safety management, including the safety policy, objectives, procedures and individual safety responsibilities. (b) The contents of the safety management manual should include all of the following: (1) scope of the safety management system; (2) safety policy and objectives; (3) safety accountability of the accountable manager; (4) safety responsibilities of key safety personnel; (5) documentation control procedures; (6) hazard identification and risk management schemes; (7) safety action planning; (8) safety performance monitoring; (9) incident investigation and reporting; (10) emergency response planning; (11) management of change (including organisational changes with regard to safety responsibilities); (12) safety promotion. (c) The SMM may be contained in (one of) the manual(s) of the organisation. AMC1 ORA.GEN.200(a)(6) Management system COMPLIANCE MONITORING - GENERAL (a) Compliance monitoring The implementation and use of a compliance monitoring function should enable the organisation to monitor compliance with the relevant requirements of this Part and other applicable Parts. (1) The organisation should specify the basic structure of the compliance monitoring function applicable to the activities conducted. (2) The compliance monitoring function should be structured according to the size of the organisation and the complexity of the activities to be monitored. (b) Organisations should monitor compliance with the procedures they have designed to ensure safe activities. In doing so, they should as a minimum, and where appropriate, monitor: (1) privileges of the organisation; (2) manuals, logs, and records; (3) training standards; (4) management system procedures and manuals. (c) Organisational set up (1) To ensure that the organisation continues to meet the requirements of this Part and other applicable Parts, the accountable manager should designate a

text: Annex to ED Decision 2012/007/R

text: compliance monitoring manager. The role of the compliance monitoring manager is to ensure that the activities of the organisation are monitored for compliance with the applicable regulatory requirements , and any additional requirements as established by the organisation, and that these activities are being carried out properly under the supervision of the relevant head of functional area. (2) The compliance monitoring manager should be responsible for ensuring that the compliance monitoring programme is properly implemented, maintained and continually reviewed and improved. (3) The compliance monitoring manager should: (i) have direct access to the accountable manager; (ii) not be one of the other persons referred to in ORA.GEN.210 (b); (iii) be able to demonstrate relevant knowledge, background and appropriate experience related to the activities of the organisation; including knowledge and experience in compliance monitoring; and (iv) have access to all parts of the organisation, and as necessary, any contracted organisation. (4) In the case of a non-complex organisation, this task may be exercised by the accountable manager provided he/she has demonstrated having the related competence as defined in (c)(3)(iii). (5) In the case the same person acts as compliance monitoring manager and as safety manager, the accountable manager, with regards to his/her direct accountability for safety, should ensure that sufficient resources are allocated to both functions, taking into account the size of the organisation and the nature and complexity of its activities. (6) The independence of the compliance monitoring function should be established by ensuring that audits and inspections are carried out by personnel not responsible for the function, procedure or products being audited. (d) Compliance monitoring documentation (1) Relevant documentation should include the relevant part(s) of the organisation’s management system documentation. (2) In addition, relevant documentation should also include the following: (i) terminology; (ii) specified activity standards; (iii) a description of the organisation; (iv) the allocation of duties and responsibilities; (v) procedures to ensure regulatory compliance; (vi) the compliance monitoring programme, reflecting: (A) schedule of the monitoring programme; (B) audit procedures; (C) reporting procedures; (D) follow-up and corrective action procedures; and (E) recording system. (vii) the training syllabus referred to in (e)(2); (viii) document control.

text: Annex to ED Decision 2012/007/R

text: (e) Training (1) Correct and thorough training is essential to optimise compliance in every organisation. In order to achieve significant outcomes of such training, the organisation should ensure that all personnel understand the objectives as laid down in the organisation’s management system documentation. (2) Those responsible for managing the compliance monitoring function should receive training on this task. Such training should cover the requirements of compliance monitoring, manuals and procedures related to the task, audit techniques, reporting and recording. (3) Time should be provided to train all personnel involved in compliance management and for briefing the remainder of the personnel. (4) The allocation of time and resources should be governed by the volume and complexity of the activities concerned. GM1 ORA.GEN.200(a)(6) Management system COMPLIANCE MONITORING - GENERAL (a) The organisational set-up of the compliance monitoring function should reflect the size of the organisation and the nature and complexity of its activities. The compliance monitoring manager may perform all audits and inspections himself/herself or appoint one or more auditors by choosing personnel having the related competence as defined in AMC1 ORA.GEN.200(a)(6) point (c)(3)(iii), either from within or outside the organisation. (b) Regardless of the option chosen it must be ensured that the independence of the audit function is not affected, in particular in cases where those performing the audit or inspection are also responsible for other functions within the organisation. (c) In case external personnel are used to perform compliance audits or inspections: (1) any such audits or inspections are performed under the responsibility of the compliance monitoring manager; and (2) the organisation remains responsible to ensure that the external personnel has relevant knowledge, background and experience as appropriate to the activities being audited or inspected; including knowledge and experience in compliance monitoring. (d) The organisation retains the ultimate responsibility for the effectiveness of the compliance monitoring function in particular for the effective implementation and follow-up of all corrective actions. GM2 ORA.GEN.200(a)(6) Management system COMPLEX ORGANISATIONS - COMPLIANCE MONITORING PROGRAMME FOR ATOs (a) Typical subject areas for compliance monitoring audits and inspections for approved training organisations (ATOs) should be the following: (1) facilities; (2) actual flight and ground training; (3) technical standards. (b) ATOs should monitor compliance with the training and operations manuals they have designed to ensure safe and efficient training. In doing so, they should, where appropriate, additionally monitor the following: (1) training procedures;

text: Annex to ED Decision 2012/007/R

text: (2) flight safety; (3) flight and duty time limitations, rest requirements and scheduling; (4) aircraft maintenance/operations interface. GM3 ORA.GEN.200(a)(6) Management system AUDIT AND INSPECTION (a) ‘Audit’ means a systematic, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which requirements are complied with. (b) ‘Inspection’ means an independent documented conformity evaluation by observation and judgement accompanied as appropriate by measurement, testing or gauging, in order to verify compliance with applicable requirements. AMC1 ORA.GEN.200(b) Management system SIZE, NATURE AND COMPLEXITY OF THE ACTIVITY (a) An organisation should be considered as complex when it has a workforce of more than 20 full time equivalents (FTEs) involved in the activity subject to

text: Regulation (EC) No 216/2008

text: and its Implementing Rules. (b) Organisations with up to 20 full time equivalents (FTEs) involved in the activity subject to

text: Regulation (EC) No 216/2008

text: and its Implementing Rules, may also be considered complex based on an assessment of the following factors: (1) in terms of complexity, the extent and scope of contracted activities subject to the approval; (2) in terms of risk criteria, whether any of the following are present: (i) operations requiring the following specific approvals: performance-based navigation (PBN), low visibility operation (LVO), extended range operations with two-engined aeroplanes (ETOPS), helicopter hoist operation (HHO), helicopter emergency medical service (HEMS), night vision imaging system (NVIS) and dangerous goods (DG); (ii) different types of aircraft used; (iii) the environment (offshore, mountainous area etc.); (c) Regardless of the criteria mentioned in (a) and (b), the following organisations should always be considered as non-complex: (1) Approved Training Organisations (ATOs) only providing training for the light aircraft pilot licence (LAPL), private pilot licence (PPL), sailplane pilot licence (SPL) or balloon pilot licence (BPL) and the associated ratings and certificates; (2) Aero-Medical Centres (AeMCs).

text: Regulation (EC) No 216/2008

text: of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing

text: Council Directive 91/670/EEC

text: Regulation (EC) No 1592/2002

text: and Directive

text: . OJ L 79, 19.3.2008, p. 1.

text: Annex to ED Decision 2012/007/R

text: AMC1 ORA.GEN.205 Contracted activities RESPONSIBILITY WHEN CONTRACTING ACTIVITIES (a) The organisation may decide to contract certain activities to external organisations. (b) A written agreement should exist between the organisation and the contracted organisation clearly defining the contracted activities and the applicable requirements. (c) The contracted safety related activities relevant to the agreement should be included in the organisation's safety management and compliance monitoring programmes. (d) The organisation should ensure that the contracted organisation has the necessary authorisation or approval when required, and commands the resources and competence to undertake the task. GM1 ORA.GEN.205 Contracted activities RESPONSIBILITY WHEN CONTRACTING ACTIVITIES (a) Regardless of the approval status of the contracted organisation, the contracting organisation is responsible to ensure that all contracted activities are subject to hazard identification and risk management as required by ORA.GEN.200 (a)(3) and to compliance monitoring as required by ORA.GEN.200 (a)(6). (b) When the contracted organisation is itself certified to carry out the contracted activities, the organisation’s compliance monitoring should at least check that the approval effectively covers the contracted activities and that it is still valid. (c) If the organisation requires the contracted organisation to conduct an activity which exceeds the contracted organisation’s terms of approval, this will be considered as the contracted organisation working under the approval of the contracting organisation. AMC1 ORA.GEN.215 Facility requirements ATOs PROVIDING TRAINING FOR THE CPL, MPL AND ATPL AND THE ASSOCIATED RATINGS AND CERTIFICATES (a) For ATOs providing flight training, the following flight operations accommodation should be available: (1) an operations room with facilities to control flying operations; (2) a flight planning room with the following facilities: (i) appropriate current maps and charts; (ii) current aeronautical information service (AIS) information; (iii) current meteorological information; (iv) communications to air traffic control (ATC) and the operations room; (v) any other flight safety related material. (3) adequate briefing rooms/cubicles of sufficient size and number; (4) suitable offices for the supervisory personnel and room(s) to allow flight instructors to write reports on students, complete records and other related documentation; (5) furnished crew-room(s) for instructors and students.

text: Annex to ED Decision 2012/007/R

text: (b) For ATOs providing theoretical knowledge training, the following facilities for theoretical knowledge instruction should be available: (1) adequate classroom accommodation for the current student population; (2) suitable demonstration equipment to support the theoretical knowledge instruction; (3) a radiotelephony training and testing facility; (4) a reference library containing publications giving coverage of the syllabus; (5) offices for the instructional personnel. AMC2 ORA.GEN.215 Facility requirements ATOs PROVIDING TRAINING FOR THE LAPL, PPL, SPL OR BPL AND THE ASSOCIATED RATINGS AND CERTIFICATES (a) The following flight operations accommodation should be available: (1) a flight planning room with the following facilities: (i) appropriate current aviation maps and charts; (ii) current AIS information; (iii) current meteorological information; (iv) communications to ATC (if applicable); (v) any other flight safety related material. (2) adequate briefing room(s)/cubicles of sufficient size and number; (3) suitable office(s) to allow flight instructors to write reports on students, complete records and other related documentation; (4) suitable rest areas for instructors and students, where appropriate to the training task; (5) in the case of ATOs providing training for the BPL or LAPL(B) only, the flight operations accommodation listed in (a)(1) to (a)(4) may be replaced by other suitable facilities when operating outside aerodromes. (b) The following facilities for theoretical knowledge instruction should be available: (1) adequate classroom accommodation for the current student population; (2) suitable demonstration equipment to support the theoretical knowledge instruction; (3) suitable office(s) for the instructional personnel. (c) A single room may be sufficient to provide the functions listed in (a) and (b). AMC1 ORA.GEN.220(b) Record-keeping GENERAL (a) The record-keeping system should ensure that all records are accessible whenever needed within a reasonable time. These records should be organised in a way that ensures traceability and retrievability throughout the required retention period. (b) Records should be kept in paper form or in electronic format or a combination of both. Records stored on microfilm or optical disc format are also acceptable. The

text: Annex to ED Decision 2012/007/R

text: records should remain legible throughout the required retention period. The retention period starts when the record has been created or last amended. (c) Paper systems should use robust material which can withstand normal handling and filing. Computer systems should have at least one backup system which should be updated within 24 hours of any new entry. Computer systems should include safeguards against the ability of unauthorised personnel to alter the data. (d) All computer hardware used to ensure data backup should be stored in a different location from that containing the working data and in an environment that ensures they remain in good condition. When hardware or software changes take place, special care should be taken that all necessary data continues to be accessible at least through the full period specified in the relevant Subpart. In the absence of such indication, all records should be kept for a minimum period of 5 years. GM1 ORA.GEN.220(b) Record-keeping RECORDS Microfilming or optical storage of records may be carried out at any time. The records should be as legible as the original record and remain so for the required retention period.

text: Annex to ED Decision 2012/007/R

text: Subpart ATO - Approved Training Organisations SECTION I – GENERAL GM1 ORA.ATO.100 Scope The content of this Section contains the requirements applicable to all ATOs providing training for pilot licences and the associated ratings and certificates. It is applicable to ATOs providing training for: (a) the LAPL, PPL, SPL and BPL and the associated ratings and certificates; and (b) the commercial pilot licence (CPL), multi-crew pilot licence (MPL) and airline transport pilot licence (ATPL) and the associated ratings and certificates.

text: Annex to ED Decision 2012/007/R

text: AMC1 ORA.ATO.105 Application APPLICATION FORM APPLICATION FORM FOR AN ATO CERTIFICATE

text: N° Question Supplementary information 1. Name of training organisation under which address, fax number, e-mail, URL the activity is to take place 2. Training courses offered theory and/or flight training 3. Name of head of training type and number of licence full/part-time 4. Name of chief flight instructor as (3) 5. Name of chief theoretical knowledge as (3) instructor 6. Name of flight instructor(s), where applicable as (3) 7. Aerodrome(s) / operating site(s) to be used IFR approaches, if applicable night flying, if applicable air traffic control flight testing facilities, if applicable data reply facilities, if applicable 8. Flight operations accommodation location, number and size of rooms 9. Theoretical instruction facilities location, number and size of rooms 10. Description of training devices (as FFS, FNPT I, II and III, FTD 1, 2 and 3, and 3, and applicable) BITD 11. Description of aircraft Class/type(s) of aircraft registration of aircraft IFR equipped, if applicable Flight test instrumentation, if applicable 12. Proposed administration and manuals : (a) course programmes (submit with application if required ) (b) training records (c) operations manual (d) training manual 13. Details of proposed compliance monitoring system Note 1: If answers to any of the above questions are incomplete, the applicant should provide full details of alternative arrangements separately. Note 2: instrument flight rules (IFR), full flight simulator (FFS), flight and navigation procedures trainer (FNPT), flight training device (FTD), basic instrument training device (BITD) I, (name), on behalf of (name of training organisation) certify that all the above named persons are in compliance with the applicable requirements and that all the above information given is complete and correct.

text: (Date) (Signature)

text: Annex to ED Decision 2012/007/R

text: AMC1 ORA.ATO.110(b) Personnel requirements HEAD OF TRAINING The nominated head of training (HT) should have the overall responsibility to ensure that the training is in compliance with the appropriate requirements. In an ATO providing training courses for different aircraft categories, the HT shall be assisted by one or more nominated deputy HT(s) for certain flight training courses. AMC1 ORA.ATO.110(c) Personnel requirements THEORETICAL KNOWLEDGE INSTRUCTORS Theoretical knowledge instructors should, before appointment, prove their competency by giving a test lecture based on material they have developed for the subjects they are to teach. AMC1 ORA.ATO.120(a);(b) Record-keeping ATOs PROVIDING TRAINING ONLY FOR THE LAPL, PPL, SPL OR BPL AND THE ASSOCIATED RATINGS AND CERTIFICATES The details of ground, flight and flight instruction by using FSTD given to a specific individual student and the detailed progress reports from instructors may be kept also in a student’s progress card. This progress card should contain all the exercises of the training syllabus. The instructor should sign this card if a certain exercise has been completed or a specific assessment has been conducted. AMC1 ORA.ATO.125 Training programme GENERAL Flight training in an FSTD and theoretical knowledge instruction should be phased in such a manner as to ensure that students are able to apply to flight exercises the knowledge gained on the ground. Arrangements should be made so that problems encountered during instruction can be resolved during subsequent training. AMC2 ORA.ATO.125 Training programme TYPE RATING COURSES – AEROPLANES (a) Introduction (1) When developing the training programme for a type rating course, in addition to complying with the standards included in the operational suitability data (OSD), as established in accordance with

text: Regulation (EC) 1702/2003

text: for the applicable type, the ATO should also follow any further recommendations contained therein.

text: Commission Regulation (EC) No 1702/2003 of 24 September 2003

text: laying down implementing rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations (Part 21) (OJ L 243, 27.9.2003, p. 6). Regulation as last amended by

text: Regulation (EC) No 1194/2009

text: (OJ L 321, 8.12.2009, p. 5).

text: Annex to ED Decision 2012/007/R

text: (2) The type rating course should, as far as possible, provide for a continual process of ground, FSTD and flight training to enable the student to assimilate the knowledge and skills required to operate a specific aircraft type safely and efficiently. The student’s ability to do this should be determined by the demonstration of a satisfactory level of theoretical knowledge of the aircraft determined by progressive checking of knowledge and examination, progressive assessment by the ATO during flight training and the successful completion of a practical skill test with an examiner. (3) The type rating course should normally be conducted as a single, full-time course of study and training. However, in the situation where the course is intended to enable a pilot to fly a further aircraft type while continuing to fly a current type, such as to enable mixed fleet flying with the same operator, some elements of the theoretical knowledge course conducted by self-study may be undertaken while the student continues to fly the current type. (b) Variants (1) Familiarisation training: Where an aeroplane type rating also includes variants of the same aircraft type requiring familiarisation training, the additional familiarisation training may be included in the theoretical knowledge training of the initial type rating course. Flight training should be conducted on a single variant within the type. (2) Differences training: Where an aeroplane type rating also includes variants of the same aircraft type for which difference training is required, the initial training course should be directed towards a single variant. Additional training to operate other variants within the same type rating should be completed after successful completion of the initial type rating course. However, elements of this differences training may be undertaken at appropriate stages of the initial course, with the agreement of the competent authority. (c) Programme of theoretical knowledge and flight training (1) The training programme should specify the time allocated to theoretical knowledge training, FSTD training and, if not approved for zero flight-time training (ZFTT), the aeroplane. The initial type rating course should be programmed on the basis that the student has the minimum licensing and experience requirements for entry to the course. For a first type rating on a multi-pilot aeroplane (MPA), the course should also provide for consolidation and type-specific training in those elements of basic multi-crew cooperation (MCC) training relevant to the type or variant. (2) If the ATO wishes to provide a training course that includes credit for previous experience on similar types of aircraft, such as those with common systems or operating procedures with the new type, the entry requirements to such courses should be specified by the ATO and should define the minimum level of experience and qualification required of the flight crew member. (3) The ATO is permitted to contract elements of training to a third party training provider. In such cases the contracted organisation should normally be approved to conduct such training. When the contracted organisation is not an ATO, the competent authority should, within the approval process of the ATO, include the contracted organisation and be satisfied that the standard of training intended to be given meets the requirements. The other obligations of the ATO, such as student progress monitoring and an adequate management system, can be exercised by the ATO seeking approval and which retains responsibility for the whole course. GROUND TRAINING (d) Syllabus

text: Annex to ED Decision 2012/007/R

text: The ground training syllabus should provide for the student to gain a thorough understanding of the operation, function and, if appropriate, abnormal and emergency operation of all aircraft systems. This training should also include those systems essential to the operation of the aircraft, such as ‘fly-by-wire’ flight control systems, even if the flight crew have little or no control of their normal or abnormal operation. (e) Theoretical knowledge instruction The theoretical knowledge instruction training should meet the general objectives of (but not be limited to) giving the student: (1) a thorough knowledge of the aircraft structure, powerplant and systems, and their associated limitations, including mass and balance, aircraft performance and flight planning considerations; (2) a knowledge of the positioning and operation of the cockpit controls and indicators for the aircraft and its systems; (3) an understanding of system malfunctions, their effect on aircraft operations and interaction with other systems; and (4) the understanding of normal, abnormal and emergency procedures. (f) Facilities and training aids The ATO should provide adequate facilities for classroom instruction and have available appropriately qualified and experienced instructors. Training aids should enable students to gain practical experience of the operation of systems covered by the theoretical knowledge syllabus and, in the case of multi-pilot aeroplanes, enable such practical application of the knowledge to be carried out in a multi-crew environment. Facilities should be made available for student self-study outside the formal training programme. (g) Computer-based training (CBT) CBT provides a valuable source of theoretical instruction, enabling the students to progress at their own pace within specified time limits. Many such systems ensure that syllabus subjects are fully covered and progress can be denied until a satisfactory assimilation of knowledge has been demonstrated. Such systems may allow self-study or distance learning, if they incorporate adequate knowledge testing procedures. When CBT is used as part of the theoretical knowledge instruction phase, the student should also have access to a suitably qualified instructor able to assist with areas of difficulty for the student. (h) Self-study and distance learning Elements of the theoretical knowledge syllabus may be adequately addressed by distance learning, if approved, or self-study, particularly when utilising CBT. Progress testing, either by self-assessed or instructor-evaluated means should be included in any self-study programme. If self-study or distance learning is included in the theoretical knowledge training, the course should also provide for an adequate period of supervised consolidation and knowledge testing. (i) Progress tests and final theoretical knowledge examination (1) The theoretical knowledge training programme should provide for progressive testing of the assimilation of the required knowledge. This testing process should also provide for retesting of syllabus items so that a thorough understanding of the required knowledge is assured. This should be achieved by intervention by a qualified instructor or, if using CBT with a self-testing facility, and by further testing during the supervised consolidation phase of the ground course. (2) The final theoretical knowledge examination should cover all areas of the theoretical knowledge syllabus. The final examination should be conducted as a supervised written (including computer-based) knowledge test without reference

text: Annex to ED Decision 2012/007/R

text: to course material. The pass mark of 75% assumes the achievement of satisfactory levels of knowledge during the progressive phase tests of the course. The student should be advised of any areas of lack of knowledge displayed during the examination and, if necessary, given remedial instruction. A successful pass of the theoretical knowledge course and final examination should be a pre-requisite for progression to the flight training phase of the type rating course, unless otherwise determined in the OSD established in accordance with

text: Regulation (EC) 1702/2003

text: . FLIGHT TRAINING (j) Flight simulation training devices (FSTDs) A type rating course for a multi-pilot aeroplane should include FSTD training. The amount of training required when using FSTDs will depend on the complexity of the aeroplane concerned, and to some extent on the previous experience of the pilot. Except for those courses giving credit for previous experience (c.2.), a minimum of 32 hours of FSTD training should be programmed for a crew of a multi-pilot aeroplane, of which at least 16 hours should be in an FFS operating as a crew. FFS time may be reduced if other qualified FSTDs used during the flight training programme accurately replicate the cockpit environment, operation and aeroplane response. Such FSTDs may typically include flight management computer (FMC) training devices using hardware and computer programmes identical to those of the aeroplane. (k) Aeroplane training with FFS (1) with the exception of courses approved for ZFTT, certain training exercises normally involving take-off and landing in various configurations should be completed in the aeroplane rather than an FFS. For MPAs where the student pilot has more than 500 hours of MPA experience in aeroplanes of similar size and performance, these should include at least four landings of which at least one should be a full-stop landing, unless otherwise specified in the OSD established in accordance with

text: Regulation (EC) 1702/2003

text: , when available. In all other cases the student should complete at least six landings. This aeroplane training may be completed after the student pilot has completed the FSTD training and has successfully undertaken the type rating skill test, provided it does not exceed 2 hours of the flight training course. (2) courses approved for ZFTT During the specific simulator session before line flying under supervision (LIFUS), consideration should be given to varying conditions, for example: (i) runway surface conditions; (ii) runway length; (iii) flap setting; (iv) power setting; (v) crosswind and turbulence conditions; and (vi) maximum take-off mass (MTOM) and maximum landing mass (MLM). (3) the landings should be conducted as full-stop landings. The session should be flown in normal operation. Special attention should be given to the taxiing technique: (i) a training methodology should be agreed with the competent authority that ensures the trainee is fully competent with the exterior inspection of the aeroplane before conducting such an inspection un-supervised;

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text: (ii) the LIFUS should be performed as soon as possible after the specific FFS session; (iii) the licence endorsement should be entered on the licence after the skill test, but before the first four take-offs and landings in the aeroplane. At the discretion of the competent authority, provisional or temporary endorsement and any restriction should be entered on the licence. Where a specific arrangement exists between the ATO and the commercial air transport operator, the operator proficiency check (OPC) and the ZFTT specific details should be conducted using the operator's standard operating procedures (SOPs). (l) Aeroplane without FFS (1) Flight training conducted solely in an aeroplane without the use of FSTDs cannot cover the crew resource management (CRM) and multi-crew cockpit (MCC) aspects of MPA flight training, and for safety reasons cannot cover all emergency and abnormal aircraft operation required for the training and skill test. In such cases, the ATO should demonstrate to the competent authority that adequate training in these aspects can be achieved by other means. For training conducted solely on an MPA where two pilots are trained together without the use of an FSTD, a minimum of 8 hours of flight training as pilot flying (PF) for each pilot should normally be required. For training on a single-pilot aeroplane, 10 hours of flight training should normally be required. It is accepted that for some relatively simple single or multi-engine aircraft without systems such as pressurisation, flight management system (FMS) or electronic cockpit displays, this minimum may be reduced. (2) Aeroplane training normally involves an inherent delay in achieving an acceptable flight situation and configuration for training to be carried out in accordance with the agreed syllabus. These could include ATC or other traffic delay on the ground prior to take-off, the necessity to climb to height or transit to suitable training areas and the unavoidable need to physically reposition the aircraft for subsequent or repeat manoeuvres or instrument approaches. In such cases it should be ensured that the training syllabus provides adequate flexibility to enable the minimum amount of required flight training to be carried out. SKILL TEST (m) Upon completion of the flight training, the pilot will be required to undergo a skill test with an examiner to demonstrate adequate competency of aircraft operation for issue of the type rating. The skill test should be separate from the flight training syllabus, and provision for it cannot be included in the minimum requirements or training hours of the agreed flight training programme. The skill test may be conducted in an FFS, the aeroplane or, in exceptional circumstances, a combination of both. COURSE COMPLETION CERTIFICATE (n) The HT, or a nominated representative, should certify that all training has been carried out before an applicant undertakes a skill test for the type rating to be included in the pilot’s licence. If an ATO is unable to provide certain elements of the training that is required to be carried out on an aircraft the ATO may issue such a certificate confirming the completion of the ground training or the training in an FSTD. AMC3 ORA.ATO.125 Training programme TYPE RATING COURSES - HELICOPTERS (a) Introduction

text: Annex to ED Decision 2012/007/R

text: (1) when developing the training programme for a type rating course, in addition to complying with the standards included in the OSD as established in accordance with

text: Regulation (EC) 1702/2003

text: for the applicable type, the ATO should also follow any further recommendations contained therein. (2) the course should, as far as possible, provide for integrated ground, FSTD and flight training designated to enable the student to operate safely and qualify for the grant of a type rating. The course should be directed towards a helicopter type, but where variants exist, all flying and ground training forming the basis of the course should relate to a single variant. (b) Variants (1) Familiarisation training: where a helicopter type rating also includes variants of the same aircraft type requiring familiarisation training, the additional familiarisation training may be included in the theoretical knowledge training of the initial type rating course. (2) Differences training: where a helicopter type rating also includes variants of the same aircraft type for which difference training is required, the initial training course should be directed towards a single variant. Additional training to operate other variants within the same type rating should be completed after successful completion of the initial type rating course, although elements of this differences training may be undertaken at appropriate stages of the initial course, with the agreement of the competent authority. (c) Training in helicopter and FSTDs The training programme should specify the amounts of flight training in the helicopter type and in FSTDs (FFSs, flight training devices (FTDs), or other training devices (OTDs)). Where a suitable FFS is geographically remote from the normal training base, the competent authority may agree to some additional training being included in the programme at a remote facility. (d) Skill test The content of the flight training programme should be directed towards the skill test for that type. The practical training given in Part-FCL should be modified as necessary. The skill test may be completed in a helicopter, in an FFS or partially in a helicopter and in an FSTD. The use of an FSTD for skill tests is governed by the level of approval of the flight simulator and the previous experience of the candidate. Where an FSTD is not available, abnormal operations of systems should not be practised in a helicopter other than as allowed for in the skill test form for the type. (e) Phase progress tests and final theoretical knowledge examination Prior to the final theoretical knowledge examination covering the whole syllabus, the training programme should provide for phase progress tests associated with each phase of theoretical knowledge instruction. The phase progress tests should assess the candidate’s knowledge on completion of each phase of the training programme. (f) Facilities: ground school equipment, training facilities and aids The ATO should provide, as a minimum, facilities for classroom instruction. Additional classroom training aids and equipment including, where appropriate, computers, should reflect the content of the course and the complexity of the helicopter. For multi-engine and multi-pilot helicopters, the minimum level of ground training aids should include equipment that provides a realistic cockpit working environment. Task analysis and the latest state-of–the-art training technology is encouraged and should be fully incorporated into the training facilities wherever possible. Facilities for self and supervised testing should be available to the student.

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text: (g) Training devices An FTD or OTD may be provided to supplement classroom training in order to enable students to practice and consolidate theoretical instruction. Where suitable equipment is not available, or is not appropriate, a helicopter or flight simulator of the relevant variant should be available. If an FTD represents a different variant of the same helicopter type for which the student is being trained, then differences or familiarisation training is required. (h) Computer-based training (CBT) Where CBT aids are used as a training tool, the ATO should ensure that a fully qualified ground instructor is available at all times when such equipment is being used by course students. Other than for revision periods, CBT lessons should be briefed and debriefed by a qualified ground instructor. (i) Theoretical knowledge instruction The theoretical knowledge instruction training should meet the general objectives of giving the student: (1) a thorough knowledge of the helicopter structure, transmissions, rotors and equipment, powerplant and systems, and their associated limitations; (2) a knowledge of the positioning and operation of the cockpit controls and indicators for the helicopter and its systems; (3) a knowledge of performance, flight planning and monitoring, mass and balance, servicing and optional equipment items; (4) an understanding of system malfunctions, their effect on helicopter operations and interaction with other systems; and (5) the understanding of normal, abnormal and emergency procedures and giving the student the understanding of potential control problems near the edge of the handling envelope. In particular, the phenomenon of ‘servo transparency’ (also known as ‘jack stall’) should be covered for those helicopter types where it is a known problem. The amount of time and the contents of the theoretical instruction will depend on the complexity of the helicopter type involved and, to some extent, on the previous experience of the student. (j) Flight training (1) FSTDs The level of qualification and the complexity of the type will determine the amount of practical training that may be accomplished in an FSTD, including completion of the skill test. Prior to undertaking the skill test, a student should demonstrate competency in the skill test items during the practical training. (2) Helicopter (with FSTD ) With the exception of courses approved for ZFTT, the amount of flight time in a helicopter should be adequate for completion of the skill test. (3) Helicopters (without FSTD) Whenever a helicopter is used for training, the amount of flight time practical training should be adequate for the completion of the skill test. The amount of flight training will depend on the complexity of the helicopter type involved and, to some extent, on the previous experience of the applicant.

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text: AMC4 ORA.ATO.125 Training programme FLIGHT TEST TRAINING COURSES – AEROPLANES AND HELICOPTERS (a) Introduction (1) The flight test training course should, as far as possible, provide for a continuous process of ground and flight training to enable the student to assimilate the knowledge and skills required to conduct flight testing safely and efficiently. The student’s ability to do this should be determined by the demonstration of a satisfactory level of theoretical knowledge of flight testing determined by progressive checking of knowledge and examination and progressive assessment by the ATO during flying training. There should be no difference in the level of knowledge or competency required of the student, irrespective of the intended role of the student as test pilot or other flight test personnel (for example, flight test engineer) within the flight crew. (2) The flight test training course should normally be conducted as a single, full-time course of study and training. (b) Programme of theoretical knowledge and flight training (1) The training programme should specify the time allocated to theoretical knowledge training and flying training. (2) If the ATO wishes to provide a flight test training course that includes credit for previous experience on flight testing activity, the entry requirements to such courses should be specified by the ATO and should define the minimum level of experience and qualification required of the flight test crew member. GROUND TRAINING (c) Syllabus (1) The ground training syllabus should provide for the student to gain a thorough understanding of flight testing techniques. (d) Theoretical knowledge instruction (1) The theoretical knowledge instruction training should give the student a thorough knowledge of the academic requirements of flight testing. (e) Facilities and training aids (1) The ATO should provide adequate facilities for classroom instruction and have available appropriately qualified and experienced instructors. Training aids should enable students to gain practical experience of flight testing covered by the theoretical knowledge syllabus and enable such practical application of the knowledge to be carried out in a multi-crew environment. Facilities should be made available for student self-study outside the formal training programme. (f) Computer-based training (CBT) (1) CBT provides a valuable source of theoretical instruction, enabling the student to progress at his/her own pace within specified time limits. Many such systems ensure that syllabus subjects are fully covered and progress can be denied until a satisfactory assimilation of knowledge has been demonstrated. Such systems may allow self-study or distance learning, if they incorporate adequate knowledge testing procedures. When CBT is used as part of the theoretical knowledge instruction phase, the student should also have access to a suitably qualified instructor able to assist with areas of difficulty for the student. (g) Self-study and distance learning (1) Elements of the theoretical knowledge syllabus may be adequately addressed by distance learning, if approved, or self-study, particularly when utilising CBT. Progress testing, either by self-assessed or instructor-evaluated means, should

text: Annex to ED Decision 2012/007/R

text: be included in any self-study programme. If self-study or distance learning is included in the theoretical knowledge training, the course should also provide for an adequate period of supervised consolidation and knowledge testing prior to the commencement of flight training. (h) Progress tests and final theoretical knowledge examination (1) The theoretical knowledge training programme should provide for progressive testing of the assimilation of the required knowledge. This testing process should also provide for retesting of syllabus items so that a thorough understanding of the required knowledge is assured. This should be achieved by intervention by a qualified instructor or, if using CBT with a self-testing facility, and by further testing during the supervised consolidation phase of the ground course. (2) The theoretical knowledge examinations should cover all areas of the theoretical knowledge syllabus. The examinations should be conducted as supervised written or oral knowledge tests without reference to course material. The pass mark (as defined by the ATO) assumes the achievement of satisfactory levels of knowledge during the progressive phase tests of the course. The student should be advised of any areas of lack of knowledge displayed during the examination and, if necessary, given remedial instruction. FLIGHT TRAINING (i) Aeroplane and helicopter training (1) It is widely accepted that flying training normally involves inherent delay in achieving an acceptable flight situation and configuration for training to be carried out in accordance with the agreed syllabus. These could include ATC or other traffic delay on the ground prior to take off, the necessity to climb to height or transit to suitable training areas and the unavoidable need to physically reposition the aircraft for subsequent or repeat manoeuvres or instrument approaches. In such cases it should be ensured that the training syllabus provides adequate flexibility to enable the minimum amount of required flight training to be carried out. FINAL IN-FLIGHT EXERCISE (j) Upon completion of the flight test training, the test pilot or flight test engineer will be required to undergo in-flight exercise with a flight test instructor (FTI) to demonstrate adequate competency of flight testing for issue of the flight test rating. The final inflight exercise must be conducted in an appropriate aeroplane or helicopter (as applicable). COURSE COMPLETION CERTIFICATE (k) The HT is required to certify that the applicant has successfully completed the training course. AMC1 ORA.ATO.135 Training aircraft and FSTDs ALL ATOs, EXCEPT THOSE PROVIDING FLIGHT TEST TRAINING (a) The number of training aircraft may be affected by the availability of FSTDs. (b) Each training aircraft should be: (1) equipped as required in the training specifications concerning the course in which it is used; (2) except in the case of balloons or single-seat aircraft, fitted with primary flight controls that are instantly accessible by both the student and the instructor (for example dual flight controls or a centre control stick). Swing-over flight controls should not be used.

text: Annex to ED Decision 2012/007/R

text: (c) The fleet should include, as appropriate to the courses of training: (1) aircraft suitably equipped to simulate instrument meteorological conditions (IMC) and for the instrument flight training required. For flight training and testing for the instrument rating, an adequate number of IFR-certificated aircraft should be available; (2) in the case of aeroplanes and sailplanes, aircraft suitable for demonstrating stalling and spin avoidance; (3) for the flight instructor (FI) training courses on aeroplanes and sailplanes, aircraft suitable for spin recovery at the developed stage; (4) in the case of helicopters, helicopters suitable for autorotation demonstration; (5) in the case of a non-complex ATO, one aircraft fulfilling all the required characteristics for a training aircraft might be sufficient; (6) each FSTD should be equipped as required in the training specifications concerning the course in which it is used. AMC1 ORA.ATO.140 Aerodromes and operating sites GENERAL (a) Except in the case of balloons, the base aerodrome or operating site and any alternative base aerodromes at which flight training is being conducted should have at least the following facilities: (1) at least one runway or final approach and take-off area (FATO) that allows training aircraft to make a normal take-off or landing within the performance limits of all the aircraft used for the training flights. (2) a wind direction indicator that is visible at ground level from the ends of each runway or at the appropriate holding points; (3) adequate runway electrical lighting if used for night training; (4) an air traffic service, except for uncontrolled aerodromes or operating sites where the training requirements may be satisfied safely by another acceptable means of air-to-ground communication. (b) Except in the case of ATOs providing flight test training, in addition to (a), for helicopters, training sites should be available for: (1) confined area operation training; (2) simulated engine off autorotation; and (3) sloping ground operation. (c) In the case of balloons, the take-off sites used by the ATO should allow a normal take-off and clearing of all obstacles in the take-off flight path by at least 50 ft. AMC1 ORA.ATO.145 Pre-requisites for training ENTRANCE REQUIREMENTS ATOs providing training for other than the LAPL, PPL, SPL or BPL and the associated ratings and certificates should establish entrance requirements for students in their procedures. The entrance requirements should ensure that the students have enough knowledge, particularly of physics and mathematics, to be able to follow the courses.

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text: SECTION II - ADDITIONAL REQUIREMENTS FOR ATOs PROVIDING TRAINING FOR CPL, MPL AND ATPL AND THE ASSOCIATED RATINGS AND CERTIFICATES AMC1 ORA.ATO.210 Personnel requirements GENERAL (a) The management structure should ensure supervision of all grades of personnel by persons having the experience and qualities necessary to ensure the maintenance of high standards. Details of the management structure, indicating individual responsibilities, should be included in the ATOs operations manual. (b) The ATO should demonstrate to the competent authority that an adequate number of qualified, competent staff is employed. (c) In the case of an ATO offering integrated courses, the HT, the chief flying instructor (CFI) and the chief theoretical knowledge instructor (CTKI) should be employed fulltime or part-time, depending upon the scope of training offered. (d) In the case of an ATO offering only one of the following: (1) modular courses, (2) type rating courses, (3) theoretical knowledge instruction, the positions of HT, CFI and CTKI may be combined and filled by one or two persons with extensive experience in the training conducted by the training organisation, fulltime or part-time, depending upon the scope of training offered. (e) The ratio of all students to flight instructors, excluding the HT, should not exceed 6:1. (f) Class numbers in ground subjects involving a high degree of supervision or practical work should not exceed 28 students. THEORETICAL KNOWLEDGE INSTRUCTORS (g) The theoretical knowledge instruction for type or class ratings should be conducted by instructors holding the appropriate type or class rating, or having appropriate experience in aviation and knowledge of the aircraft concerned. (h) For this purpose, a flight engineer, a maintenance engineer or a flight operations officer should be considered as having appropriate experience in aviation and knowledge of the aircraft concerned. AMC2 ORA.ATO.210 Personnel requirements QUALIFICATION OF HEAD OF TRAINING AND CHIEF FLIGHT INSTRUCTOR (a) Head of training (HT) The nominated HT should hold or have held in the 3 years prior to first appointment as HT, a professional pilot licence and associated ratings or certificates issued in accordance with Part-FCL, related to the flight training courses provided. (b) Chief flight instructor (CFI) (1) The CFI may delegate standardisation and supervision to the flight instructors. In all cases it is the CFI who is ultimately responsible for ensuring quality and standards. (2) The CFI should, except in the case of ATOs providing flight test training, have completed 1 000 hours of flight time as pilot-in-command (PIC). At least 500 of

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text: those hours should be on flying instructional duties related to the flying courses provided, of which 200 hours may be instrument ground time. AMC1 ORA.ATO.230(a) Training manual and operations manual TRAINING MANUAL Training manuals for use at an ATO conducting integrated or modular flight training courses should include the following: (a) The training plan: (1) The aim of the A statement of what the student is expected to do as a result course (ATP, CPL/IR, of the training, the level of performance, and the training CPL, etc. as applicable) constraints to be observed. (2) Pre-entry (i) Minimum age, educational requirements (including requirements language), medical requirements; (ii) Any individual Member State requirements. (3) Credits for previous To be obtained from the competent authority before training experience begins. (4) Training syllabi As applicable, the flying syllabus (single-engine or multiengine, as applicable), the flight simulation training syllabus and the theoretical knowledge training syllabus. (5) The time scale and Arrangements of the course and the integration of syllabi time. scale, in weeks, for each syllabus (6) Training programme (i) The general arrangements of daily and weekly programmes for flying, theoretical knowledge training and training in FSTDs, if applicable; (ii) Bad weather constraints; (iii) Programme constraints in terms of maximum student training times, (flying, theoretical knowledge, on FSTDs), for example per day, week or month; (iv) Restrictions in respect of duty periods for students; (v) Duration of dual and solo flights at various stages; (vi) Maximum flying hours in any day or night; (vii) Maximum number of training flights in any day or night; (viii) Minimum rest period between duty periods. (7) Training records (i) Rules for security of records and documents; (ii) Attendance records; (iii) The form of training records to be kept; (iv) Persons responsible for checking records and students’ log books; (v) The nature and frequency of record checks; (vi) Standardisation of entries in training records; (vii) Rules concerning log book entries.

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text: (8) Safety training (i) Individual responsibilities; (ii) Essential exercises; (iii) Emergency drills (frequency); (iv) Dual checks (frequency at various stages); (v) Requirement before first solo day, night or navigation etc. if applicable. (9) Tests and (i) Flying: examinations (A) progress checks; (B) skill tests. (ii) Theoretical knowledge: (A) progress tests; (B) theoretical knowledge examinations. (iii) Authorisation for test; (iv) Rules concerning refresher training before retest; (v) Test reports and records; (vi) Procedures for examination paper preparation, type of question and assessment, standard required for ‘pass’; (vii) Procedure for question analysis and review and for raising replacement papers; (viii) Examination resit procedures. (10) Training (i) Individual responsibilities; effectiveness (ii) General assessment; (iii) Liaison between departments; (iv) Identification of unsatisfactory progress (individual students); (v) Actions to correct unsatisfactory progress; (vi) Procedure for changing instructors; (vii) Maximum number of instructor changes per student; (viii) Internal feedback system for detecting training deficiencies; (ix) Procedure for suspending a student from training; (x) Discipline; (xi) Reporting and documentation. (11) Standards and (i) Individual responsibilities; level of performance at (ii) Standardisation; various stages (iii) Standardisation requirements and procedures; (iv) Application of test criteria. (b) Briefing and air exercises: (1) Air exercise A detailed statement of the content specification of all the air exercises to be taught, arranged in the sequence to be flown with main and subtitles. (2) Air exercise An abbreviated list of the above exercises giving only main and reference list subtitles for quick reference, and preferably in flip-card form to facilitate daily use by instructors.

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text: (3) Course structure: A statement of how the course will be divided into phases, phase of training indication of how the above air exercises will be divided between the phases and how they will be arranged to ensure that they are completed in the most suitable learning sequence and that essential (emergency) exercises are repeated at the correct frequency. Also, the syllabus hours for each phase and for groups of exercises within each phase should be stated and when progress tests are to be conducted, etc. (4) Course structure: The manner in which theoretical knowledge and flight training integration of syllabi in an aircraft or an FSTD will be integrated so that as the flying training exercises are carried out students will be able to apply the knowledge gained from the associated theoretical knowledge instruction and flight training. (5) Student progress The requirement for student progress and include a brief but specific statement of what a student is expected to be able to do and the standard of proficiency he/she must achieve before progressing from one phase of air exercise training to the next. Include minimum experience requirements in terms of hours, satisfactory exercise completion, etc. as necessary before significant exercises, for example night flying. (6) Instructional The ATO requirements, particularly in respect of pre- and postmethods flying briefing, adherence to syllabi and training specifications, authorisation of solo flights, etc. (7) Progress tests The instructions given to examining staff in respect of the conduct and documentation of all progress tests. (8) Glossary of terms Definition of significant terms as necessary. (9) Appendices (i) Progress test report forms; (ii) Skill test report forms; (iii) ATO certificates of experience, competence, etc. as required. (c) Flight training in an FSTD, if applicable: Structure generally as for (b) (d) Theoretical knowledge instruction: (1) Structure of the A statement of the structure of the course, including the theoretical knowledge general sequence of the topics to be taught in each subject, course the time allocated to each topic, the breakdown per subject and an example of a course schedule. Distance learning courses should include instructions of the material to be studied for individual elements of the course. (2) Lesson plans A description of each lesson or group of lessons including teaching materials, training aids, progress test organisation and inter-connection of topics with other subjects. (3) Teaching materials Specification of the training aids to be used (for example study materials, course manual references, exercises, selfstudy materials, demonstration equipment). (4) Student progress The requirement for student progress, including a brief but specific statement of the standard that must be achieved and the mechanism for achieving this, before application for

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text: theoretical knowledge examinations. (5) Progress testing The organisation of progress testing in each subject, including topics covered, evaluation methods and documentation. (6) Review procedure The procedure to be followed if the standard required at any stage of the course is not achieved, including an agreed action plan with remedial training if required. AMC1 ORA.ATO.230(b) Training manual and operations manual ALL ATOs, EXCEPT THOSE PROVIDING FLIGHT TEST TRAINING OPERATIONS MANUAL The operations manual for use at an ATO conducting integrated or modular flight training courses should include the following: (a) General: (1) a list and description of all volumes in the operations manual; (2) administration (function and management); (3) responsibilities (all management and administrative staff); (4) student discipline and disciplinary action; (5) approval or authorisation of flights; (6) preparation of flying programme (restriction of numbers of aircraft in poor weather); (7) command of aircraft; (8) responsibilities of the PIC; (9) carriage of passengers; (10) aircraft documentation; (11) retention of documents; (12) flight crew qualification records (licences and ratings); (13) revalidation (medical certificates and ratings); (14) flight duty period and flight time limitations (flying instructors); (15) flight duty period and flight time limitations (students); (16) rest periods (flight instructors); (17) rest periods (students); (18) pilots’ log books; (19) flight planning (general); (20) safety (general): equipment, radio listening watch, hazards, accidents and incidents (including reports), safety pilots etc.. (b) Technical: (1) aircraft descriptive notes; (2) aircraft handling (including checklists, limitations, maintenance and technical logs, in accordance with relevant requirements, etc.); (3) emergency procedures; (4) radio and radio navigation aids;

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text: (5) allowable deficiencies (based on the master minimum equipment list (MMEL), if available). (c) Route: (1) performance (legislation, take-off, route, landing etc.); (2) flight planning (fuel, oil, minimum safe altitude, navigation equipment etc.); (3) loading (load sheets, mass, balance and limitations); (4) weather minima (flying instructors); (5) weather minima (students – at various stages of training); (6) training routes or areas. (d) Personnel training (1) appointments of persons responsible for standards/competence of flight personnel; (2) initial training; (3) refresher training; (4) standardisation training; (5) proficiency checks; (6) upgrading training; (7) ATO personnel standards evaluation.

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text: SECTION III - ADDITIONAL REQUIREMENTS FOR ATOs PROVIDING SPECIFIC TYPES OF TRAINING Chapter 1 – Distance Learning Course AMC1 ORA.ATO.300 General DISTANCE LEARNING (a) A variety of methods is open to ATOs to present course material. It is, however, necessary for ATOs to maintain comprehensive records in order to ensure that students make satisfactory academic progress and meet the time constraints laid down in Part-FCL for the completion of modular courses. (b) The following are given as planning guidelines for ATOs developing the distance learning element of modular courses: (1) an assumption that a student will study for at least 15 hours per week; (2) an indication throughout the course material of what constitutes a week’s study; (3) a recommended course structure and order of teaching; (4) one progress test for each subject for every 15 hours of study, which should be submitted to the ATO for assessment. Additional self-assessed progress tests should be completed at intervals of five to 10 study hours; (5) appropriate contact times throughout the course when a student can have access to an instructor by telephone, fax, email or the Internet; (6) measurement criteria to determine whether a student has satisfactorily completed the appropriate elements of the course to a standard that, in the judgement of the HT, or CGI, will enable them to be entered for the Part-FCL theoretical examinations with a good prospect of success; (7) if the ATO provides the distance learning by help of IT solutions, for example the Internet, instructors should monitor students’ progress by appropriate means. Chapter 2 - Zero Flight-Time Training (ZFTT) AMC1 ORA.ATO.330 General INITIAL APPROVAL For an initial approval to conduct ZFTT, the operator should have held an air operator's certificate for commercial air transport for at least 1 year. This period may be reduced where the operator and the ATO have experience of type rating training.

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text: SUBPART FSTD –REQUIREMENTS FOR ORGANISATIONS OPERATING FLIGHT SIMULATION TRAINING DEVICES (FSTDS) AND THE QUALIFICATION OF FSTDS SECTION I - REQUIREMENTS FOR ORGANISATIONS OPERATING FSTDS AMC1 ORA.FSTD.100 General COMPLIANCE MONITORING PROGRAMME – ORGANISATIONS OPERATING FSTDS (a) Introduction. (1) The purpose of this AMC is to provide additional and specific information to an organisation operating FSTDs on how to establish a compliance monitoring programme (CMP) that enables compliance with the applicable requirements. (b) Compliance monitoring programme (1) Typical subject areas for inspections are the following: (i) actual FSTD operation; (ii) maintenance; (iii) technical Standards; (iv) FSTD safety features. (c) Audit scope (1) Organisations operating FSTDs are required to monitor compliance with the procedures they have designed to ensure specified performance and functions. In doing so they should as a minimum, and where appropriate, monitor the following: (i) organisation; (ii) plans and objectives; (iii) maintenance procedures; (iv) FSTD qualification level; (v) supervision; (vi) FSTD technical status; (vii) manuals, logs and records; (viii) defect deferral; (ix) personnel training; (x) aircraft modifications; (xi) FSTD configuration management. AMC2 ORA.FSTD.100 General COMPLIANCE MONITORING PROGRAMME –ORGANISATIONS OPERATING FSTDS One acceptable means of measuring FSTD performance is contained in ARINC report 433-1 th (December 14 , 2007 or as amended) Standard Measurements for Flight Simulation Quality.

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text: AMC3 ORA.FSTD.100 General COMPLIANCE MONITORING PROGRAMME – ORGANISATIONS OPERATING BASIC INSTRUMENT TRAINING DEVICES (BITDs) (a) The compliance monitoring programme together with a statement acknowledging completion of a periodic review by the accountable manager should include the following: (1) a maintenance facility that provides suitable BITD hardware and software test and maintenance capability; (2) a recording system in the form of a technical log in which defects, deferred defects and development work are listed, interpreted, actioned and reviewed within a specified time scale; and (3) planned routine maintenance of the BITD and periodic running of the qualification test guide (QTG) with adequate manning to cover BITD operating periods and routine maintenance work. (b) A planned audit schedule and a periodic review should be used to verify that corrective action was carried out and that it was effective. The auditor should have adequate knowledge of BITDs. GM1 ORA.FSTD.100 General COMPLIANCE MONITORING – ORGANISATIONS OPERATING FSTDS – GENERAL (a) The concept of compliance monitoring (CM) is a fundamental requirement for organisations operating FSTDs. An effective CM function is vitally important in supporting operation of the devices, in a structured way, to ensure they remain in compliance with the technical standards of CS-FSTD(A) and CS-FSTD(H) and continue to be effective training tools. An effective CM function is also essential to support any level of extended recurrent evaluation period as permitted by ORA.FSTD.225(b). (b) The following guidance has been developed to provide additional material to help both organisations operating FSTDs and competent authorities in developing effective CM that satisfy the applicable requirements and ensure the highest standards of training are maintained. (c) Additional GM provide a compliance checklist for organisations operating FSTDs (GM2 ORA.FSTD.100) and guidance detailing the preparation for an evaluation by the competent authority (GM3 ORA.FSTD.100). The compliance checklist should be used by the competent authorities as a standardised checklist for the elements that are expected in the CM function of an organisation operating FSTDs. The organisation should complete as a minimum the second column of the checklist by providing appropriate manual or procedure references for each of the identified elements of the CM function. Additional information can be provided in the third column to aid assessment of the checklist as appropriate. This would then be provided to the competent authority. Use of this checklist should assist in ensuring a consistent approach by the competent authorities and also provide organisations operating FSTDs with additional guidance on all the elements of a CM function that the competent authorities will expect. The guidance is provided to help organisations operating FSTDs to prepare for authority visits. (d) The documentation of the CM may be electronic, provided the necessary controls can be demonstrated. This should include control of any paper copies that may be downloaded for use by individuals. It is recommended that any such copies are automatically designated as uncontrolled as part of the download process. Whilst electronic signatures on master documents may be accepted, with appropriate

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text: protections, a hardcopy master of the CM manual should be provided, with wet-ink signatures to be held by the applicant. (e) It should be recognised that whatever CM is developed, it will not be effective unless it becomes an integral part of the way in which the organisation works. It includes both the necessary procedures for maintaining compliance with all the applicable requirements and a compliance monitoring programme (CMP) to monitor the execution of these procedures. A successful CM will ensure that the highest training tool is available at all times. If the CM is viewed as an add-on to existing processes it will become a burden and it will never be wholly effective. It should also be noted that compliance control or inspection is only a small part of a CM. If the CM is working effectively, inspections such as fly-outs should become routine revealing little beyond day-to-day unserviceabilities. Systematic defects should be captured by the CMP. (f) The competent authority should be satisfied that the accountable manager is able to adequately provide the required level of resources to properly support the FSTD. Detailed knowledge of FSTD requirement standards are not necessary, only sufficient to understand his/her responsibility for ensuring the FSTD is properly supported. The assessment of the compliance monitoring manager should concentrate on establishing that the nominee has sufficient knowledge and experience of both CM management and FSTD operations to operate a compliance monitoring system (CMS) within an organisation operating FSTDs. This is likely to require experience of working in the compliance monitoring field and sufficient knowledge of FSTDs and the technical standards with which they should comply. (g) If an organisation operating FSTDs is certified under any international quality standard it should assure that it fully covers the applicable organisation requirements of Part- ORA and the qualification basis. (h) For small organisations, it is perfectly acceptable to combine the roles of compliance monitoring manager and accountable manager. For other organisations that hold multiple certificates and may cover multiple sites, it is advantageous to have a common CM function with an overall compliance monitoring manager. However, it is essential, particularly where sites may be significantly separated geographically, that there is a nominated representative at each site and possibly for each certificate. These representatives should hold the delegated responsibility of the CM manager for the day-to-day CM role at their site and in their function and have the necessary direct reporting line to the overall CM manager. It will also be necessary to ensure that local representatives are also acceptable to the local competent authority. In many cases the local representatives may perform other functions in addition to this role. This is acceptable provided the necessary independence of any compliance monitoring activity is maintained. (i) CM, as a whole, begins with the requirements with which the system seeks to comply. These include both the technical standards, in this case the relevant parts of CS- FSTD(A)/(H) plus any other specific standards, for example health and safety regulations, and the compliance monitoring objectives, such as defect rates and rectification intervals and FSTD reliability targets. The CM should define the process by which these standards are made available to those who require them. (j) The next part of CM is that part which defines the day-to-day procedures or working practices by which the standards will be achieved. These procedures should include as a minimum defect reporting systems, defect rectification processes, tracking mechanisms, preventative maintenance programmes, spares handling, equipment calibration and configuration management of the device. They should include checks to assess the compliance of the performed actions. These procedures and standards should be made readily available to anybody involved in the maintenance and day-today operation of the FSTD.

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text: (k) The third part of CM is the method by which the organisation operating an FSTD confirms the device is maintained in compliance with the defined standards and is being operated in accordance with the defined procedures. This is the compliance monitoring programme (CMP) and includes the audit methods, reporting and corrective action procedures and feedback, management reviews and schedules for audits of all aspects of the FSTD operation. (l) Across all aspects of CM, and most important to it, are the people. CM includes the definition of the responsibilities of all staff and should include a declaration of the minimum levels of resource proposed for the direct support of the FSTD plus the levels of support and managerial staff proposed. The levels of resource can be affected by factors such as local health and safety regulations, existence of weekend and/or night usage of the device(s), etc. CM also includes definition of the skills and experience required for staff and leads to definition of any required training programmes. Training needs cover both technical training and audit training, including QTG running and checking and fly-out techniques for flight crew. (m) The documentation of CM may be provided in any number of documents provided there are appropriate cross-references in all documents such that the system is fully traceable in both directions from end to end. For all but small organisations at least two documents would be expected: (1) Firstly, a CM manual containing the policy, terminology, organisational charts and responsibilities, an overview of all processes, within the system, including those for maintaining regulatory compliance such as QTG running and fly-outs (function and subjective testing), CMP including the audit schedule and audit procedures including reporting and corrective action procedures. In addition, the CM manual should include, either directly or by reference, the identification of skills and experience and associated training. (2) Secondly, a procedures manual containing, as a minimum, software and hardware control procedures, configuration control procedures including, for example, control of training loads, updates to visual models, navigation and instructor operation station (IOS) databases, QTG running and checking procedures, fly-out procedures, maintenance procedures including both defect rectification and preventative maintenance processes. Any standard forms and checklists should also be included. (n) The CM documentation also includes all records such as technical logs, QTG runs, flyout reports and maintenance job cards. (o) For organisations with several certificates, separate and modular procedures manuals with a single CM manual covering all approvals, may be acceptable. (p) It is important to understand the difference between compliance assurance and compliance control. An effective CM will contain elements of both. Compliance control is normally done by inspection of the product; it provides confirmation at the time of the inspection that the product conforms to a defined standard. (q) The compliance assurance element is essential to ensure the standard is maintained throughout the periods between product (FSTD) inspections. Within a CMP, the processes are defined that are necessary to provide confidence that the FSTD(s) is/are being supported and maintained to the highest possible standard and in compliance with the relevant requirements. A programme of internal audits is then set in place to confirm that the processes are being followed and are effective. The competent authority would normally oversee a certified organisation by process and system audit, however, in the case of FSTDs, authority oversight includes an inspection element in the form of the recurrent FSTD evaluation. (r) In addition to the normal process and system audits, the compliance assurance audit schedule should include the schedule for each FSTD for fly-outs and QTG running through the audit year.

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text: (s) The audit procedure should include, at least, the following: statement of scope, planning, initiation of audit, collection of evidence, analysis, reporting of findings, identification and agreement of corrective actions and feedback, including reporting significant findings to the competent authority, where appropriate. The review of published material could include, in addition to the CM and procedures manuals, QTG records, fly-out reports, technical log sheets, maintenance records and configuration control records. (t) In addition to basic knowledge of FSTD requirements and operation, it is expected that auditors have received training in CM and audit techniques. (u) The routine fly-outs of the device are a specialised part of the audit programme. It is essential that the pilots tasked with carrying out these fly-outs are adequately experienced. They would be expected to be type rating instructor/examiner (TRI/TRE) qualified on the type, and should have experience of simulator evaluations carried out by the competent authority. The assignment of such pilots can present difficulties, particularly for the independent organisation operating FSTDs not directly associated with an airline. It is vital for the organisation to ensure their users are aware of the importance of the fly-outs as part of the continued qualification of the device and the need to assist in the provision of suitably qualified pilots to carry them out. It is worth noting that simulator users are required to satisfy themselves that the training devices they use are assessed for continued suitability, as part of their own CMP. Involvement in fly-outs assists in meeting this need. (v) Whilst it is accepted that the number of audits required in an organisation with a single device will be significantly less than those in larger organisations with multiple devices, the CMP should still meet the same criteria, and cover all aspects of the operation within a 12 month period. The independence of the audit personnel should be maintained at all times. The audit programme, whether by full audit or by using a checklist system should still be sufficiently comprehensive to provide the necessary level of confidence that the device is maintained and operated to the highest possible standard. This includes monitoring and review of corrective actions and feedback processes. (w) The successful use of sub-contractors who play a significant role in the provision of services, such as maintenance or engineering services, to an organisation operating FSTDs is reliant on the sub-contractor operating under the CM of the organisation. All requirements that an organisation is expected to meet are equally applicable to his/her sub-contractor. It is the organisation’s responsibility to ensure that the subcontractor complies with its CM. (x) It is essential that a proper understanding of the CM and how it applies to each and every staff member is provided by appropriate training to all, not just those directly involved in operating the CM, such as the accountable manager, the CM manager, representatives and the auditors. The training given to those directly involved in CM should cover the CM, audit techniques and applicable technical standards. CM familiarisation training should be an integral part of any induction training and recurrent training. Update training on technical standards for audit personnel, is also of particular importance. (y) Any effective CM will include measurement of its effectiveness. The organisation should develop performance measures that can be monitored against objectives. Such measures, often referred to as metrics, should be reviewed by the competent authority as part of its oversight of the CM within the organisation and during recurrent evaluations. In addition they should form part of the data reviewed during scheduled management reviews as part of the CM. (z) ARINC 433 provides good guidance on FSTD compliance measurement. Metrics should monitor not only individual FSTD performance but, for larger organisations, how each FSTD is performing within the fleet. It is also recommended that metrics data be

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text: shared, regularly, with the FSTD manufacturers to allow monitoring for generic problems such as design issues, which may be best addressed with a fleet-wide solution.

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text: GM2 ORA.FSTD.100 General COMPLIANCE MONITORING – ASSESSMENT FOR ORGANISATIONS OPERATING FSTDs COMPLIANCE MONITORING ASSESSMENT FOR ORGANISATIONS OPERATING FSTDs Organisation: Site Assessed: Date of Assessment: Accountable Manager: Compliance Monitoring Manager: Number and Type of FSTDs: CM Manual Reference:

text: Audit Area CM/Proc Ref Comments Satisfactory

text: Y/N

text: 1. ACCOUNTABLE MANAGER

text: Has an accountable manager (AM) with overall responsibility for compliance monitoring (CM) been nominated? Does the accountable manager have corporate authority to ensure all necessary activities can be financed and carried out to the standard required by the competent authority? Has a formal written compliance policy statement been established, included in the CM manual and signed by the accountable manager?

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text: 2. COMPLIANCE MONITORING MANAGER

text: Has a compliance monitoring manager (CM manager) been nominated?

text: Are the posts of CM manager and AM combined? If so, is the independence of compliance audits assured?

text: Does the CM manager have overall responsibility and authority to: a) verify that standards are met; and b) ensure that the compliance monitoring programme is established, implemented and maintained?

text: Does the CM manager have direct access to the AM?

text: Does the CM manager have access to all parts of the organisation operating an FSTD and as necessary any sub-contractor’s organisation?

text: 3. COMPLIANCE MONITORING (CM)

text: Has CM been established by the operator?

text: Is CM properly documented? (see Section 4)

text: Is the CM structured according to the size and complexity of the operator?

text: Does the CM include the following as a minimum: a) monitoring of compliance a) with required technical standards; b) b) identification of corrective actions and person responsible for rectification; c) a feedback system to c) accountable manager to ensure corrective action are promptly addressed; d) d) reporting of significant non-compliances to the competent authority; e) a compliance monitoring e) programme to verify continued compliance with

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text: applicable requirements, standards and procedures.

text: Are the responsibilities of the CM manager defined to include, as a minimum: a) monitoring of corrective a) action programme; b) ensuring that the corrective actions contain b) the necessary elements; c) providing management c) with an independent assessment of corrective action, implementation and completion; d) evaluation of the d) effectiveness of the corrective action programme.

text: Are adequate financial, material and human resources in place to support CM?

text: Are management evaluations/reviews of CM held at least quarterly?

text: Does the management evaluation ensure that the CMS is working effectively and is it comprehensive and well documented? Does the compliance monitoring programme identify the processes necessary and the persons within the organisation who have the training, experience, responsibility and authority to carry out the following: a) schedule and perform a) quality inspections and audits, including unscheduled audits when required; b) b) identify and record any concerns or findings, and the evidence necessary to substantiate such concerns or findings; c) initiate or recommend c) solutions to concerns or findings through designated reporting channels; d) d) verify the implementation of

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text: solutions within specific timescales.

text: Is there sufficient auditor resource available and can their required level of independence be demonstrated?

text: Do the auditors report directly to the compliance monitoring manager? Does the defined audit schedule cover the following areas, within each 12 month period?

text: a) organisation a)

text: b) plans and objectives b)

text: c) maintenance procedures c)

text: d) FSTD qualification level; d)

text: e) supervision e)

text: f) FSTD technical status f)

text: g) manuals, logs and records g)

text: h) defect deferral h)

text: i) i) personnel training

text: j) j) aircraft and simulator configuration management, including Airworthiness Directives

text: How are audit non-compliances recorded? Are procedures in place to ensure that corrective actions are taken in response to findings?

text: Are records of the compliance monitoring programme: a) a) accurate b) complete and b) c) readily accessible? c)

text: Is there an acceptable and effective procedure for providing a briefing on the CM to all personnel?

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text: Is there an acceptable and effective procedure for ensuring that all those responsible for managing the CM receive training covering: a) a) an introduction to the concept of the CM; b) compliance management; b) c) the concept of compliance c) assurance; d) CM manuals; d) e) audit techniques; e) f) reporting and recording; f) g) how the CM supports continuous g) improvement within the organisation.

text: Are suitable training records maintained?

text: Are activities within the CM subcontracted out to external agencies?

text: Do written agreements exist between the organisation and the sub-contractor clearly defining the services and standard to be provided?

text: Are the procedures in place to ensure that the necessary authorisations/approval when required are held by a subcontractor?

text: Are the procedures in place to establish that the sub-contractor has the necessary technical competence?

text: 4. CM MANUAL

text: What is the current status of the CM manual – amendment and issue date?

text: Is there a procedure in place to control copies and the distribution of the CM manual?

text: Is the CM manual signed by the accountable manager and the compliance monitoring manager?

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text: Does the CM manual include, either directly or by reference to other documents, the following: a) a description of the a) organisation; b) b) reference to appropriate FSTD technical standards; c) allocation of duties and c) responsibilities; d) d) audit procedures; e) e) reporting procedures; f) f) ollow-up and corrective action procedures; g) document retention policy; g) h) training records h)

text: Is there a document retention policy covering: a) audit schedules; a) b) inspection and audit b) reports; c) responses to findings; c) d) corrective action reports; d) e) follow-up and closure e) reports; f) management evaluation reports. f)

text: Does the CM manual include, either directly or by reference to other documents, the following procedures for day to day operation of the FSTD: a) a) defect reporting systems; b) b) defect rectification processes; c) c) tracking mechanisms; d) d) preventative maintenance programmes; e) spares handling; e) f) equipment calibration; f) g) configuration g) management of the device including visual, IOS and navigation databases; h) h) configuration control system to ensure the continued integrity of the hardware and software qualified; i) QTG running and function i) and subjective tests.

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text: Does the CM manual include, either directly or by reference to other documents, procedures for notification of the competent authorities of the following: a) any change in the a) organisation including company name, location, management; b) major changes to a b) qualified device; c) deactivation or relocation c) of a qualified device; d) major failures of a d) qualified device; e) major safety issue associated with the e) installation.

text: Does the CM manual define acceptable and effective procedures to ensure compliance with applicable health and safety regulations, including: a) safety briefings; b) fire/smoke detection and a) suppression; b) c) protection against electrical, mechanical, hydraulic and pneumatic hazards; c) d) other items as defined in AMC1 ORA.FSTD.115 d)

text: Does the CM manual include acceptable and effective procedures for regularly checking FSTD safety features such as emergency stops and emergency lighting, and are such tests recorded?

text: 5. COMPLIANCE MEASURES

text: Have compliance monitoring objectives been developed from the policy statement, and included either directly or by reference in the CMS manual?

text: Does the CMS include processes to produce and review appropriate metrics data?

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text: Do these compliance measures track the following: a) a) FSTD availability; b) numbers of defects; b) c) open defects; c) d) defect closure rates; d) e) training session interrupt e) rates; f) training session compliance f) rating. Do the compliance measures support the compliance objectives?

text: Required actions/Comments Signature:……………………………………………………… Date:…………………………………. GM3 ORA.FSTD.100 General COMPLIANCE MONITORING SYSTEM – GUIDANCE FOR ORGANISATIONS OPERATING FSTDS TO PREPARE FOR A COMPETENT AUTHORITY EVALUATION (a) Introduction The following material provides guidance on what is expected by the competent authorities to support the discussion during the preliminary briefing, which is a first step of any initial or recurrent evaluation of an FSTD carried out by a competent authority. This document has been developed as well to standardise working methods throughout Member States and to develop effective CM spot checks to satisfy the applicable requirements and therefore to ensure the highest standards of training are attained. (b) Document form Different document forms can be considered. Nevertheless, it appears that the best solution is a dossier, which includes all the information required by the competent authority to perform an evaluation. (c) Contents of the dossier for an initial evaluation: (1) type of FSTD and qualification level requested; (2) evaluation agenda: including date of evaluation, name of people involved for the competent authority, contact details for the FSTD operator, schedules for the subjective flight profile, QTG rerun; (3) FSTD identification and detailed technical specification including, type of FSTD, manufacturer, registration number, date of entry into service, host computer, visual system, motion system, type of IOS, simulated version(s), standards of all the aircraft computers, if applicable. Manuals needed for an evaluation (e.g. flight manuals, system manuals, acceptance test manual, IOS user manual etc. – if applicable) could already be provided as part of the dossier in an electronic format;

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text: (4) planned modifications; (5) subjective open defect(s); (6) airport visual databases including for each visual scene, name of the airport, IATA and ICAO codes, type of visual scene (specific or generic), additional capabilities (e.g. snow model, WGS 84 compliance, enhanced ground proximity warning system (EGPWS)); and (7) QTG status: the list should include for each QTG test available the status of the tests following the FSTD operator and competent authority reviews. (d) Contents of the dossier for a recurrent evaluation: (1) type of FSTD and qualification level requested; (2) evaluation agenda, including date of evaluation, name of people involved for the competent authority, contact details for the operator, schedules for the subjective flight profile, QTG rerun and QTG review; (3) FSTD identification, including type of FSTD, manufacturer, registration number, date of entry into service, host computer, visual system, motion system, type of IOS, simulated version(s), standards of all the aircraft computers, if applicable; (4) status of items raised during the last evaluation and date of closure; (5) reliability data: training hours month by month during the past year, numbers of complaints mentioned in the technical log, training hours lost, availability rate; (6) operational data: a list of FSTD users over the previous 12 months should be provided, with number of training hours; (7) failure tabulation including categorisation of failures (by ATA chapter and Pareto diagram, ARINC classification); (8) details of main failures leading to training interruption or multiple occurrences of some failures; (9) hardware and/or software updates or changes since last evaluation and planned hardware and/or software updates or changes; (10) subjective open defect(s); (11) airport visual databases including for each visual scene, name of the airport, ATA and ICAO codes, type of visual scene (specific or generic), additional capabilities (snow model, WGS 84 compliance, EGPWS); (12) QTG status: the list should include for each QTG test available, the date of run during the past year, any comment, and the status of the tests; and (13) results of scheduled internal audits and additional quality inspections (if any) since last evaluation and a summary of actions taken. AMC1 ORA.FSTD.110 Modifications GENERAL (a) The FSTD, where applicable, should be maintained in a configuration that accurately represents the aircraft being simulated. This may be a specific aircraft tail number or may be a representation of a common standard. (b) Users of the device should always establish a differences list for any device they intend to use, and to identify how any differences should be covered in training. In order to ensure each device is maintained in the appropriate configuration, the organisation operating an FSTD should have a system that ensures that all relevant airworthiness directives (ADs) are introduced where applicable on affected FSTDs.

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text: (c) ADs from both the State of Design of the aircraft and the State where the FSTD is located should be monitored. ADs from the State of Design of an aircraft are usually automatically applicable, unless specifically varied by the aircraft’s State of Registry. (d) Where appropriate, ADs issued by States where users of the device have aircraft registered should also be monitored. In addition to ADs, the FSTD operator should also put in place processes that ensure all aircraft modifications are reviewed for any effect on training, testing and checking. This can be achieved by reviewing the aircraft manufacturer’s service bulletins and may require a specific link to the aircraft manufacturer to be developed. In practice this link is often established through aircraft operators who use the device. (e) Organisations operating FSTDs should notify the competent authority of major changes. (f) This does not imply that the competent authority will always wish to directly evaluate the change. The competent authority should be mindful of the potential burden placed on the organisation by a special evaluation and should always consider that burden when deciding if such an evaluation is necessary. (g) The organisation operating FSTDs should have an internal acceptance process for modifications, to be used when implementing all modifications, even if the competent authority has made a decision to carry out an evaluation. GM1 ORA.FSTD.110 Modifications EXAMPLES OF MAJOR MODIFICATIONS The following are examples of modifications that should be considered as major. This list is not exhaustive and modifications need to be classified on a case-by-case basis: (a) any change that affects the QTG; (b) introduction of new standards of equipment such as flight management and guidance computer (FMGC) and updated aerodynamic data packages; (c) re-hosting of the FSTD software; (d) introduction of features that model new training scenarios; e.g. airborne collision avoidance system (ACAS), EGPWS; (e) aircraft modifications that could affect the FSTD qualification; and (f) FSTD hardware or software modifications that could affect the handling qualities, performance or system representation. AMC1 ORA.FSTD.115 Installations MINIMUM ELEMENTS FOR SAFE OPERATION (a) Introduction (1) This AMC identifies those elements that are expected to be addressed, as a minimum, to ensure that the FSTD installation provides a safe environment for the users and operators of the FSTD under all circumstances. (b) Expected elements (1) Adequate fire/smoke detection, warning and suppression arrangements should be provided to ensure safe passage of personnel from the FSTD. (2) Adequate protection should be provided against electrical, mechanical, hydraulic and pneumatic hazards, including those arising from the control loading and

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text: motion systems, to ensure maximum safety of all persons in the vicinity of the FSTD. (3) Other areas that should be addressed include the following: (i) a two-way communication system that remains operational in the event of a total power failure; (ii) emergency lighting; (iii) escape exits and escape routes; (iv) occupant restraints (seats, seat belts etc.); (v) external warning of motion and access ramp or stairs activity; (vi) danger area markings; (vii) guard rails and gates; (viii) motion and control loading emergency stop controls accessible from either pilot or instructor seats; (ix) a manual or automatic electrical power isolation switch. GM1 ORA.FSTD.115 Installations GENERAL (a) The intent of ORA.FSTD.115 is to establish that the organisation operating an FSTD has all the necessary procedures in place to ensure that the FSTD installation remains in compliance with all requirements affecting the safety of the device and its users. (b) Based on experience, the competent authority should pay particular attention to the quality of safety briefings on the FSTD provided to users and instructors, and to the execution of regular checks on the FSTD safety features. (c) It is recognised that certain checks, such as that of the emergency stop, can have adverse impact on the FSTD if carried out in full. (d) It is acceptable to develop a procedure that protects elements of the device by shutting them down in advance, in a more controlled manner, provided it can be shown that the procedure still demonstrates the whole device can be shut down by the operation of a single emergency stop button, when required. SECTION II – REQUIREMENTS FOR THE QUALIFICATION OF FSTDs AMC1 ORA.FSTD.200 Application for FSTD qualification LETTER OF APPLICATION FOR INITIAL QUALIFICATION OF AN FSTD; EXCEPT BASIC INSTRUMENT TRAINING DEVICE (BITD) A sample of letter of application is provided overleaf. Part A To be submitted not less than 3 months prior to requested qualification date (Date) (Office – Competent Authority) (Address)…………………………………………….

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text: (City)………………………………………………….. (Country)…………………………………………….

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text: Type of Aircraft Qualification Level Sought FSTD Type/class Full Flight A B C D Sp./Cat Simulator FFS Flight 1 2 3 Training Device FTD Flight and I II III II MCC III MCC Navigation Procedures Trainer FNPT

text: Interim Qualification Level requested: YES/NO Dear, <Name of Applicant> requests the evaluation of its flight simulation training device<operator’s identification of the FSTD> for qualification. The <FSTD manufacturer’s name> FSTD with its <visual system and manufacturer’s name, if applicable>visual system. Evaluation is requested for the following configurations and engine fits as applicable: e.g. 767 PW/GE and 757RR Dates requested are: <date(s)> and the FSTD will be located at <place>. The objective tests of the QTG will be submitted by <date> and in any event not less than 30 days before the requested evaluation date unless otherwise agreed with the competent authority. Comments: ………………………………………………………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………………………………………………. Signed ……………………………………………………… Print name: …………….. Position/appointment held: …………….. Email address: …………….. Telephone number: ……………..

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text: Part B To be completed with attached QTG results (Date) ………………………. We have completed tests of the FSTD and declare that it meets all applicable requirements except as noted below. The following QTG tests still have to be provided: Tests Comments (Add boxes as required) It is expected that they will be completed and submitted 3 weeks prior to the evaluation date. Signed ……………………………………………………… Print name: …………….. Position/appointment held: …………….. E-mail address: …………….. Telephone number: ……………..

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text: Part C To be completed not less than 7 days prior to initial evaluation (Date) ………………………. The FSTD has been assessed by the following evaluation team: (Name) …………………. Qualification ………………………………………….. (Name) …………………. Qualification ………………………………………….. (Name) …………………. Qualification ………………………………………….. (Name) …………………. Pilot’s Licence Nr …………………………………..  FFS/FTD: This team attests that the <type of FSTD> conforms to the aeroplane flight deck/helicopter cockpit configuration of <name of aircraft operator (if applicable), type of aeroplane/helicopter> aeroplane/helicopter within the requirements for <type of FSTD and level> and that the simulated systems and subsystems function equivalently to those in that aeroplane/helicopter. The pilot of this evaluation team has also assessed the performance and the flying qualities of the FSTD and finds that it represents the designated aeroplane/helicopter.  FNPT: This team attest(s) that the <type of FSTD> represents the flight deck or cockpit environment of a <aeroplane/helicopter or class of aeroplane/type of helicopter> within the requirements for <type of FSTD and level> and that the simulated systems appear to function as in the class of aeroplane/type of helicopter. The pilot of this evaluation team has also assessed the performance and the flying qualities of the FSTD and finds that it represents the designated class of aeroplane/type of helicopter. (Additional comments as required) ……………………………………………………………. ……………………………………………………………. ……………………………………………………………. Signed ……………………………………………………… Print name: …………….. Position/appointment held: …………….. E-mail address: …………….. Telephone number: ……………..

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text: GM1 ORA.FSTD.200 Application for FSTD qualification USE OF FOOTPRINT TESTS IN QUALIFICATION TEST SUBMISSION (a) Introduction (1) Recent experience during initial qualification of some FFSs has required acceptance of increasing numbers of footprint tests. This is particularly true for FFSs of smaller or older aircraft types, where there may be a lack of aircraft flight test data. However, the large number of footprint tests offered in some QTGs has given rise to concern. (2) This guidance is applicable to FFS aeroplane, FTD aeroplane, FFS helicopter and FTD helicopter qualifications. (b) Terminology (1) Footprint test - footprint test data are derived from a subjective assessment carried out on the actual FSTD requiring qualification. The assessment and validation of these data are carried out by a pilot appointed by the competent authority. The resulting data are the footprint validation data for the FSTD concerned. (c) Recommendation (1) It is permitted to use footprint data where flight test data is not available. Only when all other alternative possible sources of data have been thoroughly reviewed without success may a footprint test be acceptable, subject to a caseby-case review with the competent authorities concerned, and taking into consideration the level of qualification sought for the FSTD. (2) Footprint test data should be: (i) constructed with initial conditions and FFS set up in the appropriate configuration (e.g. correct engine rating) for the required validation data; (ii) a manoeuvre representative of the particular aircraft being simulated; (iii) manually flown out by a type rated pilot who has current experience on type* and is deemed acceptable by the competent authority**; (iv) constructed from validation data obtained from the footprint test manoeuvre and transformed into an automatic test; (v) an automatic test run as a fully integrated test with pilot control inputs; and (vi) automatically run for the initial qualification and recurrent evaluations. * In this context, ‘current’ refers to the pilot experience on the aircraft and not to the Part-FCL standards. ** The same pilot should sign off the complete test as being fully representative. (3) A clear rationale should be included in the QTG for each footprint test. These rationales should be added to and clearly recorded within the validation data roadmap (VDR) in accordance with and as defined in Appendix 2 to AMC1-CS- FSTD(A).300. (4) Where the number of footprint tests is deemed by the competent authority to be excessive, the maximum level of qualification may be affected. The competent authority should review each area of validation test data where the use of footprint tests as the basis for the validation data is proposed. Consideration should be given to the extent to which footprint tests are used in any given area. For example, it would be unacceptable if all or the vast majority of take-off tests were proposed as footprint tests, with little or no flight test data being

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text: presented. It should be recognised, therefore, that it may be necessary for new flight test data to be gathered if the use of footprint tests becomes excessive, not just overall, but also in specific areas. (5) For recurrent evaluation purposes an essential match is to be expected. Validation tests using footprint data which do not provide an essential match should be justified to the satisfaction of the competent authority. (6) The competent authority should be consulted at the point of definition of the aircraft data for qualification prior to the procurement of the device if footprint tests need to be used. AMC1 ORA.FSTD.225(b)(4) Duration and continued validity The assigned person should have experience in FSTDs and training. The person may have FSTD experience or training experience with an education in FSTD evaluation procedures only, provided the other element of expertise is available within the organisation and a procedure for undertaking the annual review and reporting to the competent authority is documented within the compliance monitoring function. AMC1 ORA.FSTD.230(b) Changes to the qualified FSTD UPDATING AND UPGRADING EXISTING FSTDS (a) An update is a result of a change to the existing device where it retains its existing qualification level. The change may be certified through a recurrent inspection or an extra inspection if deemed necessary by the competent authority according to the applicable requirements in effect at the time of initial qualification. (b) If such a change to an existing device would imply that the performance of the device could no longer meet the requirements at the time of initial qualification, but that the result of the change would, in the opinion of the competent authority, clearly mean an improvement to the performance and training capabilities of the device altogether, then the competent authority might accept the proposed change as an update while allowing the device to retain its original qualification level. (c) An upgrade is defined as the raising of the qualification level of a device, or an increase in training credits, which can only be achieved by undergoing an initial qualification according to the latest applicable requirements. (d) As long as the qualification level of the device does not change, all changes made to the device should be considered to be updates pending approval by the competent authority. (e) An upgrade, and consequent initial qualification according to the latest applicable requirements, is only applicable when the organisation requests another qualification level (recategorisation) for the FSTD. AMC1 ORA.FSTD.240 Record-keeping FSTD RECORDS (a) FSTD records to be kept should include the following: (1) for the lifetime of the device: (i) the master QTG (MQTG) of the initial evaluation; (ii) the qualification certificate of the initial evaluation; and (iii) the initial evaluation report;

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text: (2) for a period of at least 5 years (in paper or electronic format): (i) recurrent QTG runs; (ii) recurrent evaluation reports; (iii) reports of internal functions and subjective testing; (iv) technical log; (v) CMS report; (vi) audit schedule; (vii) evaluation programme; (viii) management evaluation reports; (ix) obsolete procedures and forms.

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text: Subpart AeMC – Aero-medical Centres SECTION I – GENERAL AMC1 ORA.AeMC.115 Application GENERAL (a) The documentation for the approval of an AeMC should include the names and qualifications of all medical staff, a list of medical and technical facilities for initial class 1 aero-medical examinations and of supporting specialist consultants. (b) The AeMC should provide details of clinical attachments to hospitals, medical institutions and/or specialists. AMC1 ORA.AeMC.135 Continued validity EXPERIENCE (a) At least 200 class 1 aero-medical examinations and assessments should be performed at the AeMC every year. (b) In Member States where the number of aero-medical examinations and assessments mentioned in (a) cannot be reached due a low number of professional pilots, a proportionate number of class 1 aero-medical examinations and assessments should be performed. (c) In these cases, the continuing experience of the head of the AeMC and aero-medical examiners on staff should also be ensured by them performing aero-medical examinations and assessments for: (1) class 2 medical certificates as established in Part-MED; and/or (2) third country class 1 medical certificates. (d) Aero-medical research including publication in peer reviewed journals may also be accepted as contributing to the continued experience of the head of, and aero-medical examiners at, an AeMC. SECTION II – MANAGEMENT GM1 ORA.AeMC.200 Management system RESEARCH If aero-medical research is conducted at an AeMC, its management system should include processes to conduct that research and publish the results. AMC1 ORA.AeMC.210 Personnel requirements GENERAL (a) The aero-medical examiner (AME) should have held class 1 privileges for at least 5 years and have performed at least 200 aero-medical examinations for a class 1 medical certificate before being nominated as head of an AeMC. (b) The AeMC may provide practical AME training for persons fully qualified and licensed in medicine.

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text: AMC1 ORA.AeMC.215 Facility requirements MEDICAL-TECHNICAL FACILITIES The medical-technical facilities of an AeMC should consist of the equipment of a general medical practice and, in addition, of: (a) Cardiology Facilities to perform: (1) 12-lead resting ECG; (2) stress ECG; (3) 24-hour blood pressure monitoring; and (4) 24-hour heart rhythm monitoring. (b) Ophthalmology Facilities for the examination of: (1) near, intermediate and distant vision; (2) external eye, anatomy, media and fundoscopy; (3) ocular motility; (4) binocular vision; (5) colour vision (anomaloscopy or equivalent); (6) visual fields; (7) refraction; and (8) heterophoria. (c) Hearing (1) pure-tone audiometer (d) Otorhinolaryngology Facilities for the clinical examination of mouth and throat and: (1) otoscopy; (2) rhinoscopy; (3) tympanometry or equivalent; and (4) clinical assessment of vestibular system. (e) Examination of pulmonary function (1) spirometry (f) The following facilities should be available at the AeMC or arranged with a service provider: (1) clinical laboratory facilities; and (2) ultrasound of the abdomen.