Organisational Reviews and Risk Management in Aviation Training: ATO Compliance, Exercises of Aviation

Download Organisational Reviews and Risk Management in Aviation Training: ATO Compliance and more Exercises Aviation in PDF only on Docsity! ee a on TU CURT NR CUS Part-ORA - Content V1, June 2016 1 | P a g e Annex VII - Part ORA Disclaimer ..................................................................................................................... 6 Consolidated version ..................................................................................................... 6 Amendments ................................................................................................................ 7 SUBPART GEN - GENERAL REQUIREMENTS .................................................................... 8 SECTION I – General ...................................................................................................... 8 GM1 ORA.GEN.005 ..................................................................................................................... 8 ORA.GEN.105 Competent authority ............................................................................................... 9 ORA.GEN.115 Application for an organisation certificate ............................................................ 10 ORA.GEN.120 Means of compliance ............................................................................................. 10 AMC1 ORA.GEN.120(a) Means of compliance .......................................................................... 10 ORA.GEN.125 Terms of approval and privileges of an organisation ............................................ 10 AMC1 ORA.GEN.125 Terms of approval and privileges of an organisation .............................. 10 ORA.GEN.130 Changes to organisations ....................................................................................... 11 AMC1 ORA.GEN.130 Changes to organisations ........................................................................ 11 GM1 ORA.GEN.130(a) Changes to organisations ..................................................................... 11 GM2 ORA.GEN.130(a) Changes to organisations ..................................................................... 12 ORA.GEN.135 Continued validity .................................................................................................. 12 ORA.GEN.140 Access ..................................................................................................................... 13 ORA.GEN.150 Findings .................................................................................................................. 13 AMC1 ORA.GEN.150(b) Findings ............................................................................................... 13 GM1 ORA.GEN.150 Findings ..................................................................................................... 13 ORA.GEN.155 Immediate reaction to a safety problem ............................................................... 13 ORA.GEN.160 Occurrence reporting ............................................................................................. 14 AMC1 ORA.GEN.160 Occurrence reporting .............................................................................. 14 SECTION II - Management ........................................................................................... 15 ORA.GEN.200 Management system ............................................................................................. 15 AMC1 ORA.GEN.200(a)(1);(2);(3);(5) Management system ..................................................... 15 AMC1 ORA.GEN.200(a)(1) Management system ...................................................................... 16 GM1 ORA.GEN.200(a)(1) Management system........................................................................ 17 GM2 ORA.GEN.200(a)(1) Management system........................................................................ 17 AMC1 ORA.GEN.200(a)(2) Management system ...................................................................... 18 GM1 ORA.GEN.200(a)(2) Management system........................................................................ 18 AMC1 ORA.GEN.200(a)(3) Management system ...................................................................... 19 GM1 ORA.GEN.200(a)(3) Management system........................................................................ 20 Part-ORA - Content V1, June 2016 4 | P a g e ORA.FSTD.100 General .................................................................................................................. 69 AMC1 ORA.FSTD.100 General ................................................................................................... 69 AMC2 ORA.FSTD.100 General ................................................................................................... 70 AMC3 ORA.FSTD.100 General ................................................................................................... 70 GM1 ORA.FSTD.100 General ..................................................................................................... 70 GM2 ORA.FSTD.100 General ..................................................................................................... 74 GM3 ORA.FSTD.100 General ..................................................................................................... 82 ORA.FSTD.105 Maintaining the FSTD qualification ....................................................................... 84 ORA.FSTD.110 Modifications ........................................................................................................ 84 AMC1 ORA.FSTD.110 Modifications.......................................................................................... 85 GM1 ORA.FSTD.110 Modifications ........................................................................................... 85 ORA.FSTD.115 Installations ........................................................................................................... 86 AMC1 ORA.FSTD.115 Installations ............................................................................................ 86 GM1 ORA.FSTD.115 Installations .............................................................................................. 87 ORA.FSTD.120 Additional equipment ........................................................................................... 87 SECTION II - Requirements for the qualification of FSTDs.............................................. 88 ORA.FSTD.200 Application for FSTD qualification ........................................................................ 88 AMC1 ORA.FSTD.200 Application for FSTD qualification .......................................................... 88 GM1 ORA.FSTD.200 Application for FSTD qualification ............................................................ 90 ORA.FSTD.205 Certification specifications for FSTDs ................................................................... 92 ORA.FSTD.210 Qualification basis ................................................................................................. 92 ORA.FSTD.225 Duration and continued validity ........................................................................... 92 AMC1 ORA.FSTD.225(b)(4) Duration and continued validity .................................................... 93 ORA.FSTD.230 Changes to the qualified FSTD .............................................................................. 93 AMC1 ORA.FSTD.230(b) Changes to the qualified FSTD ........................................................... 94 ORA.FSTD.235 Transferability of an FSTD qualification ................................................................ 94 ORA.FSTD.240 Record-keeping ..................................................................................................... 94 AMC1 ORA.FSTD.240 Record-keeping ....................................................................................... 95 SUBPART AeMC - AERO-MEDICAL CENTRES ................................................................. 96 SECTION I – General .................................................................................................... 96 ORA.AeMC.105 Scope ................................................................................................................... 96 ORA.AeMC.115 Application .......................................................................................................... 96 AMC1 ORA.AeMC.115 Application ............................................................................................ 96 ORA.AeMC.135 Continued validity ............................................................................................... 96 AMC1 ORA.AeMC.135 Continued validity ................................................................................. 96 Part-ORA - Content V1, June 2016 5 | P a g e SECTION II – Management .......................................................................................... 98 ORA.AeMC.200 Management system .......................................................................................... 98 GM1 ORA.AeMC.200 Management system .............................................................................. 98 ORA.AeMC.210 Personnel requirements ..................................................................................... 98 AMC1 ORA.AeMC.210 Personnel requirements ........................................................................ 98 ORA.AeMC.215 Facility requirements .......................................................................................... 98 AMC1 ORA.AeMC.215 Facility requirements ............................................................................ 99 ORA.AeMC.220 Record-keeping ................................................................................................. 100 Part-ORA - Content V1, June 2016 6 | P a g e Disclaimer This version has been prepared by the Agency in order to provide stakeholders with an updated and easy-to-read publication. It has been prepared by combining the officially published texts of the corresponding regulations together with the Acceptable Means of Compliance and Guidance Material (including the amendments) adopted so far. However, this is not an official publication and the Agency accepts no liability for damage of any kind resulting from the risks inherent in the use of this document. This document will be updated regularly if needed to take into account further amendments. The format of this document has been adjusted in order to make it easier to read and for reference purposes. Readers are invited and encouraged to report to fcl.easa.europa.eu any perceived errors, or comments relating to this publication. Consolidated version Subpart Version Subpart GEN V1, June 2016 Subpart ATO V1, June 2016 Subpart FSTD V1, June 2016 Subpart AeMC V1, June 2016 Part-ORA – Subpart GEN, AMC and GM V1, June 2016 Go back to Subpart GEN Go back to the content 9 | P a g e 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 VDR validation data roadmap ZFTT zero flight-time training ORA.GEN.105 Competent authority (a) For the purpose of this Part, the competent authority exercising oversight over: (1) organisations subject to a certification obligation shall be: (i) for organisations having their principal place of business in a Member State, the authority designated by that Member State; (ii) for organisations having their principal place of business located in a third country, the Agency; (2) FSTDs shall be: (i) the Agency, for FSTDs: - located outside the territory of the Member States, or, - located within the territory of the Member States and operated by organisations having their principal place of business located in a third country, Part-ORA – Subpart GEN, AMC and GM V1, June 2016 Go back to Subpart GEN Go back to the content 10 | P a g e (ii) for FSTDs located within the territory of the Member States and operated by organisations having their principal place of business in a Member State, the authority designated by the Member State where the organisation operating it has its principle place of business, or the Agency, if so requested by the Member State concerned. (b) When the FSTD located outside the territory of the Member States is operated by an organisation certified by a Member State, the Agency shall qualify this FSTD in coordination with the Member State that has certified the organisation that operates such FSTD. ORA.GEN.115 Application for an organisation certificate (a) The application for an organisation certificate or an amendment to an existing certificate shall be made in a form and manner established by the competent authority, taking into account the applicable requirements of Regulation (EC) No 216/2008 and its Implementing Rules. (b) Applicants for an initial certificate shall provide the competent authority with documentation demonstrating how they will comply with the requirements established in Regulation (EC) No 216/2008 and its Implementing Rules. Such documentation shall include a procedure describing how changes not requiring prior approval will be managed and notified to the competent authority. ORA.GEN.120 Means of compliance (a) Alternative means of compliance to the AMC adopted by the Agency may be used by an organisation to establish compliance with Regulation (EC) No 216/2008 and its Implementing Rules. (b) When an organisation wishes to use an alternative means of compliance, it shall, prior to implementing it, provide the competent authority with a full description of the alternative means of compliance. The description shall include any revisions to manuals or procedures that may be relevant, as well as an assessment demonstrating that Regulation (EC) No 216/2008 and its Implementing Rules are met. The organisation may implement these alternative means of compliance subject to prior approval by the competent authority and upon receipt of the notification as prescribed in ARA.GEN.120(d). 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. ORA.GEN.125 Terms of approval and privileges of an organisation A certified organisation shall comply with the scope and privileges defined in the terms of approval attached to the organisation’s certificate. 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 Part-ORA – Subpart GEN, AMC and GM V1, June 2016 Go back to Subpart GEN Go back to the content 11 | P a g e scope of activities defined in the management system documentation should be consistent with the terms of approval. ORA.GEN.130 Changes to organisations (a) Any change affecting: (1) the scope of the certificate or the terms of approval of an organisation; or (2) any of the elements of the organisation’s management system as required in ORA.GEN.200(a)(1) and (a)(2), shall require prior approval by the competent authority. (b) For any changes requiring prior approval in accordance with Regulation (EC) No 216/2008 and its Implementing Rules, the organisation shall apply for and obtain an approval issued by the competent authority. The application shall be submitted before any such change takes place, in order to enable the competent authority to determine continued compliance with Regulation (EC) No 216/2008 and its Implementing Rules and to amend, if necessary, the organisation certificate and related terms of approval attached to it. The organisation shall provide the competent authority with any relevant documentation. The change shall only be implemented upon receipt of formal approval by the competent authority in accordance with ARA.GEN.330. The organisation shall operate under the conditions prescribed by the competent authority during such changes, as applicable. (c) All changes not requiring prior approval shall be managed and notified to the competent authority as defined in the procedure approved by the competent authority in accordance with ARA.GEN.310(c). 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 Part-ORA – Subpart GEN, AMC and GM V1, June 2016 Go back to Subpart GEN Go back to the content 14 | P a g e (b) any relevant mandatory safety information issued by the Agency, including airworthiness directives. ORA.GEN.160 Occurrence reporting (a) The organisation shall report to the competent authority, and to any other organisation required by the State of the operator to be informed, any accident, serious incident and occurrence as defined in Regulation (EU) No 996/2010 of the European Parliament and of the Council [1] and Directive 2003/42/EC of the European Parliament and of the Council [2]. (b) Without prejudice to paragraph (a) the organisation shall report to the competent authority and to the organisation responsible for the design of the aircraft any incident, malfunction, technical defect, exceeding of technical limitations and any occurrence that would highlight inaccurate, incomplete or ambiguous information contained in the operational suitability data established in accordance with Commission Regulation (EU) No 748/2012 or other irregular circumstance that has or may have endangered the safe operation of the aircraft and that has not resulted in an accident or serious incident. (c) Without prejudice to Regulation (EU) No 996/2010, Directive 2003/42/EC, Commission Regulation (EC) No 1321/2007 and Commission Regulation (EC) No 1330/2007, the reports referred in paragraphs (a) and (b) shall be made in a form and manner established by the competent authority and contain all pertinent information about the condition known to the organisation. (d) Reports shall be made as soon as practicable, but in any case within 72 hours of the organisation identifying the condition to which the report relates, unless exceptional circumstances prevent this. (e) Where relevant, the organisation shall produce a follow-up report to provide details of actions it intends to take to prevent similar occurrences in the future, as soon as these actions have been identified. This report shall be produced in a form and manner established by the competent authority. 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 2003/43/EC2 on occurrence reporting in civil aviation. (b) In addition to the reports required by AMC 20-8 and Directive 2003/43/EC, the organisation should report volcanic ash clouds encountered during flight. 2 Directive 2003/42/EC 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. Part-ORA – Subpart GEN, AMC and GM V1, June 2016 Go back to Subpart GEN Go back to the content 15 | P a g e SECTION II - Management ORA.GEN.200 Management system (a) The organisation shall establish, implement and maintain a management system that includes: (1) clearly defined lines of responsibility and accountability throughout the organisation, including a direct safety accountability of the accountable manager; (2) a description of the overall philosophies and principles of the organisation with regard to safety, referred to as the safety policy; (3) the identification of aviation safety hazards entailed by the activities of the organisation, their evaluation and the management of associated risks, including taking actions to mitigate the risk and verify their effectiveness; (4) maintaining personnel trained and competent to perform their tasks; (5) documentation of all management system key processes, including a process for making personnel aware of their responsibilities and the procedure for amending this documentation; (6) a function to monitor compliance of the organisation with the relevant requirements. Compliance monitoring shall include a feedback system of findings to the accountable manager to ensure effective implementation of corrective actions as necessary; and (7) any additional requirements that are prescribed in the relevant subparts of this Part or other applicable Parts. (b) The management system shall correspond to the size of the organisation and the nature and complexity of its activities, taking into account the hazards and associated risks inherent in these activities. (c) Notwithstanding point (a), in an organisation providing training only for the LAPL, PPL, SPL or BPL and the associated ratings or certificates, safety risk management and compliance monitoring defined in points (a)(3) and (a)(6) may be accomplished by an organisational review, to be performed at least once every calendar year. The competent authority shall be notified about the results of this review by the organisation without undue delay. 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. Part-ORA – Subpart GEN, AMC and GM V1, June 2016 Go back to Subpart GEN Go back to the content 16 | P a g e (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 (vii) ensure initiation and follow-up of internal occurrence / accident investigations. (b) Safety review board Part-ORA – Subpart GEN, AMC and GM V1, June 2016 Go back to Subpart GEN Go back to the content 19 | P a g e 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 (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; Part-ORA – Subpart GEN, AMC and GM V1, June 2016 Go back to Subpart GEN Go back to the content 20 | P a g e (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; (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: Part-ORA – Subpart GEN, AMC and GM V1, June 2016 Go back to Subpart GEN Go back to the content 21 | P a g e (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. GM3 ORA.GEN.200(a)(3) Management system APPROVED TRAINING ORGANISATIONS - RISK MANAGEMENT OF FLIGHT OPERATIONS WITH KNOWN OR FORECAST VOLCANIC ASH CONTAMINATION (a) Responsibilities The ATO is responsible for the safety of its operations, including within an area with known or forecast volcanic ash contamination. The ATO should complete this assessment of safety risks related to known or forecast volcanic ash contamination as part of its management system before initiating operations into airspace forecast to be or aerodromes/operating sites known to be contaminated with volcanic ash. This process is intended to ensure the ATO takes into account the likely accuracy and quality of the information sources it uses in its management system and to demonstrate its own competence and capability to interpret data from different sources in order to achieve the necessary level of data integrity reliably and correctly resolve any conflicts among data sources that may arise. In order to decide whether or not to operate into airspace forecast to be or aerodromes/operating sites known to be contaminated with volcanic ash, the ATO should make use of the safety risk assessment within its management system as required by ORA.GEN.200. The ATO’s safety risk assessment should take into account all relevant data including data from the type certificate holders (TCHs) regarding the susceptibility of the aircraft they operate to volcanic cloud-related airworthiness effects, the nature and severity of these effects and the related pre-flight, in-flight and post-flight precautions to be observed by the ATO. The ATO should ensure that personnel required to be familiar with the details of the safety risk assessments receives all relevant information (both pre-flight and in-flight) in order to be in a position to apply appropriate mitigation measures as specified by the safety risk assessments. (b) Procedures The ATO should have documented procedures for the management of operations into airspace forecast to be or aerodromes/operating sites known to be contaminated with volcanic ash. These procedures should ensure that, at all times, flight operations remain within the accepted safety boundaries as established through the management system allowing for any variations in information sources, equipment, operational experience or organisation. Procedures should include those for flight crew and any other relevant personnel such that they are in a position to evaluate correctly the risk of flights into airspace forecast to be contaminated by volcanic ash and to plan accordingly. Continuing airworthiness personnel should be provided with procedures allowing them to correctly assess the need for and to execute relevant maintenance or continuing airworthiness interventions. The ATO should retain sufficient qualified and competent staff to Part-ORA – Subpart GEN, AMC and GM V1, June 2016 Go back to Subpart GEN Go back to the content 24 | P a g e (4) Determining whether the consequent risk is acceptable and within the ATO’s risk performance criteria. At this stage of the process, the safety risks should be classified as acceptable or unacceptable. The assessment of tolerability will be subjective, based on qualitative data and expert judgement, until specific quantitative data are available in respect of a range of parameters. (5) Taking action to reduce the safety risk to a level that is acceptable to the ATO’s management. Appropriate mitigation for each unacceptable risk identified should then be considered in order to reduce the risk to a level acceptable to the ATO’s management. (e) Procedures to be considered when identifying possible mitigations actions When conducting a volcanic ash safety risk assessment, the ATO should consider the following non-exhaustive list of procedures and processes as mitigation: (1) Type certificate holders Obtaining advice from the TCHs and other engineering sources concerning operations in potentially contaminated airspace and/or aerodromes/operating sites contaminated by volcanic ash. This advice should set out: (i) the features of the aircraft that are susceptible to airworthiness effects related to volcanic ash; (ii) the nature and severity of these effects; (iii) the effect of volcanic ash on operations to/from contaminated aerodromes/operating sites, including the effect on take-off and landing aircraft performance; (iv) the related pre-flight, in-flight and post-flight precautions to be observed by the ATO including any necessary amendments to aircraft operating manuals, aircraft maintenance manuals, master minimum equipment list/dispatch deviation or equivalents required to support the ATO; and (v) the recommended inspections associated with inadvertent operations in volcanic ash contaminated airspace and operations to/from volcanic ash contaminated aerodromes/operating sites; this may take the form of instructions for continuing airworthiness or other advice. (2) ATO/contracted organisations’ personnel Definition of procedures for flight planning and operations ensuring that: (i) flight crews are in a position to evaluate correctly the risk of encountering volcanic ash contaminated airspace, or aerodromes/operating sites, and can plan accordingly; (ii) flight planning and operational procedures enable crews to avoid areas and aerodromes/operating sites with unacceptable volcanic ash contamination; (iii) flight crew are aware of the possible signs of entry into a volcanic ash cloud and execute the associated procedures; (iv) continuing airworthiness personnel are able to assess the need for, and to execute, any necessary maintenance or other required interventions; and Part-ORA – Subpart GEN, AMC and GM V1, June 2016 Go back to Subpart GEN Go back to the content 25 | P a g e (v) crews are provided with appropriate aircraft performance data when operating to/from aerodromes/operating sites contaminated with volcanic ash. (3) Provision of enhanced flight watch This should ensure: (i) close and continuous monitoring of VAA, VAR/AIREP, SIGMET, NOTAM and ASHTAM and other relevant information, and information from crews, concerning the volcanic ash cloud hazard; (ii) access to plots of the affected areas from SIGMETs, NOTAMs and other relevant information for crews; and (iii) communication of the latest information to crews in a timely fashion. (4) Flight planning Flexibility of the process to allow re-planning at short notice should conditions change. (5) Departure, destination and alternate aerodromes For the airspace to be traversed, or the aerodromes/operating sites in use, parameters to evaluate and take account of: (i) the probability of contamination; (ii) any additional aircraft performance requirements; (iii) required maintenance considerations; (iv) fuel requirements for re-routeing and extended holding. (6) Routing policy Parameters to evaluate and take account of: (i) the shortest period in and over the forecast contaminated area; (ii) the hazards associated with flying over the contaminated area; (iii) drift down and emergency descent considerations; (iv) the policy for flying below the contaminated airspace and the associated hazards. (7) Diversion policy Parameters to evaluate and take account of: (i) maximum allowed distance from a suitable aerodrome/operating site; (ii) availability of aerodromes/operating sites outside the forecast contaminated area; (iii) diversion policy after an volcanic ash encounter. (8) Minimum equipment list Additional provisions in the MEL, if applicable, for dispatching aircraft with unserviceabilities that might affect the following non-exhaustive list of systems: (i) air conditioning packs; Part-ORA – Subpart GEN, AMC and GM V1, June 2016 Go back to Subpart GEN Go back to the content 26 | P a g e (ii) engine bleeds; (iii) pressurisation system; (iv) electrical power distribution system; (v) air data system; (vi) standby instruments; (vii) navigation systems; (viii) de-icing systems; (ix) engine driven generators; (x) auxiliary power unit (APU); (xi) airborne collision avoidance system (ACAS); (xii) terrain awareness warning system (TAWS); (xiii) autoland systems; (xiv) provision of crew oxygen; (xv) supplemental oxygen for passengers. (9) Standard operating procedures Crew training to ensure they are familiar with normal and abnormal operating procedures and particularly any changes regarding but not limited to: (i) pre-flight planning; (ii) in-flight monitoring of volcanic ash cloud affected areas and avoidance procedures; (iii) diversion; (iv) communications with ATC; (v) in-flight monitoring of engine and systems potentially affected by volcanic ash cloud contamination; (vi) recognition and detection of volcanic ash clouds and reporting procedures; (vii) in-flight indications of a volcanic ash cloud encounter; (viii) procedures to be followed if a volcanic ash cloud is encountered; (ix) unreliable or erroneous airspeed; Part-ORA – Subpart GEN, AMC and GM V1, June 2016 Go back to Subpart GEN Go back to the content 29 | P a g e 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. Part-ORA – Subpart GEN, AMC and GM V1, June 2016 Go back to Subpart GEN Go back to the content 30 | P a g e 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. Part-ORA – Subpart GEN, AMC and GM V1, June 2016 Go back to Subpart GEN Go back to the content 31 | P a g e (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 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 Part-ORA – Subpart GEN, AMC and GM V1, June 2016 Go back to Subpart GEN Go back to the content 34 | P a g e 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 Regulation (EC) No 216/20083 and its Implementing Rules. (b) Organisations with up to 20 full time equivalents (FTEs) involved in the activity subject to Regulation (EC) No 216/2008 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). 3 Regulation (EC) No 216/2008 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 Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC. OJ L 79, 19.3.2008, p. 1. Part-ORA – Subpart GEN, AMC and GM V1, June 2016 Go back to Subpart GEN Go back to the content 35 | P a g e AMC1 ORA.GEN.200(c) Management system ATOs PROVIDING TRAINING ONLY FOR THE LAPL, PPL, SPL AND BPL AND THE ASSOCIATED RATINGS OR CERTIFICATES — ORGANISATIONAL REVIEW (a) The primary objective of the organisational review is to enable the organisation to ensure that its management system remains effective by verifying that it: (1) has continually identified its aviation safety hazards; (2) has effectively mitigated the associated risks; and (3) monitors compliance with the applicable requirements. (b) Safety risk management should: (1) be performed using internal safety or occurrence reports, hazard checklists, risk registers or similar risk management tools or processes, integrated into the activities of the organisation; (2) in particular address safety risks related to a change; making use of the existing hazard identification, risk assessment and mitigation tools or processes; and (3) include provisions for emergency response or a formal Emergency Response Plan (ERP). (c) As part of the management system documentation required by ORA.GEN.200(a)(5), the organisation should describe the organisational review programme and related responsibilities. Persons responsible for the organisational review should have a thorough knowledge of the applicable requirements and of the organisation’s procedures. (d) The status of all corrective and risk mitigation actions should be monitored by the person responsible for the organisational review programme and implemented within a specified time frame. Action closure should be recorded by the person responsible for the organisational review programme, along with a summary of the action taken. (e) The results of the organisational review, including all non-compliance findings and new risks identified during the review, should be presented to the accountable manager and the person or group of persons nominated in accordance with ORA.GEN.210(b) prior to notification to the competent authority. All level 1 findings in the sense of ARA.GEN.350 should be immediately notified to the competent authority and all necessary actions immediately taken. (f) Based on the results of the organisational review, the accountable manager should determine the need for and initiate, as appropriate, further actions to address deficiencies in or further improve the organisation’s management system. GM1 ORA.GEN.200(c) Management system ATOs PROVIDING TRAINING ONLY FOR THE LAPL, PPL, SPL OR BPL AND THE ASSOCIATED RATINGS OR CERTIFICATES — ORGANISATIONAL REVIEW PROGRAMME (a) The organisational review programme may consist of: Part-ORA – Subpart GEN, AMC and GM V1, June 2016 Go back to Subpart GEN Go back to the content 36 | P a g e (1) checklist(s) covering all items necessary to be addressed in order to ensure that the organisation identified its aviation safety hazards, effectively mitigates the associated risks and ensures effective compliance with the applicable requirements. These should address all procedures described in the management system documentation and training manual; and (2) a schedule for the accomplishment of the different checklist items, with each item being checked at least once within any 12-month period. The organisation may choose to conduct one full review annually or to conduct several partial reviews. (b) Performance of organisational reviews: Each review item may be addressed using an appropriate combination of: (1) review of training records, training documentation; (2) review of internal safety reports (e.g. notified difficulties in using current procedures and training material, etc.); (3) review of the risk register and hazard checklists, as applicable; (4) sample check of training courses; (5) witnessing of examinations, as appropriate; (6) interview of the personnel involved; and (7) review of the feedback provided by students and customers. (c) It is recommended that internal safety reports and occurrence reports be reviewed on a continual basis with the aim of identifying possible corrective and risk mitigation actions. GM2 ORA.GEN.200(c) Management system ATOs PROVIDING TRAINING ONLY FOR THE LAPL, PPL, SPL OR BPL AND THE ASSOCIATED RATINGS OR CERTIFICATES — ORGANISATIONAL REVIEW ITEMS The following provides a list of typical items for an organisational review checklist, to be adapted as necessary to cover all relevant procedures described in the management system documentation and training manual: (a) Terms of approval Check that: (1) no training has been performed outside the terms of approval; (2) changes not requiring prior approval have been properly managed. (b) Training syllabi and course material Check that: Part-ORA – Subpart GEN, AMC and GM V1, June 2016 Go back to Subpart GEN Go back to the content 39 | P a g e (iv) the assumptions made for the risk assessment remain valid; (2) Verify the effectiveness of all risk mitigation actions initiated since the last organisational review. ORA.GEN.205 Contracted activities (a) Contracted activities include all activities within the organisation’s scope of approval that are performed by another organisation either itself certified to carry out such activity or if not certified, working under the contracting organisation’s approval. The organisation shall ensure that when contracting or purchasing any part of its activity, the contracted or purchased service or product conforms to the applicable requirements. (b) When the certified organisation contracts any part of its activity to an organisation that is not itself certified in accordance with this Part to carry out such activity, the contracted organisation shall work under the approval of the contracting organisation. The contracting organisation shall ensure that the competent authority is given access to the contracted organisation, to determine continued compliance with the applicable requirements. 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. Part-ORA – Subpart GEN, AMC and GM V1, June 2016 Go back to Subpart GEN Go back to the content 40 | P a g e (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. ORA.GEN.210 Personnel requirements (a) The organisation shall appoint an accountable manager, who has the authority for ensuring that all activities can be financed and carried out in accordance with the applicable requirements. The accountable manager shall be responsible for establishing and maintaining an effective management system. (b) A person or group of persons shall be nominated by the organisation, with the responsibility of ensuring that the organisation remains in compliance with the applicable requirements. Such person(s) shall be ultimately responsible to the accountable manager. (c) The organisation shall have sufficient qualified personnel for the planned tasks and activities to be performed in accordance with the applicable requirements. (d) The organisation shall maintain appropriate experience, qualification and training records to show compliance with paragraph (c). (e) The organisation shall ensure that all personnel are aware of the rules and procedures relevant to the exercise of their duties. ORA.GEN.215 Facility requirements The organisation shall have facilities allowing the performance and management of all planned tasks and activities in accordance with the applicable requirements. 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. Part-ORA – Subpart GEN, AMC and GM V1, June 2016 Go back to Subpart GEN Go back to the content 41 | P a g e (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. (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; Part-ORA - Subpart ATO, AMC and GM V1, June 2016 Go back to Subpart ATO Go back to the content 44 | P a g e (b) Flight test training organisations. Notwithstanding (a)(1)(iv) and (v), training organisations providing flight test training shall only need to provide: (1) the name(s) and address(es) of the main aerodromes and/or operating site(s) at which the training is to be conducted; and (2) a list of the types or categories of aircraft to be used for flight test training. (c) In the case of a change to the certificate, applicants shall provide the competent authority with the relevant parts of the information and documentation referred to in (a). AMC1 ORA.ATO.105 Application APPLICATION FORM APPLICATION FORM FOR AN ATO CERTIFICATE N° Question Supplementary information 1. Name of training organisation under which the activity is to take place address, fax number, e-mail, URL 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 instructor as (3) 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 applicable) FFS, FNPT I, II and III, FTD 1, 2 and 3, and 3, and 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 : (submit with application if required ) (a) course programmes (b) training records (c) operations manual (d) training manual Part-ORA - Subpart ATO, AMC and GM V1, June 2016 Go back to Subpart ATO Go back to the content 45 | P a g e 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. (Date) (Signature) ORA.ATO.110 Personnel requirements (a) An HT shall be nominated. The HT shall have extensive experience as an instructor in the areas relevant for the training provided by the ATO and shall possess sound managerial capability. (b) The HT’s responsibilities shall include: (1) ensuring that the training provided is in compliance with Part-FCL and, in the case of flight test training, that the relevant requirements of Part-21 and the training programme have been established; (2) ensuring the satisfactory integration of flight training in an aircraft or a flight simulation training device (FSTD) and theoretical knowledge instruction; and (3) supervising the progress of individual students. (c) Theoretical knowledge instructors shall have: (1) practical background in aviation in the areas relevant for the training provided and have undergone a course of training in instructional techniques; or (2) previous experience in giving theoretical knowledge instruction and an appropriate theoretical background in the subject on which they will provide theoretical knowledge instruction. (d) Flight instructors and flight simulation training instructors shall hold the qualifications required by Part- FCL for the type of training that they are providing. 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. Part-ORA - Subpart ATO, AMC and GM V1, June 2016 Go back to Subpart ATO Go back to the content 46 | P a g e 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. ORA.ATO.120 Record-keeping The following records shall be kept for a period of at least 3 years after the completion of the training: (a) details of ground, flight, and simulated flight training given to individual students; (b) detailed and regular progress reports from instructors including assessments, and regular progress flight tests and ground examinations; and (c) information on the licences and associated ratings and certificates of the students, including the expiry dates of medical certificates and ratings. 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. ORA.ATO.125 Training programme (a) A training programme shall be developed for each type of course offered. (b) The training programme shall comply with the requirements of Part-FCL and, in the case of flight test training, the relevant requirements of Part-21. 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. Part-ORA - Subpart ATO, AMC and GM V1, June 2016 Go back to Subpart ATO Go back to the content 49 | P a g e 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 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 Regulation (EC) 1702/2003. 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 multipilot 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 Regulation (EC) 1702/2003, 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 Part-ORA - Subpart ATO, AMC and GM V1, June 2016 Go back to Subpart ATO Go back to the content 50 | P a g e 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; (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 multicrew 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 Part-ORA - Subpart ATO, AMC and GM V1, June 2016 Go back to Subpart ATO Go back to the content 51 | P a g e 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. 4 Commission Regulation (EC) No 1702/2003 of 24 September 2003 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 Regulation (EC) No 1194/2009 (OJ L 321, 8.12.2009, p. 5). AMC3 ORA.ATO.125 Training programme TYPE RATING COURSES - HELICOPTERS (a) Introduction (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 Regulation (EC) 1702/2003 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 Part-ORA - Subpart ATO, AMC and GM V1, June 2016 Go back to Subpart ATO Go back to the content 54 | P a g e (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 Part-ORA - Subpart ATO, AMC and GM V1, June 2016 Go back to Subpart ATO Go back to the content 55 | P a g e 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 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 in-flight 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. Part-ORA - Subpart ATO, AMC and GM V1, June 2016 Go back to Subpart ATO Go back to the content 56 | P a g e ORA.ATO.130 Training manual and operations manual (a) The ATO shall establish and maintain a training manual and operations manual containing information and instructions to enable personnel to perform their duties and to give guidance to students on how to comply with course requirements. (b) The ATO shall make available to staff and, where appropriate, to students the information contained in the training manual, the operations manual and the ATO’s approval documentation. (c) In the case of ATOs providing flight test training, the operations manual shall comply with the requirements for the flight test operations manual, as established in Part-21. (d) The operations manual shall establish flight time limitation schemes for flight instructors, including the maximum flying hours, maximum flying duty hours and minimum rest time between instructional duties in accordance with Part-ORO. ORA.ATO.135 Training aircraft and FSTDs (a) The ATO shall use an adequate fleet of training aircraft or FSTDs appropriately equipped for the training courses provided. (b) The ATO shall only provide training in FSTDs when it demonstrates to the competent authority: (1) the adequacy between the FSTD specifications and the related training programme; (2) that the FSTDs used comply with the relevant requirements of Part-FCL; (3) in the case of full flight simulators (FFSs), that the FFS adequately represents the relevant type of aircraft; and (4) that it has put in place a system to adequately monitor changes to the FSTD and to ensure that those changes do not affect the adequacy of the training programme. (c) If the aircraft used for the skill test is of a different type to the FFS used for the visual flight training, the maximum credit shall be limited to that allocated for flight and navigation procedures trainer II (FNPT II) for aeroplanes and FNPT II/III for helicopters in the relevant flight training programme. (d) Flight test training organisations. Aircraft used for flight test training shall be appropriately equipped with flight testing instrumentation, according to the purpose of the training. 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; Part-ORA - Subpart ATO, AMC and GM V1, June 2016 Go back to Subpart ATO Go back to the content 59 | P a g e SECTION II - Additional requirements for ATOs providing training for CPL, MPL and ATPL and the associated ratings and certificates ORA.ATO.210 Personnel requirements (a) Head of training (HT). Except in the case of ATOs providing flight test training, the nominated HT shall have extensive experience in training as an instructor for professional pilot licences and associated ratings or certificates. (b) Chief flight instructor (CFI). The ATO providing flight instruction shall nominate a CFI who shall be responsible for the supervision of flight and flight simulation training instructors and for the standardisation of all flight instruction and flight simulation instruction. The CFI shall hold the highest professional pilot licence and associated ratings related to the flight training courses conducted and hold an instructor certificate with the privilege to instruct for at least one of the training courses provided. (c) Chief theoretical knowledge instructor (CTKI). The ATO providing theoretical knowledge instruction shall nominate a CTKI who shall be responsible for the supervision of all theoretical knowledge instructors and for the standardisation of all theoretical knowledge instruction. The CTKI shall have extensive experience as a theoretical knowledge instructor in the areas relevant for the training provided by the ATO. 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 full-time 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, full-time 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. Part-ORA - Subpart ATO, AMC and GM V1, June 2016 Go back to Subpart ATO Go back to the content 60 | P a g e 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 those hours should be on flying instructional duties related to the flying courses provided, of which 200 hours may be instrument ground time. ORA.ATO.225 Training programme (a) The training programme shall include a breakdown of flight and theoretical knowledge instruction, presented in a week-by-week or phase layout, a list of standard exercises and a syllabus summary. (b) The content and sequence of the training programme shall be specified in the training manual. ORA.ATO.230 Training manual and operations manual (a) The training manual shall state the standards, objectives and training goals for each phase of training that the students are required to comply with and shall address the following subjects: - training plan, - briefing and air exercises, - flight training in an FSTD, if applicable, - theoretical knowledge instruction. Part-ORA - Subpart ATO, AMC and GM V1, June 2016 Go back to Subpart ATO Go back to the content 61 | P a g e (b) The operations manual shall provide relevant information to particular groups of personnel, as flight instructors, flight simulation training instructors, theoretical knowledge instructors, operations and maintenance personnel, and shall include general, technical, route and staff training information. 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 course (ATP, CPL/IR, CPL, etc. as applicable) A statement of what the student is expected to do as a result of the training, the level of performance, and the training constraints to be observed. (2) Pre-entry requirements (i) Minimum age, educational requirements (including language), medical requirements; (ii) Any individual Member State requirements. (3) Credits for previous experience To be obtained from the competent authority before training begins. (4) Training syllabi As applicable, the flying syllabus (single-engine or multi-engine, as applicable), the flight simulation training syllabus and the theoretical knowledge training syllabus. (5) The time scale and scale, in weeks, for each syllabus Arrangements of the course and the integration of syllabi time. (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. (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. Part-ORA - Subpart ATO, AMC and GM V1, June 2016 Go back to Subpart ATO Go back to the content 64 | P a g e (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 inpoor 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; (5) allowable deficiencies (based on the master minimum equipment list (MMEL), if available). (c) Route: Part-ORA - Subpart ATO, AMC and GM V1, June 2016 Go back to Subpart ATO Go back to the content 65 | P a g e (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. Part-ORA - Subpart ATO, AMC and GM V1, June 2016 Go back to Subpart ATO Go back to the content 66 | P a g e SECTION III - Additional requirements for ATOs providing specific types of training Chapter 1 - Distance Learning Course ORA.ATO.300 General The ATO may be approved to conduct modular course programmes using distance learning in the following cases: (a) modular courses of theoretical knowledge instruction; (b) courses of additional theoretical knowledge for a class or type rating; or (c) courses of approved pre-entry theoretical knowledge instruction for a first type rating for a multi- engined helicopter. 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. Part-ORA Subpart FSTD, AMC and GM V1, June 2016 Go back to Subpart FSTD Go back to the content 69 | P a g e SUBPART FSTD - REQUIREMENTS FOR ORGANISATIONS OPERATING FLIGHT SIMULATION TRAINING DEVICES (FSTDs) AND THE QUALIFICATION OF FSTDs SECTION I - Requirements for organisations operating FSTDs ORA.FSTD.100 General (a) The applicant for an FSTD qualification certificate shall demonstrate to the competent authority that it has established a management system in accordance with ORA.GEN Section II. This demonstration shall ensure that the applicant has, directly or through contract, the capability to maintain the performance, functions and other characteristics specified for the FSTD’s qualification level and to control the installation of the FSTD. (b) If the applicant is the holder of a qualification certificate issued in accordance with this Part, the FSTD specifications shall be detailed: (1) in the terms of the ATO certificate; or (2) in the case of an AOC holder, in the training manual. 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; Part-ORA Subpart FSTD, AMC and GM V1, June 2016 Go back to Subpart FSTD Go back to the content 70 | P a g e (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 (December 14th, 2007 or as amended) Standard Measurements for Flight Simulation Quality. 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 Part-ORA Subpart FSTD, AMC and GM V1, June 2016 Go back to Subpart FSTD Go back to the content 71 | P a g e (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 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. Part-ORA Subpart FSTD, AMC and GM V1, June 2016 Go back to Subpart FSTD Go back to the content 74 | P a g e 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 sub-contractor 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 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. GM2 ORA.FSTD.100 General COMPLIANCE MONITORING – ASSESSMENT FOR ORGANISATIONS OPERATING FSTDs COMPLIANCE MONITORING ASSESSMENT FOR ORGANISATIONS OPERATING FSTDs Organisation: Part-ORA Subpart FSTD, AMC and GM V1, June 2016 Go back to Subpart FSTD Go back to the content 75 | P a g e Site Assessed: Date of Assessment: Accountable Manager: Compliance Monitoring Manager: Number and Type of FSTDs: CM Manual Reference: Audit Area CM/Proc Ref Comments Satisfactory Y/N 1. ACCOUNTABLE MANAGER 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? 2. COMPLIANCE MONITORING MANAGER Has a compliance monitoring manager (CM manager) been nominated? Are the posts of CM manager and AM combined? If so, is the independence of compliance audits assured? 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? Does the CM manager have direct access to the AM? Does the CM manager have access to all parts of the organisation operating an FSTD and as Part-ORA Subpart FSTD, AMC and GM V1, June 2016 Go back to Subpart FSTD Go back to the content 76 | P a g e necessary any sub-contractor’s organisation? 3. COMPLIANCE MONITORING (CM) Has CM been established by the operator? Is CM properly documented? (see Section 4) Is the CM structured according to the size and complexity of the operator? Does the CM include the following as a minimum: a) monitoring of compliance with required technical standards; b) identification of corrective actions and person responsible for rectification; c) a feedback system to accountable manager to ensure corrective action are promptly addressed; d) reporting of significant non-compliances to the competent authority; e) a compliance monitoring programme to verify continued compliance with applicable requirements, standards and procedures. a) b) c) d) e) Are the responsibilities of the CM manager defined to include, as a minimum: a) monitoring of corrective action programme; b) ensuring that the corrective actions contain the necessary elements; c) providing management with an independent assessment of corrective action, implementation and completion; d) evaluation of the effectiveness of the corrective action programme. a) b) c) d) Part-ORA Subpart FSTD, AMC and GM V1, June 2016 Go back to Subpart FSTD Go back to the content 79 | P a g e Is there an acceptable and effective procedure for ensuring that all those responsible for managing the CM receive training covering: a) an introduction to the concept of the CM; b) compliance management; c) the concept of compliance assurance; d) CM manuals; e) audit techniques; f) reporting and recording; g) how the CM supports continuous improvement within the organisation. a) b) c) d) e) f) g) Are suitable training records maintained? Are activities within the CM sub- contracted out to external agencies? Do written agreements exist between the organisation and the sub-contractor clearly defining the services and standard to be provided? Are the procedures in place to ensure that the necessary authorisations/approval when required are held by a sub- contractor? Are the procedures in place to establish that the sub-contractor has the necessary technical competence? 4. CM MANUAL Is there a procedure in place to control copies and the distribution of the CM manual? What is the current status of the CM manual – amendment and issue date? Is the CM manual signed by the accountable manager and the compliance monitoring manager? Part-ORA Subpart FSTD, AMC and GM V1, June 2016 Go back to Subpart FSTD Go back to the content 80 | P a g e Does the CM manual include, either directly or by reference to other documents, the following: a) a description of the organisation; b) reference to appropriate FSTD technical standards; c) allocation of duties and responsibilities; d) audit procedures; e) reporting procedures; f) ollow-up and corrective action procedures; g) document retention policy; h) training records a) b) c) d) e) f) g) h) Is there a document retention policy covering: a) audit schedules; b) inspection and audit reports; c) responses to findings; d) corrective action reports; e) follow-up and closure reports; f) management evaluation reports. a) b) c) d) e) f) 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) defect reporting systems; b) defect rectification processes; c) tracking mechanisms; d) preventative maintenance programmes; e) spares handling; f) equipment calibration; g) configuration management of the a) b) c) d) e) f) Part-ORA Subpart FSTD, AMC and GM V1, June 2016 Go back to Subpart FSTD Go back to the content 81 | P a g e device including visual, IOS and navigation databases; h) configuration control system to ensure the continued integrity of the hardware and software qualified; i) QTG running and function and subjective tests. g) h) i) 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 organisation including company name, location, management; b) major changes to a qualified device; c) deactivation or relocation of a qualified device; d) major failures of a qualified device; e) major safety issue associated with the installation. a) b) c) d) e) 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 suppression; c) protection against electrical, mechanical, hydraulic and pneumatic hazards; d) other items as defined in AMC1 ORA.FSTD.115 a) b) c) d) Part-ORA Subpart FSTD, AMC and GM V1, June 2016 Go back to Subpart FSTD Go back to the content 84 | P a g e (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. ORA.FSTD.105 Maintaining the FSTD qualification (a) In order to maintain the qualification of the FSTD, an FSTD qualification certificate holder shall run the complete set of tests contained within the master qualification test guide (MQTG) and functions and subjective tests progressively over a 12-month period. (b) The results shall be dated, marked as analysed and evaluated, and retained in accordance with ORA.FSTD.240, in order to demonstrate that the FSTD standards are being maintained. (c) A configuration control system shall be established to ensure the continued integrity of the hardware and software of the qualified FSTD. ORA.FSTD.110 Modifications (a) The holder of an FSTD qualification certificate shall establish and maintain a system to identify, assess and incorporate any important modifications into the FSTDs it operates, especially: (1) any aircraft modifications that are essential for training, testing and checking, whether or not enforced by an airworthiness directive; and (2) any modification of an FSTD, including motion and visual systems, when essential for training, testing and checking, as in the case of data revisions. (b) Modifications of the FSTD hardware and software that affect handling, performance and systems operation or any major modifications of the motion or visual system shall be evaluated to determine the impact on the original qualification criteria. The organisation shall prepare amendments for any affected validation tests. The organisation shall test the FSTD to the new criteria. Part-ORA Subpart FSTD, AMC and GM V1, June 2016 Go back to Subpart FSTD Go back to the content 85 | P a g e (c) The organisation shall inform the competent authority in advance of any major changes to determine if the tests carried out are satisfactory. The competent authority shall determine if a special evaluation of the FSTD is necessary prior to returning it to training following the modification. 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. (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; Part-ORA Subpart FSTD, AMC and GM V1, June 2016 Go back to Subpart FSTD Go back to the content 86 | P a g e (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. ORA.FSTD.115 Installations (a) The holder of an FSTD qualification certificate shall ensure that: (1) the FSTD is housed in a suitable environment that supports safe and reliable operation; (2) all FSTD occupants and maintenance personnel are briefed on FSTD safety to ensure that they are aware of all safety equipment and procedures in the FSTD in case of an emergency; and (3) the FSTD and its installations comply with the local regulations for health and safety. (b) The FSTD safety features, such as emergency stops and emergency lighting, shall be checked at least annually and recorded. 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 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; Part-ORA Subpart FSTD, AMC and GM V1, June 2016 Go back to Subpart FSTD Go back to the content 89 | P a g e <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 1.....…... 2.....…... 3.....…... 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: …………….. 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: …………….. Part-ORA Subpart FSTD, AMC and GM V1, June 2016 Go back to Subpart FSTD Go back to the content 90 | P a g e 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 ………………………………….. (Name) ….............. Flight Engineer’s Licence Nr (if applicable) …….  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: …………….. 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. Part-ORA Subpart FSTD, AMC and GM V1, June 2016 Go back to Subpart FSTD Go back to the content 91 | P a g e (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 case-by-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 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. Part-ORA Subpart FSTD, AMC and GM V1, June 2016 Go back to Subpart FSTD Go back to the content 94 | P a g e meets its original qualification standard. A copy of the test documentation shall be retained together with the FSTD records for review by the competent authority. The competent authority may perform an evaluation of the FSTD after relocation. The evaluation shall be in accordance with the original qualification basis of the FSTD. (d) If an organisation plans to remove an FSTD from active status for prolonged periods, the competent authority shall be notified and suitable controls established for the period during which the FSTD is inactive. The organisation shall agree with the competent authority a plan for the de-activation, any storage and reactivation to ensure that the FSTD can be restored to active status at its original qualification level. AMC1 ORA.FSTD.230(b) Changes to the qualified FSTD (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 (re- categorisation) for the FSTD. ORA.FSTD.235 Transferability of an FSTD qualification (a) When there is a change of the organisation operating an FSTD, the new organisation shall inform the competent authority in advance in order to agree upon a plan of transfer of the FSTD. (b) The competent authority may perform an evaluation in accordance with the original qualification basis of the FSTD. (c) When the FSTD no longer complies with its initial qualification basis, the organisation shall apply for a new FSTD qualification certificate. ORA.FSTD.240 Record-keeping The holder of an FSTD qualification certificate shall keep records of: Part-ORA Subpart FSTD, AMC and GM V1, June 2016 Go back to Subpart FSTD Go back to the content 95 | P a g e (a) all documents describing and proving the initial qualification basis and level of the FSTD for the duration of the FSTD’s lifetime; and (b) any recurrent documents and reports related to each FSTD and to compliance monitoring activities for a period of at least 5 years. 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; (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. Part-ORA Subpart AeMC, AMC and GM V1, June 2016 Go back to Subpart AeMC Go back to the content 96 | P a g e SUBPART AeMC - AERO-MEDICAL CENTRES SECTION I – General ORA.AeMC.105 Scope This Subpart establishes the additional requirements to be met by an organisation to qualify for the issue or continuation of an approval as an aero-medical centre (AeMC) to issue medical certificates, including initial class 1 medical certificates. ORA.AeMC.115 Application Applicants for an AeMC certificate shall: (a) comply with MED.D.005; and (b) in addition to the documentation for the approval of an organisation required in ORA.GEN.115, provide details of clinical attachments to or liaison with designated hospitals or medical institutes for the purpose of specialist medical examinations. 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. ORA.AeMC.135 Continued validity The AeMC certificate shall be issued for an unlimited duration. It shall remain valid subject to the holder and the aero-medical examiners of the organisation: (a) complying with MED.D.030;and (b) ensuring their continued experience by performing an adequate number of class 1 medical examinations every year. 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.