AMC & GM to Part-ORA — Issue 1, Amendment 8

Annex V to ED Decision 2025/002/R ‘AMC and GM to Part-ORA — Issue 1, Amendment 8’

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The Annex to Decision 2012/017/R of the Executive Director of the Agency of 19 April 2012 is amended as follows:

AMC1 ORA.GEN.160 Occurrence reporting system

GENERAL

(a) In addition to occurrence reporting in accordance with Regulation (EU) No 376/2014, Tthe organisation should report all occurrences defined in AMC 20-8, and as required by the applicable national rules implementing Directive 2003/43/EC 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. Rationale RMT.0587 The Directive referred to in this AMC was repealed by Regulation (EU) No 376/2014, hence the text is revised, and the reference is updated. Additionally, since the obligation to report volcanic ash encounter is mandatory as per Regulation (EU) 2015/1018, point (b) of this AMC is obsolete and can be deleted.

AMC12 ORA.GEN.200(a)(5) Management system

COMPLEX ORGANISATIONS – ORGANISATION’S SAFETY MANAGEMENT MANUAL

[…] Rationale RMT.0587 Based on a Member State’s input, it was detected that there are two AMC that have the reference ‘AMC1 ORA.GEN.200(a)(5)’. The latter one, placed after GM1 ORA.GEN.200(a)(5) and addressing a complex organisation’s safety management manual, needs to be renamed to ‘AMC2 ORA.GEN.200(a)(5)’.

GM1 ORA.ATO.110(d) Personnel requirements

(a) Before allowing an FI that is experienced as specified in point FCL.905.FI(h)(3) to supervise SPIC flights during an IR training course, the ATO should consider at least the following factors: (1) the experience of the FI; (2) the experience of the student pilot; (3) the nature and complexity of the SPIC flight to be performed; (4) the complexity and characteristics of the training aircraft; and

(5) the prevailing weather conditions. (b) The ATO should identify the hazards related to the SPIC supervision and apply appropriate mitigation measures to reduce the associated risks. Rationale RMT.0678 See NPA 2020-14, page 63. After a further internal review, the phrase ‘or FSTD’ in point (a)(4) is deleted since SPIC flights are not conducted in FSTDs.

AMC2 ORA.ATO.125 Training programme

[…] (b) Variants (1) Familiarisation training: Where an aeroplane type rating also includes variants of the same aircraft type requiring familiarisation training, the additional familiarisation elements training may be included in the theoretical knowledge training of the initial type rating course. Flight training should be conducted on a single variant within the type. […]

AMC1 ORA.ATO.135 Training aircraft and FSTDs

[…] (c) The fleet should include, as appropriate to the courses of training: (1) aircraft suitably equipped to simulate instrument meteorological conditions (IMC) and for the instrument flight training required. For flight training and testing for the instrument rating and the basic instrument rating (BIR) en-route instrument rating (EIR), an adequate number of IFR certificated aircraft should be available; […]

AMC1 ORA.ATO.210 Personnel requirements

[…]

(c) In the case of an ATO offering integrated courses, the head of training (HT), the chief flying instructor (CFI) and the chief theoretical-knowledge instructor (CTKI) should be employed fulltime or part-time, depending upon the scope of training offered. The three positions of HT, CFI, and CTKI should not be combined but should be filled by three persons.

(d) In all other the cases of an ATO offering only one of the following:

(1) modular courses,

(2) type rating courses, and

(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 parttime, depending upon the scope of training offered, provided that the organisation has demonstrated to the competent authority the adequacy of such personnel set-up for its organisation (point ORA.GEN.200(b)).

AMC1 ORA.ATO.230(b) Training manual and operations manual

[…] (d) Personnel training (5) proficiency checks to verify that training personnel is proficient with regard to all internal ATO standards, processes and procedures; […]

AMC1 ORA.ATO.300 General

[…] (b) […] (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 CTKI CGI, will enable them to be entered for the Part-FCL theoretical examinations with a good prospect of success; Rationale RMT.0587 Based on input from a stakeholder, it is proposed to replace the term ‘CGI’ with the term ‘CTKI’. The term CGI refers to ‘chief ground instructor’, as used in JAR-FCL. In Part-FCL, the term chief theoretical knowledge instructor (CTKI) is used.

AMC1 ORA.FSTD.225(b)(4) Duration and continued validity

The assigned person should have experience in FSTDs and training. The person may have FSTD experience or training experience with an education in FSTD evaluation procedures only, provided the other element of expertise is available within the organisation and a procedure for undertaking the annual review and reporting to the competent authority is documented within the compliance monitoring function.

EXPERIENCE OF THE ASSIGNED PERSON OR GROUP OF PERSONS

(a) A person or a group of persons assigned in accordance with point ORA.FSTD.225(b) should:

(1) be qualified in flight simulation hardware, software, computer modelling or equivalent with sufficient technical knowledge and experience to understand and analyse objective test results, and assess that the FSTD complies with the applicable certification specifications;

(2) be qualified to assess the performance, handling and features of the FSTD, hold or have held an instructor certificate and meet either of the following:

(i) hold(s) or has (have) held a type/class rating on the aircraft being simulated; or

(ii) is (are) assisted by an instructor that holds or has held a rating as specified in point (2)(i), with sufficient flying experience in that type/class to support the evaluation team;

(3) have been involved at least in an initial evaluation or one recurrent evaluation carried out by a competent authority within the past 36 months.

(b) The organisation that operates the FSTD should maintain the list of assigned person(s) qualified to perform the task.

AMC2 ORA.FSTD.225(b) Duration and continued validity

EXTENDED RECURRENT EVALUATION PERIOD — ORGANISATION’S DOCUMENTATION

(a) For the purpose of extending the recurrent evaluation period of an FSTD, the organisation that operates the FSTD should provide the following to the competent authority: (1) a declaration that the organisation that operates the FSTD fulfils the criteria of point ARA.FSTD.120(c)(1); (2) the procedures in accordance with point ARA.FSTD.120(c)(4); (3) the qualification and experience of the person(s) assigned in accordance with point ORA.FSTD.225(b); (4) the FSTD performance evaluation metrics developed in accordance with AMC2 ORA.FSTD.100 for the previous 2 years; (5) the evaluation reports together with the follow-up reports for the previous 2 years. (b) The assigned person or group of persons should provide a dossier with the same content as for a recurrent evaluation for information to the competent authority 14 days before performing the tasks under point ORA.FSTD.225(b). Note: Further guidance on the content of the dossier for a recurrent evaluation can be found in GM3 ORA.FSTD.100, point(d). (c) The assigned person or group of persons should prepare a report following the objective, functions and subjective testing with results, including any items identified during the conduct of the tasks described in point ORA.FSTD.225(b). The report should be submitted to the competent authority within the period specified in point ORA.FSTD.225(b).

GM1 ORA.FSTD.225(b) Duration and continued validity

INDEPENDENCE OF THE ASSIGNED PERSON(S)

An effective compliance monitoring function is necessary to support the implementation of the extended evaluation period. It is essential that an appropriate level of independence be maintained, and the tasks referred to in point ORA.FSTD.225(b) should not be undertaken by a person that, within the previous 12-month recurrent period, was involved in the tasks referred to in point ORA.FSTD.105(b) for the relevant FSTD being evaluated.

GM2 ORA.FSTD.225(b) Duration and continued validity

PROCESS TO CONDUCT THE FUNCTIONS AND SUBJECTIVE TESTS

When conducting the functions and subjective tests, especially for a complex motor-powered aircraft, the assigned person or group of persons, when being qualified in accordance with point (a)(2)(i) of AMC1 ORA.FSTD.225(b), should be supported by a pilot who holds or has held a rating on the same or similar type as the aircraft being simulated.

Subpart AeMC — Aero-medical Centres

SECTION I — GENERAL

GM1 ORA.AeMC.105 Scope

It is recommended that AeMCs provide support to regional AME peer groups in order to enhance professional expertise. Rationale RMT.0287 In the previous update of Part-MED, EASA recommended the creation of AME peer groups to mitigate the risk of working in isolation. Discussions during the MEG meeting revealed the fact that such AME peer groups have not been created in most of the Member States. The MEG members considered that the AeMCs should play a role in supporting such support groups. In reaction to the feedback received during the MEG meeting, the rulemaking group considered that the development of GM would be beneficial to demonstrate the role of the AeMC in the development of the regional AME peer groups. In this context, and following the comments mentioned above, this new GM was created.

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 and of supporting specialist consultants, and a list of medical and technical facilities for initial class 1 and class 3 aero-medical examinations, as applicable according to the scope of the AeMC approval and of supporting specialist consultants. (b) The AeMC should provide details of clinical attachments to hospitals, medical institutions and/or specialists. (b) Medical staff should be sufficient to perform the standard required medical examinations to be performed within the organisation of the AeMC. (c) The standard required medical examinations should at least encompass the following specialities: ophthalmology including colour vision, otorhinolaryngology, cardiology and mental health. (d) Contracted activities with designated hospitals or medical institutes for the purpose of additional specialist medical examinations include clinical attachments or liaison with hospitals, medical institutions and/or specialists. Rationale RMT.0287 The standardisation experience and the discussions in the MEG highlighted the fact that many organisations when applying for AeMCs do not have sufficient medical experts on staff to cover the

AMC1 ORA.AeMC.135 Continued validity

EXPERIENCE

(a) A total of Aat least 200 class 1, class 3 or equivalent military aero-medical examinations and assessments should be performed at an the AeMC every year. (b) In Member States where the number of aero-medical examinations and assessments mentioned in point (a) cannot be reached due to a low number of professional pilots or ATCOs, a proportionate number, as defined by the competent authority, of class 1 or class 3 aeromedical examinations and assessments should be performed. (c) In these cases, the continueding experience of the head of AMEs in an the AeMC and aeromedical examiners on staff should may also be ensured by them performing aero-medical examinations and assessments for: (1) class 2 medical certificates as established in Part-MED; and/or (2) third-country class 1, class 3 or equivalent military medical certificates. (d) Aero-medical research including publication in peer-reviewed journals may also be accepted as contributing to the continued experience of the AMEs in head of, and aero-medical examiners at, an AeMC.

SECTION II — MANAGEMENT

AMC1 ORA.AeMC.200 Management system

(a) In order to maintain personnel trained and competent to perform their tasks as specified in ORA.GEN.200(a)(4), the management system should ensure that each AME performs a sufficient number of aero-medical examinations and assessments to meet the professional standards of an AeMC. The required activity of each AME should be specified in the management system. (b) The management system should encompass regular exchange of professional expertise including case analysis.

GM2 ORA.AeMC.200 Management system

The assessment of the AeMC’s management system by a national health authority may be a part of the AeMC’s overall management system.

AMC1 ORA.AeMC.205(a) Contracted activities

In addition to the documentation for the approval of an organisation listed in AMC1 ORA.GEN.205, the AeMC should provide a written declaration of their subcontractor that contracted examinations or assessments will be performed on the basis of the requirements of Regulation (EU) No 1178/2011 and associated AMC and GM.

AMC1 ORA.AeMC.210 Personnel requirements

GENERAL

(a) The An aero-medical examiner (AME) should have held AME class 1 privileges, as applicable in accordance with the scope defined in the terms of approval attached to the AeMC’s certificate for at least 5 years and have performed at least 200 aero-medical examinations and assessments for a class 1, class 3 or equivalent military medical certificate before being nominated as head of an AeMC. (b) The AeMC may provide practical AME training for persons fully qualified and licensed in medicine. Rationale RMT.0287 The rulemaking group and the discussions in the MEG highlighted the importance of having properly trained and qualified head of AeMC making decisions on initial class 1 or class 3 aero-medical examinations and providing training for other AMEs. Consequently, the rulemaking group proposed to clarify the previous wording. Additionally, the group proposed to delete point (b) of this AMC as its content was added to ORA.AeMC.105.

AMC1 ORA.AeMC.215 Facility requirements

MEDICAL-TECHNICAL FACILITIES

The medical-technical facilities of an AeMC should consist of the equipment of a general medical practice and, in addition, of equipment for: (a) Cardiology Facilities to perform: (1) 12-lead resting ECG; (2) stress ECG; (3) 24-hour blood pressure monitoring; and (4) 24-hour heart rhythm monitoring. (b) Ophthalmology Facilities for the examination of: (1) near, intermediate and distant vision; (2) external eye, anatomy, media and fundoscopy; (3) ocular motility; (4) binocular vision; (5) colour vision (anomaloscopy or equivalent); (6) visual fields;

(7) refraction; and (8) heterophoria; and (9) contrast sensitivity, including mesopic conditions with and without glare. (c) Hearing (1) pure-tone audiometer (d) Otorhinolaryngology (ENT) Facilities for the clinical examination of mouth and throat and: (1) otoscopy; (2) rhinoscopy; (3) tympanometry or equivalent; and (4) clinical assessment of vestibular system. (e) Examination of pulmonary function (1) spirometry (f) The following facilities should be available at the AeMC or arranged through contracted activities with a service provider: (1) clinical laboratory facilities; and (2) ultrasound of the abdomen; (3) exercise ECG; (4) 24-hour heart rhythm monitoring; (5) 24-hour blood pressure monitoring; and (6) mental health assessment including psychometric testing.