Sofema Aviation Services (SAS) www.sassofia.com considers the key features of Aircrew Regulation EU 1178/2011 related to Organisation Requirements – Aircrew (Part-ORA)
Introduction – Section I General
The following is a redacted summary of the applicable requirements – for specific clarification please refer to the applicable regulation.
ORA.GEN.105 Competent Authority (Regulation (EU) No 1178/2011)
Regarding the Organisation – Responsible Authority for the Member States is the appointed CA & for Third countries EASA directly. (Location of Principle place of business)
Regarding Flight Simulator Training Devices (FSTD) – Organisation – Responsible Authority for the Member States is the appointed CA & for Third countries EASA directly. (Location of Principle place of business)
Note 1 – EASA will support the oversight of FSTD if requested by the authority of the member state.
Note 2 – If FSTD is located outside of the EU operated by EU certified organisation then joint certification between EASA and applicable CA.
ORA.GEN.115 Application for an organisation certificate – Regulation (EU) No 1178/2011
Application to comply with Basic Regulation Requirements and include a procedure how changes not requiring prior approval will be managed and CA notified.
ORA.GEN.120 Means of compliance – Regulation (EU) No 290/2012
AMC maybe used – shall receive prior approval from the CA – reference – ARA.GEN.120(d).
- Note – full description shall include any revisions to manuals or procedures that may be relevant, as well as an assessment demonstrating compliance with Basic regulation (BR) and Implementing rules (IR).
ORA.GEN.125 Terms of approval and privileges of an organisation – Regulation (EU) No 1178/2011
A certified organisation shall comply with the scope and privileges defined in the terms of approval attached to the organisation’s certificate.
ORA.GEN.130 Changes to Organisations – Regulation (EU) No 1178/2011
Prior Approval Required for:
- Changes to Scope,
- Changes to the Management system ref ORA.GEN.200(a)(1) and (a)(2),
- Note – Changes Requiring Prior Approval – approval required in advance (Organisation to provide all relevant documentation),
- Change implemented only after approval I.A.W ARA.GEN.330,
- Changes not requiring prior approval are managed and notified in accordance with ARA.GEN.310(c).
ORA.GEN.135 Continued validity – Regulation (EU) No 1178/2011
Certificate Validity:
- Organisation remaining in compliance with BR & IR
- Findings managed I.A.W. ORA.GEN.150
- CA provided with access at all times (ORA.GEN.140)
Note – Upon revocation or surrender the certificate shall be returned to the competent authority without delay.
ORA.GEN.140 Access – Regulation (EU) No 290/2012
Full Access to be granted to:
- The competent authority defined in ORA.GEN.105; or
- The authority acting under the provisions of ARA.GEN.300(d), ARA.GEN.300(e) or ARO.RAMP.
ORA.GEN.150 Findings – Regulation (EU) No 1178/2011
Following receipt of findings:
- Identify the root cause of the non-compliance;
- Define a corrective action plan; and
- Demonstrate corrective action implementation to CA within a period agreed ref. ARA.GEN.350(d).
ORA.GEN.155 Immediate reaction to a safety problem – Regulation (EU) No 1178/2011
The organisation shall implement:
- Safety measures required by CA ref ARA.GEN.135(c); and
- Mandatory safety information issued by the Agency. (inc AD’s)
ORA.GEN.160 Occurrence reporting – Regulation (EU) No 70/2014
Mandatory requirement to report:
- Accident, serious incident and occurrence Ref (EU) No 996/2010 and Directive 2003/42/EC.
- Report to CA & TCH / Design Approval Holder (DAH) any incident, malfunction, technical defect, exceeding of technical limitations.
- Any occurrence that would highlight inaccurate, incomplete, or ambiguous information contained in the operational suitability data (OSD).
- 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.
Reports shall contain all pertinent information about the condition known to the organisation.
Reports shall be made as soon as practicable, but in any case within 72 hours. (unless special circumstances)
ORA.GEN.200 Management system – Regulation (EU) 2015/445
Management System (appropriate to size & nature of the Organisation) require:
- Defined lines of responsibility and accountability;
- Direct safety accountability of the accountable manager;
- Safety Policy – philosophies and principles related to safety;
- Identification of aviation safety hazards, evaluation and the management of associated risks, actions to mitigate the risk and verify their effectiveness;
- Trained & Competent Personnel;
- Documentation of Key Processes and communication related to roles & responsibilities;
- A function to monitor compliance of the organisation Inc. Feedback to the AM to ensure corrective actions carried out 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
- To comply with any other applicable regulatory requirements.
Organizational Review (Instead of Full System) Acceptable for:
- LAPL,
- PPL,
- SPL or
- BPL.
Note – Organizational Review for safety risk management and 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 ORA.GEN.205 Contracted activities – Regulation (EU) No 290/2012
- 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.
Contract / Subcontract
- 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.
Note – The contracting organisation shall ensure that the competent authority is given access to the contracted organisation, to determine continued compliance with the applicable requirements.
ORA.GEN.210 Personnel requirements – Regulation (EU) No 290/2012
- AM Appointed – Corporate authority for Finance
- AM Responsible for the Management System
- Nominated Persons – To ensure Compliance – Report to AM
- Sufficient qualified personnel for the planned tasks and activities to be performed in accordance with the applicable requirements
- Maintain records of Staff to Demonstrate Compliance
- Communication – Awareness of Individual Rules & Procedures
(ORA.GEN.215) Facility requirements – Regulation (EU) No 1178/2011
The organisation shall have facilities allowing the performance and management of all planned tasks and activities in accordance with the applicable requirements.
ORA.GEN.220 Record-keeping – Regulation (EU) No 1178/2011
The organisation shall establish a system of record–keeping that allows adequate storage and reliable traceability of all activities developed, covering in particular all the elements indicated in ORA.GEN.200.
- The format of the records shall be specified in the organisation’s procedures.
- Records shall be stored in a manner that ensures protection from damage, alteration and theft.
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