SIASA project Support to the Improvement of Aviation Safety in Africa This project is funded by the European Union and implemented by EASA. Annex Report 1 – Draft AMCAA regulation on the safety oversight of air navigation services *This document has been produced with the financial assistance of the European Union. The contents of this document are the sole responsibility of the European Aviation Safety Agency and can under no circumstances be regarded as reflecting the position of the European Union.* FO.GEN.00404-003 © European Aviation Safety Agency. All rights reserved. ISO9001 Certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA-Internet/Intranet. An agency of the European Union Page 1 of 10 SIASA project Support to the Improvement of Aviation Safety in Africa This project is funded by the European Union and implemented by EASA. Draft AMCAA regulation on the safety oversight of air navigation services The [Authority in charge of the adoption], Having regard to the Treaty/Act/Convention … on [the regional entity]; …. Adopts this regulation on the safety oversight of air navigation services. Article I – Subject matter and scope 1) This regulation establishes requirements to be applied to the exercise of the safety oversight function by competent aeronautical authorities concerning air navigation services (ANS), as defined in Article 2 below. 2) This regulation shall apply to the activities of the competent aeronautical authorities and qualified entities acting on their behalf regarding the safety oversight of air navigation services (ANS). Article 2 - Definitions For purposes of this regulation, the following definitions apply: 1) "Air navigation services (ANS)" services provided to air traffic during all phases of operation and including: The Air Traffic Management (ATM) Communications services, navigation and surveillance (CNS) Meteorological services for air navigation (MET), Search and Rescue (SAR), Aeronautical Information Management (AIM) which includes aeronautical information services (AIS) and aeronautical charts (MAP); And procedures for air navigation services and aircraft operations (PANS - OPS); 2) "Competent aeronautical authority" means any entity designated by a Party exercising the power to adopt and monitor the implementation of acts regulating safety and environmental compatibility of civil aviation; 3) "Qualified entity" means a body which may be allocated a specific certification or oversight task by a competent aeronautical authority and under the control and responsibility of the latter; a qualified entity shall not issue a certificate; 4) "Parts" means the States and African regional economic integration organizations that have acceded to the Treaty/Act/Convention on [the regional entity]; 5) "Community law" means all applicable provisions defined in the sense of the Treaty/Act/Convention on [the regional entity]; 6) “Corrective action” means an action to eliminate the cause of a detected nonconformity; 7) “Functional system” means a combination of systems, procedures and human resources organized to perform a function within the context of ATM; 8) "Organisation" means an air navigation service provider; 9) "Process" means a set of interrelated or interacting activities which transforms inputs into output elements; 10) "Safety regulatory audit" means a systematic and independent examination conducted by a competent aeronautical authority or on behalf of such an authority to determine if all or part of the safety-related measures, it s' both processes and their results, products or services, comply with required safety are implemented effectively and are suitable to achieve expected results; 11) "Safety" situation in which the risk of personal injury or property damage is reduced to an acceptable level and maintained at that level or below this level through a continuing process of hazard identification and risk management; 12) “Safety objective” means a qualitative or quantitative statement that defines the maximum frequency or probability of occurrence male-expected to a hazard; *This document has been produced with the financial assistance of the European Union. The contents of this document are the sole responsibility of the European Aviation Safety Agency and can under no circumstances be regarded as reflecting the position of the European Union.* FO.GEN.00404-003 © European Aviation Safety Agency. All rights reserved. ISO9001 Certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA-Internet/Intranet. An agency of the European Union Page 2 of 10 SIASA project Support to the Improvement of Aviation Safety in Africa This project is funded by the European Union and implemented by EASA. 13) "Acceptable level of regional safety" minimum level of safety intended to assess the extent, performance and quality of a regional safety system; 14) 'Certificate' means any approval, license or other document issued in connection with and after the certification; 15) "Certification" means any form of verification that an aircraft, a product, parts and equipments, organization or person meets the applicable requirements, as well as the issuance of corresponding certificate attesting such compliance; 16) "Surveillance": tasks to ensure that laws and regulations are respected by the administration at any time, as well as the adoption of any safeguard measure; 17) "Verification" means confirmation through tangible evidence that specified requirements have been fulfilled; 18) "Regulatory safety requirement" means any requirement established through Community legislation or national legislation relating to the provision of air navigation services and dealing with the competence and technical and operational ability to provide these services and exercise those functions, on safety management, as well as systems, components and associated procedures; 19) "Safety requirement" means a risk mitigation instrument, resulting from the risk mitigation strategy that achieves a particular safety objective, including organizational, operational, procedural, functional, performance, and interoperability requirements or environmental characteristics; 20) “Safety directive” means a document issued or adopted by a competent aeronautical authority which mandates actions to be performed on a functional system to restore safety, when evidence shows that aviation safety may be compromised; 21) "Safety Demonstration" the demonstration and evidence that a proposed change to a functional system can be implemented within the targets or standards established through the existing regulatory framework, in a manner consistent with the requirements regulatory safety. Article 3 - Competent aviation authorities for oversight For the purpose of this regulation and without prejudice to mutual recognition of certificates for air navigation service providers, the competent aeronautical authorities for supervision are the national aviation authorities, [the regional entity] according to the provisions of Article … of the Treaty/Act/Convention on [the regional entity], and/or entities acting on their behalf. Article 4 - Safety oversight function Competent aeronautical authorities shall exercise safety oversight as part of their supervision of requirements applicable to air navigation services (ANS), in order to monitor the safe provision of these activities and to verify that the applicable safety regulatory requirements and their implementing arrangements are met. Article 5 - Monitoring of safety performance 1) Competent aeronautical authorities shall provide regular monitoring and assessment of the levels of safety achieved in order to determine whether they comply with the safety regulatory requirements applicable in the airspace under their responsibility. 2) Competent aeronautical authorities shall use the results of monitoring of safety in particular to determine areas in which the verification of compliance with safety regulatory requirements is necessary as a matter of priority. Article 6 - Verification of compliance with safety regulatory requirements 1) Competent aeronautical authorities shall establish a process in order to verify: *This document has been produced with the financial assistance of the European Union. The contents of this document are the sole responsibility of the European Aviation Safety Agency and can under no circumstances be regarded as reflecting the position of the European Union.* FO.GEN.00404-003 © European Aviation Safety Agency. All rights reserved. ISO9001 Certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA-Internet/Intranet. An agency of the European Union Page 3 of 10 SIASA project Support to the Improvement of Aviation Safety in Africa This project is funded by the European Union and implemented by EASA. a) Compliance with regulatory safety requirements prior to the issuance or renewal of a certificate necessary to provide air navigation services including safety-related conditions attached to it; b) Compliance with any safety-related obligations in the acts giving permission to provide air navigation services; c) On-going compliance of the organizations with applicable safety regulatory requirements; d) Implementation of safety objectives, safety requirements and other safety-related conditions identified in: i. The systems audit statements, including any relevant declaration of conformity or suitability for use of system components; ii. Risk assessment and mitigation procedures required by safety regulatory requirements applicable to air navigation services; e) The implementation of safety directives. 2) The process referred to in paragraph 1 shall: a) Be based on documented procedures; b) Be supported by documentation specifically intended to provide safety oversight personnel with guidance to perform their functions; c) Provide the organizations concerned with an indication of the results of the safety oversight activity; d) Be based on safety regulatory audits and reviews conducted in accordance with Articles 7, 9 and 10 of this regulation; e) Provide to the competent aeronautical authority with the evidence needed for the adoption of additional measures, after consulting the Board of [the regional entity], in case of safety regulatory requirements not complied with. Article 7 - Safety regulatory audits 1) Competent aeronautical authorities or qualified entities acting on their behalf, shall conduct safety regulatory audits. 2) The safety regulatory audits referred to in paragraph 1: a) Provide the competent aeronautical authorities with evidence of compliance with applicable safety requirements and with implementing arrangements by evaluating the need for improvement or corrective action; b) Be independent of internal auditing activities undertaken by the organization concerned as part of its safety or quality management systems; c) Be conducted by auditors qualified in accordance with the requirements of Article 12 of this regulation; d) Apply to all or part of the implementation arrangements, and to processes, products or services; e) Used to determine whether: i. The implementing arrangements comply with safety regulatory requirements; *This document has been produced with the financial assistance of the European Union. The contents of this document are the sole responsibility of the European Aviation Safety Agency and can under no circumstances be regarded as reflecting the position of the European Union.* FO.GEN.00404-003 © European Aviation Safety Agency. All rights reserved. ISO9001 Certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA-Internet/Intranet. An agency of the European Union Page 4 of 10 SIASA project Support to the Improvement of Aviation Safety in Africa This project is funded by the European Union and implemented by EASA. ii. The measures taken are consistent with the implementing arrangements; iii. The results of actions taken match the results expected from the implementing arrangements; f) Lead to the correction of any identified non-conformities in accordance with Article 8 of this regulation. 3) Within the inspection program required by Article 8 of [the regional entity] regulation establishing common requirements for the provision of air navigation services, competent aeronautical authorities shall establish and update at least annually a programme of safety regulatory audits in order to: a) Cover all the areas of potential safety concern, with a focus on those areas where problems have been identified; b) Audit all the organizations, services and network functions operating under the supervision of the competent aeronautical authority; c) Ensure that audits are conducted in a manner proportionate to the level of risk posed by the activities of the organizations; d) Ensure that sufficient audits are conducted over a period of two years to check the compliance of all the relevant organizations with applicable safety regulatory requirements in all the relevant areas of the functional system; e) Monitor the implementation of corrective actions. 4) Competent aeronautical authorities may decide to modify the scope of planned audits and to include additional audits wherever that need arises. 5) Competent aeronautical authorities shall decide which arrangements, elements, services, functions, products, physical locations and activities are to be audited within a specified time frame. 6) The findings and non-conformities shall be documented. Non-conformities shall be supported by evidence, and identified in terms of applicable safety regulatory requirements and their implementing arrangements against which the audit has been conducted. 7) An audit report containing details of the non-conformities, shall be developed. Article 8 - Corrective Actions 1) Competent aeronautical authorities shall communicate the audit findings to audited organizations and shall simultaneously request corrective actions to address the non-conformities identified without prejudice to any additional action required by the applicable safety regulatory requirements. 2) Audited organization shall determine the corrective actions deemed necessary to correct non-conformities and the time frame for their implementation. 3) Competent aeronautical authorities shall assess the corrective actions as well as their implementation as determined by the audited organizations and accept them, provided that the assessment concludes that they are sufficient to address the non-conformities identified. 4) Audited organization shall initiate the corrective actions agreed by competent aeronautical authorities. These corrective actions and the subsequent follow-up process shall be performed within the time period accepted by competent aeronautical authority. Article 9 - Safety oversight of changes to functional systems a) Organizations shall only use procedures accepted by their competent aeronautical authority to decide to bring their functional systems change related to safety. In the case of air traffic service providers, *This document has been produced with the financial assistance of the European Union. The contents of this document are the sole responsibility of the European Aviation Safety Agency and can under no circumstances be regarded as reflecting the position of the European Union.* FO.GEN.00404-003 © European Aviation Safety Agency. All rights reserved. ISO9001 Certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA-Internet/Intranet. An agency of the European Union Page 5 of 10 SIASA project Support to the Improvement of Aviation Safety in Africa This project is funded by the European Union and implemented by EASA. and communication service providers, navigation or surveillance, the acceptance of these procedures by the competent aeronautical authority is under [the regional entity] regulation establishing common requirements for the provision of air navigation services. b) Agencies shall notify their competent aviation authority all planned safety related changes. The competent aeronautical authorities establish for this purpose appropriate administrative procedures in accordance with national law. c) Except in case of application of Article 10 of this regulation, organizations can implement the changes notified following the procedures specified in paragraph 1 of this Article. Article 10 - Procedure for review of proposed changes 1) The competent aeronautical authorities review the safety arguments associated with new functional systems or changes an organization proposes to make to existing functional systems in the following cases: a) The severity assessment conducted in accordance with Annex II, Section 2.2. Section 4, of [the regional entity] regulation laying down common requirements for the provision of air navigation services, concludes a severity A or B potential impacts of identified hazards; or b) The implementation of the changes requires the introduction of new aviation standards. When the competent aeronautical authorities conclude that the need for a review in situations other than those referred to in points a) and b), they shall notify the air navigation service provider of its decision to conduct a safety review of the notified changes. 2) The examination is conducted in a manner proportionate to the level of risk posed by the new functional system or the proposed changes to be made to existing functional systems. This review: a) Uses documented procedures; b) Be supported by documentation specifically designed to provide guidance to the safety oversight of staff in the performance of his duties; c) Consider the safety objectives, safety requirements and other proposed changes relating to safety requirements set out in: i. Declarations of verification of systems on the interoperability of the ANSP Air Traffic Management network; ii. Declarations of conformity or suitability for use of constituents of systems on the interoperability of the ANSP Air Traffic Management network; iii. Documentation relating to the assessment and mitigation of risks, established in accordance with regulatory requirements applicable safety; d) Determines, as appropriate, additional safety conditions related to the implementation of the change; e) Assess the acceptability of safety arguments presented, taking into account: i. Hazard identification; ii. The consistency of the classification in severity; *This document has been produced with the financial assistance of the European Union. The contents of this document are the sole responsibility of the European Aviation Safety Agency and can under no circumstances be regarded as reflecting the position of the European Union.* FO.GEN.00404-003 © European Aviation Safety Agency. All rights reserved. ISO9001 Certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA-Internet/Intranet. An agency of the European Union Page 6 of 10 SIASA project Support to the Improvement of Aviation Safety in Africa This project is funded by the European Union and implemented by EASA. iii. The validity of the safety objectives; iv. The validity, effectiveness and feasibility of safety requirements and any other safety condition set; v. The demonstration that the safety objectives, safety requirements and other safety-related conditions are continuously met; vi. The demonstration that the process used to produce the safety arguments meets the applicable safety regulatory requirements; f) Verify the processes used by organizations to produce the safety arguments in relation to the new functional system or changes they intend to make to existing functional systems; g) Determines the need to verify ongoing compliance; h) Include any necessary coordination activities with the authorities responsible for overseeing the safety of airworthiness and aircraft operations; i) Provide notification of the acceptance, if necessary under certain conditions, or refused, stating reasons, the proposed change; 3) The implementation of the change that is the subject of this review, is subject to acceptance by the competent aviation authority. Article 11 - Qualified entities 1) Where competent aeronautical authority decides to delegate to a qualified entity the conduct of safety regulatory audits or safety reviews in accordance with this regulation, it shall ensure that the criteria set out in Annex I to choose an entity among qualified entities include the following: a) The qualified entity has experience in assessing safety in aviation entities; b) The qualified entity is not simultaneously involved in the activities that the organization conducts in-house as part of its safety or quality management systems; c) All personnel concerned with the conduct of safety regulatory audits or safety reviews are adequately trained and qualified and meet the qualification criteria set out in Article 12, paragraph 3, of this regulation. 2) The qualified entity shall accept the possibility of being audited by the competent aeronautical authority or any other body acting on its behalf. 3) The competent aeronautical authorities keep a register of qualified entities commissioned to conduct safety regulatory audits or safety reviews on their behalf. The records shall document compliance with the requirements referred to in paragraph 1 above. Article 12 - Safety Oversight Capabilities 1) The parties to the Treaty/ACT/Convetion on [the regional entity] shall ensure that the competent aeronautical authorities have the capacity to ensure the safety oversight of all organizations within their jurisdiction and have sufficient resources particularly to implement the measures defined in this regulation. 2) The competent aeronautical authorities shall produce and update every two years, an evaluation of human resources required for the performance of their safety oversight functions, that based on the analysis of the processes required by this regulation and their application. *This document has been produced with the financial assistance of the European Union. The contents of this document are the sole responsibility of the European Aviation Safety Agency and can under no circumstances be regarded as reflecting the position of the European Union.* FO.GEN.00404-003 © European Aviation Safety Agency. All rights reserved. ISO9001 Certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA-Internet/Intranet. An agency of the European Union Page 7 of 10 SIASA project Support to the Improvement of Aviation Safety in Africa This project is funded by the European Union and implemented by EASA. 3) The competent aeronautical authorities shall ensure that all persons involved in safety oversight activities are competent to perform their functions. In this regard, they: a) Define and document the education, training, technical and operational knowledge, experience and qualifications necessary to perform the duties of each position involved in the safety oversight activities within their structure; b) Ensure that persons involved in safety oversight activities within their structure receive specific training; c) Ensure that personnel responsible for conducting safety regulatory audits, including auditing personnel qualified entities, meet specific qualification criteria defined by the competent aviation authority. These criteria are: i. Knowledge and understanding of the requirements related to air navigation services, the light of which can perform the safety regulatory audits; ii. The use of assessment techniques; iii. The skills required for managing an audit; iv. The demonstration of competence of auditors through evaluation or other acceptable means. Article 13 – Safety instructions 1) The competent aeronautical authorities issue a safety directive when it has determined the existence, within a functional system, an unsafe condition requiring immediate reaction. 2) The safety instructions are transmitted to the organizations concerned and contain at least the following information: a) Identification of the unsafe condition; b) Identification of the functional system; c) The actions required and their rationale; d) The period within which the necessary actions required to comply with the safety requirements; e) Its effective date. 3) The competent aeronautical authorities forward a copy of the safety directive to [the regional entity] and all other relevant aeronautical authorities. 4) The competent aeronautical authorities verify compliance with applicable safety regulations. Article 14 - Safety oversight records The competent aeronautical authorities shall keep appropriate records and maintain access to the appropriate records related to their safety oversight processes, including the reports of all safety regulatory audits and other safety-related records related to certificates, designations, the safety oversight of changes, safety directives and the use of qualified entities. *This document has been produced with the financial assistance of the European Union. The contents of this document are the sole responsibility of the European Aviation Safety Agency and can under no circumstances be regarded as reflecting the position of the European Union.* FO.GEN.00404-003 © European Aviation Safety Agency. All rights reserved. ISO9001 Certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA-Internet/Intranet. An agency of the European Union Page 8 of 10 SIASA project Support to the Improvement of Aviation Safety in Africa This project is funded by the European Union and implemented by EASA. Article 15 - Reports on safety oversight 1) The competent aeronautical authorities compile an annual report on the safety oversight on measures taken pursuant to this regulation. The annual report on the safety oversight also contains information on the following questions: a) Organizational structure and procedures of the competent aeronautical authority; b) Qualified entities commissioned to conduct safety regulatory audits; c) Current levels of the competent aeronautical authority resources; d) Any safety issues identified through the safety oversight processes implemented by the competent aviation authority. 2) The annual safety oversight is made available to the Member States concerned within the programs or activities conducted in accordance with agreed international arrangements to monitor or audit the implementation of the safety oversight air navigation services. Article 16 - Information exchange between competent aeronautical authorities The competent aeronautical authorities are taking steps to ensure close cooperation with each other and exchange relevant information to ensure the safety oversight of all organizations that provide services or perform functions cross-border nature. Article 17 - Transitional Provisions 1) Actions accomplished before the entry into force specified in Article 19 below and on the basis of national rules, subject to a point to the secretariat [the regional entity]. 2) Activities undertaken before the entry into force specified in Article 19 below and on the basis of national provisions, are managed in accordance with the provisions of this regulation. Article 18 - Revision and amendment The revision and / or amendment of this regulation shall be made in accordance with operation of [the regional entity] organs. Article 19 - Entry into force This regulation shall enter into force ......................... This regulation shall be binding in its entirety and directly applicable in all State Party as of the effective date. *This document has been produced with the financial assistance of the European Union. The contents of this document are the sole responsibility of the European Aviation Safety Agency and can under no circumstances be regarded as reflecting the position of the European Union.* FO.GEN.00404-003 © European Aviation Safety Agency. All rights reserved. ISO9001 Certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA-Internet/Intranet. An agency of the European Union Page 9 of 10 SIASA project Support to the Improvement of Aviation Safety in Africa This project is funded by the European Union and implemented by EASA. ANNEX I Criteria for the selection of qualified entities 1) The entity, its Director and the staff responsible for carrying out the verification tests must not become involved either directly or as authorized representatives in the design, manufacture, marketing or maintenance of products, parts, appliances, constituents or systems or in their operations, commissioning or use. This does not preclude the possibility of exchanges of technical information between the involved organizations and the qualified entity. 2) The entity and the staff responsible for the certification must perform their duties with the utmost professional integrity and the greatest possible technical competence and must be free of any pressure and incentive, such as financial which may affect their judgment or the results of their investigations, especially from persons or groups of persons affected by the results of the certification tasks. 3) The entity must employ staff and resources necessary to perform the technical and administrative tasks related to the certification process; it must also have access to the equipment needed for exceptional checks. 4) The staff responsible for investigation must have: a) Enjoy a strong technical and professional training; b) Be familiar with the requirements of the certification tasks they carry out and adequate experience of such activities; c) The ability required to draw up the declarations, records and reports to demonstrate that the investigations were carried out. 5) The impartiality of the investigation staff must be guaranteed. Their remuneration must not depend on the number of investigations carried out or on the results. 6) The entity must take out liability insurance unless that liability is covered by a Member State under its national legislation. 7) The staff of the entity must observe professional secrecy with regard to all information acquired in the course of performing its duties under this regulation. *This document has been produced with the financial assistance of the European Union. The contents of this document are the sole responsibility of the European Aviation Safety Agency and can under no circumstances be regarded as reflecting the position of the European Union.* FO.GEN.00404-003 © European Aviation Safety Agency. All rights reserved. ISO9001 Certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA-Internet/Intranet. An agency of the European Union Page 10 of 10