NPA 2016-19

European Aviation Safety Agency Notice of Proposed Amendment 2016-19 Alignment of implementing rules and acceptable means of compliance/guidance material with Regulation (EU) No 376/2014 — Occurrence reporting RMT.0681 EXECUTIVE SUMMARY The specific objective of this Notice of Proposed Amendment (NPA) is to update the implementing rules (IRs) of Regulation (EU) No 216/2008 and the related acceptable means of compliance (AMC)/guidance material (GM) in order to be aligned with Regulation (EU) No 376/2014 as regards the reporting, analysis and follow-up of occurrences in civil aviation. This NPA proposes changes to ensure that the IRs of Regulation (EU) No 216/2008 and the related AMC/GM adequately reflect the specific obligations stemming from Regulation (EU) No 376/2014 for the European Aviation Safety Agency (EASA) Member States’ competent authorities, individuals, as well as organisations having their principal place of business in an EASA Member State. These obligations currently exist in parallel with the reporting obligations of Regulation (EU) No 216/2008 and its IRs. While all the aforementioned Regulations are overall deemed to be consistent with one another, in practice, there is potential for overlaps and ambiguities that need to be addressed. The proposed changes are expected to: — increase legal certainty by clarifying the occurrence-reporting requirements within the scope of Regulation (EU) No 216/2008; — prepare the ground for standardisation inspections to monitor the implementation of Regulation (EU) No 376/2014; and — support the implementation of effective occurrence-reporting systems by all stakeholders concerned. Action area: Safety management Affected rules: — Initial Airworthiness: Part-21 and related AMC/GM; — Continuing Airworthiness: Part-M, Part-145 and related AMC/GM; — Aircrew: Part-ARA, Part-ORA and related AMC/GM; — Air Operations (Air OPS): Part-ARO, Part-ORO and related AMC/GM; — Aerodromes (ADR): Part-ADR.AR., Part-ADR.OR and related AMC/GM; — Air Traffic Management (ATM)/Air Navigation Services (ANS): Part-ATM/ANS.AR, Part-ATM/ANS.OR; — Air Traffic Controllers (ATCOs): Part-ATCO.AR, Part-ATCO.OR and related AMC/GM; — AMC-20 ‘General Acceptable Means of Compliance for Airworthiness of Products, Parts and Appliances’ Affected stakeholders: Operators, pilots, maintenance organisations (MOs), approved training organisations (ATOs), manufacturers, continuing-airworthiness management organisations (CAMOs), aerodrome operators, ATM/ANS service providers, ATCO training organisations (TOs), competent authorities, and Member States. Driver: Safety Rulemaking group: No Impact assessment: None Rulemaking procedure: Standard 30.9.2015 19.12.2016 2017/Q4 open open TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 1 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 Table of contents Table of contents 1. Procedural information .............................................................................................................................. 3 1.1. The rule development procedure...................................................................................................... 3 1.2. The structure of this NPA and related documents ............................................................................ 3 1.3. How to comment on this NPA ........................................................................................................... 3 1.4. The next steps in the procedure........................................................................................................ 3 2. Explanatory Note........................................................................................................................................ 5 2.1. Overview of the issues to be addressed ............................................................................................ 5 2.1.1. Scope of the amendments .......................................................................................................... 5 2.2. Objectives .......................................................................................................................................... 6 2.3. Summary of the IA ............................................................................................................................. 7 2.4. Overview of the proposed amendments .......................................................................................... 7 3. Proposed amendments ............................................................................................................................ 15 3.1. Draft Regulation (Draft EASA Opinion) — Part-21 .......................................................................... 15 3.2. Draft AMC/GM (Draft EASA Decision) — Part-21............................................................................ 18 3.3. Draft Regulation (Draft EASA Opinion) — Part-M ........................................................................... 21 3.4. Draft Regulation (Draft EASA Opinion) — Part-145 ........................................................................ 23 3.5. Draft AMC/GM (Draft EASA Decision) — Part-M ............................................................................ 25 3.6. Draft AMC/GM (Draft EASA Decision) — Part-145.......................................................................... 29 3.7. Draft Regulation (Draft EASA Opinion) — Part-ARA ........................................................................ 32 3.8. Draft Regulation (Draft EASA Opinion) — Part-ORA ....................................................................... 33 3.9. Draft AMC/GM (Draft EASA Decision) — Part-ARA ......................................................................... 35 3.10. Draft AMC/GM (Draft EASA Decision) — Part-ORA......................................................................... 37 3.11. Draft Regulation (Draft EASA Opinion) — Part-ARO ....................................................................... 42 3.12. Draft Regulation (Draft EASA Opinion) — Part-ORO ....................................................................... 44 3.13. Draft AMC/GM (Draft EASA Decision) — Part-ARO......................................................................... 45 3.14. Draft AMC/GM (Draft EASA Decision) — Part-ORO ........................................................................ 47 3.15. Draft Regulation (Draft EASA Opinion) — Part-ADR.AR .................................................................. 53 3.16. Draft Regulation (Draft EASA Opinion) — Part-ADR.OR .................................................................. 54 3.17. Draft AMC/GM (Draft EASA Decision) — Part-ADR.AR ................................................................... 56 3.18. Draft AMC/GM (Draft EASA Decision) — Part-ADR.OR ................................................................... 58 3.19. Draft Regulation (Draft EASA Opinion) — Part-ATM/ANS.AR ......................................................... 62 3.20. Draft Regulation (Draft EASA Opinion) — Part-ATM/ANS.OR ......................................................... 64 3.21. Draft Regulation (Draft EASA Opinion) — Part-ATCO.AR ................................................................ 65 3.22. Draft Regulation (Draft EASA Opinion) — Part-ATCO.OR................................................................ 66 3.23. Draft AMC/GM (Draft EASA Decision) — Part-ATCO.AR ................................................................. 68 3.24. Draft AMC/GM (Draft EASA Decision) — Part-ATCO.OR ................................................................. 69 3.25. Draft AMC/GM (Draft EASA Decision) — AMC-20........................................................................... 72 4. IA .............................................................................................................................................................. 96 5. References ................................................................................................................................................ 97 5.1. Affected regulations ........................................................................................................................ 97 5.2. Affected CSs, AMC and GM ............................................................................................................. 97 5.3. Reference documents...................................................................................................................... 98 6. Appendices ............................................................................................................................................... 99 6.1. Appendix 1 — Overview of changes and correspondence between IRs and AMC/GM across the different domains ....................................................................................................................................... 99 TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 2 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 1. Procedural information 1. Procedural information 1.1. The rule development procedure EASA developed this NPA in line with Regulation (EC) No 216/20081 (hereinafter referred to as the ‘Basic Regulation’) and the Rulemaking Procedure2. This rulemaking activity is included in the EASA 5- year Rulemaking Programme (RMP)3 under rulemaking task (RMT).0681. The text of this NPA has been developed by EASA. It is hereby submitted to all interested parties4 for consultation. The major milestones of this rulemaking activity are presented on the title page. 1.2. The structure of this NPA and related documents Chapter 1 of this NPA contains the procedural information related to this task. Chapter 2 (Explanatory Note) explains the core technical content. Chapter 3 contains the proposed text for the new requirements. No impact assessment (IA) is provided in this NPA as no new requirements are introduced and the proposed changes are limited to what is necessary to be aligned with Regulation (EU) No 376/20145, which is applicable since 15 November 2015. It is understood that competent authorities and organisations have already adapted their policies, procedures and manuals to be aligned with said Regulation. 1.3. How to comment on this NPA Please submit your comments using the automated comment-response tool (CRT) available at http://hub.easa.europa.eu/crt/6. The deadline for submission of comments is 20 March 2017. 1.4. The next steps in the procedure Following the closing of the public commenting period, EASA will review all comments. 1 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) (http://eur-lex.europa.eu/legal- content/EN/TXT/?qid=1467719701894&uri=CELEX:32008R0216). 2 EASA is bound to follow a structured rulemaking process as required by Article 52(1) of the Basic Regulation. Such a process has been adopted by the EASA Management Board and is referred to as the ‘Rulemaking Procedure’. See MB Decision No 18-2015 of 15 December 2015 replacing Decision 01/2012 concerning the procedure to be applied by the Agency for the issuing of opinions, certification specifications and guidance material (http://www.easa.europa.eu/the-agency/management- board/decisions/easa-mb-decision-18-2015-rulemaking-procedure). 3 https://www.easa.europa.eu/document-library/rulemaking-programmes/2016-2020-rulemaking-programme 4 In accordance with Article 52 of the Basic Regulation and Articles 6(3) and 7 of the Rulemaking Procedure. 5 Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis and follow- up of occurrences in civil aviation, amending Regulation (EU) No 996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and Commission Regulations (EC) No 1321/2007 and (EC) No 1330/2007 (OJ L 122, 24.4.2014, p. 18) (http://eur-lex.europa.eu/legal- content/EN/TXT/?qid=1478765387003&uri=CELEX:32014R0376). 6 In case of technical problems, please contact the CRT webmaster ([email protected]). TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 3 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 1. Procedural information Based on the comments received, EASA will develop an opinion containing the proposed amendments to the EU regulations listed under ‘Affected rules’ on the cover page of this NPA. The opinion to the European Commission will be used as a technical basis in order to prepare EU regulations. However, in order to reduce the burden linked with implementing multiple regulatory changes, the related amendments will be consolidated with the subsequent rule amendments in each particular domain. Likewise, following the adoption of the regulations, EASA will consolidate the corresponding AMC/GM amendments with the subsequent AMC/GM amendments by developing decisions amending AMC/GM to the regulations in each domain. The comments received and the EASA responses thereto will be reflected in a comment-response document (CRD), which will be annexed to the opinion. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 4 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 2. Explanatory Note 2. Explanatory Note 2.1. Overview of the issues to be addressed Regulation (EU) No 376/2014 on the reporting, analysis and follow-up of occurrences in civil aviation contains specific obligations for EASA, Member States’ competent authorities, individuals and approved organisations. These exist in parallel with the reporting obligations of the Basic Regulation and its IRs. While all the aforementioned Regulations are overall deemed to be consistent with one another, in practice, there is potential for overlaps and ambiguities in particular in relation to safety management/management system requirements, applicable to competent authorities and organisations, respectively. These potential issues can be addressed by updating the requirements in the affected IRs in order to render them fully consistent with Regulation (EU) No 376/2014. The basic principle that reporting obligations can be discharged by using one single reporting channel is maintained. The proposed changes will provide clarity on the relevant organisation requirements related to the maintenance of mandatory and voluntary reporting systems, the analysis and follow-up of occurrences or groups of occurrences, the implementation of ‘just culture’ principles as well as to the protection of the source of information. These requirements must be subject to the organisation’s internal audit/compliance monitoring function, and to the competent authority’s oversight. Regulation (EU) No 376/2014 does not apply to organisations not having their principal place of business in an EU Member State7, but staff of any EASA-approved organisations not having their principal place of business in an EU Member State are covered by Regulation (EU) No 376/2014. However, taking into account the objective of that Regulation, i.e. to ensure that relevant information is provided to the relevant competent authority in order for it to address potential safety issues, and considering that this type of occurrence reporting is also covered by the Basic Regulation and applicable Bilateral Aviation Safety Agreements (BASAs), EASA already receives the requested information through channels established in accordance with those existing rules and agreements. 2.1.1. Scope of the amendments Amendments to the IRs and the related AMC/GM are made in the following domains: — Initial Airworthiness: Annex I (Part-21) to Regulation (EU) No 748/20128; — Continuing Airworthiness: Annex I (Part-M) and Annex II (Part-145) to Regulation (EU) No 1321/20149; 7 Or, in the area of ATM/ANS, to organisations not located in the territory subject to the provisions of the Treaty establishing the European Union and responsible for providing services in the airspace of the territory to which the Treaty applies. 8 Commission Regulation (EU) No 748/2012 of 3 August 2012 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 (OJ L 224, 21.8.2012, p. 1) http://eur-lex.europa.eu/legal- content/EN/TXT/?qid=1478780094447&uri=CELEX:32012R0748). 9 Commission Regulation (EU) No 1321/2014 of 26 November 2014 on the continuing airworthiness of aircraft and aeronautical products, parts and appliances, and on the approval of organisations and personnel involved in these tasks (OJ L 362, 17.12.2014, p. 1) (http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1478780189135&uri=CELEX:32014R1321). TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 5 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 2. Explanatory Note — Aircrew: Annex VI (Part-ARA) and Annex VII (Part-ORA) to Regulation (EU) No 1178/201110; — Air OPS: Annex II (Part-ARO) and Annex III (Part-ORO) to Regulation (EU) No 965/201211; — ADR: Annex II (Part-ADR.AR.) and Annex III (Part-ADR.OR) to Regulation (EU) No 139/201412; — ATM/ANS: (Annex II (Part-ATM/ANS.AR) and Annex III (Part-ATM/ANS.OR) to Regulation (EU) 2016/137713; and — ATCOs: Annex II (Part-ATCO.AR) and Annex III (Part-ATCO.OR) to Regulation (EU) 2015/34014. Note: no AMC/GM to Regulation (EU) No 2016/1377 have been published so far. The proposed changes are replicated in each one of the IRs and related AMC/GM with regard to the various domain-specific authority and organisation requirements (or the equivalent Section B and Section A requirements in the airworthiness domain). EASA initiated an evaluation of the regulatory structure of the authority and organisation requirements, aimed at providing a qualitative and quantitative judgement on the regulatory design of these requirements in the various aviation domains and at developing recommendations to enhance ‘better regulation’ and efficiency in respect of the rules’ structure. This initiative responds to the calls from stakeholders and authorities, requesting EASA to provide a common and understandable strategy on regulating authority and organisation requirements. The outcome of this evaluation will be considered for determining how best to incorporate the changes that are required for aligning the various IRs with Regulation (EU) No 376/2014, and that are resulting from this RMT. 2.2. Objectives The overall objectives of the EASA system are defined in Article 2 of the Basic Regulation. This proposal will contribute to the achievement of the overall objectives by addressing the issues outlined in Chapter 2 of this NPA. The specific objective of this proposal is to update the IRs to the Basic Regulation and the related AMC/GM in order to properly reflect the requirements defined in Regulation (EU) No 376/2014. 10 Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down technical requirements and administrative procedures related to civil aviation aircrew pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 311, 25.11.2011, p. 1) (http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1478780712414&uri=CELEX:32011R1178). 11 Commission Regulation (EU) No 965/2012 of 5 October 2012 laying down technical requirements and administrative procedures related to air operations pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 296, 25.10.2012, p. 1) (http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1478780823722&uri=CELEX:32012R0965). 12 Commission Regulation (EU) No 139/2014 of 12 February 2014 laying down requirements and administrative procedures related to aerodromes pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 44, 14.2.2014, p. 1) (http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1478780869431&uri=CELEX:32014R0139). 13 Commission Implementing Regulation (EU) 2016/1377 of 4 August 2016 laying down common requirements for service providers and the oversight in air traffic management/air navigation services and other air traffic management network functions, repealing Regulation (EC) No 482/2008, Implementing Regulations (EU) No 1034/2011 and (EU) No 1035/2011 and amending Regulation (EU) No 677/2011 (OJ L 226, 19.8.2016, p. 1) (http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1478780917614&uri=CELEX:32016R1377). 14 Commission Regulation (EU) 2015/340 of 20 February 2015 laying down technical requirements and administrative procedures relating to air traffic controllers’ licences and certificates pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council, amending Commission Implementing Regulation (EU) No 923/2012 and repealing Commission Regulation (EU) No 805/2011 (OJ L 63, 6.3.2015, p. 1) (http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1478780979164&uri=CELEX:32015R0340). TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 6 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 2. Explanatory Note This will: — provide legal certainty with regard to the reporting obligations and underlying reporting systems; — clarify the scope of the competent authority’s oversight; and — support the implementation and promotion of a ‘just culture’. 2.3. Summary of the IA No IA is provided as this NPA transposes requirements of Regulation (EU) No 376/2014 already applicable since 15 November 2015.15 2.4. Overview of the proposed amendments Changes are introduced into all domains to update regulatory references as follows: — all references to Directive 2003/42/EC16, as well as to Regulations (EC) Nos 1321/200717 and 1330/200718, are removed as these legal acts have been repealed by Regulation (EU) No 376/2014; — any reference to Regulation (EU) No 996/201019 related to Article 19 ‘Obligation to notify accidents and serious incidents’ thereof is removed as this Article has been repealed by Regulation (EU) No 376/2014; and — existing AMC/GM related to the occurrence-reporting requirements are adapted to include references to Regulation (EU) No 2015/101820 that provides the list of occurrences to be mandatorily reported. Changes are proposed to all occurrence-reporting and management system IRs, AMC and GM. These changes are intended to provide clarity to organisations and authorities as to the need to consider the additional authority and organisation requirements stemming from Regulation (EU) No 376/2014 as part of their respective management systems. With the exception of Part-21 (where the initial structure and wording of the occurrence-reporting requirements are maintained as far as practicable), the relevant IRs are proposed to be amended based on the following ‘master text’: 15 The impact assessment performed by the European Commission for Regulation (EU) No 376/2014 is available under: http://eur-lex.europa.eu/resource.html?uri=cellar:9535bf18-ec24-48fe-96ee-4cb01156a525.0001.02/DOC_1&format=PDF. 16 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) (http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1478785175933&uri=CELEX:32003L0042). 17 Commission Regulation (EC) No 1321/2007 of 12 November 2007 laying down implementing rules for the integration into a central repository of information on civil aviation occurrences exchanged in accordance with Directive 2003/42/EC of the European Parliament and of the Council (OJ L 294, 13.11.2007, p. 3) (http://eur-lex.europa.eu/legal- content/EN/TXT/?qid=1478784931616&uri=CELEX:32007R1321). 18 Commission Regulation (EC) No 1330/2007 of 24 September 2007 laying down implementing rules for the dissemination to interested parties of information on civil aviation occurrences referred to in Article 7(2) of Directive 2003/42/EC of the European Parliament and of the Council (OJ L 295, 14.11.2007, p. 7) (http://eur-lex.europa.eu/legal- content/EN/TXT/?qid=1478784994489&uri=CELEX:32007R1330). 19 Regulation (EU) No 996/2010 of the European Parliament and of the Council of 20 October 2010 on the investigation and prevention of accidents and incidents in civil aviation and repealing Directive 94/56/EC (OJ L 295, 12.11.2010, p. 35) (http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1478785043261&uri=CELEX:32010R0996). 20 Commission Implementing Regulation (EU) 2015/1018 of 29 June 2015 laying down a list classifying occurrences in civil aviation to be mandatorily reported according to Regulation (EU) No 376/2014 of the European Parliament and of the Council (OJ L 163, 30.6.2015, p. 1) (http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1478785102896&uri=CELEX:32015R1018). TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 7 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 2. Explanatory Note Occurrence reporting (organisation requirements) (a) As part of its management system, the organisation shall implement an occurrence-reporting system, including mandatory and voluntary reporting. For organisations having their principal place of business in a Member State, such system shall meet the requirements of Regulation (EU) No 376/2014 and its implementing rules. (b) The organisation shall report to the competent authority and any other organisation required by the State of the operator to be informed: (1) any safety-related event or condition that endangers or, if not corrected or addressed, could endanger flight safety; and (2) any accident and serious incident, as defined in Regulation (EU) No 996/2010. (c) Without prejudice to paragraph (b) above, the organisation shall report to the competent authority and the organisation responsible for the design of the aircraft any occurrence that would highlight inaccurate, incomplete or ambiguous information, contained in data established in accordance with Regulation (EU) No 748/2012, or other irregular circumstance that has or may have endangered flight safety and has not resulted in an accident or serious incident. (d) For organisations not having their principal place of business in a Member State: (1) initial reports shall: (i) 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; (ii) be made in a form and manner established by the Agency; and (iii) contain all pertinent information about the condition known to the organisation; (2) where relevant, a follow-up report providing details of actions the organisation intends to take to prevent similar occurrences in the future shall be made as soon as these actions have been identified; those follow-up reports shall: (i) be sent to relevant entities initially reported to as per paragraphs (b) and (c) above; and (ii) be produced in a form and manner established by the Agency. — Point (a) addresses the implementation and maintenance of the system for collecting data and reporting. Organisations having their principal place of business (PPB) in a Member State must demonstrate that their system is fully compliant with Regulation (EU) No 376/2014. GM is proposed to be added to clarify the meaning of ‘occurrence-reporting system complying with Regulation (EU) No 376/2014’. — Point (b) defines what needs to be reported and to whom. In point (b)(1), the reference to ‘any safety-related event or condition that endangers or, if not corrected or addressed, could TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 8 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 2. Explanatory Note endanger flight safety’ is intended to cover more than what is to be mandatorily reported under Regulation (EU) No 376/2014 and its IRs (reference to voluntary reporting). — Point (c) addresses operational suitability data (OSD)-related reporting and is adapted depending on the domain to reflect similar requirements for reporting to organisations responsible for the design of aerodrome equipment or of ATM/ANS systems and constituents as such reporting is not explicitly addressed in Regulation (EU) No 376/2014. — Point (d) addresses reporting requirements for organisations that are not subject to Regulation (EU) No 376/2014. It should be noted that in accordance with Article 6(3) of Regulation (EU) No 376/2014, each Member State shall designate one or more competent authorities to establish a mechanism to independently collect, evaluate, process, analyse and store details of occurrences reported pursuant to Articles 4 ‘Mandatory reporting’ and 5 ‘Voluntary reporting’ of said Regulation. This may lead to situations where the competent authority responsible for occurrence reporting is different from the one responsible for the oversight of the organisation. As occurrence reports provide a vital source of information for the competent authority responsible for the oversight, it is proposed to keep the current rule references to the ‘competent authority’. A new GM to the authority management system requirements is proposed to be inserted to clarify the need for Member States to ensure proper coordination in case different competent authorities are established for occurrence reporting and oversight respectively (see ‘master GM text’ below). GM to Management system (authority requirements) (a) Where a Member State designates different competent authorities to manage occurrences reported pursuant to Articles 4 ‘Mandatory reporting’ and 5 ‘Voluntary reporting’ of Regulation (EU) No 376/2014 and for the oversight of persons and organisations in accordance with Regulation (EC) No 216/2008 and its implementing rules respectively: (1) the areas of competence of each competent authority must be clearly defined; (2) proper coordination must be established between those authorities to ensure effective oversight of all persons and organisations subject to Regulation (EC) No 216/2008 and its implementing rules within their respective remits; and (3) occurrence reports addressed to the competent authority responsible for the oversight of persons and organisations in accordance with Regulation (EC) No 216/2008 and its implementing rules must be shared with the competent authority established for managing occurrence reports pursuant to Regulation (EU) No 376/2014. (b) The organisational set-up in terms of competent authorities designated under Regulations (EU) No 376/2014, (EC) No 216/2008, and their implementing rules, must not result in a duplication of the reporting obligations for persons or organisations subject to those Regulations. Linked to the above, a change to Section B ‘Authority Requirements’ on reporting and coordination is proposed in order to clarify that safety-significant information stemming from occurrence reports to be provided to EASA should consider any occurrence stored in the national database, and not only the TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 9 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 2. Explanatory Note occurrences received by the competent authority (cf. 21.B.45, ARA.GEN.125, ARO.GEN.125, ADR.AR.A.025, ATM/ANS.AR.A.020 and ATCO.AR.A.020). A summary of the changes introduced into the various domains is included below: In the domain of Initial Airworthiness (Part-21), changes are introduced into the reporting obligations of: — any holder of a type certificate (TC), restricted type certificate (RTC), supplemental type certificate (STC), European technical standard order (ETSO) authorisation, major repair design approval or any other relevant approval deemed to have been issued under Part-21; — production organisations; and — design organisations. In addition, the following changes are introduced: — 21.A.3A ‘Failures, malfunctions and defects’ is amended to clarify that the occurrence-reporting system established by EASA design approval holders (DAHs) having their PPB in a Member State shall meet the requirements of Regulation (EU) No 376/2014; — AMC 21.A.3A(b)(2) is deleted as the items defined therein are already addressed in Section 6 ‘REPORTING TIME — MANDATORY REPORTING’ of AMC 20-8; — new point 21.B.45(c) is inserted to ensure that EASA receives safety-significant information stemming from occurrence reports received by Member States’ competent authorities; — new AMC/GM to new point 21.B.45(c) are added to clarify the competent authorities’ obligations in relation to the exchange of safety-significant information with EASA; — EASA Form 56, Part 2, is changed to include a reference to Regulation (EU) No 376/2014; and — references to European Parts Approval (EPA)/EPA holder are deleted. In the domain of Continuing Airworthiness (Part-M and Part-145), the following changes are introduced: Part-M — M.A.202 ‘Occurrence Reporting ‘ and the related AMC are amended to reflect Regulation (EU) No 376/2014. The scope of M.A.202 is amended to make it applicable to persons only, organisational occurrence-reporting requirements being proposed with new M.A.620 and M.A.718, respectively. New GM1 M.A.202 is added to include a reference to AMC 20-8. — New M.A.620 is added with occurrence-reporting requirements for maintenance organisations approved in accordance with Subpart F of Part M. Two new AMC (AMC1 M.A.620 and AMC2 M.A.620) and one new GM (GM1 M.A.620) are added to clarify the reporting requirements; new AMC1 M.A.620(a) is extracted from the existing AMC M.A.202(a). — New M.A.718 is added with occurrence-reporting requirements for CAMOs approved in accordance with Subpart G of Part-M. In addition, two new AMC (AMC1 M.A.718 and AMC2 M.A.718) and one new GM (GM1 M.A.718) are added to clarify the reporting requirements. Point (a) of new AMC1 M.A.718 is extracted from the existing AMC1 to M.A.202(a). TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 10 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 2. Explanatory Note — In Section B, new requirement M.B.106 ‘Information to the Agency’ is added. It is complemented by one new AMC and three new GM to clarify the competent authorities’ obligations in relation to the exchange of safety-significant information with EASA. In addition, new GM1 M.B.106 is added addressing the need for Member States to ensure proper coordination in case different competent authorities are established for occurrence reporting and oversight respectively. Note: the proposed changes to Subpart F and Subpart G of Part-M are introduced independently of the changes proposed with Opinions Nos 05/201621 ‘Task force for the review of Part-M for General Aviation (PHASE II)’ and 06/201622 ‘Embodiment of safety management system (SMS) requirements into Commission Regulation (EU) No 1321/2014 — SMS in Part-M’, respectively. Pending the adoption of the related amending regulations by the European legislator, Subparts F and G of Part-M may be ‘phased out’ and replaced by the new proposed Annex Vd (Part-CAO) as well as Annex Vc (Part-CAMO) to Regulation (EU) No 1321/2014. The reporting requirements proposed by this NPA will be considered for inclusion in Part-CAO and Part-CAMO, as required. Part-145 — 145.A.60 is amended to reflect Regulation (EU) No 376/2014 and further aligned with occurrence-reporting requirements in the other domains. The related AMC 145.A.60(a) GM 145.A.60(a) and GM1 145.A.60(c) are replaced accordingly by AMC1 145.A.60, AMC2 145.A.60 and GM1 145.A.60. — New 145.A.62 ‘Internal safety-reporting scheme’ is added to introduce and further elaborate upon the internal reporting scheme currently included in 145.A.60. This takes into account the future introduction of SMS requirements into Part-145. — In Section B, new 145.B.62 ‘Information to the Agency’ is added. It is complemented by one new AMC and three new GM to clarify the competent authorities’ obligations in relation to the exchange of safety-significant information with EASA. In addition, new GM1 145.B.62 is added addressing the need for Member States to ensure proper coordination in case different competent authorities are established for occurrence reporting and oversight respectively. More extensive changes are introduced into the following domains: Aircrew, Air OPS, ADR, ATM/ANS and ATCOs. The proposed changes consider that the general authority and organisation requirements in these domains take already account of the International Civil Aviation Organization (ICAO) Standards and Recommended Practices (SARPs) on safety management, as set out in ICAO Annex 19. It should be noted that reporting requirements for the organisation’s internal reporting systems are currently not consistent across domains: only Part-ADR.OR contains a specific requirement (cf. ADR.OR.D.030 ‘Safety-reporting system’) and Part-145 a requirement for an internal safety-reporting scheme in 145.A.60. As this RMT is strictly limited to alignment with Regulation (EU) No 376/2014, the changes required to harmonise internal safety-reporting requirements across domains cannot be proposed by this NPA. 21 https://www.easa.europa.eu/document-library/opinions/opinion-052016 22 https://www.easa.europa.eu/document-library/opinions/opinion-062016 TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 11 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 2. Explanatory Note These changes should be addressed by a separate RMT which will review the consistency of management system requirements and enhance the general organisation requirements related to safety management, across domains. This could also be the opportunity to review the management system requirements in order to address the changes introduced by ICAO Annex 19, 2nd Edition. The Agency seeks the views of stakeholders on the need for, as well as on the main items to be included in, future rulemaking as regards reviewing and enhancing the general organisation requirements related to safety management, across domains. The following provides a summary of changes made in the domains of Aircrew, Air OPS, ADR, ATM/ANS and ATCOs: (a) changes to the relevant authority requirements and corresponding AMC/GM: (1) clarification of competent authorities’ obligations in relation to the exchange of safety- significant information with EASA; (2) new GM to the management system requirements addressing the need for Member States to ensure proper coordination in case different competent authorities are established for occurrence reporting and oversight respectively; (3) clarification that the competent authorities’ management system must consider the additional requirements stemming from Regulation (EU) No 376/2014; and (4) clarification that changes to the competent authorities’ management system must consider the possible effects on the competent authority’s capability to perform its tasks and discharge its responsibilities stemming from Regulation (EU) No 376/2014. (b) changes to the relevant organisation requirements related to occurrence-reporting and management system, and corresponding AMC and GM: (1) amendment to the occurrence-reporting requirements to address mandatory and voluntary reporting and require all organisations having their PPB in a Member State to implement an occurrence-reporting system compliant with Regulation (EU) No 376/2016; (2) inclusion of a new AMC addressing reporting between organisations, based on the items currently included in AMC 20-8, Item 9 (the applicability of AMC-20 is limited to airworthiness); this AMC clarifies among other items that any organisation reporting to the organisation responsible for the design is expected to actively support any investigations that may be initiated, to provide timely response to information requests, and to make available affected components for the purpose of the investigation, subject to an agreement with the respective component owners23 (for Part-21, Part-M and Part-145, this material is included in AMC 20-8 to limit duplication); (3) inclusion of a new GM describing the main elements of an occurrence-reporting system compliant with Regulation (EU) No 376/2014 (for Airworthiness, such GM is included in AMC 20-8 to limit duplication); 23 This addresses Action 2016-3.4 agreed in the 6th International Workshop on Voluntary Reporting System (IORS workshop) organised by the Agency. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 12 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 2. Explanatory Note (4) clarification that the organisation’s management system must consider all applicable requirements, including those of Regulation (EU) No 376/2014; and (5) complementation of the existing GM to the management system requirements dealing with safety policy in order to highlight the importance of adopting ‘just culture’ principles. In addition to the above, in the domain of Air OPS, point (g) of AMC1 ORO.AOC.130 ‘Flight data monitoring — aeroplanes’ is proposed to be reworded for the following reasons: — AMC1 ORO.AOC.130 falls within the scope of the flight data monitoring (FDM) programme, which should be under the responsibility of the safety manager. Hence, AMC1 ORO.AOC.130 is primarily addressed to the safety manager and to the staff involved in the FDM programmes while the current wording of point (g) of said AMC is confusing in the sense that it seems to be addressed to flight crews. Therefore, the new wording places more emphasis on what should be done by the safety management team or the FDM team to receive a retrospective report by the flight crew. — In addition, through the adoption of Regulation (EU) No 376/2014, an interpretation issue concerning point (g) arose. In fact, point (g) addresses only internal reporting by flight crews for the purpose of analysing FDM events. When an FDM event is considered to bear sufficient risk to justify an analysis in the frame of the operator’s SMS, then, a flight crew report is necessary to complete the picture gained through the FDM data. However, a significant risk-bearing FDM event is not necessarily linked to an occurrence for which reporting to authorities is mandated by Regulation (EU) No 376/2014. The new wording clarifies that point (g) refers to another (and older) process than occurrence reporting defined by Regulation (EU) No 376/2014. Moreover, in the domain of ADR, the AMC and GM to ADR.OR.C.030 ‘Occurrence reporting’ and ADR.OR.D.030 ‘Safety-reporting system’ have been reviewed to better clarify the link between the operator’s own safety-reporting system and mandatory/voluntary reporting to the competent authority as required by Regulation (EU) No 376/2014, as well as to highlight the importance of reporting between organisations. The Part-ADR.AR requirements on the safety-reporting system and related AMC/GM may serve as a basis for harmonising organisation requirements across domains. AMC 20-8 (as last amended by ED Decision 2015/017/R) AMC 20-8 is amended as a consequence of the above changes. Changes to AMC 20-8 are summarised below: — elements already sufficiently addressed in other parts of the regulations are removed; — guidance on what constitutes an occurrence-reporting system compliant with Regulation (EU) No 376/2014 is added (cf. Section 7 of AMC 20-8); this way, no repetition of the same text in Part-21, Part-M and Part-145 is needed; — further guidance on reporting between organisations is provided (cf. Section 8 of AMC 20-8), this way, no repetition of the same text in Part-21, Part-M and Part-145 is needed; and — the list of reportable occurrences, superseded by Regulation (EU) 2015/1018 providing the list of occurrences that are subject to mandatory reporting, is removed. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 13 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 2. Explanatory Note The Agency seeks the views of stakeholders on the need for, as well as on the main items that could be transferred into, a set of ‘cross-domain’ AMC and GM (similar to AMC-20, but not limited to airworthiness) to address all common elements of organisation’s management and occurrence-reporting systems, with the objective to ensure overall consistency, while eliminating duplication of common contents in the different domain-specific AMC and GM. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 14 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments 3. Proposed amendments The text of the amendment is arranged to show deleted text, new or amended text as shown below: (a) deleted text is marked with strike through; (b) new or amended text is highlighted in grey; (c) an ellipsis (…) indicates that the remaining text is unchanged in front of or following the reflected amendment. 3.1. Draft Regulation (Draft EASA Opinion) — Part-21 SECTION A — TECHNICAL REQUIREMENTS SUBPART A — GENERAL PROVISIONS 1. 21.A.3A is amended as follows: 21.A.3A Failures, malfunctions and defects (a) System for Collection, Investigation and Analysis of Data The holder of a type-certificate, restricted type-certificate, supplemental type- certificate, European Technical Standard Order (ETSO) authorisation, major repair design approval or any other relevant approval deemed to have been issued under this Regulation shall haveestablish and maintain a system for collecting, investigating and analysing reports of and information related to failures, malfunctions, defects or other occurrences which cause or might cause adverse effects on the continuing airworthiness of the product, part or appliance covered by the type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, major repair design approval or any other relevant approval deemed to have been issued under this Regulation. For organisations having their principal place of business in a Member State, such system shall include provisions for mandatory and voluntary reporting that meet the requirements of Regulation (EU) No 376/2014 and its implementing rules. Information about this system shall be made available to all known operators of the product, part or appliance and, on request, to any person authorised under other associated implementing Regulations. (b) Reporting to the Agency 1. The holder of a type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, major repair design approval or any other relevant approval deemed to have been issued under this Regulation shall report to the Agency any failure, malfunction, defect or other occurrence of which it is aware related to a product, part, or appliance covered by the type-certificate, restricted type-certificate, supplemental type certificate, ETSO authorisation, major repair design approval or any other relevant approval deemed to have been issued under this Regulation, and which has resulted in or may result in an unsafe condition. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 15 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments 2. These reports shall be made in a form and manner established by the Agency, as soon as practicable and in any case dispatched not later than 72 hours after the identification of the possible unsafe condition, unless exceptional circumstances prevent this. (…) SUBPART F — PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL 2. 21.A.129 is amended as follows: 21.A.129 Obligations of the manufacturer Each manufacturer of a product, part or appliance being manufactured under this Subpart shall: (…) (e) establish and maintain an internal occurrence reporting system in the interest of safety, to enable the collection and assessment of occurrence reports in order to identify adverse trends or to address deficiencies, and to extract reportable occurrences.in the interest of safety, establish and maintain an occurrence-reporting system, including mandatory and voluntary reporting, to enable the collection and assessment of occurrence reports in order to identify adverse trends or address deficiencies, and extract reportable occurrences. This system shall include evaluation of relevant information relating to occurrences, and the promulgation of related information. For manufacturers having their principal place of business in a Member State, such system shall meet the requirements of Regulation (EU) No 376/2014 and its implementing rules. (f) 1. report to the holder of the type-certificate, restricted type-certificate or design approval, all cases where products, parts or appliances have been released by the manufacturer and subsequently identified to have deviations from the applicable design data, and investigate with the holder of the type-certificate, restricted type-certificate or design approval to identify those deviations which could lead to an unsafe condition; 2. report to the Agency and the competent authority of the Member State the deviations which could lead to an unsafe condition identified according to point (1). Such reports shall be made in a form and manner established by the Agency under point 21.A.3A(b)(2) or accepted by the competent authority of the Member State; 3. where the manufacturer acts as supplier to another production organisation, report also to that other organisation all cases where it has released products, parts or appliances to that organisation and subsequently identified them to have possible deviations from the applicable design data. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 16 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments SUBPART G — PRODUCTION ORGANISATION APPROVAL 3. 21.A.165 is amended as follows: 21.A.165 Obligations of the holder The holder of a production organisation approval shall: (…) (e) establish and maintain an internal occurrence reporting system in the interest of safety, to enable the collection and assessment of occurrence reports in order to identify adverse trends or to address deficiencies, and to extract reportable occurrences. This system shall include evaluation of relevant information relating to occurrences and the promulgation of related informationestablish and maintain an occurrence-reporting system, including mandatory and voluntary reporting, to enable the collection and assessment of occurrence reports in order to identify adverse trends or address deficiencies, and extract reportable occurrences. This system shall include evaluation of relevant information relating to occurrences and the promulgation of related information. For organisations having their principal place of business in a Member State, such system shall meet the requirements of Regulation (EU) No 376/2014 and its implementing rules; (f) 1. report to the holder of the type-certificate or design approval, all cases where products, parts or appliances have been released by the production organisation and subsequently identified to have possible deviations from the applicable design data, and investigate with the holder of the type-certificate or design approval in order to identify those deviations which could lead to an unsafe condition; 2. report to the Agency and the competent authority of the Member State the deviations which could lead to an unsafe condition identified according to point (1). Such reports shall be made in a form and manner established by the Agency under point 21.A.3A(b)(2) or accepted by the competent authority of the Member State; 3. where the holder of the production organisation approval is acting as a supplier to another production organisation, report also to that other organisation all cases where it has released products, parts or appliances to that organisation and subsequently identified them to have possible deviations from the applicable design data; (…) TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 17 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments SECTION B — PROCEDURES FOR COMPETENT AUTHORITIES SUBPART A — GENERAL PROVISIONS 4. 21.B.45 is amended as follows: 21.B.45 Reporting/coordination (a) The competent authority of the Member State shall ensure coordination as applicable with other related certification, investigation, approval or authorisation teams of that authority, other Member States and the Agency to ensure efficient exchange of information relevant for safety of the products, parts and appliances. (b) The competent authority of the Member State shall notify any difficulty in the implementation of this Annex I (Part 21) to the Agency. (c) Without prejudice to Regulation (EU) No 376/2014, the competent authority of the Member State shall provide the Agency with safety-significant information stemming from the occurrence reports stored in the national database. 3.2. Draft AMC/GM (Draft EASA Decision) — Part-21 SECTION A SUBPART A — GENERAL 1. GM 21.A.3A(b) is amended as follows: GM 21.A.3A(b) Occurrence reporting For occurrence reporting, refer to the latest edition of AMC 20-8 (see AMC-20 document) and to the list of reportable occurrences provided in Regulation (EU) 2015/1018. 2. AMC 21.A.3A(b)(2) is deleted as the items defined therein are already addressed in Section 6 ‘REPORTING TIME — MANDATORY REPORTING’of AMC 20-8. SECTION B SUBPART A — GENERAL PROVISIONS 3. New AMC1 21.B.45(c) is added as follows: AMC1 21.B.45(c) Reporting/coordination EXCHANGE OF SAFETY-SIGNIFICANT INFORMATION WITH THE AGENCY Each competent authority should appoint a coordinator to act as the contact point for the exchange of safety-significant information between the competent authority and the Agency. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 18 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments 4. New GM1 21.B.45 is added as follows: GM1 21.B.45 Reporting/coordination COMPETENT AUTHORITY ESTABLISHED IN ACCORDANCE WITH REGULATION (EU) No 376/2014 (a) Where a Member State designates different competent authorities to manage occurrences reported pursuant to Articles 4 ‘Mandatory reporting’ and 5 ‘Voluntary reporting’ of Regulation (EU) No 376/2014 and for the oversight of persons and organisations in accordance with Regulation (EC) No 216/2008 and its implementing rules respectively: (1) the areas of competence of each competent authority must be clearly defined; (2) proper coordination must be established between those authorities to ensure effective oversight of all persons and organisations subject to Regulation (EC) No 216/2008 and its implementing rules within their respective remits; and (3) occurrence reports addressed to the competent authority responsible for the oversight of persons and organisations in accordance with Regulation (EC) No 216/2008 and its implementing rules must be shared with the competent authority established for managing occurrence reports pursuant to Regulation (EU) No 376/2014. (b) The organisational set-up in terms of competent authorities designated under Regulations (EU) No 376/2014, (EC) No 216/2008, and their implementing rules, must not result in a duplication of the reporting obligations for persons or organisations subject to those Regulations. 5. New GM1 21.B.45(c) is added as follows: GM1 21.B.45(c) Information to the Agency MEANING OF SAFETY-SIGNIFICANT INFORMATION STEMMING FROM OCCURRENCE REPORTS Safety-significant information stemming from occurrence reports means: (a) a conclusive safety analysis which summarises individual occurrence data and provides an in- depth analysis of a safety issue, and which may be relevant for the Agency’s safety action planning; and (b) individual occurrence data for the cases where the Agency is the competent authority and which fulfils the reporting criteria of GM3 21.B.45(c). 6. New GM2 21.B.45(c) is added as follows: GM2 21.B.45(c) Information to the Agency RECOMMENDED CONTENT FOR CONCLUSIVE SAFETY ANALYSES A conclusive safety analysis should contain the following: (a) a detailed description of the safety issue, including the scenario in which the safety issue takes place; and (b) an indication of the stakeholders affected by the safety issue, including types of operations and organisations; and, as appropriate: TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 19 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (c) a risk assessment establishing the severity and likelihood of all the possible consequences of the safety issue; (d) information about the existing safety barriers that the aviation system has in place to prevent the likely safety issue consequences from occurring; (e) any mitigating actions already in place or developed to deal with the safety issue; (f) recommendations for future actions to control the risk; and (g) any other element the competent authority considers essential for the Agency to properly assess the safety issue. 7. New GM3 21.B.45(c) is added as follows: GM3 21.B.45(c) Information to the Agency OCCURRENCES WHERE THE AGENCY IS THE COMPETENT AUTHORITY Occurrences related to organisations or products, certified by the Agency, should be notified to the Agency if: (a) the occurrence is defined as a reportable occurrence in accordance with the applicable regulation; (b) the organisation responsible for addressing the occurrence is certified by the Agency; and (c) the Member State competent authority has come to the conclusion that: (1) the organisation certified by the Agency to which the occurrence relates has not been informed of the occurrence; or (2) the occurrence has not been properly addressed or has been left unattended by the organisation certified by the Agency. SECTION B SUBPART G — PRODUCTION ORGANISATION APPROVAL 8. EASA Form 56 ‘RECOMMENDATION REPORT IN SUPPORT OF Part 21 SUBPART G APPROVAL ISSUE/CONTINUATION/VARIATION/SIGNIFICANT CHANGE — PART TWO OF FIVE PARTS: Part 21 SUBPART G COMPLIANCE’ is amended as follows: (…) PART TWO OF FIVE (CONTINUED): SURVEY REFERENCE: (…) EASA Form 56 Issue 34 TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 20 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments 3.3. Draft Regulation (Draft EASA Opinion) — Part-M SECTION A — TECHNICAL REQUIREMENTS SUBPART B — ACCOUNTABILITY 1. The content of M.A.202 is replaced by the following: M.A.202 Occurrence reporting (a) Any person responsible in accordance with M.A.201 shall report to the competent authority designated by the State of Registry, to the organisation responsible for the type design or supplemental type design and, if applicable, to the Member State of the operator any safety- related event or identified condition of an aircraft or component that endangers or, if not corrected or addressed, could endanger flight safety. (b) Where the person maintaining the aircraft is contracted by an owner or an operator to carry out maintenance, the person shall also report to the owner, the operator or the continuing- airworthiness management organisation (CAMO) any such safety-related event or identified condition affecting the owner’s or operator’s aircraft or component. (c) Without prejudice to paragraphs (a) and (b) above, the person shall report to the competent authority and the organisation responsible for the design of the aircraft any incident, malfunction, technical defect, exceeding of technical limitations, occurrence that would highlight inaccurate, incomplete or ambiguous information, contained in data established in accordance with Regulation (EU) No 748/2012, or other irregular circumstance that has or may have endangered the safe operation of the aircraft. (d) Without prejudice to Regulation (EU) No 376/2014, reports in accordance with paragraphs (a) and (c) above shall: (1) be made as soon as practicable, but in any case, within 72 hours of the person identifying the event or condition to which the report relates unless exceptional circumstances prevent this; (2) be made in a form and manner established by the competent authority, as defined in M.1; and (3) contain all pertinent information about the condition known to the person. SUBPART F —MAINTENANCE ORGANISATION 2. New M.A.620 is added as follows: M.A.620 Occurrence reporting (a) The organisation shall implement an occurrence-reporting system, including mandatory and voluntary reporting, that meets the requirements of Regulation (EU) No 376/2014 and its implementing rules. (b) The organisation shall report to: TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 21 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (1) the competent authority, the State of Registry, and the organisation responsible for the design of the aircraft or component any safety-related event or condition of an aircraft or component identified by the organisation that endangers or, if not corrected or addressed, could endanger flight safety. (2) the competent authority, and any other organisation required by the State of the operator to be informed, any accident and serious incident, as defined in Regulation (EU) No 996/2010. (c) Where the organisation is contracted by an owner or an operator to carry out maintenance, the organisation shall also report to the owner, the operator or the continuing-airworthiness management organisation (CAMO) any such event or condition affecting the owner’s or operator’s aircraft or component. (d) Without prejudice to paragraphs (b) and (c) above, the organisation shall report to the competent authority and the organisation responsible for the design of the aircraft any incident, malfunction, technical defect, exceeding of technical limitations, occurrence that would highlight inaccurate, incomplete or ambiguous information, contained in data established in accordance with Regulation (EU) No 748/2012, or other irregular circumstance that has or may have endangered the safe operation of the aircraft. SUBPART G — CONTINUING AIRWORTHINESS MANAGEMENT ORGANISATION 3. New M.A.718 is added as follows: M.A.718 Occurrence reporting (a) The organisation shall implement an occurrence-reporting system, including mandatory and voluntary reporting. For organisations having their principal place of business in a Member State, such system shall meet the requirements of Regulation (EU) No 376/2014 and its implementing rules. (b) The organisation shall report to: (1) the competent authority, the State of Registry, and the organisation responsible for the design of the aircraft or component any safety-related event or condition of an aircraft or component identified by the organisation that endangers or, if not corrected or addressed, could endanger flight safety. (2) the competent authority, and any other organisation required by the State of the operator to be informed, any accident and serious incident, as defined in Regulation (EU) No 996/2010. (c) Without prejudice to paragraph (b) above, the organisation shall report to the competent authority and the organisation responsible for the design of the aircraft any incident, malfunction, technical defect, exceeding of technical limitations, occurrence that would highlight inaccurate, incomplete or ambiguous information, contained in data established in accordance with Regulation (EU) No 748/2012, or other irregular circumstance that has or may have endangered the safe operation of the aircraft. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 22 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (d) For organisations not having their principal place of business in a Member State: (1) initial reports shall: (i) 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; (ii) be made in a form and manner established by the Agency; and (iii) contain all pertinent information about the condition known to the organisation; (2) where relevant, a follow-up report providing details of actions the organisation intends to take to prevent similar occurrences in the future shall be made as soon as these actions have been identified; those follow-up reports shall: (i) be sent to relevant entities initially reported to as per paragraphs (b) and (c) above; and (ii) be produced in a form and manner established by the Agency. SECTION B — PROCEDURES FOR COMPETENT AUTHORITIES SUBPART A — GENERAL 4. New M.B.106 is added as follows: M.B.106 Information to the Agency (a) The competent authority shall without undue delay notify the Agency in case of any significant problems with the implementation of Regulation (EC) No 216/2008 and its implementing rules. (b) The competent authority shall provide the Agency with safety-significant information stemming from the occurrence reports it has received pursuant to M.A.202, M.A.620 and M.A.718. 3.4. Draft Regulation (Draft EASA Opinion) — Part-145 SECTION A TECHNICAL REQUIREMENTS 1. The content of 145.A.60 is replaced by the following: 145.A.60 Occurrence reporting (a) The organisation shall implement an occurrence-reporting system, including mandatory and voluntary reporting. For organisations having their principal place of business in a Member State, such system shall meet the requirements of Regulation (EU) No 376/2014 and its implementing rules. (b) The organisation shall report to: TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 23 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (1) the competent authority, the State of Registry, and the organisation responsible for the design of the aircraft or component any safety-related event or condition of an aircraft or component identified by the organisation that endangers or, if not corrected or addressed, could endanger flight safety. (2) the competent authority, and any other organisation required by the State of the operator to be informed, any accident and serious incident, as defined in Regulation (EU) No 996/2010. (c) Where the organisation is contracted by an owner or an operator to carry out maintenance, the organisation shall also report to the owner, the operator or the continuing-airworthiness management organisation (CAMO) any such event or condition affecting the owner’s or operator’s aircraft or component. (d) Without prejudice to paragraphs (b) and (c) above, the organisation shall report to the competent authority and the organisation responsible for the design of the aircraft any incident, malfunction, technical defect, exceeding of technical limitations, occurrence that would highlight inaccurate, incomplete or ambiguous information, contained in data established in accordance with Regulation (EU) No 748/2012, or other irregular circumstance that has or may have endangered the safe operation of the aircraft. (e) For organisations not having their principal place of business in a Member State: (1) initial reports shall: (i) 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; (ii) be made in a form and manner established by the Agency; and (iii) contain all pertinent information about the condition known to the organisation; (2) where relevant, a follow-up report providing details of actions the organisation intends to take to prevent similar occurrences in the future shall be made as soon as these actions have been identified; those follow-up reports shall: (i) be sent to relevant entities initially reported to as per paragraphs (b) and (c) above; and (ii) be produced in a form and manner established by the Agency. 2. New 145.A.62 is added as follows: 145.A.62 Internal safety-reporting scheme (a) The organisation shall establish an internal safety-reporting scheme, as detailed in the exposition, to enable the collection and evaluation of such occurrences to be reported under 145.A.60. For organisations having their principal place of business in a Member State, such system shall meet the requirements of Regulation (EU) No 376/2014 and its implementing rules. (b) The scheme shall also enable the collection and evaluation of those errors, near-misses and hazards reported internally that do not fall under point (a) above. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 24 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (c) Through this scheme, the organisation shall: (1) identify and address the factors contributing to incidents in order to reduce the likelihood of such incidents reoccurring; (2) identify adverse trends, as well as corrective actions taken or to be taken by the organisation to address deficiencies; (3) ensure evaluation of all known relevant information relating to errors, near misses and hazards, and provide a method to circulate the information, as necessary; and (4) ensure that immediate action is taken in case of occurrences that have an impact on the safety of aircraft or components on which maintenance is performed, or which have already been released to service. SECTION B PROCEDURE FOR COMPETENT AUTHORITIES 3. New 145.B.62 is added as follows: 145.B.62 Information to the Agency (a) The competent authority shall without undue delay notify the Agency in case of any significant problems with the implementation of Regulation (EC) No 216/2008 and its implementing rules. (b) The competent authority shall provide the Agency with safety-significant information stemming from the occurrence reports it has received pursuant to 145.A.60. 3.5. Draft AMC/GM (Draft EASA Decision) — Part-M SECTION A — TECHNICAL REQUIREMENTS SUBPART B — ACCOUNTABILITY 1. AMC M.A.202(a) is amended as follows: AMC M.A.202(a) Occurrence reporting Accountable persons or organisations should ensure that the organisation responsible for the design of the aircraft or componenttype certificate (TC) holder receives adequate reports of occurrences for that aircraft or componenttype, to enable it to issue appropriate service instructions and recommendations to all owners or operators. Liaison with the organisation responsible for the design of the aircraft or componentTC holder is recommended, to establish whether published or proposed service information will resolve the problem or to obtain a solution to a particular problem. An approved continuing airworthiness management or maintenance organisation should assign responsibility for co-ordinating action on airworthiness occurrences and for initiating any necessary TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 25 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments further investigation and follow-up activity to a suitably qualified person with clearly defined authority and status. (b) In respect of maintenance, reporting a condition which endangers flight safety is normally limited to: (1) serious cracks, permanent deformation, burning or serious corrosion of structure found during scheduled maintenance of the aircraft or component. (2) failure of any emergency system during scheduled testing. 2. AMC M.A.202(b) is deleted as the means to report are now addressed in M.A.202 and the information to be provided is defined in Annex I to Regulation (EU) No 376/2014. 3. New GM1 M.A.202 is added for consistency within Regulation (EU) No 1321/2014 as follows: GM1 M.A.202 Occurrence reporting AMC-20 ‘General Acceptable Means of Compliance for Airworthiness of Products, Parts and Appliances’ provides further guidance on occurrence reporting (AMC 20-8). SUBPART F — MAINTENANCE ORGANISATION 4. New AMC1 M.A.620 is added as follows: AMC1 M.A.620 Occurrence reporting The organisation should assign responsibility for coordinating action on airworthiness occurrences and for initiating any necessary further investigation and follow-up activity to a suitably qualified person with clearly defined authority. 5. New AMC2 M.A.620 is added as follows: AMC2 M.A.620 Occurrence reporting The organisation should ensure that the organisation responsible for the design of the aircraft or component receives adequate occurrence reports for their aircraft or component in order to enable it to issue appropriate service instructions and recommendations to all owners or operators. Liaison with the organisation responsible for the design of the aircraft or component is recommended to establish whether published or proposed service information will resolve the problem or to obtain a solution to a particular problem. 6. New GM1 M.A.620 is added as follows: GM1 M.A.620 Occurrence reporting AMC-20 ‘General Acceptable Means of Compliance for Airworthiness of Products, Parts and Appliances’ provides further guidance on occurrence reporting (AMC 20-8). Section 7 thereof provides specific guidance on the main characteristics of an occurrence-reporting system compliant with Regulation (EU) No 376/2014 and its implementing rules. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 26 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments SUBPART G — CONTINUING AIRWORTHINESS MANAGEMENT ORGANISATION 7. New AMC1 M.A.718 is added as follows: AMC1 M.A.718 Occurrence reporting The organisation should assign responsibility for coordinating action on airworthiness occurrences and for initiating any necessary further investigation and follow-up activity to a suitably qualified person with clearly defined authority. 8. New AMC2 M.A.718 is added as follows: AMC2 M.A.718 Occurrence reporting The organisation should ensure that the organisation responsible for the design of the aircraft or component receives adequate occurrence reports for their aircraft or component in order to enable it to issue appropriate service instructions and recommendations to all owners or operators. Liaison with the organisation responsible for the design of the aircraft or component is recommended to establish whether published or proposed service information will resolve the problem or to obtain a solution to a particular problem. 9. New GM1 M.A.718 is added as follows: GM1 M.A.718 Occurrence reporting AMC-20 ‘General Acceptable Means of Compliance for Airworthiness of Products, Parts and Appliances’ provides further guidance on occurrence reporting (AMC 20-8). Section 7 thereof provides specific guidance on the main characteristics of an occurrence-reporting system compliant with Regulation (EU) No 376/2014 and its implementing rules. SECTION B — PROCEDURE FOR COMPETENT AUTHORITIES SUBPART A — GENERAL 10. New AMC1 M.B.106(b) is added as follows: AMC1 M.B.106(b) Information to the Agency EXCHANGE OF SAFETY-SIGNIFICANT INFORMATION WITH THE AGENCY Each competent authority should appoint a coordinator to act as the contact point for the exchange of safety-significant information between the competent authority and the Agency. 11. New GM1 M.B.106 is added as follows: GM1 M.B.106 Information to the Agency COMPETENT AUTHORITY ESTABLISHED IN ACCORDANCE WITH REGULATION (EU) No 376/2014 (a) Where a Member State designates different competent authorities to manage occurrences reported pursuant to Articles 4 ‘Mandatory reporting’ and 5 ‘Voluntary reporting’ of Regulation TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 27 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (EU) No 376/2014 and for the oversight of persons and organisations in accordance with Regulation (EC) No 216/2008 and its implementing rules respectively: (1) the areas of competence of each competent authority must be clearly defined; (2) proper coordination must be established between those authorities to ensure effective oversight of all persons and organisations subject to Regulation (EC) No 216/2008 and its implementing rules within their respective remits; and (3) occurrence reports addressed to the competent authority responsible for the oversight of persons and organisations in accordance with Regulation (EC) No 216/2008 and its implementing rules must be shared with the competent authority established for managing occurrence reports pursuant to Regulation (EU) No 376/2014. (b) The organisational set-up in terms of competent authorities designated under Regulations (EU) No 376/2014, (EC) No 216/2008, and their implementing rules, must not result in a duplication of the reporting obligations for persons or organisations subject to those Regulations. 12. New GM1 M.B.106(b) is added as follows: GM1 M.B.106(b) Information to the Agency MEANING OF SAFETY-SIGNIFICANT INFORMATION STEMMING FROM OCCURRENCE REPORTS Safety-significant information stemming from occurrence reports means: (a) a conclusive safety analysis which summarises individual occurrence data and provides an in- depth analysis of a safety issue, and which may be relevant for the Agency’s safety action planning; and (b) individual occurrence data for the cases where the Agency is the competent authority and which fulfils the reporting criteria of GM3 M.B.106. 13. New GM2 M.B.106(b) is added as follows: GM2 M.B.106(b) Information to the Agency RECOMMENDED CONTENT FOR CONCLUSIVE SAFETY ANALYSES A conclusive safety analysis should contain the following: (a) a detailed description of the safety issue, including the scenario in which the safety issue takes place; and (b) an indication of the stakeholders affected by the safety issue, including types of operations and organisations; and, as appropriate: (c) a risk assessment establishing the severity and likelihood of all the possible consequences of the safety issue; (d) information about the existing safety barriers that the aviation system has in place to prevent the likely safety issue consequences from occurring; (e) any mitigating actions already in place or developed to deal with the safety issue; TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 28 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (f) recommendations for future actions to control the risk; and (g) any other element the competent authority considers essential for the Agency to properly assess the safety issue. 14. New GM3 M.B.106(b) is added as follows: GM3 M.B.106(b) Information to the Agency OCCURRENCES WHERE THE AGENCY IS THE COMPETENT AUTHORITY Occurrences related to organisations or products, certified by the Agency, should be notified to the Agency if: (a) the occurrence is defined as a reportable occurrence in accordance with the applicable regulation; (b) the organisation responsible for addressing the occurrence is certified by the Agency; and (c) the Member State competent authority has come to the conclusion that: (1) the organisation certified by the Agency to which the occurrence relates has not been informed of the occurrence; or (2) the occurrence has not been properly addressed or has been left unattended by the organisation certified by the Agency. 3.6. Draft AMC/GM (Draft EASA Decision) — Part-145 SECTION A — TECHNICAL REQUIREMENTS 1. AMC 145.A.60(a), GM 145.A.60(a) and GM1 145.A.60(c) are replaced by the following new AMC1 145.A.60, AMC2 145.A.60 and GM1 145.A.60, which ensures alignment with related changes in Part-M, Subparts F and G: AMC1 145.A.60 Occurrence reporting The organisation should assign responsibility for coordinating action on airworthiness occurrences and for initiating any necessary further investigation and follow-up activity to a suitably qualified person with clearly defined authority. AMC2 145.A.60 Occurrence reporting The organisation should ensure that the organisation responsible for the design of the aircraft or component receives adequate occurrence reports for their aircraft or component in order to enable it to issue appropriate service instructions and recommendations to all owners or operators. Liaison with the organisation responsible for the design of the aircraft or component is recommended to establish whether published or proposed service information will resolve the problem or to obtain a solution to a particular problem. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 29 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments GM1 145.A.60 Occurrence reporting AMC-20 ‘General Acceptable Means of Compliance for Airworthiness of Products, Parts and Appliances’ provides further guidance on occurrence reporting (AMC 20-8). Section 7 thereof provides specific guidance on the main characteristics of an occurrence-reporting system compliant with Regulation (EU) No 376/2014 and its implementing rules. 2. A new AMC1 145.B.62(b) is added as follows: AMC1 145.B.62(b) Information to the Agency EXCHANGE OF SAFETY-SIGNIFICANT INFORMATION WITH THE AGENCY Each competent authority should appoint a coordinator to act as the contact point for the exchange of safety-significant information between the competent authority and the Agency. 3. New GM1 145.B.62 is added as follows: GM1 145.B.62 Information to the Agency COMPETENT AUTHORITY ESTABLISHED IN ACCORDANCE WITH REGULATION (EU) No 376/2014 (a) Where a Member State designates different competent authorities to manage occurrences reported pursuant to Articles 4 ‘Mandatory reporting’ and 5 ‘Voluntary reporting’ of Regulation (EU) No 376/2014 and for the oversight of persons and organisations in accordance with Regulation (EC) No 216/2008 and its implementing rules respectively: (1) the areas of competence of each competent authority must be clearly defined; (2) proper coordination must be established between those authorities to ensure effective oversight of all persons and organisations subject to Regulation (EC) No 216/2008 and its implementing rules within their respective remits; and (3) occurrence reports addressed to the competent authority responsible for the oversight of persons and organisations in accordance with Regulation (EC) No 216/2008 and its implementing rules must be shared with the competent authority established for managing occurrence reports pursuant to Regulation (EU) No 376/2014. (b) The organisational set-up in terms of competent authorities designated under Regulations (EU) No 376/2014, (EC) No 216/2008, and their implementing rules, must not result in a duplication of the reporting obligations for persons or organisations subject to those Regulations. 4. A new GM1 145.B.62(b) is added as follows: GM1 145.B.62(b) Information to the Agency MEANING OF SAFETY-SIGNIFICANT INFORMATION STEMMING FROM OCCURRENCE REPORTS Safety-significant information stemming from occurrence reports means: (a) a conclusive safety analysis which summarises individual occurrence data and provides an in- depth analysis of a safety issue, and which may be relevant for the Agency’s safety action planning; and TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 30 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (b) individual occurrence data for the cases where the Agency is the competent authority and which fulfils the reporting criteria of GM3 145.B.62. 5. New GM2 145.B.62(b) is added as follows: GM2 145.B.62(b) Information to the Agency RECOMMENDED CONTENT FOR CONCLUSIVE SAFETY ANALYSES A conclusive safety analysis should contain the following: (a) a detailed description of the safety issue, including the scenario in which the safety issue takes place; and (b) an indication of the stakeholders affected by the safety issue, including types of operations and organisations; and, as appropriate: (c) a risk assessment establishing the severity and likelihood of all the possible consequences of the safety issue; (d) information about the existing safety barriers that the aviation system has in place to prevent the likely safety issue consequences from occurring; (e) any mitigating actions already in place or developed to deal with the safety issue; (f) recommendations for future actions to control the risk; and (g) any other element the competent authority considers essential for the Agency to properly assess the safety issue. 6. New GM3 145.B.62(b) is added as follows: GM3 145.B.62(b) Information to the Agency OCCURRENCES WHERE THE AGENCY IS THE COMPETENT AUTHORITY Occurrences related to organisations or products, certified by the Agency, should be notified to the Agency if: (a) the occurrence is defined as a reportable occurrence in accordance with the applicable regulation; (b) the organisation responsible for addressing the occurrence is certified by the Agency; and (c) the Member State competent authority has come to the conclusion that: (1) the organisation certified by the Agency to which the occurrence relates has not been informed of the occurrence; or (2) the occurrence has not been properly addressed or has been left unattended by the organisation certified by the Agency. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 31 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments 3.7. Draft Regulation (Draft EASA Opinion) — Part-ARA SUBPART GEN — GENERAL REQUIREMENTS SECTION I — GENERAL 1. ARA.GEN.125 is amended as follows: ARA.GEN.125 Information to the Agency (a) The competent authority shall without undue delay notify the Agency in case of any significant problems with the implementation of Regulation (EC) No 216/2008 and its Iimplementing Rrules. (b) Without prejudice to Regulation (EU) No 376/2014, tThe competent authority shall provide the Agency with safety-significant information stemming from the occurrence reports it has receivedstored in the national database. 2. ARA.GEN.135 is amended as follows: ARA.GEN.135 Immediate reaction to a safety problem (a) Without prejudice to Directive 2003/42/EC of the European Parliament and of the Council ( 5 )Regulation (EU) No 376/2014 and its implementing rules, the competent authority shall implement a system to appropriately collect, analyse and disseminate safety information. (b) The Agency shall implement a system to appropriately analyse any relevant safety information received and without undue delay provide to Member States and the Commission any information, including recommendations or corrective actions to be taken, necessary for them to react in a timely manner to a safety problem involving products, parts, appliances, persons or organisations subject to Regulation (EC) No 216/2008 and its Implementing Rules. (c) Upon receiving the information referred to in (a) and (b), the competent authority shall take adequate measures to address the safety problem. (d) Measures taken under (c) shall immediately be notified to all persons or organisations which need to comply with them under Regulation (EC) No 216/2008 and its Implementing Rules. The competent authority shall also notify those measures to the Agency and, when combined action is required, the other Member States concerned. SECTION II — MANAGEMENT 3. ARA.GEN.200 is amended as follows: ARA.GEN.200 Management system (a) The competent authority shall establish and maintain a management system, including as a minimum: (1) documented policies and procedures to describe its organisation, means and methods to achieve compliance with Regulation (EC) 216/2008, and its Iimplementing Rrules, as well as Regulation (EU) No 376/2014 and its implementing rules. The procedures shall be kept TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 32 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments up-to-date and serve as the basic working documents within that competent authority for all related tasks; (…) 4. ARA.GEN.210 is amended as follows: ARA.GEN.210 Changes in the management system (a) The competent authority shall have a system in place to identify changes that affect its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EC) No 216/2008, and its Iimplementing Rrules, as well as Regulation (EU) No 376/2014 and its implementing rules. This system shall enable it to take action as appropriate to ensure that its management system remains adequate and effective. (b) The competent authority shall update its management system to reflect any change to Regulation (EC) No 216/2008, and its Iimplementing Rrules, as well as Regulation (EU) No 376/2014 and its implementing rules in a timely manner, so as to ensure effective implementation. (c) The competent authority shall notify the Agency of changes affecting its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EC) No 216/2008, and its Iimplementing Rrules, as well as Regulation (EU) No 376/2014 and its implementing rules. 3.8. Draft Regulation (Draft EASA Opinion) — Part-ORA SUBPART GEN — GENERAL REQUIREMENTS SECTION I — GENERAL 1. The content of ORA.GEN.160 is replaced by the following: ORA.GEN.160 Occurrence reporting (a) As part of its management system, the organisation shall implement an occurrence-reporting system, including mandatory and voluntary reporting. For organisations having their principal place of business in a Member State, such system shall meet the requirements of Regulation (EU) No 376/2014 and its implementing rules. (b) The organisation shall report to the competent authority and any other organisation required by the State of the operator to be informed: (1) any safety-related event or condition that endangers or, if not corrected or addressed, could endanger flight safety; and (2) any accident and serious incident, as defined in Regulation (EU) No 996/2010. (c) Without prejudice to paragraph (b) above, the organisation shall report to the competent authority and the organisation responsible for the design of the aircraft any incident, malfunction, technical defect, exceeding of technical limitations, occurrence that would highlight inaccurate, incomplete or ambiguous information, contained in data established in accordance TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 33 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments with Regulation (EU) No 748/2012, or other irregular circumstance that has or may have endangered flight safety and has not resulted in an accident or serious incident. (d) For organisations not having their principal place of business in a Member State: (1) initial reports shall: (i) 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; (ii) be made in a form and manner established by the Agency; and (iii) contain all pertinent information about the condition known to the organisation; (2) where relevant, a follow-up report providing details of actions the organisation intends to take to prevent similar occurrences in the future shall be made as soon as these actions have been identified; those follow-up reports shall: (i) be sent to relevant entities initially reported to as per paragraphs (b) and (c) above; and (ii) be produced in a form and manner established by the Agency. SECTION II — MANAGEMENT 2. ORA.GEN.200 is amended as follows: 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; (…) (7) any additional relevant requirements that are prescribed in the relevant subparts of this Part or other applicable Partsthis Regulation, as well as in the applicable requirements of Regulation (EU) No 376/2014 and its implementing rules. (…) TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 34 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments 3.9. Draft AMC/GM (Draft EASA Decision) — Part-ARA SUBPART GEN — GENERAL REQUIREMENTS SECTION I — GENERAL 1. New AMC1 ARA.GEN.125(b) is added as follows: AMC1 ARA.GEN.125(b) Information to the Agency EXCHANGE OF SAFETY-SIGNIFICANT INFORMATION WITH THE AGENCY Each competent authority should appoint a coordinator to act as the contact point for the exchange of safety-significant information between the competent authority and the Agency. 2. New GM1 ARA.GEN.125(b) is added as follows: GM1 ARA.GEN.125(b) Information to the Agency MEANING OF SAFETY-SIGNIFICANT INFORMATION STEMMING FROM OCCURRENCE REPORTS Safety-significant information stemming from occurrence reports means: (a) a conclusive safety analysis which summarises individual occurrence data and provides an in- depth analysis of a safety issue, and which may be relevant for the Agency’s safety action planning; and (b) individual occurrence data for the cases where the Agency is the competent authority and which fulfils the reporting criteria of GM3 ARA.GEN.125(b). 3. New GM2 ARA.GEN.125(b) is added as follows: GM2 ARA.GEN.125(b) Information to the Agency RECOMMENDED CONTENT FOR CONCLUSIVE SAFETY ANALYSES A conclusive safety analysis should contain the following: (a) a detailed description of the safety issue, including the scenario in which the safety issue takes place; and (b) an indication of the stakeholders affected by the safety issue, including types of operations and organisations; and, as appropriate: (c) a risk assessment establishing the severity and likelihood of all the possible consequences of the safety issue; (d) information about the existing safety barriers that the aviation system has in place to prevent the likely safety issue consequences from occurring; (e) any mitigating actions already in place or developed to deal with the safety issue; (f) recommendations for future actions to control the risk; and TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 35 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (g) any other element the competent authority considers essential for the Agency to properly assess the safety issue. 4. New GM3 ARA.GEN.125(b) is added as follows: GM3 ARA.GEN.125(b) Information to the Agency OCCURRENCES WHERE THE AGENCY IS THE COMPETENT AUTHORITY Occurrences related to organisations or products, certified by the Agency, should be notified to the Agency if: (a) the occurrence is defined as a reportable occurrence in accordance with the applicable regulation; (b) the organisation responsible for addressing the occurrence is certified by the Agency; and (c) the Member State competent authority has come to the conclusion that: (1) the organisation certified by the Agency to which the occurrence relates has not been informed of the occurrence; or (2) the occurrence has not been properly addressed or has been left unattended by the organisation certified by the Agency. SECTION II — MANAGEMENT 5. New GM1 ARA.GEN.200 is added as follows: GM1 ARA.GEN.200 Management system COMPETENT AUTHORITY ESTABLISHED IN ACCORDANCE WITH REGULATION (EU) No 376/2014 (a) Where a Member State designates different competent authorities to manage occurrences reported pursuant to Articles 4 ‘Mandatory reporting’ and 5 ‘Voluntary reporting’ of Regulation (EU) No 376/2014 and for the oversight of persons and organisations in accordance with Regulation (EC) No 216/2008 and its implementing rules respectively: (1) the areas of competence of each competent authority must be clearly defined; (2) proper coordination must be established between those authorities to ensure effective oversight of all persons and organisations subject to Regulation (EC) No 216/2008 and its implementing rules within their respective remits; and (3) occurrence reports addressed to the competent authority responsible for the oversight of persons and organisations in accordance with Regulation (EC) No 216/2008 and its implementing rules must be shared with the competent authority established for managing occurrence reports pursuant to Regulation (EU) No 376/2014. (b) The organisational set-up in terms of competent authorities designated under Regulations (EU) No 376/2014, (EC) No 216/2008, and their implementing rules, must not result in a duplication of the reporting obligations for persons or organisations subject to those Regulations. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 36 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments 3.10. Draft AMC/GM (Draft EASA Decision) — Part-ORA SUBPART GEN — GENERAL REQUIREMENTS SECTION I — GENERAL 1. AMC1 ORA.GEN.160 is deleted as its content is now addressed in Regulation (EU) 2015/1018 laying down a list classifying occurrences in civil aviation to be mandatorily reported in accordance with Regulation (EU) No 376/2014. 2. New AMC1 ORA.GEN.160(b) is added as follows: AMC1 ORA.GEN.160(b) Occurrence reporting REPORTING BETWEEN ORGANISATIONS (a) In addition to reporting occurrences to the competent authority, depending on the type of the organisation, its interfaces with other organisations and their respective safety policies and procedures, additional reporting requirements may exist for reporting between organisations. (b) Organisations may develop a customised list of occurrences to be reported between organisations, adapted to their particular aircraft, operation or product and the organisations they interface with. Such customised list of occurrences to be reported between organisations is usually included or referenced in the organisation’s management system documentation. Any such lists should however not be considered to be definitive or exhaustive, and the reporter’s judgement of the degree of risk or potential hazard involved is essential. (c) The following provides a non-exhaustive list of reporting lines that exist for reporting of occurrences between organisations: (1) maintenance organisation/continuing-airworthiness management organisation (CAMO) to the organisation responsible for the design; (2) maintenance organisation/CAMO to the operator; (3) operator to the organisation responsible for the design; and (4) for air traffic, aerodrome occurrences or bird/wildlife strikes, the operator should also notify the appropriate air navigation services (ANS) provider, aerodrome operator or ground handling service provider. (d) The ‘organisation responsible for the design’ is a general term, which may be any or a combination of the following organisations: (1) holder of a type certificate (TC) of an aircraft, engine or propeller; (2) holder of a supplemental type certificate (STC) of an aircraft, engine or propeller; (3) holder of a European technical standard order (ETSO) authorisation; or (4) organisations responsible for the design of aerodrome equipment or air traffic management (ATM)/ANS systems and constituents. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 37 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (e) If it can be determined that the occurrence has an impact on, or is related to, an aircraft component covered by a separate design approval/authorisation (TC, STC, or ETSO), then the holders of such approval/authorisation should be informed. If an occurrence concerns a component which is covered by a TC, STC, or ETSO (e.g. during maintenance), then only that TC, STC, or ETSO authorisation holder needs to be informed. (f) In the interest of safety, any organisation reporting to the organisation responsible for the design is expected to actively support any investigations that may be initiated by that organisation. Support should be provided by a timely response to information requests and by making available affected components, parts or appliances for the purpose of the investigation, subject to an agreement with the respective component, part or appliance owners. (g) The form and timescale of reports to be exchanged between organisations is left for individual organisations to determine with due regard to the safety management policies and procedures in place. It is important that: (1) an interface is established between the organisations to ensure that there is an effective and timely exchange of information relating to occurrences; and (2) any relevant safety issue is identified, and it is clearly established which party is responsible for taking further action, if required. (h) Organisations should establish procedures to be used for reporting between organisations, which should include as a minimum: (1) a description of the applicable requirements for reporting; (2) a description of the reporting mechanism, including reporting forms, means, and deadlines; and (3) responsibilities of the organisations and personnel responsible for reporting, including for reporting to the competent authority. Such procedures should be included in the organisation’s management system documentation. 3. New GM1 ORA.GEN.160(a) is added as follows: GM1 ORA.GEN.160(a) Occurrence reporting OCCURRENCE-REPORTING SYSTEM COMPLIANT WITH REGULATION (EU) No 376/2014 (a) The below provides an overview of the main elements of the occurrence-reporting system to comply with Regulation (EU) No 376/2014. It also provides references to the relevant articles of Regulation (EU) No 376/2014. (b) Organisations are required to implement a system that caters both for mandatory and voluntary reporting (cf. Articles 4 and 5). Occurrences qualifying for mandatory reporting are those defined in Regulation (EU) 2015/1018. (c) Organisations are required to designate one or more persons to handle independently the collection, evaluation, processing, analysis and storage of details of occurrences with regard to data collection and hazard identification (cf. Article 6(1)). Nevertheless, small organisations may, in agreement with their competent authority, make use of simplified mechanisms to ensure the TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 38 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments collection, evaluation, processing, analysis and storage of details of occurrences, possibly by sharing those tasks with other similar organisations. (d) An existing internal safety-reporting scheme, established to collect safety-relevant data, proposals and information, including on potential safety issues that have not resulted in any occurrence, may serve as a basis for the mandatory and voluntary occurrence-reporting system. (e) Organisations are required to store occurrence reports qualifying for mandatory and voluntary reporting in one or more databases, as defined in Article 4(5), and establish data quality checking processes, as defined in Article 7(3), to ensure that the information initially collected and the data stored in the database(s) are consistent. (f) Organisations are required to: (1) identify the safety hazards associated with identified occurrences or groups of occurrences (cf. Article 13(1)); (2) analyse the related risks in terms of likelihood and severity of the outcome, as well as assess risks in terms of tolerability; (3) based on the result of the risk assessment, determine the need for mitigation action, as required for improving aviation safety (cf. Article 13(2)); and (4) monitor the timely implementation and effectiveness of any mitigation action required (cf. Article 13(2)). (g) In addition to the actions required under paragraph (c) above, organisations are required to ensure that the following information is transmitted to the competent authority within 30 days from the date of notification of the occurrence (both mandatory and voluntary reports) to the authority (cf. Article 13(4)): (1) the preliminary results of the risk analysis performed; and (2) any mitigation action to be taken. Furthermore, organisations are required to ensure that the final results of the risk analysis, where required, are transmitted to the competent authority as soon as they are available and, in principle, no later than 3 months from the date of notification of the occurrence to the authority (cf. Article 13(4)). (h) As part of their safety policy, organisations, after consulting staff representatives, are required to adopt rules describing how ‘just culture’ principles are guaranteed and implemented within the organisation. The purpose of those rules is to ensure that employees and contracted personnel that report or are mentioned in occurrence reports collected as part of the occurrence-reporting system are not subject to any prejudice by their employer or any other organisation for which the services are provided on the basis of the information supplied by the reporter (cf. Article 16). (i) Organisations are required to ensure that employees and contracted personnel are regularly provided with information concerning the analysis of, and follow-up on, occurrences for which mitigation action is taken (cf. Article 13(3)). In doing so, they ensure that only disidentified information is disseminated. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 39 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (j) Organisations are required to ensure that reports addressed to the competent authority contain at least the information listed in Annex I to Regulation (EU) No 376/2014. SECTION II — MANAGEMENT 4. AMC1 ORA.GEN.200(a)(1);(2);(3);(5) is amended as follows: AMC1 ORA.GEN.200(a)(1);(2);(3);(5) Management system NON-COMPLEX ORGANISATIONS — GENERAL (a) Safety risk management may be performed using hazard checklists or similar risk management tools or processes, which are integrated into the activities of the organisation. (b) The organisation should manage safety risks related to a change. The management of change should be a documented process to identify external and internal change that may have an adverse effect on safety. It should make use of the organisation’s existing hazard identification, risk assessment and mitigation processes. (c) The organisation should identify a person who fulfils the role of safety manager and who is responsible for coordinating the safety -management-systemrelated processes and tasks. 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 : (1) improve towards the highest safety standards, comply with all applicable legal requirements,; (2) meet all applicable standards, consider best practices and provide appropriate resources; and (3) apply ‘just culture’ principles and, in particular, not to make available or use the information on occurrences: (i) to attribute blame or liability to someone for reporting something that would not have been otherwise detected; or (ii) for any purpose other than the maintenance or improvement of aviation safety. (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. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 40 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments 5. New GM1 ORA.GEN.200(a)(1);(2);(3);(5) is added as follows: GM1 ORA.GEN.200(a)(1);(2);(3);(5) Management system ‘JUST CULTURE’ PRINCIPLES Regulation (EU) No 376/2014 defines the ‘just culture’ principles (refer in particular to Article 16(11) thereof). 6. AMC1 ORA.GEN.200(a)(2) is amended as follows: AMC1 ORA.GEN.200(a)(2) Management system COMPLEX ORGANISATIONS — SAFETY POLICY (a) The safety policy should: (1) be endorsed by the accountable manager; (2) reflect organisational commitments regarding safety and its proactive and systematic management; (3) be communicated, with visible endorsement, throughout the organisation; and (4) include safety-reporting principles. (b) The safety policy should include a commitment: (1) to improve towards the highest safety standards; (2) to comply with all applicable legislation, meet all applicable standards and consider best practices; (3) to provide appropriate resources; (4) to enforce safety as one primary responsibility of all managers; and (5) not to blame someone for reporting something which would not have been otherwise detectedto apply ‘just culture’ principles and, in particular, not to make available or use the information on occurrences: (i) to attribute blame or liability to someone for reporting something that would not have been otherwise detected; or (ii) for any purpose other than the maintenance or improvement of aviation safety. (c) Senior management should: (1) continually promote the safety policy to all personnel and demonstrate their commitment to it; (2) provide necessary human and financial resources for its implementation; and (3) establish safety objectives and performance standards. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 41 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments 7. GM1 ORA.GEN.200(a)(2) is amended as follows: GM1 ORA.GEN.200(a)(2) Management system SAFETY POLICY (a) 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 or serious incident as far as is reasonably practicable. It reflects the management’s commitment to safety, and should reflect the organisation’s philosophy of safety management, as well as become the foundation on which the organisation’s management system is built. It serves as a reminder of ‘how we do business here’. The creation of a positive safety culture begins with the issuance of a clear, unequivocal direction. The safety policy should state that the purpose of safety reporting and internal investigations is to improve safety, not to apportion blame to individuals. (b) The commitment to apply ‘just culture’ principles forms the basis for the organisation’s internal rules describing how ‘just culture’ principles are guaranteed and implemented. (c) For organisations having their principal place of business in a Member State, Regulation (EU) No 376/2014 defines the ‘just culture’ principles to be applied (refer in particular to Article 16(11) thereof). 3.11. Draft Regulation (Draft EASA Opinion) — Part-ARO SUBPART GEN — GENERAL REQUIREMENTS SECTION I — GENERAL 1. ARO.GEN.125 is amended as follows: ARO.GEN.125 Information to the Agency (a) The competent authority shall without undue delay notify the Agency in case of any significant problems with the implementation of Regulation (EC) No 216/2008 and its Iimplementing Rrules. (b) Without prejudice to Regulation (EU) No 376/2014, Tthe competent authority shall provide the Agency with safety-significant information stemming from the occurrence reports it has receivedstored in the national database. 2. ARO.GEN.135 is amended as follows: ARO.GEN.135 Immediate reaction to a safety problem (a) Without prejudice to Directive 2003/42/EC of the European Parliament and of the Council ( 5 )Regulation (EU) No 376/2014 and its implementing rules, the competent authority shall implement a system to appropriately collect, analyse and disseminate safety information. (b) The Agency shall implement a system to appropriately analyse any relevant safety information received and without undue delay provide to Member States and the Commission any TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 42 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments information, including recommendations or corrective actions to be taken, necessary for them to react in a timely manner to a safety problem involving products, parts, appliances, persons or organisations subject to Regulation (EC) No 216/2008 and its Iimplementing Rrules. (c) Upon receiving the information referred to in (a) and (b), the competent authority shall take adequate measures to address the safety problem. (d) Measures taken under (c) shall immediately be notified to all persons or organisations which need to comply with them under Regulation (EC) No 216/2008 and its Iimplementing Rrules. The competent authority shall also notify those measures to the Agency and, when combined action is required, the other Member States concerned. SECTION II — MANAGEMENT 3. ARO.GEN.200 is amended as follows: ARO.GEN.200 Management system (a) The competent authority shall establish and maintain a management system, including as a minimum: (1) documented policies and procedures to describe its organisation, means and methods to achieve compliance with Regulation (EC) No 216/2008, and its Iimplementing Rrules, as well as with Regulation (EU) No 376/2014 and its implementing rules. The procedures shall be kept up-to-date and serve as the basic working documents within that competent authority for all related tasks; (…) 4. ARO.GEN.205 is amended as follows: ARO.GEN.210 Changes in the management system (a) The competent authority shall have a system in place to identify changes that affect its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EC) No 216/2008, and its Iimplementing Rrules, as well as Regulation (EU) No 376/2014 and its implementing rules. This system shall enable it to take action as appropriate to ensure that its management system remains adequate and effective. (b) The competent authority shall update its management system to reflect any change to Regulation (EC) No 216/2008, and its Iimplementing Rrules, as well as Regulation (EU) No 376/2014 and its implementing rules in a timely manner, so as to ensure effective implementation. (c) The competent authority shall notify the Agency of changes affecting its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EC) No 216/2008, and its Iimplementing Rrules, as well as Regulation (EU) No 376/2014 and its implementing rules. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 43 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments 3.12. Draft Regulation (Draft EASA Opinion) — Part-ORO SUBPART GEN — GENERAL REQUIREMENTS SECTION I — GENERAL 1. The content of ORO.GEN.160 is replaced by the following: ORO.GEN.160 Occurrence reporting (a) As part of its management system, the operator shall implement an occurrence-reporting system, including mandatory and voluntary reporting, that meets the requirements of Regulation (EU) No 376/2014 and its implementing rules. (b) The operator shall report to the competent authority and any other organisation required by the State of the operator to be informed: (1) any safety-related event or condition that endangers or, if not corrected or addressed, could endanger flight safety. (2) any accident and serious incident, as defined in Regulation (EU) No 996/2010. (c) Without prejudice to paragraph (b) above, the operator shall report to the competent authority and the organisation responsible for the design of the aircraft any incident, malfunction, technical defect, exceeding of technical limitations, occurrence that would highlight inaccurate, incomplete or ambiguous information, contained in data established in accordance with Regulation (EU) No 748/2012, or other irregular circumstance that has or may have endangered flight safety and has not resulted in an accident or serious incident. (d) Without prejudice to paragraphs (b) and (c) above, the operator shall consider additional reporting requirements for occurrences related to the transport of dangerous goods, as laid down in the relevant requirements of the applicable Annexes to this Regulation (Annex IV (Part-CAT), Annex VI (Part-NCC), Annex VII (Part-NCO), and Annex VIII (Part-SPO)). SECTION II — MANAGEMENT 2. ORO.GEN.200 is amended as follows: ORO.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 operator, including a direct safety accountability of the accountable manager; (…) (7) any additional relevant requirements that are prescribed in the relevant subparts of this Annex or other applicable Annexesthis Regulation, as well as in the applicable requirements of Regulation (EU) No 376/2014 and its implementing rules. (…) TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 44 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments 3.13. Draft AMC/GM (Draft EASA Decision) — Part-ARO SUBPART GEN — GENERAL REQUIREMENTS SECTION I — GENERAL 1. New AMC1 ARO.GEN.125(b) is added as follows: AMC1 ARO.GEN.125(b) Information to the Agency EXCHANGE OF SAFETY-SIGNIFICANT INFORMATION WITH THE AGENCY Each competent authority should appoint a coordinator to act as the contact point for the exchange of safety-significant information between the competent authority and the Agency. 2. New GM1 ARO.GEN.125(b) is added as follows: GM1 ARO.GEN.125(b) Information to the Agency MEANING OF SAFETY-SIGNIFICANT INFORMATION STEMMING FROM OCCURRENCE REPORTS Safety-significant information stemming from occurrence reports means: (a) a conclusive safety analysis which summarises individual occurrence data and provides an in- depth analysis of a safety issue, and which may be relevant for the Agency’s safety action planning; and (b) individual occurrence data for the cases where the Agency is the competent authority and which fulfils the reporting criteria of GM3 ARO.GEN.125(b). 3. New GM2 ARO.GEN.125(b) is added as follows: GM2 ARO.GEN.125(b) Information to the Agency RECOMMENDED CONTENT FOR CONCLUSIVE SAFETY ANALYSES A conclusive safety analysis should contain the following: (a) a detailed description of the safety issue, including the scenario in which the safety issue takes place; and (b) an indication of the stakeholders affected by the safety issue, including types of operations and organisations; and, as appropriate: (c) a risk assessment establishing the severity and likelihood of all the possible consequences of the safety issue; (d) information about the existing safety barriers that the aviation system has in place to prevent the likely safety issue consequences from occurring; (e) any mitigating actions already in place or developed to deal with the safety issue; (f) recommendations for future actions to control the risk; and TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 45 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (g) any other element the competent authority considers essential for the Agency to properly assess the safety issue. 4. New GM3 ARO.GEN.125(b) is added as follows: GM3 ARO.GEN.125(b) Information to the Agency OCCURRENCES WHERE THE AGENCY IS THE COMPETENT AUTHORITY Occurrences related to organisations or products, certified by the Agency, should be notified to the Agency if: (a) the occurrence is defined as a reportable occurrence in accordance with the applicable regulation; (b) the organisation responsible for addressing the occurrence is certified by the Agency; and (c) the Member State competent authority has come to the conclusion that: (1) the organisation certified by the Agency to which the occurrence relates has not been informed of the occurrence; or (2) the occurrence has not been properly addressed or has been left unattended by the organisation certified by the Agency. SECTION II — MANAGEMENT 5. New GM1 ARO.GEN.200 is added as follows: GM1 ARO.GEN.200 Management system COMPETENT AUTHORITY ESTABLISHED IN ACCORDANCE WITH REGULATION (EU) No 376/2014 (a) Where a Member State designates different competent authorities to manage occurrences reported pursuant to Articles 4 ‘Mandatory reporting’ and 5 ‘Voluntary reporting’ of Regulation (EU) No 376/2014 and for the oversight of persons and organisations in accordance with Regulation (EC) No 216/2008 and its implementing rules respectively: (1) the areas of competence of each competent authority must be clearly defined; (2) proper coordination must be established between those authorities to ensure effective oversight of all persons and organisations subject to Regulation (EC) No 216/2008 and its implementing rules within their respective remits; and (3) occurrence reports addressed to the competent authority responsible for the oversight of persons and organisations in accordance with Regulation (EC) No 216/2008 and its implementing rules must be shared with the competent authority established for managing occurrence reports pursuant to Regulation (EU) No 376/2014. (b) The organisational set-up in terms of competent authorities designated under Regulations (EU) No 376/2014, (EC) No 216/2008, and their implementing rules, must not result in a duplication of the reporting obligations for persons or organisations subject to those Regulations. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 46 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments 3.14. Draft AMC/GM (Draft EASA Decision) — Part-ORO SUBPART GEN — GENERAL REQUIREMENTS SECTION I — GENERAL 1. AMC1 ORO.GEN.160 is amended as follows: AMC1 ORO.GEN.160 Occurrence reporting GENERAL (a) The operator should report all occurrences that may involve an actual or potential aviation safety risk and in any case those defined in AMC 20-8,Regulation (EU) 2015/1018 laying down a list classifying occurrences in civil aviation to be mandatorily reported in accordance with Regulation (EU) No 376/2014 and as required by the applicable national rules implementing Directive 2003/43/EC3 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. New AMC1 ORO.GEN.160(b) is added as follows: AMC1 ORO.GEN.160(b) Occurrence reporting REPORTING BETWEEN ORGANISATIONS (a) In addition to reporting occurrences to the competent authority, depending on the type of the organisation, its interfaces with other organisations and their respective safety policies and procedures, additional reporting requirements may exist for reporting between organisations. (b) Organisations may develop a customised list of occurrences to be reported between organisations, adapted to their particular aircraft, operation or product and the organisations they interface with. Such customised list of occurrences to be reported between organisations is usually included or referenced in the organisation’s management system documentation. Any such lists should however not be considered to be definitive or exhaustive, and the reporter’s judgement of the degree of risk or potential hazard involved is essential. (c) The following provides a non-exhaustive list of reporting lines that exist for reporting of occurrences between organisations: (1) maintenance organisation/continuing-airworthiness management organisation (CAMO) to the organisation responsible for the design; (2) maintenance organisation/CAMO to the operator; (3) operator to the organisation responsible for the design; and (4) for air traffic, aerodrome occurrences or bird/wildlife strikes, the operator should also notify the appropriate air navigation services (ANS) provider, aerodrome operator or ground handling service provider. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 47 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (d) The ‘organisation responsible for the design’ is a general term, which may be any or a combination of the following organisations: (1) holder of a type certificate (TC) of an aircraft, engine or propeller; (2) holder of a supplemental type certificate (STC) of an aircraft, engine or propeller; (3) holder of a European technical standard order (ETSO) authorisation; or (4) organisations responsible for the design of aerodrome equipment or air traffic management (ATM)/ANS systems and constituents. (e) If it can be determined that the occurrence has an impact on or is related to an aircraft component covered by a separate design approval/authorisation (TC, STC, or ETSO), then the holders of such approval/authorisation should be informed. If an occurrence concerns a component which is covered by a TC, STC, or ETSO (e.g. during maintenance), then only that TC, STC, or ETSO authorisation holder needs to be informed. (f) In the interest of safety, any organisation reporting to the organisation responsible for the design is expected to actively support any investigations that may be initiated by that organisation. Support should be provided by a timely response to information requests and by making available affected components, parts or appliances for the purpose of the investigation, subject to an agreement with the respective component, part or appliance owners. (g) The form and timescale of reports to be exchanged between organisations is left for individual organisations to determine with due regard to the safety management policies and procedures in place. It is important that: (1) an interface is established between the organisations to ensure that there is an effective and timely exchange of information relating to occurrences; and. (2) any relevant safety issue is identified, and it is clearly established which party is responsible for taking further action, if required. (h) Organisations should establish procedures to be used for reporting between organisations, which should include as a minimum: (1) a description of the applicable requirements for reporting; (2) a description of the reporting mechanism, including reporting forms, means, and deadlines; and (3) responsibilities of the organisations and personnel responsible for reporting, including for reporting to the competent authority. Such procedures should be included in the organisation’s management system documentation. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 48 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments 3. New GM1 ORO.GEN.160(a) is added as follows: GM1 ORO.GEN.160(a) Occurrence reporting OCCURRENCE-REPORTING SYSTEM COMPLIANT WITH REGULATION (EU) No 376/2014 (a) The below provides an overview of the main elements of the occurrence-reporting system to comply with Regulation (EU) No 376/2014. It also provides references to the relevant articles of Regulation (EU) No 376/2014. (b) Organisations are required to implement a system that caters both for mandatory and voluntary reporting (cf. Articles 4 and 5). Occurrences qualifying for mandatory reporting are those defined in Regulation (EU) 2015/1018. (c) Organisations are required to designate one or more persons to handle independently the collection, evaluation, processing, analysis and storage of details of occurrences with regard to data collection and hazard identification (cf. Article 6(1)). Nevertheless, small organisations may, in agreement with their competent authority, make use of simplified mechanisms to ensure the collection, evaluation, processing, analysis and storage of details of occurrences, possibly by sharing those tasks with other similar organisations. (d) An existing internal safety-reporting scheme, established to collect safety-relevant data, proposals and information, including on potential safety issues that have not resulted in any occurrence, may serve as a basis for the mandatory and voluntary occurrence-reporting system. (e) Organisations are required to store occurrence reports qualifying for mandatory and voluntary reporting in one or more databases, as defined in Article 4(5), and establish data quality checking processes, as defined in Article 7(3), to ensure that the information initially collected and the data stored in the database(s) are consistent. (f) Organisations are required to: (1) identify the safety hazards associated with identified occurrences or groups of occurrences (cf. Article 13(1)); (2) analyse the related risks in terms of likelihood and severity of the outcome, as well as assess risks in terms of tolerability; (3) based on the result of the risk assessment, determine the need for mitigation action, as required for improving aviation safety (cf. Article 13(2)); and (4) monitor the timely implementation and effectiveness of any mitigation action required (cf. Article 13(2)). (g) In addition to the actions required under paragraph (c) above, organisations are required to ensure that the following information is transmitted to the competent authority within 30 days from the date of notification of the occurrence (both mandatory and voluntary reports) to the authority (cf. Article 13(4)): (1) the preliminary results of the risk analysis performed; and (2) any mitigation action to be taken. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 49 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments Furthermore, organisations are required to ensure that the final results of the risk analysis, where required, are transmitted to the competent authority as soon as they are available and, in principle, no later than 3 months from the date of notification of the occurrence to the authority (cf. Article 13(4)). (h) As part of their safety policy, organisations, after consulting staff representatives, are required to adopt rules describing how ‘just culture’ principles are guaranteed and implemented within the organisation. The purpose of those rules is to ensure that employees and contracted personnel that report or are mentioned in occurrence reports collected as part of the occurrence-reporting system are not subject to any prejudice by their employer or any other organisation for which the services are provided on the basis of the information supplied by the reporter (cf. Article 16). (i) Organisations are required to ensure that employees and contracted personnel are regularly provided with information concerning the analysis of, and follow-up on, occurrences for which mitigation action is taken (cf. Article 13(3)). In doing so, they ensure that only disidentified information is disseminated. (j) Organisations are required to ensure that reports addressed to the competent authority contain at least the information listed in Annex I to Regulation (EU) No 376/2014. SECTION II — Management 4. AMC1 ORO.GEN.200(a)(1);(2);(3);(5) is amended as follows: AMC1 ORO.GEN.200(a)(1);(2);(3);(5) Management system NON-COMPLEX OPERATORS — 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 operator. (b) The operator 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 operator’s existing hazard identification, risk assessment and mitigation processes. (c) The operator should identify a person who fulfils the role of safety manager and who is responsible for coordinating the safety -management -system-related processes and tasks. This person may be the accountable manager or a person with an operational role in the operator. (d) Within the operator, responsibilities should be identified for hazard identification, risk assessment and mitigation. (e) The safety policy should include a commitment to : (1) improve towards the highest safety standards, comply with all applicable legal requirements,; (2) meet all applicable standards, consider best practices and provide appropriate resources; and TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 50 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (3) apply ‘just culture’ principles in accordance with Regulation (EU) No 376/2014 and, in particular, not to make available or use the information on occurrences: (i) to attribute blame or liability to someone for reporting something that would not have been otherwise detected; or (ii) for any purpose other than the maintenance or improvement of aviation safety. (f) The operator 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 operator or specified individuals in an emergency and reflect the size, nature and complexity of the activities performed by the operator. 5. AMC1 ORO.GEN.200(a)(2) is amended as follows: AMC1 ORO.GEN.200(a)(2) Management system COMPLEX OPERATORS — SAFETY POLICY (a) The safety policy should: (1) be endorsed by the accountable manager; (2) reflect organisational commitments regarding safety and its proactive and systematic management; (3) be communicated, with visible endorsement, throughout the operator; and (4) include safety-reporting principles. (b) The safety policy should include a commitment: (1) to improve towards the highest safety standards; (2) to comply with all applicable legislation, meet all applicable standards and consider best practices; (3) to provide appropriate resources; (4) to enforce safety as one primary responsibility of all managers; and (5) not to blame someone for reporting something which would not have been otherwise detectedto apply ‘just culture’ principles in accordance with Regulation (EU) No 376/2014 and, in particular, not to make available or use the information on occurrences: (i) to attribute blame or liability to someone for reporting something that would not have been otherwise detected; or (ii) for any purpose other than the maintenance or improvement of aviation safety. (c) Senior management should: (1) continually promote the safety policy to all personnel and demonstrate their commitment to it; (2) provide necessary human and financial resources for its implementation; and TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 51 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (3) establish safety objectives and performance standards. 6. GM1 ORO.GEN.200(a)(2) is amended as follows: GM1 ORO.GEN.200(a)(2) Management system SAFETY POLICY (a) The safety policy is the means whereby the operator 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 or serious incident as far as is reasonably practicable. It reflects the management’s commitment to safety, and should reflect the operator’s philosophy of safety management, as well as become the foundation on which the operator’s management system is built. It serves as a reminder of ‘how we do business here’. The creation of a positive safety culture begins with the issuance of a clear, unequivocal direction. The safety policy should state that the purpose of safety reporting and internal investigations is to improve safety, not to apportion blame to individuals. (b) The commitment to apply ‘just culture’ principles forms the basis for the operator’s internal rules describing how ‘just culture’ principles are guaranteed and implemented, as required by Article 16(11) of Regulation (EU) No 376/2014. SUBPART AOC — AIR OPERATOR CERTIFICATION 7. AMC1 ORO.AOC.130 is amended as follows: AMC1 ORO.AOC.130 Flight data monitoring — aeroplanes FLIGHT DATA MONITORING (FDM) PROGRAMME (a) The safety manager, as defined under AMC1-ORO.GEN.200(a)(1), should be responsible for the identification and assessment of issues and their transmission to the manager(s) responsible for the process(es) concerned. The latter should be responsible for taking appropriate and practicable safety action within a reasonable period of time that reflects the severity of the issue. (…) (g) Every crew member should be responsible for reporting events. Significant risk-bearing incidents detected by FDM should therefore normally be the subject of mandatory occurrence reporting by the crew. If this is not the case, then they should submit a retrospective report that should be included under the normal process for reporting and analysing hazards, incidents and accidentsSignificant risk-bearing FDM events should normally be the subject of reporting by the flight crew for analysis in the framework of the operator’s management system. If this is not the case, then the flight crew should be requested to submit a retrospective report. (…) TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 52 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments 3.15. Draft Regulation (Draft EASA Opinion) — Part-ADR.AR SUBPART A — GENERAL REQUIREMENTS (ADR.AR.A) 1. ADR.AR.A.025 is amended as follows: ADR.AR.A.025 Information to the Agency (a) The Ccompetent Aauthority shall without undue delay notify the Agency in case of any significant problems with the implementation of Regulation (EC) No 216/2008 and its Iimplementing Rrules. (b) Without prejudice to Regulation (EU) No 376/2014, Tthe competent authority shall provide the Agency with safety-significant information stemming from the occurrence reports it has receivedstored in the national database. 2. ADR.AR.A.030 is amended as follows: ADR.AR.A.030 Immediate reaction to a safety problem (a) Without prejudice to Directive 2003/42/EC of the European Parliament and of the Council ( 1 )Regulation (EU) No 376/2014 and its implementing rules, the competent authority shall implement a system to appropriately collect, analyse and disseminate safety information. (…) SUBPART B — MANAGEMENT (ADR.AR.B) 3. ADR.AR.B.005 is amended as follows: ADR.AR.B.005 Management system (a) The competent authority shall establish and maintain a management system, including as a minimum: (1) documented policies and procedures to describe its organisation, means and methods to achieve compliance with Regulation (EC) No 216/2008, and its Iimplementing Rrules, as well as with Regulation (EU) No 376/2014 and its implementing rules. The procedures shall be kept up-to-date and serve as the basic working documents within that competent authority for all related tasks; (…) 4. ADR.AR.B.015 is amended as follows: ADR.AR.B.015 Changes in the management system (a) The competent authority shall have a system in place to identify changes that affect its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EC) No 216/2008, and its Iimplementing Rrules, as well as Regulation (EU) No 376/2014 and its implementing rules. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 53 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments This system shall enable it to take action as appropriate to ensure that its management system remains adequate and effective. (b) The competent authority shall update its management system to reflect any change to Regulation (EC) No 216/2008, and its Iimplementing Rrules, as well as Regulation (EU) No 376/2014 and its implementing rules in a timely manner, so as to ensure effective implementation. (c) The competent authority shall notify the Agency of changes affecting its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EC) No 216/2008, and its Iimplementing Rrules, as well as Regulation (EU) No 376/2014 and its implementing rules. 3.16. Draft Regulation (Draft EASA Opinion) — Part-ADR.OR SUBPART C — ADDITIONAL AERODROME OPERATOR RESPONSIBILITIES (ADR.OR.C) 1. The content of ADR.OR.C.030 is replaced by the following: ADR.OR.C.030 Occurrence reporting (a) The aerodrome operator and the provider of apron management services shall report: (1) to the competent authority any safety-related event or condition that endangers or, if not corrected or addressed, could endanger safety. (2) to the competent authority and any other organisation required by the State of the aerodrome operator to be informed any accident and serious incident, as defined in Regulation (EU) No 996/2010. (b) Without prejudice to paragraph (a) above, the aerodrome operator shall report to the competent authority and the organisation responsible for the design of the aerodrome equipment any malfunction, technical defect, exceeding of technical limitations, occurrence or other irregular circumstance that has or may have endangered safety and that has not resulted in an accident or serious incident. (c) Where relevant, and without prejudice to Regulation (EU) No 376/2014, the aerodrome operator and the provider of apron management services shall produce to relevant entities, initially reported to as per paragraphs (a) and (b) above, a follow-up report providing details of actions they intend 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. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 54 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments SUBPART D — MANAGEMENT (ADR.OR.D) 2. ADR.OR.D.005 is amended as follows: ADR.OR.D.005 Management system (a) The aerodrome operator shall implement and maintain a management system integrating a safety management system. (b) The management system shall include: (…) (11) a formal process to monitor compliance of the organisation with the relevant requirements.; and (12) any additional relevant requirements prescribed in this Regulation, as well as the applicable requirements of Regulation (EU) No 376/2014 and its implementing rules. (…) 3. ADR.OR.D.025 is amended as follows: ADR.OR.D.025 Coordination with other organisations The aerodrome operator shall: (a) ensure that theits management system of the aerodrome addresses the coordination and interface with the safety procedures of other organisations operating or providing services at the aerodrome; and (b) ensure that such organisations have safety procedures in place to comply with the applicable requirements of Regulation (EC) No 216/2008, and its Iimplementing Rrules, and, where relevant, with the applicable requirements of Regulation (EU) No 376/2104 and its implementing rules, as well as with and the requirements laid down in the aerodrome manual. 4. ADR.OR.D.030 is amended as follows: ADR.OR.D.030 Safety -reporting system (a) As part of its management system, Tthe aerodrome operator shall establish and implement a safety -reporting system for all personnel and organisations operating or providing services at the aerodrome, in order to promote safety at, and the safe use of, the aerodrome. Such system shall meet the requirements of Regulation (EU) No 376/2014 and its implementing rules. (b) The aerodrome operator, in accordance with ADR.OR.D.005 (b)(3), shall: (1) require that the personnel and organisations mentioned in point (a) use the safety -reporting system for the mandatory reporting of any accident, serious incident and other occurrence, as required by Regulations (EU) Nos 996/2010 and 376/2014; and (2) ensure that the safety -reporting system may also be used for the voluntary reporting, as required by Regulation (EU) No 376/2014, of any defect, fault and safety hazard which TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 55 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments could impact safetysafety-related event or condition that endangers or, if not corrected or addressed, could endanger safety. (c) The safety-reporting system shall protect the identity of the reporter, encourage voluntary reporting and include the possibility that reports may be submitted anonymously. (d) The aerodrome operator shall: (1) record all reports submitted; (2) analyse and assess the reports, as appropriate, in order to address safety deficiencies and identify trends; (3) ensure that all organisations operating or providing services at the aerodrome which are relevant to the safety concern, participate in the analysis of such reports and that any corrective and/or preventive measures identified are implemented; (4) conduct investigations of reports, as appropriate; and (5) refrain from attribution of blame in line with the ‘just culture’ principles. 3.17. Draft AMC/GM (Draft EASA Decision) — Part-ADR.AR SUBPART A —GENERAL REQUIREMENTS (ADR.AR.A) 1. New AMC1 ADR.AR.A.025(b) is added as follows: AMC1 ADR.AR.A.025(b) Information to the Agency EXCHANGE OF SAFETY-SIGNIFICANT INFORMATION WITH THE AGENCY Each competent authority should appoint a coordinator to act as the contact point for the exchange of safety-significant information between the competent authority and the Agency. 2. New GM1 ADR.AR.A.025(b) is added as follows: GM1 ADR.AR.A.025(b) Information to the Agency MEANING OF SAFETY-SIGNIFICANT INFORMATION STEMMING FROM OCCURRENCE REPORTS Safety-significant information stemming from occurrence reports means a conclusive safety analysis that summarises individual occurrence data and provides an in-depth analysis of a safety issue, which may be relevant for the Agency’s safety action planning. 3. New GM2 ADR.AR.A.025(b) is added as follows: GM2 ADR.AR.A.025(b) Information to the Agency RECOMMENDED CONTENT FOR CONCLUSIVE SAFETY ANALYSES A conclusive safety analysis should contain the following: (a) a detailed description of the safety issue, including the scenario in which the safety issue takes place; and TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 56 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (b) an indication of the stakeholders affected by the safety issue, including types of operations and organisations; and, as appropriate: (c) a risk assessment establishing the severity and likelihood of all the possible consequences of the safety issue; (d) information about the existing safety barriers that the aviation system has in place to prevent the likely safety issue consequences from occurring; (e) any mitigating actions already in place or developed to deal with the safety issue; (f) recommendations for future actions to control the risk; and (g) any other element the competent authority considers essential for the Agency to properly assess the safety issue. SECTION II — MANAGEMENT 4. New GM1 ADR.AR.B.005 is added as follows: GM1 ADR.AR.B.005 Management system COMPETENT AUTHORITY ESTABLISHED IN ACCORDANCE WITH REGULATION (EU) No 376/2014 (a) Where a Member State designates different competent authorities to manage occurrences reported pursuant to Articles 4 ‘Mandatory reporting’ and 5 ‘Voluntary reporting’ of Regulation (EU) No 376/2014 and for the oversight of persons and organisations in accordance with Regulation (EC) No 216/2008 and its implementing rules respectively: (1) the areas of competence of each competent authority must be clearly defined; (2) proper coordination must be established between those authorities to ensure effective oversight of all persons and organisations subject to Regulation (EC) No 216/2008 and its implementing rules within their respective remits; and (3) occurrence reports addressed to the competent authority responsible for the oversight of persons and organisations in accordance with Regulation (EC) No 216/2008 and its implementing rules must be shared with the competent authority established for managing occurrence reports pursuant to Regulation (EU) No 376/2014. (b) The organisational set-up in terms of competent authorities designated under Regulations (EU) No 376/2014, (EC) No 216/2008, and their implementing rules, must not result in a duplication of the reporting obligations for persons or organisations subject to those Regulations. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 57 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments 3.18. Draft AMC/GM (Draft EASA Decision) — Part-ADR.OR SUBPART C — ADDITIONAL RESPONSIBILITIES (ADR.OR.C) 1. The content of AMC1 ADR.OR.C.030 is replaced by the following: AMC1 ADR.OR.C.030 Occurrence reporting GENERAL (a) The aerodrome operator and the provider of apron management services should report as a minimum all occurrences defined in Regulation (EU) 2015/1018 laying down a list classifying occurrences in civil aviation to be mandatorily reported according to Regulation (EU) No 376/2014. (b) The aerodrome operator and the provider of apron management services should establish procedures to be used for reporting to the competent authority and any other organisation required to report to, which should include: (1) a description of the applicable requirements for reporting; (2) a description of the reporting mechanism, including reporting forms, means, and deadlines; and (3) responsibilities of the organisations and personnel responsible for reporting. (c) Such procedures should be included in the aerodrome manual and the respective manual of the apron management services provider. 2. AMC1 ADR.OR.D.030 is amended as follows: AMC1 ADR.OR.D.030 Safety -reporting system SAFETY -REPORTING SYSTEM (a) Safety reporting system — General (1) An effective safety -reporting system should include, apart from aerodrome operator’s personnel, aircraft operators, ground handling service providers, air navigation service providers, and any other organisation operating on the aerodrome, or providing services at the aerodrome. (2) The safety -reporting system should include voluntary reporting possibilities intended for safety hazards identified by the reporter, and that may have potential safety consequences. (3) The aerodrome operator should identify which events are mandatory to be reported. (4) The aerodrome operator should provide the means and the format for reporting which should be such that meets the existing reporting requirements foreseen in the applicable legislation in terms of time, format, and required information to be reported. (3) The aerodrome operator should provide sufficient means for reporting, including forms that may be used for this purpose. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 58 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (54) The safety -reporting system should include an acknowledgement to the reporter for the submission of the report. (65) The reporting process should be as simple as possible, and well documented, including details as to what, how, where, whom, and when to report.; (76) Regardless of the source or method of submission, once the information is received, it should be stored in a manner suitable for easy retrieval and analysis.; (87) Access to the submitted reports should be restricted to persons responsible for storing and analysing them.; (98) Protection of the identity of the reporter should be ensured, and the procedures established by the aerodrome operator to gather additional information for analyses, or investigations should respect this principle.; (109) The safety-reporting system should include a feedback system to the reporting person, on the outcome of the occurrence analysis. (b) The aerodrome operator should establish written arrangements with all organisations operating or providing services at the aerodrome, defining their reporting obligations under the safety-reporting system of the aerodrome operator. (b)(c) Wildlife hazard reporting (1) The aerodrome operator should ensure that its safety-reporting system specifically addresses the requirement for all third parties (aircraft operators, aircraft mechanics, air traffic controllers, and other Air Traffic Services personnel, etc.) and all aerodrome personnel, to report to the aerodrome operator wildlife strikes, and relevant identified hazards. (2) The reporting of such third parties should be done irrespectively of any other requirements, defined in Regulation (EU) No 216/2008, its implementing rules, in Regulation (EU) No 376/2014 and its implementing rules, as well as in Regulation (EU) No 996/2010, according to which they have to report to the Ccompetent Aauthority of the aerodrome, the relevant safety investigation authority or the state of rRegistry of the aircraft involved, or any other Competent Authority in the context of the national occurrence reporting programme. 3. New GM1 ADR.OR.D.030 is added as follows: GM1 ADR.OR.D.030 Safety-reporting system SAFETY-REPORTING SYSTEM COMPLIANT WITH REGULATION (EU) No 376/2014 (a) The below provides an overview of the main elements of the safety-reporting system to comply with Regulation (EU) No 376/2014. It also provides references to the relevant articles of Regulation (EU) No 376/2014. (b) Aerodrome operators are required to implement a system that caters both for mandatory and voluntary reporting (cf. Articles 4 and 5). TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 59 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (c) Aerodrome operators are required to designate one or more persons to handle independently the collection, evaluation, processing, analysis and storage of details of occurrences with regard to data collection and hazard identification (cf. Article 6(1)). Nevertheless, small aerodrome operators may, in agreement with their competent authority, make use of simplified mechanisms to ensure the collection, evaluation, processing, analysis and storage of details of occurrences, possibly by sharing those tasks with other similar organisations. (d) Aerodrome operators are required to store occurrence reports qualifying for mandatory and voluntary reporting in one or more databases, as defined in Article 4(5), and establish data quality checking processes, as defined in Article 7(3), to ensure that the information initially collected and the data stored in the database(s) are consistent. (e) By applying their safety risk management and monitoring processes, established as part of their management system, aerodrome operators are able to: (1) identify the safety hazards associated with identified occurrences or groups of occurrences (cf. Article 13(1)); (2) analyse the related risks in terms of likelihood and severity of the outcome, as well as assess risks in terms of tolerability; (3) based on the result of the risk assessment, determine the need for mitigation action, as required for improving aviation safety (cf. Article 13(2)); and (4) monitor the timely implementation and effectiveness of any mitigation action required (cf. Article 13(2)). (f) In addition to the actions required by the established safety risk management processes, aerodrome operators are required to ensure that the following information is transmitted to the competent authority within 30 days from the date of notification of the occurrence (both mandatory and voluntary reports) to the authority (cf. Article 13(4)): (1) the preliminary results of the risk analysis performed; and (2) any mitigation action to be taken. Furthermore, aerodrome operators are required to ensure that the final results of the risk analysis, where required, are transmitted to the competent authority as soon as they are available and, in principle, no later than 3 months from the date of notification of the occurrence to the authority (cf. Article 13(4)). (g) As part of their safety policy, aerodrome operators, after consulting staff representatives, are required to adopt rules describing how ‘just culture’ principles are guaranteed and implemented within the aerodrome operator. The purpose of those rules is to ensure that employees and contracted personnel that report or are mentioned in occurrence reports collected as part of the occurrence-reporting system are not subject to any prejudice by their employer or any other organisation for which the services are provided on the basis of the information supplied by the reporter (cf. Article 16). (h) As part of the established safety training and safety promotion activities, aerodrome operators are required to ensure that employees and contracted personnel are regularly provided with information concerning the analysis of, and follow-up on, occurrences for which mitigation TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 60 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments action is taken (cf. Article 13(3)). In doing so, they ensure that only disidentified information is disseminated. (i) Aerodrome operators are required to ensure that reports addressed to the competent authority contain at least the information listed in Annex I to Regulation (EU) No 376/2014. To this end, the aerodrome operator should ensure that all relevant information is gathered through its safety-reporting system. 4. AMC1 ADR.OR.D.005(b)(2) is amended as follows: AMC1 ADR.OR.D.005(b)(2) Management system SAFETY POLICY (…) (b) The safety policy should: (1) include a commitment: (i) to improve towards the highest safety standards; (ii) to comply with all applicable legal requirements, meet all applicable standards, and consider best practices; (iii) to provide appropriate resources; (iv) to enforce safety as one primary responsibility of all managers and staff; and (v) to apply ‘just culture’ principles in accordance with Regulation (EU) No 376/2014, and, in particular, not to make available or use the information on occurrences: (A) to attribute blame or liability to someone for reporting something that would not have been otherwise detected; or (B) for any purpose other than the maintenance or improvement of aviation safety; (2) include the safety -reporting procedures; (3) with reference to a ‘just culture’, clearly indicate which types of operational behaviours are unacceptable, and include the conditions under which disciplinary action would not apply; and (4) be periodically reviewed to ensure it remains relevant and appropriate. (…) TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 61 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments 5. GM1 ADR.OR.D.005(b)(2)) is amended as follows: GM1 ADR.OR.D.005(b)(2) Management system SAFETY POLICY (a) Safety policy — General The safety policy is the means whereby the aerodrome operator 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 or serious incident as far as is reasonably practicable. It reflects the management‘s commitment to safety, and should reflect the aerodrome operator’s philosophy of safety management, as well as become the foundation on which the aerodrome operator’s management system is built. It serves as a reminder of ‘how we do business here‘. The creation of a positive safety culture begins with the issuance of a clear, unequivocal direction. The safety policy should state that the purpose of safety reporting and internal investigations is to improve safety, not to apportion blame to individuals. The commitment to apply ‘just culture’ principles forms the basis for the aerodrome operator’s internal rules describing how ‘just culture’ principles are guaranteed and implemented, as required by Article 16(11) of Regulation (EU) No 376/2014. (b) Safety policy — Just culture The safety policy should actively encourage effective safety reporting and, by defining the line between acceptable performance (often unintended errors) and unacceptable performance (such as negligence, recklessness, violations, or sabotage), provide fair protection to reporters. A safety or just culture may not, however, preclude the ‘criminalisation of error’, which is legally, ethically, and morally within the sovereign rights of any Member State, provided European Union law and established international agreements are observed. A judicial investigation, and consequences of some form, may be expected following an accident or serious incident especially if a failure resulted in lives lost or property damaged, even if no negligence or ill intent existed. A potential issue could, therefore, exist if voluntary hazard reports, which relate to latent deficiencies of a system or its performance, are treated in the same way as those concerning accident, and serious incident investigations. The intent of protecting hazard reports should not challenge the legitimacy of a judicial investigation, or demand undue immunity. However, legal argument does usually take precedence over any technical or safety-related argument. 3.19. Draft Regulation (Draft EASA Opinion) — Part-ATM/ANS.AR SUBPART A — GENERAL REQUIREMENTS 1. ATM/ANS.AR.A.020 is amended as follows: ATM/ANS.AR.A.020 Information to the Agency (a) The competent authority shall without undue delay notify the Agency in case of any significant problems with the implementation of Regulation (EC) No 216/2008 and its Iimplementing Rrules. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 62 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (b) Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council (1), the competent authority shall provide the Agency with safety-significant information stemming from the occurrence reports it has receivedstored in the national database. SUBPART B — MANAGEMENT (ATM/ANS.AR.B) 2. ATM/ANS.AR.B.001 is amended as follows: ATM/ANS.AR.B.001 Management system (a) The competent authority shall establish and maintain a management system, including, as a minimum, the following elements: (1) documented policies and procedures to describe its organisation, means and methods to achieve compliance with Regulation (EC) No 216/2008 and its Iimplementing Rrules, as well as with Regulation (EU) No 376/2014 and its implementing rules, as necessary for the exercise of its certification, oversight and enforcement tasks under the present Regulation. The procedures shall be kept up to date and serve as the basic working documents within that competent authority for all related tasks; (…) 3. ATM/ANS.AR.B.010 is amended as follows: ATM/ANS.AR.B.010 Changes in the management system (a) The competent authority shall have a system in place to identify changes that affect its capability to perform its tasks and discharge its responsibilities under this Regulation, as well as under Regulation (EU) No 376/2014 and its implementing rules. This system shall enable it to take action, as appropriate, to ensure that the management system remains adequate and effective. (b) The competent authority shall update its management system to reflect any change to this Regulation, as well as to Regulation (EU) No 376/2014 and its implementing rules, in a timely manner, so as to ensure effective implementation. (c) The competent authority shall notify the Agency of significant changes affecting its capability to perform its tasks and discharge its responsibilities under this Regulation, as well as under Regulation (EU) No 376/2014 and its implementing rules. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 63 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments 3.20. Draft Regulation (Draft EASA Opinion) — Part-ATM/ANS.OR SUBPART A — GENERAL REQUIREMENTS (ATM/ANS.OR.A) 1. The content of ATM/ANS.OR.A.065 is replaced by the following: ATM/ANS.OR.A.065 Occurrence reporting (a) As part of its management system, the service provider shall implement an occurrence-reporting system, including mandatory and voluntary reporting. For service providers located in the territory subject to the provisions of the Treaty establishing the European Union and responsible for providing services in the airspace of the territory to which the Treaty applies, such system shall meet the requirements of Regulation (EU) No 376/2014 and its implementing rules. (b) The service provider shall report to the competent authority and any other organisation required by the Member State where the service provider provides its services to be informed: (1) any safety-related event or condition that endangers or, if not corrected or addressed, could endanger flight safety; and (2) any accident and serious incident, as defined in Regulation (EU) No 996/2010. (c) Without prejudice to paragraph (b) above, the service provider shall report to the competent authority and the organisation responsible for the design of the air traffic management (ATM)/air navigation services (ANS) systems and constituents, if different from the service provider, any malfunction, technical defect, exceeding of technical limitations, occurrence, or other irregular circumstance that has or may have endangered the safety of services and that has not resulted in an accident or serious incident. (d) For service providers not located in the territory subject to the provisions of the Treaty establishing the European Union and responsible for providing services in the airspace of the territory to which the Treaty applies: (1) initial reports shall: (i) 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; (ii) be made in a form and manner established by the Agency; and (iii) contain all pertinent information about the condition known to the organisation; (2) where relevant, a follow-up report providing details of actions the organisation intends to take to prevent similar occurrences in the future shall be made as soon as these actions have been identified; those follow-up reports shall: (i) be sent to relevant entities initially reported to as per paragraphs (b) and (c) above; and (ii) be produced in a form and manner established by the Agency. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 64 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments 2. ATM/ANS.OR.B.005 is amended as follows: ATM/ANS.OR.B.005 Management system (a) A service provider shall implement and maintain a management system that includes: (1) clearly defined lines of responsibility and accountability throughout its organisation, including a direct accountability of the accountable manager; (…) (6) a process to ensure that the personnel of the service provider are trained and competent to perform their duties in a safe, efficient, continuous and sustainable manner. In this context, the service provider shall establish policies for the recruitments and training of its personnel; and (7) a formal means for communication that ensures that all personnel of the service provider are fully aware of the management system, that allows critical information to be conveyed and that makes it possible to explain why particular actions are taken and why procedures are introduced or changed.; and (8) any additional relevant requirements that are prescribed in this Regulation, as well as in Regulation (EU) No 376/2014 and its implementing rules. (...) 3.21. Draft Regulation (Draft EASA Opinion) — Part-ATCO.AR SUBPART A — GENERAL REQUIREMENTS 1. ATCO.AR.A.025 is amended as follows: ATCO.AR.A.025 Immediate reaction to a safety problem (a) Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council ( 1 )and its implementing rules, the competent authority shall implement a system to appropriately collect, analyse and disseminate safety information. (b) The Agency shall implement a system to appropriately analyse any relevant safety information received and without undue delay provide to Member States and the Commission any information, including recommendations or corrective actions to be taken, necessary for them to react in a timely manner to a safety problem involving products, parts, appliances, persons or organisations subject to Regulation (EC) No 216/2008 and its Iimplementing Rrules. (c) Upon receiving the information referred to in (a) and (b), the competent authority shall take adequate measures to address the safety problem. (d) Measures taken under (c) shall immediately be notified to all persons or organisations which need to comply with them under Regulation (EC) No 216/2008 and its Iimplementing Rrules. The competent authority shall also notify those measures to the Agency and, when combined action is required, the other Member States concerned. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 65 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments SUBPART B — MANAGEMENT 2. ATCO.AR.B.001 is amended as follows: ATCO.AR.B.001 Management system (a) The competent authority shall establish and maintain a management system, including as a minimum: (1) documented policies and procedures to describe its organisation, means and methods to achieve compliance with Regulation (EC) 216/2008, its implementing rules, as well as with Regulation (EU) No 376/2014 and its implementing rules and this Regulation. The procedures shall be kept up-to-date and serve as the basic working documents within that competent authority for all related tasks; (…) 3. ATCO.AR.B.010 is amended as follows: ATCO.AR.B.010 Changes to the management system (a) The competent authority shall have a system in place to identify changes that affect its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EC) 216/2008, its implementing rules, as well as with Regulation (EU) No 376/2014 and its implementing rules and this Regulation. It shall enable it to take action, as appropriate, to ensure that the management system remains adequate and effective. (b) The competent authority shall update its management system to reflect any change to Regulation (EC) 216/2008, its implementing rules, as well as with Regulation (EU) No 376/2014 and its implementing rules and this Regulation in a timely manner in order to ensure effective implementation. (c) The competent authority shall notify the Agency of changes affecting its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EC) 216/2008, its implementing rules, as well as with Regulation (EU) No 376/2014 and its implementing rules and this Regulation. 3.22. Draft Regulation (Draft EASA Opinion) — Part-ATCO.OR SUBPART B — REQUIREMENTS FOR AIR TRAFFIC CONTROLLER TRAINING ORGANISATIONS 1. The content of ATCO.OR.B.040 is replaced by the following: ATCO.OR.B.040 Occurrence reporting (a) As part of their management system, training organisations providing on-the-job training shall implement an occurrence-reporting system, including mandatory and voluntary reporting. For training organisations located in the territory subject to the provisions of the Treaty establishing the European Union and providing on-the-job training in the territory to which the Treaty TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 66 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments applies, such system shall meet the requirements of Regulation (EU) No 376/2014 and its implementing rules. (b) Training organisations providing on-the-job training shall report to the competent authority and any other organisation required by the Member State where the service provider provides its services to be informed: (1) any safety-related event or condition that endangers or, if not corrected or addressed, could endanger flight safety; and (2) any accident and serious incident, as defined in Regulation (EU) No 996/2010. (c) Without prejudice to paragraph (b) above, the training organisation shall report to the competent authority and the organisation responsible for the design of the air traffic management (ATM)/air navigation services (ANS) systems and constituents, if different from the training organisation, any malfunction, technical defect, exceeding of technical limitations, occurrence, or other irregular circumstance that has or may have endangered the safety of services and that has not resulted in an accident or serious incident. (d) For training organisations not located in the territory subject to the provisions of the Treaty establishing the European Union and providing on-the-job training in the territory to which the Treaty applies: (1) initial reports shall: (i) 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; (ii) be made in a form and manner established by the Agency; and (iii) contain all pertinent information about the condition known to the organisation; (2) where relevant, a follow-up report providing details of actions the organisation intends to take to prevent similar occurrences in the future shall be made as soon as these actions have been identified; those follow-up reports shall: (i) be sent to relevant entities initially reported to as per paragraphs (b) and (c) above; and (ii) be produced in a form and manner established by the Agency. 2. ATCO.OR.C.001 is amended as follows: ATCO.OR.C.001 Management system of training organisations Training organisations shall establish, implement and maintain a management system that includes: (…) (g) The management system shall be proportionate to the size of the organisation and its activities, taking into account the hazards and associated risks inherent in those activities. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 67 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (g) any additional relevant requirements that are prescribed in this Regulation, as well as in Regulation (EU) No 376/2014 and its implementing rules. 3.23. Draft AMC/GM (Draft EASA Decision) — Part-ATCO.AR SUBPART A — GENERAL REQUIREMENTS 1. New AMC1 ATCO.AR.A.020(b) is added as follows: AMC1 ATCO.AR.A.020(b) Information to the Agency EXCHANGE OF SAFETY-SIGNIFICANT INFORMATION WITH THE AGENCY Each competent authority should appoint a coordinator to act as the contact point for the exchange of safety-significant information between the competent authority and the Agency. 2. The content of GM1 ATCO.AR.A.020(b) is replaced by the following: GM1 ATCO.AR.A.020(b) Information to the Agency MEANING OF SAFETY-SIGNIFICANT INFORMATION STEMMING FROM OCCURRENCE REPORTS Safety-significant information stemming from occurrence reports means a conclusive safety analysis that summarises individual occurrence data and provides an in-depth analysis of a safety issue, which may be relevant for the Agency’s safety action planning. 3. New GM2 ATCO.AR.A.020(b) is added as follows: GM2 ATCO.AR.A.020(b) Information to the Agency RECOMMENDED CONTENT FOR CONCLUSIVE SAFETY ANALYSES A conclusive safety analysis should contain the following: (a) a detailed description of the safety issue, including the scenario in which the safety issue takes place; and (b) an indication of the stakeholders affected by the safety issue, including types of operations and organisations; and, as appropriate: (c) a risk assessment establishing the severity and likelihood of all the possible consequences of the safety issue; (d) information about the existing safety barriers that the aviation system has in place to prevent the likely safety issue consequences from occurring; (e) any mitigating actions already in place or developed to deal with the safety issue; (f) recommendations for future actions to control the risk; and (g) any other element the competent authority considers essential for the Agency to properly assess the safety issue. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 68 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments SUBPART B — MANAGEMENT 4. New GM1 ATCO.AR.B.001 is added as follows: GM1 ATCO.AR.B.001 Management system COMPETENT AUTHORITY ESTABLISHED IN ACCORDANCE WITH REGULATION (EU) No 376/2014 (a) Where a Member State designates different competent authorities to manage occurrences reported pursuant to Articles 4 ‘Mandatory reporting’ and 5 ‘Voluntary reporting’ of Regulation (EU) No 376/2014 and for the oversight of persons and organisations in accordance with Regulation (EC) No 216/2008 and its implementing rules respectively: (1) the areas of competence of each competent authority must be clearly defined; (2) proper coordination must be established between those authorities to ensure effective oversight of all persons and organisations subject to Regulation (EC) No 216/2008 and its implementing rules within their respective remits; and (3) occurrence reports addressed to the competent authority responsible for the oversight of persons and organisations in accordance with Regulation (EC) No 216/2008 and its implementing rules must be shared with the competent authority established for managing occurrence reports pursuant to Regulation (EU) No 376/2014. (b) The organisational set-up in terms of competent authorities designated under Regulations (EU) No 376/2014, (EC) No 216/2008, and their implementing rules, must not result in a duplication of the reporting obligations for persons or organisations subject to those Regulations. 3.24. Draft AMC/GM (Draft EASA Decision) — Part-ATCO.OR SUBPART B — REQUIREMENTS FOR AIR TRAFFIC CONTROLLER TRAINING ORGANISATIONS 1. New AMC1 ATCO.OR.B.040 is added as follows: AMC1 ATCO.OR.B.040 Occurrence reporting GENERAL The training organisation should report all occurrences that may involve an actual or potential aviation safety risk and in any case those defined in Regulation (EU) 2015/1018 that lays down a list classifying occurrences in civil aviation to be mandatorily reported in accordance with Regulation (EU) No 376/2014. 2. GM1 ATCO.OR.B.040 is amended as follows: GM1 ATCO.OR.B.040 Occurrence reporting GENERAL The training organisation’s report should focus on occurrences taking place during on-the-job training with regard to the training aspects involved. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 69 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments Without prejudice to Regulation (EU) No 376/2014, tThe report may be submitted together with or as an integral part of the report prepared by the air navigation service provider. 3. New GM2 ATCO.OR.B.040 is added as follows GM2 ATCO.OR.B.040 Occurrence reporting TRAINING ORGANISATIONS PROVIDING ON-THE-JOB TRAINING — OCCURRENCE-REPORTING SYSTEM COMPLIANT WITH REGULATION (EU) No 376/2014 (a) The below provides an overview of the main elements of the occurrence-reporting system to comply with Regulation (EU) No 376/2014. It also provides references to the relevant articles of Regulation (EU) No 376/2014. (b) Organisations are required to implement a system that caters both for mandatory and voluntary reporting (cf. Articles 4 and 5). Occurrences qualifying for mandatory reporting are those defined in Regulation (EU) 2015/1018. (c) Organisations are required to designate one or more persons to handle independently the collection, evaluation, processing, analysis and storage of details of occurrences with regard to data collection and hazard identification (cf. Article 6(1)). Nevertheless, small organisations may, in agreement with their competent authority, make use of simplified mechanisms to ensure the collection, evaluation, processing, analysis and storage of details of occurrences, possibly by sharing those tasks with other similar organisations. (d) An existing internal safety-reporting scheme, established as part of the organisation’s management system for collecting safety-relevant data, proposals and information, including on potential safety issues that have not resulted in any occurrence, may serve as a basis for the mandatory and voluntary occurrence-reporting system. (e) Organisations are required to store occurrence reports qualifying for mandatory and voluntary reporting in one or more databases, as defined in Article 4(5), and establish data quality checking processes, as defined in Article 7(3), to ensure that the information initially collected and the data stored in the database(s) are consistent. (f) By applying their safety risk management and monitoring processes, established as part of their management system, organisations are able to: (1) identify the safety hazards associated with identified occurrences or groups of occurrences (cf. Article 13(1)); (2) analyse the related risks in terms of likelihood and severity of the outcome, as well as assess risks in terms of tolerability; (3) based on the result of the risk assessment, determine the need for mitigation action, as required for improving aviation safety (cf. Article 13(2)); and (4) monitor the timely implementation and effectiveness of any mitigation action required (cf. Article 13(2)). (g) In addition to the actions required by the established safety risk management processes, organisations are required to ensure that the following information is transmitted to the TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 70 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments competent authority within 30 days from the date of notification of the occurrence (both mandatory and voluntary reports) to the authority (cf. Article 13(4)): (1) the preliminary results of the risk analysis performed; and (2) any mitigation action to be taken. Furthermore, organisations are required to ensure that the final results of the risk analysis, where required, are transmitted to the competent authority as soon as they are available and, in principle, no later than 3 months from the date of notification of the occurrence to the authority (cf. Article 13(4)). (h) As part of their safety policy, organisations, after consulting staff representatives, are required to adopt rules describing how ‘just culture’ principles are guaranteed and implemented within the organisation. The purpose of those rules is to ensure that employees and contracted personnel that report or are mentioned in occurrence reports collected as part of the occurrence-reporting system are not subject to any prejudice by their employer or any other organisation for which the services are provided on the basis of the information supplied by the reporter (cf. Article 16). (i) As part of the established safety training and safety promotion activities, organisations are required to ensure that employees and contracted personnel are regularly provided with information concerning the analysis of, and follow-up on, occurrences for which mitigation action is taken (cf. Article 13(3)). In doing so, they ensure that only disidentified information is disseminated. (j) Organisations are required to ensure that reports addressed to the competent authority contain at least the information listed in Annex I to Regulation (EU) No 376/2014. SUBPART C — MANAGEMENT OF AIR TRAFFIC CONTROLLER TRAINING ORGANISATIONS 4. AMC1 ATCO.OR.C.001(b) is amended as follows: AMC1 ATCO.OR.C.001(b) Management system of training organisations SAFETY POLICY The safety policy should: (a) be endorsed by the accountable manager; (b) clearly identify safety as the highest organisational priority over commercial, operational, environmental or social pressures; (c) include a commitment to: (1) improve towards the highest safety standards; (2) comply with all applicable legal requirements, meet all applicable standards and consider best practices; (3) provide appropriate resources; and (4) enforce safety as the primary responsibility of all managers and staff; and TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 71 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (5) apply ‘just culture’ principles in accordance with Regulation (EU) No 376/2014 and, in particular, not to make available or use the information on occurrences: (i) to attribute blame or liability to someone for reporting something that would not have been otherwise detected; or (ii) for any purpose other than the maintenance or improvement of aviation safety; (d) be communicated, with visible endorsement, throughout the organisation; (e) include safety -reporting and just culture principles; (f) enhance and embed safety culture and safety awareness; and (g) be periodically reviewed to ensure it remains relevant and appropriate to the training organisation. 5. The content of GM1 ATCO.OR.C.001(b) is replaced by the following: GM1 ATCO.OR.C.001(b) Management system of training organisations SAFETY POLICY (a) 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 or serious incident as far as is reasonably practicable. It reflects the management’s commitment to safety, and should reflect the organisation’s philosophy of safety management, as well as become the foundation on which the organisation’s management system is built. It serves as a reminder of ‘how we do business here’. The creation of a positive safety culture begins with the issuance of a clear, unequivocal direction. (b) The commitment to apply ‘just culture’ principles forms the basis for the organisation’s internal rules describing how ‘just culture’ principles are guaranteed and implemented, as required by Article 16(11) of Regulation (EU) No 376/2014. 3.25. Draft AMC/GM (Draft EASA Decision) — AMC-20 1. AMC 20-8 is amended as follows: AMC 20-8 Occurrence Rreporting 1. INTENT This AMC is interpretative material and provides guidance in order to determine whenwhich occurrences should be reported to the Agency, competentnational authorities and to other organisations, and it provides guidance on the timescale for submission of such reports. It also describes the objective of the overall occurrence -reporting system including internal and external functions. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 72 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments 2. APPLICABILITY (a) This AMC only applies to occurrence reporting by persons/organisations regulated bysubject to Regulation (EC) No 1592/2002(EU) No 216/2008 of the European Parliament and of the Council. It does not address reporting by aerodrome organisations, air navigation service providers and authorities themselves. (b) In most cases the obligation to report is on the holders of a certificate or approval, which in most cases are organisations, but in some cases can be a naturalsingle person. In addition some reporting requirements are directed to persons. However, in order not to complicate the text, only the term ‘organisation’ is used. (c) The AMC also does not apply tospecifically address dangerous goods reporting. The definition of reportable dangerous goods occurrences is different from the other occurrences and the reporting system is also separate. This subject is covered in specific operating requirements and guidance and ICAO Documents, namely: (i) ICAO Annex 18, The safe Transport of Dangerous Goods by Air, Chapter 12 (ii) ICAO Doc 9284-AN/905, Technical Instructions for the Safe Transport of Dangerous Goods by Air (i) Regulation (EU) No 965/2012 laying down technical requirements and administrative procedures related to air operations pursuant to Regulation (EC) No 216/2008; (ii) ICAO Annex 18, The safe Transport of Dangerous Goods by Air; and (iii) ICAO Doc 9284-AN/905, Technical Instructions for the Safe Transport of Dangerous Goods by Air. 3. OBJECTIVE OF OCCURRENCE REPORTING (a) The occurrence -reporting system is an essential part of the overall monitoring function. The objective of the occurrence-reporting, collection, investigation and analysis systems described in the applicable requirements of Regulation (EC) No 216/2008 and its implementing rules, as well as of Regulation (EU) No 376/2014 and its implementing rulesthe operating rules, and the airworthiness rules is to use the reported information to contribute to the improvement of aviation safety, and not to attribute blame, impose fines or take other enforcement actions. (b) The detailed objectives of the occurrence -reporting systems are: (i) To enable an assessment of the safety implications of each occurrence to be made, including previous similar occurrences, so that any necessary action can be initiated. This includes determining what and why it had occurred and what might prevent a similar occurrence in the future. (ii) To ensure that knowledge of occurrences is disseminated so that other persons and organisations may learn from them. (c) The occurrence -reporting system is complementary to the normal day to day procedures and 'control' systems and is not intended to duplicate or supersede any of them. The TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 73 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments occurrence -reporting system is a tool to identify those occasions where routine procedure s have failed. (d) Occurrences should remain in the database when judged reportable by the person submitting the report as the significance of such reports may only become obvious at a later date. 4. REPORTING TO THE AGENCY AND COMPETENTNATIONAL AUTHORITIES (a) Regulation (EU) 2015/1018 provides the list of occurrences that are subject to mandatory reporting. This list is based on the following general rRequirements: (i) As detailed in the operating rules, occurrences defined as an incident, malfunction, defect, technical defect or exceedance of technical limitations that endangers or could endanger the safe operation of the aircraft must be reported to the nationalcompetent authority. (ii) The products and part and appliances design rules prescribe that occurrences defined as a failure, malfunction, defect or other occurrence which has resulted in or may result in an unsafe condition must be reported to the Agency. (iii) According to the product and part and appliances production rules occurrences defined as a deviation which could lead to an unsafe conditiondeviations from applicable design data that may lead to a potential unsafe condition, as identified with the type certificate (TC) holder or design approval holder (DAH), must be reported to the Agency and the nationalcompetent authority. (iv) The continuing-airworthinessmaintenance rules stipulate that occurrences defined as any condition of the aircraft or aircraft component that has resulted or may result in an unsafe condition that seriously hazards flight safetycould seriously hazard the aircraft must be reported to the nationalcompetent authority. (b) Paragraph 10.g. of this AMC provides guidance as to what should be reported by an organisation to the authority. The list of criteria provided may be used as guidance for establishing which occurrences shall be reported by which organisation. For example, the organisation responsible for the design will not need to report certain operational occurrences that it has been made aware of, if the continuing airworthiness of the product is not involved.In addition, the rules on operational suitability data (OSD) prescribe that any incident, malfunction, technical defect, exceedance of technical limitations, occurrence that may highlight inaccurate, incomplete or ambiguous information, contained in data established in accordance with Regulation (EU) No 748/2012, or other irregular circumstance that has or may have endangered the safe operation of the aircraft and has not resulted in an accident or serious incident be reported to the competent authority and to the organisation responsible for the design of the aircraft. (vc) Reporting does not remove the reporter’s or organisation’s responsibility to commenceinitiate corrective actions to prevent similar occurrences in the future. Known and planned preventive actions should be included within the occurrence report. (d) Reports relating to ‘security incidents’ should also be notified to the appropriate local security agency. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 74 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (e) Specific operational approvals, e.g. reduced vertical separation minima (RVSM), extended range operations with two-engined aeroplanes (ETOPS), area navigation (RNAV), or a design or maintenance programme, may include additional reporting requirements for failures or malfunctions associated with that approval or programme. 5. NOTIFICATION OF ACCIDENTS AND SERIOUS INCIDENTS In addition to the requirement to notify the appropriate accidentsafety investigating authorities directly of any accident or serious incident, operators should also report to the nationalcompetent authority in charge of overseeingsupervising the reporting organisation. 6. REPORTING TIME — MANDATORY REPORTING (a) The period of 72 hours is normally understood to start from when the person or organisation became aware of the occurrence took place or from the time when the reporterperson or organisation determined that there was, or could have been, a potentially hazardous or unsafe condition. (b) For many occurrences there is no evaluation needed; it must be reported. However, there will be occasions when, as part of a Flight Safety and Accident Prevention programme or Quality Programme, a previously non-reportable occurrence is determined to be reportable. (cb) Within the overall limit of 72 hours for the submission of a report, the degree of urgency should be determined by the level of riskhazard judged to have resulted from the occurrence: (i) Where an occurrence is judged to have resulted in an immediate and particularly significant riskhazard, the Agency and/or competentnational authority expects to be advised immediately, and by the fastest possible means (e.g. telephone, fax, telex, e- mail) of whatever details are available at that time. This initial notification should then be followed up by a report within 72 hours. (ii) Where the occurrence is judged to have resulted in a less immediate a nd less significant riskhazard, report submission may be delayed up to the maximum of 72 hours in order to provide more details or more reliable information. 7. CONTENT OF REPORTSOCCURRENCE-REPORTING SYSTEM COMPLIANT WITH REGULATION (EU) No 376/2014 (a) The below provides an overview of the main elements of the occurrence-reporting system to comply with Regulation (EU) No 376/2014. It also provides references to the relevant articles of Regulation (EU) No 376/2014. (b) Organisations are required to implement a system that caters both for mandatory and voluntary reporting (cf. Articles 4 and 5). Occurrences qualifying for mandatory reporting are those defined in Regulation (EU) 2015/1018. (c) Organisations are required to designate one or more persons to handle independently the collection, evaluation, processing, analysis and storage of details of occurrences with regard to data collection and hazard identification (cf. Article 6(1)). Nevertheless, small organisations may, in agreement with their competent authority, make use of simplified mechanisms to ensure the TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 75 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments collection, evaluation, processing, analysis and storage of details of occurrences, possibly by sharing those tasks with other similar organisations. (d) An existing internal safety-reporting scheme, established to collect safety-relevant data, proposals and information, including on potential safety issues that have not resulted in any occurrence, may serve as a basis for the mandatory and voluntary occurrence-reporting system. (e) Organisations are required to store occurrence reports qualifying for mandatory and voluntary reporting in one or more databases, as defined in Article 4(5), and establish data quality checking processes, as defined in Article 7(3), to ensure that the information initially collected and the data stored in the database(s) are consistent. (f) Organisations are required to: (i) identify the safety hazards associated with identified occurrences or groups of occurrences (cf. Article 13(1)); (ii) analyse the related risks in terms of likelihood and severity of the outcome, as well as assess risks in terms of tolerability; (iii) based on the result of the risk assessment, determine the need for mitigation action, as required for improving aviation safety (cf. Article 13(2)); and (iv) monitor the timely implementation and effectiveness of any mitigation action required (cf. Article 13(2)). (g) In addition to the actions required under paragraph (c) above, organisations are required to ensure that the following information is transmitted to the competent authority within 30 days from the date of notification of the occurrence (both mandatory and voluntary reports) to the authority (cf. Article 13(4)): (i) the preliminary results of the risk analysis performed; and (ii) any mitigation action to be taken. Furthermore, organisations are required to ensure that the final results of the risk analysis, where required, are transmitted to the competent authority as soon as they are available and, in principle, no later than 3 months from the date of notification of the occurrence to the authority (cf. Article 13(4)). (h) As part of their safety policy, organisations, after consulting staff representatives, are required to adopt rules describing how ‘just culture’ principles are guaranteed and implemented within the organisation. The purpose of those rules is to ensure that employees and contracted personnel that report or are mentioned in occurrence reports collected as part of the occurrence-reporting system are not subject to any prejudice by their employer or any other organisation for which the services are provided on the basis of the information supplied by the reporter (cf. Article 16). (i) Organisations are required to ensure that employees and contracted personnel are regularly provided with information concerning the analysis of, and follow-up on, occurrences for which mitigation action is taken (cf. Article 13(3)). In doing so, they ensure that only disidentified information is disseminated. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 76 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (j) Organisations are required to ensure that reports addressed to the competent authority contain at least the information listed in Annex I to Regulation (EU) No 376/2014. (a) Notwithstanding other required reporting means as promulgated in national requirements (e.g. AIRPROX reporting), may be transmitted in any form considered acceptable to the Agency and/or national authority. The amount of information in the report should be commensurate with the severity of the occurrence. Each report should at least contain the following elements, as applicable to each organisation: (i) Organisation name (ii) Approval reference (if relevant) (iii) Information necessary to identify the aircraft or part affected. (iv) Date and time if relevant (v) A written summary of the occurrence (vi) Any other specific information required (b) For any occurrence involving a system or component, which is monitored or protected by a warning and/or protection system (for example: fire detection/extinguishing) the occurrence report should always state whether such system(s) functioned properly. 8. NOTIFICATION TO OTHER AGENCIES For approved operations organisations, in addition to reporting occurrences to the national authority, the following agencies should also be notified in specific cases: (a) Reports relating to ‘security incidents’ should also be notified to the appropriate local security agency (b) Reports relating to air traffic, aerodrome occurrences or bird strikes should also be notified to the appropriate air navigation , aerodrome or ground agency (c) Requirements for reporting and assessment of safety occurrences in ATM within the ECAC Region are harmonised within EUROCONTROL document ESARR 2. 89. REPORTING BETWEEN ORGANISATIONS (a) In addition to reporting occurrences to the competent authority or the Agency, depending on the type of the organisation, its interfaces with other organisations and their respective safety policies and procedures, additional reporting requirements may exist for reporting between organisations. (b) Organisations may develop a customised list of occurrences to be reported between organisations, adapted to their particular aircraft, operation or product and the organisations they interface with. Such customised list of occurrences to be reported between organisations is usually included or referenced in the organisation’s expositions/handbooks/manuals. Any such lists should however not be considered to be definitive or exhaustive, and the reporter’s judgement of the degree of risk or potential hazard involved is essential. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 77 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (a)(c) Requirements exist that address theThe following provides a non-exhaustive list of reporting lines that exist for reporting of occurrences between organisationsdata relating to unsafe or unairworthy conditions. These reporting lines are: (i) Production Oorganisation to the organisation responsible for the design; (ii) Maintenance organisation/continuing-airworthiness management organisation (CAMO) to the organisation responsible for the design; (iii) Maintenance organisation/CAMO to the operator; (iv) Operator to the organisation responsible for the design; (v) Production organisation to another production organisation; (b)(d) The ‘Oorganisation responsible for the design’ is a general term, which can be any one or a combination of the following organisations: (i) Hholder of Ttype Ccertificate (TC) of an Aaircraft, Eengine or Ppropeller; (ii) Hholder of a Ssupplemental Ttype Ccertificate (STC) on an Aaircraft, Eengine or Ppropeller; (iii) Hholder of a European Ttechnical Sstandard Oorder (ETSO) Aauthorisation.; or (iv) Holder of a European Part Approval (EPA) (c)(e) If it can be determined that the occurrence has an impact on or is related to an aircraft component which is covered by a separate design approval/authorisation (TC, STC, or ETSO or EPA), then the holders of such approval/authorisation should be informed. If an occurrence concernshappens on a component which is covered by an TC, STC, or ETSO or EPA (e.g. during maintenance), then only that TC, STC, or ETSO Aauthorisation or EPA holder needs to be informed. (f) In the interest of safety, any organisation reporting to the organisation responsible for the design is expected to actively support any investigations that may be initiated by that organisation. Support should be provided by a timely response to information requests and by making available affected components, parts or appliances for the purpose of the investigation, subject to an agreement with the respective component, part or appliance owners. Organisations responsible for the design are expected to provide feedback to the reporting organisations on the results of their investigations. (d)(g) The form and timescale forof reports to be exchanged between organisations is left for individual organisations to determine with due regard to the safety policies and procedures in place. WhatIt is important is that: (1) a relationship existsan interface is established between the organisations to ensure that there is an effective and timely exchange of information relating to occurrences; and. (2) any relevant safety issue is identified, and it is clearly established which party is responsible for taking further action, if required. (h) Organisations should establish procedures to be used for reporting between organisations, which should include as a minimum: (1) a description of the applicable requirements for reporting; TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 78 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (2) a description of the reporting mechanism, including reporting forms, means, and deadlines; and (3) responsibilities of the organisations and personnel responsible for reporting, including for reporting to the competent authority. Such procedures should be included in the organisation’s expositions/handbooks/manuals. (e) Paragraph 10.g. of this AMC provides guidance as to what should be reported by an organisation to the authority. The list of criteria provided may be used as guidance for establishing which occurrences shall be reported to which organisation. For example, certain operational occurrences will not need to be reported by an operator to the design or production organisation. 10. REPORTABLE OCCURRENCES (a) General. There are different reporting requirements for operators (and/or pilots in command commanders), maintenance organisations, design organisations and production organisations. Moreover, as explained in paragraph 4. and 8. 9. above, there are not only requirements for reporting to the Agency and national authority, but also for reporting to other (private) entities. The criteria for all these different reporting lines are not the same. For example the authority will not receive the same kind of reports from a design organisation than as from an operator. This is a reflection of the different perspectives of the organisations based on their activities. Figure 1 presents a simplified scheme of reporting lines. Figure 1 TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 79 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments Figure 1 9. REPORTABLE OCCURRENCES — MANDATORY REPORTING Regulation (EU) 2015/1018 provides the list of occurrences that are subject to mandatory reporting. (b) Operations and Maintenance. The list of examples of reportable occurrences offered below under g. is established from the perspective of primary sources of occurrence information in the operational area (operators and maintenance organisations) to provide guidance for those persons developing criteria for individual organisations on what they need to report to the Agency and/or national authority. The list is neither definitive nor exhaustive and judgement by the reporter of the degree of hazard or potential hazard involved is essential. (c) Design. The list of examples will not be used by design organisations directly for the purpose of determining when a report has to be made to the authority, but it can serve as guidance for the establishment of the system for collecting data. After receipt of reports from the primary sources of information, designers will normally perform some kind of analysis to determine whether an occurrence has resulted or may result in an unsafe condition and a report to the authority should be made. An analysis method for determining when an unsafe condition exists in relation to continuing airworthiness is detailed in the AMCs regarding the issuance of Airworthiness Directives. (d) Production. The list of examples is not applicable to the reporting obligation of production organisations . Their primary concern is to inform the design organisation of deviations. Only in cases where an analysis in conjunction with that design organisation shows that the deviation could lead to an unsafe condition, should a report be made to the Agency and/or national authority (see also c. above). TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 80 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (e) Customised list. Each approval, certificate, authorisation other than those mentioned in sub paragraph c and d above, should develop a customised list adapted to its aircraft, operation or product. The list of reportable occurrences applicable to an organisation is usually published within the organisation’s expositions/handbooks/manuals (f) Internal reporting. The perception of safety is central to occurrence reporting. It is for each organisation to determine what is safe and what is unsafe and to develop its reporting system on that basis. The organisation should establish an internal reporting system whereby reports are centrally collected and reviewed to establish which reports meet the criteria for occurrence reporting to the Agency and/or national authority and other organisations, as required. (g) List of examples of reportable occurrences The following is a generic list. Not all examples are applicable to each reporting organisation. Therefore each organisation should define and agree with the Agency and/or national authority a specific list of reportable occurrences or a list of more generic criteria, tailor ed to its activity and scope of work (see also 10.e above). In establishing that customised list, the organisation should take into account the following considerations: Reportable occurrences are those where the safety of operation was or could have been endangered or which could have led to an unsafe condition. If in the view of the reporter an occurrence did not hazard the safety of the operation but if repeated in different but likely circumstances would create a hazard, then a report should be made. What is judged to be reportable on one class of product, part or appliance may not be so on another and the absence or presence of a single factor, human or technical, can transform an occurrence into a serious incident or accident. Specific operational approvals, e.g. RVSM, ETOPS, RNAV, or a design or maintenance programme, may have specific reporting requirements for failures or malfunctions associated with that approval or programme. A lot of the qualifying adjectives like ‘significant’ have been deleted from the list. Instead it is expected that all examples are qualified by the reporter using the general criteria that are applicable in his field, and specified in the requirement. (e.g. for operators: ‘hazards or could have hazarded the operation’) CONTENTS: I. AIRCRAFT FLIGHT OPERATIONS II. AIRCRAFT TECHNICAL III. AIRCRAFT MAINTENANCE AND REPAIR IV AIR NAVIGATION SERVICES, FACILITIES AND GROUND SERVICES TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 81 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments I. AIRCRAFT FLIGHT OPERATIONS A. Operation of the Aircraft (1) (a) Risk of collision with an aircraft, terrain or other object or an unsafe situation when avoidance action would have been appropriate. (b) An avoidance manoeuvre required to avoid a collision with an aircraft, terrain or other object. (c) An avoidance manoeuvre to avoid other unsafe situations. (2) Take-off or landing incidents, including precautionary or forced landings. Incidents such as under-shooting, overrunning or running off the side of runways. Take-offs, rejected take-offs, landings or attempted landings on a closed, occupied or incorrect runway. Runway incursions. (3) Inability to achieve predicted performance during take-off or initial climb. (4) Critically low fuel quantity or inability to transfer fuel or use total quantity of usable fuel. (5) Loss of control (including partial or temporary loss of control) from any cause. (6) Occurrences close to or above V 1 resulting from or producing a hazardous or potentially hazardous situation (e.g. rejected take-off, tail strike, engine power loss etc.). (7) Go-around producing a hazardous or potentially hazardous situation. (8) Unintentional significant deviation from airspeed, intended track or altitude. (more than 91 m (300 ft)) from any cause. (9) Descent below decision height/altitude or minimum descent height/altitude without the required visual reference. (10) Loss of position awareness relative to actual position or to other aircraft. (11) Breakdown in communication between flight crew (CRM) or between Flight crew and other parties (cabin crew, ATC, engineering). (12) Heavy landing - a landing deemed to require a 'heavy landing check'. (13) Exceedance of fuel imbalance limits. (14) Incorrect setting of an SSR code or of an altimeter subscale. (15) Incorrect programming of, or erroneous entries into, equipment used for navigation or performance calculations, or use of incorrect data. (16) Incorrect receipt or interpretation of radiotelephony messages. (17) Fuel system malfunctions or defects, which had an effect on fuel supply and/or distribution. (18) Aircraft unintentionally departing a paved surface. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 82 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (19) Collision between an aircraft and any other aircraft, vehicle or other ground object. (20) Inadvertent and/or incorrect operation of any controls. (21) Inability to achieve the intended aircraft configuration for any flight phase (e.g. landing gear and doors, flaps, stabilisers, slats etc). (22) A hazard or potential hazard which arises as a consequence of any deliberate simulation of failure conditions for training, system checks or training purposes. (23) Abnormal vibration. (24) Operation of any primary warning system associated with manoeuvring of the aircraft e.g. configuration warning, stall warning (stick shake), over speed warning etc. unless: (a) the crew conclusively established that the indication was false. Provided that the false warning did not result in difficulty or hazard arising from the crew response to the warning; or (b) operated for training or test purposes. (25) GPWS/TAWS ‘warning’ when: (a) the aircraft comes into closer proximity to the ground than had been planned or anticipated; or (b) the warning is experienced in IMC or at night and is established as having been triggered by a high rate of descent (Mode 1); or (c) the warning results from failure to select landing gear or land flap by the appropriate point on the approach (Mode 4); or (d) any difficulty or hazard arises or might have arisen as a result of crew response to the ‘warning’ e.g. possible reduced separation from other traffic. This could include warning of any Mode or Type i.e. genuine, nuisance or false. (26) GPWS/TAWS ‘alert’ when any difficulty or hazard arises or might have arisen as a result of crew response to the ‘alert’. (27) ACAS RAs. (28) Jet or prop blast incidents resulting in significant damage or serious injury. B. Emergencies (1) Fire, explosion , smoke or toxic or noxious fumes, even though fires were extinguished. (2) The use of any non-standard procedure by the flight or cabin crew to deal with an emergency when: (a) the procedure exists but is not used; or TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 83 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (b) a procedure does not exist; or (c) the procedure exists but is incomplete or inappropriate; or (d) the procedure is incorrect; or (e) the incorrect procedure is used. (3) Inadequacy of any procedures designed to be used in an emergency, including when being used for maintenance, training or test purposes. (4) An event leading to an emergency evacuation. (5) Depressurisation. (6) The use of any emergency equipment or prescribed emergency procedures in order to deal with a situation. (7) An event leading to the declaration of an emergency (‘Mayday’ or ‘Pan’). (8) Failure of any emergency system or equipment, including all exit doors and lighting, to perform satisfactorily, including when being used for maintenance, training or test purposes. (9) Events requiring any emergency use of oxygen by any crew member. C. Crew Incapacitation (1) Incapacitation of any member of the flight crew, including that which occurs prior to departure if it is considered that it could have resulted in incapacitation after take-off. (2) Incapacitation of any member of the cabin crew which renders them unable to perform essential emergency duties. D. Injury (1) Occurrences, which have or could have led to significant injury to passengers or crew but which are not considered reportable as an accident. E. Meteorology (1) A lightning strike which resulted in damage to the aircraft or loss or malfunction of any essential service. (2) A hail strike which resulted in damage to the aircraft or loss or malfunction of any essential service. (3) Severe turbulence encounter – an encounter resulting in injury to occupants or deemed to require a ‘turbulence check’ of the aircraft. (4) A windshear encounter. (5) Icing encounter resulting in handling difficulties, damage to the aircraft or loss or malfunction of any essential service. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 84 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments F. Security (1) Unlawful interference with the aircraft including a bomb threat or hijack. (2) Difficulty in controlling intoxicated, violent or unruly passengers. (3) Discovery of a stowaway. G. Other Occurrences (1) Repetitive instances of a specific type of occurrence which in isolation would not be considered 'reportable' but which due to the frequency at which they arise, form a potential hazard. (2) A bird strike which resulted in damage to the aircraft or loss or malfunction of any essential service. (3) Wake turbulence encounters. (4) Any other occurrence of any type considered to have endangered or which might have endangered the aircraft or its occupants on board the aircraft or on the ground. II. AIRCRAFT TECHNICAL A. Structural Not all structural failures need to be reported. Engineering judgement is required to decide whether a failure is serious enough to be reported. The following examples can be taken into consideration: (1) Damage to a Principal Structural Element that has not been qualified as damage tolerant (life limited element). Principal Structural Elements are those which contribute significantly to carrying flight, ground, and pressurisation loads, and whose failure could result in a catastrophic failure of the aircraft. Typical examples of such elements are listed for large aeroplanes in AC/AMC 25.571(a) "damage tolerance and fatigue evaluation of structure", and in the equivalent AMC material for rotorcraft. (2) Defect or damage exceeding admissible damages to a Principal Structural Element that has been qualified as damage tolerant. (3) Damage to or defect exceeding allowed tolerances of a structural element which failure could reduce the structural stiffness to such an extent that the required flutter, divergence or control reversal margins are no longer achieved. (4) Damage to or defect of a structural element, which could result in the liberation of items of mass that may injure occupants of the aircraft. (5) Damage to or defect of a structural element, which could jeopardise proper operation of systems. See paragraph II.B. below. (6) Loss of any part of the aircraft structure in flight. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 85 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments B. Systems The following generic criteria applicable to all systems are proposed: (1) Loss, significant malfunction or defect of any system, subsystem or set of equipment when standard operating procedures, drills etc. could not be satisfactorily accomplished. (2) Inability of the crew to control the system, e.g.: (a) uncommanded actions; (b) incorrect and or incomplete response, including limitation of movement or stiffness; (c) runaway; (d) mechanical disconnection or failure. (3) Failure or malfunction of the exclusive function(s) of the system (one system could integrate several functions). (4) Interference within or between systems. (5) Failure or malfunction of the protection device or emergency system associated with the system. (6) Loss of redundancy of the system. (7) Any occurrence resulting from unforeseen behaviour of a system. (8) For aircraft types with single main systems, subsystems or sets of equipment: Loss, significant malfunction or defect in any main system, subsystem or set of equipment. (9) For aircraft types with multiple independent main systems, subsystems or sets of equipment: The loss, significant malfunction or defect of more than one main system, subsystem or set of equipment (10) Operation of any primary warning system associated with aircraft systems or equipment unless the crew conclusively established that the indication was false provided that the false warning did not result in difficulty or hazard arising from the crew response to the warning. (11) Leakage of hydraulic fluids, fuel, oil or other fluids which resulted in a fire hazard or possible hazardous contamination of aircraft structure, systems or equipment, or risk to occupants. (12) Malfunction or defect of any indication system when this results in the possibility of misleading indications to the crew. (13) Any failure, malfunction or defect if it occurs at a critical phase of flight and relevant to the operation of that system. (14) Occurrences of significant shortfall of the actual performances compared to the approved performance which resulted in a hazardous situation (taking into TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 86 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments account the accuracy of the performance calculation method) including braking action, fuel consumption etc. (15) Asymmetry of flight controls; e.g. flaps, slats, spoilers etc. Annex 1 to this AMC gives a list of examples of reportable occurrences resulting from the application of these generic criteria to specific systems C. Propulsion (including Engines, Propellers and Rotor Systems) and APUs (1) Flameout, shutdown or malfunction of any engine. (2) Overspeed or inability to control the speed of any high speed rotating component (for example: Auxiliary power unit, air starter, air cycle machine, air turbine motor, propeller or rotor). (3) Failure or malfunction of any part of an engine or powerplant resulting in any one or more of the following: (a) non containment of components/debris; (b) uncontrolled internal or external fire, or hot gas breakout; (c) thrust in a different direction from that demanded by the pilot; (d) thrust reversing system failing to operate or operating inadvertently; (e) inability to control power, thrust or rpm; (f) failure of the engine mount structure; (g) partial or complete loss of a major part of the powerplant; (h) Dense visible fumes or concentrations of toxic products sufficient to incapacitate crew or passengers; (i) inability, by use of normal procedures, to shutdown an engine; (j) inability to restart a serviceable engine. (4) An uncommanded thrust/power loss , change or oscillation which is classified as a loss of thrust or power control (LOTC) as defined in AMC 20-1: (a) for a single engine aircraft; or (b) where it is considered excessive for the application, or (c) where this could affect more than one engine in a multi-engine aircraft, particularly in the case of a twin engine aircraft; or (d) for a multi engine aircraft where the same, or similar, engine type is used in an application where the event would be considered hazardous or critical. (5) Any defect in a life controlled part causing retirement before completion o f its full life. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 87 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (6) Defects of common origin which could cause an in flight shut down rate so high that there is the possibility of more than one engine being shut down on the same flight. (7) An engine limiter or control device failing to operate when required or operating inadvertently. (8) exceedance of engine parameters. (9) FOD resulting in damage. Propellers and -transmission (10) Failure or malfunction of any part of a propeller or powerplant resulting in any one or more of the following: (a) an overspeed of the propeller; (b) the development of excessive drag; (c) a thrust in the opposite direction to that commanded by the pilot; (d) a release of the propeller or any major portion of the propeller; (e) a failure that results in excessive unbalance; (f) the unintended movement of the propeller blades below the established minimum in-flight low-pitch position; (g) an inability to feather the propeller; (h) an inability to command a change in propeller pitch; (i) an uncommanded change in pitch; (j) an uncontrollable torque or speed fluctuation; (k) The release of low energy parts. Rotors and -transmission (11) Damage or defect of main rotor gearbox / attachment which could lead to in flight separation of the rotor assembly, and /or malfunctions of the rotor control. (12) Damage to tail rotor, transmission and equivalent systems. APUs (13) Shut down or failure when the APU is required to be available by operational requirements, e.g. ETOPS, MEL. (14) Inability to shut down the APU. (15) Overspeed. (16) Inability to start the APU when needed for operational reasons. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 88 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments D. Human Factors (1) Any incident where any feature or inadequacy of the aircraft design could have led to an error of use that could contribute to a hazardous or catastrophic effect. E. Other Occurrences (1) Any incident where any feature or inadequacy of the aircraft design could have led to an error of use that could contribute to a hazardous or catastrophic effect. (2) An occurrence not normally considered as reportable (for example, furnishing and cabin equipment, water systems), where the circumstances resulted in endangering of the aircraft or its occupants. (3) A fire, explosion, smoke or toxic or noxious fumes. (4) Any other event which could hazard the aircraft, or affect the safety of the occupants of the aircraft, or people or property in the vicinity of the aircraft or on the ground. (5) Failure or defect of passenger address system resulting in loss or inaudible passenger address system. (6) Loss of pilots seat control during flight. III. AIRCRAFT MAINTENANCE AND REPAIR A. Incorrect assembly of parts or components of the aircraft found during an inspection or test procedure not intended for that specific purpose. B. Hot bleed air leak resulting in structural damage. C. Any defect in a life controlled part causing retirement before completion of its full life. D. Any damage or deterioration (i.e. fractures, cracks, corrosion, delamination, disbonding etc) resulting from any cause (such as flutter, loss of stiffness or structu ral failure) to: (1) primary structure or a principal structural element (as defined in the manufacturers’ Repair Manual) where such damage or deterioration exceeds allowable limits specified in the Repair Manual and requires a repair or complete or partial replacement of the element; (2) secondary structure which consequently has or may have endangered the aircraft; (3) the engine, propeller or rotorcraft rotor system. E. Any failure, malfunction or defect of any system or equipment, or damage or deterioration found as a result of compliance with an Airworthiness Directive or other mandatory instruction issued by a Regulatory Authority, when: TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 89 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (1) it is detected for the first time by the reporting organisation implementing compliance; (2) on any subsequent compliance where it exceeds the permissible limits quoted in the instruction and/or published repair/rectification procedures are not available. F. Failure of any emergency system or equipment, including all exit doors and lighting, to perform satisfactorily, including when being used for maintenance or test purposes. G. Non compliance or significant errors in compliance with required maintenance procedures. H. Products, parts, appliances and materials of unknown or suspect origin. I. Misleading, incorrect or insufficient maintenance data or procedures that could lead to maintenance errors. J. Failure, malfunction or defect of ground equipment used for test or checking of aircraft systems and equipment when the required routine inspection and test procedures did not clearly identify the problem when this results in a hazardous situation. IV. AIR NAVIGATION SERVICES, FACILITIES AND GROUND SERVICES A. Air Navigation Services (1) Provision of significantly incorrect, inadequate or misleading information from any ground sources, e.g. Air Traffic Control (ATC), Automatic Terminal Information Service (ATIS), Meteorological Services, navigation databases, maps, charts, manuals, etc. (2) Provision of less than prescribed terrain clearance. (3) Provision of incorrect pressure reference data (i.e. altimeter setting). (4) Incorrect transmission, receipt or interpretation of significant messages when this results in a hazardous situation. (5) Separation minima infringement. (6) Unauthorised penetration of airspace. (7) Unlawful radio communication transmission. (8) Failure of ANS ground or satellite facilities. (9) Major ATC/ Air Traffic Management (ATM) failure or significant deterioration of aerodrome infrastructure. (10) Aerodrome movement areas obstructed by aircraft, vehicles, animals or foreign objects, resulting in a hazardous or potentially hazardous situation. (11) Errors or inadequacies in marking of obstructions or hazards on aerodrome movement areas resulting in a hazardous situation. TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 90 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (12) Failure, significant malfunction or unavailability of airfield lighting. B. Aerodrome and Aerodrome Facilities (1) Significant spillage during fuelling operations. (2) Loading of incorrect fuel quantities likely to have a significant effect on aircraft endurance, performance, balance or structural strength. (3) unsatisfactory ground de-icing / anti-icing C. Passenger Handling, Baggage and Cargo (1) Significant contamination of aircraft structure, or systems and equipment arising from the carriage of baggage or cargo. (2) Incorrect loading of passengers, baggage or cargo, likely to have a significant effect on aircraft mass and/or balance. (3) Incorrect stowage of baggage or cargo (including hand baggage) likely in any way to hazard the aircraft, its equipment or occupants or to impede emergency evacuation. (4) Inadequate stowage of cargo containers or other substantial items of cargo. (5) Dangerous goods incidents reporting: see operating rules. D. Aircraft Ground Handling and Servicing (1) Failure, malfunction or defect of ground equipment used for test or checking of aircraft systems and equipment when the required routine inspection and test procedures did not clearly identify the problem when this results in a hazardous situation. (2) Non compliance or significant errors in compliance with required servicing procedures. (3) Loading of contaminated or incorrect type of fuel or other essential fluids (including oxygen and potable water). Reportable occurrences to specific systems The following subparagraphs give examples of reportable occurrences resulting from the application of the generic criteria to specific systems listed in paragraph 10.g. II.B of this AMC. 1. Air conditioning/ventilation (a) complete loss of avionics cooling (b) depressurisation 2. Autoflight system (a) failure of the autoflight system to achieve the intended operation while engaged TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 91 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (b) significant reported crew difficulty to control the aircraft linked to autoflight system functioning (c) failure of any autoflight system disconnect device (d) Uncommanded autoflight mode change 3. Communications (a) failure or defect of passenger address system resulting in loss or inaudible passenger address (b) total loss of communication in flight 4. Electrical system (a) loss of one electrical system distribution system ( AC or DC) (b) total loss or loss or more than one electrical generation system (c) failure of the back up ( emergency ) electrical generating system 5. Cockpit/Cabin/Cargo (a) pilot seat control loss during flight (b) failure of any emergency system or equipment, including emergency evacuation signalling system , all exit doors , emergency lighting, etc (c) loss of retention capability of the cargo loading system 6. Fire protection system (a) fire warnings, except those immediately confirmed as false (b) undetected failure or defect of fire/smoke detection/protection system, which could lead to loss or reduced fire detection/protection (c) absence of warning in case of actual fire or smoke 7. Flight controls (a) Asymmetry of flaps, slats, spoilers etc. (b) limitation of movement, stiffness or poor or delayed response in the operation of primary flight control systems or their associated tab and lock systems (c) flight control surface run away (d) flight control surface vibration felt by the crew (e) mechanical flight control disconnection or failure (f) significant interference with normal control of the aircraft or degradation of flying qualities 8. Fuel system (a) fuel quantity indicating system malfunction resulting in total loss or erroneous indicated fuel quantity on board TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 92 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments (b) leakage of fuel which resulted in major loss, fire hazard , significant contamination (c) malfunction or defects of the fuel jettisoning system which resulted in inadvertent loss of significant quantity, fire hazard, hazardous contamination of aircraft equipment or inability to jettison fuel (d) fuel system malfunctions or defects which had a significant effect on fuel supply and/or distribution (e) inability to transfer or use total quantity of usable fuel 9. Hydraulics (a) loss of one hydraulic system (ETOPS only) (b) failure of the isolation system to operate (c) loss of more than one hydraulic circuits (d) failure of the back up hydraulic system (e) inadvertent Ram Air Turbine extension 10. Ice detection/protection system (a) undetected loss or reduced performance of the anti-ice/de-ice system (b) loss of more than one of the probe heating systems (c) inability to obtain symmetrical wing de icing (d) abnormal ice accumulation leading to significant effects on performance or handling qualities (e) crew vision significantly affected 11. Indicating/warning/recording systems (a) malfunction or defect of any indicating system when the possibility of significant misleading indications to the crew could result in an inappropriate crew action on an essential system (b) loss of a red warning function on a system (c) for glass cockpits: loss or malfunction of more than one display unit or computer involved in the display/warning function 12. Landing gear system /brakes/tyres (a) brake fire (b) significant loss of braking action (c) unsymmetrical braking leading to significant path deviation (d) failure of the L/G free fall extension system ( including during scheduled tests) (e) unwanted gear or gear doors extension/retraction (f) multiple tyres burst TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 93 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments 13. Navigation systems (including precision approaches system) and air data systems (a) total loss or multiple navigation equipment failures (b) total failure or multiple air data system equipment failures (c) significant misleading indication (d) significant navigation errors attributed to incorrect data or a database coding error (e) unexpected deviations in lateral or vertical path not caused by pilot input. (f) problems with ground navigational facilities leading to significant navigation errors not associated with transitions from inertial navigation mode to radio navigation mode. 14. Oxygen (a) for pressurised aircraft: loss of oxygen supply in the cockpit (b) loss of oxygen supply to a significant number of passengers ( more than 10%), including when found during maintenance or training or test purposes 15. Bleed air system (a) hot bleed air leak resulting in fire warning or structural damage (b) loss of all bleed air systems (c) failure of bleed air leak detection system TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 94 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 3. Proposed amendments INTENTIONALLY LEFT BLANK TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 95 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 4. IA 4. IA N/a (please refer to Section 2.3 ‘Summary of the IA’ above). TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 96 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 5. References 5. References 5.1. Affected regulations — Commission Regulation (EU) No 748/2012 of 3 August 2012 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 (OJ L 224, 21.8.2012, p. 1) — Commission Regulation (EU) No 1321/2014 of 26 November 2014 on the continuing airworthiness of aircraft and aeronautical products, parts and appliances, and on the approval of organisations and personnel involved in these tasks (OJ L 362, 17.12.2014, p. 1) — Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down technical requirements and administrative procedures related to civil aviation aircrew pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 311, 25.11.2011, p. 1) — Commission Regulation (EU) No 965/2012 of 5 October 2012 laying down technical requirements and administrative procedures related to air operations pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 296, 25.10.2012, p. 1) — Commission Regulation (EU) No 139/2014 of 12 February 2014 laying down requirements and administrative procedures related to aerodromes pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 44, 14.2.2014, p. 1) — Commission Implementing Regulation (EU) 2016/1377 of 4 August 2016 laying down common requirements for service providers and the oversight in air traffic management/air navigation services and other air traffic management network functions, repealing Regulation (EC) No 482/2008, Implementing Regulations (EU) No 1034/2011 and (EU) No 1035/2011 and amending Regulation (EU) No 677/2011 (OJ L 226, 19.8.2016, p. 1)) — Commission Regulation (EU) 2015/340 of 20 February 2015 laying down technical requirements and administrative procedures relating to air traffic controllers’ licenses and certificates pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council, amending Commission Implementing Regulation (EU) No 923/2012 and repealing Commission Regulation (EU) No 805/2011 (OJ L 63, 6.3.2015, p. 1) 5.2. Affected CSs, AMC and GM — Decision N° 2012/020/R of the Executive Director of the Agency of 30th October 2012 on acceptable means of compliance and guidance material 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 (‘AMC and GM to Part 21’) repealing Decision No 2003/01/RM of the Executive Director of the Agency of 17 October 2003 — Executive Director Decision 2015/029/R of 17 December 2015 issuing acceptable means of compliance and guidance material to Part-M, Part-145, Part-66, and Part-147 of Regulation (EU) No 1321/2014 and repealing Decision 2003/19/RM of the Executive Director of the Agency of 28 November 2003 ‘AMC and GM to the Annexes to Regulation (EU) No 1321/2014 — Issue 2’ TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 97 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 5. References — Decision N° 2012/006/Directorate R of the Executive Director of the Agency of 19th April 2012 on Acceptable Means of Compliance and Guidance Material to Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down technical requirements and administrative procedures related to civil aviation aircrew pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council ‘Acceptable Means of Compliance and Guidance Material to Part-ARA’ — Decision 2014/025/R of the Executive Director of the Agency of 28 July 2014 adopting Acceptable Means of Compliance and Guidance Material to Part-ARO of Regulation (EU) No 965/2012 and repealing Decision 2014/014/R of the Executive Director of the Agency of 24 April 2014 ‘AMC and GM to Part-ARO — Issue 3’ — Decision 2014/017/R of the Executive Director of the Agency of 24 April 2014 adopting Acceptable Means of Compliance and Guidance Material to Part-ORO of Regulation (EU) No 965/2012 and repealing Decision 2012/017/R of the Executive Director of the Agency of 24 October 2012 ‘AMC and GM to Part-ORO — Issue 2’ — Decision 2014/012/R of the Executive Director of the Agency of 27 February 2014 adopting Acceptable Means of Compliance and Guidance Material to Regulation (EU) No 139/2014, ‘AMC/GM for Aerodromes — Initial Issue’ — Executive Director Decision 2015/010/R of the Executive Director of the Agency of 13 March 2015 adopting Acceptable Means of Compliance and Guidance Material to Commission Regulation (EU) 2015/340 — Decision No. 2003/12/RM of the Executive Director of the Agency of 5 November 2003 on general acceptable means of compliance for airworthiness of products, parts and appliances (‘AMC-20’) 5.3. Reference documents — Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis and follow-up of occurrences in civil aviation, amending Regulation (EU) No 996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and Commission Regulations (EC) No 1321/2007 and (EC) No 1330/2007 (OJ L 122, 24.4.2014, p. 18) — Commission Implementing Regulation (EU) 2015/1018 of 29 June 2015 laying down a list classifying occurrences in civil aviation to be mandatorily reported according to Regulation (EU) No 376/2014 of the European Parliament and of the Council (OJ L 163, 30.6.2015, p. 1) — ICAO Annex 19 ‘Safety Management’, Chapter 5 ‘Safety data collection, analysis and exchange’, Edition 2, July 2016 TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 98 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 6. Appendices 6. Appendices 6.1. Appendix 1 — Overview of changes and correspondence between IRs and AMC/GM across the different domains Subject Part-21 Part-M Part-145 Aircrew Air OPS ADR ATM/ANS ATCOs ORGANISATION REQUIREMENTS Occurrence 21.A.3A M.A.202 145.A.60 ORA.GEN.160 ORO.GEN.160 ADR.OR.C.030 ATM/ANS.OR.A.065 ATCO.OR.B.040 reporting; failures, GM21.A.3(A)(b) AMC1 M.A.202 (a) AMC1 145.A.60 AMC1 ORA.GEN.160 AMC1 ORO.GEN.160 AMC1 ADR.OR.C.030 Occurrence reporting AMC1 ATCO.OR.B.040 malfunctions and AMC 21.A.3A(b)(2) GM1 M.A.202 AMC2 145.A.60 GM1 ORA.GEN.160 GM1 ORO.GEN.160 GM1 ADR.OR.C.030 (no AMC/GM issued GM1 ATCO.OR.B.040 defects; 21.A.129 M.A.620 GM1 145.A.60 AMC1 ORO.AOC.130 so far) Obligations of the 21.A.165 AMC1 M.A.620 AMC-20/8 (FDM related) manufacturer/ 21.A.265 AMC2 M.A.620 holder AMC-20/8 GM1 M.A.620 M.A.718 AMC1 M.A.718 AMC2 M.A.718 GM1 M.A.718 AMC 20/8 Occurrence AMC-20/8 AMC-20/8 AMC-20/8 GM1 ORA.GEN.160(a) GM1 ORO.GEN.160(a) GM1 ADR.OR.D.030 (no AMC/GM issued GM2 ATCO.OR.B.040 reporting system point 7 point 7 point 7 so far) compliant with Reg. (EU) No 376/2014 Internal safety n/a (SMS not yet n/a (SMS not yet 145.A.62 n/a n/a ADR.OR.D.030 n/a n/a reporting scheme applicable) applicable) AMC1 ADR.OR.D.030 Proposed with Opinion 06/2016 (cf. CAMO.A.202) Coordination/ AMC-20/8 AMC-20/8 AMC-20/8 AMC1 ORA.GEN.160(b) AMC1 ADR.OR.D.025 (no AMC/GM issued n/a reporting between point 8 point 8 point 8 ORO.GEN.160(b) so far) (addressed under organisations ATM/ANS) Management n/a n/a n/a ORA.GEN.200 ORO.GEN.200 ADR.OR.D.005 ATM/ANS.OR.B.005 ATCO.OR.C.001 system / Safety (SMS not yet (SMS not yet (SMS not yet AMC1 AMC1 AMC1 AMC1 ATCO.OR.C.001(b) policy (just culture applicable) applicable) applicable) ORA.GEN.200(a)(1);(2); ORO.GEN.200(a)(1);(2) ADR.OR.D.005(b)(2) GM1 ATCO.OR.C.001(b) principles) (3);(5) ;(3);(5) GM1 GM1 GM1 ADR.OR.D.005(b)(2) ORA.GEN.200(a)(1);(2); ORO.GEN.200(a)(1);(2) (3);(5) ;(3);(5) AMC1 AMC1 ORA.GEN.200(a)(2) ORO.GEN.200(a)(2) GM1 GM1 ORA.GEN.200(a)(2) ORO.GEN.200(a)(2) TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 99 of 100 An agency of the European Union  European Aviation Safety Agency NPA 2016-19 6. Appendices Subject Part-21 Part-M Part-145 Aircrew Air OPS ADR ATM/ANS ATCOs AUTHORITY REQUIREMENTS Reporting/ 21.B.45 (c) M.B.106 145.B.62 ARA.GEN.125 ARO.GEN.125 ADR.AR.A.025 ATM/ANS.AR.A.020 ATCO.AR.A.020 coordination; AMC1 21.B.45(c) AMC1 M.B.106(b) AMC1 145.B.62(b) AMC1 ARA.GEN.125 (b) AMC1 ARO.GEN.125 AMC1 AMC1 ATCO.AR.A.020 information to the GM1 21.B.45(c) GM1 M.B.106(b) GM1 145.B.62(b) GM1 ARA.GEN.125 (b) (b) ADR.AR.A.025(b) GM1 ATCO.AR.A.020 Agency GM2 21.B.45(c) GM2 M.B.106(b) GM2 145.B.62(b) GM2 ARA.GEN.125 (b) GM1 ARO.GEN.125 (b) GM1 ADR.AR.A.025(b) GM2 ATCO.AR.A.020 GM3 21.B.45(c) GM3 M.B.106(b) GM3 145.B.62(b) GM3 ARA.GEN.125 (b) GM2 ARO.GEN.125 (b) GM2 ADR.AR.A.025(b) No GM3 (not relevant for GM3 ARO.GEN.125 (b) No GM3 (not relevant ATCO TOs) for ADR) Competent authority GM1 21.B.45 M1 M.B.106 GM1 145.B.62 GM1 ARA.GEN.200 GM1 ARO.GEN.200 GM1 ADR.AR.B.005 (no AMC/GM issued GM1 ATCO.A.B.001 established i.a.w. Reg. so far) (EU) No 376/2014 Immediate reaction (Section B not yet (Section B not yet (Section B not yet ARA.GEN.135 ARO.GEN.135 ADR.AR.A.030 No change to ATCO.AR.A.025 to a safety problem aligned with ARX) aligned with ARX) aligned with ARX) ATM/ANS.OR.A.060 (different text compared to ARA/ARO/ADR) Management system (Section B not yet (Section B not yet (Section B not yet ARA.GEN.200 ARO.GEN.200 ADR.AR.B.005 ATM/ANS.AR.B.001 ATCO.AR.B.001 aligned with ARX) aligned with ARX) aligned with ARX) Changes to the (Section B not yet (Section B not yet (Section B not yet ARA.GEN.210 ARO.GEN.210 ADR.AR.B.015 ATM/ANS.AR.B.010 ATCO.AR.B.010 management system aligned with ARX) aligned with ARX) aligned with ARX) TE.RPRO.00034-004 © European Aviation Safety Agency. All rights reserved. ISO 9001 certified. Proprietary document. Copies are not controlled. Confirm revision status through the EASA intranet/internet. Page 100 of 100 An agency of the European Union