EHSIT/ST meeting Marignane, 27 & 28 October The future EASA rules on Management Systems. Régine Hamelijnck Rulemaking Officer Product Safety

Transcription

1 EHSIT/ST meeting Marignane, 27 & 28 October 2011 The future EASA rules on Management Systems Régine Hamelijnck Rulemaking Officer Product Safety

2 History EASA Rulemaking tasks: OPS.001 & FCL.001 started in July 2006 extend scope of EASA regulations to flight crew licensing and air operations, while implementing the relevant ICAO Standards on SMS Proposal for Part Authority Requirements (AR) and Part Organisation Requirements (OR) NPA published in October 2008 NPA published in January 2009 Opinion 03/2011 published in April 2011 Part-ARA and Part-ORA for air crew (Flight Crew Licensing) Passed EASA Committee Regulation expected March 2012 Opinion 04/2011 published in June 2011 Part-ARO, Part-ORO and technical requirements for air operations (Commercial Air Transport) Passed EASA Committee Regulation expected Summer 2012 See: 28 Oct

3 Outline Introduction rule structure current status The EASA approach main features The draft rule ORO.GEN.200 AMCs & GMs 28 Oct

4 Rule structure the big picture Basic Regulation Airworthiness Flight Standards ATM/ANS Aerodromes First extension Regulation Initial airworthiness Regulation Air crew Regulation ATCO Regulation ADR Regulation Continuing airworthiness Regulation Air operations Regulation SERA Regulation TCO Regulation AUR ADR: Aerodromes ATCO: licensing and medical certification of air traffic controllers AUR: common airspace usage requirements and operating procedures SERA: Standardised European Rules of the Air Regulation ATM/ANS Systems 28 Oct

5 Rule structure Air Operations Regulation Air operations Annex I Annex II Annex III Annex IV Annex V Annex VI Annex VII Annex VIII DEF Part-ARO Part-ORO Part-CAT Part-SPA Part-NCC Part-NCO Part-SPO Aligned with Air Crew.GEN.GEN.GEN.GEN.GEN.GEN.GEN.OPS.AOC.OP.PBN.OP.OP.OP.RAMP.DEC.POL.MNPS.POL.POL.POL.MLR.IDE.RVSM.IDE.IDE.IDE.SEC.FC.LVO.ETOPS Opinion not yet published.spec.cc.dg SPA: specific Approvals (ETOPS, PBN etc ) SPO: specialised Operations (aerial work) NCC: non-commercial with CMPA NCO: non commercial other than CMPA.TC.FTL.NVIS.HHO 28 Oct HEMS

6 Transition measures The European Commission is currently negotiating the different transition measures with Member States. The above information is therefore to be considered PROVISIONAL: implementation of JAR-OPS 3 with varying degrees of compliance conversion procedure is foreseen for CAT helicopter AOCs issued before the new rules will apply no opt-out from the new rules. Conversion process starts from date of entry into force of the OPS-CAT Regulation. Regulation does not set a deadline for completion of the conversion process (at the discretion of each Member State) Competent authorities to prepare a conversion report indicating among other things how and when the holders of CAT helicopter AOCs under their regulatory control will be requiredtomovetofullcompliancewithofpartsoro,catand,ifapplicable,spa. The conversion report shall be established in consultation with the Agency. 28 Oct

7 Organisation Requirements: GEN & OPS ORO.GEN contains the general provisions that are applicable to all approved organisations(operators, ATOs, AeMCs,) Section 1: GENERAL Section 2: MANAGEMENT SYSTEM These are complemented with OPS specific provisions ORO.AOC ORO.DEC(non-commercial with CMPA) ORO.MLR ORO.SEC ORO.FC/CC/TC ORO.FTL(still in progress task OPS.055) 28 Oct

8 Part-ORO GEN Sec.1 - corresponding ARs Ref. Part-OR Title Corresponding AR ORO.GEN.115 Application for an organisation certificate ARO.GEN.310(a) ORO.GEN.120 Means of compliance ARO.GEN.120 ORO.GEN.125 Terms of approval and privileges of an organisation ARO.GEN.310(b) ORO.GEN.130 Changes to organisations ARO.GEN.330 ORO.GEN.135 Continued validity ARO.GEN.310(b) ORO.GEN.140 Access ARO.GEN.350 ORO.GEN.150 Findings ARO.GEN.350 ORO.GEN.155 Immediate reaction to a safety problem ARO.GEN.135 ORO.GEN.160 Occurrence reporting ARO.GEN Oct Management System 8

9 Part-ORO Subpart GEN Section 2 Paragraph Title ORO.GEN.200 Management system ORO.GEN.205 Contracted activities ORO.GEN.210 Personnel requirements ORO.GEN.215 Facility requirements ORO.GEN.220 Record-keeping 28 Oct Management System 9

10 Organisation Requirements & SMS ORs do not explicitly refer to SMS. Section 2 of Part-ORO Subpart GEN deals with management system. ORO.GEN Sec. 2 and related AMCs/GM set out what is needed in terms of management system. These, together with the relevant provisions of the Basic Regulation, provide for compliance with the relevant ICAO SARPS on SMS. See Annex III to the Explanatory Note to the CRD Part-OR Safety Management Requirements for organisations - Comparison between the ICAO standards and Part-OR & Basic Regulation (Essential requirements) 10

11 Organisation Requirements & Safety Management Who will be required to implement a management system as defined in ORX.GEN.200? First extension(air Crew and Air Operations): Air Operators: commercial and non-commercial if operating complex motorpowered aircraft(cmpa) Approved Training Organisations- Pilots Holders of an FSTD qualification certificate Aero-medical Centres In a second stage(airworthiness- RM tasks MDM.055 and MDM.060): Design organisations and Production organisations(part-21) Maintenance organisations(part-m Subpart F and Part-145) Continuing Airworthiness Management Organisations(Part-M Subpart G) Maintenance Training Organisations(Part-147) 11

12 Organisation Requirements & SMS the EASA approach Total system approach Integrated approach Proportionality & flexibility 28 Oct Management System 12

13 EASA remit: towards a total system Current remit Initial airworthiness & environmental (Regulation 1702/2003) Continuing airworthiness (Regulation 2042/2003) First extension Flight crew licensing Cabin crew Medical Air Operations Third Country Operators Second extension Air Traffic Management Air navigation Services Aerodromes 28 Oct Management System 13

14 EASA remit: towards a total system Current remit Initial airworthiness & environmental (Regulation 1702/2003) First extension Flight crew licensing Second extension Air Traffic Management Cabin crew Air navigation Services EASA total aviation Medicalsystem approach: Aerodromes Continuing common airworthiness logic Air & Operations semantics of rules (Regulation 2042/2003) Third Country Operators 28 Oct Management System 14

15 Total system approach in terms of SMS Ensure all service providers «speak the same language» when it comes to safety management Facilitate the identification of hazards stemming from the interactions between service providers Facilitate streamlined implementation of the ICAO standards, in particular for organisations holding approvals in different areas 28 Oct Management System 15

16 Integrated approach Safety management Finance & Budget Contracting Integrated management shall enable managers to recognise and take into Management System account all significant influences on their organisation. Compliance monitoring Responsibilities & Accountability Facilities Human Resources 28 Oct Management System 16

17 Integrated approach Safety management Finance & Budget Compliance monitoring Contracting Management System Responsibilities & Accountability Facilities Human Resources 28 Oct Management System 17

18 Integrated approach SMS should not be implemented through an additional management system requirement superimposed onto the existing rules, but be fully integrated in the organisation s existing management system. Safety management should include every facet of management that may impact aviation safety (financial, operational, health and safety, etc ). Safety, as well as compliance with rules, should be a concern for all personnel and for all activities of an organisation. 28 Oct Management System 18

19 Flexibility Principles of performance-based rules Essential safety elements are defined at the level of implementing rules, non-essential implementation aspects are included as AMC. Details of safety management implementation are defined in form of AMCs this opens the possibility to apply for an alternative means of compliance (i.a.w. ORO.GEN.120). Performance based rules are necessary to ensure that safety management may deploy its full potential: The organisation should be allowed flexibility to implement specific means to mitigate safety risks as it sees fit. 19

20 Proportionality The management system shall correspond to the size of the organisation and the complexity of its activities, taking into account the hazards and associated risks inherent in these activities. (see also ICAO Annex 6 Appendix 7) How is this achieved? different sets of AMCs for complex and non-complex organisations details of SMS implementation are included as AMC (altmoc possible) 20

21 Proportionality Definition of organisational complexity - three sets of criteria : Size, in terms of staffing Complexity of the activities number of operating sites, number and type of contractors, Risks involved type of operations, e.g. specialised operations (helicopter hoist) type of aircraft, variety of aircraft types operated operating environment (mountainous areas, offshore.) Some organisations are non-complex by default Cf. AMC1-ORO.GEN.200(b) 21

22 AMC1-ORO.GEN.200(a)(1)(2)(3)(5) Possibility to use hazard checklists for safety, integrated into the activities of the organisation Management of safety risks related to a change Safety manager to be identified, may be the accountable manager or other operational person within the organisation Responsibilities need to be identified for hazard identification, risk assessment and mitigation Safety policy to include a commitment to improve safety and to comply with requirements Organisation to develop & maintain an Emergency Response plan (ERP) 22

23 AMC1-ORO.GEN.200(a)(1)(2)(3)(5) Possibility to use hazard checklists for safety, integrated into the activities of the organisation Management proportionate of safety risks related means to a change of Safety manager to be identified, may be the accountable manager compliance or other operational for person non-complex within the organisation Responsibilities need to be identified for hazard organisations identification, risk assessment and mitigation Safety policy to include a commitment to improve safety and to comply with requirements Organisation to develop & maintain an Emergency Response plan (ERP) 23

24 ORO.GEN.200 (extract) An organisation shall establish, implement and maintain a management system that includes: (1) clearly defined lines of responsibility and accountability throughout the organisation, including a direct safety accountability of the accountable manager; (2) a description of the overall philosophies and principles of the organisation with regard to safety, referred to as the safety policy; (3) the identification of aviation safety hazards entailed by the activities of the organisation, their evaluation and the management of associated risks, including taking effective actions to mitigate the risk; (4) maintaining personnel trained and competent to perform their tasks; (5) documentation of all management system key processes, including a process for making personnel aware of their responsibilities, and its amendment procedure; (6) a function to monitor compliance of the organisation with the relevant requirements. Compliance monitoring shall include a feedback system of findings to the accountable manager to ensure effective implementation of corrective actions as necessary. 24

25 Overview of AMCs and GM to ORO.GEN.200 Reference Applies to Subject AMC1- ORO.GEN.200(a)(1)(2)(3)(5) AMC1-ORO.GEN.200(a)(1) non-complex complex - Responsibility and accountability - Safety policy - Hazard identification, risk management - Documentation of management system key processes - Safety manager - Emergency response plan Organisation and accountabilities: - Safety manager - Safety review board (SRB) GM1-ORO.GEN.200(a)(1) complex Safety action group (OPTIONAL - to assist the SRB) AMC1-ORO.GEN.200(a)(2) complex Safety policy and management commitment GM1-ORO.GEN.200(a)(2) all Definition of safety policy Safety risk management: AMC1-ORO.GEN.200(a)(3) complex - Risk management - Management of change - Continuous improvement - Emergency response plan 25

26 AMCs and GM to ORO.GEN.200 Reference Applies to Subject GM1-ORO.GEN.200(a)(3) all Internal occurrence reporting scheme AMC1 -ORO.GEN.200(a)(4) all Training and communication on safety AMC1-ORO.GEN.200(a)(5) all Organisation management system documentation GM1-ORO.GEN.200(a)(5) all Organisation management system documentation AMC1-ORO.GEN.200(a)(5) GM1-ORO.GEN.200(a)(5) AMC1-ORO.GEN.200(a)(6) complex all all Organisation management system documentation Safety management manual (SMM) Development of new / amendment of Standard Operating Procedures Compliance monitoring - general - Designation of a compliance monitoring manager - Compliance monitoring documentation - Training AMC2-ORO.GEN.200(a)(6) non-complex Compliance monitoring - Inspection checklist GM1.ORO.GEN.200(a)(6) complex Compliance monitoring - Typical subjects AMC1-ORO.GEN.200(b) all Size, nature and complexity of the activity 26

27 Management System building blocks Safety Policy Monitoring (compliance & performance) Responsibilities & accountabilities system & process analysis Documentation Hazard identification & risk management Training and communication 28 Oct

28 GM1-ORO.GEN.200(a)(2) SAFETY POLICY The safety policy is the means whereby the organisation states its intention to maintain and, where practicable, improve safety levels in all its activities and to minimise its contribution to the risk of an aircraft accident as far as is reasonably practicable. starting point for the organisation s MS 28

29 AMC1-ORO.GEN.200(a)(2) SAFETY POLICY (endorsed by the accountable manager) establish safety objectives and performance standards reflect organisational commitments regarding safety and its proactive and systematic management; enforce safety as one primary responsibility of all managers to be communicated throughout the organisation senior management should continually promote the safety policy to all personnel and demonstrate their commitment to it should include safety reporting principles commitment not to blame someone for reporting something which would not have been detected otherwise. 29

30 AMC1-ORO.GEN.200(a)(1) AMC1-ORO.GEN.200(a)(6) Organisation Accountable Manager (AM) Safety Manager (SM) Compliance Monitoring Manager (CMM) Safety Review Board (SRB) Accountable Manager plus Heads of functional areas Safety Action Group (SAG) 30

31 Safety Manager AMC1-ORO.GEN.200(a)(1) Functions of the safety manager: 1. facilitate hazard identification, risk analysis and management; 2. monitor the implementation of actions taken to mitigate risks, as listed in the safety action plan; 3. provide periodic reports on safety performance; 4. ensure maintenance of safety management documentation; 5. ensure that there is safety management training available and that it meets acceptable standards; 6. provide advice on safety matters; and 7. initiate and participate in internal occurrence / accident investigations. 31

32 Safety Review Board AMC1-ORO.GEN.200(a)(1) high level committee, chaired by the AM - considers matters of strategic safety & ensure appropriate resources are allocated to achieve safety objectives Main functions of the SRB: 1. monitor safety performance against the safety policy and objectives; 2. monitor safety actions are taken in a timely manner; 3. ensure the organisation s safety management processes remain effective. 32

33 Safety Action Group GM1-OR.GEN.200(a)(1) optional May be established as a standing group or as an ad-hoc group to assist or act on behalf of the SRB. More than one safety action group may be established depending on the scope of the task and specific expertise required. A safety action group should report to and take strategic direction from the safety review board and should be comprised of managers, supervisors and personnel from operational areas. e.g. to assess impact on safety of operational changes, such as: introduction of a new type of aircraft use of a new contractor implementation of new software for component tracking 33

34 SAFETY RISK MANAGEMENT AMC1-ORO.GEN.200(a)(3) Hazard identification processes reactive : incidents and accidents proactive : intrinsic threats and potential failures Risk assessment and mitigation processes analysis, assessment and control of risks Internal safety investigation following occurrences Not limited to occurrences required to be reported Safety performance monitoring and measurement Combination of safety reporting, safety studies, safety reviews, safety audits, safety surveys. Management of change Identify changes that may adversely affect safety Use existing tools and mechanisms to assess and manage related risks 34

35 RISK ASSESSMENT GUIDANCE GM2-ORO.GEN.200(a)(5) Planning (what, when how, who) Analysis of causes/contributing factors & probability Analysis of consequences Conclusion (for decision-making & prioritising) Risk evaluation (acceptability/ mitigation) Risk description (severity/probability) Risk mitigation Documentation (records procedures to be amended) Monitoring & Review 35

36 SAFETY RISK MANAGEMENT AMC1-ORO.GEN.200(a)(3) Continuous improvement reactive and proactive evaluation of facilities, equipment, documentation, procedures (audits and surveys) Evaluation of individual s performance in terms of safety responsibilities Reactive evaluation of effectiveness of risk controls Emergency Response Plan Actions to be taken in case of an emergency Ensure orderly and safe transition from normal to emergency operation Need to co-ordinate with ERPs of other organisations where appropriate 36

37 SAFETY RISK MANAGEMENT Some recommendations Adopt a phased approach: start with a basic outline and add sophistication as your management system matures e.g. start with process indicators first, then outcome indicators Make use of existing templates, guidance, tools BUT: adapt them to your organisation (complexity specificity) e.g.: SKYBRARY also has an Operators Guide to Human Factors in Aviation (OGHFA) ESSI (ECAST EGAST EHEST) lots of guidance, including advanced methodology for operational risk assessment ICAO SMM: Note that ICAO is currently reviewing the manual; do not rely on it too extensively. 37

38 GM1-ORO.GEN.200(a)(3) Internal Occurrence Reporting scheme one important element of the hazard identification process, improve the safety performance without attributing blame to identify instances where routine procedures have failed assessment of safety implications to determine need for action dissemination of information regarding relevant incidents and accidents reactive evaluation of effectiveness of risk controls All reports to be retained, as significance may only become obvious at a later stage Example of occurrence : Temporary exceedance of aircraft operating limitations /flight envelope during a training flight 38

39 AMC1-ORO.GEN.200(a)(4) TRAINING AND COMMUNICATION ON SAFETY All personnel to receive safety training as relevant to their responsibilities Communication on safety matters: Raise awareness on safety management activities Convey safety critical information on risks identified Explain why actions are taken, why procedures are introduced or changed Communication - How? Possible options: Regular meetings with personnel where information, actions and procedures are discussed Safety newsletters 39

40 AMC1-ORO.GEN.200(a)(5) ORGANISATION MANAGEMENT SYSTEM DOCUMENTATION General items to be covered (minimum required for all organisations) Statement by the accountable manager organisation will continuously work in accordance with the applicable requirements and the organisation s documentation Scope of activities Names of nominated post holders Organisation chart with lines of responsibility Procedures specifying how compliance with requirements is ensured (auditing) Management system documentation amendment procedure Organisations may adopt any title for this document 40

41 AMC1-ORO.GEN.200(a)(5)-Complex SAFETY MANAGEMENT MANUAL complex organisations key instrument for communicating the approach to safety for the whole of the organisation, to document all aspects of safety management: 1. scope of safety management 2. safety policy and objectives 3. safety accountability of the accountable manager 4. safety responsibilities of key safety personnel 5. hazard identification and risk management schemes 6. safety action planning 7. safety performance monitoring 8. incident investigation and reporting 9. emergency response planning 10. management of change 11. safety promotion 41

42 GM1-ORO.GEN.200(a)(5) ORGANISATION MANAGEMENT SYSTEM DOCUMENTATION The information may be contained in any of the organisation manuals safety management manual, operations manual, training manual These manuals may also be combined, e.g. the SMM can be one chapter of the operations manual or the operations manual can be integrated with the SMM. It is not required to duplicate information in several manuals, however the organisation must be able to demonstrate that all items are covered 42

43 SAFETY MANAGEMENT MANUAL Some recommendations (1/2) Ensure uniformity in terminology used staff personnel employee manager - post-holder forerunner event precursor event likelihood probability gravity - severity Provide definitions in a separate section Keep forms separate to minimise need for updates Simplify manual administration (e-version, may be printed but only the master copy is to serve as reference) Limit the use of jargon, avoid proliferation of advanced SMS terminology or models 43

44 SAFETY MANAGEMENT MANUAL Some recommendations (2/2) Clearly describe the management system key processes and how they interface with each other and with your operational processes (process mapping) Hazard identification Safety risk management Safety performance measurement Compliance monitoring Documentation Etc Do not mix up conceptual information with the description of the organisation and its safety management processes Do not duplicate the ICAO SMM describe how SM works in your organisation Check other manuals / procedures to be updated to consider SM 44

45 DOCUMENTATION OPS Additional requirements on the operational elements are defined in: ORO.MLR Manuals, Logs and Records ORO.MLR.100 Operations manual General & related AMCs ORO.MLR.101 Operations manual Structure & related AMCs 45

46 AMC1-ORO.GEN.200(a)(6) COMPLIANCE MONITORING FUNCTION Accountable manager to designate a compliance monitoring manager (CMM) Functions of the CMM: verify that all applicable standards are complied with verify that the organisation s own requirements (policies and procedures) are complied with ensure that a compliance monitoring programme is implemented and continually reviewed & improved Organisations may adopt a different title for this function 46

47 AMC1-ORO.GEN.200(a)(6) COMPLIANCE MONITORING FUNCTION Position of the CMM: direct access to the accountable manager not one of those nominated to be responsible for the operational areas (referred to in ORO.GEN.210(b)) have access to all parts of the organisation and as necessary, to contracted organisations The same person may act as CMM and SMM (BUT: need to ensure independent audits) Non-complex ORG: AM can be the CMM 47

48 AMC1-ORA.GEN.200(a)(6) COMPLIANCE MONITORING DOCUMENTATION Integrated with organisation s management system documentation, to describe : the allocation of duties and responsibilities (coordination & auditing) procedures to ensure regulatory compliance the compliance monitoring programme, reflecting schedule of the monitoring programme; audit procedures; reporting procedures; follow-up and corrective action procedures; training on compliance monitoring ; recording system. No fixed audit planning cycles according to size of the organisation and its complexity dynamic planning (performance based) 48

49 GM1-ORO.GEN.200(a)(6) OPS COMPLIANCE MONITORING PROGRAMME complex organisations Typical subject areas for compliance monitoring inspections: actual flight operations; ground de-icing/anti-icing; flight support services; load control; and technical standards. Operators should monitor compliance with the operational procedures they have designed to ensure safe operations. In doing so, they should, where appropriate, additionally monitor: operational procedures; flight safety procedures; operational control and supervision; aircraft performance; all weather operations; communications and navigational equipment and practices; mass, balance and aircraft loading; Etc. 49

50 Compliance & safety management Without compliance no effective safety management, but compliance alone does not mean the organisation is safe. Safety performance Compliance monitoring and effective implementation of corrective actions Compliance Policies, objectives hazard identification and risk management 50

51 Compliance & safety management Compliance monitoring shall also look into the requirements on identification of aviation safety hazards and management of associated risks. Are policies and procedures in place and adhered to? Are hazard identified and risks assessed? The verification of the effectiveness of the hazard identification process and mitigation actions is within the remit of the safety management function (safety manager SRB SAG) How effectively have risks been mitigated? Has overall safety performance increased? If the same person acts as SM and CM, he/she cannot audit SM processes 51

52 QMS and SMS QMS and SMS may use the same tools and techniques e.g. performance monitoring KPIs management of business risks process analysis auditing an effective QMS will clearly support the implementation of an effective safety management BUT Processes designed to produce a quality product/service will not guarantee a safe product. More on this topic: Steven C. McNeely, Manager, Safety Management Systems, Jet Solutions, L.L.C, published by "Flight Safety Information February 12, 2010 No.034", Lessons Learned from Toyota 2010-QMS vs SMS (FAA website). 52

53 Safety management implementation Challenges Culture takes time to change how to influence contractors? how to get buy-in from non-operational areas? how to measure safety culture? Commercial environment competitive environment (protection versus production) return on SM investment may take time Oversight (CAA) & monitoring the application of rules (EASA) how to assess safety performance? just culture in oversight 53

54 SMS What comes next? 54

55 Future Rulemaking on SM Task MDM.094 Safety Management Review of Part-ORX and Part-ARX following publication of ICAO Annex 19 consider latest developments at ICAO and SM- International Collaboration Group (SM-ICG) provide further guidance on: the management of safety risks stemming from interactions with other organisations safety performance monitoring & measurement 55

56 KEY POINTS: Organisation Requirements & SM SM is addressed in Organisation Requirements Part- ORO Subpart GEN Section 2 Management Organisation Requirements are ICAO SMS compliant are compatible with existing management systems encourage integrated management provide flexibility (details in AMC) provide proportionality (complex versus non-complex organisations) Part-ORO Management system requirements set the standard for implementing SM in other areas within EASA s remit not yet addressing SM. 56

57 KEY POINTS: Enablers to effective SM Leadership (actions speak louder than words) Integration into day-to-day business System approach identifying, understanding and managing interrelated processes as a system Ability to transform data into safety information for management Safety culture covering the full range Flexible culture Just culture Learning culture Informed culture Reporting culture 57

58 KEY POINTS: Enablers to effective SM Leadership (actions speak louder than words) Integration into day-to-day business System approach identifying, understanding and managing interrelated processes as a system Ability to transform data into safety information for management Safety culture covering the full range Flexible culture Just culture Learning culture Informed culture Reporting culture There is no no standard formula! 58

59 - end of presentation - Thank you for your attention! regine.hamelijnck@easa.europa.eu