SMS and the EASA management system requirements

Transcription

1 SAE 2013 SMS in Design & Manufacture Madrid, March 2013 SMS and the EASA management system requirements Eric SIVEL EASA Rulemaking Deputy Director

2 EASA management system framework - State of play (Rulemaking) ICAO SMS framework./. EASA management system framework EASA Part-21 & SMS 2

3 EASA management system framework - State of play (Rulemaking) ICAO SMS framework./. EASA management system framework EASA Part-21 & SMS 3

4 Organisation Requirements - SMS EASA approach main features Total system approach Same general management system features for all approved organisations, with the same core requirements Integrated approach A holistic approach to management will result in more effective operations and safety management. Proportionality The management system shall correspond to the size, nature and complexity of the organisation. Flexibility Allow the use of alternative means of compliance. Authority and Organisation Requirements FAA ARC Feb 22,

5 SMS./. Management System in EASA rules There is no requirement to implement an SMS, but a requirement to implement a management system with specific features. This is aligned with the essential requirements of the Basic Regulation (see Annex I Art. 3.a.2). The organisation must implement and maintain a management system to ensure compliance and aim for continuous improvement of the system. Existing management systems within the scope of Reg. (EC) 2042/2003 mainly focus on compliance (quality system) FAA ARC Feb 22,

6 Regulating SMS - Airworthiness Basic Regulation Airworthiness Flight Standards ATM/ANS Aerodromes Airworthiness (initial Agency remit) Regulation Initial airworthiness Regulation Continuing airworthiness Regulation Air crew Regulation Air operations Regulation ATCO Regulation SERA Regulation ADR Regulation TCO Regulation AUR Regulation ATM/ANS Systems 15

7 Initial airworthiness Regulation 748/2012 (ex-1702/2003) Scope: Design TC, restricted TC, changes to TC and restricted TC, STC Design Organisation Approval Manufacture Production Organisation Approval (POA) Production without POA EASA is the competent authority for: Product Certification, DOA, third country POA single POA (Airbus) 16

8 Initial airworthiness Regulation 748/2012 (ex-1702/2003) SMS not yet implemented will be introduced through Rulemaking Task MDM.060 SMS elements will be based on those developed for Aircrew and OPS POAs and DOAs (not only those designing/manufacturing aircraft, engines or propellers) will be required to adapt their management system to address safety management 17

9 Continuing airworthiness Regulation 2042/2003 Scope: Maintenance (Part-145 / Part-M Subpart F) Continuing Airworthiness Management (Part-M Subpart G - CAMO) Maintenance Training (Part-147) Aircraft Mechanics Licensing (Part-66) EASA is the competent authority for: third country organisations (Maintenance, Maintenance Training and Continuing Airworthiness Management Organisations) SMS not yet implemented Will be introduced through rulemaking Task MDM.055 initiated 07/2011 SMS elements will be based on those developed for Air crew and OPS (ORX) NPA published in January 2013 (NPA ) Opinion/Decision: 1 st Quarter 2014 (Regulation one year later) Further info: &page=Conference%3A_%22SMS_in_Part-M_and_Part- 145%22_%28RMT_MDM.055%29 18

10 Rule structure general approach Implementing Rule AR: Authority Requirements SSP OR: Organisation Requirements SMS Technical Requirements Subpart GEN: general requirements AMCs & GM Subpart GEN: general requirements AMCs & GM Subpart ABC AMCs & GM Subpart XXX: Specific, additional requirements AMCs & GM Subpart XXX: Specific, additional requirements AMCs & GM Subpart DEF AMCs & GM 27

11 EASA management system framework - State of play (Rulemaking) ICAO SMS framework./. EASA management system framework EASA Part-21 & SMS 28

12 ICAO SARPS versus EU/EASA rules ICAO EU/EASA Chicago Convention Basic Regulation Standards Implementing rules Copy/paste of the ICAO SMS framework not an option! Recommended Practices? AMCs Guidance (Doc. 9859) GM 29

13 ICAO SARPS versus EU/EASA rules FAA ARC Feb 22,

14 Proportionality ( Scalability ) The management system shall be commensurate with the size of the service provider and the complexity of its aviation products or services. (draft ICAO Annex (c)) How is this achieved? different sets of AMCs for complex and non-complex organisations details of MS implementation are contained as AMC possibility to apply for an alternative MOC 31

15 How to ensure ICAO compliance through AMCs? Organisation intends to use an alternative means of compliance (altmoc) Organisation to perform risk assessment of the altmoc and apply to the competent authority (EASA for DOA) incl. supporting documents Competent authority will approve such altmoc only when it has established that an equivalent level of safety is ensured - this may entail an inspection of the organisation Organisation may only implement the altmoc when approved by its competent authority the altmoc is only valid for that organisation FAA ARC Feb 22,

16 altmoc EASA s role CA provides all info on altmoc approved to EASA CA: Competent Authority RMT: Rulemaking Task altmoc: alternative Means of Compliance Competent Authority Verification : - Due process? - General interest? EASA Ensure altmoc process is properly implemented EASA Standardisation Recurrent RMT: altmoc of general interest will become EASA AMC EASA Rulemaking FAA ARC Feb 22,

17 SMS versus MS: How to ensure equivalence? Equivalence is not only related to harmonized SMS regulatory requirements Harmonised criteria for assessment should lead to a finding of equivalence, regardless of the applicable SMS framework Equivalence is fundamentally the assurance of acceptable safety performance by all States (so it is relevant both for SSP and SMS) Each participating authority has confidence in the service provider s safety performance, regardless of which authority established acceptability FAA ARC Feb 22,

18 KEY POINTS SMS is addressed in Organisation Requirements Part-ORX Subpart GEN Section 2 Management System Organisation Requirements address all elements of the ICAO SMS framework are compatible with existing management systems shall encourage integrated management provide flexibility (details in AMC) provide proportionality (complex versus non-complex organisations) Part-ORX Management System requirements set the standard for implementing SMS in all areas within EASA s remit not yet addressing SMS. FAA ARC Feb 22,

19 EASA management system framework - State of play (Rulemaking) ICAO SMS framework./. EASA management system framework EASA Part-21 & SMS 38

20 Current Part-21 approach PRODUCT SAFETY (TC example) The Applicant must demonstrate design capability The Applicant must demonstrate compliance with cert. basis (incl. 2X.1309 (Safety Management element)) No unsafe feature or characteristic (SM element) Demonstration of compliance is verified by EASA What is verified? - individual (risk-based) decision-making by EASA C staff (without commonly adopted and declared criteria) Credit to recognised designed capability FAA ARC February

21 Current Part-21 approach DEMONSTRATION OF DESIGN CAPABILITY 3 ways: Standard (DOA with privileges) Alternative (AP DOA) Certification program only FAA ARC February

22 Current Part-21 approach STANDARD DEMONSTRATION OF DESIGN CAPABILITY Design Organisation Approval (DOA) TC/DOA applicant s organisation must have Technical staff in sufficient number and qualification with authority (SMS element) Facilities and equipment (SMS element) Established communication links between and within technical departments (SMS element) Data (Documentation) (SMS element) FAA ARC February

23 Current Part-21 approach STANDARD DEMONSTRATION OF DESIGN CAPABILITY Design assurance system (DAS) (SMS element) assuring Product compliance with TC basis Independent checking function of the showing of compliance Control and supervision (management) over design processes (SMS element) Independent compliance monitoring system of the organisation (SMS element) Feedback system to a person or group of persons responsible for correction actions (SMS element) Checking function for acceptability of the tasks performed by partners or sub-contractors (SMS element) Design Assurance System (DAS) change management (SMS element) FAA ARC February

24 Current Part-21 approach STANDARD DEMONSTRATION OF DESIGN CAPABILITY What is missing for full SMS? Safety risk management (non product safety risks) Hazard identification Safety risk assessment and mitigation Safety assurance (non product safety): Safety performance monitoring and measurement Safety promotion Training and education on SM Safety communication FAA ARC February

25 Current Part-21 approach ALTERNATIVE DEMONSTRATION OF DESIGN CAPABILITY No Organisation required Set of procedures for design practices, resources an sequence of activities (SMS element) Can only be accepted for ELA 2 aircraft (not complex motor-powered under 2000 kg of mass) Engines on ELA 2 Piston engines Fixed or adjustable propeller FAA ARC February

26 Current Part-21 approach DEMONSTRATION OF DESIGN CAPABILITY THEOUGH CERTIFICATION PROGRAM ONLY The applicant provides the Agency with Certification Program with MoC only Can only be accepted for ELA 1 aircraft (not complex motor-powered under 1200 kg of mass) Engines on ELA 1 FAA ARC February

27 Drivers for a Part-21 change Aviation safety improvement through Safety Management of latent safety risks potentially existing which may not be addressed by the current (compliance based) system Provide more legal certainty to EASA C staff Shift from prescriptive to performance based rules More efficient use of existing resources (staff, financial.) ICAO SMS standards EASA Total system approach FAA ARC February

28 Drivers for a Part-21 change Facilitate integration of different systems in a single organisation under a single Management System (COrA) Improve efficiency by applying Performance Based Oversight (PBO) using risk-based decision-making in Product certification Organisation oversight (D & M organisations) Address Human Factors in D & M FAA ARC February

29 Who is affected? D & M Organisations (MS & third countries) EASA units involved in Part-21 activities: C Directorate: Product/Parts & Appliances (ETSO) certification staff S Directorate DOA section (DOA approval & oversight) POA Section (foreign POA approval & single0 Standardisation- Initial Airworthiness R Directorate (Initial Airworthiness) MS NAAs (POA approval & oversight) FAA ARC February

30 MDM.060 task Scope: Part-21 Section A: Subparts B, D, E, J, P and Part-21 Section B: Authority requirements 2 sub-tasks under one umbrella Level of involvement (LOI) of the Agency in product certification) SMS for D & M organisations Working method: Agency task Industry going to be involved via - Pilot projects Selected product certification projects Selected D & M organisations Consultation of EASA advisory bodies (RAG/TAG/SSCC) Workshops FAA ARC February

31 MDM.060 Concept principles No revolutionary change to Part-21 Find a smooth way of SM incorporation into the existing Part- 21 structure Not replace but complement the existing DAS (DOA) and QS (POA) systems Avoid undue burden for organisations, NAAs and EASA Details (Concept paper) under development Final concept & planning following endorsement by IETC(ISC) FAA ARC February

32 MDM.060 Tentative planning LOI phase Draft material ready Pilot certification projects to start immediately Concept paper Q2/2013 NPA Q4/2013 Draft rule (EASA Opinion) Q2/2014 Adoption before end 2015 Applicability: Rule: 2017 (synchronised with SMS part) In individual C projects earlier : application via agreed C procedures and CM FAA ARC February

33 MDM.060 Tentative planning SMS phase Will run in parallel (with a time shift) to LOI Rule drafting to start September 2013 (based on existing EASA SM rules developed for Air Operations and Air Crew) Pilot projects to start Q3/2013 NPA Q4/2014 Opinion Q4/2015 Adoption Q4/2016 FAA ARC February

34 Support/Inputs Internal EASA SM coordination group TOR limited to Implementation pending approval Safety analysis department (EASp (SSP)) CoRA Report External Inputs from industry (Pilot projects ) SM ICG outputs ICAO Annex 19 phase 2 + revised SMM FAA (+others) developments to ensure sure ( equivalency ) FAA ARC February

35 EASA Part-21 & SMS main challenges Change Management within Industry and within the Authorities Evolution of concept from product safety & product reliability to management of safety better focus on risk-based decision making related to organisational and systemic issues Interfaces Design manufacture operation - maintenance ATM etc systems safety (TCH responsibilities as related to airframe, components, systems) Need to consider the entire product lifecycle for effective SMS Operational suitability, continuing airworthiness process, Instructions for continued airworthiness etc Need to create an adequate framework in order to better address Human Factors in D&M FAA ARC February

36 Thank you for your attention!