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SAE 2013 SMS in Design & Manufacture Madrid, 19-20 March 2013

SMS and

the EASA management system requirements

Eric SIVEL EASA Rulemaking Deputy Director

EASA management system framework -State of play (Rulemaking)

ICAO SMS framework ./. EASA management system framework

EASA Part-21 & SMS

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EASA Part-21 & SMS

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Organisation Requirements - SMS EASA approach main features

Same general management system features for all approved organisations, with the same core requirements

Total system approach

A holistic approach to management will result in more effective operations and safety management.

Integrated approach

The management system shall correspond to the size, nature and complexity of the organisation.

Proportionality

Allow the use of alternative means of compliance.

Flexibility

Authority and Organisation Requirements

4 FAA ARC Feb 22, 2013

SMS ./. Management System in EASA rules

5

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, 2013

Basic Regulation

Airworthiness

Regulation Initial

airworthiness

Regulation Continuing

airworthiness

Flight Standards

Regulation Air crew

Regulation Air operations

Regulation TCO

ATM/ANS

Regulation ATCO

Regulation SERA

Regulation AUR

Regulation ATM/ANS

Systems

Aerodromes

Regulation ADR

Regulating SMS - Airworthiness

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Airworthiness (initial Agency remit)

Initial airworthiness

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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)

Initial airworthiness

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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

Continuing airworthiness

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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 2013-01) Opinion/Decision: 1st Quarter 2014 (Regulation one year later) Further info: http://easa.europa.eu/events/events.php?startdate=13-12-

2012&page=Conference%3A_%22SMS_in_Part-M_and_Part-145%22_%28RMT_MDM.055%29

http://easa.europa.eu/events/events.php?startdate=13-12-2012&page=Conference:_"SMS_in_Part-M_and_Part-145"_(RMT_MDM.055)http://easa.europa.eu/events/events.php?startdate=13-12-2012&page=Conference:_"SMS_in_Part-M_and_Part-145"_(RMT_MDM.055)http://easa.europa.eu/events/events.php?startdate=13-12-2012&page=Conference:_"SMS_in_Part-M_and_Part-145"_(RMT_MDM.055)http://easa.europa.eu/events/events.php?startdate=13-12-2012&page=Conference:_"SMS_in_Part-M_and_Part-145"_(RMT_MDM.055)http://easa.europa.eu/events/events.php?startdate=13-12-2012&page=Conference:_"SMS_in_Part-M_and_Part-145"_(RMT_MDM.055)http://easa.europa.eu/events/events.php?startdate=13-12-2012&page=Conference:_"SMS_in_Part-M_and_Part-145"_(RMT_MDM.055)http://easa.europa.eu/events/events.php?startdate=13-12-2012&page=Conference:_"SMS_in_Part-M_and_Part-145"_(RMT_MDM.055)http://easa.europa.eu/events/events.php?startdate=13-12-2012&page=Conference:_"SMS_in_Part-M_and_Part-145"_(RMT_MDM.055)http://easa.europa.eu/events/events.php?startdate=13-12-2012&page=Conference:_"SMS_in_Part-M_and_Part-145"_(RMT_MDM.055)

Implementing Rule

AR: Authority Requirements

Subpart GEN: general

requirements

Subpart XXX: Specific, additional

requirements

OR: Organisation Requirements

Subpart GEN: general

requirements

Subpart XXX: Specific, additional

requirements

Technical Requirements

Subpart ABC

Subpart DEF

Rule structure general approach

27

AMCs & GM

AMCs & GM

AMCs & GM

AMCs & GM

AMCs & GM

AMCs & GM

SSP SMS



EASA Part-21 & SMS

28

ICAO SARPS versus EU/EASA rules

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ICAO

Chicago Convention

Standards

Recommended Practices

Guidance (Doc. 9859)

EU/EASA

Basic Regulation

Implementing rules

AMCs

GM

?

Copy/paste of the ICAO SMS framework

not an option !

30

ICAO SARPS versus EU/EASA rules


31

Proportionality (Scalability)

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

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 19 4.1.1 (c))

34

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

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altMOC EASAs role


CA provides all info on altMOC approved to

EASA

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

CA: Competent Authority RMT: Rulemaking Task altMOC: alternative Means of Compliance

36

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 providers safety performance, regardless of which authority established acceptability

37

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 EASAs remit not yet addressing SMS.




EASA Part-21 & SMS

38

Current Part-21 approach

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

39 FAA ARC February 2013

PRODUCT SAFETY (TC example)


3 ways:

Standard (DOA with privileges)

Alternative (AP DOA)

Certification program only


DEMONSTRATION OF DESIGN CAPABILITY


Design Organisation Approval (DOA)

TC/DOA applicants 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)


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)




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




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


ALTERNATIVE DEMONSTRATION OF DESIGN CAPABILITY



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

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


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


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)


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


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)


MDM.060 Tentative planning

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


LOI phase

MDM.060 Tentative planning

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


SMS phase

Support/Inputs

EASA SM coordination group TOR limited to Implementation pending approval

Safety analysis department (EASp (SSP)) CoRA Report


Internal

External Inputs from industry (Pilot projects) SM ICG outputs ICAO Annex 19 phase 2 + revised SMM FAA (+others) developments to ensure

sure (equivalency)

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EASA Part-21 & SMS main challenges

FAA ARC February 2013

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

Thank you for your

attention!

Slide Number 2Slide Number 3Organisation Requirements - SMSEASA approach main featuresSMS ./. Management System in EASA rulesSlide Number 6Rules already in placeOrganisation RequirementsAuthority RequirementsPart-ORX Subpart GENSection II Management SystemManagement System requirementsORX.GEN.200 Complex/non-complex org. (example OPS)Related AMCs and GM (1/2)Related AMCs and GM (2/2)Slide Number 15Initial airworthiness Initial airworthiness Continuing airworthiness Slide Number 19Flight Standards: Air Crew Flight Standards: Air Crew Flight Standards: Air Operations Flight Standards: Air Operations Slide Number 24Slide Number 25Slide Number 26Slide Number 27Slide Number 28ICAO SARPS versus EU/EASA rules ICAO SARPS versus EU/EASA rules Proportionality (Scalability)Slide Number 32ICAO SARPS ./. EASA rules How to ensure ICAO compliance through AMCs? altMOC EASAs role SMS versus MS: How to ensure equivalence ? KEY POINTSSlide Number 38Current Part-21 approachCurrent Part-21 approachCurrent Part-21 approachCurrent Part-21 approachCurrent Part-21 approachCurrent Part-21 approachCurrent Part-21 approachDrivers for a Part-21 changeDrivers for a Part-21 changeWho is affected?MDM.060 taskMDM.060 Concept principlesMDM.060 Tentative planningMDM.060 Tentative planningSupport/InputsEASA Part-21 & SMS main challenges Thank you for your attention!

Documents

SAE 2013 SMS in Design & Manufacture - rec …rec-aerospace.com/wp-content/uploads/2014/01/The-EASA-Manage…SAE 2013 . SMS in Design & Manufacture . Madrid, 19-20 March 2013 . SMS