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NPA 2013-01 Embodiment of Safety Management System (SMS) requirements into Commission Regulation (EC) No 2042/2003 CAMO & 145 (MF) Presentatör Johan Brunnberg, Flygteknisk Inspektör & Del-M Koordinator Sjö- och luftfartsavdelningen Operatörsenheten Sektionen för teknisk operation 2013-04-22 1

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NPA 2013-01

Embodiment of Safety Management System (SMS) requirements

into Commission Regulation (EC) No 2042/2003

CAMO & 145 (MF)

Presentatör

Johan Brunnberg, Flygteknisk Inspektör & Del-M Koordinator

Sjö- och luftfartsavdelningen

Operatörsenheten

Sektionen för teknisk operation

2013-04-22

1

OBS:

• Denna presentation är baserad på vår uppfattning av

NPA 2013-01.

• Hur reglerna slutligen utformas efter beslut hos

Europeiska kommissionen och EASA kan komma

ändras.

2013-04-22

2

Innehåll

• Allmänt

• Management System

• Övrigt i reglerna som påverkas

• (Möjlighet påverka regelstrukturen)

2013-04-22

3

Allmänt

2013-04-22

4

SMS implementering

2013-04-22

5

Infört

1178/2011

• Del-ORA (FCL)

965/2012

• Del-ORO

(OPS)

NPA 2013-01

2042/2003

Del 1

•RIA

•Artiklarna

Del 2

•Del-MF

•Del-MG

Del3

•Del-145

Nästa steg

2042/2003

•Del-66

•Del-147

Senare

748/2012

•Del-21G POA

•Del-21J DOA

OBS: Remisstiden förlängd till 22 MAJ 2013

ORA = Organisation Requirements for Air Crew

ORO = Organisation Requirements for Air Operations

RIA = Regulatory Impact Assessment

A- och B-delen påverkas

SMS

A-delen

• Management System

• Safety Risk

Management

• Compliance

Monitoring

• Alternative Means of

Compliance

SSP/EASP

B-delen

• Management System

• Riskbased oversight

– Möjligt med 24, 36, 48

mån mellan VK.

(även kortare)

• Compliance Monitoring

• Alternative Means of

Compliance2013-04-22

6SSP = State Safety Programme

EASP = European Aviation Safety Programme

Management System

Följande element är det som adresseras i reglerna för

Management System och tillhörande AMC/GM:

• Management Structure

• Safety Policy

• Internal Reporting

• Management of Change

• Safety Risk Management

• Safety Performance Monitoring

• Emergency Response Planning

• Training and Communication on Safety

• Management System Documentation

• Compliance Monitoring2013-04-22

7

Förslag på implementeringstid

2 år för:

• CAMO för CAT & CMPA

(CAT indirekt från 28 okt 2014)

• 145.

3 år för:

• CAMO non-CAT & non-CMPA

• MF.

Räknat från beslutsdatum.

2013-04-22

8(A16)CMPA = Complex Motorpowered Aircraft

CAT = Commersial Air Transport

Flera länder har redan börjat med implementeringen

• “Similarly, as a number of Member States have already

strongly encouraged SMS implementation for Part-145

maintenance organisations (such as France,

Switzerland, and the United Kingdom, together

representing 40 % of all EASA States’ Part-145

maintenance organisations, based on 2011 figures)”

2013-04-22

9(A23)

Varför SMS

Tidigare olyckor

• Pga allmänna orsaker. Kunde påverkas med regler.

Nuvarande olyckor

• Mer slumpmässiga (unika).

• Det kräver att organisationerna själva försöker

identifiera och undvika att det sker.

CAMO inte immun mot HF errors

• Nyckelroll i luftvärdighetsarbetet.

• Kan skapa egna problem och sätta “tryck” på

underhållsorganisationerna.

2013-04-22

10(A20)

Management SystemM.A.616, M.A.712, 145.A.65

(ORO.GEN.200, ORA.GEN.200)

2013-04-22

11

Idag

Quality System

• Quality Manager

• Compliance Monitoring

• MG activities acc to

procedures

• Contracted maintenance

• Compliance requirements

Det är mera en beskrivning

av ett

Quality Audit System.

Enligt NPA 2013-01

Management System

• Responsibility & accountability

• Safety policy

• Safety Risk Management

• Safety Manager

• Trained & competent personnel

• Documentation of processes

• Compliance Monitoring

• Compliance Monitoring Manager

• Corresponds to size &

complexity

2013-04-22

12

M.A.712 Management system (M.A.616, 145.A.65, ORO.GEN.200, ORA.GEN.200)

(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;

(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 actions to mitigate the risk and verify their effectiveness;

(4) maintaining personnel trained and competent to perform their safety

management related duties and tasks;

(5) documentation of all management system key processes, including a

process for making personnel aware of their responsibilities and the

procedure for amending this documentation;

2013-04-22

13

M.A.712 Management system (M.A.616, 145.A.65, ORO.GEN.200, ORA.GEN.200)

(a) The organisation shall establish, implement, and maintain

a management system that includes:

(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; and

(7) any additional requirements that are prescribed in this Regulation

(b) The management system shall correspond to the size of the

organisation and the nature and complexity of its activities, taking into

account the hazards and associated risks inherent in these activities.

(c) Where the organisation holds one or more additional organisation certificates within

the scope of Regulation (EC) 216/2008, the management system may be

combined or integrated with that required under the additional certificate (s) held.

• Punkt c finns inte i ORO, ORA

2013-04-22

14

Complex vs non-complex organisation

(CAMO/145)

Criteria for determining organisational complexity are

proposed in a dedicated AMC.

These do not only consider the size of the organisation,

but also specific risk criteria related to the type of

activity

(cf. AMC1 M.A.712(b) and AMC1 145.A.65(b) „size,

nature, and complexity of the activity‟).

2013-04-22

15(A8)

Complex vs non-complex organisation

(MF/CAMO/145)

2013-04-22

16

Regel

Management System

•M.A.616, M.A.712, 145.A.65

AMC ”Z”

non-complex

organisation

AMC ”Y”

complex

organisation

OBS:

MF alltid non-complex organisation

CAMO non-complex organisation

SIZE, NATURE AND COMPLEXITY OF THE ACTIVITY

(a) An organisation should be considered as

non-complex when:

1)≤10 full-time FTEs; and

2)not involved in of complex motor-powered

aircraft, or aircraft in commercial air transport.

(b) Where the organisation holds approvals pursuant to any other

Part, this should be taken into consideration to determine

whether it is complex or non-complex.

(c) Organisations only involved in the management of continuing

airworthiness of balloons or sailplanes should be considered

non-complex by default.

AMC1 M.A.712 (b) Management system 2013-04-22

17

CAMO non-complex organisation

AMC1 M.A.712 (b) Management system

SIZE, NATURE AND COMPLEXITY OF THE ACTIVITY

(a) An organisation should be considered as non-complex when:

(1) it has no more than 10 full-time equivalents (FTEs) actively engaged

in continuing airworthiness management; and (

2) it is not involved in the management of continuing airworthiness of

complex motor-powered aircraft, or aircraft used in commercial air

transport.

(b) Where the organisation holds approvals pursuant to any other Part, this

should be taken into consideration to determine whether it is complex or

non-complex.

(c) Notwithstanding point (a), organisations only involved in the management

of continuing airworthiness of balloons or sailplanes should be

considered non-complex by default.

2013-04-22

18

145 complex, non-complex organisation

SIZE, NATURE AND COMPLEXITY OF THE ACTIVITY

(a)An organisation should be considered as complex when it has

>20 FTE maintenance staff engaged in carrying out maintenance.

(b) Organisations with ≤20 FTE may also be considered complex

based on an assessment of the following factors:

1) complexity, the extent and scope of subcontracted

activities; and

2) risk criteria, the number and variety of A, B, C or D ratings.

(c) following organisations should always be considered as non-

complex:

1) only holding a D rating; and

2) only holding three or less of the following C ratings:

C2, C3, C4, C5,C6, C9, C12, C13, C14, C15, C17, C18, C19, or C20.

AMC1 145.A.65(b) Management system 2013-04-22

19

145 complex, non-complex organisation

AMC1 145.A.65(b) Management system

SIZE, NATURE AND COMPLEXITY OF THE ACTIVITY

(a) An organisation should be considered as complex when it has more than 20 Full

Time Equivalent (FTE) maintenance staff actively engaged in carrying out

maintenance under the Part-145 certificate .

(b) Organisations with up to 20 FTE maintenance staff actively engaged in carrying out

maintenance under the Part-145 certificate may also be considered complex

based on an assessment of the following factors:

(1) in terms of complexity, the extent and scope of subcontracted activities subject

to the Part-145 certificate; and

(2) in terms of risk criteria, the number and variety of aircraft (A), engine (B),

component (C) type ratings, and specialised services (D) ratings.

(c) Notwithstanding points (a) and (b) above, the following organisations should

always be considered as non-complex:

(1) organisations only holding a D rating; and

(2) organisations only holding three or less of the following C ratings: C2, C3, C4,

C5,C6, C9, C12, C13, C14, C15, C17, C18, C19, or C20.

2013-04-22

20

Management System

Både complex och non-complex organisation

• Safety Manager

• Safety Risk Management process

• Emergency Response Planning

• Management of changes

• Compliance Monitoring function (CMM)

• Compliance Monitoring system

• ”Small organisation” kan ersätta Compliance

Monitoring function med organisational review.

2013-04-22

21

Management System

Complex organisation

• Safety Review Board

• Safety Action Group

• Tränade investigators

2013-04-22

22

Vilka funktioner kan kombineras

Note 1. Det är möjligt att samma person har funktionen som

Safety Manager och Compliance Monitoring Manager.

Note 2. I non-complex organisations, kan funktionen som Safety

Manager kombineras med

• Accountable Manager eller

• Compliance Monitoring Manager eller

• en nominated post-holder (“TC”).

2013-04-22

23

CMM

AM

SM ”TC”

(A23)

Skillnad mellan CAMO o 145

Del-145 kräver FRMS

(Fatigue Risk Management Scheme)

• AMC1 145.A.47(b) Production planning

• GM7 145.A.65(a)(3) Management system

• Arbetstider enligt Directive 2003/88/EC ska följas.

• Om inte AMC1 ska följas, ska en Risk Assessment

göras som sedan ska godkännas av NAA.

2013-04-22

24(C77, 111)

För Safety Risk Management rekommenderas GM3

145.A.65(a)(3) Management system att börja med.

a) Purpose

b) Scope

c) Elements that will influence the safety risk assessment

d) Risk acceptance criteria

e) Risk assessment process steps

f) Continued validity

2013-04-22

25

GM3 145.A.65(a)(3) Management system

e) Risk assessment process steps

1) Planning

2) System description

3) Working group

4) Selection of methods and data basis

5) Hazard identification

6) Analysis of likelihood

7) Analysis of severity

8) Risk assessment

9) Risk evaluation

10) Identification of risk mitigation actions

11) Conclusions and documentation 2013-04-22

26

Övrigt i reglerna som påverkas

2013-04-22

27

Det är några Del-M punkter som gäller Del-145 idag.

De har duplicerats och även kommit in i Del-145 för att

förtydliga att de gäller även dessa.

Tex:

• Components

• Independent inspection

2013-04-22

28

Nya rubriker i expositions (CAME, MOE)

• Alternative means of compliance procedure

• Hazard identification and safety risk management

schemes

• Safety action planning

• Safety performance monitoring

• Incident investigation and safety reporting

• Emergency response planning

• Management of change (including organisational

changes with regard to safety responsibilities)

• Safety promotion

• Management system record keeping2013-04-22

29OBS: Se Del-B sid 186 & 195 på vad som förväntas

vara beskrivet bakom rubrikerna.

M.A.702 Application

• Blir ” Application for an organisation certificate ”

• Förtydligat vad sökande ska bifoga och redovisa.

M.A.704 CAME

• Safety policy

• Hur man jobbar med Safety

• Dokumenterade processer

• Alltid vara ”up to date”

2013-04-22

30

M.A.706 Personnel requirement

• Human Factor vid CMPA & CAT.

• Krav på HF-instruktören.

• Befattningshavare ska ha träning i SMS & QS.

• CMM tillhör utsedda befattningshavare (NPHCA/CAM)

även vad gäller kvalifikationskraven.

2013-04-22

31

M.A.708 Continuing airworthiness management

(d) The organisation shall ensure that human factors

and human performance limitations are taken into

account during continuing airworthiness management

resulting in good maintenance practices.

AMC:

• Identifiera flight safety tasks.

• HF vid utveckling av AMP.

• HF vid framtagning av documentation.

Tex använda sig av “simplified English”.

2013-04-22

32

M.A.712 Management System

• Mer än ett namnbyte….

M.A.713 Changes to the organisation

• Förtydligande vad som gäller ändringar.

• Tidsramar.

2013-04-22

33

M.A.716 Findings

• Identifiering av Root cause krävs.

• Corrective Action Plan krävs.

• Definitioner för:

• Correction

• Corrective Action

• Preventive Action

• Vad förväntas av en Root-cause analys.

2013-04-22

34

M.A.717 Management system record keeping

• Ny punkt.

• Ett system för lagring och spårbarhet av dokument.

• Specificerat format.

M.A.720 Means of compliance (M.A.203, M.A.620, 145.A.82)

• Möjlighet att söka om ”egna” AMC. (”Alternativa AMC”)

• Resultatet av risk assessment ska bifogas för att

bevisa att sättet är minst lika bra som gällande AMC.

(equivalent level of safety)

• Ska godkännas av myndigheten.

2013-04-22

35

M.A.721 Internal safety reporting scheme

• Ett internt säkerhetsrapporteringssystem som ska vara

en del av Management Systemet. Även M.A.202.

• Insamling och utvärdering av:

• Errors

• Near-misses

• Hazards.

• Vid CAT & CMPA ska utredningar göras i samarbete

med relevanta organisationer.

• Just culture.

• Appropriate Corrective actions.

2013-04-22

36

M.A.721 Internal safety reporting scheme

• Definitioner

• Closed-loop

• Feedback:

• Reporter

• Organisation

• Continuation training

Complex organisations

• Tränade investigators

• Analys av data och trender

2013-04-22

37

M.A.722 Immediate reaction to a safety problem

The organisation shall implement:

(a) any safety measures mandated by the competent

authority in accordance with M.B.106; and

(b) any relevant mandatory safety information issued by

the Agency.

2013-04-22

38

M.A.202 External occurrence reporting

• Ett AMC som förtydligar vad rapporten ska innehålla.

M.A.203 Means of compliance

• ”Alternativt AMC” för privat luftvärdighetsansvarig och

”fristående tekniker”.

M.A.302 Maintenance Programme

• Begreppet ”indirect approval” försvinner.

Men inte som möjlighet.

2013-04-22

39

Sammanfattning

• Allmänt

• Management System

• Övrigt i reglerna som påverkas

• (Möjlighet påverka regelstrukturen)

2013-04-22

40

OBS:

• Denna presentation är baserad på vår uppfattning av

NPA 2013-01.

• Hur reglerna slutligen utformas efter beslut hos

Europeiska kommissionen och EASA kan komma

ändras.

2013-04-22

41

SLUT

2013-04-22

42

Möjlighet påverka regelstrukturen

Option A

• Som i OPS/FCL. GEN + MF/MG/145 specifika.

Option B

Gemensamt nummersystem Tex M.A.200, 145.A.200,

ORO.GEN.200 Management System.

Option C

Bryta ut AMC/GM till en gemensam del för MF/MG/145.

• Motsvarande AMC20.

Option D

Bryta ut AMC/GM till en gemensam del för M.B, 145.B.

• „Oversight principles‟ and „Oversight programme‟.2013-04-22

43Se NPA 2013-01 (A) sid 14-16

Alternativ A

Note: Option A would require a new rulemaking task.2013-04-22

44

Alternativ B

Note: Options B could be implemented as part of this

rulemaking task.2013-04-22

45

Alternativ C

Note: Options C could be implemented as part of this

rulemaking task.2013-04-22

46

M.A.616

Management System

M.A.712

Management System

145.A.65

Management System

AMC/GM M.A.616

Management System

AMC/GM M.A.712

Management System

AMC/GM 145.A.65

Management System

Alla Management System AMC/GM

i ett dokument liknande AMC20

(MF/CAMO/145/147)

Alternativ C

Keeping the current rule structure and numbering system,

while extracting all AMC and GM related to the new

„Management system’ requirements in Sections A

of Part-M Subpart F, Part-M Subpart G, and Part-145

(and later on Part-147) to include them in a single

document, similar to current Agency AMC-20 or

CASA draft Advisory Circular AC 145-1(0). This would

mainly concern the AMC and GM to M.A.616; M.A.712,

and 145.A.65 (and later on 147.A.130).

Note: Options C could be implemented as part of this

rulemaking task.2013-04-22

47

Alternativ D

Note: Options D could be implemented as part of this

rulemaking task.2013-04-22

48

M.B.130, 604Oversight principles‟ and

„Oversight proramme

M.B.130, 704Oversight principles‟ and

„Oversight proramme

145.B.30, 33Oversight principles‟ and

„Oversight proramme

AMC/GM

M.B.130, 604Oversight principles‟ and

„Oversight proramme

AMC/GM

M.B.130, 704Oversight principles‟ and

„Oversight proramme

AMC/GM

145.B.30, 33Oversight principles‟ and

„Oversight proramme

Alla

Oversight principles‟ and „Oversight programme

AMC/GM i ett dokument som alternativ C

(MF/CAMO/145/147)

Alternativ D

Keeping the current rule structure and numbering system,

while extracting all AMC and GM related to

„Oversight principles‟ and „Oversight programme‟ in

Sections B of Part-M Subpart F, Part-M Subpart G,

and Part-145 (and later on Part-147) to include them in

a single document, as for option C.

Note: Options D could be implemented as part of this

rulemaking task.2013-04-22

49