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 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. 2
Innehåll Allmänt Management System Övrigt i reglerna som påverkas (Möjlighet påverka regelstrukturen) 3
Allmänt 4
SMS implementering 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 5
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 Compliance SSP = State Safety Programme EASP = European Aviation Safety Programme 6
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 Monitoring 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. CMPA = Complex Motorpowered Aircraft CAT = Commersial Air Transport (A16) 8
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) (A23) 9
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. (A20) 10
Management System M.A.616, M.A.712, 145.A.65 (ORO.GEN.200, ORA.GEN.200) 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 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; 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 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 ). (A8) 15
Complex vs non-complex organisation (MF/CAMO/145) Regel Management System M.A.616, M.A.712, 145.A.65 AMC Y complex organisation AMC Z non-complex organisation OBS: MF alltid non-complex organisation 16
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 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. 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 noncomplex: 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 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. 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. 21
Management System Complex organisation Safety Review Board Safety Action Group Tränade investigators 22
Vilka funktioner kan kombineras AM SM TC CMM 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 ). (A23) 23
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. (C77, 111) 24
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 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 26
Övrigt i reglerna som påverkas 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 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 keeping OBS: Se Del-B sid 186 & 195 på vad som förväntas vara beskrivet bakom rubrikerna. 29
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 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. 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. 32
M.A.712 Management System Mer än ett namnbyte. M.A.713 Changes to the organisation Förtydligande vad som gäller ändringar. Tidsramar. 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. 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. 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. 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 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. 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. 39
Sammanfattning Allmänt Management System Övrigt i reglerna som påverkas (Möjlighet påverka regelstrukturen) 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. 41
SLUT 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. Se NPA 2013-01 (A) sid 14-16 43
Alternativ A Note: Option A would require a new rulemaking task. 44
Alternativ B Note: Options B could be implemented as part of this rulemaking task. 45
Alternativ C M.A.616 Management System AMC/GM M.A.616 Management System M.A.712 Management System AMC/GM M.A.712 Management System 145.A.65 Management System AMC/GM 145.A.65 Management System Alla Management System AMC/GM i ett dokument liknande AMC20 (MF/CAMO/145/147) Note: Options C could be implemented as part of this rulemaking task. 46
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. 47
Alternativ D M.B.130, 604 Oversight principles and Oversight proramme AMC/GM M.B.130, 604 Oversight principles and Oversight proramme M.B.130, 704 Oversight principles and Oversight proramme AMC/GM M.B.130, 704 Oversight principles and Oversight proramme 145.B.30, 33 Oversight principles and Oversight proramme AMC/GM 145.B.30, 33 Oversight principles and Oversight proramme Alla Oversight principles and Oversight programme AMC/GM i ett dokument som alternativ C (MF/CAMO/145/147) Note: Options D could be implemented as part of this rulemaking task. 48
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. 49