1. Introduction. The core part of the EASA management system framework focuses on the following elements:
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1 EASA survey to RMT.0251 Phase II SMS for EASA Part-21 design organisations, EASA Part-21 production organisations and EASA Part-145 maintenance organisations Fields marked with * are mandatory. 1. Introduction In the context of the preparation of the Regulatory Impact Assessment for RMT.0251 Embodiment of safety management system (SMS) requirements into Commission Regulations (EU) 1321/2014 and 748/2012 "Phase II SMS for EASA Part-21 design organisations, EASA Part-21 production organisations and EASA Part-145 maintenance organisations", EASA is launching a survey to the competent authorities and industry. The survey is aimed at supporting the determination of SMS applicability and identifying where proportionality is needed, as well as at collecting data on potential impacts, difficulties and opportunities in SMS implementation. The collected data will help the Agency to take an informed and evidence-based decision on regulating SMS requirements for EASA Part-21 design organisations, EASA Part-21 production organisations and EASA Part-145 maintenance organisations. When developing SMS requirements for EASA Part-21 design organisations, production organisations and EASA Part-145 maintenance organisations, EASA will consider the management system requirements for Continuing Airworthiness Management Organisation (CAMO) as defined in the EASA Opinion 06/2016 Embodiment of safety management system (SMS) requirements into Commission Regulation (EU) 1321/2014 SMS in Part-M.[1] These build upon the EASA management system framework for safety management defined for the other domains (Air Operations, Aircrew, Aerodrome operators, etc.). The EASA management system framework (IRs and related AMCs) addresses all elements of the ICAO SMS framework defined in Appendix 2 to Annex 19 and promotes an integrated approach to the management of an organisation. It encourages organisations to embed safety management and risk-based decisionmaking into all of their activities, instead of superimposing another system onto their existing management system and governance structure. The core part of the EASA management system framework focuses on the following elements: clearly defined responsibilities and accountabilities for the activities that are subject to the relevant EASA rules; a safety policy and related safety objectives; implementation of safety reporting procedures in line with just culture principles; 1
2 identification of aviation safety hazards, ensuring their assessment, and the management of associated risks; including:(1) taking actions to mitigate the risks that are not acceptable after risk assessment;(2) verifying the effectiveness of actions taken to mitigate risks; a function to monitor compliance and provide feedback on findings to the accountable manager; maintaining personnel trained, competent, and informed about significant safety issues; and documentation of all management system key processes. In the EASA management system framework non- essential implementation aspects are proposed to be included at the AMC level to provide flexibility. When reference is made to SMS in this survey this may mean either the EASA management system framework or the ICAO Annex 19 Appendix 2 SMS framework (or any equivalent framework). [1] 20te.pdf 2. Confidentiality Please note that the collected data will be treated with confidentiality. It will be aggregated in a report (at Member State level and/or per type of stakeholder) to avoid the possibility to recognise any entity or person who answered to the survey. Any information that will be used for the purpose of the report will be de-identified to ensure the confidentiality of the respondents. 3. Next steps The results of the surveys will be aggregated and used for the preparation of the Regulatory Impact Assessment which will accompany the NPA for the RMT.0251 SMS Phase II. 4. Deadlines for submitting responses to the survey Responses can be submitted by 15 February Any response submitted after the closure date of the survey will not be considered. Please note that responding to this survey should not take you longer than 20 minutes. 5. Instructions for organisations holding multiple approvals For organisations holding multiple approvals the Agency would welcome a consolidated response, representing all those approvals. Should this not be considered adequate, individual responses corresponding to each approval held can be provided, by means of separate submissions. Should this option be used, organisations are invited to use the first question below (Part 1, question 1) to identify the approval corresponding to each submission. 2
3 Part 1 General questions * 1. I am responding to this survey representing: European competent authority (EASA Member States) Part-145 Maintenance Organisation Part-21 Approved Design Organisation (DOA) (Subpart J) TC-Holder Part-21 Approved Design Organisation (DOA) (Subpart J) STC-Holder Part-21 Approved Design Organisation (DOA) (Subpart J) Minor change minor repair approval holder Part-21 Approved Design Organisation (DOA) (Subpart J) ETSO approval holder (for APU) ETSO approval holder (other than APU) Part-21 Approved Production Organisation (POA) (Subpart G) Part-21 Alternative Procedures to Approved Design Organisation (ADOA) TC-Holder Part-21 Alternative Procedures to Approved Design Organisation (ADOA) STC-Holder Part-21 Alternative Procedures to Approved Design Organisation (ADOA) - Minor change minor repair approval holder Part-21 Production organisation without Approval (Subpart F) Part-21 Design Organisation with certification programme TC-Holder Part-21 Design Organisation with certification programme STC-Holder Part-21 Design Organisation with certification programme - Minor change minor repair approval holder Continuing Airworthiness Maintenance Organisation (CAMO) Part-147 Maintenance Training Organisation Air Operator with Air Operator Certificate (AOC) Approved Training Organisation (ATO) Other (please specify) * If other, please specify * 1a. What products are you designing/manufacturing? Aircraft ELA 1 Aircraft ELA 2 (other than ELA 1) Other aircraft Engine Propeller Part and appliance * 1b. Please identify your class rating (only for Part-145 maintenance organisations) Aircraft A1 Aircraft A2 Aircraft A3 Aircraft A4 Engines B1 Engines B2 3
4 Engines B3 C components to be installed on complex motor-powered aircraft (CMPA) C components to be installed on other than CMPA D1 NDT * Contact details Austria Belgium Bulgaria Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Iceland Ireland Italy Latvia Liechtenstein Lithuania Luxembourg Malta Netherlands rway Other Poland Portugal Romania Slovak Republic Slovenia Spain Sweden Switzerland United Kingdom * If other, please specify Name of your organisation 4
5 Your first, family name Your position * Your Questions to organisations 1. Select your company size (number of employees for all the approvals/ activities that you selected in Part 1.1 of the survey): > In your opinion are there any organisations/activities/products addressed in EASA Part-21 that should not be subject to any SMS requirements? * If yes, please specify which organisations/activities/ products. * 2b. Please justify your answer 5
6 3. In your opinion are there any categories of EASA Part-145 organisations that should not be subject to any SMS requirements? Background: a new Part-CAO (Continuing Airworthiness Organisation) type of maintenance organisation without SMS requirements shall be adopted (for other than complex motor-powered aircraft used by other than licensed air carriers) (reference to Opinion 05/2016) * If yes, please specify which organisations/activities. * 3a. Please justify your answer. 4. Have you already implemented SMS in your company? 4a. If yes, could you list the approvals for which you have implemented SMS? 4b. The decision to implement SMS was made: due to national aviation regulations mandating SMS to comply with contractual requirements mandating SMS on a voluntary basis due to multiple approvals held by the organisation (e.g. organisation also holding an AOC) other (please specify) If other, please specify 6
7 4c. Did you consider any industry standards for the development of your SMS? Do not know If yes, which ones? 4d. Any other comments on industry standards for SMS. 5. In your opinion, what are the three main cost drivers in SMS implementation? between 1 and 3 choices Additional staff Training (e.g. safety training development) Software & other tools (e.g. reporting system, risk analysis tools, risk registers) Internal audits Safety investigations Organisational changes, such as creation of additional working groups (e.g. Safety Review Board, Safety Action Group) Documentation (e.g. new procedures/manuals and updates to existing ones) Safety promotion & communication Consultancy Oversight (authority fees, time spent in audits & assessments) Other (please specify) If other, please specify 5a. Do you have any additional comments on the costs of SMS implementation? 7
8 5b. Have you encountered any negative impacts, regarding the SMS implementation (other than cost impact)? Please justify. 6. In your opinion, what are the main difficulties in SMS implementation? Please justify. 7. In your opinion, what are the three most significant benefits in SMS implementation? between 1 and 3 choices Improved compliance (e.g. lower number of findings in internal or external audits) Improved internal reporting (number and types of reports) Improved senior management commitment Better safety culture Better hazard identification leading to better risk control More efficient allocation of resources Faster resolution of safety issues Improved relationship with the competent authority Improved communication on safety issues within the company Improved communication on safety issues with other parties Improved efficiency of internal processes in general terms Better management of changes Other (please specify) If other, please specify 8
9 7a. Do you have any additional comments on the benefits of SMS implementation? 8. Do you have any other comments or proposals related to the implementation of SMS in the area of design, manufacture and maintenance? Questions to the authorities 1. Do you have consolidated information/statistics on: number and details of class rating(s) for each Part-145 organisation under your oversight according to the different Class rating(s) (A1, A2, A3, A4, B1, etc.) number of employees covered by the Part-145 approval? other, please specify If other, please specify 1a. Would you agree to share this information with EASA? 2. In your opinion are there any organisations/activities/products addressed in EASA Part-21 that should not be subject to any SMS requirements? * If yes, please specify which organisations/activities/ products. 9
10 * Please justify your answer. 3. In your opinion are there any categories of EASA Part-145 organisations that should not be subject to any SMS requirements? Background: a new Part-CAO (Continuing airworthiness organisation) type of maintenance organisation without SMS requirements shall be adopted (for other than complex motor-powered aircraft used by other than licensed air carriers) (reference to Opinion 05/2016) * If yes, please specify which organisations/activities. * Please justify your answer. 4. What is your experience and lessons learnt with SMS implementation with your industry (production organisations, Part-145 organisations)? 10
11 5. Did you notice any difference in the implementation and/or benefits of SMS depending on the scope of Part-145 or production organisations (e.g. notable differences in A-rated compared to B-rated Part-145 organisations)? 6. Taking into consideration the RMT objective to introduce the general authority requirements as proposed with Opinion 06/2016 Part-CAMO and as already applicable in the other domains: a. What initial costs for do you expect for the competent authority related to the implementation of those authority requirements within the scope of Part-21 and Part-145? Could you please estimate these costs in terms of working hours? 6b. Which costs savings and other benefits do you expect? 7. How are you preparing/did you prepare your inspectors for the introduction of SMS in Part-21 and Part- 145? 8. Did you already publish specific guidance for your industry dealing with SMS implementation in design, manufacturing and/or maintenance? 8a. If yes, could you please provide copies/links to those documents? 11
12 Please upload your file Please upload your file Please upload your file 9. Do you have any other comments on SMS implementation in the area of design, manufacture and maintenance? 12
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