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ELEVENTH MEETING OF THE CONFORMITY ASSESSMENT TASK FORCE CATF11

ELEVENTH MEETING OF THE CONFORMITY ASSESSMENT TASK FORCE (CATF

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ELEVENTH MEETING OF THE CONFORMITY ASSESSMENT TASK FORCE CATF11

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    1. ELEVENTH MEETING OF THE CONFORMITY ASSESSMENT TASK FORCE (CATF#11)

    2. ELEVENTH MEETING OF THE CONFORMITY ASSESSMENT TASK FORCE (CATF#11)

    3. ELEVENTH MEETING OF THE CONFORMITY ASSESSMENT TASK FORCE (CATF#11)

    4. ELEVENTH MEETING OF THE CONFORMITY ASSESSMENT TASK FORCE (CATF#11)

    5. CATF#11 8th October 2007 Slide # 5 Regulatory Framework for EU Legislation The Resolution of 7 May 1985 : Stresses importance of European Standards to improve competitiveness Requests EU legislation to be limited to essential safety requirements Asks for the adoption of voluntary European Standards Indicates that standards ensure presumption of compliance with Essential Requirements Requires that manufacturers declare conformity of products after compliance with CA procedures Foresees possible prohibition of putting on the market by Member States if lack of compliance

    6. CATF#11 8th October 2007 Slide # 6 Regulatory Framework for EU Legislation Decision 93/465/EEC : Decision 93/465/EEC replaces decision 90/683/EEC and implements Council Resolution 1989 on Global Approach to Conformity Assessment. The Decision: Elaborates modules describing conformity evaluation and assessment Specifies recourse to Notified Bodies by Member States in order to perform conformity assessment – preferentially by using accreditation to verify competence Advises manufacturers on Quality Assurance System implementation Specifies manufacturer responsibility to ensure conformity of marketed products.

    7. CATF#11 8th October 2007 Slide # 7 The Draft Regulation

    8. CATF#11 8th October 2007 Slide # 8 The Draft Regulation Regulation directly applicable 2 years after adoption 1. ACCREDITATION: New : Common provisions for European infrastructure for accreditation of conformity assessment bodies (CAB) Ensure coherent procedures based upon European standards and peer evaluation Encourage the application of accreditation Impact: Harmonised European procedures applicable when accreditation of certification bodies is applied Accreditation mandatory for in-house bodies

    9. CATF#11 8th October 2007 Slide # 9 The Draft Regulation 2. Market Surveillance New : Common provision for a coherent market surveillance approach in order to Reduce probability of using non-compliant products Ensure exchange of information between Authorities Ensure rapid EU action in case of serious and immediate risks.

    10. CATF#11 8th October 2007 Slide # 10 The Draft Regulation Impact : Common provisions shall be implemented by Member States Perform random verifications of constituents on the market Action : Evaluate market activities implemented under SES Interoperability Regulation Show equivalence between draft Regulation provisions and provisions resulting from implementation of SES Regulation Request exclusion of EATMN sector from draft Regulation

    11. CATF#11 8th October 2007 Slide # 11 The Draft Regulation 3. Border Control New : Substituting current Regulation on custom checks of imported products Co-operation between customs and market surveillance authorities Impact : Draft Regulation applies to the EATM sector Implement relevant provision of the draft Regulation

    12. CATF#11 8th October 2007 Slide # 12 The Draft Decision

    13. CATF#11 8th October 2007 Slide # 13 The Draft Decision Replaces Decision 93/165/EEC Not directly applicable but to be taken into account for new legislation Integrates many provisions of the Regulation of 7th May 1985 : Safeguard procedures Management of European Standards Comitology

    14. CATF#11 8th October 2007 Slide # 14 The Draft Decision 1. Conformity Assessment Procedures New : Modules as in present decision except module B Module B completed by 2 variants: Asessment of the design documentation only Assesment of the design documentation and of critical elements of the product-type Impact : Allows more flexibility for EC-type examination procedures Better suited for the EATMN sector Action : Evaluate opportunity of elaborating modules adapted to the EATMN sector

    15. CATF#11 8th October 2007 Slide # 15 The Draft Decision 2. Economic Operators: New : Obligations for Importers and distributors Traceability requirements between economic operators in the distribution chain Impact : Ensure good distribution practices Action : Evaluate specific EATMN market surveillance approach Demonstrate compliance with relevant requirements of draft Decision

    16. CATF#11 8th October 2007 Slide # 16 The Draft Decision 3. Certification Bodies New : Common criteria for assessment of Bodies to be notified Requirements applicable to Notifying Authorities Some conformity assessment tasks performed by in-house bodies Impact : Strict provisions for notification of 3rd party assessment bodies Option to designate in-house conformity assessment bodies Designation of Notifying Authorities

    17. CATF#11 8th October 2007 Slide # 17 The Draft Decision 4. In-house Bodies New : Conformity Assessment performed by in-house bodies under certain conditions In-house bodies may be acting for manufacturers or users In-house bodies shall : Act only for the undertaking it is a member of Perform verifications: only procedures described by modules A1,A2, C1 and C2 Be accredited though not notified

    18. CATF#11 8th October 2007 Slide # 18 The Draft Decision 4. In-house Bodies Impact: Useful option for in-house user bodies (ANSPs) Accreditation mandatory Action: Extend activities of in-house user bodies to modules F, F1 and G Designate procedures for Notified Bodies EATMN in–house user bodies shall be notified

    19. CATF#11 8th October 2007 Slide # 19 Points to be discussed Is it meaningful to apply market surveillance as described by the draft Regulation for the EATMN sector? Should in-house user bodies be authorised to perform tasks described in modules F, F1 and G? Should in-house user bodies be designated and notified by the procedures applicable for Notified Bodies? Would it be useful to elaborate conformity assessment procedures for the EATMN sector?

    20. CATF#11 8th October 2007 Slide # 20 Proposed Actions 1. Draft Regulation and Decision Prepare a list of points to be modified and elaborate explanatory memoranda Propose corresponding amendments and justifications Invite the Commission to present the amendments to the Council and the European Parliament

    21. CATF#11 8th October 2007 Slide # 21 Proposed Actions 2. Certification Procedures Elaborate draft implementing measures describing: Custom made conformity assessment modules coherent with the draft Decision Designating procedures for Notified Bodies and in-house bodies Invite the Commission to adopt the draft measure

    22. ELEVENTH MEETING OF THE CONFORMITY ASSESSMENT TASK FORCE (CATF#11)

    23. 23 8th October 2007 Summary Progress report for the EC verification of the new ILS/DME at Bordeaux airport ER3 in CA plan for ILS/DME Understanding of ER3 Safety Implementation for ILS/DME conformity assessment

    24. 24 8th October 2007 Bordeaux ILS/DME trial : progress report

    25. 25 8th October 2007 ER3 in CA plan for ILS/DME REVIEW OF ER3 Definition Understanding Applicability for ILS/DME IMPLEMENTATION IN ILS/DME CA PLAN Conformity Assessment process description System Definition Safety Requirements for the ILS/DME Means of compliance for ILS/DME Managing Verification of Conformity Overall design verification Development and Integration Verification Operational Integration Verification Maintenance provisions Verification

    26. 26 8th October 2007 Definition of ER3 Systems and operations of the EATMN shall achieve agreed high levels of safety. Agreed safety management and reporting methodologies shall be established to achieve this. In respect of appropriate ground-based systems, or parts thereof, these high levels of safety shall be enhanced by safety nets which shall be subject to agreed common performance characteristics. A harmonised set of safety requirements for the design, implementation, maintenance and operation of systems and their constituents, both for normal and degraded modes of operation, shall be defined with a view to achieving the agreed safety levels, for all phases of flight and for the entire EATMN. Systems shall be designed, built, maintained and operated, using the appropriate and validated procedures, in such a way that the tasks assigned to the control staff are compatible with human capabilities, in both the normal and degraded modes of operation, and are consistent with required safety levels. Systems shall be designed, built, maintained and operated using the appropriate and validated procedures, in such a way as to be free from harmful interference in their normal operational environment.

    27. 27 8th October 2007 Understanding of ER3-1 Systems and operations of the EATMN shall achieve agreed high levels of safety. Agreed safety management and reporting methodologies shall be established to achieve this. ER3 applies to systems defined in annex I of regulation 552/2004 ER3 encompasses the systems in their operational environment Objectives shall be commonly accepted objectives by stakeholders, potentially at two levels, national or at community level These levels of safety shall be quantitative or qualitative Specific safety processes shall ensure that the objectives are taken into account Control and monitoring procedures shall be implemented, as part of SMS ER3-1 as the core of ER3 requirement Rest of ER3 considered as supporting requirements for ER3-1

    28. 28 8th October 2007 Understanding of ER3-2 In respect of appropriate ground-based systems, or parts thereof, these high levels of safety shall be enhanced by safety nets which shall be subject to agreed common performance characteristics. This requirement is only applicable to a subset of EATMN (“appropriate […]”) In order to reach ER3-1 requirements, safety nets would be mandatory A possible confusion remains on the meaning of safety nets in this broad context Ground-based systems safety nets refer to STCA, MSAW and APW From a more general perspective a safety net may be interpreted as any system or constituent to enhance safety level The performance characteristics of these safety nets shall be agreed Similar to ER3-1 provision

    29. 29 8th October 2007 Understanding of ER3-3 A harmonised set of safety requirements for the design, implementation, maintenance and operation of systems and their constituents, both for normal and degraded modes of operation, shall be defined with a view to achieving the agreed safety levels, for all phases of flight and for the entire EATMN. Safety objectives shall be considered for the entire life cycle All modes of operation shall be taken into account ER3 encompasses gate-to-gate operations

    30. 30 8th October 2007 Understanding of ER3-4 Systems shall be designed, built, maintained and operated, using the appropriate and validated procedures, in such a way that the tasks assigned to the control staff are compatible with human capabilities, in both the normal and degraded modes of operation, and are consistent with required safety levels. Human Factors issues shall be taken into account Associated processes shall implemented along the life cycle Appropriate is insufficient or redundant with “validated” “Validated” needs to define which organisation is in charge of this validation.

    31. 31 8th October 2007 Understanding of ER3-5 Systems shall be designed, built, maintained and operated using the appropriate and validated procedures, in such a way as to be free from harmful interference in their normal operational environment. This requirement might aim at complementing R&TTE directive 1999/5/EC : to be confirmed. This requirement shall be clearly identified for all phases of life cycle.

    32. 32 8th October 2007 The essence of ER3 ER3-1 as the core of ER3 requirement ER3 applies to systems defined in annex I of regulation 552/2004 in their operational environment Objectives shall be commonly accepted objectives by stakeholders, potentially at two levels, national or at community level Specific safety processes shall ensure that the objectives are taken into account Rest of ER3 considered as supporting requirements for ER3-1 Safety nets shall be implemented to secure specific systems or constituents To be confirmed : Ground-based systems safety nets refer to STCA, MSAW and APW Scope Safety objectives shall be considered over the entire life cycle All modes of operation shall be taken into account Gate-to-gate operations Processes shall be developed for the entire life cycle of the system Human Factors issues shall be taken in account

    33. 33 8th October 2007 ER3 in CA plan for ILS/DME REVIEW OF ER3 Definition Understanding Applicability for ILS/DME IMPLEMENTATION IN ILS/DME CA PLAN Conformity Assessment process description System Definition Safety Requirements for the ILS/DME Means of compliance for ILS/DME Managing Verification of Conformity Overall design verification Development and Integration Verification Operational Integration Verification Maintenance provisions Verification

    34. 34 8th October 2007 CA process description

    35. 35 8th October 2007 Identification of the regulatory baseline

    36. 36 8th October 2007 ER3 Means of compliance – Community level

    37. 37 8th October 2007 ER3 Means of compliance – National level DSNA example “Directive(s)” Maintenance provisions Flight inspections Putting into service Procurement technical specifications Safety argument (2096/2005) FAA Order 6750.24D: Instrument Landing System and ancillary electronic component configuration and performance requirements

    38. 38 8th October 2007 Implementation in ILS/DME CA plan

    39. 39 8th October 2007 Conclusion

    40. ELEVENTH MEETING OF THE CONFORMITY ASSESSMENT TASK FORCE (CATF#11)

    41. CATF#11 8th October 2007 Slide # 41 Introduction COMPARATIVE STUDY Of : Airworthiness Operational approval processes And Compliance verification to EATM constituents and systems

    42. CATF#11 8th October 2007 Slide # 42 Objectives Comparison of both EASA and SES regulatory environments (airworthiness and operational approval / verification of compliance) Provide recommendations about possible evolution of both regulatory contexts : Ensure consistency of airworthiness and verification of compliance Provide recommendations to streamline verification of compliance , mitigate possible non end to end interoperability risks

    43. CATF#11 8th October 2007 Slide # 43 Heading lines of the study Step 1 What is required by regulators? Step 2 How stakeholders meet regulations? Step 3 Recommendations for improvement of both regulatory environments and recommendations for mitigation of risks of non end to end interoperability

    44. CATF#11 8th October 2007 Slide # 44 A: Comparative description of EASA and SES regulatory environments Scoping the domains for comparison Lifecycle of products design, production, installation, use, maintenance, repair and decommissioning Regulatory requirements Requirements applicable to products Requirements applicable to processes ruling the product lifecycle Requirements applicable to organisations responsible for operations during the product lifecycle Requirements applicable to certification / approval activities Comparison of EASA & SES regulatory environments

    45. CATF#11 8th October 2007 Slide # 45 B: Description of certification, approval processes applicable to products supporting data link services Airworthiness certification and operational approval of avionics data link products Verification of compliance and safety acceptance of EATMN systems supporting data link services (under SES future Regulation DLS IR) Relationship and dependency between certification / verification of EATM systems / safety acceptance

    46. CATF#11 8th October 2007 Slide # 46 C: Safety acceptance and conformity assessment of EATMN systems Safety assessment and related safety acceptance Granularity of systems subject to safety approval Scope of the safety assessment in respect of the lifecycle of systems Changes / Verification methods Responsibility of organisations Conformity assessment of EATMN systems Scope of the conformity assessment in respect of the lifecycle of EATMN systems Changes / verification methods Responsibility of organisations

    47. CATF#11 8th October 2007 Slide # 47 D: Recommendations for improvement Recommendations for both regulatory environments Cross-verification of regulation and standardisation materials Merging EC declarations for constituents with EASA certificates Management of safeguards and non compliance cases Recommendations for the safety assessment and conformity assessment of EATMN systems Recommendations for the supervision of compliance of EATMN constituents and systems

    48. CATF#11 8th October 2007 Slide # 48 Further impact of study results Identification of possible amendments of the service provision and interoperability Regulation Improve the development process of implementing rules and specifications including an air – ground segment

    49. ELEVENTH MEETING OF THE CONFORMITY ASSESSMENT TASK FORCE (CATF#11)

    50. CATF#11 8th October 2007 Slide # 50 Working sessions for what ? Operate as an informal forum to discuss specific issues and define coordinated initiative for specific objectives relating to CA matters Early stages of application of CA Clarifications needed so to avoid deviations in the application of CA, (granularity of constituents and systems, contents of CA products (technical file)…)

    51. CATF#11 8th October 2007 Slide # 51 Coordinated initiative based on the following proposed approach Step 1 - Development of a consultation package with notably a enquiry addressing users’ needs for the application of CA to EATMN systems and constituents Step 2 - Informal consultation of stakeholders on the basis of the questionnaire Step 3 - Assessment of stakeholders replies collected during the consultation and synthesis of users’ needs Step 4 - Proposed products supporting the application of CA to EATMN systems and constituents

    52. CATF#11 8th October 2007 Slide # 52 Why an enquiry? Tool to collect views of many stakeholders (manufacturers, ANSPs, NSAs, Notified Bodies,….) about the application of CA to constituents and systems: to assess and characterize the needs for further materials to ensure that: regulatory requirements are interpreted in the same way by all stakeholders (who should issue an EC declaration of conformity or suitability for use, under which conditions ??) conformity assessment of constituents and systems is implemented in an harmonised way (notably, granularity of constituents and systems, contents of the technical file,…) by all stakeholders to propose possible evolutions of existing SES regulations on CA-related matters (airborne constituents, list of systems in Annex I, specific Modules,…) to plan and coordinate further actions responding to stakeholders concerns

    53. CATF#11 8th October 2007 Slide # 53 Step 1 Brainstorming session to prepare a consultation package: Achieve a common understanding of WHAT is required by the SES interoperability Regulation Define the scope of the enquiry List of questions to collect views of stakeholders Define the list of organizations consulted 2 – 3 sessions expected before the launch of the (informal) consultation

    54. CATF#11 8th October 2007 Slide # 54 Scope of the enquiry /2

    55. CATF#11 8th October 2007 Slide # 55 Scope of the enquiry /2

    56. CATF#11 8th October 2007 Slide # 56 Key points discussed /1 Scenario for the application of CA to constituents & systems Case 1: the coverage of implementing rules and community specifications is not sufficient to delineate interchangeable constituents. CA should be conducted by: applying a responsibility scheme negotiated between the ANSP and the manufacturer-developer corresponding to existing practices, although this scheme may deviate from the basic principles of the Global Approach; using the EC declaration of suitability for use issued by the manufacturer-developer

    57. CATF#11 8th October 2007 Slide # 57 Key points discussed/2 Case 2 the coverage of implementing rules and community specifications is sufficient to delineate interchangeable constituents . CA should be conducted by: applying a responsibility scheme in line with the basic principles of the Global Approach; using the EC declaration of suitability for use or EC declaration of conformity.

    58. CATF#11 8th October 2007 Slide # 58 Proposed way forward Finalization of the questionnaire Launch of the informal consultation Analysis of the received responses and publication of results Propose further actions and products following the stakeholders’ input

    59. ELEVENTH MEETING OF THE CONFORMITY ASSESSMENT TASK FORCE (CATF#11)

    60. ELEVENTH MEETING OF THE CONFORMITY ASSESSMENT TASK FORCE (CATF#11)

    61. ELEVENTH MEETING OF THE CONFORMITY ASSESSMENT TASK FORCE (CATF#11)

    62. ELEVENTH MEETING OF THE CONFORMITY ASSESSMENT TASK FORCE (CATF#11)

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