CONFORMITY ASSESSMENT TASK FORCE

Transcription

1 Conformity Assessment Task Force EUROCONTROL CATF#11 - REPORT CONFORMITY ASSESSMENT TASK FORCE REPORT OF THE ELEVENTH MEETING (8 th October 2007) Prepared by the Regulatory Unit

2 TABLE OF CONTENTS 1. INTRODUCTION DATE AND ATTENDANCE APPROVAL OF AGENDA PAPERS DISTRIBUTED TO CATF MEMBERS DRAFT EUROPEAN COMMISSION REGULATION ESTABLISHING A SAFETY OVERSIGHT FUNCTION REVIEW OF THE NEW APPROACH AND ITS POTENTIAL IMPACT UPON SES INTEROPERABILITY PROGRESS REPORT ON EC VERIFICATION OF ILS & CONFORMITY ASSESSMENT AND SAFETY APPROVAL PROGRESS REPORT ON EC VERIFICATION OF ILS CONFORMITY ASSESSMENT AND SAFETY APPROVAL OBJECTIVES OF THE STUDY ON EASA CERTIFICATION AND SINGLE EUROPEAN SKY VERIFICATION PROCESSES PROGRESS REPORT OF FIRST WORKING SESSION ON THE DEFINITION OF CONSTITUENTS AND SYSTEMS OPEN TOUR DE TABLE FOR REPORTING ON CA ACTIVITIES PROGRESS REPORT ON EC MANDATES A.O.B ANNEX 1 PARTICIPANTS ANNEX 2 AGENDA ANNEX 3 SLIDES File: CATF#11-REPORTv1.1 Page 2 of 12

3 1. INTRODUCTION 1.1 Date and Attendance The eleventh meeting of the Conformity Assessment Task Force (CATF#11) was held in Brussels on 8 th October The Chairman welcomed the following new members to the meeting: Mr Philippe CREBASSA EGIS Mr Enrique GISMERA AENA SPAIN Mr Jose Maria LORENZO AENA SPAIN 1.2 Approval of Agenda The Draft Agenda as shown in Annex 2 was agreed Paragraphs 3.4, 6.2 and 6.6. of the CATF# 10 report had been revised following comments received from UAC Maastricht. It was agreed to post the revised report, version 1.1, on the CATF website Jean-Luc Garnier thanked those CATF members who had submitted much appreciated proposals for the enhancement of the Initial Guidelines for Conformity Assessment and informed them that further information on this enhancement would be communicated at a later stage. 1.3 Papers distributed to CATF members On 3 October 2007, the following INFORMATION PAPERS were distributed to CATF members by CATF Information Paper "Impact of the review of the New Approach on the Interoperability Regulation". CATF Information Paper "Progress Report of first Conformity Assessment working session on Constituents and Systems" + 3 Annexes (Annex 1: Participants' list/annex 2: Slides/Annex 3: Agenda). CATF Information Paper "Progress Report on EC verification of ILS". 2. DRAFT EUROPEAN COMMISSION REGULATION ESTABLISHING A SAFETY OVERSIGHT FUNCTION 2.1 Please refer to Annex 3 for the slides used. 2.2 Juan Vazquez from the EUROCONTROL Safety Regulation Unit gave a comprehensive overview of ESARR 1 Safety Oversight in ATM which establishes requirements to be implemented by ANSPs and National Supervisory Authority NSAs and defines a process-based approach for safety auditing and the safety oversight of changes. He reported that the text of the Implementing Rule (IR) intended to be transposed into EC Law had been agreed in April 2007 and that the publication of the IR was imminent. 1 The revised report can be downloaded from: File: CATF#11-REPORTv1.1 Page 3 of 12

4 2.3 Juan Vazquez explained that the EC text transposing ESARR 1 does not use the words major and minor but nevertheless classifies the changes in exactly the same manner. The IR establishes the acceptance of changes by the NSA for certain types of changes: Changes are classified in relation to the NSA process that will deal with them. At least all changes associated with hazards with severity 1 or 2 resulting from the application of the severity classification scheme, specified in Common Requirements, Annex 2 are subject to a review of the safety argument. 2.4 The general applicability date for the IR will be November 2007, except for the acceptance of changes by the NSA, which has been postponed for one year (until December 2008). 2.5 Juan Vazquez responded that the date of applicability for changes which would be introduced after publication of the IR (i.e. which were not classified) but which were started years ago, had still to be agreed this aspect would be part of the decision/negotiation process between NSAs and ANSPs. 2.6 Jean-Paul Doré from the EUROCONTROL Regulatory Unit, highlighted two issues which need to be solved in order to fully align the safety regulation and conformity assessment processes: whereas safety processes apply to constituents, systems and processes, conformity assessment procedures only apply to constituents and systems (and do not consider processes); constituents and systems need to be defined at the right level of granularity so that ANSPs can integrate safety and conformity assessment processes and that NSAs can verify them in a combined way. 3. REVIEW OF THE NEW APPROACH AND ITS POTENTIAL IMPACT UPON SES INTEROPERABILITY 3.1 CATF Information Paper 11.1 "Impact of the review of the New Approach on the Interoperability Regulation" refers. Please refer to Annex 3 for the slides used. 3.2 Joseph Putzeys presented, on behalf of the Regulatory Unit, the draft regulation and draft decision which the European Commission prepared in order to complete and improve the New Approach regulatory framework. 3.3 The draft regulation specifies common provisions for: a European infrastructure for the accreditation of conformity assessment bodies; market surveillance of EU products, and controls of products entering the EU. The draft regulation will be directly applicable. 3.4 The draft decision sets guidelines for a framework for the marketing of products. It defines the elements necessary to ensure conformity of the products and sets out obligations for economic operators. The draft decision will not be directly applicable but will have to be taken into account for new legislation. 3.5 Mr Putzeys illustrated how the draft regulation and draft decision might affect the interoperability regulation and the conformity assessment procedures and raised a couple of questions in slide 19. File: CATF#11-REPORTv1.1 Page 4 of 12

5 3.6 Jean-Luc Garnier invited participants to react on questions rised in slide 19 about the impact of the revision of the new approach and its potential impact upon SES Regulations. He added that any concern or problem that CATF members might have regarding this draft regulation should be channelled in the context of usual procedures for the development of EC regulations with respective national representatives. 3.7 Eduardo Morere of the European Commission confirmed that DG TREN does not anticipate problems between this draft regulation and SES interoperability Regulation: In-house users bodies are already used in SES interoperability implementing rules, although not explicitly designated as in-house users bodies. Customization of modules is authorised by the draft regulation and leaves the door open to modules specific for SES interoperability IRs. The interoperability regulation provides for the legal tools to adapt the conformity assessment procedures, if necessary, to the specific ATM context; i.e. the comitology procedure allows the European Commission to address exemption requests. Based upon the opinion of the Single Sky Committee, the Commission can grant or not grant specific exemptions. 3.8 J. Putzeys drew the attention of attendants on the fact that in-house users bodies must be accredited and that they cannot apply all existing modules. The issue was not further debated. 3.9 J. Hermens of the Dutch NSA requested further clarification upon the designation of Notifying Authorities. Eduardo Morere explained that each member state must designate a notifying authority for each sector. The process of designation of a notifying authority is not standardised but obviously requires technical skills specific of the sector. 4. PROGRESS REPORT ON EC VERIFICATION OF ILS & CONFORMITY ASSESSMENT AND SAFETY APPROVAL 4.1 Progress Report on EC verification of ILS Please refer to Annex 3 for the slides used Philippe Crebassa from Egis explained that the putting into service and operation of the new Instrument Landing System (ILS) at Bordeaux airport had been delayed by one year due to an unsuccessful call for tenders. A Distance Measuring Equipment (DME) has been included in the system scope. The flight check is now planned for the end of June Following the flight check, the observation period will be of 400 hours of operation. 4.2 Conformity assessment and safety approval In support of the EC verification of an EATMN system, Egis identified the verification tasks to be undertaken by an ANSP in relation to Essential Requirement (ER) 3 Safety by applying these to the ILS/DME test case. CATF Information Paper "Progress Report on EC verification of ILS Safety in Conformity Assessment" refers Firstly, ER 3 had been analysed in-depth whereby ER 3-1 (first paragraph) had been identified as the core of the ER 3 requirements, whereas the other File: CATF#11-REPORTv1.1 Page 5 of 12

6 paragraphs had been considered as supporting requirements for the first paragraph The EC verification of conformity of an ILS/DME had been organised along the structure of a conformity assessment plan: The ILS/DME system is identified (overall functional overview). The regulatory baselines applicable for interoperability of ILS/DME systems are the essential requirements of the interoperability regulation as no IRs relative to ILS/DME exist. The regulatory baseline and means of compliance for ER 3 are mapped. The verification protocol to demonstrate compliance of the ILS/DME with its regulatory baseline for ER3 is defined. The items to be included in the technical file are identified Luc Deneufchatel of the French DSNA reported that the methodology of the conformity assessment plan had been experienced as a valuable methodology which enhances traceability and allows for a formal recording of all activities. Peripheral elements of the ILS equipment (e.g. the status reporting to ATCOs) were more difficult to process because of the human factors elements but the French DSNA welcomes a harmonised processes to implement ILS/DME systems (there are 24 ILS Cat III in France) Stéphane Serabian of the French NSA asked whether it was possible to develop a generic safety case for a specific system, independent from the site where it is installed. Peter Stastny of the Safety Regulation Unit reported that the current thinking indicated that it would be possible to develop a partially generic safety case under the condition that the boundaries would be carefully defined Jules Hermens pointed out that the approach was not sufficient to ensure a harmonised conformity assessment of ILS in Europe. There are still significant differences between States in respect of verification methods, flight inspection applied to ILS. An ad hoc implementing rule should be envisaged to set up a precise, harmonised verification context of ILS. 5. OBJECTIVES OF THE STUDY ON EASA CERTIFICATION AND SINGLE EUROPEAN SKY VERIFICATION PROCESSES 5.1 Jean-Paul Doré reported that the Regulatory Unit had launched a call for tender for a comparative study between the airworthiness and operational approval processes of EASA on one side, and the verification of compliance processes of the Single European Sky framework on the other side. EASA and the European Commission have been consulted for the definition of the study. 5.2 The objective of the study will be to provide recommendations about the possible evolution of both regulatory contexts in a global air transport perspective so as to increase the consistency and overall efficiency of both frameworks. The study proposes a phased approach (please refer to the slides in Annex 3) which includes a practical application of certification and approval processes to interoperable data link services. 5.3 Peter Stastny clarified that the study is not intended to solve legal issues between the airborne and ground frameworks, nor does it consider the proposed extension of EASA s role to ATM safety. 5.4 Eduardo Morere reported that the main elements of the proposed revised European Commission legislation would be announced in the near future through a File: CATF#11-REPORTv1.1 Page 6 of 12

7 Communication from the European Commission to the European Parliament and the Council. The actually revised legislation should not be expected to enter into force before PROGRESS REPORT OF FIRST WORKING SESSION ON THE DEFINITION OF CONSTITUENTS AND SYSTEMS 6.1 Please refer to Information Paper CATF 11.2 for a résumé of this working session and to Annex 3 for the slides used. 6.2 Jean-Paul Doré recalled that, following the outcomes of CATF#10 and the request from several CATF members, the working sessions were set up to commonly define clear objectives, assess stakeholders needs, and establish a related work plan in order to come to a concrete technical interpretation of: the concepts of 'Constituents' and 'Systems' as defined within the Framework and Interoperability Regulation and how ANSPs and manufacturers should approach the formal declarations (verification of systems, conformity or suitability for use) required. 6.3 The approach proposed by the RU is as follows: 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 6.4 During the interactive working session, a key point was identified concerning the availability of implementing rules and community specifications addressing notably the standardised architecture to support the definition of constituents and systems. 6.5 L Deneufchatel pointed out that today SES architecture-related materials are not mature enough. A progressive top down approach for the application of conformity assessment should be considered at first and should not hamper the convergence towards a common harmonised architecture in the future. 6.6 Jean-Paul Doré gave his view that because of the lack of an architecture, the verification of systems should start a high level; a high level granularity approach could be further refined in future whereas an opposite approach would create too much burden upon NSAs. 6.7 Following a question from Yves Morier of EASA, it was confirmed that the working sessions would only focus on ground aspects of conformity assessment (and not on airborne and space aspects). 6.8 A second CATF working session on the definition of Constituents and Systems will take place on Monday 19 th November from 10H00 to 16H30 at the Sofitel Brussels Airport Hotel (in the vicinity of the EUROCONTROL premises). File: CATF#11-REPORTv1.1 Page 7 of 12

8 7. OPEN TOUR DE TABLE FOR REPORTING ON CA ACTIVITIES 7.1 Jules Hermens from the Dutch NSA reported that the NSA is in the process of establishing formal interfaces with 2 ANSPs (LVNL and UAC Maastricht) about the conformity assessment declarations. So far, they have agreed on a list of systems which will be subject to the conformity assessment process; there will be about 70 systems for LVNL and 30 to 40 systems for UAC Maastricht 7.2 Frank Greven from UAC Maastricht reported that: the Flight Data Processing System (FDPS) should go into operation at the end of The conformity assessment plan for the FDPS has been drafted with the NSA and pending a few modifications, will be finalised soon. Frank Greven observed that it had not been possible to combine the safety assessment and conformity assessment activities in respect of the FDPS. He hoped to report at a next CATF meeting on the putting into operation of the FDPS system. The provisional acceptance of the DLFEP project is expected in June By then the supplier should be able to deliver the declaration of suitability for use and based upon that the system verification will be carried out. It is expected that the manufacturer of a new VCS system in the fall back environment will deliver the first declaration of suitability for use early next year. 7.3 AENA, who attended the CATF meeting for the first time, reported that they initiated the setting up of a conformity assessment process with the Spanish NSA; they hope to report back on the progress made at a next CATF meeting. 7.4 Mathy Gonon of the French DSNA reported that, apart from the pilot verification project on an ILS system (see point 4 above), they are in the process of developing a new process for system engineering of ATM systems. In the course of this work it is envisaged to capture the two levels of constituents and systems. Mathy Gonon hoped to report on the outcomes of this process at the next CATF meeting. 7.5 Mike Waller from NATS reported that they put some 15 to 20 technical files through their regulator and received approval on these. So far, they received about 6 declarations from manufacturers. They also agreed on a way forward with their regulator in respect of how to address a legacy piece of equipment. 8. PROGRESS REPORT ON EC MANDATES 8.1 Regarding the ongoing interoperability mandates, Jean-Luc Garnier reported that: The Final Reports for the draft Implementing Rules on Data Link Services (DLS) and Aeronautical Data Integrity (ADI) would be submitted to the European Commission around mid-october A second Stakeholder Consultation Workshop on the draft implementing rule on Mode S Interrogator Code Allocation (MSI) would take place on Thursday 25 October 2007 from 10H00 to 15H00 at EUROCONTROL HQ, Pollux conference room. The aim of this one-day workshop is to present and discuss the results of the formal consultation and to present the approach which the Agency intends to follow based on the selected option. The formal consultation had been closed on 26 September File: CATF#11-REPORTv1.1 Page 8 of 12

9 As regards the mandate on Surveillance performance and interoperability requirements (SPI), the Regulatory Approach document had been submitted to the European Commission in September It is expected to have the draft IR ready for consultation in February It is expected that the Draft Implementing Rule on Air-Ground Voice Channel Spacing (VCS) above FL 195 will be published this month by the European Commission. No firm plan has been made yet regarding the development of the extension of the VCS IR to the airspace below FL For further details, the Single European Sky (SES) pages of the EUROCONTROL web site can be consulted: Peter Stastny informed the meeting that, in respect of the draft rule on the Risk Classification Scheme (RCS), a focal group had been acting as an informal consultation forum throughout the summer. The draft rule and justification material had been finalised and would be submitted in the near future through a formal ENPRM consultation process. A consultation workshop has been scheduled for 18 th December The final completion date for the RCS rule is foreseen for April A.O.B. 9.1 A date for the next meeting (CATF#12) will be communicated at a later stage. It is foreseen to organise this meeting in February File: CATF#11-REPORTv1.1 Page 9 of 12

10 ANNEX 1 PARTICIPANTS CATF#10 8 th October 2007 Participants Ms Delphine BLAIS AIRBUS Mr Philippe CREBASSA EGIS Mr Luc DENEUFCHATEL DSNA FRANCE Mr Philippe DE GOUTTES AIRBUS Mr Jean-Paul DORE EUROCONTROL Mr Jean-Luc GARNIER EUROCONTROL Co-Chairman Mr Enrique GISMERA AENA SPAIN Mr Mathy GONON DSNA DTI FRANCE Mr Frank GREVEN EUROCONTROL UAC MAASTRICHT Mr Svatopluk HALEN CAA CZECH REPUBLIC Mr Jules HERMENS CAA THE NETHERLANDS Mr Jose Maria LORENZO AENA SPAIN Mr Patrick MANA EUROCONTROL Mr Eduardo MORERE EUROPEAN COMMISSION Mr Yves MORIER EASA Mr Michael MOWINSKI FRAPORT GERMANY Mr Bernard PAULY THALES ATM Mr Joseph PUTZEYS EUROCONTROL Mr Stéphane SERABIAN NSA STAC FRANCE Mr Peter STASTNY EUROCONTROL Co-Chairman Ms Inge TIERENS EUROCONTROL Mr Juan VAZQUEZ EUROCONTROL Mr Mike WALLER NATS UNITED KINGDOM Mr Stephen WILLIAMS NATS UNITED KINGDOM Apologies Ms Martine BLAIZE Mr Terry DUNFORD Mr Patrick GEURTS Mr Enrique MAURER Ms Ana PINTO Mr Mike ROGERS Ms Claudia VIRLAN Mr David WINSHIP EUROCONTROL EXPERIMENTAL CENTRE CAA UK SITA AENA SPAIN NAV PORTUGAL RAYTHEON CAA ROMANIA IRISH AVIATION AUTHORITY File: CATF#11-REPORTv1.1 Page 10 of 12

11 ANNEX 2 AGENDA CATF#11 8 th October H30 Coffee Available in Atrium Item Time Subject Reference Presented by 1 10H00 Opening & Approval of Agenda AG Jean-Luc Garnier Head RU Peter Stastny Head SRU 2 10H05 Draft European Commission Regulation establishing a safety oversight function Presentation Juan Vazquez SRU 3 10H50 Review of the New Approach, potential impact upon SES interoperability 4 11H30 Progress Report on EC Verification of ILS Conformity assessment & Safety Approval Information Paper Information Paper + Presentation Joseph Putzeys RU Mathy Gonon DSNA / DCS Philippe Crebassa Sofreavia 12H30-13H30 Lunch Break 5 13H30 Objectives of the study on EASA certification and SES verification processes 6 14H00 Progress report of CA working session on constituents and systems 7 15H00 Open Tour de Table for reporting on CA Activities Verbal Presentation Verbal + Presentation Jean-Paul Doré RU RU All 8 15H45 Progress Report on EC Mandates Verbal RU 9 15H55 A.O.B. Verbal All 16H00 End of Meeting File: CATF#11-REPORTv1.1 Page 11 of 12

12 ANNEX 3 SLIDES CATF#11 8 th October 2007 PLEASE SEE SEPARATE POWERPOINT FILE File: CATF#11-REPORTv1.1 Page 12 of 12