Conformity Assessment Task Force. Fourth Meeting

Transcription

1 EUROPEAN ORGANISATION FOR THE SAFETY OF AIR NAVIGATION EUROCONTROL Conformity Assessment Task Force Fourth Meeting EUROCONTROL HQ 23rd February 2005 Edition Number : 1.0 Edition Date : 31 rst March 2005 Status : Draft Issue Intended for : General Public Category : Working Document EUROCONTROL REGULATORY UNIT

2 DOCUMENT CHARACTERISTICS TITLE Conformity Assessment Task Force Fourth Meeting Eurocontrol HQ 23rd February 2005 Reference: Document Identifier Edition Number: 1.0 Edition Date: 31 rst March 2005 Abstract This document forms the minutes of meeting of the Fourth Meeting of the Conformity Assessment Task force. Keywords Contact Person(s) Tel Unit Mr Jean-Paul Doré DG/Regulatory Unit DOCUMENT STATUS AND TYPE Status Intended for Category Working Draft General Public Rule Draft Restricted EUROCONTROL Specification Proposed Issue Restricted RC Guideline Released Issue Restricted RU Policy Document Summary of Responses Working Document ELECTRONIC SOURCE Path: Host System Software Size Page ii

3 DOCUMENT APPROVAL The following table identifies all management authorities who have successively approved the present issue of this document. AUTHORITY NAME AND SIGNATURE DATE Co-Chairman of CATF Jean-Luc GARNIER 9 th March 2005 Co-Chairman of CATF Peter STASTNY Page iii

4 DOCUMENT CHANGE RECORD The following table records the complete history of the successive editions of the present document. EDITION NUMBER EDITION DATE REASON FOR CHANGE PAGES AFFECTED Initial document (draft) All sections Document reviewed by Jean-Luc Garnier All sections /03/05 Amendments following final internal review Page iv :

5 CONTENTS 1. Introduction Meeting Participants Meeting Agenda Opening and approval of the agenda Status of work Overview of the OATA Logical architecture Proposals of confirmity assessment procedures by the DFS Review of conformity assessment requirements for COTR & FMTP Short term ses implementation issues Objectives of the CATF for A.O.B....8 ANNEX 1: CATF#4 - List of meeting participants...10 ANNEX2: CATF#4 - Agenda...11 Page v

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7 1. INTRODUCTION The Conformity Assessment Task Force (CATF) held its Fourth Meeting at EUROCONTROL Headquarters on 23rd February The meeting started at 09:30 AM and finished at 04:30 PM. This document forms the minutes of the Fourth Meeting of the Conformity Assessment Task Force. 2. MEETING PARTICIPANTS The list of participants to the meeting is provided in Annex MEETING AGENDA The proposed agenda for the meeting is attached in Annex OPENING AND APPROVAL OF THE AGENDA On behalf of EUROCONTROL, Jean-Luc GARNIER (Head of the EUROCONTROL Regulation Unit) and Peter STASTNY (Head of EUROCONTROL Safety Regulation Unit), as co-chairs of the meeting, welcomed the participants. Mr STASTNY explained that Gary Morton, who had been supporting the SRU on Conformity Assessment work, had moved to a new job in EUROCONTROL Luxembourg. Mr STASTNY introduced Ms Françoise GIRARD from the SRU who will now support the CATF work, replacing Mr MORTON. Mr GARNIER introduced the proposed agenda, which was adopted without modifications. 5. STATUS OF WORK Mr DORE updated the meeting regarding the status of the work achieved by the CATF so far. Please refer to ANNEX 3 for the details of Mr DORE s presentation. Mr RICHES stated that for him the relationship between the NSA on one hand and the ANSP/Manufacturers on the other hand was not totally clear, and would require further investigation. He noted that the comments received from EASA regarding the top-down approach should be taken into account. He also stressed that the use of modules might be envisaged but will likely require some adaptations. Page 1

8 Regarding slide 12, Mr ZETSCHE questioned the consequences of different types of Implementing Rules (IR) regarding Conformity Assessment (CA) requirements, and more particularly the possibility that this leads to several CA processes. Mr GARNIER explained that, so far, the types of IRs that have been identified seem well suited. He emphasized that initial CA requirements for each type have been identified, but that further work is needed to fully respond to this question. Regarding slide 19, Mr ZETSCHE noted that identifying constituent(s) associated with a particular interoperability target in the IR is often difficult. Mr GARNIER explained that this was recognised and that identifying systems/constituents in the IR is not always necessary, nor always desirable, as implementations may vary. In such cases, the identification of such systems/constituents in the CA declaration forms is left to the manufacturers/ansp at implementation time. Mr PUTZEYS questioned the relationship of CA requirements for the Interoperability Regulation with the Service Provision Regulation, which also puts requirements on safety and interoperability. Mr STASTNY emphasized that all this work shall come together. Mr GARNIER described the situation in the High Speed Railways area, where the scope of requirements to be considered for the verification of systems comes from the Directive, the IRs, but also the Treaty itself. Mr MORERE explained that the Interoperability Regulation is a layer of regulation in addition to existing regulations which have to be taken into account for consistency purposes. After discussion, it was recognised by all that all existing regulations are applicable and shall be taken into account to provide a consistent set of CA requirements, with a view of defining a unique verification process in order to remain simple, practical and avoid compatibility problems. Mr ROBERT expressed his concerns that satisfying all such requirements may prove time- and money- consuming. Mr GARNIER stressed that the goal was to simplify the process by avoiding conflicts of inputs. He recognised that economical impacts will need to be taken into account. Ms GARTEMANN noted that in the Top-Down report, she had reservations on section 5.2 regarding consistency of the material with the applicability of modules. It was agreed that this would be analysed further. 6. OVERVIEW OF THE OATA LOGICAL ARCHITECTURE Messrs PRISTER and NIJHOF presented an overview of the OATA Programme. Please refer to ANNEX 4 for the details of Mr PRISTER s and Mr NIJHOF s presentation. Page 2 :

9 Mr GARNIER explained that having a common reference architecture would be very helpful for the work on interoperability regulatory matters. He stressed however that the right level of details must be found for such an architecture, and that the level of details actually required for this regulatory work is still unclear. To a question from Ms GARTERMANN, asking who agreed that the OATA architecture could be the SES reference, Mr MORERE responded that the Interoperability Regulation identifies the need for a reference architecture, and that obviously the OATA architecture is a direct contribution to such requirement. Mr TAYLOR stressed the need to ensure that stakeholders are appropriately involved in the definition of safety requirements coming from OATA. Mr PRISTER noted that the OATA PSG and TRG welcome active participation of all stakeholders. Mr DORE noted that the OATA Safety Policy is well aligned with the categories of IRs that have been identified. Mr STASTNY expressed his view that OATA may provide the framework for the overall consistency of regulatory material, in particular regarding the safety aspects. Mr TAYLOR noted that matching the specific safety requirements of IRs onto the overall safety process, which may be provided by OATA, was difficult unless such process is clearly understood and agreed. Mr STASTNY answered that the determination of specific safety requirements in IRs was performed following a top-down approach, in which the SRU was involved. Mr GARNIER added that the specific safety requirements of IRs are not sufficient to ensure safety of systems and that a more general safety process was needed (in general imposed by NSAs). From his point of view, specific safety requirements of IRs only represent a set of minimum common basis. Mr TAYLOR stressed that the fact that the overall safety process may not be clearly understood and agreed may even raise legal or costs issues at ANSPs level given that ANSPs have to provide their NSA with an overall safety case, including their hypotheses on their own operational and technical mitigation means, and that this may prove inconsistent with the hypotheses taken when drafting safety requirements of specific IRs. Mr STASTNY noted that avoiding such inconsistencies were one of the goals of the stakeholders consultation process. Mr HALEN asked what was meant by OATA with QoS classification. It was explained that such QoS relates to non functional requirements of components, like e.g. communication transit delays, and not to ATM user QoS. It was recognised that this reflects a terminology issue. In that spirit, Mr MACEY requested that the SRU/RU clarifies the use of the term safety and of its scope of use in the context of regulatory matters, such that a common understanding be possible. Mr STATSNY answered that he saw no different ways of defining safety and agreed that the SRU will prepare a working paper on this subject for the next meeting of the task force. Page 3

10 Mr PRISTER thanked the audience and offered his further help if and when needed for the further work of the task force. He recognized in particular that further work was certainly needed on the level of architecture details required to support the work on regulatory matters. 7. PROPOSALS OF CONFIRMITY ASSESSMENT PROCEDURES BY THE DFS Ms GARTERMANN presented a proposal from DFS regarding CA procedures and the use of CA modules. This work is the result of an input from DFS to its NSA regarding CA, and is proposed by DFS as an input for discussion in the CATF. Please refer to ANNEX 5 for the details of Ms GARTERMANN s presentation. Mr GARNIER thanked Ms GARTERMANN and DFS for a very impressive piece of work and a very valuable input to the CATF top-down approach for the definition of long-term CA processes. Mr PUTZEYS warned that one must be cautious on a number of principles from the New and Global Approach, in particular that: In slide 5, if there is no question that quality assurance is required only in modules D,E, and H, and that ISO9001 may include modules D and E, no decision has been taken so far regarding such inclusion. Module H is not generally combined with any other module. From Mr PUTZEYS point of view, regarding slide 7, the only modules left are actually: Module H, Module H+ (including for example some evaluation of prototypes), and Module G. Mr Robert noted that in Recital 13 and in article 3d of the Interoperability Regulation, it is unclear whether the use of should and/or where appropriate is applicable to only Notified Bodies and/or to Notified Bodies and modules. Mr MORERE clarified that in Article 3d, where appropriate applies only to Notified Bodies, and that the use of modules as a starting point is required. In other words, IRs shall contain CA provisions based on the modules and where appropriate Notified Bodies. Mr PUTZEYS further noted that modules have been designed for massproduction industries, and that ATM requirements may lead to large deviation compared to these original needs. He stressed that this needs to be understood by all parties. Page 4 :

11 Mr MORERE noted that module G (Unit Verification) can be applied and may be well suited for non mass-production industries. Mr PUTZEYS stressed however that module G is normally applicable to manufacturers only, and that in general ANSPs are not manufacturers. Regarding Notified Bodies, Mr PUTZEYS stressed that 2 nd Party (i.e. by users) verification could be used in ATM. In that sense, ANSPs may be considered as acting as Notified Bodies towards manufacturers and/or themselves under certain conditions (and always under the scrutiny of NSAs). Mr ZETSCHE concluded that it would be nice to use existing modules but that this may prove not possible and/or that adaptations may be required. Mr STASTNY stressed that to better appreciate such needs, a complete picture including NSAs, ANSPs and manufacturers must be built. He also emphasized that the current CA practices are not out of scope and that an approach could be to formalize them, as far as possible based on the existing modules. 8. REVIEW OF CONFORMITY ASSESSMENT REQUIREMENTS FOR COTR & FMTP Mr CIOARA presented for review the updated CA requirements for COTR and FMTP. The update presented takes into account the comments received from the stakeholders, in particular following the 26/01/05 workshop. Please refer to ANNEX 6 for the details of Mr CIOARA s presentation. The following general comments were expressed during the meeting: Mr ZETSCHE noted that provisions in section 4.2 are general requirements, i.e. are not specific to the IR, and that it might more appropriate to move such provisions into a more generic CA material. Mr GARNIER agreed in principle with this view, but explained that the current approach of keeping such provisions in the IR was followed to keep in line with previous discussions on this subject within the group, and in order to provide a fully-documented, self-contained short-term solution for the initial mandates. Ms GARTERMANN stressed that such provisions could be better placed in the Common Requirements. Mr GARNIER noted that such Common Requirements are not fully available yet, and that in any case, there is nothing in Common Requirements regarding CA issues. Mr MORERE and Mr PUTZEYS agreed. Mr TAYLOR noted that in section 4.2. Annex, the requirements should be placed on the ANSP rather that than its personnel. This was agreed. Ms GARTERMANN noted that CA modules are not prescribed and that self-assessment seems to be assumed. She questioned why module A Page 5

12 was not prescribed. Mr GARNIER and MR PUTZEYS explained that the provisions in 4.2. Annex do not describe processes but rather describe a set of criteria that must be met by the ANSP personnel. They stressed that verification is always performed under the ANSP responsibility, either by a Notified Body, or by the ANSP personnel if criteria prescribed in the provisions are met. In that sense, such provisions do not relate to modules. Mr MACEY questioned what was the level of liability of Notified Bodies involved in CA assessments. Mr PUTZEYS clarified that the liability of Notified Bodies never includes product liability. It is restricted to performance of their duties in a professional manner. This raised another question from Mr MACEY regarding what would happen if the implementing rule itself was wrong. Mr PUTZEYS explained that at the end product liability always remains with manufacturers, who, unless the rule is very prescriptive, are considered experts enough to have noticed that the regulation was mistaken. The proposed material was then reviewed in detail by the meeting. The following points were addressed during this discussion: In section 4.1., it was noted and agreed that if military authorities provide service to civil traffic, they could be considered as an ANSP from this point of view. However this is only an interpretation of how the SES Regulations could be read. The RU does not intend to make this explicit in the implementing rules. In section 4.2. NSA item 1: o o It was agreed that where appropriate would be added. It was agreed to remove the term regulatory before authorities. o Mr MORERE noted that item 1 is clearly necessary for the IFPL IR (impacting more parties than ANSPs only). He judges it also useful here for consistency purposes. In section 4.2. NSA item 2: o Mr TAYLOR expressed the view that this item could be suppressed as it is overcome by item 3 and Annex 5. o Mr LANDY expressed his view that the paragraph should be stopped after undue influence. In section 4.2. NSA item 4: o It was recognized that this item should refer to an obligation on NSAs to direct ANSPs to subcontract the verification to a Notified Body in such a case. An obligation shall also follow for Page 6 :

13 ANSPs so directed to either rectify to become compliant with the set of criteria required, or to subcontract such verification to a Notified Body. o Mr PUTZEYS questioned why not using Notified Body instead of independent body recognized competent. Mr. GARNIER answered that this was to leave the possibility for Notified Bodies to intervene only in certain situations: the SES interoperability Regulation seems to require, within each implementing rule, the definition, for Notified Bodies, of common criteria which would apply to all ANSPs/Manufacturers. This interpretation requires however to be confirmed. This triggered a question from Mr TAYLOR regarding the possibility that an ANSP acts as an independent body recognized competent vis-à-vis another ANSP in another country. Mr PUTZEYS expressed his view that this should be possible in principle, as long as there is no conflict of interest, and noting that this may require such controlling ANSP to be formally recognised as competent. In section 4.2. Annex [..] o It was recognised that the requirements of items 1 to 5 shall apply to ANSPs, and not directly to their personnel. o Mr TAYLOR suggested that item 6 should be removed. In section 4.3. Annex IV o Mr TAYLOR questioned whether the provisions in this annex actually mandate use of test tools. He expressed concerns that this may not always be appropriate. Mr GARNIER responded that such use would be clarified in the justification material sent by EUROCONTROL to the EC with the IR, as such material would identify specific associated Community Specifications. As a conclusion of this review, Mr GARNIER asked that all stakeholders shall send their written comments on the proposed material to the RU before the 4 th of March, so as to allow the RU to send a revised draft to the EC before end of March SHORT TERM SES IMPLEMENTATION ISSUES This agenda item related to the definition of transitional arrangements, as defined in the Interoperability Regulation Article 10, regarding CA from the date of applicability of the regulation (20 October 2005). It was recognised by all that advice regarding such arrangements would be welcome as soon as possible. Mr GARNIER explained that this will be the Page 7

14 subject of a specific study to be conducted by EUROCONTROL in the coming months. Mr MORERE explained that the original intention was to have a specific IR in place before the applicability date, but that will not be possible. In such a situation, he welcomed the production of guidelines by the task force. Such guidelines could then be used at a later stage to produce a specific IR on this subject. 10. OBJECTIVES OF THE CATF FOR 2005 Mr DORE presented the RU proposal regarding the objectives of the CATF for Please refer to ANNEX 7 for the details of Mr DORE s presentation. The task force generally endorsed the proposed objectives with the following general comments: Mr HALEN expressed the view that it was necessary to clearly define QM systems, and the need for their certification or not. Mr DORE clarified that the idea was to work on the definition of processes, and that certification of QA systems was another issue. Mr ROBERT would prefer to refer to Quality Assurance Processes rather than to Quality Management Systems. 11. A.O.B. Ms GARTERMANN expressed her view that the CA provisions in short-term IRs are adequate, but that they may need to be revisited once the overall work on CA and the applicability of modules will have been progressed further. Mr MORERE responded that this may be covered in a transversal set of CA provisions (e.g. a specific rule of CA). Mr DORE expressed his expectations and confidence that existing material will not be found contradictory with more general CA provisions while work will be further progressed on a top-down approach of CA. Mr PUTZEYS warned that regulatory provisions should remain stable, so shall be sufficiently general in short-term IRs. He referred to an expected nominal period of stability of 5 years. Mr ROBERT expressed his concerns that because of the high time-pressure for the development of short-term IRs there may be issues that could be found on such IRs before a 5 years period, and that modifications to such IRs could be necessary sooner than expected. He explicitly referred to the specification of the use of IP-V6 in the FMTP IR, which could raise issues in the future. Mr GARNIER clarified that in such a case, modification of the IR at the right moment would be possible if found necessary. Page 8 :

15 Mr HALLEUX questioned whether from 20 October 2005 only the provisions of short-term IRs would become compulsory. Mr MORERE clarified that from this date, the entire interoperability regulation will become applicable. Mr HALLEUX expressed his concerns that, except for short-term IRs, CA provisions regarding the entire interoperability regulation were too general to be applicable. Mr GARNIER explained that this was one of the reasons for launching a study for the definition of guidelines for the short-term implementation of CA as discussed in agenda item 9. The next meeting of the CATF was decided to be held at EUROCONTROL HQ Brussels on 9th June Page 9

16 ANNEX 1: CATF#4 - LIST OF MEETING PARTICIPANTS Mr Françis BRANGIER, Sofreavia Ms Andrea GARTEMANN, DFS Germany Mr Régis GAUTIER, THALES ATM Mr Svatopluk HALEN, ANS Czech Republic Mr Georges HALLEUX, CAA France Mr Jules HERMENS, CAA The Netherlands Mr Maurice LANDY, Irish Aviation Authority Mr Ian MACEY, NATS UK Mr Eduardo MORERE MOLINERO, European Commission Ms Ana PINTO, NAV Portugal Mr Joseph PUTZEYS, Consultant Mr Graeme RICHES, CAA UK Mr Patrice ROBERT, CAA France Mr Mike TAYLOR, NATS UK Mr Frank ZETSCHE, DFS Germany Mr Octavian CIOARA, EUROCONTROL RU Mr Jean-Paul DORE, EUROCONTROL RU Mr Jean-Luc GARNIER, EUROCONTROL RU Ms Françoise GIRARD, EUROCONTROL SRU Mr Bert NIJHOF, EUROCONTROL OATA Programme Mr Allesandro PRISTER, EUROCONTROL OATA Programme Mr Peter STASTNY, EUROCONTROL SRU *** Page 10 :

17 ANNEX2: CATF#4 - AGENDA DRAFT AGENDA 09H00-09H30 Coffee Available at Lobby Item Time Subject Reference Presented by 1 09H30 Opening & Approval of Agenda AG RU/SRU 2 09H35 Status of work AP CATF 4.1 RU/SRU 3 10H45 Overview of the OATA logical architecture Verbal A. Prister 11H15-11H30 Coffee Break 4 11H30 Proposals of conformity assessment procedures by the DFS IP CATF 4.2 DFS 13H00-14H00 Lunch Break 5 14H00 Review of conformity assessment requirements for COTR & FMTP AP CATF 4.3 RU 6 15H00 Short term SES implementation issues Verbal RU/EC 7 15H45 Objectives of the CATF for 2005 Verbal RU/SRU 8 16H25 A.O.B. Verbal All 16H30 End of Meeting Page 11