Part 21 Design Organisation Approval (DOA) Implementation Workshop Questions and Answers Session Subject Reply QUESTIONS RAISED BEFORE THE WORKSHOP Mission Equipment A rulemaking task will start 1Q 2012 dealing with “New categories of parts for which Problem: Form 1 is not required” (RMT.0018). This will look at the ‘commercial parts’ concept 21A.307 states that as introduced in FAR-21 and will also look at certain non-required equipment in small “No part or appliance (except a standard part), shall be eligible for aircraft. It should solve the problems identified in the question. installation in a type-certificated product unless it is: (a) Accompanied by an authorised release certificate (EASA Form 1), certifying that the item was manufactured in conformity to approved design data and is in a condition for safe operation; and (b) Marked in accordance with Subpart Q.” Similar requirements can be found in Part M (M.A.501) and Part 145 (145.A.42) Especially for some special operations mission- (or role-) equipment is used that originally was not intended for airborne use but might be essential or helpful for the performance of the operation (e.g. introduction of a ship-transponder for off-shore SAR missions in order to have information on all available rescue means in the area). Initial installation of such equipment is normally covered by a change to the type design. If such equipment fails and needs to be either replaced or repaired by the equipment manufacturer there is no way for the contracted Maintenance Organisation to receive an EASA Form 1 required for the installation of the replacement or repaired part. Part 21 DOA Implementation Workshop (Industry) Page 1 of 13 29th-30th November 2011 Part 21 Design Organisation Approval (DOA) Implementation Workshop Subject Reply General question: Is an EASA Form 1 required at all? All above mentioned requirements (21A.307; M.A.501; 145.A.42) in the end refer to “Parts and appliances” that require an EASA Form 1 (Part 21 directly, Parts M and 145 via the term “components” which is defined in Reg.2042/2003 Article 2 as meaning “…any engine, propeller, part or appliance”. According to Reg. 216/2008 Article 3 “…‘parts and appliances’ shall mean any instrument, equipment, mechanism, part, apparatus, appurtenance, software or accessory, including communications equipment, that is used or intended to be used in operating or controlling an aircraft in flight; it shall include parts of an airframe, engine or propeller, or equipment used to manoeuvre the aircraft from the ground;…” There is an argument that mission-/role-equipment is neither used nor intended to be used in operating or controlling an aircraft therefore an EASA Form 1 would not be required. On the other hand as also this equipment might have (and normally has) an influence on the aircraft and the initial change design has in most cases just provided evidence for one special piece of equipment by testing the installation the question remains how the same level of safety can be guaranteed for a replacement or repaired part. In present rulemaking there is no guidance on this matter. There are however some procedures that are in general accepted by Certification. The most common is to cover the replacement of such equipment by another “minor change”. But also to include the replacement by a part provided with a CoC in the Instructions for Continued Airworthiness might be an approach. Part 21 DOA Implementation Workshop (Industry) Page 2 of 13 29th-30th November 2011 Part 21 Design Organisation Approval (DOA) Implementation Workshop Subject Reply Reason to propose this topic for Workshop: Present rules leave some room for interpretation on this topic as such equipment is not properly addressed. On the other hand quite a number of Design Organizations is confronted with having to find solutions for this gap. Presenting an EASA position could help DO’s to develop a safe approach to solve this problem. EU-US Bilateral Agreement See related presentation; The bilateral agreement between US and EC on Cooperation in the Regulation of Civil Aviation Safety is of interest of many DOA holders. How the agreement work and what does is the experience so far? Presentation of some practical examples. EPA Marking If a changed part (example: armrest of a seat) is put on an ETSO approved According to our understanding of the marking requirement, seat, the armrest would have to carry EPA marking. On the ETSO approved EPA has only to be applied to new parts and must not put seat a “modification placard” would need to be applied adjacent to the seat on changed parts. identification plate (ETSO marking). This modification placard would carry the modification No. or the SB No. by So, if I apply a new part for a change or a repair to the which the new armrest was installed. ETSO article the (sub-) part has to be marked by "EPA", the This modification placard would not necessarily need to state EPA. ETSO article not.? Part 21 DOA Implementation Workshop (Industry) Page 3 of 13 29th-30th November 2011 Part 21 Design Organisation Approval (DOA) Implementation Workshop Subject Reply QUESTIONS RAISED DURING THE WORKSHOP EASA Update Stakeholders’ feedback Availability of results The results of the stakeholder feedback will be sent to the organizations that replied the questionnaire. Additionally some general information will be published in the EASA web site. For NAAs the information will be available in the SYNAPSE tool. EASA Internal Occurrence Reporting System (IORS) Identification of the people with access rights to the occurrence The access is limited to EASA staff and people working on behalf of EASA database (from NAA). There are different provisions in the legal framework in force to protect the data: 1) Regulation on personal data protection 2) Regulation on intellectual property protection 3) Data may be related to the development of Airworthiness Directive and should be protected to avoid bias in the directive final output. What about the participation of STC holders in the first phase? TC holders have been selected for this initial phase for practical reasons, as the process has been launched starting with top reporting organisations. Most of the STC holders are likely to use the IORS Form.pdf (ref FO.IORS.00044-004) for reporting rather than the electronic bridge given the fact that they do not report too much. This form may be downloaded from the address EASA Internet /Occurrence Reporting What are the advantages of the IORS system for DOA holders? The benefit is indirect. Globally the Agency will be able to process the occurrences in a more effective way which in turns will improve the occurrence system of the DOAs Part 21 DOA Implementation Workshop (Industry) Page 4 of 13 29th-30th November 2011 Part 21 Design Organisation Approval (DOA) Implementation Workshop Subject Reply Status of Rulemaking Activities Affecting Part 21 In relation to acceptance of parts without Form 1, how can The parts that are mentioned in the rulemaking task are simple and can be an aircraft owner know if a part conforms to its design? produced relatively easily. The concept is basically similar to the standard parts. The operator has to take responsibility. This issue will be dealt with consistently in Part 21, 145 and M. In relation to flight testing organisations, can an operator No, flight testing is primary related to design activities and so it must establish such an organization? What about sister remain located in the design organisation area of competences. Similarly, organisations? the necessary qualification of test pilots is an activity related to the definition of the flight conditions, falling again in the design area. Regarding sister organisations, it is important to keep in mind that subcontracting is an open possibility for DOAs, this meaning that it is possible to establish the flight testing organization in a sister organization (DOA may use other parties to do tasks on their behalf). Is there any tentative date for the entry into force of the The CDR is scheduled to be published in December 2011, the Opinion could flight testing Opinion? be ready in April 2012, and after that it is difficult to predict how long the legislative procedure will take to amend the implementing rule (adoption process by the Commission may take 9 months or longer). Can be the PtF concept extended to maintenance facilities to Yes, if the flights are not safety design related (eg flights performed as part cover fly test that are carried out after performing of the release to service not involving testing of changes not yet approved). maintenance? Ref. 21A.711(d) privilege given to CAMO to issue permit to fly. In relation to replacement parts, this subject was initially This is the case. The rulemaking was postponed knowing that with the considered as a priority, but now it seems that it has been current widely diverging views in industry it will be difficult to establish a Part 21 DOA Implementation Workshop (Industry) Page 5 of 13 29th-30th November 2011 Part 21 Design Organisation Approval (DOA) Implementation Workshop Subject Reply postponed. proposal that would be acceptable to all. If the industry could come up with a proposal the rulemaking process would possibly start earlier. In relation to PtF issued by EASA, will it be issued for 1st No, PtF would be issued for all test flights. flight only? In relation to PtF issued by EASA. Is the provision intended The provision in the Basic Regulation is intended for flight test purposes. It for prototypes? How will EASA ensure that the aircraft for will be quite challenging to develop this provision in the implementing rule which a PtF is issued is airworthy? This is usually a task of for the reason mentioned by you. the State of Registry. DOA privilege to approve major repairs to APU: is it for an It is for all APU (it is not relevant whether the APU is essential or not) essential or non essential APU? Will the future Part 26 be harmonized with the FAA? The EASA Part 26 will not be similar to the FAA Part 26, as many of the future topics included in EASA Part 26 are currently in FAA Part 121. There will also be issues similar to FAR-26. In general all the retroactive design requirements are harmonized with the FAA. Implementation of Operational Suitability Data (OSD) Will there be a CS for the OSD? There will be a separate CS for each 5 elements of the OSD, e.g. CS-MMEL Where will be the boundary between generic OSD and type The generic concept is only applicable to the MMEL element of the OSD, dependent OSD? provided that the aircraft is in the category of aircraft other than complex motor-powered. For the rest of cases and elements of the OSD no generic data will be available. Is the OSD concept only applicable to TCs in current The OSD will be applicable to new TC/STC. Additionally, there will be a production only? mandatory catch up for existing TCs that are still in production, where a certain transition period to develop the OSD will be given. Part 21 DOA Implementation Workshop (Industry) Page 6 of 13 29th-30th November 2011 Part 21 Design Organisation Approval (DOA) Implementation Workshop Subject Reply The Independent Checking Function of the Showing of Compliance Part time/ contracted CVE It is up to DOA how it is hiring the CVE; EASA is checking the competence and the availability of CVE, and the DOA handbook should cross reference the contract. CVE per discipline/ATA chapters/CS Paragraphs The various options are possible. EASA checks that the CVE specialty is clearly defined. Appropriate CVE ratio The CVE must be able to perform correctly her/his function and not be overloaded in a way that will put at risk adequacy and pertinence of independent verification. Interface between Design Organisations and Part 145 Organisations What organization should manage the CRS? DOA or P145? The release of a component or an aircraft is a responsibility of the P145, as a DOA will not release them. The complete release will be done based on approved data. When the prototype is finished, the organization can show that the prototype is identical to the approved data. EASA rules do not contemplate the possibility of signing a CRS with incomplete maintenance data, on opposition to the FAA which accepts this possibility. Nevertheless, P145 allows releasing an aircraft with incomplete maintenance performed. EASA rulemaking considers that release with unapproved data is incomplete maintenance release, and as such it is acceptable. Once the STC is approved it is up to the DOA to declare that the Part 21 DOA Implementation Workshop (Industry) Page 7 of 13 29th-30th November 2011 Part 21 Design Organisation Approval (DOA) Implementation Workshop Subject Reply data is now approved and to the P145 to do the complete release. Additionally, the P145 needs to have procedures in their MOA for the incomplete release and the subsequent final release, and for this the DOA should arrange the procedure in contact with the P145. For a new engine prototype, what organization should issue It can be a POA. The release is upon the engine configuration as specified in the statement of conformity before the flight? the flight conditions. Design Assurance System Accountability for Design and Task performed by Partners or Subcontractors General information What is the benefit that this approach may have in the DO- In the assessment criteria for subcontracting developed by the DOA, credit DO interface? can be taken to the fact that the subcontractor is a DOA, but anyway the assessment procedure must be followed because the final responsibility of the subcontracted work still follows in the DOA which is subcontracting. Is necessary to make a difference between external CVEs You can make the difference, but in both cases the DOA that is and the rest of subcontracted works/tasks? subcontracting must assess the subcontractors and mention them in their Handbook There are different classes of subcontractors, which are Yes, the DOA has to assess their subcontractors in a proportionate way in based on the responsibility taken. The subcontractor can respect to the complexity or the risks associated. Also the assessment can just prepare the documentation, while the CVEs remain be proportionate to the control that the DOA exercises on the subcontractor. internal to the DOA which subcontracted the job. In those For example, if the control is strong the assessment can be reduced. The cases, shouldn’t the surveillance of the subcontractor be level of DOA involvement should be defined. adapted? A ‘partner’ organization should be considered as part of the Only one organization can be holder of the DOA, so the partner should be DOA or subcontractor? considered as subcontractor. Part 21 DOA Implementation Workshop (Industry) Page 8 of 13 29th-30th November 2011 Part 21 Design Organisation Approval (DOA) Implementation Workshop Subject Reply ICOP Test House – Dutch industry proposal The UK CAA recognizes test houses. Why these recognized The main reason is that P21 does not allow such scheme. The topic has test houses cannot be accepted by EASA? been discussed with FAA and TCCA, as well as in former workshops. Unfortunately, it cannot be accepted given the fact that there is no legal link that allows this. It is known that some NAA are approving test houses, but this activity can only be considered in relation to the area of competences that are still within the NAAs. AS 9100 and ISO 17025 are standard for acceptance and can be taken into Reference standards account, but in order to have a robust enough scheme of accreditation, additional technical requirement should be added to the evaluation references. Previous experience shows that some companies that meet mentioned standards for acceptance still lack of significant element necessary to do test for the aviation industry. Some areas where problems were previously identified are qualification of auditors and recurrent training. Industry associations are encouraged to share information and come up with a robust standard of accreditation standard. Some elements of the NAA accreditation system of test houses could be Finding a globally acceptable scheme for accreditation of taken into account in the development of the EASA system, but they cannot test houses is not an easy task. Some credit should be work in parallel because the legislation in force does not allow this. taken from the NAA accreditation of test houses to avoid Currently NAA system cannot be mentioned in the future EASA procedure duplication of work. In some cases it could be advisable to because the NAAs have no competence in design issues that are within the work in parallel with the NAA accreditation of test houses area of competence of the Agency. process In the past we applied for the approval of a STC to the FAA In such cases, please contact the Agency for support. The BASA is based in and proposed a French laboratory, which was not accepted mutual trust between FAA and EASA. If there are problems in the by FAA. Finally we had to use an USA laboratory. implementation, as the one that you have referred, EASA needs to know it Part 21 DOA Implementation Workshop (Industry) Page 9 of 13 29th-30th November 2011 Part 21 Design Organisation Approval (DOA) Implementation Workshop Subject Reply to contact FAA and solve the problem. There is a system in place applicable to fuel quality Industry is encouraged to share all information and initiatives in the process measurements that could be taken as an example for the of development of their proposal, as this will make the future accreditation development of the accreditation of test houses scheme. scheme more useful for all stakeholders. Everybody is invited to join now This system (IFQP) is audited by IATA and works properly this effort because in the end there will be only one scheme that will be applicable to all the DOAs. This is the right approach. P21 implementation intends to follow this path. Raise awareness and make training are preferred options P21 will be changed only when experience has shown that there is a need to rather than reinforce/restrict the P21 standards when do it. negative findings are detected. The future third party organisation tasked with the Yes, in fact the ICOP scheme already includes a similar provision accreditation of the test houses should be audited by EASA to make sure that the system is robust enough Relationship between subcontractors surveillance and Both processes should be put in context, given the fact that with the accreditation of test houses legislation currently in force, the third party organisation tasked with the accreditation of test houses can be considered as a Tier 1 subcontractor, while the test houses could be considered as Tier 2 subcontractors. This approach will not need any amendment of the P21 and could be issued as AMC/GM. Even a system where some DOAs agree on common requirements for the joint surveillance of the test houses, on a sharing basis, could be acceptable without the need of an third party organisation. This last approach will have the disadvantage that it would be a solution only for some DOAs and not a system that could be used by all DOAs Changes and repairs affecting ETSO Articles Lufthansa Technik presentation: Changes to ETSO articles versus TC products Part 21 DOA Implementation Workshop (Industry) Page 10 of 13 29th-30th November 2011
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