How will the Agency notify the acceptance of the certification basis?
It could be made in different ways depending on the size of the project, the forms used by the applicant and other circumstances. In general, any traceable way is acceptable (e.g. emails, formal letters, specific CAI etc). In the future SEPIAC will have a feature to trace this acceptance.
Is there a maximum timeframe considered for EASA to accept a Certification Program and further for the acceptance or adjustment to the Level Of Involvement proposed by the DOA?
There is no maximum timeframe for EASA to accept a Certification Program and notify its LOI, nor to update it on the basis of new information impacting the risk previously assessed. Nevertheless, the Agency is committed to reduce this timeframe as much as possible: we strive to review documents (including certification plans) within 30 days, which we achieve on average. (ref also to ‘Code of good administrative practice for the staff of the EASA in their relations with the public’, ED Decision 2009/078/E).
Is it not possible to consider the number of Compliance Demonstration Items (CDIs) as a criterion before starting with Level Of Involvement . For instance projects with less than twenty CDIs. Should the CDI list be defined and sent to EASA?
No, the EASA LOI decision has to be based on a risk-assessment and the number of CDIs does not have a direct influence on the risk. Additionally, the number of CDIs could be very small (e.g. containing a single document) or very large (e.g. containing the whole project) depending on the approach selected by the applicant.
How will the privilege of submitting compliance documents without further involvement be modified by the Level Of Involvement process?
The point 21.A.263 (b) will be cancelled by the next amendment to Part-21 (ref to Opinion 07/2016).
According to the new concept, any application for major change/repair, STC, APU ETSO or TC submitted to the Agency shall be complemented by a risk-assessment and a LOI proposal prepared by the applicant. After acceptance of the Certification Program/LOI, data and activities not included in the EASA LOI will be accepted without further verification.
Regarding the tests, is it possible to submit only the plans and have the report validated by the Compliance Verification Engineer without EASA checking if all the tests are "passed"?
The test reports shall be submitted to the Agency only if they have been retained as part of the EASA LOI.
Nevertheless, regardless of the LOI determination, it must be noted that the amended Part-21 will contain a new provision requiring applicants to inform the Agency in case of unexpected difficulties encountered during demonstration of compliance (ref to Opinion 07/2016 point 21.A.20(b)):
a significant failure or finding resulting from the tests performed as per points 21.A.33 or 21.A.35 is to be notified to the Agency.
The Level Of Involvement risk analysis is a transfer of the Agency workload. Could applicants expect to have a reduction of the STC fees in the future ?
The risk-assessment to be performed in order to propose an LOI is not a transfer of Agency workload and in consequence no reduction of STC fees is expected.
Has the Level Of Involvement definition for an STC a direct impact on the STC fees?
No, the new LOI concept does not have an impact on the fees.
Is the overall DOA performance indicator based on feedback of DOA Teamleader and Product Certification Manager? Panel feedback per panel, or on average?
The overall DOA performance takes into account feedback from DOA TLs (surveillance activities), PCMs and experts (projects).
The performance at panel level mainly takes into account feedback from PCMs and experts. Additionally, DOA TLs feedback can also be considered for performance at panel level.
The Agency is currently working on an evolution of the DOA performance system.
What is the minimum amount of 'DOA Holder Performance' to not be always at the bottom of the scale in the matrix?
To obtain a higher DOA performance, the applicant should strive to obtain a higher rating by EASA experts and PCMs during certification projects considering:
Project planning and communication
Applicable requirements and means of compliance
Compliance documents
If the DOA is newly established, or in the case of a very low number of applications submitted to EASA, the DOA performance will be assessed as unknown/low.
Do we have to document the justification of the Level Of Involvement selection and submit it with the Certification Program to EASA as a supporting document?
The applicant is requested to provide a proposal for the risk assessment of all the CDIs as part of the Certification Program. Where not obvious or where the applicant thinks it is necessary to explain the proposal, a justification should be submitted.
Each DOA has the freedom to select the most adequate physical document structure for the certification program which, has to consist of the points listed under 21.A.15(b).
The aircraft manufacturers do not take into consideration customized configurations when issuing documentation (such as Service Bulletin). What is EASA policy in order to cope with this issue?
In order to perform any change, the STC applicant shall identify the configuration of the aircraft to be changed as per Part 21.A.101 along with the associated certification basis. It is worth to remind that 'Prior to installation of this change/repair it must be determined that the interrelationship between this change/repair and any other previously installed change and/ or repair will introduce no adverse effect upon the airworthiness of the product.'
What is the validity of a Non Technical Objection (NTO) statement from Airworthiness point of view?
NTOs are usually used in the context of Flight Condition approval process. Nevertheless, if there is a connection between two organisations that are concurring on the same topic, the primary Design Organisation could issue an NTO to confirm that there is no safety impact on the existing design. In that case the NTO will support the compliance demonstration without constituting in itself a Means of Compliance. The responsibility of the new design relies ultimately on the Applicant.
Part 21: Will be a dedicated qualification needed to perform the risk assessment associated to the Level of Involvement proposal?
No. There are no specific requirements for the qualification of persons that perform the risk assessment in Part-21. The company has to ensure as part of their procedures and training provisions that competent persons with sufficient experience perform the tasks they are assigned for within their DO
What is the expected benefit when the new Level Of Involvement concept is implemented in Part 21 and a low to very low involvement of EASA is agreed on a project?
The associated involvement corresponds to focus of the Agency on elements of projects where the risk of a non-compliance is higher.