AMC No 2 to 21.B.100(b) Level of involvement (LoI) in European technical standard order authorisation (ETSOA) projects

• ED Decision 2019/018/R found in: Initial Airworthiness and Environmental Protection (748/2012) Part-21 Part-21L (Jul 2024)

AMC No 2 to 21.B.100(b) Level of involvement (LoI) in European technical standard order authorisation (ETSOA) projects ED Decision 2019/018/R The applicant for an ETSOA is required to demonstrate its capability by obtaining EASA’s agreement for the use of procedures that incorporate its specific design practices. The assessment by EASA that these procedures are properly applied is performed solely through the various ETSOA projects of the applicant. No regular audits of the organisation are performed by EASA outside the ETSOA projects. A properly completed Form 34 and the certification programme, including a technical description of the proposed design of the ETSO article, are the basis for the determination of EASA’s initial LoI. EASA assesses the compliance of the proposed ETSO article with the ETSO requirements as defined in the applicable CS-ETSO standards, as well as compliance with Part 21 Subpart O (e.g. the declaration of design and performance (DDP), ETSO marking, rating of performance, etc.). The ETSOA applicant should deliver a complete data package per point [21.A.605](#_DxCrossRefBm1649096862). EASA’s LoI is further reassessed and adapted throughout the certification project until the ETSOA is issued, depending on the applicant’s data, as well as on the ETSO project changes regarding the applicant’s compliance demonstration (e.g. methods, design changes, deviations, limitations, problem reports, etc.). 1.       Principles EASA’s LoI in ETSO projects is defined based both on the responsibility of EASA to assess the applicant’s demonstration of compliance, and on the risk evaluated, according to the following criteria: — the applicant’s level of experience in the ETSO process and scope of work; — the applicant’s level of performance in the ETSO scope of work; — the use of novelties in the technology/design or in the means of compliance; and — the complexity of the ETSO article. 1.1.    Applicant’s experience in the ETSOA process and scope of work This Section addresses the experience of the applicant’s organisation in the ETSOA process, as well as in the scope of the certification basis of the ETSO article, and of the related requirements. The presence of any of the following aspects contributes to EASA’s identification of the risk related to the level of experience of the applicant in the ETSOA process, or to the scope of work of the article: — the applicant is new and has just applied for the acceptance of its procedures by EASA, or it is the first project of the applicant after EASA has accepted such procedures; — the organisation has changed significantly the agreed procedures; and — the scope of work of the ETSOA project (ETSO standards) is new to the applicant. 1.2.    ETSOA applicant’s performance within its scope of work The ETSOA applicant’s level of performance within its scope of work is evaluated using criteria that enable EASA to identify risks in the applicant’s performance due to the following situations: — the applicant has deficiencies in the procedures that it uses to demonstrate compliance with the certification requirements; — the applicant has changed its methods or procedures to demonstrate compliance with the certification requirements; — the assessment of the applicant’s compliance on previous projects in the same ETSO scope of work has revealed significant issues in complying with the certification requirements, in the completion of data, or in the repetition of errors; — the scope of work is new to the applicant’s team at the facilities where the project is developed, or the team had significant issues on preceding projects; — EASA has not conducted an ETSOA project assessment of the applicant in the same ETSO scope of work for a long period (i.e. 2 or 3 years); and — the applicant did not regularly report minor changes or occurrences in a timely manner. 1.3.    Novelty in the technology or in the means of compliance A ‘novelty’ is understood to be the use of new technology, new sensors, new material, the use of new requirements or the use of new means of compliance. When an applicant is faced with a technology for the first time, or when that applicant is relatively unfamiliar with the technology, this is considered to be ‘novel’ even if other applicants may be already familiar with that technology. Also related to novelty is the extent to which requirements, means of compliance or guidance need to be adapted due to particular novel features of the design. The following list includes some examples: — recently issued CS-ETSO standards, with which the applicant has limited experience; — novel deviations; — new guidance; — new means of compliance (i.e. other than those previously applied by the applicant) or unusual means of compliance (different from the existing guidance material and/or different from industry standard practices); — the use of new industry standards or new in-house methods, as well as EASA’s familiarity with these new standards and methods; — changes in methodology, tools or assumptions (compared with those previously applied by the applicant), including changes in software tools/programs. Technology or means of compliance may be new/novel either from a global industry, applicant or EASA perspective. 1.4.    Complexity Complexity may result from the design, technology, associated manufacturing process, compliance demonstration (including test set-ups or analysis), as well as from the variety of ETSOs with which the applicant intends to comply, and their possible interactions. The demonstration of compliance may be ‘complex’ for complex (or highly integrated) equipment, so it typically requires more effort from the applicant. 1.5.    Criticality of the design and of the technology The criticality levels of the design and of the technology of the ETSO article are considered, but have a minor impact on the definition of EASA’s LoI. The main reasons are: — the assessment of ETSO compliance is as important for an ETSO article that hosts a critical function as it is for equipment that host less critical functions (e.g. flight data recorders); and — the criticality of the design or technology is not always defined for an ETSO article, and it may depend on the installation of the design or technology (e.g. a multifunction display), which may only occur later. 2.       Determination of EASA’s LoI EASA’s LoI in the assessment of the applicant’s compliance demonstration is determined by EASA on the basis of the qualitative risk class and EASA’s responsibilities in assessing the ETSO project certification data package, together with the procedures for compliance with the ETSO requirements (Part 21 Subpart O, and CS-ETSO). EASA’s LoI is defined in the following paragraph 2.1 and, as per point [21.B.100](#_DxCrossRefBm1649096973)(c), the EASA’s LoI that is applicable to each project is notified to the applicant. To every LoI class corresponds a list of activities that govern EASA’s involvement. By means of these activities, EASA verifies the demonstration of compliance (e.g. by document review and acceptance, test witnessing, sampling on the applicant’s site, desktop assessments, etc.). The ETSO applicant is responsible for providing a complete ETSO certification data package. 2.1.    Definition of the LoI classes EASA’s LoI for an ETSO certification project is classified as one of the following: — class high, — class high reduced, — class medium, or — class basic. Class ‘high reduced’ is, by default, EASA’s initial LoI in an ETSO project. The following is a description of each LoI class: — High EASA evaluates and samples/checks in an extensive manner all the compliance data to assess the applicant’s demonstration of compliance with the applicable ETSO standards. EASA assesses the applicant’s DDP and general compliance with Part 21 Subpart O. EASA performs desktop reviews, as well as on-site assessments of compliance demonstrations. This occurs when design and verification evidence is available. — High reduced EASA assesses all the compliance data; sampling/checking is significant and adapted to the likelihood of an unidentified non-compliance. The sampling rate may be reduced if the content of the life cycle data provides confidence in compliance and is focused in the area where confidence needs to be gained. EASA assesses the DDP and general compliance with Part 21 Subpart O. EASA performs desktop reviews, as well as an on-site assessment of the applicant’s compliance demonstration. This occurs when design and verification evidence is available. — Medium EASA assesses all the compliance data, but for some compliance data, it performs no or limited sampling/checking. EASA adapts its sampling and focuses on the likelihood of an unidentified non-compliance, taking into account the level of complexity and novelty of the project. EASA assesses the DDP and general compliance with Part 21 Subpart O. EASA performs desktop reviews and may perform an on-site assessment of the applicant’s compliance demonstration. — Basic EASA assesses the DDP and general compliance with Part 21 Subpart O, and verifies the completeness of the data package. Generally, EASA performs a desktop assessment. 3.       The process of determining EASA’s LoI The determination of EASA’s LoI is captured as a process. This process is performed mainly in three steps and is illustrated in the following figure: ![Aviation.Bot AI suggestion, not from EASA source: [Image caption skipped for debugging]](/static/files/file_ocz75zUMmy4/image030.png) Figure 1: Process of determination of EASA’s LoI in ETSO certification projects Step 1 consists of the initial LoI determination which EASA evaluates by assessing: — the applicant’s experience in the ETSOA process and scope of work according to Section 1.1 above, and — the ETSOA applicant’s performance within its scope of work according to Section 1.2 above. The result of this determination of EASA’s initial LoI is either high or high reduced. Step 2 consists of reassessing EASA’s LoI. Throughout the ETSO project, EASA receives project deliverables (e.g. plans, reports), means of compliance, requests for deviations, limitations, etc., and interacts with the applicant. If EASA’s LoI has been initially set to high reduced, EASA re-evaluates it considering: — the novelty in the technology or in the means of compliance according to Section 1.3 above, and — the complexity of the ETSO project according to Section 1.4 above. The result of this reassessment may vary from high to medium according to the following table: <table border="1" cellpadding="0" cellspacing="0" width="566"> <tr> <td valign="top" width="373"> <p><b>Assessment results </b></p> </td> <td valign="top" width="193"> <p><b>LoI adaptation </b></p> </td> </tr> <tr> <td valign="top" width="373"> <p>The ETSO article is novel and complex or a significant issue is detected during the compliance demonstration. </p> </td> <td valign="top" width="193"> <p>LoI is increased to high. </p> </td> </tr> <tr> <td valign="top" width="373"> <p>The ETSO article is novel or complex or a new deviation is requested (¹). </p> </td> <td valign="top" width="193"> <p>LoI is confirmed as high reduced. </p> </td> </tr> <tr> <td valign="top" width="373"> <p>The ETSO article is non-novel and non-complex, no issue is detected during the compliance demonstration or method, and no novel deviation or new limitation is requested. </p> </td> <td valign="top" width="193"> <p>LoI is decreased to medium. </p> </td> </tr> <tr> <td valign="top" width="373"> <p>There is a major change with straightforward redemonstration of the ETSO compliance (²). </p> </td> <td valign="top" width="193"> <p>LoI is reduced to basic. </p> </td> </tr> </table> 1        It refers to deviations from ETSO minimum operational performance standards (MOPSs), excluding deviations for requesting compliance with a new revision of an industry MOPS standard. 2        When EASA agrees that a major change only requires a straightforward redemonstration of the ETSO compliance using previous methods, without any identified risk, then EASA’s LoI is reduced to basic. Please note that this may only be defined after a minimum assessment of the applicant’s compliance demonstration methods. Note:   For a minor change, this process does not apply; in that case, EASA’s LoI consists of an assessment of the minor change classification, an update of the certificate, and, when needed, an assessment of the DDP. ##### AMC No 2 to 21.B.100(b) Level of involvement (LoI) in European technical standard order authorisation (ETSOA) projects *ED Decision 2019/018/R* The applicant for an ETSOA is required to demonstrate its capability by obtaining EASA’s agreement for the use of procedures that incorporate its specific design practices. The assessment by EASA that these procedures are properly applied is performed solely through the various ETSOA projects of the applicant. No regular audits of the organisation are performed by EASA outside the ETSOA projects. A properly completed Form 34 and the certification programme, including a technical description of the proposed design of the ETSO article, are the basis for the determination of EASA’s initial LoI. EASA assesses the compliance of the proposed ETSO article with the ETSO requirements as defined in the applicable CS-ETSO standards, as well as compliance with Part 21 Subpart O (e.g. the declaration of design and performance (DDP), ETSO marking, rating of performance, etc.). The ETSOA applicant should deliver a complete data package per point [21.A.605](#_DxCrossRefBm485230352). EASA’s LoI is further reassessed and adapted throughout the certification project until the ETSOA is issued, depending on the applicant’s data, as well as on the ETSO project changes regarding the applicant’s compliance demonstration (e.g. methods, design changes, deviations, limitations, problem reports, etc.). 1. Principles EASA’s LoI in ETSO projects is defined based both on the responsibility of EASA to assess the applicant’s demonstration of compliance, and on the risk evaluated, according to the following criteria: — the applicant’s level of experience in the ETSO process and scope of work; — the applicant’s level of performance in the ETSO scope of work; — the use of novelties in the technology/design or in the means of compliance; and — the complexity of the ETSO article. 1.1. Applicant’s experience in the ETSOA process and scope of work This Section addresses the experience of the applicant’s organisation in the ETSOA process, as well as in the scope of the certification basis of the ETSO article, and of the related requirements. The presence of any of the following aspects contributes to EASA’s identification of the risk related to the level of experience of the applicant in the ETSOA process, or to the scope of work of the article: — the applicant is new and has just applied for the acceptance of its procedures by EASA, or it is the first project of the applicant after EASA has accepted such procedures; — the organisation has changed significantly the agreed procedures; and — the scope of work of the ETSOA project (ETSO standards) is new to the applicant. 1.2. ETSOA applicant’s performance within its scope of work The ETSOA applicant’s level of performance within its scope of work is evaluated using criteria that enable EASA to identify risks in the applicant’s performance due to the following situations: — the applicant has deficiencies in the procedures that it uses to demonstrate compliance with the certification requirements; — the applicant has changed its methods or procedures to demonstrate compliance with the certification requirements; — the assessment of the applicant’s compliance on previous projects in the same ETSO scope of work has revealed significant issues in complying with the certification requirements, in the completion of data, or in the repetition of errors; — the scope of work is new to the applicant’s team at the facilities where the project is developed, or the team had significant issues on preceding projects; — EASA has not conducted an ETSOA project assessment of the applicant in the same ETSO scope of work for a long period (i.e. 2 or 3 years); and — the applicant did not regularly report minor changes or occurrences in a timely manner. 1.3. Novelty in the technology or in the means of compliance A ‘novelty’ is understood to be the use of new technology, new sensors, new material, the use of new requirements or the use of new means of compliance. When an applicant is faced with a technology for the first time, or when that applicant is relatively unfamiliar with the technology, this is considered to be ‘novel’ even if other applicants may be already familiar with that technology. Also related to novelty is the extent to which requirements, means of compliance or guidance need to be adapted due to particular novel features of the design. The following list includes some examples: — recently issued CS-ETSO standards, with which the applicant has limited experience; — novel deviations; — new guidance; — new means of compliance (i.e. other than those previously applied by the applicant) or unusual means of compliance (different from the existing guidance material and/or different from industry standard practices); — the use of new industry standards or new in-house methods, as well as EASA’s familiarity with these new standards and methods; — changes in methodology, tools or assumptions (compared with those previously applied by the applicant), including changes in software tools/programs. Technology or means of compliance may be new/novel either from a global industry, applicant or EASA perspective. 1.4. Complexity Complexity may result from the design, technology, associated manufacturing process, compliance demonstration (including test set-ups or analysis), as well as from the variety of ETSOs with which the applicant intends to comply, and their possible interactions. The demonstration of compliance may be ‘complex’ for complex (or highly integrated) equipment, so it typically requires more effort from the applicant. 1.5. Criticality of the design and of the technology The criticality levels of the design and of the technology of the ETSO article are considered, but have a minor impact on the definition of EASA’s LoI. The main reasons are: — the assessment of ETSO compliance is as important for an ETSO article that hosts a critical function as it is for equipment that host less critical functions (e.g. flight data recorders); and — the criticality of the design or technology is not always defined for an ETSO article, and it may depend on the installation of the design or technology (e.g. a multifunction display), which may only occur later. 2. Determination of EASA’s LoI EASA’s LoI in the assessment of the applicant’s compliance demonstration is determined by EASA on the basis of the qualitative risk class and EASA’s responsibilities in assessing the ETSO project certification data package, together with the procedures for compliance with the ETSO requirements (Part 21 Subpart O, and CS-ETSO). EASA’s LoI is defined in the following paragraph 2.1 and, as per point [21.B.100](#_DxCrossRefBm485230464)(c), the EASA’s LoI that is applicable to each project is notified to the applicant. To every LoI class corresponds a list of activities that govern EASA’s involvement. By means of these activities, EASA verifies the demonstration of compliance (e.g. by document review and acceptance, test witnessing, sampling on the applicant’s site, desktop assessments, etc.). The ETSO applicant is responsible for providing a complete ETSO certification data package. 2.1. Definition of the LoI classes EASA’s LoI for an ETSO certification project is classified as one of the following: — class high, — class high reduced, — class medium, or — class basic. Class ‘high reduced’ is, by default, EASA’s initial LoI in an ETSO project. The following is a description of each LoI class: — High EASA evaluates and samples/checks in an extensive manner all the compliance data to assess the applicant’s demonstration of compliance with the applicable ETSO standards. EASA assesses the applicant’s DDP and general compliance with Part 21 Subpart O. EASA performs desktop reviews, as well as on-site assessments of compliance demonstrations. This occurs when design and verification evidence is available. — High reduced EASA assesses all the compliance data; sampling/checking is significant and adapted to the likelihood of an unidentified non-compliance. The sampling rate may be reduced if the content of the life cycle data provides confidence in compliance and is focused in the area where confidence needs to be gained. EASA assesses the DDP and general compliance with Part 21 Subpart O. EASA performs desktop reviews, as well as an on-site assessment of the applicant’s compliance demonstration. This occurs when design and verification evidence is available. — Medium EASA assesses all the compliance data, but for some compliance data, it performs no or limited sampling/checking. EASA adapts its sampling and focuses on the likelihood of an unidentified non-compliance, taking into account the level of complexity and novelty of the project. EASA assesses the DDP and general compliance with Part 21 Subpart O. EASA performs desktop reviews and may perform an on-site assessment of the applicant’s compliance demonstration. — Basic EASA assesses the DDP and general compliance with Part 21 Subpart O, and verifies the completeness of the data package. Generally, EASA performs a desktop assessment. 3. The process of determining EASA’s LoI The determination of EASA’s LoI is captured as a process. This process is performed mainly in three steps and is illustrated in the following figure:  ***Figure 1: Process of determination of EASA’s LoI in ETSO certification projects*** **Step 1** consists of the initial LoI determination which EASA evaluates by assessing: — the applicant’s experience in the ETSOA process and scope of work according to Section 1.1 above, and — the ETSOA applicant’s performance within its scope of work according to Section 1.2 above. The result of this determination of EASA’s initial LoI is either high or high reduced. **Step 2** consists of reassessing EASA’s LoI. Throughout the ETSO project, EASA receives project deliverables (e.g. plans, reports), means of compliance, requests for deviations, limitations, etc., and interacts with the applicant. If EASA’s LoI has been initially set to high reduced, EASA re-evaluates it considering: — the novelty in the technology or in the means of compliance according to Section 1.3 above, and — the complexity of the ETSO project according to Section 1.4 above. The result of this reassessment may vary from high to medium according to the following table: <table bgcolor="#d9d9d9" cellpadding="7" cellspacing="0"> <col/> <col/> <tr valign="top"> <td bgcolor="#808080"><p align="center"> <b>Assessment results </b> </p> </td> <td bgcolor="#808080"><p align="center"> <b>LoI adaptation </b> </p> </td> </tr> <tr valign="top"> <td bgcolor="#d9d9d9"><p align="left"> The ETSO article is novel and complex or a significant issue is detected during the compliance demonstration. </p> </td> <td bgcolor="#d9d9d9"><p align="left"> LoI is increased to high. </p> </td> </tr> <tr valign="top"> <td bgcolor="#d9d9d9"><p align="left"> The ETSO article is novel or complex or a new deviation is requested (¹). </p> </td> <td bgcolor="#d9d9d9"><p align="left"> LoI is confirmed as high reduced. </p> </td> </tr> <tr valign="top"> <td bgcolor="#d9d9d9"><p align="left"> The ETSO article is non-novel and non-complex, no issue is detected during the compliance demonstration or method, and no novel deviation or new limitation is requested. </p> </td> <td bgcolor="#d9d9d9"><p align="left"> LoI is decreased to medium. </p> </td> </tr> <tr valign="top"> <td bgcolor="#d9d9d9"><p align="left"> There is a major change with straightforward redemonstration of the ETSO compliance (²). </p> </td> <td bgcolor="#d9d9d9"><p align="left"> LoI is reduced to basic. </p> </td> </tr> </table> 1 It refers to deviations from ETSO minimum operational performance standards (MOPSs), excluding deviations for requesting compliance with a new revision of an industry MOPS standard. 2 When EASA agrees that a major change only requires a straightforward redemonstration of the ETSO compliance using previous methods, without any identified risk, then EASA’s LoI is reduced to basic. Please note that this may only be defined after a minimum assessment of the applicant’s compliance demonstration methods. Note: For a minor change, this process does not apply; in that case, EASA’s LoI consists of an assessment of the minor change classification, an update of the certificate, and, when needed, an assessment of the DDP.