AMC 21L.B.241(a)(1) and 21L.B.242(a)(1) Critical design review of the design and physical inspection and assessment of the aircraft

• ED Decision 2023/013/R found in: Initial Airworthiness and Environmental Protection (748/2012) Part-21 Part-21L (Jul 2024)

AMC 21L.B.241(a)(1) and 21L.B.242(a)(1) Critical design review of the design and physical inspection and assessment of the aircraft ED Decision 2023/013/R PHYSICAL INSPECTION AND CRITICAL DESIGN REVIEW OF PRODUCTS TO BE CERTIFIED 1.       Introduction For the purposes of this AMC, ‘physical inspection and critical design review’ includes: a.       the investigation prior to the issuance of a permit to fly, which consists of a physical inspection of the aircraft by the competent authority; and b.       the investigation prior to the approval of the flight conditions, which consists of a critical design review of the design and a physical inspection and assessment of the aircraft by the Agency. Note: The competent authority may determine that it is necessary to conduct an oversight visit at the applicant’s facilities prior to the submission of the application for the approval of the flight conditions and the issuance of a permit to fly to ensure the conformity of the aircraft for which a permit to fly has been requested. For example, this could be due to the need to conduct a conformity check of subassemblies prior to their incorporation into the final prototype. 2.       Purpose The purposes of the physical inspection and the critical design review prior to the approval of the flight conditions and the issuance of a permit to fly for a particular aircraft design for which an application for a type certificate has been submitted are: a.       for EASA to verify[[102]](#_ftn102) that the demonstration-of-compliance activities conducted by the applicant under point [21L.A.25](#_DxCrossRefBm1649097803) have reached a sufficient level of maturity to progress to flight testing in order to conclude the demonstration of compliance; b.       for EASA to ensure that the design configuration for which the flight conditions have been requested is capable of conducting safe flight during flight testing; c.       in case the applicant is a declared design organisation, for EASA to conduct the first oversight visit in accordance with point [21L.B.183](#_DxCrossRefBm1649097817)(b) of Subpart J in order to ensure that the applicant is able to discharge its obligations; d.       for the competent authority to ensure the conformity of the aircraft with the configuration for which the issuance of a permit to fly has been requested; e.       in case the applicant is a declared production organisation, for the competent authority to conduct the first oversight visit in accordance with point [21L.B.143](#_DxCrossRefBm1649097816)(b) of Subpart G and point [21L.B.241](#_DxCrossRefBm1649098150) of Subpart P in order to ensure that the applicant is able to discharge its obligations and is capable of producing or controlling the production of aircraft, products and parts that conform with the design data. 3.       Methodology and evidence The physical inspection and the critical design review should be conducted by EASA and the competent authority at an appropriate location(s) selected by the applicant for the type certificate.  This (these) location(s) should include the physical location of the aircraft for which the approval of the flight conditions and the issuance of a permit to fly have been requested and should be in the principal place of business (which in accordance with [Article 8](#_DxCrossRefBm1649096867)(2) of Regulation (EU) No 748/2012 must be in an EU Member State). The Agency and the competent authority should conduct a physical inspection of the aircraft, engine or propeller for which the approval of the flight conditions and the issuance of a permit to fly have been requested. This inspection, along with any other activity that EASA or the competent authority deems necessary (for example, see point [21L.A.25](#_DxCrossRefBm1649097803)(e)), should ensure that the objectives mentioned in point 2 are met. Additional sources of evidence during the visit at the applicant’s facilities may include: a.       witnessing or participating to live testing of the aircraft, engine, propeller, systems or components; b.       evaluation of the compliance-demonstration plan produced by the applicant; c.       evaluation of supporting compliance documentation and test reports; d.       discussions with key design and production personnel; e.       review of conformity documentation; f.       review of the relevant design or production processes and procedures (for non-approved organisations). The above list of additional sources of evidence is not exhaustive. 4.       Aircraft condition and configuration The aircraft presented to EASA and the competent authority should be in a condition for first flight and be in the configuration for which the approval of the flight conditions and the issuance of a permit to fly have been requested. If this is not the case, then a judgement should be made whether the critical design review and physical inspection can be conducted or not based upon any differences between the ‘as presented’ configuration and condition and the configuration that will be used for flight testing. 5.       Availability of supporting documentation and key personnel The applicant is required to make available supporting documentation as well as compliance and conformity data at the time of the visit by EASA and the competent authority at the applicant’s facilities. Key design and production personnel should be made available by the applicant to EASA and the competent authority in case of need. The Agency and the competent authority may wish to withhold the approval of the flight conditions and the issuance of the permit to fly if this is not the case. 6.       Findings and resolution If a non-compliance is discovered by EASA or the competent authority in the process of the activities mentioned in point 2, an appropriate finding may be raised against the particular aircraft or declared design organisation or declared production organisation. Depending upon their nature, these findings may need to be resolved before the flight conditions are approved or the permit to fly is issued. 7.       Duration and schedule The physical inspection and the critical design review may be a single visit or, if necessary, multiple visits depending on the complexity of the design, the maturity of the design and any unique characteristics that are identified in the compliance-demonstration plan. It should not solely be viewed as a single one-day event. --- [[102]](#_ftnref102) The verification is limited to the scope of the activities that can be conducted under point 3 and the elements of the design that are selected for review based upon a risk-based approach to compliance. AMC 21L.B.241(a)(1) and 21L.B.242(a)(1) Critical design review of the design and physical inspection and assessment of the aircraft ED Decision 2023/013/R PHYSICAL INSPECTION AND CRITICAL DESIGN REVIEW OF PRODUCTS TO BE CERTIFIED 1.       Introduction For the purposes of this AMC, ‘physical inspection and critical design review’ includes: a.       the investigation prior to the issuance of a permit to fly, which consists of a physical inspection of the aircraft by the competent authority; and b.       the investigation prior to the approval of the flight conditions, which consists of a critical design review of the design and a physical inspection and assessment of the aircraft by the Agency. Note: The competent authority may determine that it is necessary to conduct an oversight visit at the applicant’s facilities prior to the submission of the application for the approval of the flight conditions and the issuance of a permit to fly to ensure the conformity of the aircraft for which a permit to fly has been requested. For example, this could be due to the need to conduct a conformity check of subassemblies prior to their incorporation into the final prototype. 2.       Purpose The purposes of the physical inspection and the critical design review prior to the approval of the flight conditions and the issuance of a permit to fly for a particular aircraft design for which an application for a type certificate has been submitted are: a.       for EASA to verify[[104]](#_ftn104) that the demonstration-of-compliance activities conducted by the applicant under point [21L.A.25](#_DxCrossRefBm1649097803) have reached a sufficient level of maturity to progress to flight testing in order to conclude the demonstration of compliance; b.       for EASA to ensure that the design configuration for which the flight conditions have been requested is capable of conducting safe flight during flight testing; c.       in case the applicant is a declared design organisation, for EASA to conduct the first oversight visit in accordance with point [21L.B.183](#_DxCrossRefBm1649097817)(b) of Subpart J in order to ensure that the applicant is able to discharge its obligations; d.       for the competent authority to ensure the conformity of the aircraft with the configuration for which the issuance of a permit to fly has been requested; e.       in case the applicant is a declared production organisation, for the competent authority to conduct the first oversight visit in accordance with point [21L.B.143](#_DxCrossRefBm1649097816)(b) of Subpart G and point [21L.B.241](#_DxCrossRefBm1649098150) of Subpart P in order to ensure that the applicant is able to discharge its obligations and is capable of producing or controlling the production of aircraft, products and parts that conform with the design data. 3.       Methodology and evidence The physical inspection and the critical design review should be conducted by EASA and the competent authority at an appropriate location(s) selected by the applicant for the type certificate.  This (these) location(s) should include the physical location of the aircraft for which the approval of the flight conditions and the issuance of a permit to fly have been requested and should be in the principal place of business (which in accordance with [Article 8](#_DxCrossRefBm1649096867)(2) of Regulation (EU) No 748/2012 must be in an EU Member State). The Agency and the competent authority should conduct a physical inspection of the aircraft, engine or propeller for which the approval of the flight conditions and the issuance of a permit to fly have been requested. This inspection, along with any other activity that EASA or the competent authority deems necessary (for example, see point [21L.A.25](#_DxCrossRefBm1649097803)(e)), should ensure that the objectives mentioned in point 2 are met. Additional sources of evidence during the visit at the applicant’s facilities may include: a.       witnessing or participating to live testing of the aircraft, engine, propeller, systems or components; b.       evaluation of the compliance-demonstration plan produced by the applicant; c.       evaluation of supporting compliance documentation and test reports; d.       discussions with key design and production personnel; e.       review of conformity documentation; f.       review of the relevant design or production processes and procedures (for non-approved organisations). The above list of additional sources of evidence is not exhaustive. 4.       Aircraft condition and configuration The aircraft presented to EASA and the competent authority should be in a condition for first flight and be in the configuration for which the approval of the flight conditions and the issuance of a permit to fly have been requested. If this is not the case, then a judgement should be made whether the critical design review and physical inspection can be conducted or not based upon any differences between the ‘as presented’ configuration and condition and the configuration that will be used for flight testing. 5.       Availability of supporting documentation and key personnel The applicant is required to make available supporting documentation as well as compliance and conformity data at the time of the visit by EASA and the competent authority at the applicant’s facilities. Key design and production personnel should be made available by the applicant to EASA and the competent authority in case of need. The Agency and the competent authority may wish to withhold the approval of the flight conditions and the issuance of the permit to fly if this is not the case. 6.       Findings and resolution If a non-compliance is discovered by EASA or the competent authority in the process of the activities mentioned in point 2, an appropriate finding may be raised against the particular aircraft or declared design organisation or declared production organisation. Depending upon their nature, these findings may need to be resolved before the flight conditions are approved or the permit to fly is issued. 7.       Duration and schedule The physical inspection and the critical design review may be a single visit or, if necessary, multiple visits depending on the complexity of the design, the maturity of the design and any unique characteristics that are identified in the compliance-demonstration plan. It should not solely be viewed as a single one-day event. --- [[104]](#_ftnref104) The verification is limited to the scope of the activities that can be conducted under point 3 and the elements of the design that are selected for review based upon a risk-based approach to compliance. ##### AMC 21L.B.241(a)(1) and 21L.B.242(a)(1) Critical design review of the design and physical inspection and assessment of the aircraft *ED Decision 2023/013/R* **PHYSICAL INSPECTION AND CRITICAL DESIGN REVIEW OF PRODUCTS TO BE CERTIFIED** 1. Introduction For the purposes of this AMC, ‘physical inspection and critical design review’ includes: a. the investigation prior to the issuance of a permit to fly, which consists of a physical inspection of the aircraft by the competent authority; and b. the investigation prior to the approval of the flight conditions, which consists of a critical design review of the design and a physical inspection and assessment of the aircraft by the Agency. *Note*: The competent authority may determine that it is necessary to conduct an oversight visit at the applicant’s facilities prior to the submission of the application for the approval of the flight conditions and the issuance of a permit to fly to ensure the conformity of the aircraft for which a permit to fly has been requested. For example, this could be due to the need to conduct a conformity check of subassemblies prior to their incorporation into the final prototype. 2. Purpose The purposes of the physical inspection and the critical design review prior to the approval of the flight conditions and the issuance of a permit to fly for a particular aircraft design for which an application for a type certificate has been submitted are: a. for EASA to verify[[87]](#_ftn87) that the demonstration-of-compliance activities conducted by the applicant under point [21L.A.25](#_DxCrossRefBm485231299) have reached a sufficient level of maturity to progress to flight testing in order to conclude the demonstration of compliance; b. for EASA to ensure that the design configuration for which the flight conditions have been requested is capable of conducting safe flight during flight testing; c. in case the applicant is a declared design organisation, for EASA to conduct the first oversight visit in accordance with point [21L.B.183](#_DxCrossRefBm485231313)(b) of Subpart J in order to ensure that the applicant is able to discharge its obligations; d. for the competent authority to ensure the conformity of the aircraft with the configuration for which the issuance of a permit to fly has been requested; e. in case the applicant is a declared production organisation, for the competent authority to conduct the first oversight visit in accordance with point [21L.B.143](#_DxCrossRefBm485231312)(b) of Subpart G and point [21L.B.241](#_DxCrossRefBm485231647) of Subpart P in order to ensure that the applicant is able to discharge its obligations and is capable of producing or controlling the production of aircraft, products and parts that conform with the design data. 3. Methodology and evidence The physical inspection and the critical design review should be conducted by EASA and the competent authority at an appropriate location(s) selected by the applicant for the type certificate. This (these) location(s) should include the physical location of the aircraft for which the approval of the flight conditions and the issuance of a permit to fly have been requested and should be in the principal place of business (which in accordance with [Article 8](#_DxCrossRefBm485230357)(2) of Regulation (EU) No 748/2012 must be in an EU Member State). The Agency and the competent authority should conduct a physical inspection of the aircraft, engine or propeller for which the approval of the flight conditions and the issuance of a permit to fly have been requested. This inspection, along with any other activity that EASA or the competent authority deems necessary (for example, see point [21L.A.25](#_DxCrossRefBm485231299)(e)), should ensure that the objectives mentioned in point 2 are met. Additional sources of evidence during the visit at the applicant’s facilities may include: a. witnessing or participating to live testing of the aircraft, engine, propeller, systems or components; b. evaluation of the compliance-demonstration plan produced by the applicant; c. evaluation of supporting compliance documentation and test reports; d. discussions with key design and production personnel; e. review of conformity documentation; f. review of the relevant design or production processes and procedures (for non-approved organisations). The above list of additional sources of evidence is not exhaustive. 4. Aircraft condition and configuration The aircraft presented to EASA and the competent authority should be in a condition for first flight and be in the configuration for which the approval of the flight conditions and the issuance of a permit to fly have been requested. If this is not the case, then a judgement should be made whether the critical design review and physical inspection can be conducted or not based upon any differences between the ‘as presented’ configuration and condition and the configuration that will be used for flight testing. 5. Availability of supporting documentation and key personnel The applicant is required to make available supporting documentation as well as compliance and conformity data at the time of the visit by EASA and the competent authority at the applicant’s facilities. Key design and production personnel should be made available by the applicant to EASA and the competent authority in case of need. The Agency and the competent authority may wish to withhold the approval of the flight conditions and the issuance of the permit to fly if this is not the case. 6. Findings and resolution If a non-compliance is discovered by EASA or the competent authority in the process of the activities mentioned in point 2, an appropriate finding may be raised against the particular aircraft or declared design organisation or declared production organisation. Depending upon their nature, these findings may need to be resolved before the flight conditions are approved or the permit to fly is issued. 7. Duration and schedule The physical inspection and the critical design review may be a single visit or, if necessary, multiple visits depending on the complexity of the design, the maturity of the design and any unique characteristics that are identified in the compliance-demonstration plan. It should not solely be viewed as a single one-day event. --- [[87]](#_ftnref87) The verification is limited to the scope of the activities that can be conducted under point 3 and the elements of the design that are selected for review based upon a risk-based approach to compliance. ##### AMC 21L.B.241(a)(1) and 21L.B.242(a)(1) Critical design review of the design and physical inspection and assessment of the aircraft *ED Decision 2023/013/R* **PHYSICAL INSPECTION AND CRITICAL DESIGN REVIEW OF PRODUCTS TO BE CERTIFIED** 1. Introduction For the purposes of this AMC, ‘physical inspection and critical design review’ includes: a. the investigation prior to the issuance of a permit to fly, which consists of a physical inspection of the aircraft by the competent authority; and b. the investigation prior to the approval of the flight conditions, which consists of a critical design review of the design and a physical inspection and assessment of the aircraft by the Agency. *Note*: The competent authority may determine that it is necessary to conduct an oversight visit at the applicant’s facilities prior to the submission of the application for the approval of the flight conditions and the issuance of a permit to fly to ensure the conformity of the aircraft for which a permit to fly has been requested. For example, this could be due to the need to conduct a conformity check of subassemblies prior to their incorporation into the final prototype. 2. Purpose The purposes of the physical inspection and the critical design review prior to the approval of the flight conditions and the issuance of a permit to fly for a particular aircraft design for which an application for a type certificate has been submitted are: a. for EASA to verify[[89]](#_ftn89) that the demonstration-of-compliance activities conducted by the applicant under point [21L.A.25](#_DxCrossRefBm485231299) have reached a sufficient level of maturity to progress to flight testing in order to conclude the demonstration of compliance; b. for EASA to ensure that the design configuration for which the flight conditions have been requested is capable of conducting safe flight during flight testing; c. in case the applicant is a declared design organisation, for EASA to conduct the first oversight visit in accordance with point [21L.B.183](#_DxCrossRefBm485231313)(b) of Subpart J in order to ensure that the applicant is able to discharge its obligations; d. for the competent authority to ensure the conformity of the aircraft with the configuration for which the issuance of a permit to fly has been requested; e. in case the applicant is a declared production organisation, for the competent authority to conduct the first oversight visit in accordance with point [21L.B.143](#_DxCrossRefBm485231312)(b) of Subpart G and point [21L.B.241](#_DxCrossRefBm485231647) of Subpart P in order to ensure that the applicant is able to discharge its obligations and is capable of producing or controlling the production of aircraft, products and parts that conform with the design data. 3. Methodology and evidence The physical inspection and the critical design review should be conducted by EASA and the competent authority at an appropriate location(s) selected by the applicant for the type certificate. This (these) location(s) should include the physical location of the aircraft for which the approval of the flight conditions and the issuance of a permit to fly have been requested and should be in the principal place of business (which in accordance with [Article 8](#_DxCrossRefBm485230357)(2) of Regulation (EU) No 748/2012 must be in an EU Member State). The Agency and the competent authority should conduct a physical inspection of the aircraft, engine or propeller for which the approval of the flight conditions and the issuance of a permit to fly have been requested. This inspection, along with any other activity that EASA or the competent authority deems necessary (for example, see point [21L.A.25](#_DxCrossRefBm485231299)(e)), should ensure that the objectives mentioned in point 2 are met. Additional sources of evidence during the visit at the applicant’s facilities may include: a. witnessing or participating to live testing of the aircraft, engine, propeller, systems or components; b. evaluation of the compliance-demonstration plan produced by the applicant; c. evaluation of supporting compliance documentation and test reports; d. discussions with key design and production personnel; e. review of conformity documentation; f. review of the relevant design or production processes and procedures (for non-approved organisations). The above list of additional sources of evidence is not exhaustive. 4. Aircraft condition and configuration The aircraft presented to EASA and the competent authority should be in a condition for first flight and be in the configuration for which the approval of the flight conditions and the issuance of a permit to fly have been requested. If this is not the case, then a judgement should be made whether the critical design review and physical inspection can be conducted or not based upon any differences between the ‘as presented’ configuration and condition and the configuration that will be used for flight testing. 5. Availability of supporting documentation and key personnel The applicant is required to make available supporting documentation as well as compliance and conformity data at the time of the visit by EASA and the competent authority at the applicant’s facilities. Key design and production personnel should be made available by the applicant to EASA and the competent authority in case of need. The Agency and the competent authority may wish to withhold the approval of the flight conditions and the issuance of the permit to fly if this is not the case. 6. Findings and resolution If a non-compliance is discovered by EASA or the competent authority in the process of the activities mentioned in point 2, an appropriate finding may be raised against the particular aircraft or declared design organisation or declared production organisation. Depending upon their nature, these findings may need to be resolved before the flight conditions are approved or the permit to fly is issued. 7. Duration and schedule The physical inspection and the critical design review may be a single visit or, if necessary, multiple visits depending on the complexity of the design, the maturity of the design and any unique characteristics that are identified in the compliance-demonstration plan. It should not solely be viewed as a single one-day event. --- [[89]](#_ftnref89) The verification is limited to the scope of the activities that can be conducted under point 3 and the elements of the design that are selected for review based upon a risk-based approach to compliance.