GM2 21.A.239(d)(3) Design management system

• ED Decision 2022/021/R found in: Initial Airworthiness and Environmental Protection (748/2012) Part-21 Part-21L (Jul 2024)

GM2 21.A.239(d)(3) Design management system ED Decision 2022/021/R DESIGN ASSURANCE ELEMENT — PARTNER AND SUBCONTRACTOR ARRANGEMENTS When defining the arrangements between the design organisation (DO) and its partners and subcontractors, both elements of the design management system should be taken into account, i.e. the safety management element and the design assurance element. The following guidance should therefore be considered applicable to both elements. (a)     When the DO subcontracts activities, the arrangements should consider the safety risk management process that is part of its safety management element (see point [21.A.239](#_DxCrossRefBm1649096880)(c)(3)). When the subcontractor does not have a safety management element, the subcontractor should be integrated into the safety management element of the DO; when the subcontractor has implemented a safety management system (such as for design organisation approval (DOA) or production organisation approval (POA)), the two safety management systems, i.e. of the DO and of the subcontractor, should be harmonised. (b)     Depending on the complexity and criticality of those arrangements, the following elements within the arrangements should be addressed: (1)     coordination and interfaces between all the parties involved; (2)     applicable procedures; (3)     safety culture, including internal safety reporting scheme (see point [21.A.3A](#_DxCrossRefBm1649096889)). (4)     communication between all the parties involved, including reporting, regular meetings, and feedback channels; (5)     allocation of tasks, of clear accountability, and of responsibilities; and (6)     the qualifications and competency of key personnel with reference to point [21.A.245](#_DxCrossRefBm1649096919). (c)      The safety risk management should focus on the needs to exchange safety data and safety information that are deemed significant for the determination of relevant risks in terms of likelihood, severity, impact, and acceptability, such as, wherever appropriate, but not limited to the following: (1)     (at product level) failure, malfunction, defect, or other occurrences, non-conformity or outcome of the compliance monitoring function, component failure analysis, in-service event, etc.; (2)     (at documentation level) key processes (e.g. airworthiness directives, design and certification documentation, design processes); and (3)     (at organisation level) changes, disruptive events, resources’ issues, human performance (HP) issues. (d)     Regular communication should be ensured between all the parties involved, to discuss work progress, risk mitigation measures, changes to the arrangements, as well as any other significant issues. ##### GM2 21.A.239(d)(3) Design management system *ED Decision 2022/021/R* **DESIGN ASSURANCE ELEMENT — PARTNER AND SUBCONTRACTOR ARRANGEMENTS** When defining the arrangements between the design organisation (DO) and its partners and subcontractors, both elements of the design management system should be taken into account, i.e. the safety management element and the design assurance element. The following guidance should therefore be considered applicable to both elements. (a) When the DO subcontracts activities, the arrangements should consider the safety risk management process that is part of its safety management element (see point [21.A.239](#_DxCrossRefBm485230370)(c)(3)). When the subcontractor does not have a safety management element, the subcontractor should be integrated into the safety management element of the DO; when the subcontractor has implemented a safety management system (such as for design organisation approval (DOA) or production organisation approval (POA)), the two safety management systems, i.e. of the DO and of the subcontractor, should be harmonised. (b) Depending on the complexity and criticality of those arrangements, the following elements within the arrangements should be addressed: (1) coordination and interfaces between all the parties involved; (2) applicable procedures; (3) safety culture, including internal safety reporting scheme (see point [21.A.3A](#_DxCrossRefBm485230380)). (4) communication between all the parties involved, including reporting, regular meetings, and feedback channels; (5) allocation of tasks, of clear accountability, and of responsibilities; and (6) the qualifications and competency of key personnel with reference to point [21.A.245](#_DxCrossRefBm485230410). (c) The safety risk management should focus on the needs to exchange safety data and safety information that are deemed significant for the determination of relevant risks in terms of likelihood, severity, impact, and acceptability, such as, wherever appropriate, but not limited to the following: (1) (at product level) failure, malfunction, defect, or other occurrences, non-conformity or outcome of the compliance monitoring function, component failure analysis, in-service event, etc.; (2) (at documentation level) key processes (e.g. airworthiness directives, design and certification documentation, design processes); and (3) (at organisation level) changes, disruptive events, resources’ issues, human performance (HP) issues. (d) Regular communication should be ensured between all the parties involved, to discuss work progress, risk mitigation measures, changes to the arrangements, as well as any other significant issues.