AMC1 21.A.239(e) Design management system

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

AMC1 21.A.239(e) Design management system ED Decision 2022/021/R INDEPENDENT MONITORING FUNCTION (a)     The independent monitoring function should ensure that: (1)     the activities of the design organisation (DO) are monitored for their compliance with the applicable requirements and with any additional requirements as established by the organisation, and that those activities are properly performed under the supervision of the nominated persons that are referred to in point [21.A.245](#_DxCrossRefBm1649096919)(b); furthermore, compliance with, and the adequacy of, the design management system should be monitored; (2)     all subcontracted design activities are monitored for adequacy and compliance with the applicable arrangements; (3)     an objective review of the complete set of design-management-related activities is provided through independent monitoring activities, such as audits, inspections, reviews; (4)     the independence of the monitoring activities is established by always ensuring that those activities and inspections are performed by staff that are not involved in the function, procedure, or products that they monitor, and that are independent from the operating managers of the function(s) being monitored; however, this should not exclude support by domain experts during monitoring; (5)     a monitoring plan is established to show when and how often the activities that are required by Part 21 will be audited; (6)     the monitoring cycle should not exceed the applicable oversight planning cycle that is established according to point [21.B.432](#_DxCrossRefBm1649097343); the determination of the monitoring plan should consider at least the following aspects: —    the criticality of the items checked; and —    the safety performance of the organisation, including any previous findings and root causes; (7)     when non-compliance is found, the root cause(s) and contributing factor(s) are identified, and corrective action is defined and followed up; and (8)     feedback is provided to the management of the DO. (b)     The independent monitoring function that is required by point [21.A.239](#_DxCrossRefBm1649096880)(e) may be undertaken by the existing quality assurance organisation if the DO is part of a larger organisation. (c)      The staff performing an independent monitoring function should have access to all the parts of the DO and, as necessary, to any subcontracted organisations. ##### AMC1 21.A.239(e) Design management system *ED Decision 2022/021/R* **INDEPENDENT MONITORING FUNCTION** (a) The independent monitoring function should ensure that: (1) the activities of the design organisation (DO) are monitored for their compliance with the applicable requirements and with any additional requirements as established by the organisation, and that those activities are properly performed under the supervision of the nominated persons that are referred to in point [21.A.245](#_DxCrossRefBm485230410)(b); furthermore, compliance with, and the adequacy of, the design management system should be monitored; (2) all subcontracted design activities are monitored for adequacy and compliance with the applicable arrangements; (3) an objective review of the complete set of design-management-related activities is provided through independent monitoring activities, such as audits, inspections, reviews; (4) the independence of the monitoring activities is established by always ensuring that those activities and inspections are performed by staff that are not involved in the function, procedure, or products that they monitor, and that are independent from the operating managers of the function(s) being monitored; however, this should not exclude support by domain experts during monitoring; (5) a monitoring plan is established to show when and how often the activities that are required by Part 21 will be audited; (6) the monitoring cycle should not exceed the applicable oversight planning cycle that is established according to point [21.B.432](#_DxCrossRefBm485230835); the determination of the monitoring plan should consider at least the following aspects: — the criticality of the items checked; and — the safety performance of the organisation, including any previous findings and root causes; (7) when non-compliance is found, the root cause(s) and contributing factor(s) are identified, and corrective action is defined and followed up; and (8) feedback is provided to the management of the DO. (b) The independent monitoring function that is required by point [21.A.239](#_DxCrossRefBm485230370)(e) may be undertaken by the existing quality assurance organisation if the DO is part of a larger organisation. (c) The staff performing an independent monitoring function should have access to all the parts of the DO and, as necessary, to any subcontracted organisations.