AMC-ELA No 4 to 21.A.239(a) Design assurance system – Independent system monitoring    

CAA ORS9 Decision No. 1

Monitoring that the implemented design assurance system (DAS) is adequate, and that it is complied with, is done by systematic means. The systematic means of monitoring may include structured experience exchanges, regular design meetings, brainstorming or lessons-learned sessions, project reviews at appropriate phases of the development, or by other similar means.

Audits may be one element of monitoring. When implemented, audits should be conducted as combined process/product (project) audits that focus on the implemented key processes or methods practised according to the DOH (or the equivalent document), and the audits should also allow the design organisation to find ways to become more efficient by continuous improvement.

Systematic means of monitoring are coordinated by the ISM, under the responsibility of the HDO, and with a direct reporting line to the HDO. If the ISM is not independent of the activity that is monitored, especially if the HDO also fulfills the role of the head of ISM, the HDO may involve auditors that have adequate knowledge of the applicable requirements and of the implemented DAS. The system monitoring function may be undertaken by the existing quality assurance organisation, provided that it has adequate reporting lines to the HDO.