Trying to familiarize myself with EASA requirements at a non POA US based manufacturer.
Background - As an ODA I-UM employed at a tier 1 supplier to an OEM/ODA I have been on the receiving end of the ODA’s conformity section of their Project Specific Certification Plan, i.e., conduct conformity inspections at my company and/or direct sub-tiers. Which in turn validates that the production facilities, drawing system, quality control system, management structure, production tooling, manufacturing processes, process controls, inspection methods, supplier control procedures, and other production system factors are capable of producing duplicate articles of the type design. Thus, too many deviations/UNSATs identified during PC Conformity Inspection typically results in repeating the conformity on a later unit/part to show production system factors are capable of producing duplicate articles of the type design.
It does not appear EASA Managed Certification Projects require a list of conformity candidates(parts, assemblies, installations) to be conformed by an independent individual/organization to show the manufacturer is capable of producing duplicate articles of the type design. It appears an EASA Managed Certification Project’s approach is systems based paired with systems based audit oversight/surveillance. The EASA method utilizes supplier processes following a Quality Management System. Hence the importance of an approved Quality Management System (QMS) and being accredited with IEC/17025, AS9100, etc. EASA requirements do not require Direct Inspection from a Delegated Regulatory Individual/Organization. Documentation supporting conformity would exist in the form of a Certificate of Conformance (C of C) and a First Article Inspection Report (FAIR) for the end item deliverable. The C of C will be utilized to verify parts were built to the design data. For production parts there would be a FAIR and a C of C. Is this an brief an accurate description of EASA Managed Certification Projects?
Background - As an ODA I-UM employed at a tier 1 supplier to an OEM/ODA I have been on the receiving end of the ODA’s conformity section of their Project Specific Certification Plan, i.e., conduct conformity inspections at my company and/or direct sub-tiers. Which in turn validates that the production facilities, drawing system, quality control system, management structure, production tooling, manufacturing processes, process controls, inspection methods, supplier control procedures, and other production system factors are capable of producing duplicate articles of the type design. Thus, too many deviations/UNSATs identified during PC Conformity Inspection typically results in repeating the conformity on a later unit/part to show production system factors are capable of producing duplicate articles of the type design.
It does not appear EASA Managed Certification Projects require a list of conformity candidates(parts, assemblies, installations) to be conformed by an independent individual/organization to show the manufacturer is capable of producing duplicate articles of the type design. It appears an EASA Managed Certification Project’s approach is systems based paired with systems based audit oversight/surveillance. The EASA method utilizes supplier processes following a Quality Management System. Hence the importance of an approved Quality Management System (QMS) and being accredited with IEC/17025, AS9100, etc. EASA requirements do not require Direct Inspection from a Delegated Regulatory Individual/Organization. Documentation supporting conformity would exist in the form of a Certificate of Conformance (C of C) and a First Article Inspection Report (FAIR) for the end item deliverable. The C of C will be utilized to verify parts were built to the design data. For production parts there would be a FAIR and a C of C. Is this an brief an accurate description of EASA Managed Certification Projects?
