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zhangyanguang12 2024-2-26 20:09
8.3.2.1.1-1        "In determining the stages and controls for design and development, the
organization shall consider: a) the objectives for each process stage; b) the
product architecture (1); c) the configuration management (see 8.1.4.1); d)
design reviews, verification and validation at defined levels of the product
architecture (2); e) design reviews, verification and validation for special
processes. "       
PLUS: In determining the stages and controls for design and development, the organization should consider: 8.3.2.1.2 a) the quality assurance methods for each design and development stage in order to meet the objectives (3); 8.3.2.1.2 b) the method to control technical requirements; 8.3.2.1.2 c) the method to control the operational maturity. (4) If requirements of special processes are inputs to the design, the risk assessment of these special processes is part of the design and development process in accordance with IRIS Guideline 6: Special Processes.        "
PLUS: During the review, verification and validation activities, the past experiences of previous projects (Lessons Learned)
and field data are taken into account. Process indicators are defined and regularly reviewed (with countermeasures, if necessary) to follow-up the fulfilment of the design and development objectives. "       
(1) e.g.: product breakdown structure. (2) e.g. starting from component design review, then sub-system design review and up to system design review (3) e.g. defined in a quality plan. (4) e.g.: for reference of maturity level of the Product and integration assessment please refer to -ISO 16290 Space systems - Definition of the Technology Readiness Levels (TRLs) and their criteria of assessment; -VDB-Guideline Quality Engineering during Design phase of Rail Vehicles and Rail Vehicle Systems (VDB = German Railway Industry Association). NOTE Design stages can be conceptual design, preliminary design, final design. NOTE 1 Controls can consider operational maturity including maturity of non-functional requirements, such as performance, integration and other non-functional requirements. NOTE 2 If requirements of special processes are inputs to the design, the risk assement of these special processes can be part of the design and development process. NOTE 3 Collaboration with external engineering can be considered as externally provided services (see 8.4).
730514shq 2024-2-23 13:38
8.3.2.1.1-1 这一列内容不完整,是否和03版的一样,我其实想了解一下ISO 16290和VDB是否还在示例里提出了。谢谢
zhangyanguang12 2024-1-31 16:46
5.3.2-1        "Process owners shall be responsible for the process compliance to requirements listed in 4.4 except availability of resources (see 4.4.1 d))."       
PLUS: Process owners lead improvement of responsible processes."       
"PLUS: Process owners implement a method to manage the interactions of the processes"

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