The current state is based on fragmented and discontinuous lifecycles and workflows, with all of the attendant pitfalls and inefficiencies which I won’t go into here. By comparison, the desired state calls for lifecycle integration and connectivity; with development, design and manufacturing being treated as inseparable items within the compliance continuum. Time for another acronym by the way: Development, Design & Manufacturing Lifecycle = DDML.
While each DDML phase has its own particularities (e.g. preconditions, handshakes, timing, protocols) and sub-phases (e.g. technology transfer, risk assessment, preliminary & detailed design, delivery, C&Q, maintenance, requalification), I am suggesting that not only can they be, but they must be, defined and managed in unison. This message invites discussion and feedback in regard to the implications of lifecycle integration as a constituent of Self-Evident Engineering (SEE).
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