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Critical process steps often exist only as 'tribal knowledge' in the R&D team. To ensure these details aren't lost during manufacturing transfer, have the lead R&D technician build a device using only the formal manufacturing process instructions (MPI) and identify any discrepancies before release.
An initial role as a technician building parts can provide design engineers with a critical understanding of manufacturability often missed in university. This hands-on experience, including breaking tools, teaches practical DFM principles and builds confidence.
Teams hyper-focus on replicating process parameters during tech transfer, but this is a blind spot. The true measure of success is a statistically powerful analytical and sampling plan that rigorously proves the process transferred successfully and can detect any deviations.
Before automating a manual process, leaders should deeply engage with the people on the line. These operators possess invaluable, often un-documented, knowledge about process nuances and potential failure modes that are critical for a successful automation project.
Critical process knowledge often exists only in operators' heads—the nuances and undocumented tricks that ensure success. Systematically capturing this 'tribal knowledge' during tech transfer is crucial for preventing hard-to-diagnose failures at the new site.
When scaling to production, the biggest pitfall is the implicit knowledge held by the original design team who unconsciously fill procedural gaps. To succeed, involve someone with a manufacturing background but no project history to rigorously review procedures and expose these unstated assumptions before scaling.
Manufacturing faces a crisis as veterans with 30+ years of experience retire, taking unwritten operational knowledge with them. Dirac's software addresses this by creating a system to document complex assembly processes, safeguarding against knowledge loss and enabling less experienced workers to perform high-skill tasks.
To drive a production-focused culture in R&D, implement a daily "shift pass-down" report. This manufacturing practice forces the team to document what they accomplished versus what they planned, and explain the deltas. It brings factory-floor accountability and rigor to the traditionally less structured R&D process.
To ensure a smooth transition from development to production, an operations or manufacturing SME must be part of the design process from the start. Otherwise, products are developed without manufacturability in mind, leading to expensive, reactive fixes and subjective quality control during scale-up.
At American Housing Corp, engineers who design components also manufacture them in the factory and assemble them in the field. This forces them to experience the "pain" of their design decisions firsthand, creating a rapid, visceral feedback loop that leads to faster and more effective product improvements.
The 'design transfer' from R&D to manufacturing is a highly formalized process in medical devices. The Design Transfer Plan (DTP) is a comprehensive document listing all equipment, procedures, sub-assemblies, and planned validation activities (PQs, OQs, TMBs), plus formal assessments from regulatory and quality teams before production can begin.