• Involved team: Engineering, Manufacturing, marketing
  • Assess changes to the PRS (only those concepts, which are to be implemented, need be included), and the DDOC and DTR2 via the change control processes (may need to go back to Phase 4 if changes are substantial). Freeze all design documents.
  • No design creativity takes place here. However, test implementation creativity is allowed.
  • Involved team: Engineering, Manufacturing.
  • It's also time to send some prototypes out to 'Friends of the Company' - some start ß-tests at this time. But, remember… the real field-testing should be done with products from the production line because the production process may slightly alter some aspect of the product - this can only be verified once the production line is running and validated.
  • Potential manufacturers need to be updated with any revised manufacturing documentation, as does the selected manufacturer, whether a CM or in-house group.
  • Don't freeze the MDOC and MTR2 at this point, as they may change somewhat during the pre-production and product verification stage, but do implement the change control process on all documents.
  • Implement the change control process on the MDOC and MTR2 and create the Product Master record (PRM) to contain 'everything one needs to know in order to manufacture, test, service, package and ship' the product.
  • Don't start the next phase until the pertinent documents are completed, approved and 'frozen', since they are the inputs to the next phase. Document control is in effect.
  • There most likely will be some design modifications resulting from the EVT and DVT (and ß-testing and field-testing). This will require some re-spinning through this phase, so plan on it.
  • If the business case is not acceptable, the project can be killed, but the investment loss could be very substantial. However, the project can be stalled at this point in case if, for example, funds are not yet available to proceed to the next phase. This phase may need to be repeated if funding is re-negotiated; this could also be costly.

 
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