Transfer Prototype to Production Process
Client : A Biotech Instrument Company
Duration : 4 months
A venture funded Biotech Company needed to evaluate and release to manufacturing a fluid handling and advanced imaging analytical instrument.
The client needed assistance in validating and planning the transfer of prototype into a finished product. This consultant was asked to review the prototype design and release drawings and develop the manufacturing procedures.
This consultant reviewed product design drawings and release documentation and made recommendations on the manufacturability, verification / validation and documentation required. This consultant developed a Design Control process and helped select OEM vendors. In addition, a custom document control was developed (see Figure 1) along with final instrument verification and validation process. This consultant also outlined the manufacturing documentation system and detailed a material flow for an MRP system (see Figure 2) and identified a validation quality group.
Figure 1 - Document Control Process developed specifically for this client
Figure 2 - Material Control flowchart using PC/MRP, customized for client
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