Regulatory Open Forum

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  • 1.  Design Verification

    Posted 26-May-2023 03:12
    In order to address lot-to-lot variability during the design verification of a device, it was decided to introduce a time gap between production runs. The question now arises: what would be the optimal duration for this time gap? Options such as 7 days, 4 days, 2 days, and 1 day are being considered. It is worth noting that controllable variables, including staff changes and power cycling, can be implemented within a short timeframe of approximately 8 hours. While the staff changes may not involve a complete overhaul but are still representative of the workforce. Additionally, it is believed that power cycling between runs would be appropriate. Assuming a minimum of 8-10 hours between runs, the question remains whether this approach is favorable. Running against time saving a single day means a lot. Any advice or recommendations on this matter would be greatly appreciated.

    V K
    Regulatory Consultant

    United Kingdom

  • 2.  RE: Design Verification

    Posted 26-May-2023 11:22

    I suspect that you have confused design verification and process capability. It is rare that design verification requires manufacturing product.

    Design verification shows that the design output meets the design input. This can usually be done by comparing the drawing, specifications sheets, etc. with the input. Let me provide a simple example. The design input calls for an AC mains power cord that is 4 meters long, plugs into a UK wall outlet, uses 16 gauge wire, is grey in color, etc. This becomes a purchasing specification, perhaps citing a specific manufacturer's part number. Design verification checks that the purchasing specification meets these requirements. You don't need to purchase 30 samples and measure the characteristics to perform design verification.

    Similarly, when you manufacture the product in house, you don't need to make any to know that that the design output meets the design input requirements.

    The design output, through design transfer, becomes the production specifications. At this point you now have the work instructions, etc. to make the product.

    My recommendation is that you rethink your approach to design verification. Change from manufacturability and production process capability to ensuring the design output includes the information required by the design input.

    Dan O'Leary CQA, CQE
    Swanzey NH
    United States