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Recently, FDA auidted our site, they raised one question on sample size for design verification as follows:
Specifically, procedures for identifying valid statistical techniques required for verifying the acceptability of product characteristics of a new design during design verification and design validation testing have not been adequately established. For example, for the design validation testing of the new product design project, only one unit was tested. No valid statistical rationale was documented for the testing of only one unit.
So according to our practice, we only finish one prototype from Lab for design verification, so how to solve this problem, do we need manufacture more prototypes from Lab for design verification?
Can anyone help me clarify this?
Thanks.
Specifically, procedures for identifying valid statistical techniques required for verifying the acceptability of product characteristics of a new design during design verification and design validation testing have not been adequately established. For example, for the design validation testing of the new product design project, only one unit was tested. No valid statistical rationale was documented for the testing of only one unit.
So according to our practice, we only finish one prototype from Lab for design verification, so how to solve this problem, do we need manufacture more prototypes from Lab for design verification?
Can anyone help me clarify this?
Thanks.