Qualification of second-source raw materials in the presence of multiple batch effects
Abstract:
Techniques for qualifying a candidate supplier are presented. Such techniques may include obtaining a part produced by a candidate supplier and measuring a quantifiable property in each of a plurality of samples to obtain an empirical data set. Such techniques may also include selecting, based on the empirical data set, and fitting to the empirical data set, an appropriate linear mixed model for the quantifiable property. Such techniques may further include computing an acceptance parameter from a mean and standard deviation obtained from the appropriate linear mixed model. The acceptance parameter may include a process capability index or a tolerance interval bound. Such techniques may further include determining that the candidate supplier qualifies based on comparing the acceptance parameter to a threshold.
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