ISO13485｜AQL 過程受控的數理底線：抽樣量不能靠感覺，Poisson 還是 Binomial？
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YouTube東佶
ISO13485｜AQL 過程受控的數理底線：抽樣量不能靠感覺，Poisson 還是 Binomial？
AQL 不是隨便設一個數字，而是基於嚴格統計技術定義可接受的不良率上限/抽樣量必須基於合理性原理與統計技術，Poisson 或 Binomial 模型選錯，整個抽樣計畫的合規性就垮了/稽核官看的不是文件數量，而是證據鏈是否完整串聯/靜態文件在穿透式查核下毫無防禦力 ...
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