「レビュ」の日本語訳について

ISO-13485やFDA QSRでは「レビュ」という単語が幾度となく出てくる。
例えば「設計レビュ」や「マネジメントレビュ」などである。

では「レビュ」の適訳は何であろうか。
実は「レビュ」は2通りに訳さなければならない。

「設計レビュ」の場合は「審査」と訳すことが適切である。
つまり設計を審査するのである。決して設計を確認するのではない。
例えば医用電気機器(ME機器)の場合、「設計審査」では、メカ、エレキ、S/Wそれぞれの設計の組合せについてその適切性、一貫性、整合性、安全性などを審査する。
審査するのであるから当然合否判定が伴う。
不合格である場合は、理由と共に差し戻し、合格するまで審査を繰り返さなければならない。
なお、QMS省令においては「レビュ」は照査と訳している。

一方で「マネジメントレビュ」の場合は「見直し」と訳すことが適切である。
つまりマネジメント(経営者)が、定期的にQMS・品質方針・品質目標等を見直すのである。
やはり決してマネジメントが報告された状況を確認する会ではない。
マネジメントレビュにおいては、品質目標の達成度合いなどから、次期の目標を見直し、必要な資源を提供し、場合によってはQMSの改訂を指示するのである。

もし貴社のQMS(SOP)で「レビュ」を「確認」と訳しているならばすぐさま改訂して欲しいと願う。

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