レビュと承認について

製薬企業・医療機器企業・CRO・ベンダー各社では、日々文書や記録のレビュと承認が実施されている。
しかしながら、本来の規制当局やISOなどの国際規格が要求するレビュや承認はほとんど実施されていないのが現状である。

ISO-9001では「レビュ」というキーワードが頻繁に登場する。
読者諸氏は、「レビュ」を何と訳しているであろうか。
多くの場合「確認」と訳していないだろうか。特に「レビュア」を「確認者」と訳していることがもっぱらである。

そうではない。ISO-9001の定義では、「レビュ」とは「設定された目標を達成するための検討対象の適切性、妥当性、及び有効性を判定するために行われる活動」としている。
すなわち、適訳は「審査」または「照査」である。
「審査」であるため、合格か不合格が決められるはずである。
間違いや不整合があった場合、それらを指摘し、修正するように指導するのである。
指導するのがレビュであるため、レビュを行う者は、作成者よりも経験や知識が多くなければならない。
そうでなければ指導できないからである。

筆者はしばしば外部監査の依頼を受ける。
その際には必ずレビュアにインタビュを行うのである。
レビュにおいてどのような「指導」を行ったのかを確認するためである。
しかしながら、ほとんどのケースでレビュは形骸化され、表紙に署名をするのみとなっている。
これでは品質保証にはなり得ない。
管理者や上司の仕事は「部下の育成にある」ことを心に刻んでおく必要がある。

一方において、「承認」とは何を意味するのであろうか。
承認者はすべての記録を精査することはできない。
ではどうやって当該文書や記録を承認するのであろうか。
承認者は、当該文書や記録に関して必要なスキルを持ったレビュアが審査(照査)し、コメントを付し、作成者がコメントに沿って全ての問題が解決したことを確認した上で承認するのである。
つまり承認者は、適正なレビュ(審査・照査)が実施され、品質が保証されていることに関して責任を持つのである。

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