日本の各省令(GMP、GVP等)においては、「自己点検」に関する要求事項がある。
PIC/S GMP等では、自己点検は「Self Inspection」である。
つまり数年に1回の当局査察(Authority Inspection)での指摘を待たずに自身で日々”査察(Inspection)”を実施して指摘を行い、CAPA(是正処置・予防処置)によって改善(再発防止)を実施するのである。
従って、Self Inspectionとは内部監査のことである。
FDAやPMDAの査察においては監査結果は調査されない。これは監査の独立性を担保するためである。
もし、当局が監査報告書を調査することとなった場合、監査報告書にまずいことを記載しなくなるであろう。
一方で欧州の考え方は異なる。監査結果を積極的に調査するのである。
その目的は、当局の指摘に頼らず、自社で指摘し改善を行っていることの確認のためである。
また査察官は監査報告書で自らが指摘し改善を実施した事項に関しては指摘してはならないという原則がある。
このような仕組みにすることによって監査が促進され、改善が進むのである。
日本は儒教の流れを汲んで「性善説」の文化である。
そのためまもなく発出予定の改正GMP省令においては自己点検結果をQA部門へ報告することとなるようである。
しかしである、QA部門は監査しなくても良いのであろうか。
一方において、欧米はキリスト教の文化であり、「性悪説」をとっている。
ここにおいても監査(自己点検)に対する考え方に相違がある。
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