品質保証(QA)とは

日本ではQAのことをQuality Auditと勘違いされているように感じます。
日本の多くの製薬企業においては、承認された成果物に対してRetrospectiveに抜き取りによって監査が行われるのが一般的です。
この方法では、非監査部門が行ったCheckを繰り返していることになります。
海外から、日本ではQA部門がQCを行っていると揶揄されることもあります。
皮肉にも日本の製薬企業が新薬申請するデータは、Checkを繰り返し行っていることから、最も精度が高いとされています。
しかしながら、業務プロセスの品質保証がなされていないと指摘されているのです。
当然のことながら、QAはQuality Assuranceのことです。
QAで大切なことは、システムの企画・設計・開発・運用の各フェーズにおいて、第三者の観点から規制要件、自社のポリシー、手順書と照らし合わせてレビュすることです。
システムの完成後に監査を行い、不足事項を指摘しても、それでは後の祭りです。QA部門は、被監査部門と協力し合って、業務の節目節目で、プロセスの品質保証を与えることが大切といえます。

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