供給者監査のメリット

医薬品企業、医療機器企業における品質システムにおいて、内部監査(品質監査)や供給者監査(ベンダーオーディット)を担当する監査員の力量を向上させることは、自社の品質改善に非常に有効である。
しかしながら、多くの場合、監査員は自社のプロセスしか知らず、他社とのベンチマークができない。
そのため、供給者監査を通じて、他社の品質システム(つまり品質向上の仕組み)を精査し、より良い品質管理や品質保証の実施方法を学ぶことが必要である。

供給者監査を計画する場合、品質の悪い企業(業者)を中心に監査先を選定しているケースが多い。
もちろん、品質の悪い企業に監査に入り、改善を指導することは重要である。
しかしである。品質の悪い企業ばかりを監査していても監査員の力量は向上しない。
むしろ、品質の良い企業を積極的に監査し、どのような品質管理や品質保証を実施しているのかを学ぶことが重要である。

多くの企業の品質システムに触れ、ベストプラクティスを考え、自社の内部監査において他社の優れた点と比較検討したうえで、監査報告書において改善を含めた指摘を検討することが可能となる。

我々、コンサルタントの利点は、多くの企業で監査を実施し、色々な品質システムに触れ、同じ規制要件や国際規格に対する各社の様々な理解や見解を知ることができることである。またそれらの理解に応じた品質システムの構築方法を学ぶことができるのである。

筆者は、監査は場数を踏むことであると考えている。
社内で監査員教育を受けたからと言って、優秀な監査員は育たない。

規制当局にとって、優秀な監査員が存在し、自ら監査(Self Inspection:自己点検)を実施し、指摘を出し、指摘に対するCAPA(是正処置/予防処置)を実施している企業は安心である。
逆に、監査が力量を持たない監査員によって実施され、誤字脱字や転記ミスなどのエラーのみを指摘しているような企業は、品質システムといった仕組みの改善が遅々として進まず、安心できない。 ぜひ、品質の悪い企業も良い企業も含めて、供給者監査を多く実施して頂きたい。

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