FDAの査察官は優秀か

筆者がある一部上場企業でFDA査察に立ち会った際、事前の打合せで当該企業の社長から次のような質問を受けた。
「FDAの査察官はそんなに優秀なのか。はたしてFDAの査察官の指摘の通りにすれば品質が良くなるのか。だってFDAの査察官は、医薬品を製造している訳ではなく、医療機器を設計製造している訳ではないじゃないか。」
疑問はごもっともである。
しかしである。当局の査察官や我々のような監査を実施するコンサルタントは、多くの企業のQMSを調査し、製造所を視察してきている。
そのため、ベンチマーク(比較)が出来るのである。
すなわち、他社で実施していることが当該企業でできていなければ、それはリスクとなる。
また、他社で発生した逸脱や回収事案などについても、当該企業が気付いていない場合、やはりリスクであろう。

このように査察や監査はリスクを見付け出すことに意味があるのである。

筆者がしばしば目にするのは、監査において過去のミスや問題のみを指摘しているケースである。
もちろんそれらは重要ではある。しかしながら、過去のミスや問題は、監査ではなくQCやQAが解決しておくべきである。
監査は問題を見付けるものではなく、問題がないことを確認するのが本来の監査なのである。

上述の通り、監査ではリスクを発見しなければならない。
しかしながら、生え抜きの従業員ではおそらくリスクを見付けることは不可能であろう。
なぜならば、他社のやり方を知らないためである。
また自社のやり方を“是”としているため、足りない事項や危ない事項には気が付かないのである。

多くの企業では、監査チェックリストに従って、監査を実施し、問題点がないかどうかを探している。
また監査員の教育も、集合教育を実施しているのみである。
これでは、百戦錬磨の査察官には太刀打ち出来ない。
では、監査員を養成するにはどうすれば良いのであろうか。
それは、供給者監査を実施し、経験を積むことである。
その際に、品質の悪い企業ばかり監査するのではなく、品質の良い企業にも監査するべきである。
場数を踏むことにより、ベンチマークが可能となるのである。
井の中の蛙では、FDAの査察官のように自社のリスクを指摘することは不可能である。

関連商品

[blogcard url=https://xn--2lwu4a.jp/qms-alex/ title=”QMS(手順書)ひな形 医薬品関連” ]

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