FDA査察ではなぜバックヤードが必要か

FDA査察に対応する際、通常査察官がドキュメントレビュを行うフロントヤード(FY)と資料を検索するバックヤード(BY)に分かれる。
ではなぜBYが必要なのであろうか。
実は米国と日本では事情が異なる、米国ではFYで査察官を前にして資料を探したり相談すれば、内情がすべてばれてしまう。
したがって、FYでは単に査察官の質問や指示を受けるだけに留めておき、BYで最良の回答を検討したり資料を検索するのである。
その結果をFYに引き渡すのである。
一方で日本の場合は、FYで相談をしたとしても言葉の問題から査察官に内情はばれたりはしないだろう。
しかしながら、最も適切な資料を検索したりバインダーから最低限の資料を抜き取る作業はやはり査察官には見えて欲しくない。

FDA査察対応の基本は、必要な資料を最低限の分量だけ査察官に見せるということである。
最もやってはいけないことは、資料をバインダーごとFYに持ち込むことである。
そうした場合、査察官はすべてのページをめくって詳細にチェックを始めるであろう。
筆者がFDA査察対応コンサルティングを実施する際にはしばしば「Don’t open the door!」ということを口にする。
ドアを開けると査察官は入って来ますよという意味である。
すなわち余計な資料を持ち込んだり説明を行ってしまうと、査察官はさらに深く質問をすることになるのである。
逆に説明が短くまた資料が最小限であれば、査察官は次の質問やより深い質問を考える糸口がつかみにくいのである。
筆者もしばしば供給者監査を実施するが、たくさん語る企業は問題点を把握しやすいし、また指摘事項もたくさん見付かるのである。

ところで企業によってはBYのことをWar Roomと呼んでいるケースがある。しかしながらFDA査察官は敵ではない。
したがって、筆者はこの呼び方は良くないと思っている。

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