ヒューマンエラーは根本的原因ではない

ヒューマンエラーは根本的原因ではない

製造プロセスや品質試験において逸脱が発生した場合、CAPAにおいてヒューマンエラーを根本的原因としているケースを多々見かける。
元 FDA の査察官によると、FDA は今から10年以上も前からヒューマンエラーを根本的原因として認めていない。

根本的原因は必ず品質システムにあるのである。
もしある従業員が失敗をし、上司がこっぴどく叱ったとしよう。
当該の従業員は二度と同じ失敗を繰り返さないかも知れない。
しかしながら組織が変更になり、新たな従業員が当該プロセスを担当した場合、また同じ失敗を繰り返す可能性がある。

したがって同様の失敗を防ぐまたは発見する仕組みを品質システムに組み込んでおく必要があるのである。
是正措置を実施する際に重要なことは、個人的なものや製品単独なものに終わってしまっては、また再発するおそれがあるということである。
組織のノウハウとして品質システムに組み込むことによって、再発防止がなされることに留意したい。
ある製品で生じた問題を会議で発表し、水平展開を図り再発防止としても、しばらくすると再発するかも知れない。

再発しないようにチェックがなされる仕組み(システム)をつくること、ノウハウとして活用できるデータベース化することなどが必要となる。
なぜこのような事態を引き起こすようになったのか、その“なぜ”を見極める必要がある。
根本的原因として、システム(仕組み)的な欠陥・弱点・不備・矛盾・曖昧さを追求することを心がけたい。

是正処置(再発防止)の核心は、システム(仕組み)的な欠陥・弱点・不備・矛盾・曖昧さに対して対処することである。
人の規律・注意力・自覚などの人為的要素を是正処置とすると、いずれ再発する。

人間の本質は怠惰・怠慢である。規律や注意力に依存するシステムはいつまでも同じ品質を持続できず、どこかで誰か(本人も含めて)が同じような問題を再発させる。
“教育訓練を徹底させた”などという是正処置はあり得ないのである。

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