根本的原因の究明
品質問題の再発防止のためには根本的原因の究明が重要である。
根本的原因が究明できなければ、問題は再発するためである。
筆者は長年CAPAについてコンサルテーションを実施しているが、修正と是正の違いを分かっていない企業が多すぎると感じている。
「修正」とは直接的原因を潰すことであり、「是正」とは根本的原因を潰すことである。
「修正」によって問題を解決することは出来るが、再発を防止することはできない。
例えば、洗濯機のホースが裂けて水漏れが起きたとしよう。
「修正」は、ホースの裂け目にテープを貼って水漏れを止めることである。
しかしながら、「修正」のみで「是正」をしなければ再発の可能性が残る。
「是正」では、根本的原因を求めなければならない。上記の場合、ホースに強い力が加わっていたのかも知れない。または設置角度が深すぎたのかも知れない。もっとひょっとすれば、メーカによるホースの材料や製造、設計に問題があったのかも知れないのである。
それら根本的原因を究明して潰さなければ、また再発してしまうことになる。
筆者が製薬企業・医療機器企業においてコンサルテーションを実施する中で、CAPAの記録を精査することがしばしばある。
しかしながら、根本的原因の究明が不十分であることが多い。
ほとんどの場合、表面的な問題を原因としてしまっており、究明が不十分である。
つまり「修正」は出来ているが「是正」が出来ていないということである。
長年の経験から筆者はCAPAを見ると直感的に再発の可能性があることに感づく。品質情報を検索してもらうと、案の定、再発していることが少なからずある。
根本的原因の究明には、スキル、経験や洞察力が必要である。一朝一夕では困難であろう。
つまりCAPAの手順を作成し、一通りの教育訓練を実施しただけでは、必ずしも根本的原因の究明は難しい。
繰り返しCAPAを実行し、ロジカルシンキングを十分に身につけて行く必要がある。
形骸化したCAPA実施では、改善は望めない。安易に修正のみで済ませてしまおうといった考えも捨てなければならない。
医薬品や医療機器の製造販売においては、問題の再発は出来る限り減少させなければならないからである。
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