CAPAの誤解

QMS省令では当然のことながら、改正GMP省令においてもCAPAの徹底した実施と管理が求められる。
しかしながら、企業の多くはCAPAを正しく理解していない。

改善について
「カイゼン」という用語は、世界で通用する有名な日本語の1つである。
1970年代に日本車が米国を席巻した。日本車は価格が安いが、故障しない。また燃費も優れている。
脅威に感じた米国の3大モータースは、日本の自動車メーカーの品質管理について徹底的に調査を行った。
その結果、たどり着いたのが「トヨタの改善方式」である。
この「カイゼン」が海を渡って米国に導入され、米国流にカスタマイズされた。
日本ではQCはボトムアップ型で実施されるが、欧米ではトップダウン型である。
CAPAは日本の「カイゼン」をトップダウン型にカスタマイズしたものなのである。
つまりCAPAは日本生まれの米国育ちである。
しかしながら、そのCAPAの実施と管理において、米国FDAなどからしばしば指摘を受けている。
本来は日本のお家芸であったにもかかわらずである。
FDAは「日本の企業はCAPAを全く理解していない」と酷評したこともあったと聞く。

修正と是正処置の違い
規制要件や国際規格(ISO-9001、ISO-13485等)では、修正と是正処置を明確に区別している。
修正(Correction)とは直接的原因を潰すことである。
一方で是正処置(Corrective Action)は、根本的原因を潰すことである。その目的は再発防止である。
例えばある装置のパイプが裂けて水が漏れたといった事故があったとしよう。修正は「パイプにテープを巻く」「パイプを交換する」などである。
しかしながら、修正だけで終えてしまうと、また再発してしまう可能性があるのである。
そこで、なぜパイプが裂けたのかという根本的原因(Root Cause)を調査しなければならない。
例えば、「パイプの材質がまずかった」「設置角度に問題があった」「過酷な使用をしてしまった」などである。
このように根本的原因を究明し解決しなければ、問題は再発するのである。
筆者はコンサルテーションを実施する中で、設計ミスがあった場合の是正処置として、しばしば設計変更(図面変更)を実施している企業を見かける。
しかしながら、設計変更(図面変更)は修正である。決して是正処置にはならない。
その理由は、設計変更(図面変更)だけでは他の個所で同様な問題が再発するからである。
是正処置としては、「なぜそのような設計をしてしまったか」といった根本的原因を調査し、再発を防止する必要があるのである。

教育訓練は是正処置ではない
やはりしばしば遭遇する間違ったCAPAでは、根本的原因が「教育不足」で是正処置が「再教育の徹底」というものがある。
しかしである。教育訓練を実施した場合、当該受講者は2度と間違いを犯さないかも知れない。しかしながら、組織が変更になり、要員が変わればまた同じ間違いを犯す可能性があるのである。
すなわち教育訓練では再発防止は不十分であり、「教育訓練を徹底する」といった是正処置などはあり得ないのである。
このような場合は必ずQMSといった仕組み(システム)を修正して、要員が変わっても間違いを犯さないようにすることが肝要である。

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