根本的原因の重要性とはCAPAの重要性

CAPA(Corrective Action and Preventive Action:是正処置・予防処置)は、医療機器業界では規制要件や国際規格であるISO-13485において実施が要求されている。
一方において、製薬業界においてはCAPA要求は、GMPには記載がない。(図参照)
したがって、CAPAの実施が必須であることに気付いていない製薬企業も存在している。

ISO-9001:2015においては予防処置に関する箇条がなくなったことは、本メルマガの第111号において解説した。

1970年代に日本の自動車が米国を席巻した。低価格にもかかわらず、低燃費かつ米国車に比べて故障が非常に少ない。
危機感を感じた米国3大モータースは、徹底的に日本の自動車産業における品質管理を研究した。
その結果「改善」という日本流の品質管理システムを見出した。「KAIZEN」という用語は、「ありがとう」「さよなら」「つなみ」などと並んで世界において通用する日本語の一つである。
改善を突き詰めるとCAPAに至る。CAPAは日本式の品質管理から生まれ、米国においてシステム化された。
実は「改善」という言葉はGMP省令中にも記載がある。

FDAによるとCAPAにおいて重要な事項の一つは「タイムリーな救済」である。
つまりCAPAには期限管理が必要である。SOPにおいて事象の発生から調査開始まで、是正処置の決定まで、是正処置の実行までなどのように実施期限を規定しておかなければならない。
ISO-13485:2016においては、CAPAにタイムフレームが要求されることとなった。

製薬企業においてCAPAが重要となるのはOOS(Out of Specification:規格外製品)の処置であろう。
OOSとなった場合、製造工程におけるその根本的原因を究明し、再発を防止しなければならない。
その場合、根本的原因は製造工程のみとは限らない。品質試験に原因があるかも知れない。

医療機器においては不適合製品が発見された際に、「特別採用」という処置が存在する。
特別採用が実施できるのは、顧客要求基準には入っているが、自社基準(許容公差など)からはみ出ている場合等に実施することができる。
しかしながら、特別採用の実施は1度しか許されない。なぜならば特別採用を連発するとモラルハザードが起きるからである。つまり「製造仕様」を遵守しなくても良いといった風潮に安易に流されてしまう。

特別採用を実施した場合、2通りの処置のいずれかを採らなければならない。

  1. 設計変更により許容公差を広げる
  2. CAPAを実施することにより工程を変更し再発を防止する

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