設計変更は是正処置ではない

設計変更は是正処置ではない

修正と是正処置は異なる

CAPA(是正処置・予防処置)を実施する中で、修正と是正処置を混同している例を多く見かける。
修正(Correction)と是正(Corrective Action)は異なる。
ISO 9000:2015 (JIS Q 9000:2015)では、修正について以下のように定義している。

3.12.3 修正(Correction)
  検出された不適合を除去するための処置。

一方で、是正処置について以下のように定義している。

3.12.2 是正処置(Corrective Action)
  不適合の原因を除去し、再発を防止するための処置。

つまり、修正とは、直接的原因を潰すこと。是正処置とは、根本的原因を潰すことである。
修正とは不適合の根本的原因の除去するのではなくて、不適合そのもの(直接的原因)だけを除去することである。
一般的には修正のことを応急処置・暫定処置または当面の処置などと呼ばれている。
是正処置とは、不適合の根本的原因を除去し、再発防止(同じ場所で再度同じことが起きないようにする)が目的である。
ただし、修正は是正処置の一部である。
修正が完了して、是正処置がスタートする。
是正処置は再発防止であり、不適合が生じた原因に対して対処する。
原因をしっかり追及し、その発生源(根本的原因)を除去すること。

予防処置はリスクマネジメントのことである

さらに予防処置について以下のように定義している。

3.12.1 予防処置(Preventive Action)
起こり得る不適合またはその他の起こり得る望ましくない状況の原因を除去するための処置。

予防処置とはリスク管理のことである。なぜならば「起こりえる不適合」とはまだ起きていない問題であり「リスク」のことであるためである。
予防処置は未然防止・先手管理(まだ起こっていない場所で予測して防止する)である。
なお、水平展開は予防処置ではない。


飲酒運転による事故に対するCAPA

飲酒運転による事故を想定して、修正(応急処置を含む)⇒是正処置⇒予防処置の流れを説明しよう。

応急処置:運転手等のけがの手当てをする。安全標識を立てる。
修正  :事故車を路肩に移動させる。
是正処置:運転手の免許証をはく奪する(飲酒運転の再発防止)
予防処置:危険運転致死傷罪を新設する(根本的原因は異なるが、同様の結果をもたらす潜在的原因の除去)

設計変更は是正処置ではない

しばしば市場からの苦情等を受けて、CAPAを実施し、設計変更を行っている例を見かける。
しかしながら、設計変更は「修正」であって「是正処置」ではない。
設計変更のみで済ませると、また別の箇所で問題が発生(再発)する恐れがある。
「なぜ設計を間違ったのか?」といった根本的原因を究明しなければならない。
是正処置で大切なことは、ヒューマンエラーや製品個別の事象を根本的原因とするのではなく、必ず仕組み(システム)を改善することである。

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