CAPAとは
日本においてCAPAを誤解している企業が多い。FDAはCAPAの査察を強化している。
CAPAとは、Corrective Action; Preventive Actionである。
日本語では、是正処置、予防処置と呼ばれている。
是正処置は「同じ場所で再度同じことが起きないようにする」ことであるのに対して、予防処置は「まだ起こっていない場所で予測して防止する」ことである。
予防処置は、リスク管理のことである。
CAPAでは、ある好ましくない事象に対して「応急処置」「修正」「是正処置」「予防処置」の順に対応を行う。
例として、飲酒運転による事故を考えてみよう。
「応急処置」けが人の手当てを行う。
「修正」2次災害が発生しないように、安全標識を立てる。
「是正処置」当該運転手の免許証を取り消す。（再発防止）
「予防処置」危険運転致死傷罪を制定する。（飲酒事故と同様な悲惨な死傷事故を招く他の行為を罰する）
海外でも、Corrective（是正）という用語をCorrection（修正）と誤解していることがしばしば指摘されている。
『修正』とは、直接的原因を調査し、その原因をつぶすことをいう。
それに対して『是正』とは、根本的原因を調査し、その原因をつぶすことを言う。
つまり、『是正』の目的は、根本的原因を取り除くことによる『再発防止』である。
FDA等の規制当局が要求するのは、言うもでもなく『修正』のみではなく『是正』である。そのためには根本的原因を追究しなければならない。
FDAのCAPA要求では、是正処置を実施した場合には、原則として予防処置を実施しなければならない。
企業によっては、是正処置と予防処置を分離している場合があるが、査察官から指摘を受ける可能性があるため、注意が必要だ。
2013年1月に、飛行中の全日空のボーイング787型機のバッテリーから発煙し、緊急着陸した事態があった。
これが直接のきっかけになって、同型機は世界で運航が止まった。
徹底的な調査を繰り返したが、根本的原因はわからずじまいであった。
つまり是正処置がとれずじまいとなった。
米国の航空当局は、バッテリーは改修されて多層的な安全装置を施されており、大事故は起きないとして、運航再開を許可した。
なぜならば、そのまま飛行を禁止すると、ボーイング社が世界の航空会社から多大な損害賠償を求められる可能性があったからだという。
根本的原因を発見できなければ、是正ができず、再発を防止できない。
そんな場合は、徹底した予防処置が必要となる。
QMS省令では当然のことながら、改正GMP省令（2020年度）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。
CAPAに関する規程・手順書・様式
| 【FDA CFR 820 QSR対応】 CAPA規程・手順書・様式 |
| FDA QSRに沿った形のCAPAに関する規程・手順書・様式集です。 QSR（品質システム規則）査察で最も指摘が出されているのがCAPAです。 これから作成する医療機器企業やISO-14971認証審査を予定している企業、認証機関から改善指示を受けた企業向けに、サンプルをご用意いたしました。 MS-Word形式ですので、貴社でご自由に加筆・修正を行っていただけます。 |
ご購入はこちら。
| 【ISO-13485:2016対応】 CAPA規程・手順書・様式 |
| ISO-13485:2016に沿った形のCAPAに関する規程・手順書・様式集です。 QSR（品質システム規則）査察で最も指摘が出されているのがCAPAです。 これから作成する医療機器企業やISO-14971認証審査を予定している企業、認証機関から改善指示を受けた企業向けに、サンプルをご用意いたしました。 MS-Word形式ですので、貴社でご自由に加筆・修正を行っていただけます。 |
ご購入はこちら。
≪様式一覧≫
※ご注文いただきますと、以下の様式を電子メールにて Wordファイル形式で納品いたします。
・ MD-QMS-F1701 CAPAフォーム
・ MD-QMS-F1702 CAPA一覧表
・ MD-QMS-F1703 CAT会議記録
・ MD-QMS-K17 是正処置・予防処置実施規程
・ MD-QMS-S1701 是正処置・予防処置実施手順書
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