予防処置とは

予防処置とは

筆者が5月25日に、あるWebinarでCAPAに関する講演を実施した際に、もっとも多く出された質問が「予防処置」についてであった。

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、飲酒運転による死傷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）
（注：国際規格などにおいては「応急処置」は「修正」に含まれており、区別していない。）

日本においてCAPAを誤解している企業が多い。
（当社記事「CAPAの誤解」参照。）

なおCAPAは7段階で構成される。
（当社記事「CAPAの7段階」参照。）

予防処置とはリスク管理である

ちなみにISO 9001：2015では「予防処置」の箇条がなくなった。
その理由は、「予防処置」の定義が以下のとおりであるためである。
「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」
ここにおいて、起こり得る不適合とは、まだ起きていない問題、すなわちリスクのことを指す。つまり、「予防処置」とは「リスク管理」のことである。
（当社記事「予防処置はリスク管理であることについて」参照。）

「予防処置」は必須である

「是正処置」を実施した場合「予防処置」の実施は必須である
ISO 9001：2008や、ISO 13485において「是正処置」と「予防処置」は、箇条が区別されている。これは認証機関が審査し、指摘を出す際に、「是正処置」に対する指摘なのか、「予防処置」に対する指摘なのかを区別するためである。
しかしながら、FDAの規制要求などでは「Corrective and Preventive Action」のように「是正処置」と「予防処置」は、区別されていない。
基本的に「是正処置」を実施した場合、「予防処置」は必須である。
これまではFDA査察において「是正処置」に重きを置いてきたが、今後は「予防処置」すなわちリスクマネジメントについても重要視する方針である。

「予防処置」とは何か？

では一体「予防処置」とは何であろうか？
筆者がコンサルテーションやセミナーを実施する際に「水平展開は予防処置ではない。是正処置である。」と説明している。
（当社記事、「水平展開は予防処置ではない理由について」参照。）
では一体「予防処置」とは何であろうか？
「予防処置」はリスクマネジメントのことであるため、基本的には当該プロセスや製品などにおける、リスク（まだ起きていない問題）を適切に把握し、未然にリスクをコントロールすることである。つまり「是正処置」が過去形（起きた問題に対する再発防止）であるのに対して、「予防処置」は未来形（まだ起きていない問題に対する未然防止）である。
例で示そう。

【例1】統計的手法による「予防処置」
冷蔵庫の温度を5℃に設定した。（冷蔵：2℃～8℃）
経時的に庫温を測定した際に、翌日は6℃になり、翌々日は7℃になっていたとしよう。
順当に考えて、このまま放置すればいずれ8℃を超え、逸脱してしまうだろう。
この場合、温度調整を再度実施することはもとより、温度上昇の根本的原因（「予防処置」においては潜在的原因と呼ぶ）を調査することになる。
例えば、冷蔵庫の経年劣化、ドアの密閉性の問題、ドアを頻繁に開閉している、ドアを開けている時間が長い、など多くの原因が考えられるであろう。
この場合、まだ温度逸脱は発生していないため、「是正処置」ではなく「予防処置」となる。

【例2】同じ重大な結果をもたらす他の根本的原因を潰す
冒頭の飲酒運転による死傷事故の例で述べたとおり、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ことが予防処置に相当する。
つまり、結果が同じであって、根本的原因が異なる事象を調査することである。
例えば、悲惨な死傷事故を起こす原因は飲酒運転以外にも、脱法ドラッグ（危険ドラッグ）を吸引して運転する、あおり運転をする、極端に疲れた体調で運転する、高齢または重大な持病がありながら運転するなどであろう。
このようにすでに起きた問題と同じ結果をもたらす別の根本的原因を調査し防止することが「予防処置」の一つであり、おなじ根本的原因を別の製品やプロセスに展開すること（水平展開）は「是正処置」であって「予防処置」ではない。

【お知らせ】

筆者が5/25の講演したビデオ（下記のバナーをクリックしても視聴できます）およびセミナー資料（PowerPoint）を無料で進呈いたします。
ご希望者は、下記まで電子メールでお知らせください。
support@ecompliance

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