『CAPA』に関する誤解

医療機器企業におけるFDA査察では、CAPA(是正処置・予防処置)に関して厳格に調査される。
その理由は、事故・不具合・回収(改修)等の再発防止である。
医療機器には何某かのリスクが伴う。もしリスクのある医療機器を製造販売してはならないとなると医療の進歩は望めなくなる。
事故は起こさないに限る。しかしながらリスクを0にすることは不可能である。
愚かなことは事故を繰り返してしまうことである。
FDAは「すみやかな救済」を求めている。
苦情や有害事象・不具合報告を受けた場合、すみやかに改善を実施しなければならない。
そのためにはCAPA(是正処置・予防処置)が重要となる。

是正と修正は異なる

是正処置(CA)で重要なことは根本的原因を究明し再発を防止することである。
ここで「是正」と「修正」は異なる。
「修正」とは不具合の直接的原因を潰すことである。
一方で「是正」は不具合の根本的原因を潰すことである。
筆者がコンサルテーションを実施する中で「修正」を「是正」として間違っている例には以下の2点がある。
・設計変更
・再教育
上記の2つはいずれも修正である。
なぜならば、設計ミスの根本的原因を究明せずに設計(例:図面、仕様等)を変更したとすれば、また別の個所で同じ間違いを繰り返してしまう。
また、再教育を実施したとしても、当該本人は再発させないかも知れないが、異動があった場合、別の要員がまた同じ間違いを犯してしまうだろう。
このように是正処置で大切なことは「根本的原因を見極める」ことであり、再発防止について有効であるかどうかを十分に検討することである。

CAPAは単一の方法で処理しなければならない

筆者がコンサルテーションを実施した医療機器企業の中で、数社「簡易CAPA」と「拡大CAPA」(いずれも仮称)といった2通りのフローを作成しているケースが見受けられた。
これは明らかに間違いである。規制要件やISO-13485にはCAPAを2通りに分けるといった要求は全く記載されていない。
苦情処理やCAPAなどの「イベント管理」は単一のフローで処理しなければならない。
大切なことは、調査が進み原因究明がなされた段階で重大性が大きい場合は優先順位を上げることである。
CAPAを起票した段階で重大か軽微かを判定してフローを区別することは良くない。

CAPAのタイムフレーム

前述の通り、FDAは「タイムリーな救済」を求めている。
ISO-13485:2016においても苦情処理やCAPAに対してタイムフレーム(期限)を設けることを要求している。
しかしである。多くの医療機器企業では苦情やCAPAが何ヶ月にも渡ってオープン状態になっていることがある。
これでは「タイムリーな救済」にはならない。
当社の販売しているCAPAに関する手順書では、1ヶ月に一度進捗を確認し、クローズが遅れているCAPAに関しては当該部門から理由書を入手することとしている。
FDA査察などでは、オープン状態のCAPAについて追及されることが多いためである。
クローズが遅れているまたはクローズが困難な案件については、正当化できる理由と暫定処置を検討しておかなければならない。

CAPAにおけるリスク判定

ひとたび事故が発生するとCAPAを起票することになるが、その際に多くの企業ではリスク判定を実施している。
しかしながら、リスクの判定方法を間違っている企業が大半である。
既に起きた事象に対して、「重大性」と「発生確率」を掛け合わせているのである。
これは全くの間違いである。
リスクとはまだ起きていない問題のことであるため、発生確率を掛け合わせるのであるが、一旦発生してしまえば発生確率は1(100%)としなければならない。
例えば、航空機事故や列車事故が発生した場合、事故調査委員会が同じ事故の発生確率が極めて低いから改善策を検討しないということはあり得ない。
苦情はCAPAではリスクは重大性でのみ判定しなければならないのである。

予防処置はリスク管理のことである

予防処置とは「起こり得る不適合の原因を除去する処置」のことを言う。
ここで「起こり得る不適合」はまだ起きていない問題であることから言い換えると「リスク」である。
つまり予防処置はリスク管理なのである。
したがって、事故等が発生してから予防処置を実施するのではなく、通常業務(設計・製造・サービス・流通等)において常にリスク管理を実施してかなければならないのである。
ISO-9001:2015では、予防処置という箇条は削除され、各箇条に「リスクおよび機会」という表現で散りばめられた所以である。

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