ハインリッヒの法則
筆者がCAPA（是正処置・予防処置）に関するセミナーを実施する際にしばしば「どのような品質問題に関してCAPAを実施するべきか」という質問を受けることがある。
その回答は、再発防止を行わなければならない事象である。
CAPAの目的は、改善すなわち再発防止である。したがって、医薬品や医療機器の品質に対する影響が大きいと判断される場合は、CAPAを実施するべきである。 しかしである。ハインリッヒの法則というものがある。これは１件の大きな事故・災害の裏には、29件の軽微な事故・災害、そしてその裏には300件のヒヤリ・ハット（事故には至らなかったもののヒヤリとした、ハッとした事例）があるとされる法則のことである。
別名１：29：300の法則とも呼ばれる。
300件もの軽微なヒヤリ・ハットを見逃すと、いずれ 29件の事故につながる。29件の事故を放置すると、１件の重大な事故につながるという法則なのである。
一つの著名な事例がある。2004年 3月、六本木ヒルズで、6歳の男の子が回転ドアに挟まれて死亡した。
六本木ヒルズは、2003年 4月のオープン直後から、回転ドアでの事故が多発し、死亡事故までの１年の間に、報告されただけでも32 件もの事故があったということである。
これはまさしくハインリッヒの法則である。 軽微な事故が頻回したことが分かった時点で、六本木ヒルズは何らかの処置をとるべきであったのである。
それを放置したために、起こるべくして起きた事故と言えるのである。
つまり、軽微な品質問題であったとしても頻回している場合には、CAPA（改善）を実行する必要があるのである。
そのためには、統計的手法により、繰り返している軽微な品質問題に関する情報を収集しておかなければならない。
例えば、1ヶ月間に同じ軽微な苦情が3回繰り返している、軽微な逸脱が同じプロセスで3回繰り返しているなどである。
ブロークンウィンドウ理論
ハインリッヒの法則を応用した理論で「ブロークンウィンドウ理論」がある。
「ブロークンウィンドウ理論」は、ラトガース大学のケリング教授による理論である。
治安の良い住宅街で車のボンネットを開けたままに1週間放置したが、何事も起こらなかった。しかし、フロントガラスの割れた車を同様に放置したところ、次々にガラスを割られ、金になる部品はほとんど盗まれてしまったというもの。
これは、小さな犯罪を放置すると、やがてそれが大きな犯罪につながるという犯罪心理学の理論である。
この理論をニューヨークの地下鉄でジュリアーニ市長が応用した。地下鉄の落書きを徹底的に消したところ、重犯罪の件数が激減したのである。
小さなミスや怠慢は、それが許されると罪の意識がなくなってミスを犯すことに抵抗がなくなってしまう（習慣化）。
たとえ罪の意識があっても、ここまで許されるならもう少しと自分で勝手にこじつけてしまう心理が働く（合理化）。
上司は部下に対して、失敗を叱ってはならない。それよりも小さなこと、些細なことを適宜注意することである。例えば「ごみを投げてゴミ箱に入れようとしたが、床に落ちてしまったのを放置した」とか「ホッチキス止めをした書類ががたがたに綴じられていた」などである。
「机の上を整理する」「掃除をする」などは当たり前のことではあるが、案外誰も注意しないものである。これくらいのことと思う気持ちがいつしか大きな失敗・損失につながりかねないのである。 実は筆者が専門とする品質管理・品質保証の考え方も同じである。小さな品質改善を行うと、大きなミス（欠陥によるリコール）が減少するのである。
ゆでガエル現象
カエルは、いきなり熱湯に入れると驚いて逃げ出すが、常温の水に入れて徐々に水温を上げていくと逃げ出すタイミングを失い、最後には死んでしまう…
ゆでガエル現象とはこのように、ゆっくりと進む環境変化や危機に対応する難しさや大切さを説く言葉として使用され、時には「ゆでガエルの法則」「ゆでガエル理論」という表現もされる。
ゆっくりと進む環境変化や危機に対して我々が鈍感なのは確かである。
まだ間に合うと仕事を先延ばしにしているうちに、取り返しのつかない事態に陥ったり、徐々に陳腐化しているスキルや知識に頼って、学ぶことを避けているうちに、すっかり時代に取り残されて、社内のポジションを失ったりしてしまう。
環境変化や危機に気付いたら、すぐに対処するように心がけたい。
State of Control（管理された状態）
FDAはしばしばState of Controlという用語を使用する。ICH Q10においてもこの用語が用いられている。
上記のハインリッヒの法則、ブロークンウィンドウ理論、ゆでガエル現象などの教訓から、企業の品質管理、品質保証について”管理された状態”に保たなければならないのである。
FDA査察等において、企業が経営者のポリシーのもと、品質システムが構築され、管理された状態（State of Control）であるかどうか調査されるのである。 管理された状態である企業は、安心な企業と言える。
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[blogcard url=”https://ecompliance.co.jp/SHOP/MD-QMS-03.html” title=”【FDA CFR 820 QSR対応】CAPA規程・手順書・様式” content=”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。”]
[blogcard url=”https://ecompliance.co.jp/SHOP/MD-QMS-104.html” title=”【ISO-13485:2016対応】CAPA規程・手順書・様式” content=”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。”]
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