リスク分析とは

医療機器規制では当然のこととして、医薬品においてもリスクマネジメントが重要である。
ただし医薬品におけるリスクマネジメントは製品の品質に及ぼすリスクに限っており「品質リスクマネジメント」(QRM:Quality Risk Management)と称している。
(当社記事「医薬品と医療機器の相違点について」参照。)

リスクマネジメントの第1ステップは「リスク分析」である。
では一体「リスク分析」とは何であろうか。

例えば、PCプロジェクターのリスクを分析するとしよう。
まずリスク分析では、当該製品(装置、機器、設備、システムなども)におけるハザードを抽出する。ハザードとは、危険の源のことである。
PCプロジェクターの場合、ハザードは「光」「熱」「温風」「電力」「電磁波」「重力」などがあげられる。
例えば、漏電すれば感電するし、天井やデスクから落下すると怪我をするかも知れない。
ここでは熱を例にリスク分析をしてみたい。
熱というハザードが高温になると「危険状態」となる。(これをリスクマネジメント用語ではハザードへの暴露と呼ぶ)
危険状態(つまり高温状態)になった箇所にヒトが接触した場合、火傷という「危害」が生じる。
危害が生じる可能性があるということは、リスクが存在することになる訳である。

ここでリスクの定義を思い出してもらいたい。
リスクとは、危害の発生する確率と、その危害の重大性を掛け合わせたものである。
まず重大性としては、火傷なので中等度としよう。(5段階の場合、3程度)
次に発生確率であるが、算出が難しい。
PCプロジェクターの場合、ハザードへの暴露(つまり高温状態)になる確率(以下、p1)は100%であろう。
ただし、発生確率は危害の発生する確率である。つまり、高温状態の個所にヒトが接触しなければ火傷といった危害は発生しない。
では、高温状態の個所にヒトが接触する確率(以下、p2)はどれくらいであろうか?
おそらく誰にも分からないのではないだろうか。
そもそもリスクはまだ起きていない問題であるため、どれくらいの確率で発生するのかは算出は困難である。
初期状態(リスクコントロール前)においては、p2は最大値を採用して構わない。(確率は小数点で表すので、1.0とする。百分率の場合は100%とする)
危害の発生する確率は、p1(1)×p2(1)=1である。つまり100%と仮定するのである。(5段階の場合、5とする)
リスク分析においては、初期の発生確率を正確に求めるのではなく、リスクコントロール(安全策の検討)後にどれくらい発生確率を下げるかが重要なのである。
例えば、アクリル板を貼り付けてヒトが接触しなくすれば(p2=0)、発生確率は0になるだろう。

PCプロジェクターにおいて、火傷を負うリスクは、重大性3×発生確率5=15である。
R-MAPにプロットしてみるとおそらく15は中等度であるだろう。
このように、ハザードから危険状態を推定し、危害を推定し、リスクを計算することをリスク分析と呼ぶ。
(注:ISO 14971などでは、上記プロセスをリスクアセスメントと呼び、リスク分析とリスク評価に細分化している。)

関連商品

[blogcard url=”https://ecompliance.co.jp/SHOP/O067.html” title=”【VOD】【180分で要点を学ぶ】改正GMPセミナーシリーズ 品質リスクマネジメント編” content=”2021年8月1日からGMP省令が改正されます。
改正GMP省令は、ICHやPIC/S等の国際標準のGMP基準に整合されました。
特にICH-Q9(品質リスクマネジメント)やICH-Q10(医薬品品質システム)の遵守が求められます。
医薬品等の製造・品質管理において、あらゆるリスクを低減し、患者の安全性を担保することは極めて重要です。
これまでICH-Q9 「品質リスクマネジメントに関するガイドライン」は課長通知として発出されていました。
品質管理・品質保証と品質リスクマネジメントは表裏一体です。どちらもPDCAサイクルを持ち、常に実践することが求められます。
しかしながら、ICH-Q9 「品質リスクマネジメントに関するガイドライン」は難解です。
改正GMP省令においては、適切に品質リスクマネジメントが活用されるよう、ICHQ9の原則に則して手順書の作成と実施が求められます。
しかしながら、品質リスクマネジメントでは、特定の部門を設置したり、新たな手順書を1冊作成すれば良いというものではありません。
すべての既存の組織におけるすべての手順書に品質リスクマネジメントに関する要素を盛り込んでいく必要があります。

本セミナーでは、難解なICH Q9を分かりやすく解説し、品質リスクマネジメントの要点をまとめます。
また、品質リスクマネジメント手順書のサンプルも配布いたします。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/EL-084.html” title=”【セミナービデオ】【180分で要点を学ぶ】改正GMPセミナーシリーズ 品質リスクマネジメント編” content=”2021年8月1日からGMP省令が改正されます。
改正GMP省令は、ICHやPIC/S等の国際標準のGMP基準に整合されました。
特にICH-Q9(品質リスクマネジメント)やICH-Q10(医薬品品質システム)の遵守が求められます。
医薬品等の製造・品質管理において、あらゆるリスクを低減し、患者の安全性を担保することは極めて重要です。
これまでICH-Q9 「品質リスクマネジメントに関するガイドライン」は課長通知として発出されていました。
品質管理・品質保証と品質リスクマネジメントは表裏一体です。どちらもPDCAサイクルを持ち、常に実践することが求められます。
しかしながら、ICH-Q9 「品質リスクマネジメントに関するガイドライン」は難解です。
改正GMP省令においては、適切に品質リスクマネジメントが活用されるよう、ICHQ9の原則に則して手順書の作成と実施が求められます。
しかしながら、品質リスクマネジメントでは、特定の部門を設置したり、新たな手順書を1冊作成すれば良いというものではありません。
すべての既存の組織におけるすべての手順書に品質リスクマネジメントに関する要素を盛り込んでいく必要があります。

本セミナーでは、難解なICH Q9を分かりやすく解説し、品質リスクマネジメントの要点をまとめます。
また、品質リスクマネジメント手順書のサンプルも配布いたします。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/O071.html” title=”【VOD】(全5コース)【180分で要点を学ぶ】改正GMPセミナーシリーズ【一括受講コース】” content=””]

[blogcard url=”https://ecompliance.co.jp/SHOP/EL-088.html” title=”【セミナービデオ】(全5コース)【180分で要点を学ぶ】改正GMPセミナーシリーズ【一括受講コース】” content=””]

[blogcard url=https://xn--2lwu4a.jp/qms-alex/ title=”QMS(手順書)ひな形 医薬品関連” ]

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