品質リスクマネジメント(QRM)について

リスクっていったい何であろうか?
こう言えばわかりやすいかも知れない。
リスクと問題点は違う。問題点は解決するものであり、リスクは回避・低減するものである。
つまり、問題点とは目の前にある障害のことであり、解決せざるを得ない。
それに対して、リスクとは将来起こり得る問題のことであって、回避・低減すべきものである。
ここで質問である。次の語群のうち、「リスク」と反対の意味を表す言葉として最もふさわしいものを選んで頂きたい。
「安心」「安全」「確実」「チャンス」「リターン」
一般的にはリスクは、不確実さのことをいう。つまり、正解は「確実」である。
経済学においては、景気予想が下に外れてもリスクであるが、上に外れてもリスクである。宝くじに当たるのも実はリスクなのである。
ISO/IEC Guide 51によると、
「リスクとは危害の発生の確率とそれが発生したときの重大性の組み合わせ」
とある。
ここで重要なことは、危害の発生する確率であって、欠陥の発生する確率ではないことに注意しなければならない。
医薬品や医療機器の製造において、欠陥が生じることがリスクではなく、欠陥によって患者等が危害を受けることがリスクなのである。
例えば、ビタミン剤や栄養剤における品質の欠陥と、抗がん剤、血液製剤における品質の欠陥では、患者に与える危害の度合いが異なる。
医療機器では、体外診断機器と放射線治療装置では、やはり危害が異なる。
リスクを判定する際には、製品を理解することから始めなければならない。

食品業界では、HACCPと呼ばれるリスク分析手法が古くから使用されてきた。
医療機器業界では、欧州で作成されたISO-14971が90年代から使用されてきた。
ところが、ICHによって医薬品業界で品質リスクマネジメントのガイドライン(ICH Q9)が作成されたのは、2005年のことである。
これだけリスクの高い製薬業界において、20世紀中は、リスクマネジメントに関するガイドラインが存在しなかったのである。
医薬品業界では、リスクマネジメントではなく、品質リスクマネジメント(QRM:Quality Risk Management)と呼ぶ。
その理由は、品質の欠陥が患者に与えるリスクを管理しなければならないからである。

医療機器においては、リスクはつきものである。
ところが、日本人の特性において、ゼロリスクを要求しがちである。
リスクを完全にゼロにすることは不可能である。
マスコミは、事故を起こした企業に対して厳しくバッシングを行う。あたかもそれが正義であるかのようにふるまう。
そのため、日本では企業はリスクの高い医療機器を製造したがらないし、規制当局もリスクの高い医療機器を承認したがらない。
医療機器が年間9,000億円もの輸入超過になる要因の一つではないかと思われる。
医療機器の発展のためには、リスクが伴うのである。 リスクは完全にゼロにはできないため、受容可能なまで低減を図らなければならない。
「安全」とは、リスクがないことではなく、受容不可能な残留リスクがないことを意味する。

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関連商品

[blogcard url=https://ecompliance.co.jp/SHOP/EL-111.html” title=”【セミナービデオ】【医薬品】品質リスクマネジメントの具体的な実施方法セミナー 【品質リスクマネジメント手順書配布・実習付き】” content=”製薬企業にとって、リスクを管理することは非常に重要です。しかしながら、リスクマネジメントは難解です。
医療機器業界では、欧州が先行し、90年代からIOS-14971が制定されました。
しかしながら、医薬品業界は、2005年にICH-Q9「品質リスクマネジメントに関するガイドライン」が合意され、翌年から本邦においても施行されています。
つまり20世紀は製薬業界において品質リスクマネジメントの概念がないまま、要員の経験と勘でリスクが管理されてきました。
品質リスクマネジメントは、特定の部署だけが対応したり、手順書を作成するだけではありません。
研究開発、臨床開発、製造販売後、流通、申請、査察にいたる製品のすべてのライフサイクル全般について、すべての部署がそれぞれの手順にリスクマネジメントの概念を取り込まなければなりません。
そのためには、品質リスクマネジメントの基本的な考え方と規制当局の期待を十分に理解しなければなりません。
本セミナーでは、難解なリスクマネジメントを初心者にもわかりやすく解説いたします。またリスクマネジメントに関するSOPのサンプルを配布し、具体的に説明いたします。”]

[blogcard url=https://ecompliance.co.jp/SHOP/191120P.html” title=”【VOD】製薬企業における品質リスクマネジメントセミナー” content=”製薬企業にとって、リスクを管理することは非常に重要です。しかしながら、リスクマネジメントは難解です。
医療機器業界では、欧州が先行し、90年代からIOS-14971が制定されました。
しかしながら、医薬品業界は、2005年にICH-Q9「品質リスクマネジメントに関するガイドライン」が合意され、翌年から本邦においても施行されています。
つまり20世紀は製薬業界において品質リスクマネジメントの概念がないまま、要員の経験と勘でリスクが管理されてきました。

品質リスクマネジメントは、特定の部署だけが対応したり、手順書を作成するだけではありません。
研究開発、臨床開発、製造販売後、流通、申請、査察にいたる製品のすべてのライフサイクル全般について、すべての部署がそれぞれの手順にリスクマネジメントの概念を取り込まなければなりません。
そのためには、品質リスクマネジメントの基本的な考え方と規制当局の期待を十分に理解しなければなりません。

本セミナーでは、難解なリスクマネジメントを初心者にもわかりやすく解説いたします。”]

[blogcard url=https://ecompliance.co.jp/SHOP/O091.html” title=”【VOD】【医薬品】品質リスクマネジメントの具体的な実施方法セミナー 【品質リスクマネジメント手順書配布・実習付き】” content=”製薬企業にとって、リスクを管理することは非常に重要です。しかしながら、リスクマネジメントは難解です。
医療機器業界では、欧州が先行し、90年代からIOS-14971が制定されました。
しかしながら、医薬品業界は、2005年にICH-Q9「品質リスクマネジメントに関するガイドライン」が合意され、翌年から本邦においても施行されています。
つまり20世紀は製薬業界において品質リスクマネジメントの概念がないまま、要員の経験と勘でリスクが管理されてきました。
品質リスクマネジメントは、特定の部署だけが対応したり、手順書を作成するだけではありません。
研究開発、臨床開発、製造販売後、流通、申請、査察にいたる製品のすべてのライフサイクル全般について、すべての部署がそれぞれの手順にリスクマネジメントの概念を取り込まなければなりません。
そのためには、品質リスクマネジメントの基本的な考え方と規制当局の期待を十分に理解しなければなりません。
本セミナーでは、難解なリスクマネジメントを初心者にもわかりやすく解説いたします。またリスクマネジメントに関するSOPのサンプルを配布し、具体的に説明いたします。”]

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