リスクとは
2005年11月に発行されたICH Q9「品質リスクマネジメントに関するガイドライン」のイントロダクションに、「一般に、リスクとは危害の発生する確率とそれが顕在化した場合の重大性の組み合わせであると認識されている。」と記載されている。
ここで、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が必要である。
つまり、企業の製品に瑕疵が生じることがリスクではなくて、何らかの危害が発生する事象をリスクという。
一般に、問題点は解決しなければならず、リスクは回避・軽減しなければならない。
なぜならば、問題点はすでに発生しているからであり、リスクはまだ発生していないからである。
「リスク」という用語の反対語は「確実」である。
つまり、リスクとは不確実なことを呼ぶ。
経済学では、予想に反して景気が悪くても、逆に良くなってもリスクと呼ぶそうである。
次のような事例を考えてみよう。
「ある零細企業が、今日中に1000万円を用意しないと倒産に至るところまで追い込まれた。万策を尽くしてかき集めた手元資金が500万円しかない。」
一見すると、倒産というかなり大きなリスクがあるように思える。
しかし、当該企業にとっては、倒産は決定であり、もはやリスクではない。
ヘルスケア業界におけるリスクとは
製薬・医療機器業界における「リスク」は、「患者・ユーザへの健康被害」のことである。
ヘルスケア業界においては、「リスクマネージメント(RM)」ではなく、「品質リスクマネージメント(QRM)」と呼ぶ。
つまり、品質に問題が発生した場合の患者・ユーザに対する健康被害を推定し、あらかじめ回避または受容可能なまで低減しなければならない。
医薬品業界における品質リスク管理
信じられないことではあるが、リスクの高い医薬品業界において、20世紀までは、リスクマネージメントに関するガイドライン等の標準がなかった。
2005年になって、やっと「品質リスクマネジメントに関するガイドライン」がICHQ9において合意された。
ICH Q9における品質リスクマネジメントの2つの主要原則は以下のとおりである。
1.品質に対するリスクの評価は、科学的知見に基づき、かつ最終的に患者保護に帰結されるべきである。
2.品質リスクマネジメントプロセスにおける労力、形式、文書化の程度は当該リスクの程度に相応すべきである。
1.は、患者目線(規制当局)の原則であり、2.は、製薬企業目線の原則である。
このようにICH Q9は、規制当局と製薬業界の利害関係が一致して合意に至った。
医療機器業界における品質リスク管理
医療機器業界においては、1993年にEU 医療機器指令(MDD)において、リスク分析が必須となった。
その後、1998年に国際規格として、ISO14971が制定された。
現在の最新版のISO14971は、2007年に改定された。
ISO13485規格及び医療機器QMS省令においては、リスクマネジメントの適用・活動が必須となっている。
ただし、米国FDAにおける21 CFR Part 820 「Quality System Regulation(QSR)」では、設計管理において、リスクマネジメントではなく、リスク分析を要求していることに注意が必要である。
IEC62304によると、医療機器に搭載するソフトウェアの安全クラスは、
クラスA:傷害が発生しない
クラスB:深刻な傷害が発生しない
クラスC:死亡または深刻な傷害が発生するおそれがある
に分類される。
ソフトウェアにおけるリスク管理
リスクとは、危害の発生する確率とそれが顕在化した場合の重大性の組み合わせであるが、ソフトウェアにおいてバグ等の「発生確率」は求められない。
したがって、確率は100%と仮定しなければならない。
![](https://ecompliance.co.jp/img/%E5%95%8F%E3%81%84%E5%90%88%E3%82%8F%E3%81%9B%E3%83%9C%E3%82%BF%E3%83%B3/information.jpg)
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[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=””]
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