製薬業界や医療機器業界以外の多くの業界においてもリスクマネジメントは重要なプロセスである。
規制要件や国際規格などは千差万別であったとしても、その基本的なリスクマネジメントプロセスはほぼ同じである。
一般的なリスクマネジメントプロセスは下図に示すとおりである。
複雑で難解そうに見えるリスクマネジメントプロセスではあるが、基本的には以下の3つのステップしかないと考えてよい。
1.リスクアセスメント
2.リスクコントロール
3.リスクレビュ
である。
例として、車道と鉄道が交差しているとしよう。
まず初めに抽出するべきなのは、ハザード(危害の源)である。
上図を見て考えて頂きたい。
この図の場合、ハザードは電車と自動車である。
ただし、正確には電車も自動車も動いていなければ危害が発生しないため、電車のスピード、自動車のスピードがハザードとなる。
では、危害は何であろうか。
危害は、自動車の運転手や同乗者が死傷する、また電車の運転手や乗客がけがをするといった事象が考えられる。
つまりリスク(健康被害)が発生することが予想される。
それでは、リスクマネジメントを実施しよう。
リスクアセスメント
まずはリスクアセスメントである。
リスクの定義は「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」である。
重大性は、死傷事故が想定されるため、”重大”または”5”であろう。
一方で発生確率の推定が困難である。その理由は、この鉄道と車道の交差がどこに存在するかが不明であるためである。
もしこの交差が都会に存在すれば、発生確率は”頻繁に発生する”または”5”であろう。
また、もしこの交差が田舎に存在すれば、発生確率は”たまに発生する”または”3”であろう。
いずれにせよ、推定した危害の発生の確率と重大性を掛けて”リスクレベル”を決定する。
リスクコントロール
次にリスクコントロールである。
リスクコントロールとは、安全策の設計のことである。
もしこの交差が都会に存在すれば、車道か鉄道のいずれかを高架にする方策がベストであろう。これにより、発生確率が0になるためである。
しかしながら、田舎で高架にすると対費用効果が悪い。
そこで「踏切」を設置することになる。これでほぼ発生確率は0に近づくものと思われる。
ここで重要なことは、リスクコントロール手段を用いても、重大性を下げることが困難であるということである。リスクマネジメントでは、主に発生確率を下げることに注力することに留意されたい。
リスクレビュ
最後にリスクレビュである。
時間の経過とともに当初実施したリスクアセスメントの結果が異なってくるため、定期的な見直しが必要である。
つまり、リスクコントロール策が有効であるかどうかを常にモニタリングしなければならない。
田舎であったと思われた場所でも、いつしか商業施設が立ち並び、ベットタウン化することであろう。
そのため、自動車の往来が増加し、電車の 運行本数も増加するだろう。
それによって、踏切事故がしばしば発生するようになるかも知れない。
その場合は、再度リスクマネジメントプロセスをまわし、高架化を検討することになる。
このようにリスクマネジメントプロセスは、PDCAが基本であり、製品等のライフサイクルを通して常に更新しなければならない。
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[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/EL-007.html” title=”【セミナービデオ】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/191121P.html” title=”【VOD】医療機器企業におけるリスクマネジメントセミナー” content=”医療機器企業にとって、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。
医療機器には何がしかのリスクが潜んでいます。リスク分析の結果は、設計管理のインプットとなります。
医療機器事故は、ユーザの意図した利用と設計者の思想のギャップによって起こるとされています。
昨今では、ユーザビリティを含め、合理的な誤使用を予測したリスク分析が求められています。
演者は多くの医療機器企業においてリスクマネジメントの指導を行ってきましたが、各社ともに我流で実施していることが多いようです。
それでは、医療機器の安全が確保できず、また回収(改修)も減少しません。
そのためには、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/EL-008.html” title=”【セミナービデオ】医療機器企業におけるリスクマネジメントセミナー” content=”医療機器企業にとって、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。
医療機器には何がしかのリスクが潜んでいます。リスク分析の結果は、設計管理のインプットとなります。
医療機器事故は、ユーザの意図した利用と設計者の思想のギャップによって起こるとされています。
昨今では、ユーザビリティを含め、合理的な誤使用を予測したリスク分析が求められています。
演者は多くの医療機器企業においてリスクマネジメントの指導を行ってきましたが、各社ともに我流で実施していることが多いようです。
それでは、医療機器の安全が確保できず、また回収(改修)も減少しません。
そのためには、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/MD-QMS-026.html” title=”【ISO 14971:2019対応】リスクマネジメント規程・手順書・様式” content=”ISO14971:2019に沿った形のリスクマネジメント規程・手順書・様式です。
医療機器設計におけるリスク分析は、ISO-14971に従って実施されています。
リスクマネジメント実施のための手順や様式を整えておかなければなりません。”]
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