3ステップメソッドとは

3ステップメソッドとは

古今東西、リスクマネジメントに関する規格は数多存在する。しかしながら、どの国際規格もISOとIECが共同で作成したISO/IEC Guide 51「安全側面-規格への導入指針」に従う必要がある。
ISO 14971においても同様である。
Guide 51では「3ステップメソッド」が用いられている。 「3ステップメソッド」とは「1.本質安全設計方策」「2.安全防護及び付加保護方策」「3.残留リスクについての情報提供」からなる設計者が実施すべき安全方策とその手順のことである。

安全原則safety principles(3 step method)


日本でPL 法が施行された1995 年当時、取扱説明書や注意ラベルで使用者に危険性を警告する活動が強化された。危険性を伝えること自体は重要なことであるが、人の注意には限度があり、リスク低減効果としては多くを望めない。大きなリスクほど、本質安全設計や保護装置を併用しなければ十分にリスクを低減できない。

リスク低減方策の優先順位

重大なリスクを低減させるためには、製造業者側のみの方策では不十分である。使用者側においても適切なリスクコントロール策が必要となる。
「1.追加保護装置」「2.訓練」「3.保護具」「4.組織」である。
リスク低減方策においては、上位にある方策を省略して、下位の方策を講じてはならない。 方策の適用はリスクアセスメントに基づくこと。

リスク低減方策の優先順位

関連商品

[blogcard url=https://xn--2lwu4a.jp/qms-md/ title=”QMS(手順書)ひな形 医療機器関連” ]

[blogcard url=https://ecompliance.co.jp/SHOP/EL-008.html title=”【セミナービデオ】【手順書付き】医療機器リスクマネジメントセミナー” ]

[blogcard url=https://ecompliance.co.jp/SHOP/O090.html title=”【VOD】【医療機器】リスクマネジメントの具体的な実施方法セミナー(ISO 14971:2019準拠) 【リスクマネジメント手順書配布・実習付き】”]

[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”]

[blogcard url= https://ecompliance.co.jp/SHOP/EL-110.html title=”【セミナービデオ】医療機器企業における設計管理・リスクマネジメント・バリデーションセミナー ~バリデーション編~”]

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