FDA査察対応苦情管理手順書の作成方法

ISO-13485とFDAの要求の違い

FDAの苦情管理要求(820.198)では、顧客(サービスレポートを含む)から苦情を受けた際に、FDAに報告すべきかどうかを判定しなければならない。

FDAの指摘の事例

苦情の受付・審査・及び評価を正式に指名された部門によって行うための手順書が適切に作成されていなかった。
貴社にはFDAに報告すべき事象か否かを決定するための苦情の評価の手順がなかった。苦情処理の手順は「品質マニュアル 不適合製品」に端的に記載されていた。この手順書には顧客クレームへの返答と返品に関するアクションが記載されていた。FDAに報告すべき事象を示すかどうかを決定するための必要な苦情情報の集計または当該情報の評価について記載されていなかった。

苦情管理に関する規程・手順書・様式

【FDA CFR 820 QSR対応】 苦情規程・手順書・様式
FDA QSRに沿った形のCAPAに関する規程・手順書・様式集です。
QSR(品質システム規則)査察で最も指摘が出されているのがCAPAです。

これから作成する医療機器企業やISO-14971認証審査を予定している企業、認証機関から改善指示を受けた企業向けに、サンプルをご用意いたしました。
MS-Word形式ですので、貴社でご自由に加筆・修正を行っていただけます。

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