苦情管理の誤解
筆者がコンサルテーションや監査を実施する中で、苦情処理について規制要件やISO 13485を遵守できていないケースをしばしば見かける。
ISO 13485:2016における苦情の定義は以下の通りである。
3.4 苦情
組織の管理下からリリースされた医療機器の同一性、品質、耐久性、信頼性、ユーザビリティ、安全性もしくは性能、または医療機器の性能に影響を及ぼすサービスの不具合を指摘するための、文書、電子媒体、または口頭によるコミュニケーション。
まず、読者諸氏の企業における苦情の定義が上記に合っているかを確認されたい。
しばしば、苦情について独自の定義を行っている企業を見かけるためである。
クレームではない
苦情のことをクレームと呼ぶ企業が多い。厳密には苦情とクレームは異なる。
ちなみに苦情の英訳はComplaintでありClaimではない。
FDA査察の際などには留意が必要だ。
無償保証期間中に発生した苦情のみ取り扱っている
苦情の定義には「耐久性」が含められている。
つまり、当該医療機器製品の仕様でうたっている、耐用年数以内の“不具合に対する指摘”は、苦情である。
しばしば、無償修理期間中のみの苦情を取り扱っており、有償修理の場合は苦情として取り扱っていないケースがある。
無償修理か有償修理かは、企業のビジネス戦略の話であり、規制要件が要求する苦情管理とは全く関係がない。
ユーザビリティ
苦情の定義にはユーザビリティも含まれている。
つまり「使いにくい」という申し立ても苦情である。
かつては、使いにくいとしてもそれは仕様であると突っぱねることが出来た。
現在では許されない。なぜならば、使いにくい医療機器は事故を招きかねないためである。
サービスレポート
ISO 13485:2016の「7.5.4 付帯サービス活動」には下記の要求がある。
7.5.4 付帯サービス活動
(略)
組織は、組織または供給者が実施する付帯サービス活動の記録を次のために分析する。
a)その情報を苦情として扱うかを判断する
b)適切な場合、改善プロセスにおける分析すべき情報源とする
つまり、サービスレポート(付帯サービス活動の記録)も苦情処理へのインプットとしなければならない。
ISO 13485:2003では「顧客の苦情」という箇条名であったのが、ISO 13485:2016では単に“苦情”となった所以である。
サービスマン(修理担当者など)が発見した不具合や故障等についても、苦情管理で取り扱わなければならない。
このように筆者がコンサルテーションや監査を実施する中で、苦情管理について独自解釈が行われており、規制要件やISO 13485を遵守できていないケースをしばしば目にする。 各社においても今一度見直されたい。
関連商品
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[blogcard url= https://ecompliance.co.jp/SHOP/QMS-MHLW-13.html title=”【2021年度改正QMS省令対応】苦情管理規程・手順書・様式”]
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