苦情管理について

苦情管理について 

ISO 13485:2003では、苦情処理が「製品受領者からの意見」と「改善」に含まれていたが、ISO 13485:2016では「8.2.2 苦情処理」として箇条を立てて独立させた。

またISO 13485:2016では、苦情処理に関して詳細化された。
「修正」と「是正処置」を明確に区別した。これは国内外を問わず修正と是正処置を混同している例が多いためである 。
またサービスレポート(修理報告書)からの情報も苦情処理の対象となった。
ISO 13485:2003では、全ての苦情に対して原則「CAPA」を要求していたが、ISO 13485:2016では、この条文は削除された。全ての苦情に対してCAPAを起票すると、品質保証部門等のマンパワーが不足し、結果的に重要なキャパが後回しになってしまうためである 
さらに全ての苦情について原則「調査の実施」を要求している。

苦情の定義

多くの企業で”苦情”ではなく、”クレーム”とQMSに記載している例があるがこれは正しくはない。

ISO 13485:2016では、“顧客の苦情”から変更され、苦情の定義が大きく見直された。

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に関連した不具合を申し立てるための、文書、電子媒体、または口頭によるコミュニケーション。

筆者がコンサルテーションする中で多く経験する事項として、苦情を保証期間(例:1年間の無償修理)に限っている例が多い。 有償で故障を修理しようが、無償で修理しようがそれは苦情管理にとっては全く関係のないことである。
定義の中に”耐久性”が含まれている所以である。機器の仕様として耐用年数が謳われている場合、当該耐用年数内の故障は全て苦情として取り扱わなければならない。
またかつては”仕様”であると済ませることもあったが、苦情の定義に”ユーザビリティ”(つまり使いやすさ)が含まれることにより、「使いづらい」という申し立ても苦情に含まれることとなった。

医療機器企業各社は、この ISO 13485:2016の苦情の定義をQMSにそのまま転記し、独自の解釈や定義を作成しないことに留意されたい。もしこの苦情の定義と異なる定義をしている場合は、早急に見直すことを推奨する。
なお、この“苦情”の定義は、ISO9000:2015の定義とは異なるため注意が必要である。

FDA QSRにおける苦情管理の要求事項

FDAのQSRにおいては、苦情管理に対して、より詳細な要求がされている。
特に苦情に関しては詳細に調査しなければならない。
例えば下記の事項は苦情調査において必須である 。

  1. 機器の名称
  2. 苦情を受け付けた日付
  3. 使用された機器のunique device identifier(UDI)またはuniversal product code(UPC)およびその他の識別及び管理番号
  4. 苦情を言ってきた人の氏名・住所・電話番号
  5. 苦情の性質及び詳細
  6. 調査の日付及び結果
  7. 講じた是正処置、並びに
  8. 苦情を言ってきた人に対する回答

苦情調査において、当該医療機器のシリアルナンバー等が不明であるということは許されない。なぜならば調査が不十分であるということになるからである。一般にシリアルナンバーが分からなければ、当該記事を製造した時点における、製造仕様や設計仕様等を参照することができず、故障の原因究明には至らないためである。
また”苦情を言ってきた人の氏名・住所・電話番号”とあるが、ここで苦情を言ってきた人とは販社や代理店の人ではなく、あくまでもエンドユーザーであることに注意されたい。
つまり医療機関等のエンドユーザーの苦情主の氏名や電話番号まで調査することが要求されているのである。
「苦情を言ってきた人への回答」については、口頭で回答する場合であっても、必ず文書を作成し、保管しておかなければならない。その理由はたとえ口頭で回答するとしても、企業としての調査調査結果および見解が適切に記載されており、回答者はその文書に従って回答しなければならないためである。

https://www.youtube.com/watch?v=FhFuvKiR0yA

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