特別採用は1度のみ

特別採用は一度のみ許される

医療機器製造の受入検査において不適合品が発見された場合は、

  1. 廃棄する
  2. リワークする（製造し直し）
  3. 特別採用する

のいずれかを選択しなければならない。
しかしながら、筆者がコンサルテーションや監査を実施する中で、特別採用（Consession）を繰り返しているケースを見かけることがある。
同じ問題により特別採用を繰り返すことは認められない。
ただし、規制要件等には特別採用を繰り返してはならないとは明記されていない。
筆者が主張する根拠は、常識的に考えて特別採用を繰り返すということは、

  • 設計基準を蔑ろにしている。
  • 製造工程を改善できていない。

のいずれかまたは両方ということになるためである。
2度と特別採用を実施しなくてよいようにするためには、

  • 設計基準を緩める
  • CAPAを廻し再発防止に努める

のいずれかの方策をとらなければならないのである。

ちなみに特別採用は、顧客が合意している（顧客要求を満たしている）ことおよび規制要件を満たしている場合に限られる。 

一般に、顧客の要求基準よりも設計基準が狭く、設計基準よりも製造基準が狭くなければならない。

関連商品

[blogcard url=”https://ecompliance.co.jp/SHOP/MD-QMS-154.html” title=”【JIS T 62366-1：2022対応】ユーザビリティエンジニアリング規程・手順書・様式”]

[blogcard url=”https://ecompliance.co.jp/SHOP/191121P.html” title=”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。

本セミナービデオでは、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。

本セミナービデオでは、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。”]

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

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