FDA査察対応CAPA手順書の作成方法

ISO-13485とFDAの要求の違い

FDAのCAPA要求では、是正処置（Corrective Action）を実施した場合には、原則として予防処置（Preventive Action）を実施しなければならない。
企業によっては、是正処置と予防処置を分離している場合があるが、FDAの査察官から指摘を受ける可能性があるため、注意が必要だ。

また、CAPAフォーム（CAPAの記録様式）には、是正処置/予防処置によって変更された手順書がある場合は、明記しておかなければならない。

さらに、是正処置/予防処置を実施した場合に、影響を受ける関係者に教育訓練を実施した記録を、CAPAフォーム（CAPAの記録様式）に記載しておかなければならない。

上記2点については、ほとんどの企業で指摘を受けていることなので、注意したい。

FDA QSRが要求するCAPAの7ステップ

QSR 820.100(a)においては、以下の7ステップを実施することが要求されている。

  1. 工程・作業・特別採用・品質監査報告・品質記録・サービス記録・苦情・返品およびその他の情報源から得た品質データに対して分析を行い、製品の不適合の現存の原因および潜在原因、またはその他の品質問題を識別する。
    適切な統計的手法を必要な場合に使用して、再発している品質問題を検出する。
  2. 製品、工程、および品質システムに関する不適合の原因を調査する。
  3. 不適合品の再発およびその他の品質問題を是正し予防するため必要な処置を識別する。
  4. 是正処置および予防処置を検証しまたは妥当性確認して、そのような処置が有効であり、完成機器に悪影響を与えないことを確実にする。
  5. 方法および手順の変更が、識別された品質問題を是正し防止するために必要になった場合、それらを実施し記録する。
  6. 不適合品および品質問題に関する情報が、そのような製品の品質に、またはそのような問題の防止に責任をもつ者に伝えられることを確実にする。
  7. 識別された品質問題、並びに是正処置および予防処置に関する情報を、マネージメント・レビュー（経営者による見直し）のために提出する。

CAPA手順書は、上記の7ステップを完全に網羅することが求められる。

FDAの指摘の事例

是正及び予防措置の手順書が適切に作成されていなかった。

当該査察官がレビュした9のCAPA記録のうち3つに不備があった。

  • 顧客の苦情#XXXXに関連したCAPA#XXXXには、変更（是正措置）された手順への言及が含まれておらず、かつ更新した手順に関するスタッフ教育の文書が含まれていない。
  • 顧客の苦情#XXXXに関連したCAPA#XXXXには、変更（是正措置）された新しい手順への言及が含まれておらず、かつ更新した手順に関するスタッフ教育の文書が含まれていない。
  • 顧客の苦情#XXXXに関連したCAPA#XXXXには、変更（是正措置）された新しい手順への言及が含まれておらず、かつ更新した手順に関するスタッフ教育の文書が含まれていない。

CAPAで重要なこと

FDAの要求事項であるCAPAでは、顧客苦情のみならず、設計工程、生産工程等での不適合にも適切な対応が求められている。CAPAは、他の業務に関わる共通モジュールの位置付けと考える。
苦情、逸脱などの情報に基づき、是正・予防措置を検討するプロセスの管理と記録の管理を行う。
FDAおよびISO-13485が要求するCAPAの要件を満たすこと。
CAPA管理において、タイムラインは基本である。CAPA完了までの時間を短縮できること。CAPAシステムでは、CAPAプロセスを簡素化し、インテグレートし、迅速な処理時間を実現すること。
CAPAシステムでは、調査や分析が進むにつれて、CAPAフォームを送付しなければならない先が変更になることがある。最初に定義したワークフローを守らなければならないのではなく、フレキシブルに変更できる機能が必要である。
また、CAPAシステムは、規制対応業務の対監査性と、規制、業務の変更に対してのシステム変更が容易であること、エンドユーザが業務遂行する上で十分に使いこなせる業務プロセス手順とシステム設計が必要である。
CAPAシステムは、FDAの規制要件21 CFR Part 820（QSR：Quality System Regulation）やPart 11（ER/ES：Electronic Records; Electronic Signatures）に適合しなければならない。
CAPAシステムでは、あらゆる情報（イベント、文書、記録等）に関して、対監査性（トレーサビリティ）が十分に確保されていなければならない。
また、規制、業務の変更に対してのシステム変更が容易であること。
エンドユーザが業務遂行する上で十分に使いこなせる業務プロセス手順とシステム設計が必要である。
規制当局への対応および当社の設計情報管理、製造管理、是正措置・予防措置、顧客苦情管理ワークフロー、教育管理、文書管理等を支援すること。
顧客からの情報、設計工程・生産工程での不適合情報等から是正措置の効果確認、予防措置までの情報および作成される文書記録等を一元管理すること。

CAPAシステムの運用上の留意点

  1. CAPAの手順が、QSR規則の要求事項に適合し、定義され、文書化されていること。
  2. 製品および品質の問題の適切な情報源が明確にされていること。
  3. 情報源からのデータが解析され、是正措置が必要かもしれない顕在化している機器や品質の問題を明確化していること。
  4. 好ましくない傾向を示す、製品および品質の情報源が明確にされていること
  5. 予防措置が必要かもしれない製品および品質の潜在問題を明確にするために、これらの情報源からのデータが分析されていること。
  6. CAPAが受け取ったデータが完全で、正確で、かつタイムリーであること。
  7. 品質問題の再発を見つけだすために、（必要な場合）適切な統計的方法が使用されていること。
  8. 製品および品質の問題の程度を識別し、発展させるために、解析結果を異なるデータ情報源と比較をしてこと。
  9. 不具合調査の手順に従っていること。
  10. 品質問題又は不適合品の調査の程度は、不適合の重大性とリスクに比例していること。
  11. （可能な場合、）根本的な原因を決定するために、故障解析を実施していること。
  12. 不適合品の出荷を防ぐための管理がなされていること。
  13. データ源から明確にされた重大な製品および品質の問題に対して、適切な措置が行われていること。
  14. 是正措置および予防措置が効果があったこと、ならびに実施前に検証またはバリデーションされていること。
  15. 是正措置および予防措置が完成機器に悪影響を与えないこと。
  16. 製品および品質の問題に対して是正措置および予防措置が実施され、文書化されていること。
  17. 不適合品および品質問題、ならびに是正措置および予防措置についての情報が、経営者による見直しも含めて、適切に周知されていること。

CAPAシステム導入の目的

CAPAを導入することにより、以下の目的を達成する。

  1. FDA査察対応
  2. 品質管理業務全般の運用負荷軽減
  3. システム化による手順書遵守の厳格化
  4. 文書の体系的な管理および作成された文書・記録の適切な管理
  5. 体系的な品質管理システムの構築
    • 苦情管理
    • 逸脱管理
    • 変更管理
    • 監査（自己点検）管理
  6. 業務の標準化および業務手順書に従った進捗管理（タスク管理）
  7. ワークフローにて実行されるタスクの記録・管理
  8. 本システムに対して関連する情報をリンクさせることによる、情報管理の効率の向上
  9. システムによる柔軟な業務・データに対応
  10. 電子ワークフローにて実行されるタスクの記録・管理
  11. 顧客からの情報、生産工程での不適合情報から是正措置の効果確認、予防措置の集中・一元管理（国内/国外からの情報）
  12. 顧客からの情報、生産工程での不適合情報、是正措置、予防措置情報の高品質化
  13. 苦情情報に関する適切な管理（入力、評価、報告進捗管理）
  14. 製品品質の向上度の統計管理

CAPAシステムの要件（抜粋）

以下の7つの段階を管理できること。
各ステップの実施記録（履歴データ）は完全に文書化すること。

  1. Identification（識別）           　 問題の明確な定義
  2. Evaluation（評価）               　 重大性と影響の見積り
  3. Investigation（調査）              問題の調査計画の立案
  4. Analysis（分析）                     綿密な評価の実行
  5. Action Plan（行動計画） 　　 　　　必要なタスクのリストの作成
  6. Implementation（実施）          行動計画の遂行
  7. Follow Up（フォローアップ）      　効果の検証と評価
総体的な要件
  1. CAPA完了までの時間を短縮できること
  2. CAPAフォームが入力・起票できること。
  3. 各CAPA対応要求に対して、プライオリティレベル（日常、一時的、緊急）が設定できること。
  4. プライオリティレベルは、エスカレーション可能であること。
  5. プライオリティレベルに応じて、最適なフォームを選択できること。
  6. 調査の段階において、W/Fが柔軟に作成・変更できること。
  7. CAPAプロセスの途中の、要員追加・削除・変更が容易なこと。
  8. CAPAの対象となる文書やSOPを簡単に検索･抽出することができること。
  9. CAPAフォームから、変更要求フォームが自動的に生成されること。
  10. その際に、自動的に関連する情報がCAPAフォームから変更要求フォームに入力されること。
  11. ユーザは、仮想的なフォルダーを作成でき、事前に設定しておいたクエリーにより、文書を抽出することができること。
  12. すべてのCAPA対応要求の一覧が管理できること。
  13. CAPAタスクのリアルタイムなステータスが表示できること。
  14. 特定のCAPA対応要求に関連するすべての文書やSOPは、CAPAフォームIDなどにより、グループ化されること。
  15. CAPAフォームとそれに関連付けられた文書は、まとまった画面上で承認することができること。
    注意）この機能は一括承認ではない。一括承認機能は、Part11に抵触する恐れがある。
  16. 教育管理システムとリンクし、CAPA完了時に関連する文書等を必要な要員に教育するよう促せること。
  17. CAPAプロセスの全体の履歴を表示させることができること。
  18. 完了したCAPAプロセスをレビュすることができ、何がCAPAのトリガーになったかを簡単に見ることができること。（対監査性：トレーサビリティ）
Identification（識別）

問題または潜在的問題を明確に定義し、個別に識別できること。

  1. 情報源
  2. 問題の詳細な説明
  3. 問題が存在するという有力な証拠の文書化
Evaluation（評価）

措置の必要性と次の必要とされる措置のレベルを、CAPAフォームに入力できること。

  1. 問題の潜在的影響
  2. 当社とその顧客へのリスク
  3. 必要になる可能性のある是正措置
Investigation（調査）

問題の調査に関する手順を作成することができること。

  1. 調査の目的
  2. 調査の戦略
  3. 責任の割り当てと必要なリソース
Analysis（分析）

問題の原因を分析する。

  1. あらゆる可能性のある原因は識別され適切なデータが集められる。
  2. データ収集の結果は文書化され整理される。
  3. 問題に関係する全ての事項は識別されなくてはならない、ただし初期目的は根本的原因を発見することでなくてはならない。
Action Plan（行動計画）

分析結果により、状況の是正（または次期発生の予防）の方法を決定し、CAPAフォームに入力できること。

  1. 問題の是正と次期発生の予防に必要とされる全てのタスクは識別され行動計画に組み込まれる。
  2. 計画書には実施すべき変更とタスクに対する責任の割り当てを記載する。
Action Implementation（行動実施）
Follow up（フォローアップ）

CAPAに関する規程・手順書・様式

【FDA CFR 820 QSR対応】　CAPA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。

ご購入はこちら。

【ISO-13485:2016対応】　CAPA規程・手順書・様式
ISO-13485:2016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。

ご購入はこちら。

≪様式一覧≫
※ご注文いただきますと、以下の様式を電子メールにて Wordファイル形式で納品いたします。

・ MD-QMS-F1701 CAPAフォーム
・ MD-QMS-F1702 CAPA一覧表
・ MD-QMS-F1703 CAT会議記録
・ MD-QMS-K17 是正処置・予防処置実施規程
・ MD-QMS-S1701 是正処置・予防処置実施手順書

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