設計開発計画書

設計開発計画書は、設計が適切に管理されているかどうかを示す重要な文書である。
計画書には、設計の各フェーズを誰が主導し、責任を負うかを記載すること。
設計のアプローチは、非常に複雑で多くのチームメンバーが関わるため、計画の様々なステージで責任を明確に定義することは非常に重要である。
例えば、品質保証グループまたはプロジェクトマネジメントグループがデザインレビュを主導するが、R&D、臨床、薬事、品質技術、製造およびマーケティングの全てのチームメンバーが、必要に応じて関わるべきである。
インターフェースの特定には、設計プロセスに関わる組織グループ(例、マーケティング、購買、品質保証、製造およびサービス)の役割の定義および彼らに転送され、受領される情報の記載が含まれる。
これは、複数の組織や外部の会社または契約者が関わる場合には、特に重要である。
必要に応じてフローチャートを作成し、インターフェースを特定すること。
設計開発計画は設計プロセスが適切にコントロールされ、機器の品質目標を満たしていることを保証するために必要である。計画は設計管理要求に沿っていなければならない。

一般的に設計開発計画で述べられる要素を次に掲げる。

  • 設計開発プログラムについての目標および対象の記述
  • 設計開発フェーズにおける、品質保証の観点での組織責任図。契約業者との関係も含めること。
  • 実施する主要なタスク、各タスクの成果物、各タスクを遂行するための個人または組織的責任(スタッフおよびリソース)の特定
  • プログラム全体の時間制約を満たす、主要なタスクのスケジューリング
  • レビュワーの選定、レビュチームの構成、レビュワーが従うべき手順
  • 設計文書の管理
  • 周知活動
設計開発計画書のレビュ・承認と更新

設計開発計画書をレビュし、承認したことを証明すること。
設計開発計画書は、設計および開発プログラムが進展する毎に適切に更新し、レビュ、承認すること。(変更管理を適切に行うこと)
レビュおよび計画書更新の頻度は、計画書内に記載すること。

設計開発計画書はDHFへ

設計開発計画書は、設計へのインプットの1つである。
計画書は、承認バージョン毎に、DHFとして保持すること 。

設計開発計画書
設計開発計画書の内容

設計開発計画書作成のための手順書を作成し、以下を記載すること。

  1. 設計開発プログラムの達成目標と目的
  2. 要員計画組織の責任の定義
    設計開発業務の責任者、リーダー、担当者等(資格の特定)
    適切なスキルをもった要員(内部および委託契約者やコンサルタント)
    誰がどの段階でデザインレビュ・検証・バリデーションに関わるのかの定義
    設計開発に携わる関連部門の責任者
    各部門間のインターフェース
  3. 設計開発のスケジュール(製品開発のライフサイクル全体)主要なタスクのマイルストーン
    主要なデザインレビュおよび設計ポイントの特定
    検証・バリデーションのタイミング
  4. 品質システムに従った設計の各フェーズに必要な要素
  5. 成果物各タスクの成果物および担当者・関係者の責任の特定
    どのレベルの詳細さがレビュおよび承認に必要かの明確な説明
  6. リスク管理計画ISO14971にもとづいたリスク管理
    リスク分析を実施するフェーズ
    リスク分析をいつどのようにして実施するか
  7. デザインレビュ・検証・バリデーション評価項目、評価基準
  8. 文書管理
  9. 進捗管理

執行責務を負うマネジメントおよびチームメンバーがプロジェクトの進捗を知る方法
ガントチャート

  • 参考

21 CFR Part820 Quality System Regulation, FDA 1997
Design Control Guidance For Medical Device Manufacturers, FDA 11 March,1997

FDA査察対応設計管理手順書サンプル

イーコンプライアンスでは、FDAが要求する設計管理に対応した、規程、手順書、様式のサンプルを販売しています。

ぜひご購入をご検討下さい。

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