FDA対応設計アウトプットの要点

設計アウトプットとは

設計アウトプットは「FDA 21CRF Part820 Quality System Regulation」の「Subpart C§820.30(d) Design output」で規定されている。

(d) Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements.
Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified.
Design output shall be documented, reviewed, and approved before release.
The approval, including the date and signature of the individual(s) approving the output, shall be documented.(d) 各製造業者は手順を確立し維持し、設計からのアウトプットを定義し文書化する。その際には設計へのインプットの要求事項に適合している旨を適切に評価出来るような用語を使用する。設計からのアウトプットの手順は、容認基準を含むか引用し、機器の適切な機能に必須の設計からのアウトプットが特定されていることを保証すること。
設計からのアウトプットの文書は文書化され審査され、発行前に承認されること。承認は、承認日付及びアウトプットを承認した者の署名を含み、文書化されること。

また、設計アウトプットは同§820.3(g)で次のように定義されている。

(g) Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record.(g)設計アウトプット(Design output)とは、各設計段階における、及び総合設計努力の終了時における、設計努力の結果をいう。完成した設計からのアウトプットは機器原簿の基礎である。総合的な完成した設計からのアウトプットは、次のものから構成される。すなわち当該機器その包装及びラベリング、および機器原簿である。
何が設計アウトプットに当たるのか？

機器の設計にあたっては、さまざまな、大量の文書・図面が発生する。それはすべて設計アウトプットなのであろうか？
ここで大切なことは、設計アウトプットも設計インプット同様、包括的で有効なものでなければならないということである。一般的に、設計タスクにおいて、設計開発計画書内に定義され、リストに記載された作業成果物および設計の実施に当たって重要な定義された要素は設計アウトプットにあたる。例えば、設計図面、フローチャート、ソフトウェアコード、詳細な設計仕様書などである。
何が設計アウトプットに当たるのかは、予め文書で定めておかなければならない。
また、しばしば設計アウトプットは次のステージにおける設計インプットになることもある。

仕様とは何か？

仕様は§820.3(y)で次のように定義されている。

(y) Specification means any requirement with which a product, process, service, or other activity must conform.(y) 仕様(Specification)とは、製品、プロセス、サービス、又は他の活動が適合しなければならない要求事項をいう。

仕様は部品の調達、組立、テスト、検査、据付け、保守、機器に関するサービス等に関する文書および図面を含む。仕様は必ずしも書かれたものであるとは限らず、ビデオによる組立インストラクションなども使用に含まれる。これらは設計アウトプットであり、DMRの一部となる。

設計アウトプット要求事項解説

820.30(d)で医療機器の製造業者が要求されているのは、以下の事項である。

  • 設計アウトプットの手順を確立し維持すること
  • 設計からのアウトプットを定義し文書化すること
  • 設計へのインプットの要求事項に適合している旨を適切に評価出来るような用語を使用すること
  • 手順では容認基準を含むか引用し、機器の適切な機能に必須の設計からのアウトプットが特定されていることを保証すること
  • 設計からのアウトプットの文書は文書化され審査され、発行前に承認されること
  • 承認は、承認日付及びアウトプットを承認した者の署名を含み、文書化されること

この章では、これらのFDAの設計インプット要求について1つずつ詳しく見ていく。

設計アウトプット手順の確立・維持
（1）設計アウトプットの手順を確立し維持すること設計からのアウトプットを定義し文書化すること設計へのインプットの要求事項に適合している旨を適切に評価出来るような用語を使用すること手順では容認基準を含むか引用し、機器の適切な機能に必須の設計からのアウトプットが特定されていることを保証すること

この要求について考える上で「確立する（establish）」という用語を正確に理解しておく必要がある。これについては820.3(k)に以下のように定義されている。

(k)Establish means define, document (in writing or electronically), and implement.(k)確立する(Establish)とは、定義し、（紙又は電子媒体で）文書化し、且つ実施することをいう。


すなわち、FDAの要求する「手順を確立する」というのは、当該作業の各手順内容（誰が何を行うか、どんな記録を残すか）を定義し、文書化（手順書の作成）し、実際に実施する（必要な記録を残す）ことを言うのである。

上記を理解したうえで、設計アウトプット手順の確立・維持に関する要求について見ていく。

手順により保証すべき事項

FDAの品質システムが設計アウトプットにおいて求めていることは以下の3つであり、下記の事項を設計アウトプットが満たすよう、手順を確立し維持することを求めている。

  1. 設計アウトプットを定義し、文書化すること。
  2. 設計アウトプットでは、設計へのインプットの要求事項に適合している旨を適切に評価出来るように表現をすること
  3. 機器の安全性および適切な機能に必須の設計の特徴を識別すること
設計アウトプットの定義・文書化

何が設計アウトプットに当たるのか、それを予め定義し文書化する必要がある。
Ⅰ.でも述べたように、設計アウトプットは図面だけとは限らない。リスク評価報告書、ソフトウェアコード、ベリフィケーションの結果、生体適合性の結果等も設計アウトプットに含まれうる。

設計インプット要求事項との適合性の評価

製造業者は、820.20(f) Design Verification で規定されるように、設計アウトプットが設計インプットの要求事項に適合していることを設計検証において確認しなければならない。そのため、設計アウトプットは設計インプットとの適合性が評価できるような表現をしなければならない。

機器の安全性および適切な機能に必須の設計の特徴の識別

機器の安全性および適切な機能に必須の設計の特徴を識別しなければならない、というこの要求の意図するところは何なのであろうか。
FDAは設計インプットにおいて、機器の機能要件、パフォーマンス要件、インターフェイス要件を規定することを求めている。
「機器の安全性および適切な機能に必須の設計の特徴」というのはすなわち、設計インプットで規定された上記の事項に関連するアウトプットのことを指す。
設計インプットにおいて規定されたこれらの事項は機器を製造・使用する上で非常に重要なポイントとなる。これらの設計インプット要求が設計アウトプットにおいて満たされていることを設計アウトプットで保証するように、というのがFDAの要求である。
例を挙げると、設計インプットにおいて「機器の外装は青色とすること」という要件があったとする。これは機器の機能、パフォーマンス、インターフェイスとなんら関係がない。こういったインプット要求に対するアウトプットと、機能・パフォーマンス・インターフェイスに関するアウトプットを明確に識別せよ、ということをここで求められているのである。

  • 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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