購買管理におけるQCDについて

購買管理におけるQCDについて

医療機器の設計・製造プロセスにおいて、購買管理は重要である。
MDSAPでは、プロセスリンケージと呼ばれる手法により、設計管理や製造管理などの監査からリンクされ、購買管理プロセスが監査されることになっている。

購買先の事前評価、定期的な再評価(例:1回/年)はとても重要である。
既に納入されている供給者の場合は、受入試験の結果などにより、品質や当該供給業者のパフォーマンス(納期遵守状況・製造数等)が評価できる。
一方で、新規供給業者の場合、調査票に基づく供給者評価を実施しなければならない。
多くの医療機器業では、供給者評価にQ(品質:Quality)、C(コスト:Cost)、D(納期:Delivery)やその他の項目を調査していると思われる。
ここで大切なことは、QCDを合計してはならないということである。
医療機器規制で重要なことは、第一に品質である。
従って、品質の評価のみで足切りをしなければならない。
QCDを合計した場合、例え品質が悪くとも、採用してしまうことがあり得るためである。
QCDを合計するということは、いわば身長と体重と血圧を合計することに等しい。
身長や体重や血圧はそれぞれの基準と照らして評価しなければならないのと同じである。

リスクに応じた供給者評価

一方で、企業のリソースは有限である。すべての供給業者の評価を厳重に実施することも現実的ではない。
供給者管理においては、供給製品や供給者のリスクに応じた管理が肝要である。
下記のようなクラス分けが必要で、各クラスでの足切り(合格基準)点も変化させる必要がある。
クラスA:重要工程委託先・・・設計・主な製造・OEM供給・滅菌等
クラスB:重要部品・重要部材(最終製品に大きな影響を及ぼすものを対象とする)
クラスC:主要でない組み立て/最終製品の保管
クラスD:部品、材料(ユニット、一般購入品含む)
クラスS:製品品質に大きな影響を与えるサービス(校正/分析・試験/運送・梱包/コンサルタント)

例えば、クラスAの場合は、

  • 契約前の供給者監査を必須とする。
  • QA間のコミュニケーションルールを文書化し、問題発覚の都度当該ルールに則り迅速に処理を行う。
  • 原則として1年に1回供給者監査を実施する。
  • 1年に1回供給者評価を実施する。

などのように供給者管理のレベルをQMSで定義しておかなければならない。
その他、全品検査が必要か、抜き取り(サンプリング)検査でも良いのかなども供給業者の供給品毎に決定しなければならない。

関連商品

[blogcard url=”https://ecompliance.co.jp/SHOP/QMS-MHLW-06.html” title=”【2021年度改正QMS省令対応】購買管理規程・手順書・様式” ]

[blogcard url=”https://ecompliance.co.jp/SHOP/MD-QMS-114.html” title=”【ISO-13485:2016対応】購買管理規程・手順書・様式” ]

[blogcard url=”https://ecompliance.co.jp/SHOP/GMP-37.html” title=”【GMP省令対応】購買管理規程・手順書・様式” ]

[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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