4M変更とは

4M 変更とは

4Mとは

4Mとは、物事をMan(人)、Machine(機械)、Material(材料)、Method(方法)の4つの要素で考える手法のことである。
4つそれぞれのアルファベットの頭文字から、4Mと呼ばれている。

Man(人)

人=現場の作業員・スタッフのことである。
一定の品質を保つには、現場の作業員・スタッフの能力を維持・管理することが不可欠である。
製造過程においては、機械の制御や操縦、材料の選別や確保、正確かつ迅速な方法を実施するなど、熟練・鍛錬された技術やスキルが必要だ。
そのためには、各作業員・スタッフのスキルや適正を分析・把握し、しっかり管理の上、作業別に的確な作業員・スタッフを配置を考えなければならない。
機械や材料、方法はすべて人の手によるものであり、「人」こそが4Mの中の基礎であり、最も重要とされている。

Machine(機械)

製造業の生産の現場には、さまざまな機械や設備が導入され、稼働している。
製品の安定した品質を維持するためには、これらの機械や設備の以下のような管理が必要である。
・最新機械や設備の導入・開発
・メンテナンスや点検
・機械や設備の的確なレイアウト(配置)
・機械や設備を効果的に使いこなす人材の配置

Material(材料)

製品を製造するには、さまざまな原材料や部品などの資材を調達することが必須である。
そして製品の品質管理において、安定した製造を行うためには、以下のような材料の管理を行う必要がある。
・材料の調達量(機会損失や過剰在庫予防)
・材料の調達手段(仕入れ先の選定・購入場所からの流通方法・購入価格)
・材料の検査(欠陥や不足がないかの確認)


Method(方法)

方法とは製品を製造する方法のことである。

品質管理において、各製造工程の標準化(決められた手順・方法)が必須である。
そのためには、マニュアルの作成、マニュアルの見直しを行う必要がある。

5M+Eとは

上記の4Mに対して、Measurement(計測)とEnvironment(環境)を加えることが多い。
これらの要素の品質のバラツキ具合が総合され、製品の品質が決定付けられるといわれている。

4M変更とは

一般の工業界では4M変更の定義は
「人(Man)」:作業者の交代
「機械(Machine)」:製造設備、治工具等の変更
「材料(Material)」:原材料・部品等の変更
「方法(Method)」:作業方法・工程・測定方法の変更等
である。
しかしながら、医療機器規制における工程変更(設計変更)で重要なのは、Machine(機械)、Material(材料)、Method(方法)、Measurement(計測)であり、Man(人)は含まない。
医療機器規制において、設計変更は完成機器の品質や患者・ユーザの安全性に影響を与えることなく、変更を厳密に実施し記録しなければならない。またユーザ要求や規制要件・国際規格等から逸脱してもならない。
一般に医療機器設計においてMan(人)は変更の対象とはしない
ただし、特殊工程(破壊検査を伴う工程のためサンプリング検査しか実施できない工程のこと。半田付け、滅菌、カシメ、接着、溶接、圧着など)においては、Man(人)の変更管理が重要となる。
特殊工程においては、あらかじめプロセスバリデーションを実施することが求められており、プロセスバリデーションは力量を持った者(訓練・経験を積んだ者)が実施しなければならないためである。

関連商品

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