データ分析について

FDAをはじめ世界の規制当局は、製薬企業、医療機器企業に対して統計的手法（データ分析）を要求している。
ではなぜデータ分析が必要なのかを考察してみたい。

なぜデータを収集するのか？

まずなぜデータを収集しなければならないのかというと、「直感」ではなく「証拠」ベースの品質保証活動を行うた めである。
例えば、

  1. この機種の苦情原因のトップ３はA,BとCである。であるから、A,BおよびCに対して重点的に対応すべきだ。
  2. ここのところ、Dを原因とする苦情が多い気がする。EとFに関する苦情も近頃見 かけるようになってきた。なのでD,EおよびFに重点を置いた対策をすべきだ。

1.は正しい。2.では対策に根拠がなくやみくもに対処しても効果が出ない可能性が高い。

じゃあ、データって何？

次にデータとは何かを考えてみよう。
データ（Data）とは「整理されていない情報」のことである。「生データ」とも呼ばれる。
データのままでは使えないだろう。なぜならば、データそのものは数字の羅列だからである。つまり整理されていない情報であるため、人間の頭では理解できない。

そこで「Data」を「Information」に変換する必要がある。
そのために「統計的手法」を使用する。

一般にデータ（Data）は、情報化（Information）し知識化（Knowledge）し、最後に有効に生かすための知恵（Wisdom）となる。
これをDIKWモデルと呼ぶ。（図参照）

なぜ統計が必要か？

次になぜ統計が必要かを考えてみたい。
統計においては、人間の頭で理解できないデータをビジュアライズする。
数字を統計的に処理・ビジュアライズすることで、人間の頭でも数字の示すところが理解できるようになるのである。
統計には以下の2種類が存在する。

1．記述統計

あるデータを集めて、表やグラフを作り、平均や傾向を見ることでデータの特徴を把握する。
工程の状態の把握、苦情率、不適合率推移の把握、苦情原因等の把握

2．推測統計

母集団からサンプルを抜き取って、そのサンプルの特性から母集団の特性を推測し、それが正しい かどうかを検定する。（図参照）
製造における抜き取り検査、サンプリングを伴う設計検証、妥当性確認等

なぜ規制要件で「適切な」統計的手法が要求されるのか？

1996年10月7日付の米国の連邦広報であるFederal Register (Volume 61, Number 195)に以下のような記載がある。

  1. 再発している品 質問題の発見のために、「適切な統計的手法」を用いること。FDAは、統計的手法を用いる必要がある際には、適切な統計ツールを使用すべきであるということを強調する。
  2. FDAは製造業者による誤った統計の使用をしばしば目にしてきた。 製造業者は問題に対処するためではなく、努力を最小限にするために統計的手法を用いていた。このような誤った統計の使用はこのセクション（820.100）への違反である。

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