CSVと品質保証

CSVのゴールがコンピュータシステムを利用した業務の「品質保証」であることは、これまでにも述べてきましたので、良くご理解いただいていると思います。
それでは「品質」とは何でしょうか?
こんな例を考えてみました。
15万円するブランド物のバックの留め金部分が汚れていたとしましょう。
客は「品質が悪い」と思ったことでしょう。
一方、駅の売店で300円で買った紙袋のすそが少し破れていました。
客は「しょうがないな」と思ったことでしょう。
この2つの違いは何でしょうか?それは価格です。
つまり「品質」とは顧客が支払う「対価」に対する「価値」の事を指します。
したがって品質とは相対的であり、また顧客がそれを決定します。
決して生産者側が「品質」を一方的に決められるものではありません。
製薬業界の場合、顧客は患者であり、価値は生命です。
生命はプライスレスであり、したがって薬剤に対する品質は最高水準を要求されるのです。
さて「品質」をご理解いただいたと思いますので、「品質保証」について触れたいと思います。
FDAでは、CSVに対して「Independent」なQAを求めています。
QA部門の役割は、第三者(つまりIndependent)に、文書化された証拠(つまりバリデーション文書)を読み、再度SOPにしたがって同様の作業を行った場合、同様の結果を導ける状態であるかどうかを判断することです。
つまり再現性があるかどうかということです。
例えば、別人物がもう一度テスト計画書を作成したとして、ほほ同規模(数)、同種類のOQテストを定義するだろうか(つまり同じ結論に行き着くか)ということです。
また、もうひとつ作業の再現性を確保するのに必要なものは、トレーサビリティです。
当社のコンサルタントが推奨する方法は、トレーサビリティマトリックスの作成です。
トレーサビリティマトリックスを利用することによって、文書間の整合性をとり、変更管理に有効に活用します。
つまりあらゆる変更は管理され、常に整合性を持ったドキュメントを維持する必要があります。
繰り返しますが、品質保証というのは、適合性のあるSOPにしたがって、再現性のある活動が文書に記録されていることを確認することです。
決して、文書の過不足や書き方、ましてや「てにをは」をチェックすることではありません。
またQAプロセスでは、品質は測定できません。
前述したとおり、品質を決めるのは顧客です。
QAが「品質が良い」という報告書を出しているとすると、少し違和感があります。
自社の品質基準に照らして「品質が保証できる」や「品質が確保されている」が望ましいでしょう。
ISO-9000の認証の際も、品質の「高い」「低い」は問題にされません。
ただし、「品質管理システム(QMS)」が機能しており、今日よりも明日、明日よりも明後日というように、品質が向上していく仕組みが完成しているかどうかが認証のポイントになります。

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