コンピュータ化システムの3大原則

2013年1月1日に改定されたPIC/S GMP ANNEX 11 「Computerised Systems」の原則には以下のような記載がある。『マニュアルベースの作業をコンピュータ化システムに置き換える場合、結果として製品の品質、プロセスコントロールつまり品質保証を劣化させてはならない。プロセスの全般的なリスクが増えてもいけない。』これはコンピュータ化システム(自動化システム)を導入する上での原則である。マニュアルベースの作業(手作業)をコンピュータ化(自動化)した際に、以下の3つを保証しなければならない。

  1. 製品の品質を劣化させない。
  2. 製品の品質保証を劣化させない。
  3. リスクを増やさない。

ということである。

たとえば、昔はお米をお釜で炊いていた。手作業で「はじめちょろちょろなかぱっぱっ 赤子泣いても蓋とるな」といった具合に、口伝でおいしいお米の炊き方を継承してきた。
現代では、お釜はマイコン炊飯ジャーにとって変わった。”マイコン”とはマイクロコンピュータの略である。すなわちお釜というハードウェアにICチップが搭載されており、ファームウェアと呼ばれる小さなプログラムによって制御(コントロール)されている。

マイコン炊飯ジャー(自動化システム)において重要なことは、

  1. お釜でお米を炊いていた時と同じおいしさ、食感、甘さ、艶加減で炊き上げる。(品質を劣化させない)
  2. 炊飯する度に品質が異ならない。(品質保証を劣化させない)
  3. 食中毒を起こさない。(リスクを増やさない)

ということである。

つまりバリデーションの目的は、手作業で出来ていたことと同じ事が、コンピュータ化されたシステムでも出来なければならないということである。

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