筆者がコンサルテーションを実施する中で、コンピュータシステムの導入を急ぐ企業が多い。
しかしながら、コンピュータシステムは拙速に導入するべきではない。
規制要件を遵守し品質を改善するためには、Process、People、Technologyの3要素が不可欠である。
また、導入順序もこの順である。つまりコンピュータシステムの導入は最後なのである。
Process、People、Technologyの導入はバランスがとれていなければならない。
１．Process
まず最初に手を付けるべきなのがプロセスである。規制要件に適合したQMS（SOP）を構築しなければならない。
品質改善の第1歩はプロセス改訂である。
特に複雑な手順を持っている企業は、シンプルで理解しやすく、変更しやすいQMSに改訂する必要があるだろう。
またプロセス中の「無理」「無駄」をなくすことも重要である。
プロセスの改訂は他の2要素に比べると比較的容易である。
なぜならば規制要件を遵守するよう取り決めるのみだからである。
２．People
プロセス改訂が完了したら、People Managementが重要である。
プロセスと要員は、車の両輪のごとくである。
品質改善のためには、プロセスパワーとピープルパワーのバランスが必要である。
前述の通り、プロセスは比較的容易に決定できるが、要員がついてこない（ついてこれない）ことの方が多い。
人はすぐには変われないからである。
People Managementの中でも特に重要なのは、Change Managementである。
プロセスの変更に伴う混乱を最小化し、最短で新プロセスへ移行しなければならない。
Change Managementでは、教育、訓練、コーチングの順に実施しなければならない。
多くの企業では、教育（座学）しか実施していないことが多い。
自動車教習所で例えると、教育は学科教習である。
学科教習のみでは、自動車の運転は不可能である。
路上教習がトレーニングに当たる。
プロセスを変更した後は混乱を来すことが多い。
そのため、トレーニングにより、混乱期を短く浅く抑える必要がある。
また新プロセスが始動した後も常にコーチングを行い、継続的に品質改善・効率改善を指導していく必要性がある。
企業において最も充実させなければならないのが、監査員である。
優秀な監査員が存在しなければQMSや組織を適切に維持することができず、またQMSの有効性も向上させることができない。
規制当局にとって安心な企業は、優秀な監査員が存在することである。
３．Technology
プロセスと要員の教育訓練が完了した後にコンピュータシステムの導入を行う。
しばしば、コンピュータシステムを導入すればプロセスが改善されると思っている企業を見かけるがそれは大きな間違いである。
「プロセスが混乱したままのシステム導入は、混乱をそのままシステム化してしまうことに過ぎない。」ということを肝に銘じなければならない。
プロセスが適正化され、要員が教育訓練されているうえでコンピュータシステムを導入をすれば、規制要件違反が減少し、効率的な品質向上、強いて言えばコストダウンにつながるだろう。
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