品質目標と経営目標について

改正GMP省令では、経営者が品質システムを構築し、品質方針および品質目標を文書化することが要求される。
これは品質マネジメント規格であるISO-9001の要求事項と同じである。
しかしである。ISO-9001の認証を受けた企業でも起きがちなことは、品質目標と経営目標が整合していないということである。
つまり、品質目標を達成したとしても経営目標が達成できないのである。
多くの場合、経営者は品質方針や品質目標において、顧客の耳障りの良いことを書く傾向にある。一方において、経営方針や経営目標では、売り上げ向上、シェア拡大、グローバル展開など、利益に関わることがもっぱらである。
つまり、経営方針と品質方針では、本音と建前が分かれている状態である。
これはよろしくない。
ISO-9001などが求めていることは、品質が向上することによって失敗コストなどが減少し、顧客満足度を上げ、その結果として利益が向上するということである。
つまり品質目標を達成したならば、経営目標が達成できなければならない。
ISO-9001では、経営目標と品質目標の整合性を求めている。

医薬品品質システム(PQS)を構築するにあたり、経営者は品質システムに品質方針を織り込み(文書化し)、各部門の長に品質目標を立てさせることになる。
各社が一体どのような品質方針・品質目標を掲げるか関心のあるところである。

 【2021年度改正QMS省令対応】QMSひな形一式

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