コミュニケーションの重要性

コミュニケーションの重要性

経営者はいつも従業員に向けて“法令を遵守する”ということを訴え続けることが重要である。
経営者のそういった姿勢があってこそ、何か問題が起きたとき、品質不良にかかわる事項が発見されたとき、迅速な対応を可能にし、従業員の中にも法令遵守意識が生まれる。

一方で、昨今のGMP調査では、品質システムが適正であるかを調査することに主眼が置かれている。
当該品質システムが個々の製品に落とし込まれて、仕組みが適正に運用されていることが重要である。
品質情報の把握・評価・対策に不備があることで製品回収につながることもある。
現場の担当者が品質上の異変に気づくこともある。それが経営者にも伝達され、組織内で共有できることが重要である。
組織として共有することで必要な対策を迅速にとることが可能になる。
組織にとって情報共有が重要であることは言うまでもない。

しかしである。
本当に報告しやすい文化を醸成しているであろうか。
人は必ず間違うし忘れる。しかしミスを上司に報告すれば叱られてしまう。
そこで小さなウソをつく。その小さなウソを隠すためにちょっと大きなウソをつく。それを隠すためにもっと大きなウソをつく。
発覚した時には対処し得ないくらいの大問題となってしまうことが世の常である。
ISO 9001のような国際規格や、データインテグリティの要件では、このコミュニケーションの重要性がうたわれている。
ミスをしたことを報告した人ほど褒められなければならない。
なぜならば改善の機会を提供したからである。

人は必ずミスを犯すのであるから、仕組み(システム:QMS)を改善してミスを発見、予防できるようなプロセスに改善しなければならない。 まずは経営者は「報告しやすい文化」を醸成することだ。

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[blogcard url= https://ecompliance.co.jp/SHOP/O019.html title=”【VOD】改正GMP省令対応の「管理監督者のGMP教育」/「企業文化」の見直し醸成セミナー”]

[blogcard url= https://ecompliance.co.jp/SHOP/O022.html title=”【VOD】医薬品の品質試験における信頼性基準適用の考え方と問題事例セミナー”]

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