手順書は何のために必要か

医薬品企業・医療機器企業において手順書（SOP）の作成は必須である。では、そもそもなぜ手順書が必要なのであろうか。
一般に日本の製造業では昔からチームワークを得意とし、助け合って品質の良い製品を上市してきた歴史がある。
その場合、必ずしも手順書がなくとも問題なく設計・製造が行われてきたのである。

そもそも手順書を見なれば作業が出来ないような人は、設計・製造等を行ってはいけないのである。
例えば、自動車を運転する際に”教則本”を読みながら運転する人はいないだろう。運転の仕方、交通ルール、標識などはすべて覚えているはずである。
では、何のために手順書が必要であるかというと、管理するためである。
欧米では、日本とは異なり、トップダウン型の社会である。管理職が部下の業務が適正に実施されていることを”管理”しなければならない。
その際に手順書に従ってチェックするのである。
または、内部監査や外部監査や当局査察の際に、手順書を見て当該企業が法令を遵守しているか、また手順書に従って適切に記録が作成されているかをチェックするのである。

当然のことながら、手順書を発行または改訂した際には、制定教育・改訂教育が必要である。
その際には、手順書を説明するだけでは不十分である。特に新人（異動者）の教育は別途教育用資料を作成する必要がある。
なぜならば、手順書は”分かる人”が読んで分かるものであるからである。新人には手順書ではなく、教育用資料を用いて十分な理解が進むように教育を実施する必要がある。
しばしば、手順書を発行した際に公開し、従業員が自習（実際には目を通すだけ）で教育に代えている企業があるが、これは非常にお粗末である。

上記のことから、手順書は法規制を遵守するための最低限の事項を極めてシンプルに記載するべきであると筆者は考えている。
企業によっては、多くの事項を書きすぎている場合や、例外事項などまで記載しているケースが見受けられる。
これでは、冒頭に記載したとおり、業務が適切に実施されているかをチェックすることが困難となってしまう。

では、業務を適切（エラーなく）実施するためには何が必要であろうか。
それは様式（書式）である。上記した通り、作業者は手順書を見ずに作業する。しかしながら、様式（書式）は必ず手元において作業するであろう。
様式（書式）をもって作業を実施し、実施した事項を記載していく訳であるが、その際に様式に記載されている項目を順に実施し、記録していけば手順書が遵守できる状態が理想である。
したがって、詳細事項が必要な場合や例外事項などが予測される際には、様式（書式）を工夫し記載できるようにしておけば良いであろう。
様式（書式）も手順書の一部であることを強調しておきたい。

ご意見ご質問等は当社の「イーコンプライアンス公式LINE」から願いたい。（ID検索の場合：@ecompliance）

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