様式はSOPか

筆者が医薬品企業や医療機器企業において多くのコンサルテーションを実施する中において、SOP（標準業務手順書）に詳細に多くのことを記載し過ぎている企業をしばしば見受ける。
またSOPの数が非常に多くなっている企業も多い。

SOPは標準業務に関する手順を記載するものであり、品目毎に異なる事項、プロセス毎に異なる事項などを詳細に記載するものではない。
筆者は常にそれら詳細事項等はSOPではなく、要領書や様式に記載すべきであることを助言している。
様式も列記とした手順書であるためである。
様式を埋めると必然的にSOPが遵守できることが望ましい。
なぜならば、通常、業務は手順書を読みながら実施しないためである。
自動車の場合、教則本や交通ルールを読みながら運転しないのと同じである。

品目毎に異なる事項、プロセス毎にSOPを作成した場合、必然的にSOPの数が増えてしまうだろう。
その場合、標準的な作業が一体何であるかが不明確となってしまう。

また日本においては、文字（文章）のみで業務手順を記載しているケースが多い。
かつて、元自衛隊に所属していた人から、下記のような興味深い話を聞いたことがあった。
自衛隊では、手榴弾の投げ方をマニュアルに記載する場合、一般に文字だけで解説をするそうである。
一方で、米国の軍隊では、文字は一切使用せず、4コマ漫画で説明をするそうだ。
これは、多国籍ならではでもあるが、それよりも異なる解釈や誤解から事故を防ぐ最も良い方法であるためである。
昨今では、プリンターの用紙詰まりを解決する際にも、ディスプレイに絵や図で説明が表示されることがあり、また絵や図で説明したラベル等が貼付されていることが多い。
百聞は一見にしかずである。

筆者はSOPや要領書などにおいて、写真や図をもっと多用すべきであると考えている。 それによって、教育不足、理解不足、思い込み、勘違いといったヒューマンエラー起因の“逸脱”を最少化することができるからである。

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