データインテグリティ対応順序

1.教育とコミュニケーション

まずデータインテグリティに関する教育が重要である。教育を実施すればするほどデータインテグリティ違反が発見される。これはデータインテグリティ違反が増加したのでなく、これまでは認識されていなかったデータインテグリティ違反が多く発見されたことにすぎない。
例えばMRに有害事象教育を実施すればするほど有害事象報告が増加する。また警察官を増員すればスピード違反や駐車違反が増加する。これらは発見数が増加したにすぎないのである。
まずは従業員にデータインテグリティに関する教育を適切に実施することが必要である。

またコミュニケーションも重要である。
昨今の規制要件や国際規格において、コミュニケーションが重要視されている。
多くの場合、ミスをした場合、従業員はそのミスを隠すために小さな嘘をつく。その小さな嘘を隠すために少し大きな嘘をつく。大きな嘘を隠すためにさらに大きな嘘をつく。最終的に事態が発覚した際には取り返しのつかない事態になっていることが多い。
そこで規制要件や国際規格はミスを気軽に報告できる企業風土を重要視している。
人は必ずミスするものである。むしろ自らがミスを行った事案を報告した者が評価されなければならない。その場合に、CAPA(改善)を実施して手順を見直し、再発を防止しなければならない。

2.リスクの発見と低減

製薬業界における各種のプロセスにはリスクがつきものである。現存するSOPの手順の中で、どこでどのようなリスクが存在するかをまず発見しなければならない。
例をあげよう。ハンバーガーを焼くプロセスがあったとしよう。製造指図書には、当該ハンバーガーは180℃で3分間に加熱することが記載されている。お分かりの通り180℃に満たない場合、または3分間に満たない場合は、ハンバーガーの中心まで熱が届かずに滅菌が十分にできない。その場合、食中毒を発生させるリスクが存在する。
この事例において、加熱温度が180度に満たないリスクはどこにあるのだろうか。例えばバーナーが故障しているや、温度計の目盛りを読み間違えるなどが考えられる。
次に3分間に満たない事例として、タイマーが故障している、タイマーの目盛りを読み間違えるなどのリスクが存在する。
そこで手順書を改訂し、それらのエラーをチェックする手順が必要となるわけである。
このようにデータインテグリティにおいても、データの信頼性を損なう重大なリスクが存在すれば、それらを発見し未然にリスクの発生を防止する必要があるのである。

3. ITシステムの導入

例えばExcelのようなスプレッドシートにおいては、故意か事故かにかかわらず、データを書き換えてしまう危険性が存在する。
また電子天秤やUV系のような単純なシステムにおいては、セキュリティがかからず、また監査証跡を記録することもできない。これがシステムの改良を実施し、データインテグリティのより強固な保証が求められるのである。

このようにデータインテグリティ保証のためのプロセスをぜひ実施して頂きたい。

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