QMSの構築方法

QMSの構築方法

QMS(Quality Management System)は、品質管理のための“仕組み”である。
通常は階層構造を持ちトップダウンで作成する。
第一階層:品質マニュアル第二階層:規程(Provisions)
第三階層:標準業務手順書(SOP)
第四階層:要領、様式
といった4階層が標準的だ。
しばしばQMSに記録を含めている企業があるが、厳密には記録はQMSではない。なぜならば“仕組み”ではないからである。“仕組み”を実行した結果が記録である
記録は文書の一種ではあるが、その管理方法は文書とは異なる。

品質マニュアル

品質マニュアルは、企業の上級経営陣(Senior Management)が作成しなければならない。
品質マニュアルには「品質方針」を含め、上級経営陣の品質に関するコミットメントを記載することになる。

なぜ同じ規制要件に対して、企業毎に品質マニュアルが異なるのかというと、当該企業が製造している製品(例:無菌製剤、胃腸薬、抗がん剤など)が異なり、当該企業が実施しているプロセス(例:製造工程、保管工程、滅菌工程、試験工程など)が異なるためである。
製品が異なれば、リスクが異なる。そのため、品質管理の程度が異なるのである。
FDA査察が実施される場合、事前に品質マニュアルを英訳して送付するよう要求されることがある。
FDAの査察官は、事前に当該企業がどのような製品を製造販売し、どのようなプロセスを担っているのか、また品質管理の程度や上級経営陣の品質に関するコミットメントを理解しておかなければならないためである。

第二階層の規程以下の文書は、品質マニュアルに従い、従業員が作成する。
ここで大切なことは、品質マニュアルを遵守するのであって、直接規制要件に遵守する訳ではない
従業員が参照し遵守するものは規制要件ではなく、品質マニュアルなのである。

筆者が製薬企業・医療機器企業でコンサルテーションや監査を実施した際に、品質マニュアルと規程・手順書等が整合して異なことがしばしばある。
多くの日本の企業はトップダウンではなく、ボトムアップでQMSを構築しているためである。
欧米のQMSの構築方法はトップダウンである。日本企業はトップダウンが極めて苦手である。

筆者が品質マニュアルと規程・手順書等との不整合を指摘すると、「品質マニュアルには記載がないが、規制要件では要求されている。」と回答を受けることがある。
これでは、品質マニュアルは“絵に描いた餅”である。

またFDA査察官などは、品質マニュアルを事前に読んだとしても、当該企業の品質管理の概要が理解できないことになってしまう。

規程(Provisions)

第二階層の規程には、品質マニュアルで記載された事項に対するルールを記載する。
ルールは規制要件を遵守していなければならないことは言うまでもない。
FDA査察などでは、手順書よりも規程を参照することが多い。なぜならば手順に正解も間違いもないが、ルールが規制要件を遵守しているか否かは明白だからである。

標準業務手順書(SOP)

第三階層の手順書には「標準手順」を記載する。
“標準”とは、品目毎に異ならず、また製造棟毎に異ならないものである。

しばしば、品目毎のSOPや製造棟毎のSOPを見かけるが、これでは当該企業の“標準”が不明であり、また不整合が発生してしまう
品目毎や製造棟毎に異なる手順がある場合は、第四階層の要領書や様式(例:製造指図書兼記録書)に落とせば良い。

通常、作業員は作業場所にSOPを持ち込まない。しかしながら記録を作成するための様式は持ち込むであろう。
したがって、SOPに品目毎や製造棟毎に異なる手順を記載しても意味がないのである。むしろいたずらにSOPの数を増やし、複雑化させるだけである。
またSOPの改訂などの手間も増えてしまう。

手順書はフローチャートが描けなければならない。逆に言うとフローチャートが描けないものは手順ではなく、ルールである。
例えば、「パスワードは6文字以上にする。」などである。
手順書にルールや詳細な要領を記載すると、読みにくく、理解しにくく、変更しにくいものになってしまう。

基本的に1プロセス=1手順書とすることが望ましい。
プロセス毎に手順書を構築すれば、理解しやすく、メンテナンスも容易になるためだ。

要領、様式

第四階層の要領、様式は、製造指図書兼記録書などのような“詳細な手順”を記載する。
基本的に1プロセス=1製造指図書兼記録書としなければならない。なぜならば自身の作業しない製造指図書兼記録書を製造現場に持ち込んでも意味がないからである。

要領や様式を遵守して作業し、記録を作成すれば標準手順が遵守でき、規程が遵守でき、品質マニュアルが遵守できる(逸脱がない)ことがゴールである。つまり規制要件が遵守できるのである。
また、規制要件を遵守できるということのみではなく、データインテグリテ違反を犯さないような要領、様式を工夫する必要がある。

上述したとおり、日本企業はトップダウン方式によるQMS構築に慣れていない。
そのため、複雑でややこしく、理解しにくく、非常に数の多いQMS体系となっている企業が多い。
すなわち似て非なる文書が乱立しているのである。

https://www.youtube.com/watch?v=mwhL6xTbYNI

関連商品

[blogcard url=https://xn--2lwu4a.jp/qms-rx/ title=”QMS(手順書)ひな形 医薬品関連” ]

[blogcard url= https://ecompliance.co.jp/SHOP/EL-006.html title=”【セミナービデオ】データインテグリティSOP作成セミナー”]

[blogcard url= https://ecompliance.co.jp/SHOP/P139.html title=”【書籍】 当局要求をふまえた データインテグリティ手順書作成の要点”]

[blogcard url= https://ecompliance.co.jp/SHOP/O089.html title=”【VOD】データインテグリティの具体的な手順書作成セミナー 【データインテグリティ書籍付】”]

[blogcard url= https://ecompliance.co.jp/SHOP/MD-QMS-01.html title=”【FDA CFR 820 QSR対応】品質マニュアル”]

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