ISO-13485:2016より「設計・開発の移管」という要求が追加された。
FDAは1996年のQSR発行当初から「設計移管」を要求してきた。
そもそも設計の目的・ゴールには2つあると筆者は考えている。
1つ目は、医療機器を(認証)申請すること。
2つ目は、医療機器を製造できるようにすることである。
今回は後者について「設計移管」を中心に解説したい。
医療機器に限らずあらゆる製造業では、設計のある時点以降は量産移行を開始するであろう。
特にリードタイムの長い部品・半製品などに関しては、早い目に工場に移行させておかなければ量産に間に合わない。
また均一の品質でかつ効率よく量産できるようにするための工程設計も実施しなければならない。
医療機器製造の場合、工程設計において、設備のクオリフィケーション(適格性評価:IQ、OQ等)と特殊工程などに対するプロセスバリデーションも実施しなければならない。
ここでしばしば勘違いされていることは、量産移行=設計移管であるという認識である。
これは正しくない。
もちろん量産移行は設計移管の一部であるが、全部ではないのである。
FDAによる設計移管の要求は以下のとおりである。
「各製造業者は機器設計が製造仕様書に正確に移し換えられることを保証すること」
つまり、設計からのアウトプットのうち、製造仕様に関するもの(例:図面、製造仕様書、検査仕様書等)をDMR(本邦における製品標準書)に正確に転写し、それを確認し、保証することである。
設計移管において重要なことは、正確に転写したことを保証した証拠が必要であるということである。
![Image Image](https://rkcl-ibis.s3-ap-northeast-1.amazonaws.com/a13.hm-f.jp/226/html_upload/img_226_20200707_070139_XWllK.png)
五月雨式の技術移転では、途中設計事項に変更があった際に工場側の製造仕様書を変更することを失念してしまうといったミスがあり得る。
FDAが設計移管で要求していることは、最終的に設計から製造へ移管された際(つまり設計バリデーションが終了した後)に再度設計からのアウトプットとDMR(製品標準書)を見比べて精査し、問題がないことを保証し、その活動を記録しておくことである。
また正確な転写が保証されたDMRはDHFに登録しておく必要もある。
もし可能であれば、設計移管終了後にDRを実施することを推奨する。
注意が必要なことは、設計からのアウトプットすべてをDMRに移し換える訳ではない。
設計からのアウトプットには製造には必要のない成果物が含まれる。例えば、各種検証記録、ソフトウェアソースコードなどである。
またDMRは設計移管のみでは完成しない。つまり、プロセスバリデーション手順、機器管理手順、校正手順等の一般に工場側(生産技術部門)で作成する成果物も含まなければならないためである。
設計移管後に設計が変更になることがある。そもそも設計は製造するために実施するため、筆者は「設計変更」=「製造変更」であると考えている。
そう考えるとわかりやすい。
設計変更を実施する度に設計移管を行い、DMRを最新のものとするとともに、当該DMRをDHFに登録する必要がある。
なぜならば、3年前に出荷した製品に対して苦情が来たとする。その場合、当時の製造仕様書を参照しなければ原因がつかめないためである。
【お知らせ】
イーコンプライアンスでは『(全16講) 医療機器QMS規制入門ライブ配信セミナー』を配信しております。詳しくはこちらをご視聴ください。
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