gmp供應(yīng)商審計(jì)ppt課件(完整版)
【正文】 management, 2022/6/2 供應(yīng)商審計(jì) 13 供應(yīng)商審計(jì)的內(nèi)容 audit contents ? 現(xiàn)場(chǎng)審計(jì)的內(nèi)容： in site audit – 現(xiàn)場(chǎng)檢查：至少包括倉(cāng)庫(kù)、儀器校驗(yàn)和生產(chǎn)現(xiàn)場(chǎng)、化驗(yàn)室，檢查時(shí)，可以按照檢查表列出來(lái)的內(nèi)容進(jìn)行并記錄，記錄應(yīng)該詳盡， In site inspection: At least, including warehouses, instrument calibration and production sites, laboratories. The inspection should be in accordance with the checklist list of content and records, the records should be detailed – 查閱文件：批記錄、批分析記錄、原輔料分析記錄、計(jì)量器具校驗(yàn)記錄、環(huán)境監(jiān)控記錄、人員培訓(xùn)記錄，人員體檢記錄和相關(guān)的 SOP等，查閱的同時(shí)，進(jìn)行詳細(xì)的記錄， Access to documents: batch records, analysis records, raw material analysis records, measuring instruments calibration records, environmental monitoring records, personnel training records, personnel and medical records and related SOP, etc., accessible at the same time, detailed records, 2022/6/2 供應(yīng)商審計(jì) 14 供應(yīng)商審計(jì)的評(píng)估和報(bào)告 The vendor evaluation and audit report ? 對(duì)現(xiàn)場(chǎng)審計(jì)的情況進(jìn)行評(píng)估， Onsite audit to assess ? 評(píng)估的標(biāo)準(zhǔn)：按照 SOP中的規(guī)定評(píng)估， Assessment criteria: assessment, in accordance with the provisions of the SOP ? 得出結(jié)論 ,可以采取打分的方法，將得分與標(biāo)準(zhǔn)進(jìn)行比較，得出是否合格的結(jié)論，Conclusion: the scoring method can be taken to pare scores with standard eligibility conclusion, ? 撰寫報(bào)告，遞交給有關(guān)領(lǐng)導(dǎo)審閱和批準(zhǔn)， Written report then submitted to relevant leaders for review and approval, ? 不管需要供應(yīng)商進(jìn)行整改的，或有其他要求，或沒(méi)有問(wèn)題的，都要向供應(yīng)商發(fā)出書面的審計(jì)報(bào)告，并要求及時(shí)反饋，可以在收到反饋后再行批準(zhǔn)， Regardless of the supplier for rectification of, or other requirements, or that there is no problem, a written audit report should be sent to the supplier, and timely feedback is required. And the approval can be released after receive feedback. 2022/6/2 供應(yīng)商審計(jì) 15 合格供應(yīng)商的名錄 Approved vendor list ? 供應(yīng)商經(jīng)過(guò)批準(zhǔn)，就成為了合格供應(yīng)商，該信息應(yīng)該及時(shí)通知有關(guān)部門， The vendor has been approved, and bee an approved vendor, the information should be informed to related departments in timely manner, ? 供應(yīng)商審計(jì) SOP應(yīng)該明確：各責(zé)任部門應(yīng)該做什么事情，包括合格供應(yīng)商名錄的發(fā)放， Supplier audit SOP should be clear: the responsible departments should do something, including the issuance of the list of qualified suppliers, ? 合格供應(yīng)商名錄應(yīng)該及時(shí)更新， List of
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