【正文】
dation Control 驗證管理 ?The process ? 屬于變更的應(yīng)已得到批準(zhǔn) ? 制定驗證方案,并進(jìn)行審批 ? 實施驗證 ? 驗證過程的偏差同樣應(yīng)得到 ? 無論驗證通過與否,都應(yīng)提交驗證報告,并進(jìn)行審批 ? 驗證失敗或需進(jìn)行變更時應(yīng)進(jìn)行再驗證 ?只有驗證通過,驗證對象方可用于投入使用 Products Release 成品放行 ?How to release a batch of finished products? Just by a piece of “COA”? 質(zhì)量是生產(chǎn)出來的 而不是檢驗出來的 NO! Products Release 成品放行 ?批檢驗合格 ≠批合格 ? 取樣的局限性 ? 檢驗項目的局限性 ?成品放行標(biāo)準(zhǔn) ? 批檢驗合格 ? 過程偏差得到解決,產(chǎn)品無質(zhì)量風(fēng)險 ? 工藝、設(shè)備、方法均驗證合格并批準(zhǔn) ? 與法規(guī)許可、備案相一致 Total Involvement 全員參與 Quality Without “U”, there is no “quality”! You are a part of the quality! It is “quality”! What it is now? It will be nothing! 謝謝觀看 /歡迎下載 BY FAITH I MEAN A VISION OF GOOD ONE CHERISHES AND THE ENTHUSIASM THAT PUSHES ONE TO SEEK ITS FULFILLMENT REGARDLESS OF OBSTACLES. BY FAITH I BY FAITH