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杭州某外資醫(yī)藥項目質(zhì)量管理手冊-wenkub

2022-11-05 18:17:31 本頁面
 

【正文】 attachment, plementary agreement, procurement contract and the labor contract. 項目部合同管理應(yīng)包括本項目相關(guān)的 總包 合同、合同附件、補充協(xié)議、采購合同、零星用工合同等。對技術(shù)資料,要準(zhǔn)確、真實并完整。 交底的方式采取書面形式、口頭形式和現(xiàn)場示范形式等 , 并做好技術(shù)交底記錄。 Technique Inspection 技術(shù)檢驗 Technology inspection is to check the materials, ponents, fittings and equipment quality. All the materials, including raw material, semi product, members and equipment, should be qualified and certified by relevant certificate. As for the materials without certificates, recheck is needed, and they can be used only their qualification is proved. 技術(shù)檢驗是對進(jìn)場材料、構(gòu)件、零配件和設(shè)備質(zhì)量進(jìn)行檢驗。 杭州 ****制藥新生產(chǎn)基地項目 3 質(zhì)量管理網(wǎng)絡(luò) Organization Chart 項目經(jīng)理 PM ***** ii 生產(chǎn) 經(jīng)理 Executive Mgr ****** 質(zhì)量 經(jīng)理 Quality Mgr ****** 材料采購 Procurement ** 質(zhì)量檢驗 Quality tester 材料供應(yīng)material man **** 設(shè)備供應(yīng)equipment support ***** 施工機具machineamp。 Manager: The quality manager also works as the assistant of Project Manager and the general quality guarantors. The quality manager is responsible for leading and monitoring the quality assurance system and approval the technical plan and quality assurance measures. The quality manager shall report the works to project manager and take responsibility to the quality control and technical responsibility. 質(zhì)量經(jīng)理 : QA/QC 經(jīng)理是項目經(jīng)理的助手 ,在項目經(jīng)理領(lǐng)導(dǎo)下 ,組織制定本工程質(zhì)量計劃 ,負(fù)責(zé)質(zhì)量計劃的執(zhí)行 , 組織實施現(xiàn)場質(zhì)量管理活動,組織對工程質(zhì)量的監(jiān)督及檢查。 anizing and ensuring the running of quality assurance system。 enterprise and inspection during the construction. 項目經(jīng)理 :項目經(jīng)理代表公司行使項目工程的管理權(quán)和指揮權(quán),對項目工程質(zhì)量負(fù)全責(zé),是項目工程質(zhì)量的第一責(zé)任人。 杭州 *****制藥新生產(chǎn)基地項目 目錄 1. Management Responsibility 管理者責(zé)任 …………………………… …… ………………… …… .…… (1) 2. Quality System 質(zhì)量系統(tǒng) …………………………………………… ………………………… ……… (4) 3. Contract Review 合同審核 ……………………………… ……………………………………… .…… (6) 4. Design Control 設(shè)計控制 ……………………………………………………………………… .… .(8) 5. Document and data control 文件和數(shù)據(jù)控制 …… ……………………………………………… ..(9) 6. Purchasing 采購 …………………………………………………………………………………… .(12) 7. Material Inspection, Acceptance and Reservation 材料驗收及保管 ………………………………… (15) 8. Materials’ Application and Management 材料使用管理 ……………………………………………… .(18) 9. Site Management of Material 材料現(xiàn)場管理 ……………………… …………………………………… (20) 10. Canceling after Material Verification and Dealing with Surplus Material 材料核銷與余料處理 ...… (21) 11. Owner Offers the Equipment Management 業(yè)主(總包方)提供設(shè)備的管理 ……………………… (22) 12. Product Identification and Traceability 產(chǎn)品識別和追蹤 …………………………………………… ....(24) 13. Process Control 過程控制 ………………………………………………………………………… .(25) 14. Compilation of Construction Schedule 施工進(jìn)度計劃的編制 ………………………………………… (26) 15. Implementation of the Construction Schedule 施工進(jìn)度計劃的實施 ……………………………… ...(30) 16. Control of Inspection, Measuring and Test Equipment 檢查,測量 amp。對參加本項目施工的職工進(jìn)行質(zhì)量管理教育,領(lǐng)導(dǎo)本項目施工的職工,貫徹執(zhí)行國家和企業(yè)頒發(fā)的保證工程質(zhì)量的規(guī)定、規(guī)程、制度和措施,并進(jìn)行檢查。 carrying out the construction procedure according to the Design Drawing, Standard, Specification and the approved process documents. The production Manager shall take the responsibility for the project quality. 生產(chǎn)經(jīng)理 : 生產(chǎn)經(jīng)理 在該項目上是項目經(jīng)理的助手,參與本工程質(zhì)量計劃的制訂,合理調(diào)配各種施工資源 ,按合同組織施工。質(zhì)量負(fù)責(zé)人向項目經(jīng)理和公司質(zhì)量管理部匯報工作,對工程質(zhì)量負(fù)直接責(zé)任。toll support **** 質(zhì)量監(jiān)督Quality Monitor 趙敬東 材料設(shè)備material amp。凡用于施工的原材料、半成品、構(gòu)配件、設(shè) 備等,必須 由 供應(yīng)部門或廠方提供的 相關(guān) 合格證明。 技術(shù)交底內(nèi)容應(yīng)包括:關(guān)鍵部位、質(zhì)量標(biāo)準(zhǔn)、 技術(shù)措施、 安全措施 、工藝要求 和主要部位 施工 等。技術(shù)文件和資料要經(jīng)各級技術(shù)負(fù)責(zé)人正式審定后才有效。 Project General Contract Management 施工項目總包合同管理 After signing the contract, the project department will carry out it, and before the implement, the pany’s operation department should do kickoff with the project department. 公司簽訂施工項目承包合同后,委托項目部履行合同。對合同履行應(yīng)進(jìn)行預(yù) 測,及早提出和解決影響合同履行的問題,以回避或減少風(fēng)險。 When plementing some agreement, the project department should finish the review work and do record according to relevant requirements. 新增 合同簽 訂時 ,項目部應(yīng)按 相關(guān) 要求,認(rèn)真完成合同項目的評審工作,做好評審記錄、評審報告。 Raise out some reasonable and verified design plan. 提出合理的優(yōu) 化的設(shè)計方案。 Fill the borrowing and lending list to well control the file procedures. 填制文件收發(fā)登記、借閱登記等臺帳,對文件的簽收、發(fā)放、 交辦 等程序進(jìn)行控制,及時做好文件與資料的歸檔管理。 For the documents related the confidential economy or technique, they should be performed in accordance with the confidential regulation of the pany. 對涉及到經(jīng)濟、技術(shù)等方面的機密文件、資料要嚴(yán)格按照公司有關(guān)保密規(guī)定執(zhí)行。 documents, guidance, letter, notice and meeting minutes from Jian Li。 Completion materials transmitted to pany from project department: 項目部移交到公司檔案科的竣工資料內(nèi)容 : Bidding not, project contract, construction anizational design, inspection materials for pletion, quality assessment certificate. 中標(biāo)通知 、 工程承包合同 、 施工組織設(shè)計 、 交工竣工驗收資料 、 質(zhì)量評定等級證書 。 采購 Purchasing should base on the construction drawing, construction anizational design, change design notice and construction budgeting and should be approved by relevant leaders. 材料采購要依據(jù)《施工圖》、《施工組織設(shè)計》、《設(shè)計變更通知單》和《施工圖預(yù)算》等要求報項目部有關(guān)領(lǐng)導(dǎo)審批后實施。包括物資名稱、規(guī)格型號、性能數(shù)量、技術(shù)參 數(shù)、執(zhí)行標(biāo)準(zhǔn)。 Bidding open, bidding evaluation and bidding assurance should be conducted and explained based on the bidding procedures. c. 按招投標(biāo)程序進(jìn)行開標(biāo)、評標(biāo), 投標(biāo)人對投標(biāo)文件進(jìn)行陳述解釋,并進(jìn)行答疑。 Feedback and Review of Proposal 回標(biāo)、開標(biāo) Proposal should be returned according to the limited time, and project department should fill the goods and materials purchasing table, if passing limited time, the proposal will not be accepted any more. Within 24hrs of the returning, all proposals should be reviewed with at least three department leaders present. The chargers will fill the summary table and department operator will sign signature. ,項目部同時填制《物資招標(biāo)采購登記表》,超過回標(biāo)時間仍未送達(dá)的標(biāo)書視為無效標(biāo)書,不再接收。 杭州 ****制藥新生產(chǎn)基地項目 15 Inspection, Acceptance and Reservation Inspection and acceptance o
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