TR1-TR6產(chǎn)品開發(fā)各階段評(píng)審要素說明

3.產(chǎn)品開發(fā)各段評(píng)審要素說明本說明作為產(chǎn)品開發(fā)流程的支持性文件，闡述了產(chǎn)品開發(fā)過程中各評(píng)審階段的評(píng)審要素及對(duì)應(yīng)的文檔或交付物，同時(shí)也TR1TR1-1TR1-2TR1-3TR1-4TR1-5TR1-6TR1-7TR1-8TR1-9TR1-10TR1-11TR1-12TR1-13TR1-14TR1-15TR1-16TR1-17TR1-18TR1-19TR1-20TR1-21TR1-22TR1-23TR1-24TR1-25TR1-26TR1-27TR1-28TR1-29TR1-30TR1-31-1-2-3-4-5-6-7-8-9-10概念評(píng)審-11TR2TR2-1TR2-2評(píng)審要素(查核要點(diǎn))產(chǎn)品開發(fā)團(tuán)隊(duì)人員及職責(zé)確認(rèn)技術(shù)概念評(píng)審需求描述(產(chǎn)品定位)產(chǎn)品對(duì)應(yīng)的適應(yīng)癥的患者規(guī)模需求特點(diǎn)及創(chuàng)新性描述是否清楚需求的產(chǎn)品目標(biāo)(上市時(shí)間、市場(chǎng)需求、定價(jià)估算)需求的時(shí)效性(短期需求還是長(zhǎng)期需求)需求分析($APPEALS分析)求要素分析)產(chǎn)品設(shè)計(jì)參考的樣件分析產(chǎn)品概念設(shè)計(jì)的設(shè)計(jì)方案產(chǎn)品概念設(shè)計(jì)中的風(fēng)險(xiǎn)及應(yīng)對(duì)措施類產(chǎn)品注冊(cè)信息(如注冊(cè)的法律法規(guī)信息)注冊(cè)可行性及注冊(cè)方案(如需注冊(cè))注冊(cè)方面的法律法規(guī)風(fēng)險(xiǎn)和管理計(jì)劃專利可行性分析(包括專利避險(xiǎn)等)產(chǎn)品是否符合整體產(chǎn)品組合規(guī)劃競(jìng)爭(zhēng)對(duì)手和競(jìng)爭(zhēng)產(chǎn)品分析是否全面產(chǎn)品市場(chǎng)的綜合競(jìng)爭(zhēng)性分析風(fēng)險(xiǎn)分析和管理計(jì)劃產(chǎn)品是否滿足市場(chǎng)需求設(shè)計(jì)可實(shí)現(xiàn)性要求是否能夠滿足產(chǎn)品可靠性要求是否能夠滿足產(chǎn)品可測(cè)試性要求是否能夠滿足技術(shù)的風(fēng)險(xiǎn)分析管理計(jì)劃產(chǎn)品可制造性要求是否能夠滿足(從加工該產(chǎn)品的技術(shù)方加工成本和相關(guān)費(fèi)用的估算產(chǎn)該產(chǎn)品對(duì)環(huán)境的影響評(píng)價(jià)分析和管理計(jì)劃全方面風(fēng)險(xiǎn)分析及控制計(jì)劃風(fēng)險(xiǎn)管理負(fù)責(zé)人確認(rèn)對(duì)TR1評(píng)審結(jié)果的審查產(chǎn)品的相關(guān)介紹(如產(chǎn)品性能、產(chǎn)品標(biāo)準(zhǔn))是否明確涉及到的知識(shí)產(chǎn)權(quán)問題是否確定解決辦法能力確認(rèn)是否制定了切實(shí)可行的市場(chǎng)營(yíng)銷策略市場(chǎng)經(jīng)濟(jì)效益評(píng)估認(rèn)定是否識(shí)別了風(fēng)險(xiǎn)、制定了風(fēng)險(xiǎn)響應(yīng)計(jì)劃評(píng)審評(píng)審點(diǎn)對(duì)應(yīng)的文檔或交付物Phase0-1項(xiàng)目立項(xiàng)任務(wù)書Phase0-2產(chǎn)品開發(fā)任命書Phase0-3原始需求報(bào)告Phase0-4產(chǎn)品概念設(shè)計(jì)報(bào)告Phase0-5法規(guī)注冊(cè)評(píng)估報(bào)告Phase0-6專利評(píng)估報(bào)告Phase0-7競(jìng)爭(zhēng)性分析報(bào)告Phase0-8技術(shù)可行性評(píng)估報(bào)告Phase0-9生產(chǎn)可行性評(píng)估報(bào)告Phase0-10風(fēng)險(xiǎn)管理計(jì)劃TR1評(píng)審記錄Phase0-12商業(yè)評(píng)估報(bào)告Phase0-13立項(xiàng)書Phase0-5法規(guī)注冊(cè)評(píng)估報(bào)告 (更新)正天產(chǎn)品開發(fā)部人經(jīng)理IPMTIPMTIPMT經(jīng)理.TR1TR1-1TR1-2TR1-3TR1-4TR1-5TR1-6TR1-7TR1-8TR1-9TR1-10TR1-11TR1-12TR1-13TR1-14TR1-15TR1-16TR1-17TR1-18TR1-19TR1-20TR1-21TR1-22TR1-23TR1-24TR1-25TR1-26TR1-27TR1-28TR1-29TR1-30TR1-31-1-2-3-4-5-6-7-8-9-10概念評(píng)審-11TR2TR2-1TR2-2TR2-3TR2-4TR2-5TR2-6TR2-7TR2-8評(píng)審要素(查核要點(diǎn))評(píng)審點(diǎn)對(duì)應(yīng)的文檔或交付物Phase0-1項(xiàng)目立項(xiàng)任務(wù)書Phase0-2產(chǎn)品開發(fā)任命書產(chǎn)品開發(fā)團(tuán)隊(duì)人員及職責(zé)確認(rèn)技術(shù)概念評(píng)審需求描述(產(chǎn)品定位)產(chǎn)品對(duì)應(yīng)的適應(yīng)癥的患者規(guī)模需求特點(diǎn)及創(chuàng)新性描述是否清楚Phase0-3需求的產(chǎn)品目標(biāo)(上市時(shí)間、市場(chǎng)需求、定價(jià)估算)需求的時(shí)效性(短期需求還是長(zhǎng)期需求)需求分析($APPEALS分析)求要素分析)Phase0-4產(chǎn)品概念設(shè)計(jì)報(bào)告Phase0-4產(chǎn)品概念設(shè)計(jì)報(bào)告產(chǎn)品概念設(shè)計(jì)的設(shè)計(jì)方案產(chǎn)品概念設(shè)計(jì)中的風(fēng)險(xiǎn)及應(yīng)對(duì)措施類Phase0-5法規(guī)注冊(cè)評(píng)估報(bào)告經(jīng)理Phase0-5法規(guī)注冊(cè)評(píng)估報(bào)告經(jīng)理Phase0-6Phase0-6專利評(píng)估報(bào)告注冊(cè)方面的法律法規(guī)風(fēng)險(xiǎn)和管理計(jì)劃專利可行性分析(包括專利避險(xiǎn)等)PhasePhase0-7競(jìng)爭(zhēng)性分析報(bào)告競(jìng)爭(zhēng)對(duì)手和競(jìng)爭(zhēng)產(chǎn)品分析是否全面產(chǎn)品市場(chǎng)的綜合競(jìng)爭(zhēng)性分析風(fēng)險(xiǎn)分析和管理計(jì)劃產(chǎn)品是否滿足市場(chǎng)需求Phase0-8Phase0-8技術(shù)可行性評(píng)估報(bào)告產(chǎn)品可靠性要求是否能夠滿足產(chǎn)品可測(cè)試性要求是否能夠滿足技術(shù)的風(fēng)險(xiǎn)分析管理計(jì)劃產(chǎn)品可制造性要求是否能夠滿足(從加工該產(chǎn)品的技術(shù)方正天產(chǎn)品開發(fā)部正天產(chǎn)品開發(fā)部Phase0-9生產(chǎn)可行性評(píng)估報(bào)告Phase0-10風(fēng)險(xiǎn)管理計(jì)劃產(chǎn)該產(chǎn)品對(duì)環(huán)境的影響評(píng)價(jià)分析和管理計(jì)劃全方面風(fēng)險(xiǎn)分析及控制計(jì)劃風(fēng)險(xiǎn)管理負(fù)責(zé)人確認(rèn)TR1評(píng)審記錄IPMT對(duì)TR1評(píng)審記錄IPMT產(chǎn)品的相關(guān)介紹(如產(chǎn)品性能、產(chǎn)品標(biāo)準(zhǔn))是否明確涉及到的知識(shí)產(chǎn)權(quán)問題是否確定解決辦法Phase0-12商業(yè)評(píng)估報(bào)告Phase0-12商業(yè)評(píng)估報(bào)告IPMT能力確認(rèn)是否制定了切實(shí)可行的市場(chǎng)營(yíng)銷策略市場(chǎng)經(jīng)濟(jì)效益評(píng)估認(rèn)定Phase0-13立項(xiàng)書IPMTPhase0-13立項(xiàng)書IPMTPhase0-5法規(guī)注冊(cè)評(píng)估報(bào)告Phase0-5法規(guī)注冊(cè)評(píng)估報(bào)告 (更新)經(jīng)理評(píng)審產(chǎn)品型號(hào)設(shè)計(jì)及關(guān)鍵設(shè)計(jì)參數(shù)Phase1-Phase1-15規(guī)格分解報(bào)告料規(guī)格Phase1-16產(chǎn)品關(guān)鍵指標(biāo)及對(duì)應(yīng)的測(cè)試標(biāo)準(zhǔn)Phase1-16產(chǎn)品關(guān)鍵指標(biāo)及對(duì)應(yīng)的測(cè)試標(biāo)準(zhǔn)TR3TR3-1TRTR3TR3-1TR3-2TR3-3TR3-4TR3-5TR3-6TR3-7TR3-8計(jì)劃評(píng)審計(jì)劃評(píng)審-1計(jì)劃評(píng)審-2計(jì)劃評(píng)審-3計(jì)劃評(píng)審-4計(jì)劃評(píng)審-5TR4TR4-1TR4-2TR4-3TR4-4TR4-5TR4-6TR4-7TR4-8TR4-9各個(gè)工程要素整合能力的評(píng)審PhasePhase1-17總體開發(fā)計(jì)劃書Phase0-10Phase0-10風(fēng)險(xiǎn)管理計(jì)劃發(fā)周期風(fēng)險(xiǎn)評(píng)估險(xiǎn)設(shè)計(jì)需求，包裝需求和設(shè)計(jì)參數(shù)是否有風(fēng)險(xiǎn)控制計(jì)劃評(píng)審TR2評(píng)審記錄TR3TR2評(píng)審記錄TR3評(píng)審記錄Phase1-15規(guī)格分解報(bào)告 (更新)Phase0-12商業(yè)評(píng)估報(bào)告 (更新)Phase1-17總體開發(fā)計(jì)劃書 (更新)部門門部門IPMTIPMTIPMTTR3評(píng)審結(jié)果的審查規(guī)格對(duì)供應(yīng)鏈成本的影響評(píng)審IPMT資組合管理IPMTIPMT開發(fā)資源匹配的優(yōu)化IPMT設(shè)計(jì)成果評(píng)審理理理理質(zhì)量部經(jīng)理理理理理經(jīng)理Phase2-19設(shè)計(jì)關(guān)鍵尺寸和部件設(shè)計(jì)圖紙的審核設(shè)計(jì)變更歷史記錄是否完整工具、刀具、檢具、工裝的設(shè)計(jì)、審核開發(fā)部設(shè)計(jì)方案的工藝確認(rèn)Phase2-20樣品生產(chǎn)工藝Phase2-21樣品生產(chǎn)采購(gòu)計(jì)劃書工藝、重點(diǎn)、難點(diǎn)是否已解決生產(chǎn)計(jì)劃是否清晰明確、可行，包括采購(gòu)計(jì)劃(刀具等采購(gòu)計(jì)劃)Phase2-18TR4-10TR4-10TR4-11TR5TR5-1樣品詳細(xì)測(cè)試計(jì)劃樣品詳細(xì)測(cè)試計(jì)劃Phase2-22器械采購(gòu)申請(qǐng)表/委托加工單Phase2-23樣品加工意見反饋表樣品質(zhì)檢報(bào)告樣品測(cè)試評(píng)審收集工廠方面對(duì)樣品的加工意見開發(fā)部正天質(zhì)量TR5-2TR5-2TR5-3TR5-4TR5-5TR5-6TR5-7TR5-8部樣品測(cè)試報(bào)告用狀況批量試制任務(wù)確認(rèn)注冊(cè)計(jì)劃(需要注冊(cè)的產(chǎn)品)樣品測(cè)試報(bào)告用狀況批量試制任務(wù)確認(rèn)注冊(cè)計(jì)劃(需要注冊(cè)的產(chǎn)品)試制評(píng)審收集對(duì)批量試制的意見(包括產(chǎn)品和器械)批量試制質(zhì)量檢驗(yàn)結(jié)果樣品測(cè)試報(bào)告量試制訂單Phase0-5法規(guī)注冊(cè)評(píng)估報(bào)告 (更新)Phase2-24批量試制采購(gòu)計(jì)劃書TR5-9TR5-9TR6正天產(chǎn)品TR6-1Phase2-26TR6-1開發(fā)部正天質(zhì)量報(bào)告Phase2報(bào)告Phase2-27臨床評(píng)估報(bào)告TR6-2TR6-3TR6-4TR6-5TR6-6部Phase2-28財(cái)務(wù)部門項(xiàng)目成本核算表Phase2項(xiàng)目成本核算表Phase2-29量產(chǎn)生產(chǎn)工藝Phase2-30量產(chǎn)生產(chǎn)采購(gòu)計(jì)劃書Phase2-31植入物生產(chǎn)訂單Phase2-32器械采購(gòu)申請(qǐng)表TR4評(píng)審記錄批量生產(chǎn)的生產(chǎn)工藝量產(chǎn)計(jì)劃、外購(gòu)件采購(gòu)計(jì)劃量產(chǎn)確認(rèn)(包括器械和產(chǎn)品)批量生產(chǎn)的生產(chǎn)工藝量產(chǎn)計(jì)劃、外購(gòu)件采購(gòu)計(jì)劃量產(chǎn)確認(rèn)(包括器械和產(chǎn)品)TR6-7TR6-7TR6-8TR6-8TR4評(píng)TR4評(píng)審結(jié)果的審查IPMT.TR5評(píng)審結(jié)果的審查TR6評(píng)TR5評(píng)審結(jié)果的審查TR6評(píng)審結(jié)果的審查核算，收益評(píng)估市場(chǎng)營(yíng)銷戰(zhàn)略和營(yíng)銷策略計(jì)劃發(fā)布產(chǎn)品驗(yàn)收標(biāo)準(zhǔn)產(chǎn)品上市后跟蹤計(jì)劃產(chǎn)品文檔歸檔移交產(chǎn)品型號(hào)設(shè)計(jì)及關(guān)鍵設(shè)計(jì)參數(shù)料規(guī)格TR5評(píng)審記錄TR6評(píng)審記錄項(xiàng)目成本核算表(更新)Phase3-33結(jié)項(xiàng)報(bào)告IPMTIPMTIPMTIPMTPhase3-34新品市場(chǎng)推廣培訓(xùn)計(jì)劃IPMT發(fā)布評(píng)審-3發(fā)布評(píng)審-5發(fā)布評(píng)審-6發(fā)布評(píng)審-7發(fā)布評(píng)審-8發(fā)布評(píng)審-9IPMTTIPMTT發(fā)布評(píng)審-1012TR2-3TR2-4TR2-5TR2-6TR2-7TR2-8TR3TR3-1TR3-2TR3-3TR3-4TR3-5TR3-6TR3-7TR3-8計(jì)劃評(píng)審計(jì)劃評(píng)審-1計(jì)劃評(píng)審-2計(jì)劃評(píng)審-3計(jì)劃評(píng)審-4計(jì)劃評(píng)審-5TR4TR4-1TR4-2TR4-3TR4-4TR4-5TR4-6TR4-7TR4-8TR4-9Phase3-35產(chǎn)品標(biāo)準(zhǔn)Phase3-36銷售任務(wù)書Phase3-37產(chǎn)品上市跟蹤計(jì)劃Phase1-15規(guī)格分解報(bào)告Phase1-1Phase1-16產(chǎn)品關(guān)鍵指標(biāo)及對(duì)應(yīng)的測(cè)試標(biāo)準(zhǔn)各個(gè)工程要素整合能力的評(píng)審研發(fā)成本預(yù)算評(píng)審Phase1-Phase1-17總體開發(fā)計(jì)劃書Phase0-Phase0-10風(fēng)險(xiǎn)管理計(jì)劃發(fā)周期風(fēng)險(xiǎn)評(píng)估設(shè)計(jì)需求，包裝需求和設(shè)計(jì)參數(shù)是否有風(fēng)險(xiǎn)控制計(jì)劃評(píng)審TR2評(píng)審記錄TR3TR2評(píng)審記錄TR3評(píng)審記錄Phase1-15規(guī)格分解報(bào)告 (更新)Phase0-12商業(yè)評(píng)估報(bào)告 (更新)Phase1-17總體開發(fā)計(jì)劃書 (更新)部門門部門IPMTIPMTIPMTTR3評(píng)審結(jié)果的審查規(guī)格對(duì)供應(yīng)鏈成本的影響評(píng)審IPMT資組合管理IPMTIPMT開發(fā)資源匹配的優(yōu)化IPMT設(shè)計(jì)成果評(píng)審理理理理質(zhì)量部經(jīng)理理理理理Phase2-19設(shè)計(jì)關(guān)鍵尺寸和部件設(shè)計(jì)圖紙的審核設(shè)計(jì)變更歷史記錄是否完整工具、刀具、檢具、工裝的設(shè)計(jì)、審核開發(fā)部設(shè)計(jì)方案的工藝確認(rèn)Phase2-20樣品生產(chǎn)工藝Phase2-21樣品生產(chǎn)采購(gòu)計(jì)劃書生產(chǎn)計(jì)劃是否清晰明確、可行，包括采購(gòu)計(jì)劃(刀具等采購(gòu)計(jì)劃)Phase2-18TR4-10TR4-10TR4-11TR5TR5-1樣品詳細(xì)測(cè)試計(jì)劃樣品詳細(xì)測(cè)試計(jì)劃Phase2-22器械采購(gòu)申請(qǐng)表/委托加工單Phase2-23樣品加工意見反饋表樣品質(zhì)檢報(bào)告樣品測(cè)試評(píng)審收集工廠方面對(duì)樣品的加工意見開發(fā)部正天質(zhì)量TR5-2TR5-2TR5-3TR5-4TR5-5TR5-6部樣品測(cè)試報(bào)告用狀況樣品測(cè)試報(bào)告樣品測(cè)試報(bào)告用狀況樣品測(cè)試報(bào)告副經(jīng)理批量試制任務(wù)確認(rèn)注冊(cè)計(jì)劃(需要注冊(cè)的產(chǎn)品)批量試副經(jīng)理批量試制任務(wù)確認(rèn)注冊(cè)計(jì)劃(需要注冊(cè)的產(chǎn)品)批量試制計(jì)劃、采購(gòu)計(jì)劃確認(rèn)TR5-7TR5-8Phase0-5法規(guī)注冊(cè)評(píng)估報(bào)告 (更新)Phase2-24批量試制采購(gòu)計(jì)劃書TRPhase2-24批量試制采購(gòu)計(jì)劃書TR5-9TR6TR6-1試制評(píng)審質(zhì)量部經(jīng)理理Phase2-26批量試制意見反饋表檢報(bào)告Phase2-27臨床評(píng)估報(bào)告開發(fā)部正天質(zhì)量TR6TR6-2TR6-3TR6-4TR6-5部Phase2-28財(cái)務(wù)部門目成本核算表人目成本核算表.TR1TR1-1TR1-2TR1-3TR1-4TR1-5TR1-6TR1-7TR1-8TR1-9TR1-10TR1-11TR1-12TR1-13TR1-14TR1-15TR1-16TR1-17TR1-18TR1-19TR1-20TR1-21TR1-22TR1-23TR1-24TR1-25TR1-26TR1-27TR1-28TR1-29TR1-30TR1-31-1-2-3-4-5-6-7-8-9-10概念評(píng)審-11TR2TR2-1TR2-2TR2-3TR2-4TR2-5TR2-6TR2-7TR2-8評(píng)審要素(查核要點(diǎn))評(píng)審點(diǎn)對(duì)應(yīng)的文檔或交付物Phase0-1項(xiàng)目立項(xiàng)任務(wù)書Phase0-2產(chǎn)品開發(fā)任命書產(chǎn)品開發(fā)團(tuán)隊(duì)人員及職責(zé)確認(rèn)技術(shù)概念評(píng)審需求描述(產(chǎn)品定位)產(chǎn)品對(duì)應(yīng)的適應(yīng)癥的患者規(guī)模需求特點(diǎn)及創(chuàng)新性描述是否清楚Phase0-3需求的產(chǎn)品目標(biāo)(上市時(shí)間、市場(chǎng)需求、定價(jià)估算)需求的時(shí)效性(短期需求還是長(zhǎng)期需求)需求分析($APPEALS分析)求要素分析)Phase0-4產(chǎn)品概念設(shè)計(jì)報(bào)告Phase0-4產(chǎn)品概念設(shè)計(jì)報(bào)告產(chǎn)品概念設(shè)計(jì)的設(shè)計(jì)方案產(chǎn)品概念設(shè)計(jì)中的風(fēng)險(xiǎn)及應(yīng)對(duì)措施類Phase0-5法規(guī)注冊(cè)評(píng)估報(bào)告經(jīng)理Phase0-5法規(guī)注冊(cè)評(píng)估報(bào)告經(jīng)理Phase0-6Phase0-6專利評(píng)估報(bào)告注冊(cè)方面的法律法規(guī)風(fēng)險(xiǎn)和管理計(jì)劃專利可行性分析(包括專利避險(xiǎn)等)PhasePhase0-7競(jìng)爭(zhēng)性分析報(bào)告競(jìng)爭(zhēng)對(duì)手和競(jìng)爭(zhēng)產(chǎn)品分析是否全面產(chǎn)品市場(chǎng)的綜合競(jìng)爭(zhēng)性分析風(fēng)險(xiǎn)分析和管理計(jì)劃產(chǎn)品是否滿足市場(chǎng)需求Phase0-8Phase0-8技術(shù)可行性評(píng)估報(bào)告產(chǎn)品可靠性要求是否能夠滿足產(chǎn)品可測(cè)試性要求是否能夠滿足技術(shù)的風(fēng)險(xiǎn)分析管理計(jì)劃產(chǎn)品可制造性要求是否能夠滿足(從加工該產(chǎn)品的技術(shù)方正天產(chǎn)品開發(fā)部正天產(chǎn)品開發(fā)部Phase0-9生產(chǎn)可行性評(píng)估報(bào)告Phase0-10風(fēng)險(xiǎn)管理計(jì)劃產(chǎn)該產(chǎn)品對(duì)環(huán)境的影響評(píng)價(jià)分析和管理計(jì)劃全方面風(fēng)險(xiǎn)分析及控制計(jì)劃風(fēng)險(xiǎn)管理負(fù)責(zé)人確認(rèn)TR1評(píng)審記錄IPMT對(duì)TR1評(píng)審記錄IPMT產(chǎn)品的相關(guān)介紹(如產(chǎn)品性能、產(chǎn)品標(biāo)準(zhǔn))是否明確涉及到的知識(shí)產(chǎn)權(quán)問題是否確定解決辦法Phase0-12商業(yè)評(píng)估報(bào)告Phase0-12商業(yè)評(píng)估報(bào)告IPMT能力確認(rèn)是否制定了切實(shí)可行的市場(chǎng)營(yíng)銷策略市場(chǎng)經(jīng)濟(jì)效益評(píng)估認(rèn)定Phase0-13立項(xiàng)書IPMTPhase0-13立項(xiàng)書IPMTPhase0-5法規(guī)注冊(cè)評(píng)估報(bào)告Phase0-5法規(guī)注冊(cè)評(píng)估報(bào)告 (更新)經(jīng)理評(píng)審產(chǎn)品型號(hào)設(shè)計(jì)及關(guān)鍵設(shè)計(jì)參數(shù)Phase1-Phase1-15規(guī)格分解報(bào)告料規(guī)格Phase1-16產(chǎn)品關(guān)鍵指標(biāo)及對(duì)應(yīng)的測(cè)試標(biāo)準(zhǔn)Phase1-16產(chǎn)品關(guān)鍵指標(biāo)及對(duì)應(yīng)的測(cè)試標(biāo)準(zhǔn)TR3TR3-1TRTR3TR3-1TR3-2TR3-3TR3-4TR3-5TR3-6TR3-7TR3-8計(jì)劃評(píng)審計(jì)劃評(píng)審-1計(jì)劃評(píng)審-2計(jì)劃評(píng)審-3計(jì)劃評(píng)審-4計(jì)劃評(píng)審-5TR4TR4-1TR4-2TR4-3TR4-4TR4-5TR4-6TR4-7TR4-8TR4-9各個(gè)工程要素整合能力的評(píng)審PhasePhase1-17總體開發(fā)計(jì)劃書Phase0-10Phase0-10風(fēng)險(xiǎn)管理計(jì)劃發(fā)周期風(fēng)險(xiǎn)評(píng)估險(xiǎn)設(shè)計(jì)需求，包裝需求和設(shè)計(jì)參數(shù)是否有風(fēng)險(xiǎn)控制計(jì)劃評(píng)審TR2評(píng)審記錄TR3TR2評(píng)審記錄TR3評(píng)審記錄Phase1-15規(guī)格分解報(bào)告 (更新)Phase0-12商業(yè)評(píng)估報(bào)告 (更新)Phase1-17總體開發(fā)計(jì)劃書 (更新)部門門部門IPMTIPMTIPMTTR3評(píng)審結(jié)果的審查規(guī)格對(duì)供應(yīng)鏈成本的影響評(píng)審IPMT資組合管理IPMTIPMT開發(fā)資源匹配的優(yōu)化IPMT設(shè)計(jì)成果評(píng)審理理理理質(zhì)量部經(jīng)理理理理理經(jīng)理Phase2-19設(shè)計(jì)關(guān)鍵尺寸和部件設(shè)計(jì)圖紙的審核設(shè)計(jì)變更歷史記錄是否完整工具、刀具、檢具、工裝的設(shè)計(jì)、審核開發(fā)部設(shè)計(jì)方案的工藝確認(rèn)Phase2-20樣品生產(chǎn)工藝Phase2-21樣品生產(chǎn)采購(gòu)計(jì)劃書工藝、重點(diǎn)、難點(diǎn)是否已解決生產(chǎn)計(jì)劃是否清晰明確、可行，包括采購(gòu)計(jì)劃(刀具等采購(gòu)計(jì)劃)Phase2-18TR4-10TR4-10TR4-11TR5TR5-1樣品詳細(xì)測(cè)試計(jì)劃樣品詳細(xì)測(cè)試計(jì)劃Phase2-22器械采購(gòu)申請(qǐng)表/委托加工單Phase2-23樣品加工意見反饋表樣品質(zhì)檢報(bào)告樣品測(cè)試評(píng)審收集工廠方面對(duì)樣品的加工意見開發(fā)部正天質(zhì)量TR5-2TR5-2TR5-3TR5-4TR5-5TR5-6TR5-7TR5-8部樣品測(cè)試報(bào)告用狀況批量試制任務(wù)確認(rèn)注冊(cè)計(jì)劃(需要注冊(cè)的產(chǎn)品)樣品測(cè)試報(bào)告用狀況批量試制任務(wù)確認(rèn)注冊(cè)計(jì)劃(需要注冊(cè)的產(chǎn)品)試制評(píng)審收集對(duì)批量試制的意見(包括產(chǎn)品和器械)批量試制質(zhì)量檢驗(yàn)結(jié)果樣品測(cè)試報(bào)告量試制訂單Phase0-5法規(guī)注冊(cè)評(píng)估報(bào)告 (更新)Phase2-24批量試制采購(gòu)計(jì)劃書TR5-9TR5-9TR6正天產(chǎn)品TR6-1Phase2-26TR6-1開發(fā)部正天質(zhì)量報(bào)告Phase2報(bào)告Phase2-27臨床評(píng)估報(bào)告TR6-2TR6-3TR6-4TR6-5TR6-6部Phase2-28財(cái)務(wù)部門目成本核算表Phase目成本核算表Phase2-29量產(chǎn)生產(chǎn)工藝Phase2-30量產(chǎn)生產(chǎn)采購(gòu)計(jì)劃書Phase2-31植入物生產(chǎn)訂單Phase2-32器械采購(gòu)申請(qǐng)表