項(xiàng)目中精益驗(yàn)證方法的運(yùn)用課件

1、Lean Validation Approach in Project項(xiàng)目中精益驗(yàn)證方法的運(yùn)用Contents主要內(nèi)容From C&Qapproach to Validation從調(diào)試&確認(rèn)到驗(yàn)證Case StudySet up lean Validation Management System案例探討構(gòu)建精益驗(yàn)證管理體系Case Study Lean Validation Activities in Project案例探討項(xiàng)目中精益驗(yàn)證活動(dòng)Contents主要內(nèi)容From C&Qapproach to Validation從調(diào)試&確認(rèn)到驗(yàn)證Case StudySet up lean Vali

2、dation Management System案例探討構(gòu)建精益驗(yàn)證管理體系Case Study Lean Validation Activities in Project案例探討項(xiàng)目中精益驗(yàn)證活動(dòng)PQ性能確認(rèn)PQ Test Plan測(cè)試計(jì)劃URS用戶需求OQ Test Plan測(cè)試計(jì)劃OQ運(yùn)行確認(rèn)IQ安裝確認(rèn)IQ Test Plan測(cè)試計(jì)劃Implement執(zhí)行Detail Design詳細(xì)設(shè)計(jì)Function Design功能設(shè)計(jì)Validation Mode -ISPE “V” Mode驗(yàn)證模式-ISPE“V”型確認(rèn)模式Validation Mode- ASTM E2500 Mode驗(yàn)證

3、模式-ASTM E2500 模式用戶需求需求文件需求鑒別關(guān)鍵系統(tǒng)測(cè)試完工報(bào)告影響因素評(píng)估調(diào)試IOQ項(xiàng)目調(diào)試 計(jì)劃完工IOQ報(bào)告確認(rèn)測(cè)試確認(rèn)矩陣 設(shè)計(jì)復(fù)核系統(tǒng)接受 報(bào)告放行設(shè)計(jì)基礎(chǔ)僅注重產(chǎn)品/工藝/法規(guī)/項(xiàng)目質(zhì)量戰(zhàn)略要求用戶和其他要求的工程文 件（如EHS)各系統(tǒng)應(yīng)有單獨(dú)完工報(bào)告測(cè)試是單一的GEP活動(dòng) 包 括 調(diào) 試 ， SAT/FAT/IOQ確認(rèn)質(zhì)量戰(zhàn)略：基于需求文件 的科學(xué)/風(fēng)險(xiǎn)導(dǎo)向流程及設(shè)計(jì)復(fù)核Validation Mode- ASTM E2500 Mode驗(yàn)證模式-ASTM E2500 模式URSRequirement DocumentRequirementsIdentification

4、 of Critical AspectsTestingClose-out ReportsImpact AssessmentCommissioningIOQPCQPIOQClose-out ReportVerification TestingVQS Matrix &Design ReviewSystem Acceptance & release reportDesign BasisFocused on product/processand regulatory/ PQS requirements onlyEngineering Document foruser and other require

5、ments (i.e.EHS)Single close-out report for systemTesting is a single GEPactivity- covering Commissioning, SAT/FAT/IOQVerification Quality Strategy:Science/Risk based approach based on requirement document and design reviewThe Old Way(1)傳統(tǒng)方法一Identification of requirements: 確定要求Company Quality 公司質(zhì)量Reg

6、ulatory considerations 法規(guī)考量Product 產(chǎn)品Process 工藝Design 設(shè)計(jì)Verification (C&Q) 確認(rèn)Acceptance & Release 驗(yàn)收和放行The Old Way(2)傳統(tǒng)方法二Documentation focused 專注于文件Late involvement of Quality Assurance質(zhì)量保證參與過晚Poor Scope definition定義范圍差Poor Commissioning definition and programs調(diào)試定義和程序差Responsibility overlap of proj

7、ect disciplines項(xiàng)目專業(yè)重疊責(zé)任The Old Way (3)傳統(tǒng)方法三DQIQOQDQIQOQPQProject StartProject StartRISK風(fēng)險(xiǎn)EFFORT努力PQPatient + ProductPatient + ProductWhy?為什么？Potential to simplify the process 工藝的潛在簡化Reduce time to deliver validation 減少驗(yàn)證時(shí)間Potential to reduce project validation costs 減少驗(yàn)證成本Successful audit 成功審核Effici

8、ency 效率What is Lean Validation (1)?什么是精益驗(yàn)證？Fundamentally, the key to successful verification by LeanValidation is a clear Quality Risk Management approach從根本上說精益驗(yàn)證的成功關(guān)鍵是一種質(zhì)量風(fēng)險(xiǎn)管理的方法。Involves the identification of critical aspects of manufacturing systems包括確定生產(chǎn)系統(tǒng)關(guān)鍵方面Science, and risk based approach科學(xué)，

9、基于風(fēng)險(xiǎn)的方法Quality integrated at the design stage設(shè)計(jì)階段的質(zhì)量整合Allows improved use of vendor documentation允許使用改進(jìn)的供應(yīng)商文件What is Lean Validation (2)?什么是精益驗(yàn)證？An approach that matches the level of detail for documentation tothe risk to patient safety and product quality一種能夠滿足病人安全和產(chǎn)品質(zhì)量的詳細(xì)文檔記錄的方法Allows flexibility

10、in changes up to final acceptance of the system允許系統(tǒng)最終驗(yàn)收的靈活性Up to acceptance, implementation is by Good Engineering Practice (GEP)直到驗(yàn)收，始終實(shí)施GEPAfter acceptance, GMP related changes are by Quality Assurance驗(yàn)收后，由QA部門決定GMP相關(guān)變化But.但Relies heavily on Good Engineering Practices (GEP)高度依靠GEPRequires fundamen

11、tal quality assurance of robust and well documented procedures for: 需要健全和完備記錄的質(zhì)量保障Engineering 設(shè)計(jì)Construction 施工Testing 測(cè)試Good Document Practices (GDP)Importance of Requirements Traceability Matrix (RTM)可追溯系統(tǒng)的重要性Additional effort at the outset前端的努力Verification TestingComparison比較CurrentASTM E2500Desi

12、gn DevelopmentEnhanced DesignReviewProcess ValidationCommissioningPQIQ & OQEngineering Change ManagementQA Change ControlDesign DevelopmentDesign ReviewProcessValidationEngineering Change ManagementQA Change ControlPerformance TestingRisk Mitigation of Critical Control ParaPTCurrent Standards v New

13、Standards現(xiàn)行標(biāo)準(zhǔn)和新標(biāo)準(zhǔn)Traditional Validation Design InputsImpact AssessmentDesign Qualification Commissioning Multiple Trial Runs to Get Things RightIQ, OQ, PQ and AcceptanceCriteria GEP scope and QA scope overlappedFocused on DocumentationDeliverablesRigid Change ManagementASTM E2500Design InputsDesign

14、ReviewRisk Mitigation Critical Control Parameters Define Acceptance Criteria Verification Testing Performance Testing GEP scope and QA scope have clear boundary Process, Product Quality and Patient Safety Quality by Design, Design Spaceand Continuous ImprovementThe New Way:新方法The new way: 新方法Verific

15、ation focus based on science and riskthrough Process User requirements確認(rèn)活動(dòng)注重基于科學(xué)和風(fēng)險(xiǎn)管理的工藝用戶要求Risk Assessment confirms appropriate risk mitigation measures identified, used through the lifecycle貫穿整個(gè)項(xiàng)目周期的風(fēng)險(xiǎn)評(píng)估以確認(rèn)規(guī)避風(fēng)險(xiǎn)的考量Project is Right First Time and C&Q is streamlined under the ASTM guidance項(xiàng)目是基于首次即正確和

16、調(diào)試和確認(rèn)是按照ASTM規(guī)定執(zhí)行的How?如何做？True Risk Assessment風(fēng)險(xiǎn)評(píng)估Failure mode analysis 故障失效模式分析Life cycle approach 生命周期方法Clear user requirement 明確用戶要求Empowerment授權(quán)Quality by Design 質(zhì)量源于設(shè)計(jì)Empower vendors & contractors 授權(quán)供應(yīng)商和承包商Good engineering practice 良好設(shè)計(jì)規(guī)范Science based approach 科學(xué)方法Demonstrate an improved underst

17、anding of the process and the trulykey critical parameters 證明一個(gè)改進(jìn)的工藝?yán)斫夂驼嬲年P(guān)鍵指標(biāo)Focus on those parameters throughout the lifecycle 在整個(gè)生命周期中注重那些指標(biāo)Streamline the validation process 合理化驗(yàn)證工藝Timeline reduction 節(jié)省時(shí)間and potential to reduce cost并且減少成本In summary:總結(jié):Contents主要內(nèi)容From C&Qapproach to Validation從調(diào)試

18、&確認(rèn)到驗(yàn)證Case StudySet up lean Validation Management System案例探討構(gòu)建精益驗(yàn)證管理體系Case Study Lean Validation Activities in Project案例探討項(xiàng)目中精益驗(yàn)證活動(dòng)Organize Project Lean Validation Team組建項(xiàng)目精益驗(yàn)證團(tuán)隊(duì)Applicabilityof Quality management system質(zhì)量管理體系的適用性O(shè)rg. of Lean Validation Team項(xiàng)目精益驗(yàn)證團(tuán)隊(duì)的組織架構(gòu)Responsibility of Lean Validat

19、ion Team項(xiàng)目精益驗(yàn)證團(tuán)隊(duì)的職責(zé)基于質(zhì)量管理體系的驗(yàn)證管理體系（1）Input of Client Quality Management Proedures質(zhì)量管理體系管理規(guī)程的導(dǎo)入Good Documentation Practice良好文件規(guī)范Deviation Management偏差管理Change Control變更管理Risk Management風(fēng)險(xiǎn)管理Validation Management 驗(yàn)證管理Supplier Management供應(yīng)商管理Notification Management通報(bào)管理Process Validation 工藝驗(yàn)證基于質(zhì)量管理體系的驗(yàn)證管

20、理體系（2）Set up Lean Validation System構(gòu)建精益驗(yàn)證管理體系Validation management for GMP project GMP項(xiàng)目的驗(yàn)證管理URS Standardization 需求的規(guī)范化Validation Planning 驗(yàn)證計(jì)劃Impact Assessment & Risk Analysis影響評(píng)估及風(fēng)險(xiǎn)分析Select supplier and audit供應(yīng)商的選擇與評(píng)估Project Based Deviation Management 項(xiàng)目驗(yàn)證偏差的處理Project Based Change Control項(xiàng)目變更的控制Un

21、itive Validation Template統(tǒng)一的驗(yàn)證模版SOP_Impact Assesment_C_V01.pdfSOP_User Requirement Specification_C_V01.pdfSOP_Validation Planning_C_V01.pdfKey to Success成功的關(guān)鍵Risk Based Validation Approach 基于風(fēng)險(xiǎn)的驗(yàn)證理念Science-Based Approach科學(xué)的方法Leadship 領(lǐng)導(dǎo)作用Subject Matter Expert (SME)領(lǐng)域工程師Critical Aspects of Manufactur

22、ing SystemsQuality by Design (QBD)Good Engineering Practice (GEP)Vendor DocumentationContinuous Process ImprovementContents主要內(nèi)容From C&Qapproach to Validation從調(diào)試&確認(rèn)到驗(yàn)證Case StudySet up lean Validation Management System案例探討構(gòu)建精益驗(yàn)證管理體系Case Study Lean Validation Activities in Project案例探討項(xiàng)目中精益驗(yàn)證活動(dòng)URS Devel

23、opment用戶需求的完善SME early involvement領(lǐng)域工程師的早期介入Supplier cooperation 與供方的合作Standardize URS documentation標(biāo)準(zhǔn)化的用戶需求文件項(xiàng)目URS.pdf項(xiàng)目URS_New.pdf干熱滅菌柜URS_10.pdf干熱滅菌柜URS_12.pdfImpact Assessment & Risk Analysis影響評(píng)估和風(fēng)險(xiǎn)分析Occasion for Impact Assessment影響因素評(píng)估的時(shí)機(jī)Occasion for Risk Analysis風(fēng)險(xiǎn)分析的時(shí)機(jī)Difference 兩者的側(cè)重點(diǎn)Templat

24、e_Risk Analysis Chart_C_V01.pdfTemplate_System Impact Assessment Chart_C_V01.pdfValidation Master Plan驗(yàn)證主計(jì)劃VMP focus on 主要討論以下幾個(gè)方面的內(nèi)容：Define Validation Scope based on impact assessment驗(yàn)證范圍的確定：基于影響因素評(píng)估結(jié)論Define Responsibility驗(yàn)證各方職責(zé)的劃分Define Validation Strategy: detailed from CD phase驗(yàn)證策略的確定：CD階段的驗(yàn)證策略的

25、深化Validation Sequence and rough schedule驗(yàn)證的順序及大致的進(jìn)度Description of key process and Technical關(guān)關(guān)鍵工藝及技術(shù)的簡要描述Description of key validation activities各項(xiàng)驗(yàn)證活動(dòng)的大致描述VMP_M.pdfTemp_MWZ_VMP.pdfDesign Qualification設(shè)計(jì)確認(rèn)DQ Mainly focus on 設(shè)計(jì)確認(rèn)的主要內(nèi)容：Responsibility definition參與確認(rèn)各方的職責(zé)界定Define applicable qualification

26、 principle and procedure適用于確認(rèn)的原則及規(guī)程System applicable checklist基于系統(tǒng)的檢查表Compliance review on design input and output設(shè)計(jì)輸入和輸出的符合性檢查Risk Analysis風(fēng)險(xiǎn)分析Conclusion結(jié)論Template_DQ_HVAC_TX.pdfFAT/SAT/Commissioning出廠/現(xiàn)場接受測(cè)試/調(diào)試FAT/SAT/Commissioning is GEP activities, validation team mainly focus on系純工程類活動(dòng)，驗(yàn)證團(tuán)隊(duì)的工作重點(diǎn)體現(xiàn)在以下幾個(gè)方面：Ensure Validation requirements have been considered in these plans審核計(jì)劃的可實(shí)施性，確保驗(yàn)證要求得到體現(xiàn)Execution personnel must be trained and qualified實(shí)施人員的資質(zhì)應(yīng)符合驗(yàn)證要求Witness to avoid duplicate work全程見證此類活動(dòng)以避免重復(fù)性執(zhí)行Integrity文件記錄的真實(shí)性、有效性、完