项目中精益验证方法的运用

Requirements
URS
Engineering Document for user and other requirements (i.e.EHS)
Verification Qualiy Strategy: Science/Risk based approach based on requirement document and design review Testing is a single GEP activity- covering Commissioning, SAT/FAT/IOQ

The Old Way(2)… 传统方法二

Documentation focused 专注于文件 Late involvement of Quality Assurance 质量保证参与过晚


Poor Scope definition定义范围差
Poor Commissioning definition and programs调试定义和程序差 Responsibility overlap of project disciplines 项目专业重叠责任
Single close-out report for system
The Old Way(1)… 传统方法一

Identification of requirements: 确定要求 - Company Quality 公司质量 - Regulatory considerations 法规考量 - Product 产品 - Process 工艺 Design 设计 Verification (C&Q) 确认 Acceptance & Release 验收和放行
What is Lean Validation (1)? 什么是精益验证？

Fundamentally, the key to successful verification by Lean Validation is a clear Quality Risk Management approach 从根本上说精益验证的成功关键是一种质量风险管理的方法。 Involves the identification of critical aspects of manufacturing systems 包括确定生产系统关键方面 Science, and risk based approach 科学，基于风险的方法 Quality integrated at the design stage 设计阶段的质量整合 Allows improved use of vendor documentation 允许使用改进的供应商文件




What is Lean Validation (2)? 什么是精益验证？

An approach that matches the level of detail for documentation to the risk to patient safety and product quality 一种能够满足病人安全和产品质量的详细文档记录的方法 Allows flexibility in changes up to final acceptance of the system 允许系统最终验收的灵活性 Up to acceptance, implementation is by Good Engineering Practice (GEP) 直到验收，始终实施GEP After acceptance, GMP related changes are by Quality Assurance 验收后，由QA部门决定GMP相关变化

Current
Commissioning PQ
Process Validation
Engineering Change Management Risk Mitigation of Critical Control Para
QA Change Control
ASTM – E2500
Design Development Design Review
Verification Testing
PT
Process Validation
Performance Testing
Current Standards v New Standards 现行标准和新标准
Traditional Validation – Design Inputs – Impact Assessment – Design Qualification – Commissioning – Multiple Trial Runs to Get Things Right – IQ, OQ, PQ and Acceptance Criteria – GEP scope and QA scope overlapped – Focused on Documentation Deliverables – Rigid Change Management ASTM E2500 – Design Inputs – Design Review – Risk 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 Space and Continuous Improvement
PQ 性能确认
Function Design 功能设计
OQ Test Plan测试计划
OQ 运行确认
Detail Design 详细设计
IQ Test Plan
测试计划
IQ 安装确认
Implement 执行
Validation Mode- ASTM E2500 Mode 验证模式-ASTM E2500 模式
需求文件 需求 用户需求
仅注重产品/工艺/法规/项 目质量战略要求
设计基础
鉴别关键系统
用户和其他要求的工程文 件（如EHS)
影响因素评估
确认矩阵 设计复核
确认质量战略：基于需求文件 的科学/风险导向流程 及设计复核
测试
调试 IOQ
确认测试
测试是单一的GEP活动 包括调试， SAT/FAT/IOQ
完工报告
案例探讨——构建精益验证管理体系

Case Study ——Lean Validation Activities in Project 案例探讨——项目中精益验证活动
Contents 主要内容

From C&Q approach to Validation 从调试&确认到验证 Case Study——Set up lean Validation Management System
mitigation measures identified, used through the lifecycle
贯穿整个项目周期的风险评估以确认规避风险的考量
Project is Right First Time and C&Q is streamlined under the ASTM guidance

The Old Way (3) 传统方法三
Project Start Project Start
RISK 风险
DQ
EFFORT 努力
DQ IQ
IQ
OQ
PQ
Patient + Product
OQ
PQ
Patient + Product
Why? 为什么？

Potential to simplify the process 工艺的潜在简化 Reduce time to deliver validation 减少验证时间 Potential to reduce project validation costs 减少验证成本 Successful audit 成功审核 Efficiency 效率
Importance
of Requirements Traceability Matrix (RTM) 可追溯系统的重要性 Additional effort at the outset 前端的努力
Comparison 比较
Engineering Change Management QA Change Control Design Development Enhanced Design Review IQ & OQ
项目是基于首次即正确和调试和确认是按照ASTM规
定执行的
How? 如何做？
1.
True Risk Assessment风险评估 Failure mode analysis 故障失效模式分析 Life cycle approach 生命周期方法 Clear user requirement 明确用户要求 Empowerment授权 Quality by Design 质量源于设计 Empower vendors & contractors 授权供应商和承包商 Good engineering practice 良好设计规范 Science based approach 科学方法
Impact Assessment
VQS Matrix &Design Review
Testing
Commissioning