ECA-确认与验证有效资格认证指南。Qualification and Validation, A guide to effective qualification... v3.0 2(2).pdfVIP

QualificationandValidation,Aguidetoeffectivequalificationbasedon

Customer-SupplierPartnership,v3.0,2024

ValidationGroup

验证组

GoodPracticeGuide

良好实践指南

QualificationandValidation

确认和验证

AguidetoeffectivequalificationbasedonCustomer-

SupplierPartnership

基于客户-供应商合作的有效确认指南

AguidancedocumentbytheECAFoundation

Version3.0,November2024

@Clear1/123

QualificationandValidation,Aguidetoeffectivequalificationbasedon

Customer-SupplierPartnership,v3.0,2024

TableofContents

目录

1Introduction介绍4

2ScopeofthisGuide本指南的范围8

3OutlineoftheApproach方法概述9

3.1Introduction介绍9

3.2CooperationbetweenCustomerandSupplier客户与供应商之间的合作10

3.3RiskManagementintheProject项目中的风险管理13

3.4RolesandResponsibilities角色和职责14

4EssentialJointActivities重要的联合活动15

4.1Overview概述15

4.2ContractingManufacturingSystemQualificationbySuppliers供应商承包制造系统确认..17

5CustomerActivities客户活动18

5.1Introduction介绍18

5.2UserRequirementSpecification用户需求规范20

5.3SupplierAssessment供应商评估20

5.4QualityRiskAssessmentandCriticalAspects质量风险评估和关键方面21

5.5CriticalAspectsRiskManagement关键方面风险管理23

5.6VerificationandQualification确证和确认26

5.7IntegrationTesting集成测试27

5.8SystemAcceptanceandReleaseReport系统验收和放行报告27

5.9ProcessValidation工艺验证27

6SupplierActivities供应商活动31

6.1Introduction介绍31

6.2AgreedURSandProjectQualityPlan(PQP)商定的URS和项目质量计划（PQP）32

6.3ChangeManagement变更管理32

6.4DeviationManagement