质量在运营准备和卓越运营中的作用.pptx

1、The Role of Quality in Operational Readiness&Operational Excellence,Alice RedmondChief Strategy Officer,CAIR|16 May 2025,AGENDA,A Tale of 2 Start-UpsIndustry Benchmark perspectivesOE Digital tools The Future the Six Pillars of ORQ&A,A TALE OF TWO STARTUPS,Case study A-unresolved risks and issues rem

2、ain after start up leading to delays and disruptive launch,Case study B-Risks are identified and addressed prior to the startup leading to an accelerated and successful launch,A TALE OF TWO STARTUPS-THE REALITY!,Large CAPEX projects Engineering Led OR and Project schedule didnt coexistDisconnect bet

3、ween projects and sustaining operations Corporate and Local divergenceQA inputs were part-timeLack of clarity where QA needs to input Project Regulatory basis-GMP statementProject and Process Risk assessment Stage gate cGMP reviews and Design reviewsBuilding of GEP systems to support GMP and PQS eff

4、ectiveness,Case study A-unresolved risks and issues remain after start up leading to delays and disruptive launch,OPERATIONAL READINESS FRAMEWORK,Six Pillars of Readiness:The framework was built on six interconnected pillars:Process Integration,Equipment&Facility Readiness,Workforce Capability,Quali

5、ty System Alignment,Digital&Data Enablement and Operational Delivery Assurance.Unified Approach-End to end execution Outcome-Focused Design:The framework planned to achieving measurable outcomes such as Day One throughput,compliance and sustainable operationsnot just task completion.Cultural Transfo

6、rmation:It fosters accountability,ownership and cross-functional collaboration to ensure readiness becomes a sustainable capability rather than a one-time project.Roadmap and Maturity Model:The phased roadmap and maturity model guided the organizations through readiness stagesfrom reactive to optimi