品质人人共享.pptx

1、2nd Quality Business Leadership SummitQuality Owned by All,Eva Gallagher,VP Operations,MSDPadraig Keane,VP Operations,BMSTim Moore,Former CTO,EVP Operations,16-May-2025,Dublin,Ireland,1,2,Confusion Between quality&Quality,quality owned by Quality,quality owned by all,PRODUCT,ORGANIZATION,Unfortunate

2、 that the same word is used for both product(attribute)and organization,“quality is everybodys responsibility”Frank Hallinan,former CEO,HPRA,2nd Quality Business Leadership(QBL)Summit,Dublin,Ireland,16-May-2025,Examples,when quality is seen as owned by QualityQuality is policing Regulatory agencies

3、during inspections mostly speak with Quality leadersLeadership evaluates Qualitys performance based on compliance performance It is thus very important to clarify this misunderstanding where it existsQuality and Executive leadership both have responsibility to avoid thisQuality leadership must throu

4、gh actions demonstrate they do not take on the sole responsibility for quality,3,Clarify that quality is not owned by Quality alone,2nd Quality Business Leadership(QBL)Summit,Dublin,Ireland,16-May-2025,4,A Balancing Act in a Highly Regulated cGMP Environment,Developed by Holger Rathgeber,If only foc

5、used on this,It can lead to,So we must balance with,But too much can lead to.,Finding the right balance of these two is the goal,Padraig,2nd Quality Business Leadership(QBL)Summit,Dublin,Ireland,16-May-2025,5,Knows and respects need to ensure compliance and product quality Meets regularly with CQO/Q

6、uality Site HeadCommunicates importance of quality&cGMP complianceUnderstands the importance of the quality SYSTEMAttends Management ReviewEnsures Psychologically safe environment Company objectives include quality goalsDesired company culture is defined and clearCompany values align with patient ex