ComplianceOnline, Online Event
2013-02-12
Why Should You Attend: Appropriate, reliable, measurable and accurate metrics are the guiding principles for successful CAPA activities. The Lean Six Sigma approach provides a systematic way to define useful and meaningful effectiveness metrics. This webinar will focus on the application of the LSS methodology to the CAPA and Risk Management processes at Drug and Device manufacturing companies. It will provide specific industry case studies of how organizations have successfully used the methodology to define an appropriate problem statement following the SMART principles (Specific, Measurable, Attainable, Relevant &Time-Bound), define Critical-to-Quality (CTQ) measures that have failed to meet customer requirements, develop metrics that best gauge the performance of the CTQ, and measure current process performance/capability. All these elements will provide the required foundation to ensuring successful root cause investigation & effectiveness of solution. Areas Covered in the Webinar: - Overview of Lean Six Sigma (LSS) Methodology
- How LSS fits into the CAPA & Risk Management framework
- Definition of robust problem statements using SMART principles
- Definition of Critical-to-Quality (CTQ) – needed for development of metrics
- Examples of accurate, measurable, relevant metrics
- Measurement of process capability
|
|