《Process烫apability燤easurement》.pdfVIP

P8: Pharmaceutical Quality System Elements: Process Performance and Product Quality Monitoring System By Lynn Torbeck Case Study: Use of Statistical Process  Control to Detect Process Drift; Using  Process Capability Measurement Lynn Torbeck Statistician Overview of Talk • Define SQC, SPC • State of control • Process capability – Statistical Tolerance Intervals – Cpk • Trending and drift • Case Study 2 Statistical Quality Control, SQC • Specific statistical techniques used for end  product quality control including data  tabulation, probability, basic statistics,  statistical sampling plans and reporting of  defects, rejects and costs. 3 P8: Pharmaceutical Quality System Elements: Process Performance and Product Quality Monitoring System By Lynn Torbeck Statistical Process Control, SPC • Specific statistical techniques used to monitor,  improve and control the manufacturing  process itself. These include probability, basic  statistics, statistical control charts, process  capability studies and experimental design for  improvement and optimization. Variability  reduction is a major goal. 4 Q10: “Establish and Maintain a State of  Control • A process can be in control for  financial  and  accounting, for  regulatory compliance, and for   organizational and managerial control. These  forms  of control are usually assumed to be in  place. There are two other states of control