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Product and Process Validation Ensure Continuous Improvement Phase I Phase II Phase II Phase III Phase III Phase III Phase III Phase IV Phase V Determine Customer Expectations and Plan for Quality Identify Key Characteristics Determine Risk and Feasibility Associate Characteristics with Process Steps and Identify Key Characteristics Expose Sources of Variation and Finalize Key Characteristics Determine Methods to Improve Process and Control Variation Implement Control Plan and Standardize the Process Ensure Customer Expectations are Met Exercise Management Oversight The Target and The Goal Marketing Communications Link Between the Documents Pr o c e s s Flo wO pera t io n N um berPr o d uct /P ro c e s sC hara c t e r is t i cInco min g So urce so f V a r ia t ionPFM E AC on t r o l P la nVa ria t io n C la s sW o rk In s t ru c t io nsProcess Flow Diagrams ? Updated after production trial run. ? Need to indicate special characteristics generated at each step. ? Completed Along with Control Plan (APQP Process). ? Generally contains same information as process traveler. Marketing Communications Process Flow Diagram Example Marketing Communications APQP Links to PFMEA W o rk In s t ru c t io nsPFM E AC han ge i n d e t e c t io nC han ge i n o c c u r e n c eC han ge i n se v e ri t yC on t r o l P la nD e s ign Ch a ng e O t h e r A c t io nororororProcess FMEA ? Must follow flow of the process flow diagram. ? Must include ALL process special characteristics (as a minimum). Marketing Communications How a PFMEA Works ? Where does the data for the PFMEA e from? ? What types of people are a part of the PFMEA team? ? What types of activities should we spend a lot of time on? PFMEAs/Control Plans and 8Ds During APQP ? PFMEAs should be driven by real data, including 8Ds (internal and external), warranty and returned part analysis ? PFMEAs should be pleted by process experts and should be a driver of the control plans and work instructions ? Work instructions (Post control log, process parameter logs, preventive maintenance, etc.) implement the control plan in the process ? When there is a quality problem there is an opportunity to improve the control plan and the work instructions APQP Links to Control Plan F i r s t/ L a s t Pi e c eM i s ta k e Pr o o fi n gC o n tr o l Pl a nP/ M C h e c k l i s tQ u a l i ty C h e c k l i s tControl Plans ? Includes product and process special characteristics. ? Includes SPC requirements. ? Follows flow of process flow chart and PFMEA. ? May require customer approval. Marketing Communications Types of Control Plans ? Prototype build control plan(s) ? Prelaunch control plan ? Production control plan Marketing Communications Prototype Build Control Plan ? A description of the dimensional measurements. ? Material tes