PAT A FRAMEWORK FOR EXCELLENCE

1. PATA FRAMEWORK FOR EXCELLENCE By Timothy Leistikow ASQ FD&C DIVISION 22. October 2004

2. PAT Goals Risk Management Current Technology Manufacturing Innovation

3. Characterization of “Future State” of manufacturing • Quality ensured through effective & efficient processes • Recognizing the capability of process control strategies to mitigate risk of poor quality • Product & process specifications based on formulation and process factors • Continuous real time quality assurance

4. Characterization of “Future State” of manufacturing • Quality ensured through effective & efficient processes • Recognizing the capability of process control strategies to mitigate risk of poor quality • Product & process specifications based on formulation and process factors • Continuous real time quality assurance

5. Process Efficiency and Effectivity Basic Process Functions? Process Failures? Failure Effect on Process and Product? Process controls? Control Effectivity?

6. Assessing Process Effectivity and Efficiency • Functional Block Diagram • Failure Modes and Effects Analysis • Characteristics Matrix • Design of Experiments • Dynamic Control Planning

7. Characterization of “Future State” of manufacturing • Quality ensured through effective & efficient processes • Recognizing the capability of process control strategies to mitigate risk of poor quality • Product & process specifications based on formulation and process factors • Continuous real time quality assurance

8. Process Control Strategies FMEA PFMEA Product Process EMEA Human Error

9. Indicates risks to process output quality Documents process control rationale Shows effects of process variation on product quality Prioritizes Continuous Improvement effort Indicates risk areas due to human error Provides direction for Poka – yoke applications Reveals Management induced errors Continuous Improvement format for operators Process FMEA & EMEA Equipment Error Modes Analysis

10. People Processes Gap Analysis

11. EMEA paradigm shift • Errors aren’t caused by “bad” personnel • It’s “good” people having bad results

12. EMEA Process The greatest discovery of my generation is that human beings can alter their lives by altering their attitudes of mind. William James

13. Characterization of “Future State” of manufacturing • Quality ensured through effective & efficient processes • Recognizing the capability of process control strategies to mitigate risk of poor quality • Product & process specifications based on formulation and process factors • Continuous real time quality assurance

14. Characteristics MatrixAutomotive Application • C = Characteristic is used for clamping • L = Characteristic used for locating • X = Characteristic changed at operation

15. Characteristics Matrix Paradigm Shift Example • X = characteristic affected by operation – see process flow diagram • S = Characteristic must be stable • NC = Characteristic not controlled

16. Measurement Capability Studies • Use of DOE to assess measurement capability • Measure capability as a ratio of variation to process/product tolerance (% tolerance) • Typical requirement – 6 sigma can be no more than 30% of tolerance

17. Characterization of “Future State” of manufacturing • Quality ensured through effective & efficient processes • Recognizing the capability of process control strategies to mitigate risk of poor quality • Product & process specifications based on formulation and process factors • Continuous real time quality assurance

18. Continuous Real Time • Measuring the characteristic • Creating the signal • Interpreting the signal • The response

19. Line of sight 4 Clean Room 6 Continuous Real Time Feedback

20. Line of sight Continuous Real Time Feedback Clean Room Operator instructions

21. Operator Feedback The real problem is not whether machines think but whether men do. • -- B. F. Skinner

22. Manufacturing Innovation

23. Innovation in manufacturingCustomer Satisfaction New Materials Customer Satisfaction New Skills New Processes

24. Manufacturing Innovation BenchmarkingAutomotive Quality Planning Advanced Product Planning and Control Plan Process (APQP)

25. Advanced Product Quality Planning and Control Plan (APQP) • PLAN – DO – STUDY – ACT (Cycle of continuous improvement) • Organizes reviews of elements that affect quality • Identifies risks to product quality • Reveals critical paths and efficiency problems

26. Goal of Product Planning Cycle The APQP cycle Upfront planning Documents the experience from one program Applies acquired knowledge to the next program

27. Learning from the past • Experience is the name every one gives his mistakes. • -- Elbert Hubbard

28. Common ToolsLoss of knowledge 10-30 years ago • Computers -DOS operating systems • Maybe 20% of current windows users know how to operate.

29. How tools have changed There is no reason for any individual to have a computer in his home. • -- Kenneth H. Olson, President of DEC, Convention of the World Future Society, 1977

30. “Success is meeting customer needs in a timely manner at a cost that represents value” • Timing of elements for Quality Planning • Simultaneous engineering

31. Planning Launch Product Design and Development Quality Planning Sequences Process Design and Development Validation Activities Production Feedback Assessment & Corrective Action

32. Things gone wrong reports Things gone right reports Capability indicators Problem resolution reports Customer returns/rejections Product Goals Reliability and Quality Goals Preliminary Process Flow Chart Preliminary listing of Product and Process Characteristics Product Assurance Plan Planning Program Inputs Outputs

33. Planning Launch Product Design and Development Quality Planning Sequences Process Design and Development Validation Activities Production Feedback Assessment & Corrective Action

34. Design for manufacturability Design reviews Product Specifications Material Specifications New tooling and facilities requirements Gages/Testing requirements Prototype Control Plan Special Product and Process Control Characteristics Product Design & Development Design Outputs Advanced Quality Planning

35. Identifying special Product and Process Characteristics Identification of testing and gauging requirements New equipment requirements Product Design & Development Concurrent Engineering Design Review Process APQP Team Design of Experiments Variation of Product Design FMEA’s Design for manufacturability

36. Design FMEA • Aids in identifying controls needed to reduce variation of product • Indicates where risk elements to Product Quality may exist • Provides an open format for listing continuous improvement tasks • Provides a knowledge base for identifying root causes.

37. Planning Launch Product Design and Development Quality Planning Sequences Process Design and Development Validation Activities Production Feedback Assessement & Corrective Action

38. Process Design and Development OUTPUTS • Packaging Standards • Process Flow Charts • Measurement Systems Analysis Plan • Process FMEA’s • Process Instructions • Characteristics Matrix

39. FMEA & EMEA Supporting Analyses • Functional Block Diagrams • Characteristics Matrix • Process Flow Charts • Design of Experiments • Cause and Effect Diagrams • Capability Studies (Process) • Capability Studies (Measurement Process)

40. Planning Launch Product Design and Development Quality Planning Sequences Process Design and Development Validation Activities Production Feedback Assessment & Corrective Action

41. Feedback Assessment & Corrective Action • Documentation of Variation sources affecting Product Quality (Risks) • Identification of critical path items affecting Delivery and Product Quality (Risks) • Continuous Improvement • Lessons learned during APQAP Project • Elements requiring further optimization • Elements requiring reduction in variation

42. Successful Risk Managementis based on • Recognizing what can go wrong • Determining the probability of occurrence • Determining the severity of occurrence

43. Final thoughts • What we anticipate seldom occurs: but what we least expect generally happens. • -- Benjamin Disraeli