1. 11-1 Quality Improvement Model Purpose: To provide a sequence of steps to improve any process so that the customers will realize the highest quality and value. Collect & Interpret Data Select Measures Define Process Is Process Capable ? Improve Process Capability Is Process Stable ? Investigate & Fix Special Causes No Yes No Yes Develop Control Plan to Maintain Current Process

2. 11-2 Define Process 1)Communicate to an individual or a team a clear understanding of the process under study. 2)Establish improved and consistent process operations. 1)Identify and list Suppliers, Inputs, Outputs, and Customers (SIPOC/Big Block) 2)Develop flow chart of process steps (Schematic). 3)Develop process map 3)Assure understanding of related procedures. 4) Verify practice vs. procedure of S.O.P's 1)Process Map Excel Workbook 2)Flow Charts or Schematic/SIPOC or Big Block/Process Map/Detailed Process Map 3) S.O.P's Purposes: Activities: Tools: Collect & Interpret Data Select Measures Define Process Is Process Capable ? Improve Process Capability Is Process Stable ? Investigate & Fix Special Causes No Yes Develop Control Plan to Maintain Current Process

3. 11-3 Select Measures 1)Develop understanding of customer needs. 2)Determine "possible" process response control points. 1)Review customer needs. 2)Identify/Develop measures that reflect those needs. 3)Describe/Review sampling/testing plans and methods. 4)Process Map Details 5)Types of Process Control (Monitor, SPC, EPC, SOP) 1)Customer Input 2)Sampling and measurement techniques 3)Process Map Master.XLS Purposes: Activities: Tools: Collect & Interpret Data Select Measures Define Process Is Process Capable ? Improve Process Capability Is Process Stable ? Investigate & Fix Special Causes No Yes Develop Control Plan to Maintain Current Process

4. 11-4 Collect & Interpret Data 1)Begin collecting and analyzing data from the process. 1)Analyze existing data from the process. 2)Determine needs for new data and develop systems for collecting data. 3)Understand sources of variation in process data 1)Run Charts 2)Histograms 3)Pareto Charts 4)Cause-Effect Matrix (CandE_Matrix.XLS) 5)Minitab Software Purposes: Activities: Tools: Collect & Interpret Data Select Measures Define Process Is Process Capable ? Improve Process Capability Is Process Stable ? Investigate & Fix Special Causes No Yes Develop Control Plan to Maintain Current Process

5. 11-5 Is Process Stable? 1)Determine stability of key measures of the product. 2)Understand differences between common and special cause sources of variation. 3)If not stable, proceed to block on "Investigate and Fix Special Causes". 4)If stable, proceed to block on "Is Process Capable?" 1)Collect data from process in time order. 2)Identify presence of special causes. 3)Understand how to calculate control limits 4)Use Minitab to create control charts 5)Understand differences between Sigma_S and Sigma_C. 6)Understand differences between control limits and specifications. 1)Control Charts 2)Minitab Software Purposes: Activities: Tools: Collect & Interpret Data Select Measures Define Process Is Process Capable ? Improve Process Capability Is Process Stable ? Investigate & Fix Special Causes No Yes Develop Control Plan to Maintain Current Process

6. 11-6 Investigate & Fix Special Causes 1)Achieve stability of the measures. 2)Establish permanency of solutions to recurring special causes. 3)Improve procedures and training. Daily Operations 1)Assure consistent operations 2)Investigate reasons for instabilities 3)Compensate process when needed 4)Document root causes of instabilities and compensation effects Long-Term System Changes 1)Implement preventive & corrective actions for special causes 2)Assure stability of raw materials 3)Analyze data for stability problems, e.g., differences among crews, equipment, etc. (Exploratory Data Analysis 1)Control Charts 2)Special Cause Action Plans 3)SOP's 4)FMEA 5)Process Map (Details!), C&E Matrix Purposes: Activities: Tools: Collect & Interpret Data Select Measures Define Process Is Process Capable ? Improve Process Capability Is Process Stable ? Investigate & Fix Special Causes No Yes Develop Control Plan to Maintain Current Process

7. 11-7 Is Process Capable? 1)Determine process adequacy. 2)If not capable, proceed to block on "Improve Process Capability". 3)If capable, proceed to block on "Develop Control Plan to Maintain Current Process". 4)Determine test method adequacy. 1)Compare histogram to customer requirements (specifications). 2)Calculate C-Family (Cp, Cpk) and P-Family (Pp, Ppk) capability indicies. 3)Analytical Labs: Calculate percent variation due to the test, percent gauge R&R and P/T Ratio. 1)Control Charts 2)Histogram 3)Minitab Software Purposes: Activities: Tools: Collect & Interpret Data Select Measures Define Process Is Process Capable ? Improve Process Capability Is Process Stable ? Investigate & Fix Special Causes No Yes Develop Control Plan to Maintain Current Process

8. 11-8 Improve Process Capability 1)Determine/Identify fundamental changes to the process to improve capability. 1)Analyze data statistically (Exploratory Data Analysis - EDA) 2)Perform trials of possible fundamental changes to the process. 3)Implement changes (if positive results occur.) 1) Standardization 2)Designed experiments (DOE) 3)Breaking out process steps (Process Map) 4)Isolating sources of variability (ASM/DOE) 5)Separating out common causes (stratification. ASM) 6)Brainstorming 7)Scatter Plots (C&E / ASM) 8)Mintab Software Purposes: Activities: Tools: Collect & Interpret Data Select Measures Define Process Is Process Capable ? Improve Process Capability Is Process Stable ? Investigate & Fix Special Causes No Yes Develop Control Plan to Maintain Current Process

9. 11-9 Develop Control Plan to Maintain Current Process 1)To maintain the process improvements that have been made 2)To continually improve the process. 1)Implement control charts, strategies for real-time problem solving, SOP and EPC. 2)Implement systems for summarizing and analyzing data for recurring special causes. 3)Develop documentation package for process. 4)Use results from DOE and data analysis to determine critical inputs to control. 1)Control Charts 2)Cause-Effect Matrix 3)Pareto Charts 4)Brainstorming 5)FMEA 6)SCAP 7)SOP's 8)Control Plan Summary Sheet.XLS 9)Process Map Details Purposes: Activities: Tools: Collect & Interpret Data Select Measures Define Process Is Process Capable ? Improve Process Capability Is Process Stable ? Investigate & Fix Special Causes No Yes Develop Control Plan to Maintain Current Process