The Quality Improvement Model Define Process The Quality Improvement Model Select Measures Collect & Interpret Data Maintain Current Process Is Process Stable ? No Investigate & Fix Special Causes Purpose: Develop a control plan to maintain the improvements for the process Document control plan Yes Is Process Capable ? No Improve Process Capability Yes Develop Control Plan to Maintain Current Process

Objectives Explore the steps for setting up controls for your project Review Control Plan elements Review the need for well documented control plans to “sustain the gains” Introduce the concept of Mistake Proofing

Critical Input Variables The Funneling Effect Process Maps Identify Outputs Identify Inputs 3 to 6 Critical Input Variables C&E Matrix Failure Modes and Effects Analysis Control Charts (SPC) Exploratory Data Analysis (EDA) Design of Experiments (ASM / DOE) Now What ? A Control Plan to: “Sustain The Gains”

Three Ways to Control Key Variables in a Process Statistical Process Control Control to a Standard Engineering Process

Control Strategy Roadmap KPIV's 1) Monitor variables for out of control conditions KPOV's Major Focus on KPIV’S to Minimize Production of Defects 2) Develop alarm and recording strategy 3) Finalize process sampling plan 4) Document control plan for each key variable 5) Identify Opportunities for Mistake Proofing

Control Strategy Roadmap Step 1 - Monitor Variables For Out Of Control Conditions Key Relationships Identified After DOE Completion Strength = 6.6444 + 1.4466 Press Yield = - 1690 + 15.7 Temp + 41.7 Press - 0.0338 TempSqr - 0.281 PressSqr - 0.169 TempPress What Should We Monitor?

Control Strategy Roadmap Step 1 - Monitor Variables For Out Of Control Conditions Strength Seems To Be In Control

Control Strategy Roadmap Step 1 - Monitor Variables For Out Of Control Conditions Looks Like a Problem With Yield – What Now ??

Control Strategy Implementation Step 1 - Monitor Variables For Out Of Control Conditions Experimental Results Indicated Yield Is A Function Of Pressure And Temperature Remember Yield = - 1690 + 15.7 Temp + 41.7 Press - 0.0338 TempSqr - 0.281 PressSqr - 0.169 TempPress Let’s Take A Look At The KPIV’s Pressure and Temperature

Control Strategy Roadmap Step 1 - Monitor Variables For Out Of Control Conditions Pressure seems to be in good control, though the pattern should be investigated.

Control Strategy Roadmap Step 1 - Monitor Variables For Out Of Control Conditions Historic Mean 124 Historic StdDev 2.7 Big Trouble on Temperature !!

Control Strategy Roadmap Step 2 - Develop Alarm and Recording Strategy Process Alarms Online alarms key to process waste reduction Identify key alarm points throughout the process Do not alarm too many points – they will be ignored SPC - Control Charts are effective alarm mechanisms Data Recording Record alarms to identify patterns of out of control conditions Online data trending assists in monitoring process shifts Record and analyze KPIV’s to prevent waste production Developing an Effective Process Alarm Strategy is Key To Reducing Waste and Defects

Control Strategy Roadmap Step 3 - Finalize Process Sampling Plan Use KPOV = f(KPIV1, KPIV2, …) predictive relationships to minimize routine process sampling Take product samples when SPC and on-line alarms indicate out of control conditions (In theory not practice) Be sure sample size is adequate through use of sample size calculations Document sampling plan and communicate to production, lab, technical, order processing and other key groups

Step 4 - Document Control Plan For Each Key Variable… Control Plan Purpose Step 4 - Document Control Plan For Each Key Variable… The Purpose Of An Effective Control Plan Is To: Operate processes on target with minimum variation Minimize process tampering (over-adjustment) Assure that process improvements become institutionalized (ISO 9000 can assist here) Provide for adequate training in all procedures Identify required maintenance schedules Revise Quarterly

Factors Impacting a Good Control Plan Step 4 - Document Control Plan For Each Key Variable… These need to be Measurement Preliminary updated before System Analysis proceeding Measurement Process System Analysis Maps Short Term %R&R, %P/T Capability Calibration C&E Requirements Matrix Initial Control Plan Assessment Sampling & FMEA Testing Plans Customer Control Plan Requirements Long Term Capability Maintenance SPC Plans Schedules Trouble Noise Variable Shooting Operating Compensation Training Aids Windows Materials Reaction Plans DOE's SOP's Improvement Procedures Activities

Control Plan Summary Sheet Step 4 - Document Control Plan For Each Key Variable… Control Plan.XLS

Control Plan Components Step 4 - Document Control Plan For Each Key Variable… Process map steps Key process output variables, targets & specs Key process input variables with control limits Important noise variables (uncontrollable inputs) Short and long term capability analysis results Designated control methods including: SPC Automated process control Checklists Mistake proofing systems Standard Operating Procedures Sampling & Testing Meas. Sys. Analysis Training Materials Maintenance schedules Reaction Plan and Procedures

Other Tips in Documenting Improvements Step 4 - Document Control Plan For Each Key Variable… Utilize your team and / or affected individuals Test the procedure exactly as it is documented Outline a method for updating procedures Date your procedures Destroy obsolete procedures Have an audit plan to verify compliance Responsibility for documenting control plan and updates New Process Step 1 Step 2 Step 3 Step 4 Project

Step 4 - Document Control Plan For Each Key Variable… Auditing Procedures Step 4 - Document Control Plan For Each Key Variable… Directly By Observation Are people actually doing what the procedure says? Are all the steps being followed? Are people referring to the procedure? By asking those using the procedure Is each step in the procedure clear? Are you having difficulty in following the procedure? Could we improve the procedure and still get results? Indirectly When was the last time the instruction was revised?

Documentation Package Control Plan Scope Customer Summary Maps MSA FMEA’s Capability Critical Parameters SOP’s Training Maint. Trouble Shooting Reaction Plans

Summary Explored the steps for setting up controls for your project Reviewed Control Plan elements Reviewed the need for well documented control plans to “sustain the gains” Control plan derived from tools and learning's in implementing model discussed in this course Identify person who will be accountable for control plan documentation and updates

Exercise 1.) Your Catapult Team should complete page 13 of the blue “Catapult Process” handout. Limit yourselves to 15 minutes for this exercise.