1. Define the Performance Problem 3. Identify Possible Causes ns cf J i oH, a ececece al ‘TIME LINE OF EVENTS: concentration = L + oe a 4 a INVESTIGATION ROADMAP 2. Collect Data © 2012 Weaver Consulting LLC 4. Test Possible Causes xf [x MULT-VART CHART Possibie cause: Yd if tf ‘TIME LINE OF CHANGES: DIFFERENCES. CAUSE S EFFECT DIAGRAM _& CHANGES 5. Identify Technical & Systemic Root Causes a © RESPONSI SOMPONENT SWAPPING bs SCREENING EXPERIMENT ROBUST TOLERANCE ANALYSIS. ZS. RISK ANALYSIS. TECHNIQUES: 6. Determine Corrective / Preventive Actions Eliminate Facilitate Mitigate Flag MISTAKE PROOFING, RISK MITIGATION 7. Verify Corrective / Preventive ActionsSelected Notes DEFINE 4, Define the Performance Problem - Develop an 1S/'S NOT Diagram What specific objecthasthe defect? Whatis the specific defect? Whatarethe detect characteristics? mat productlots nave tho mat part los ar tn \Wnat processes should be investigated” mat pattors are inthe WHAT data? What could the charecteriaicsbe, butarenot? ‘mat product its could nave the dofect but do not? sopraphicaly, but ‘Where elze could tbe onthe object but le not? Where oulditbe 1 seen in theprocess butlsn't? Whore elze could the defect be, butisnot? What pattomsare not soon the WHERE data? Where else isthe defect? What pattoms are inthe WHERE data? Wha waste defective hjact #8 mon (datsteme)? ‘mon since the % time has the defective object been seen (date & time)? What pattems are inthe WHEN data? Whon sea cout tha dalartin ahjact 1 hoon soon, Dutwasnoe? ‘mon since the 1+ tine oul the detective object have beenseen, but was not? What pattomeare not seen in the WHEN dts? ‘ow many objects have the detect? How big or small isthe defect? How many defectsare on the object? Whats the trend? (stable, worse, better What pattome are inthe HOW MUCH dota? How many objects could have the detect, but don't? How big or small could itbe, buts not? How mony defects couldbe on object butare not? What trende couldhave been seen, buthave not? ‘What pattome.are not een in the HOW MUCH data? MEASURE 2. Collect Data - Gather historical data and data that is being generated now to: + Convert the IS 1S NOT opinions into facts + Collect more detailed IS /IS NOT data + Identify pattems Identify data needed, where located, & tools to collect / analyze the data ANALYZE (Steps 3 through 5) 3. Identify Possible Causes + Look ‘or differences. Ask: “Whatis different about each IS compared to the ISNOT?: + Foreach difference identified, also ask"Whathas changed?” + Develop a timeline of changes, review the risk analysis, & brainstorm. + Listall possible causes identified through various techniques on a master list. © 2012 Weaver Consul Weaver Consulting LLC Solving Global Problems Locally 4, Test Possible Causes + Foreach possible cause ask, “tf X is the cause, how does it explain each set of IS and IS NOT data?” Record any fact not perfectly explained. Record any assumptions needed to explain the fects. Identify Technical & Systemic Root Causes Verify each assumption made in Step 4. If an assumption is not true, and there are no other assumptions that can explain the facts, eliminate the possible cause. + Forthe remaining probable causes, conduct testing or experimentation to identity the technical root cause. + Determine systemic root causes by asking, “Why did we have this problem? ‘What breakdowns did we have in our management or quality systems that allowed this to happen?” + Usethe 3L5Why tool to document technical root cause & identify systemic root causes, IMPROVE 6. Determine Corrective / Preventive Actions For mistakes, errors, or omissions, apply mistake proofing. + Forexcessive variation or improper targeting, firstreduce the variation and then optimize. + Mitigate risks with corrective / preventive actions to minimize new problems. Use an FMEA, product design verification, & / or process validation. + Establish @ control plan to maintain performance and prevent recurrence. CONTROL 7. Verify Corrective / Preventive Actions + Verify the corrective / preventive actions have been implemented + Measure effectiveness of the corrective / preventive actions & control plan. + tfonly partially effective, investigate for additional root causes &/ or improve the corrective / preventive actions. + Update the risk analysis with what has been learned. + Share the problem, corrective action, and preventive action with the rest of the organization and key suppliers. 8506 Sycamore Court McHenry, IL 60080, USA 847-846-2072 Country Code: 004 www.weaverconsulting.biz tom.weaver@weaverconsulting.biz