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Proposed Agenda

“Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, 2010 http://www.asq-temecula.org/?page_id=308 Kim Niles , ASQ Fellow, MSQA, CSSMBB, CSSBB, CQE www.KimNiles.com ; Kim.Niles@cox.net. 1. Proposed Agenda. How do we narrow in on something meaningful?

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Proposed Agenda

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  1. “Using Lean Six Sigma To Improve a Risk Management Process”ASQ Temecula; June 17, 2010http://www.asq-temecula.org/?page_id=308Kim Niles, ASQ Fellow, MSQA, CSSMBB, CSSBB, CQE www.KimNiles.com ; Kim.Niles@cox.net 1

  2. Proposed Agenda • How do we narrow in on something meaningful? • Define what we mean by LSS and RM Process • Lean (L), Six Sigma (SS), LSS, DFSS • Risk Management • Define the scope of our project • Efficacy, efficiency, accuracy, consistency • Evolutionary vs. revolutionary • Simulate a project • Typical steps, tasks, and reports • Lessons Learned • + / - Short Exercises: NGT Survey – 3 min NGT Multi-vote Project – 2min Open disc.; Simulation – 30min Lessons Learned Disc. – 5min 2

  3. Nominal Group Techniques (NGT) • Affinity Diagrams, Multi-voting, Tree diagrams, Mind mapping, Un-inhibited group discuss, Café/town hall mtgs, Unusual settings, etc. 3 3

  4. NGT Brainstorming – Sticky Notes 1=5 2=9 3=1 4=10 Rate 1 low to 10 high: Your dislike/pain for Six Sigma Your dislike/pain for Risk Management Rate your RM experience level (relative to?) Years as a Quality Professional 4

  5. What do we mean by “Lean Six Sigma”? Collections of best known methods: Models, methods, and tools Visibility Velocity Value TOC The 3V’s and the 3M’s Process Improvement Project Management Variation Management Change Management 5

  6. What do we mean by “Risk Management Project”? • Definition: A formal program used to assess, avoid/mitigate, and control all reasonable forms of business / safety risks • Contains elements listed above in some way, plus teams, measurements (subjective), action triggers / specifications • Lifespan oriented: making, using, maintaining, & obsolescing • Prioritized cost to benefit efforts (RPN based) • Typically concerned with safety & efficacy http://msdn.microsoft.com/en-us/library/cc500392.aspx

  7. Scope of RM Application • The project can cover concept (market), customer needs, design, intermediate use (i.e. labs, Drs., nurse), end user, mfg. process, equip., services, suppliers, project risks, etc. • IVD Example from ISO14971:

  8. http://www.fda.gov/RegulatoryInformation/Guidances/ucm128050.htm#IIIhttp://www.fda.gov/RegulatoryInformation/Guidances/ucm128050.htm#III • ICH / FDA guidance from 2006

  9. ISPE GAMP5 • Computerized systems

  10. Kim’s DRAFT Grand RISK Model • The Acronym RISK can help us remember • Missing: • SAE AS9100 • AIAG PPAP Tools

  11. KN Model: 4 Ways to ImproveAny Process What is the scope of the project? Effectiveness Consistency Accuracy Efficiency • Political bias > program fail Design For Lean Six Sigma (DFLSS); Revolutionary Change • Delta customer centered RM story • QPFMEA criteria bias story • List muda, mura, muri; 17 signature story Lean Six Sigma (LSS) Evolutionary Change Discuss each area relative to a target & a RM project 11

  12. NGT Brainstorming- Multi-vote likelihood (3 votes) What is a more reasonable improvement project? Evolutionary RM program efficiency (cost / benefit)? Revolutionary RM program efficiency (cost / benefit)? Evolutionary team accuracy (criteria or process)? Revolutionary team accuracy (criteria or process)? Evolutionary team consistently (following procedures)? Revolutionary team consistently (following procedures)? Evolutionary program effectiveness (end result) Revolutionary program effectiveness (end result) 12

  13. Simulated Case Study Basic Steps: Project pick lists Team selection Project kickoff Defining activities Measuring activities Analyzing activities Improving activities Controlling activities Phase gate reviews and celebratory closing meeting

  14. Spaghetti Map

  15. Run Charts

  16. Value Stream Map

  17. C&E Cascade

  18. CpK

  19. Design Space OptimizationDOE Reports Here Air Academy DARPA 2006

  20. Three C’s to Inspire Creativity Conflict Comparison Consequence Component of DFSS Someone somewhere has already solved your problem- Dr. Ellen Domb 20

  21. Control Plan Purpose / Use File: FTA_ControlPlan_v1_KN_061510 June 15, 2010 KN x 1209

  22. Risk Mgmt. Enablers • Jan 2010 • 230 comps: • 40 life sci. • 23% lg. • Little s/w use

  23. Quality Progress Poll May 2010

  24. Risk Control Measures • ISO14971 suggests forming of a list of risk control measures • Also see the annex solutions • Reliasoft software contains a related database

  25. Hazards per ISO14971

  26. Summary of Tips and Tricks • Risk management depends upon people • Focus on having fun • Minimizing the pain (no long meetings) • Pre-prioritize (i.e. by area risks) • Maximizing the value-add usingNGT • To pre-prioritize & to select criteria • Inspire creativity using the 3C’s model • Develop a control plan centric program • Many complimentary tools (i.e. FTA, Process maps with threats, FMEA) • Remember all the components using RISK

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