“Using Lean Six Sigma To Improve a Risk Management Process”
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“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 ; [email protected] 1. Proposed Agenda. How do we narrow in on something meaningful?

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“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 ; [email protected]


Proposed agenda
Proposed Agenda Process”

  • 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


    Nominal Group Techniques (NGT) Process”

    • Affinity Diagrams, Multi-voting, Tree diagrams, Mind mapping, Un-inhibited group discuss, Café/town hall mtgs, Unusual settings, etc.



    Ngt brainstorming sticky notes
    NGT Brainstorming Process” – Sticky Notes





    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


    What do we mean by lean six sigma
    What do we mean by “Lean Six Sigma”? Process”

    Collections of best known methods: Models, methods, and tools





    The 3V’s and the 3M’s

    Process Improvement








    What do we mean by risk management project
    What do we mean by “Risk Management Project”? Process”

    • 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


    Scope of rm application
    Scope of RM Application Process”

    • 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:

    Http www fda gov regulatoryinformation guidances ucm128050 htm iii

    • ICH / FDA guidance from 2006

    • ISPE GAMP5http://www.fda.gov/RegulatoryInformation/Guidances/ucm128050.htm#III

    • Computerized systems

    Kim s draft grand risk model
    Kim’s http://www.fda.gov/RegulatoryInformation/Guidances/ucm128050.htm#IIIDRAFT Grand RISK Model

    • The Acronym RISK can help us remember

    • Missing:

      • SAE AS9100

      • AIAG PPAP


    Kn model 4 ways to improve any process
    KN Model: 4 Ways to Improvehttp://www.fda.gov/RegulatoryInformation/Guidances/ucm128050.htm#IIIAny Process

    What is the scope of the project?





    • 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


    Ngt brainstorming multi vote likelihood 3 votes
    NGT Brainstorminghttp://www.fda.gov/RegulatoryInformation/Guidances/ucm128050.htm#III- 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)


    Simulated Case Studyhttp://www.fda.gov/RegulatoryInformation/Guidances/ucm128050.htm#III

    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

    Spaghetti map
    Spaghetti Maphttp://www.fda.gov/RegulatoryInformation/Guidances/ucm128050.htm#III

    Run charts
    Run Chartshttp://www.fda.gov/RegulatoryInformation/Guidances/ucm128050.htm#III

    Value stream map
    Value Stream Maphttp://www.fda.gov/RegulatoryInformation/Guidances/ucm128050.htm#III

    C e cascade
    C&E Cascadehttp://www.fda.gov/RegulatoryInformation/Guidances/ucm128050.htm#III


    Design space optimization doe reports here
    Design Space Optimizationhttp://www.fda.gov/RegulatoryInformation/Guidances/ucm128050.htm#IIIDOE Reports Here

    Air Academy DARPA 2006

    Three c s to inspire creativity
    Three C’s to Inspire Creativityhttp://www.fda.gov/RegulatoryInformation/Guidances/ucm128050.htm#III




    Component of DFSS

    Someone somewhere has already solved your problem- Dr. Ellen Domb


    Control plan purpose use
    Control Plan Purpose / Usehttp://www.fda.gov/RegulatoryInformation/Guidances/ucm128050.htm#III

    File: FTA_ControlPlan_v1_KN_061510 June 15, 2010 KN x 1209

    Risk Mgmt.http://www.fda.gov/RegulatoryInformation/Guidances/ucm128050.htm#III


    • Jan 2010

    • 230 comps:

      • 40 life sci.

      • 23% lg.

    • Little s/w use

    Quality progress poll may 2010

    Quality Progress Poll http://www.fda.gov/RegulatoryInformation/Guidances/ucm128050.htm#IIIMay 2010

    Risk control measures
    Risk Control Measureshttp://www.fda.gov/RegulatoryInformation/Guidances/ucm128050.htm#III

    • ISO14971 suggests forming of a list of risk control measures

    • Also see the annex solutions

    • Reliasoft software contains a related database

    Hazards per iso14971
    Hazards per ISO14971http://www.fda.gov/RegulatoryInformation/Guidances/ucm128050.htm#III

    Summary of Tips and Trickshttp://www.fda.gov/RegulatoryInformation/Guidances/ucm128050.htm#III

    • 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