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“Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, 2010 Kim Niles, ASQ Fellow,

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Presentation on theme: "“Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, 2010 Kim Niles, ASQ Fellow,"— Presentation transcript:

1 “Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, Kim Niles, ASQ Fellow, MSQA, CSSMBB, CSSBB, CQE ; 1 1

2 Proposed Agenda Short Exercises:
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 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 3

4 NGT Brainstorming – Sticky Notes
3 minutes T G N 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 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

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 ICH / FDA guidance from 2006

9 ISPE GAMP5 Computerized systems

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

11 KN Model: 4 Ways to Improve Any Process
What is the scope of the project? Effectiveness KN Model: 4 Ways to Improve Any Process Consistency Accuracy Efficiency Political bias > program fail Delta customer centered RM story Design For Lean Six Sigma (DFLSS); Revolutionary Change 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 1111

12 NGT Brainstorming - Multi-vote likelihood (3 votes)
2 minutes T G N 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 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 Optimization DOE Reports Here
We use DOE to map the design space … this is a cool way of showing that. Don’t worry if you don’t get it. 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
Facilitate Risk Based Decision Making Corrective Action Containment Direction Clarity Operational Impact Preventive Action Identify Risks Promote Dialog Tighten Sample Plans Regulatory Compliance Umbrella Risk Management D/P/FMEA Flow Charts & Process Maps Mitigate Collective Risks Justify Decisions Business Efficiency Reduce Sample Plans Avoid Conflict Becomes a Dashboard Collection of Knowledge Identify Strengths File: FTA_ControlPlan_v1_KN_ June 15, KN x 1209

22 Risk Mgmt. Enablers Jan 2010 230 comps: Little s/w use 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 using NGT 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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