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