proposed agenda
DESCRIPTION
“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? - PowerPoint PPT PresentationTRANSCRIPT
![Page 1: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/1.jpg)
“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
![Page 2: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/2.jpg)
Proposed Agenda
How do we narrow in on something meaningful?
1. Define what we mean by LSS and RM Process Lean (L), Six Sigma (SS), LSS, DFSS Risk Management
2. Define the scope of our project Efficacy, efficiency, accuracy, consistency Evolutionary vs. revolutionary
3. Simulate a project Typical steps, tasks, and reports
4. Lessons Learned + / -
2
Short Exercises:
1. NGT Survey – 3 min2. NGT Multi-vote
Project – 2min3. Open disc.;
Simulation – 30min4. Lessons Learned
Disc. – 5min
![Page 3: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/3.jpg)
3
Nominal Group Techniques (NGT)
Affinity Diagram for Pizza
Product Category
Service Category
Cost Category
Features Category
Post-it Notes
Extra value
Delivered Hot
45 min max wait
Friendly Drivers
Lower price
More toppings
Deals available
Quick ordering
> Crust Types
Proper change
$0 Fee Delivery
3
• Affinity Diagrams, Multi-voting, Tree diagrams, Mind mapping, Un-inhibited group discuss, Café/town hall mtgs, Unusual settings, etc.
![Page 4: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/4.jpg)
NGT Brainstorming – Sticky Notes
4
Rate 1 low to 10 high:1. Your dislike/pain for Six Sigma2. Your dislike/pain for Risk Management3. Rate your RM experience level (relative to?) 4. Years as a Quality Professional
1=52=93=1
4=10
3 minutes
TG N
![Page 5: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/5.jpg)
What do we mean by “Lean Six Sigma”?Collections of best known methods: Models, methods, and tools
Process Improvement
Visibility Value Velocity
ProjectManagement
ChangeManagement
VariationManagement
The 3V’s and the 3M’s
5
TOC
![Page 6: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/6.jpg)
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
![Page 7: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/7.jpg)
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:
![Page 8: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/8.jpg)
http://www.fda.gov/RegulatoryInformatio
n/Guidances/ucm128050.htm#III
• ICH / FDA guidance from 2006
![Page 9: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/9.jpg)
• ISPE GAMP5
Computerized systems
![Page 10: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/10.jpg)
Kim’s DRAFT Grand RISK
Model
• The Acronym RISK can help us remember
• Missing:– SAE AS9100 – AIAG PPAP
Ris
k F
acto
r Id
entif
icat
ion
Haz
ard
Ass
ess
/ Ana
lysi
s
Ris
k E
valu
atio
n
Ris
k C
ontr
ol O
ptio
n A
naly
sis
Ris
k M
easu
res
Impl
emen
t
Res
idua
l Ris
k E
valu
atio
n
Ris
k / B
enef
it A
naly
sis
Eva
l of R
isks
Fro
m C
ontr
ols
Com
plet
e R
isk
Con
trol
Ove
rall
Ris
k A
ccep
tabi
lity
Ver
ifica
tion
Tes
ting
/ DO
E
Sta
tistic
s -
Oth
er
Ris
k M
anag
emen
t Rep
ort
On-
goin
g D
ata
Gat
herin
g
Ris
k R
evie
ws
/ Mon
itorin
g
IEC 60812 (Systems Reliability) x x x x x x x
ISO13485>> 14971 Risk Management x x x x x x x x x x x x x
ISPE Gamp 5; Computerized Systems x x x x x xICH Q9 Basic RM Facilitation: FlowCharts x
Basic RM Facilitation: Chk.Sht. x
Failure Mode Effects Analysis (FMEA) x x x x x x x x
FME& Criticality Analysis (FMECA) x x x x x x x x
Fault Tree Analysis (FTA) x x x x
Haz.Anal.& Critical Control Points (HACCP) x x x x
Hazard Operability Analysis (HAZOP) x
Preliminary Hazard Analysis (PHA) x
Risk ranking and filtering x
Supporting statistical tools x
HIPPA Loss Prevention
Loss Reduction
Risk Mitigation
Claims Management Unsure of focus for each functional area
Risk Financing
Regulatory Accredidation Compliance
Operations (Risk Management Dept.)
Bioethics
SSubstantiate
(Verify)
KKnow
(Report)(Plan)
R IRealize Instigate
(Assess)
Tools
![Page 11: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/11.jpg)
KN Model: 4 Ways to ImproveAny Process Consistency
Efficiency
Effectiveness
Lean Six Sigma (LSS)Evolutionary Change
11
Design For Lean Six
Sigma (DFLSS);
Revolutionary Change
Accuracy
Discuss each area relative to a target & a RM project
• List muda, mura, muri; 17 signature story
Political bias > program fail
Delta customer centered RM story
QPFMEA criteria bias story
What is the scope of the project?
![Page 12: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/12.jpg)
NGT Brainstorming- Multi-vote likelihood (3 votes)
12
What is a more reasonable improvement project?1. Evolutionary RM program efficiency (cost / benefit)?2. Revolutionary RM program efficiency (cost / benefit)?3. Evolutionary team accuracy (criteria or process)?4. Revolutionary team accuracy (criteria or process)?5. Evolutionary team consistently (following procedures)?6. Revolutionary team consistently (following procedures)?7. Evolutionary program effectiveness (end result)8. Revolutionary program effectiveness (end result)
2 minutes
TG N
![Page 13: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/13.jpg)
Simulated Case Study
Basic Steps:1. Project pick lists2. Team selection3. Project kickoff4. Defining activities5. Measuring activities6. Analyzing activities7. Improving activities8. Controlling activities9. Phase gate reviews
and celebratory closing meeting
![Page 14: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/14.jpg)
Spaghetti Map
![Page 15: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/15.jpg)
Run Charts
![Page 16: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/16.jpg)
Value Stream Map
![Page 17: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/17.jpg)
C&E Cascade
![Page 18: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/18.jpg)
CpK
![Page 19: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/19.jpg)
Design Space OptimizationDOE Reports Here
Air Academy DARPA 2006
![Page 20: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/20.jpg)
Three C’s to Inspire Creativity
Comparison
Consequence
Conflict
Component of DFSSSomeone somewhere has already solved your problem- Dr. Ellen Domb
20
![Page 21: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/21.jpg)
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
PlansAvoid Conflict
Becomes a Dashboard
Collection of Knowledge
Identify Strengths
Control Plan Purpose / Use
File: FTA_ControlPlan_v1_KN_061510 June 15, 2010 KN x 1209
![Page 22: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/22.jpg)
Risk Mgmt.
Enablers• Jan 2010• 230 comps:
– 40 life sci. – 23% lg.
• Little s/w use
![Page 23: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/23.jpg)
Quality Progress Poll May 2010
![Page 24: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/24.jpg)
Risk Control Measures• ISO14971 suggests forming of a list of risk control measures• Also see the annex solutions• Reliasoft software contains a related database
![Page 25: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/25.jpg)
Hazards per ISO14971
![Page 26: Proposed Agenda](https://reader038.vdocuments.us/reader038/viewer/2022103023/56812b5c550346895d8f7c80/html5/thumbnails/26.jpg)
26
1. 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
2. Develop a control plan centric program– Many complimentary tools (i.e. FTA, Process
maps with threats, FMEA)
3. Remember all the components using RISK
Summary of Tips and Tricks