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

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Page 1: “Using Lean Six Sigma To Improve a Risk Management Process” · PDF file“Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, 2010 Kim Niles, ASQ

“Using Lean Six Sigma To Improve

a Risk Management Process”

ASQ Temecula; June 17, 2010http://www.asq-temecula.org/?page_id=308

Kim Niles, ASQ Fellow, MSQA, CSSMBB, CSSBB, CQE

www.KimNiles.com ; [email protected]

1

Page 2: “Using Lean Six Sigma To Improve a Risk Management Process” · PDF file“Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, 2010 Kim Niles, ASQ

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

Page 3: “Using Lean Six Sigma To Improve a Risk Management Process” · PDF file“Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, 2010 Kim Niles, ASQ

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

NGT Brainstorming

– Sticky Notes

4

Rate 1 low to 10 high:

1. Your dislike/pain for Six Sigma

2. Your dislike/pain for Risk Management

3. Rate your RM experience level (relative to?)

4. Years as a Quality Professional

1=5

2=9

3=1

4=10

3 minutes

T

G N

Page 5: “Using Lean Six Sigma To Improve a Risk Management Process” · PDF file“Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, 2010 Kim Niles, ASQ

What do we mean by “Lean Six Sigma”?Collections of best known methods: Models, methods, and tools

Process Improvement

Visibility Value Velocity

Project

Management

Change

Management

Variation

Management

The 3V’s and the 3M’s

5

Page 6: “Using Lean Six Sigma To Improve a Risk Management Process” · PDF file“Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, 2010 Kim Niles, ASQ

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

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

http://www.fda.gov/R

egulatoryInformation/

Guidances/ucm1280

50.htm#III

• ICH / FDA

guidance

from 2006

Page 9: “Using Lean Six Sigma To Improve a Risk Management Process” · PDF file“Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, 2010 Kim Niles, ASQ

• ISPE

GAMP5

Computerized

systems

Page 10: “Using Lean Six Sigma To Improve a Risk Management Process” · PDF file“Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, 2010 Kim Niles, ASQ

Kim’s DRAFT

Grand RISK

Model

• The Acronym

RISK can

help us

remember

• Missing:

– SAE AS9100

– AIAG PPAP

Ris

k F

acto

r Id

entification

Hazard

Assess / A

naly

sis

Ris

k E

valu

ation

Ris

k C

ontr

ol O

ption A

naly

sis

Ris

k M

easure

s Im

ple

ment

Resid

ual R

isk E

valu

ation

Ris

k / B

enefit A

naly

sis

Eval of R

isks F

rom

Contr

ols

Com

ple

te R

isk C

ontr

ol

Overa

ll R

isk A

ccepta

bili

ty

Verification T

esting / D

OE

Sta

tistics -

Oth

er

Ris

k M

anagem

ent R

eport

On-g

oin

g D

ata

Gath

ering

Ris

k R

evie

ws / M

onitoring

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 x

ICH 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

S

Substantiate

(Verify)

K

Know

(Report)(Plan)

R I

Realize Instigate

(Assess)

Tools

Page 11: “Using Lean Six Sigma To Improve a Risk Management Process” · PDF file“Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, 2010 Kim Niles, ASQ

KN Model: 4 Ways to Improve

Any Process Consistency

Efficiency

Effectiveness

Lean Six Sigma (LSS)

Evolutionary Change

1

1

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

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

T

G N

Page 13: “Using Lean Six Sigma To Improve a Risk Management Process” · PDF file“Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, 2010 Kim Niles, ASQ

Simulated Case Study

Basic Steps:

1. Project pick lists

2. Team selection

3. Project kickoff

4. Defining activities

5. Measuring activities

6. Analyzing activities

7. Improving activities

8. Controlling activities

9. Phase gate reviews

and celebratory

closing meeting

Page 14: “Using Lean Six Sigma To Improve a Risk Management Process” · PDF file“Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, 2010 Kim Niles, ASQ

Spaghetti Map

Page 15: “Using Lean Six Sigma To Improve a Risk Management Process” · PDF file“Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, 2010 Kim Niles, ASQ

Run Charts

Page 16: “Using Lean Six Sigma To Improve a Risk Management Process” · PDF file“Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, 2010 Kim Niles, ASQ

Value Stream Map

Page 17: “Using Lean Six Sigma To Improve a Risk Management Process” · PDF file“Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, 2010 Kim Niles, ASQ

C&E Cascade

Page 18: “Using Lean Six Sigma To Improve a Risk Management Process” · PDF file“Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, 2010 Kim Niles, ASQ

CpK

Page 19: “Using Lean Six Sigma To Improve a Risk Management Process” · PDF file“Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, 2010 Kim Niles, ASQ

Design Space OptimizationDOE Reports Here

Air Academy DARPA 2006

Page 20: “Using Lean Six Sigma To Improve a Risk Management Process” · PDF file“Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, 2010 Kim Niles, ASQ

Three C’s to Inspire

Creativity

Comparison

Consequence

Conflict

Component of DFSSSomeone somewhere has already

solved your problem- Dr. Ellen Domb20

Page 21: “Using Lean Six Sigma To Improve a Risk Management Process” · PDF file“Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, 2010 Kim Niles, ASQ

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/FMEAFlow Charts & Process Maps

Mitigate Collective

Risks

Justify Decisions Business

Efficiency

Reduce Sample Plans

Avoid 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: “Using Lean Six Sigma To Improve a Risk Management Process” · PDF file“Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, 2010 Kim Niles, ASQ

Risk Mgmt.

Enablers

• Jan 2010

• 230 comps:

– 40 life sci.

– 23% lg.

• Little s/w use

Page 23: “Using Lean Six Sigma To Improve a Risk Management Process” · PDF file“Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, 2010 Kim Niles, ASQ

Quality Progress Poll

May 2010

Page 24: “Using Lean Six Sigma To Improve a Risk Management Process” · PDF file“Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, 2010 Kim Niles, ASQ

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

Hazards per ISO14971

Page 26: “Using Lean Six Sigma To Improve a Risk Management Process” · PDF file“Using Lean Six Sigma To Improve a Risk Management Process” ASQ Temecula; June 17, 2010 Kim Niles, ASQ

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