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FUNDAMENTALS OF STATISTICS OVERVIEW

ACCURACY, PRECISION AND VARIATION COMMON vs. SPECIAL CAUSES SAMPLE FREQUENCY DISTRIBUTION HISTOGRAM & THE NORMAL CURVE POPULATION vs. SAMPLE

FUNDAMENTALS OF STATISTICS OVERVIEW (cont )


FREQUENCY

DISTRIBUTION CHARACTERISTICS MEASURES OF CENTRAL TENDENCY, DISPERSION & OTHER STATISTICAL INPUTS & OUTPUTS SPC FEEDBACK LOOP SPC & CONTINUOUS IMPROVEMENT

FUNDAMENTALS OF STATISTICS ACCURATE & PRECISE


VERY CLOSE TOGETHER

(LOW VARIATION) AND CENTERED ON TARGET (TRUE VALUE)

THE GOAL OF ANY PROCESS PRECISE AND ACCURATE


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FUNDAMENTALS OF STATISTICS

TYPICAL PROCESS MISTAKES


OVER

ADJUSTMENT

- ADJUST TOO MUCH OR TOO OFTEN


TAMPERING

- ADJUST WHEN NOT NEEDED


INCAPABLE

PROCESS

- BLAME OPERATORS WHO ARE GIVEN BAD EQUIPMENT AND/OR AN INCAPABLE PROCESS

ALL RESULT IN INCREASED VARIATION !


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FUNDAMENTALS OF STATISTICS

COMMON CAUSE
RANDOM

VARIATION SUM OF MANY SMALL VARIANCES SYSTEM-RELATED 80% OF PROCESS VARIATION RESPONSIBILITY OF MANAGEMENT WRONGLY ATTRIBUTED TO LINE EMPLOYEES
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FUNDAMENTALS OF STATISTICS

SPECIAL CAUSES
ASSIGNABLE 20%

OF PROCESS VARIATION IDENTIFIABLE TO SPECIFIC CONDITIONS OVERCOME BY REMOVAL, TRAINING, EXPERIENCE and/or COACHING

FUNDAMENTALS OF STATISTICS
SAMPLE FREQUENCY DISTRIBUTION
A METHOD OF ORGANIZING DATA TO MAKE IT MORE MEANINGFUL INVOLVES ESTABLISHING AN ARRAY

- AN ARRANGEMENT OF RAW DATA IN ASCENDING OR DESCENDING ORDER OF MAGNITUDE

HELPS VISUALIZE THE DISTRIBUTION DATA GROUPS ARE TALLIED TO SHOW THE FREQUENCY (# OF OCCURRENCES) OF EACH GROUP

FUNDAMENTALS OF STATISTICS
SAMPLE FREQUENCY DISTRIBUTION
FREQUENCY TABLE - UNGROUPED DATA
Tally of the Number of Students Talking in Class # TALKING 0 1 2 3 4 5 6 TABULATION IIII IIII III IIII IIII III IIII II III II I FREQUENCY 5 8 13 7 3 2 1

FUNDAMENTALS OF STATISTICS

HISTOGRAM
HISTOGRAM DISPLAYS LARGE AMOUNTS OF DATA THAT ARE DIFFICULT TO INTERPRET IN TABULAR FORM REVEALS THE CENTERING, VARIATION AND SHAPE OF THE DATA PROVIDES INFORMATION FOR PREDICTING FUTURE PERFORMANCE OF A PROCESS HELPS ANSWER THE QUESTION IS THE PROCESS CAPABLE OF MEETING THE CUSTOMER REQUIREMENTS? SET OF RECTANGLES THAT REPRESENT THE FREQUENCY OF OBSERVED VALUES IN EACH CATEGORY 9

FUNDAMENTALS OF STATISTICS

HISTOGRAMS
Frequency Histogram
Frequency
15 10 5 0 0 1 2 3 4 5 6 # of Students Talking

Relative Frequency Histogram


Relative Frequency
15.00 10.00 5.00 0.00 1 2 3 4 5 6 7 # of Students Talking

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FUNDAMENTALS OF STATISTICS

HISTOGRAMS
Cumulative Frequency Histogram
Cumulative Frequency
39 19 -1 1 2 3 4 5 6 7 # of Students Talking

Relative Cumulative Frequency Histogram


Relative Cumulative Frequency
1.00 0.50 0.00 1 2 3 4 5 6 7 # of Students Talking

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FUNDAMENTALS OF STATISTICS

NORMAL CURVE (DISTRIBUTION)

SAMPLE

POPULATION

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FUNDAMENTALS OF STATISTICS

NORMAL DISTRIBUTION
PROBABILITY-BASED TYPICAL

OF MANUFACTURING PROCESS OUTCOMES SUM OF ALL ATTEMPTS AT PERFECTION ESTIMATES THE POPULATION STRIVING FOR CENTRAL TENDENCY MEAN, MODE, MEDIAN
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FUNDAMENTALS OF STATISTICS

POPULATION vs. SAMPLE


SAMPLE

- small portion of representative measurements - necessary when it is impossible (or not cost effective) to get all measurements - all measurements

POPULATION

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FUNDAMENTALS OF STATISTICS

POPULATION vs. SAMPLE


SAMPLE
X - AVERAGE s - SAMPLE
STANDARD DEVIATION

POPULATION

(X0) - MEAN (s0) - STANDARD


DEVIATION

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FUNDAMENTALS OF STATISTICS

MEASURES OF CENTRAL TENDENCY


MEAN

(X-BAR): AVERAGE

- SUM OF ALL OBSERVATIONS DIVIDED BY NUMBER OF OBSERVATIONS


MODE:

MOST COMMON OBSERVATION

- COUNT REPEATS OF EACH OBSERVATION


MEDIAN:

OBSERVATION MIDPOINT

- HIGH MINUS LOW DIVIDED BY TWO

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FUNDAMENTALS OF STATISTICS NORMALIZED CENTRAL TENDENCY

MEAN, MODE, MEDIAN

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FUNDAMENTALS OF STATISTICS

MEASURES OF DISPERSION
ALTERNATIVE

TO CENTRAL

TENDENCY RANGE: HIGHEST - LOWEST STANDARD DEVIATION: PROCESS


VARIATION OF ALL MEASURES
VARIANCE: STANDARD DEVIATION

SQUARED

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FUNDAMENTALS OF STATISTICS

MEASURES OF DISPERSION
= 1.5 = 3.0 = 4.5
x
8 20 32
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FUNDAMENTALS OF STATISTICS

MEASURES OF DISPERSION

68.26%
95.46%

99.73%

-3

-2

-1

3
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FUNDAMENTALS OF STATISTICS

FEEDBACK PROCESS CONTROL


OBSERVE

DATA FROM PROCESS

- MEASURE OUTPUT - COMPARE TO DESIRED CONDITION - DETERMINE PROCESS GAP


ADJUST

PROCESS DATA AGAIN

- CLOSE GAP
OBSERVE

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FUNDAMENTALS OF STATISTICS

CONTROL LOOP
INPUT PROCESS OUTPUT MEASUREMENT

ADJUST
DECIDE ON FIX?

STATISTICS

ID GAPS
EXAMINE

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FUNDAMENTALS OF STATISTICS CAPABILITIES ANALYSIS OPTIONS


DO

NOTHING: PROCESS IN SPEC CHANGE SPECS: LIMITS UNREALISTIC CENTER PROCESS: SPEC SPREAD =
PROCESS SPREAD: ADJUST
REDUCE ACCEPT

VARIABILITY: PARTITION LOSS: NO IMMEDIATE

VARIATION: DESIGNED EXPERIMENT BREAKTHROUGH APPARENT


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FUNDAMENTALS OF PROBABILITY PROBABILITY

DEFINITIONS:
PROBABILITY

LIKELIHOOD OR CHANCE A CERTAIN EVENT WILL OCCUR


EVENT

AN OUTCOME OR COLLECTION OF OUTCOMES


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FUNDAMENTALS OF PROBABILITY PROBABILITY

FORMULA DEFINITION:

NA P(A) = N
where P(A) = probability of an event A occurring NA = number of successful outcomes of event A N = total number of possible outcomes

This definition can be used when the # of outcomes is known or found by experimentation
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FUNDAMENTALS OF PROBABILITY THEOREM 1


PROBABILITY

IS EXPRESSED AS A NUMBER BETWEEN 1.000 AND 0 WHERE 1.000 IS CERTAINTY THAT AN EVENT WILL OCCUR AND A VALUE OF 0 IS A CERTAINTY THAT AN EVENT WILL NOT OCCUR

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FUNDAMENTALS OF PROBABILITY THEOREM 2


IF

P(A) IS THE PROBABILITY THAT EVENT A WILL OCCUR, THEN THE PROBABILITY EVENT A WILL NOT OCCUR, P(A) IS 1.000 - P(A).

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FUNDAMENTALS OF PROBABILITY THEOREM 3


IF

A & B ARE MUTUALLY EXCLUSIVE EVENTS, THEN THE PROBABILITY THAT EITHER A OR B WILL OCCUR IS THE SUM OF THEIR RESPECTIVE PROBABILITIES

P(A or B) = P(A) + P(B)


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FUNDAMENTALS OF PROBABILITY THEOREM 4


IF

EVENT A & B ARE NOT MUTUALLY EXCLUSIVE EVENTS, THEN THE PROBABILITY OF EITHER A OR EVENT B OR BOTH IS GIVEN BY:

P(A or B or both) = P(A) + P(B) - P(both)

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FUNDAMENTALS OF PROBABILITY THEOREM 5


THE

SUM OF THE PROBABILITIES OF THE EVENTS OF A SITUATION IS EQUAL TO 1.000


DI ROLLING EXAMPLE:

P(1) + P(2) + P(3) + P(4) + P(5) + P(6) = 1.000

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FUNDAMENTALS OF PROBABILITY THEOREM 6


IF

A & B ARE INDEPENDENT EVENTS, THEN THE PROBABILITY OF BOTH A & B OCCURRING IS THE PRODUCT OF THEIR RESPECTIVE PROBABILITIES

P(A & B) = P(A) x P(B)

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FUNDAMENTALS OF PROBABILITY THEOREM 7


IF

A & B ARE DEPENDANT EVENTS, THE PROBABILITY OF BOTH A & B OCCURRING IS THE PRODUCT OF THE PROBABILITY OF A AND THE PROBABILITY THAT IF A OCCURRED, THEN B WILL ALSO

P(A & B) = P(A) x P(B|A)


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CONTROL CHARTS WHY INSPECTION DOESNT WORK

IN ORDER TO CONSISTENTLY SHIP QUALITY PRODUCT TO THE CUSTOMER YOU HAVE TO MONITOR THE PROCESS NOT THE PRODUCT
INSPECTION (if youre lucky) FINDS DEFECTS AFTER THE FACT THIS RESULTS IN C.O.P.Q. COSTS THAT COULD HAVE BEEN DETECTED OR AVOIDED MUCH EARLIER IN THE PROCESS
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CONTROL CHARTS BACKGROUND


DEVELOPED LINE

BY WALTER SHEWHART

- DEMINGs MENTOR (1931)

GRAPHS THAT DISPLAY DYNAMIC PICTURE OF PROCESS BEHAVIOR. >100 DATA POINTS TO START IN CONTROL: Within Control Limits OUT OF CONTROL: Exceed Control Limits
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CONTROL CHARTS TERMINOLOGY


CENTER

LINE (Process Average)

PLANNED POINT OF PRECISION

UPPER

CONTROL LIMIT (UCL):

HIGHEST POINT BEFORE PROCESS IS OUT OF CONTROL

LOWER

CONTROL LIMIT (LCL):

LOWEST POINT BEFORE PROCESS IS OUT OF CONTROL

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CONTROL CHARTS COMPONENTS


X: INDIVIDUAL MEASUREMENT
X-bar (X): SAMPLE AVERAGE X-double bar (X): GRAND AVERAGE R: SAMPLE RANGE R-bar (R): AVERAGE RANGE ALL SAMPLES s: STANDARD DEVIATION
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CONTROL CHARTS THE BASICS


CONTROL CHART
Upper Control Limit X (Grand Average or (Expected Result)

Y (results)

Lower Control Limit


X (observations)
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CONTROL CHARTS VARIATION


CONTROL

CHARTS DISTINGUISHES BETWEEN:


NATURAL VARIATION (COMMON CAUSE) UNNATURAL VARIATION (SPECIAL CAUSE)
UNNATURAL VARIATION
UCL Average LCL

NATURAL VARIATION UNNATURAL VARIATION


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CONTROL CHARTS VARIABLES CHART


SPECIFIC

PROCESS CHARACTERISTIC (MEASURABLE)


- WEIGHT, SIZE, TEMPERATURE

Xbar-R: MOST COMMON TYPE


Xbar-s: ANOTHER TYPE CONTROL

BOUNDARIES (UCL / LCL)

- NOT SPEC LIMITS - 99.73% OF POPULATION ( 3)


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CONTROL CHARTS XBAR - R CHART STEPS (1)


DETERMINE SAMPLE SIZE (n=2-6) DETERMINE FREQUENCY OF SAMPLING COLLECT 20-25 DATA SETS AVERAGE EACH SAMPLE (X-bar) RANGE FOR EACH SAMPLE (R) AVERAGE OF SAMPLE AVERAGES = X-double bar AVERAGE SAMPLE RANGES = R-bar

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CONTROL CHARTS XBAR - R CHART STEPS (2)


XBAR CONTROL

LIMITS:

- UCL = XDBAR + (A2)(RBAR) - LCL = XDBAR - (A2)(RBAR)


R

CONTROL LIMITS:
- UCL = (D4)(RBAR) - LCL = (D3)(RBAR)

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CONTROL CHARTS INTERPRETATION


SPECIAL: ANY POINT ABOVE UCL OR

BELOW LCL
RUN:

> 7 CONSECUTIVE PTS ABOVE OR BELOW CENTERLINE MORE THAN 1 POINT IN 20 CONSECUTIVE POINTS CLOSE TO UCL OR LCL 5-7 CONSECUTIVE POINTS IN ONE DIRECTION (UP OR DOWN)
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1-IN-20:

TREND:

CONTROL CHARTS
IN CONTROL w/ CHANCE VARIATION
Control Chart - Chance Variation

Y (results)

UCL

Ave. LCL
X (observations)

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CONTROL CHARTS LACK OF VARIABILITY


Control Chart - Lack of Variability

Y (results)

UCL Ave. LCL


X (observations)
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CONTROL CHARTS TRENDS


Control Chart - Trend

Y (results)

UCL Ave. LCL


X (observations)

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CONTROL CHARTS SHIFTS IN PROCESS LEVELS


Control Chart - Shifts in Process Level

Y (results)

UCL Ave. LCL


X (observations)

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CONTROL CHARTS RECURRING CYCLES


Control Chart - Recurring Cycles

Y (results)

UCL Ave. LCL


X (observations)

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CONTROL CHARTS
POINTS NEAR OR OUTSIDE LIMITS
Control Chart - Points Near or Outside Control Limits

Y (results)

UCL Ave. LCL


X (observations)

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CONTROL CHARTS ATTRIBUTE CHARTS


TRACKS ONE

CHARACTERISTICS

- SHORT OR TALL; PASS OR FAIL

CHART PER PROCESS FOLLOW TRENDS AND CYCLES EVALUATE ANY PROCESS CHANGE CONSISTS OF SEVERAL SUBGROUPS (a.k.a. - LOTS)
- SUBGROUP SIZE > 50
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CONTROL CHARTS
ATTRIBUTE CHART TYPES
p

chart = Proportion Defective np chart = Number Defective c chart = Number of nonconformities within a constant sample size u chart = Number of nonconformities within a varying sample size

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CONTROL CHARTS
np CHART EXAMPLE
np Chart
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# of Defects

20 15 10 5 0
UCL

11

13

15

17

19

Serial Number
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CONTROL CHARTS RISKS


RISK

1: FALSE ALARM
-

- REJECT GOOD LOT CALL PROCESS OUT OF CONTROL WHEN IN CONTROL


RISK

2: NO DETECTION OF PROBLEM
-

- SHIP BAD LOT CALL PROCESS IN CONTROL WHEN OUT OF CONTROL

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PROCESS CAPABILITY INDICES OVERVIEW


PROCESS CAPABILITY
FORMULAS

UNDERSTANDING WHAT
THEY MEAN

REACTING
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PROCESS CAPABILITY
MEASURE

OF THE CAPABILITY OF A PROCESS TO MEET A CUSTOMER SPECIFICATION LIMITS IT IS POSSIBLE TO HAVE A PROCESS THAT IS IN CONTROL, STABLE & PREDICTABLE YET STILL PRODUCE PRODUCT OUTSIDE OF CUSTOMER SPECIFICATION LIMITS (SCRAP)
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PROCESS CAPABILITY

THE MEASURE OF PROCESS CAPABILITY IS CALLED THE CAPABILITY INDEX

Cp

THE GOAL OF A PROCESS IS TO HAVE IT CENTERED ON THE TARGET (NOMINAL VALUE) THE MEASURE THE CENTERING IS Cpk USUALLY COMPANIES STRIVE FOR A Cp > 1.33 (2.0) & A Cpk > 1.0 (1.33)
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PROCESS CAPABILITY INDICES GETTING STARTED


THE

TRUE PROCESS CAPABILITY CAN NOT BE DETERMINE UNTIL THE PROCESS IS IN CONTROL CONTROL IS USUALLY VERIFIED VIA A CONTROL CHART CAPABILITY = 6

PROCESS

PROCESS

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SPC PROCESS CAPABILITY


PREDICTABLE

PATTERN OF STATISTICALLY STABLE BEHAVIOR CAUSES OF VARIATION COMPARED TO ENGINEERING SPECIFICATIONS NORMALLY DISTRIBUTED CONTROLLED TOLERANCES

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CONTROL CHARTS SPECIFICATION & CONTROL


OUT

OF CONTROL, IN SPECIFICATION
-

- PRODUCT CAN SHIP PROCESS NEEDS ADJUSTMENT


IN

CONTROL, OUT OF SPECIFICATION


-

- REWORK OR SCRAP PRODUCT PROCESS IS IN CONTROL BUT NOT CAPABLE POSSIBLE NEED FOR A NEW PROCESS

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Models of Six Sigma Overview

6
SIX SIGMA

Attitude
Customer

Focus

View Quality Externally From The Customers Perspective

Customers Have All The Votes Concerning Extent Of Satisfaction And Value

Strategic Focus
Voice Of The Customer
(Surveys/QMI)

Voice Of The Shareholder (Profitability Analysis)

Other Stakeholders Employees Lenders Regulators

Customer CTQ Prioritization

Stakeholder CTQs

Internal Processes And Output Measures

Core Processes And Output Measures

Key Subprocesses And Input Measures


Supplier Quality

Value Add Projects

Deployment

Principles Of Good Measures


List Of Criteria To Use In Evaluating Measurement

The Measure Must Be Important


The Measure Must Be Easy To Understand

The Measure Is Sensitive To The Right Things And Insensitive To Other Things The Measure Promotes Appropriate Analysis And Action
Data Needed Must Be Easy To Collect

Quality Measurement
There Are Two Types Of Measures

Effectiveness Measures:
The Degree To Which Customer Needs And Requirements Are Met And Exceeded Some Examples: Percent Defective Response Time

Billing Accuracy

Efficiency Measures:
The Amount Of Resources Allocated In Meeting And Exceeding Customer Requirements Some Examples: Cost Per Transaction Turnaround Time

Time Per Activity Amount Of Rework

Three Approaches to Six Sigma

Management
Process Management System
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How Do They Relate?

DAIC, DMADV And PM Systems


CTQ Tree

Process Improvement (DAIC) Project Focus On Root Causes That Drive CTQ Performance

QFD

Process Design (DMADV) Project Optimize Design Across CTQs And Subprocesses
Core Process Matrix

Process Management (PM System) Process Ongoing Management Of Processes


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Uses Of Measures And Data


Relation To The DAIC Cycle

Define

To Collect Facts About A Problem Or Opportunity

Analyze

To Collect Facts About A Problem Or Opportunity; Learn Why A Problem Is Happening; Develop Knowledge Key To Solving The Problem To Quantify The Impact Of A Solution, To Measure The Degree And Direction Of Change, To Compare Before And After Pictures Of The Process

Improve

Control

To Measure The Degree And Direction Of Change, To Communicate In An Objective Manner, To Take Action To Maintain Improvement Gains

Process Improvement Methods


The Different Faces

PDCA
Plan 1 2 3

7 STEPS
Charter/Theme Data Collection Root Cause

GEs DMAIC
Define Measure Analyze

Do

Solution Planning And Implementation


Confirming Solution Works Standardization Reflect Next Steps

Improve

Check

6 Act 7

Control

Understanding Customer Needs

Gather Input On Customer Needs (Listen To The Voice Of The Customer)

Analyze And Translate VOC Input Into Meaningful Terms

Define Requirements For The Process, Product, And/ Or Service

Process For Understanding Needs

Obtaining Information On Customer Needs


Focus

Groups Interviews Customer Observation Market Research Be A Customer Customer Complaints Surveys (e.g., Walker Surveys)

Key Issues With VOC


Qualitative Data Is Different Customer Data Can Be Overwhelming Different Voices Heard At Same Time Customers Often Have Difficulty In Expressing Requirements Short History With Tools That Deal With Qualitative Data Requires An Openness To Learning On The Part Of Providers Different Voices In Same Customer Biased By Collector

Identify The Vital Few


The Focus Of Process Improvement Y = f (X1, X2, ..., Xn) What Vital Few Process Inputs And Variables (Xs) Affect CTQ Process Performance Or Output Measures (Ys) Develop And Implement Solutions That Drive Improved Performance On These Vital Few Implement A Control Strategy For That Solution

Where To Focus
To Get Results, Should We Focus Our Behavior On The Y Or The X?

Response
Y Dependent Output Effect Symptom Monitor

Predictor

Y=

f (X)

X1...XN

Independent
Input-Process Cause

Problem
Control

Design For Six Sigma

For Quality Systems Management

Adapted from General Electric Capitol Systems Center for Learning and Organizational Excellence 1997-2000

When To Use DFSS


New

Product Or Service Introduction Or

Process Process

Broken Or Does Not Exist Has Reached Entitlement


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The 5-Step Methodology: New Tools


Additional Tools Emphasized In DMADV

Design For Six Sigma


Determine Objectives And Deployment Understand Customer Needs And Specify CTQs Determine Process Requirements, Capabilities And Options Develop Details And Optimized Process Design Verify Process Performance

Define

Measure

Analyze
NEW TOOLS

Design

Verify

MGPP

Customer Research QFD Benchmarking

QFD Benchmarking

FMEA/Errorproofing Process Simulation Service Design

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When To Use DFSS

Relation To DAIC
Define No
Process?
Does A Process Exist?

Yes Measure

Measure

Analyze

Analyze

Design

No

Is Incremental Improvement Enough?

Yes

Verify

Also Consider: Customer Impact

Improve

Competitive Environment Cost/Benefit Analysis


Control

Project Prioritization

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Deliverables

Define
Measure Analyze Design Verify

Define

Define Strategy, Deployment, Timing And Objectives


Service Concept/Target Customers Determined (High-Level) Multi-Generational Product Plan (MGPP) Developed (If Required) Business Case, Objectives And Targets Set Process Owner,Quality Facilitators, And Core Team Dynamics! Team Charter Documented And Reviewed With Process Owner Project Timeline In Place And Approved

Questions To Be Answered: What Are The Objectives Of The Project? What (Appropriate) Scope, Timeline And Resource Required?
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Roadmap Define

Measure
Measure Analyze Design Verify
Reviews: Tollgate 2 Measure Phase

Determine Customer Needs

Prioritize & Specify CTQs

Customer/Internal Risk

Identify Product/Service Customers And Stakeholders


Segmentation

Determine & Prioritize Customer CTQs At Detailed Level Determine & Prioritize Internal CTQs At Detailed Level
Risk, Financial Targets Compliance

Perform Risk Assessment Around Major CTQs


Worst-Case Scenarios Build Exit Strategies

Perform Customer Research


Interviews, Focus Groups, Existing Data, etc. Competitive Position

Review Results And Determine Impact

Determine Measures, Targets & Spec. Limits


Low, High Limits, Defect Definitions

Customer Impact Business Risks (Internal)

Prioritize Customer Needs

Tools: Quality Function Deployment (QFD) MGPP Benchmarking

Customer Research KANO Analysis

Brainstorming

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Deliverables Define

Measure
Measure Analyze Design Verify

Define Customer Needs And Specify CTQs


Customer And Internal Needs Defined Product And Service Requirements Determined Detailed And Measurable CTQs Developed Customer Expectations For CTQs Quantified And Prioritized Customer Risk Assessed

Questions To Be Answered: What Are The Most Important Requirements For The Product/Service? What Are My CTQs And What Are The Related Targets And Specifications?
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Analyze
Deliverables Define Measure Analyze Design Verify
Determine Functional Requirements, Analyze Capability Gaps, Identify Alternatives, And Choose High-Level Design, Develop Design Requirements
Map

CTQs To Design Requirements World-Class Processes And Understand Industry Standard

Benchmark Identify Assess Assess

And Quantify Capability Gaps (Existing Process Redesign)

IT and Supplier Options Process (Organization) Risk (Type High-Level (Clean Paper) Process Design

Develop

Questions To Be Answered: What Design Concepts Could Be Employed In The New Product/Service? Which Is The Best Concept? What Are The Requirements For The Detailed Design?
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Roadmap

Design
Measure Analyze Design Verify
Reviews: Tollgate 4 Design Phase

Define

Detailed Process Design

Simulation And Review

Control/Verification Plan

Divide Design Effort


Design Elements

Predict/Improve Design Capability

Develop Control Strategy

Develop Detailed Design


Develop Alternatives Choose Best Develop Details

Capability Analyses Failure Modes And Effects Analysis Simulate Process Performance

Control Charts/Measure Process Owners/Participants

Test And Validation Planning


Pilot Test Plan Developed/ Approved

Determine And Measure CTPs


Specification Limits Control Points, Measurements

Hold Design Reviews (Incl. Risk Assessment)


Capability, Produceability Compliance, Hardware, Software Integrate Design And Freeze

Hold Pilot Process Release Readiness Review

Tools: Process Map QFD Benchmarking

AND/PERT FMEA/EMEA Simulation Software

Control Plan Pilot/Test Plan

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Deliverables Define

Design
Measure Analyze Design Verify

Optimize The Design Of The Process


Design Detailed Processes, Facilities, etc. Establish Measurements For CTPs And Specify Spec. Limits

Assess Process Capability Of Design


Assess Possible Failures And Their Effects (FMEA) Complete Measurement And Control Plan Develop Verification/Test Plan

Questions To Be Answered: How Do I Create An Integrated, Optimized Design? How Will I Control My Process? How Will I Pilot The Process?
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Roadmap

Verify
Define Measure Analyze Design Verify
Reviews: Tollgate 5 Verify Phase

Execute Pilot

Analyze Results

Document/Transition

Pilot Roll-Out And Test


Limited Scale, All Functionality

Review Results Against Design Specifications


CTQs CTPs

Develop Implementation Plan Document Process, Procedures and Learnings


Lessons Learned Discussion Update DFSS Roadmap

Measure Performance

Ensure Control Plan Is Working Validate Simulation Tool

Document Test Results


Exception Reporting

Identify Root Cause Of Performance Problems


Controllable, Capable

Redesign/Re-Verify If Needed (Iterative Process) Scale Up Decision

Transition Process To Future Owners


Training

Support Commercialization Project Closure

Tools: Logbook Control Plan Procedures

Six Sigma Tools FMEA

Logbook Procedures Implementation Plan Closure Plan

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Deliverables Define Measure

Verify
Analyze Design
z Verify

Verify Product/Process Performance Against Set Project Targets


Roll-Out Pilot Process And Execute Test/Validation Plan Analyze Product/Process Performance Against Set Design Specs

Redesign If Needed To Fulfill Design Specifications (Iterative Process)


Document Process And Procedures, Learnings (Obligation 13) Transition Process And Prepare For Commercialization

Questions To Be Answered: Is The Product/Process Meeting The Set Requirements? Are All Process Steps Documented For Smooth Transition?
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End of Presentation

Thank you for your attention! We may have time for a few questions.

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