Six Sigma 5 - Control

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    D M A I C

    Control

    Control

    Six Sigma Road Map

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    Control

    QFDProcess Mapping

    Measurement Systems

    Benchmarking/Baselining

    Yield & SigmaBasic Quality Tools

    Design of Experiments

    Brainstorm & Workout

    Control Charts

    Procedures

    Training

    ProductProduct

    oror

    ServiceService

    1 Select CTQ Characteristics

    2 Define Performance Standards

    3 Validate Measurement System

    4 Establish Product Capabili ty5 Define Performance Objectives

    6 Identify Variation Sources

    7 Screen Potential Causes

    8 Discover Variable Relationships9 Establish Operating Tolerances

    10 Validate Measurement System

    11 Determine Process Capabil ity

    12 Implement Process Controls

    MMeasureeasure

    IImprovemprove

    CControlontrol

    AAnalyzenalyze

    StrategyStrategy CookbookCookbook Tools &Tools &

    ConceptsConcepts

    DDefineefine Define the problem Select cross-functional team Define team charter

    Moving into the Control Phase

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    Control: Main Objectives/Deliverables

    To make sure that ourprocess stays in control after the solution

    has been implemented.

    To quickly detect the out of control state and determine the

    associatedspecial causes so that actions can be taken to correct

    the problem before nonconformances are produced.

    Develop and implement control system

    Determine improved process capability

    Given the planned capability for controlling the Xs, what will

    be the new and improved capability for the process CTQ(s)?

    Process Before

    Improvement

    LSL USL

    Process After

    Improvement

    LSL USL

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    Maintaining Control

    Keep Xs within tolerance by using appropriate

    controls (Risk Management, Mistake Proofing, etc.)

    Apply control charts to Xs to monitor and control

    variation.

    Understand implications on existing quality plans due tomodification of current control systems.

    Establish transition plan for maintaining control of

    improved process (training plan, audit plan, etc.).

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    What is a Process Control System? A process control system

    strategy for maintaining the improved process performance

    over time

    identifies the specific actions and tools required for

    sustaining the process improvements or gains

    A control system may incorporate

    Risk Management

    Mistake-proofing devices

    Statist ical process control (SPC)

    Data collection plans

    Ongoing measurements

    Audit plans

    Response or Action plans

    Product drawings

    Process documentation

    Process ownership

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    Why is a Process

    Control System Important? Defines the actions, resources, and responsibilit iesneeded to make sure the problem remains corrected and thebenefits from the solution continue to be realized.

    Provides the methods and tools needed to maintain the

    process improvement, independent of the current team.

    Ensures that the improvements made have been

    documented (often necessary to meet regulatoryrequirements).

    Facilitates the solution's full-scale implementation by

    promoting a common understanding of the process and plannedimprovements.

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    Key Steps in

    Developing a Process Control System1. Complete an implementation plan.

    Plan and implement the solution and develop a method to controleach vital X or key sources of variation

    Define all possible areas that may require action in order to

    control the process X and then determine the appropriate course

    ofaction to take

    2. Develop a data collection plan to confirm that your solution

    meets your improvement goals. Establish ongoing measurements needed for the project Y and

    create a response plan to follow in case process performance falls

    below established standards

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    3) Communicate your strategy.

    Document the process and control plan to ensure process

    standardization and the continuation of the solution's benefits

    4) Train Personnel.

    5) Run the new process and collect the data to confirm

    your solution.

    Key Steps (contd)

    Th M i C t l M h i

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    Three Main Control Mechanisms

    Risk

    Management

    Risk

    Management

    SPCSPC

    MistakeProofingMistakeProofing

    Control

    PotentialProblems

    Avoid

    PotentialProblems

    D M A I C

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    Determine the probability and impact of each riskpresented by the planned process change.

    Link the probability and impact of occurrence to the risk,then determine the abatement action.

    Assign ownership and determine timing for eachabatement action.

    Risk Management

    Recommended tool

    Failure Modes & Effects Analysis (FMEA)

    D M A I C

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    Mistake Proofing Helps to sustain a solution by eliminating the possibility thatan X can be set outside the desired level or configuration...or

    Warns the process operator before the X goes outside limitsso preventative action can be taken.

    Mistake proofing can be used alone or with either riskmanagement or statistical process control to sustain a solution.

    D M A I C

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    Control charts can be used to monitor Xs and quicklydetect a change in the process due to special cause

    variation.

    Very helpful when your Xs cannot be mistake proofed or

    easily controlled within the required tolerance range.

    Statistical Process Control

    Tool we will look at Shewhart control charts,

    as an introduction to SPC

    D M A I C

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    Introduction to Statistical Process Control (SPC)

    (Recommended reference: Montgomery, Doug (2001).Introduction to StatisticalQuality Control, 4th edition, John Wiley & Sons, New York, NY.)

    From Montgomery:

    SPC a powerful collection of problem-solving tools useful in

    achieving process stability and improving capability through

    the reduction of variability.

    SPC can be applied to any process. Its seven major tools (often

    referred to as the magnificent seven) are:

    Histogram or stem-and-leaf display

    Check sheet

    Pareto chart Cause-and-effect diagram

    Control chart

    Scatter diagram

    Defect concentration

    diagram

    Focus of

    remaininglectures

    D M A I C

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    Concepts/definitions:

    Common cause variability Inherent or natural variability in a

    process, which is the cumulative effect of essentially unavoidable

    causes.

    Assignable cause or special cause variability - above and

    beyond the natural process variability. In a manufacturing process,this often comes from improperly adjusted machines, operator error

    or defective raw material. This may result in a shift in the process

    mean, an increase in the process variability, or both.

    Statistical process control charts are used to detect the presence

    of an assignable causes, by detecting a shift in the mean of

    the parameter being monitored, an increase in its variance,or both.

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    Statistical basis of the Control Chart

    Sample number or time

    Sam

    plequalitycharacteristic

    Upper control limit (UCL)Usually center line + 3s, where

    s is the standard error of the

    quality characteristic being plotted.

    Lower control limit (LCL)Usually center line - 3s, where

    s is the standard error of the

    quality characteristic being plotted.

    Center line avg value of the

    sample quality characteristicwhen the process is in control

    When the process is in control, all points should fall within the UCL

    and LCL, in an essentially random pattern.

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    Relationship between control charts and hypothesis testing

    Some similarities:

    Suppose the sample quality characteristic being plotted (vertical axis) is

    . If the current value of plots between the control limits, then we conclude

    that the process mean is in control; that is, it is equal to some value 0 . Ifexceeds either limit, we conclude that the process mean is out of control; that

    is, it is equal to some value 1 0.

    Type I and II errors apply to performance of control charts- Type I error is concluding that an in-control process is out of control

    - Type II error is concluding that in out-of-control process is in control

    Some differences:

    When testing statistical hypothesis, usually check for validity of

    assumptions. Control charts are used to check for departure from an assumed

    state.

    Assignable cause can result in different types of shifts in process parameters

    (e.g. sustained shift or abrupt temporary shift or steady drift).

    X

    X

    X

    D M A I C

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    Samplequalitycharacteristic Upper control limit (UCL)

    Lower control limit (LCL)

    Center line

    Detect a process shift and correct it, before it ever exceeds the

    specification limits (ie results in unacceptable quality)

    Controlling the process parameter within specification/tolerance

    Upper specification limit (USL)

    Lower specification limit (LSL)

    Sample number or time

    D M A I C

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    Process improvement using a control chart

    ProcessProcess

    Measurement SystemMeasurement System

    Input Output

    Detect assignable cause

    Identify root cause

    of the problem

    Implement

    corrective action

    Verify and

    follow up

    D M A I C

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    Guide to Univariate Process Monitoring and Control

    Continuous or Discrete data?

    Sample size Data type

    ContinousDiscrete (attribute)

    Shift sizeto detect

    n>1 n=1fraction Defects (count)

    large small large small large small large small

    SXRX,, Cusum

    EWMACusumEWMA

    CusumEWMA

    Using p

    Cusum

    EWMAUsing c,u;

    time between

    events

    cu

    pnp

    X (individuals)

    MR

    Shift sizeto detect

    Shift sizeto detect

    Shift sizeto detect

    Assumption: Process data is not autocorrelated

    Shewhart control chartsDr. Walter Shewhart, Bell Labs, 1920s

    (

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    Sensitizing rules for Shewhart control charts

    1. One or more points outside of the control limits.2. Two of 3 consecutive points outside the 2-sigma warning limits but still

    inside the control limits.

    3. Four of 5 consecutive points beyond the 1-sigma limits.

    4. A run of 8 consecutive points on one side of the center line.5. Six points in a row steadily increasing or decreasing.

    6. Fifteen points in a row in zone C.

    7. Fourteen points in a row alternating up and down.

    8. Eight points in a row on both sides of the center line with none in zone C.9. An unusual or nonrandom pattern in the data.

    10. One or more points near a warning or control limit.

    estern

    lectric

    ules

    + 1 s.e.

    -1 s.e.

    Zone C

    -2 s.e.

    + 2 s.e.

    + 3 s.e.

    -3 s.e.

    D M A I C

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    Guide to Univariate Process Monitoring and Control

    Continuous or Discrete data?

    Sample size Data type

    Continuous Discrete (attribute)

    Shift sizeto detect

    n>1 n=1fraction Defects (count)

    large small large small large small large small

    SXRX,, Cusum

    EWMACusumEWMA

    CusumEWMA

    Using p

    Cusum

    EWMAUsing c,u;

    time between

    events

    cu

    pnp

    X (individuals)

    MR

    Shift sizeto detect

    Shift sizeto detect

    Shift sizeto detect

    Assumption: Process data is not autocorrelated

    Shewhart control chartsDr. Walter Shewhart, Bell Labs, 1920s

    (

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    Control

    Shewhart control charts for a continuous Y or X

    Need to monitor both the mean and variability of the variable (Y

    or X).

    Assume n > 1, for every sample collected over time

    Monitor to control the process mean ( chart)

    Monitor S (sample std dev) or R (sample range) to control the

    process variability. (S chart or R chart)

    Typically use an S chart if n >10-12 or if n varies from sample to

    sample.

    R chart is more commonly used than an S chart.

    X X

    D M A I C

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    Constructing the and R chartsX

    Statistical basis:

    Assume that X, the process parameter to be monitored, is normallydistributed with mean and std deviation , both known.

    Assume that we are collecting m samples of size n from the processover time. The sample data can be summarized by and

    ri for i= 1, m.

    Therefore,

    ix

    =+

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    Typically, and are unknown, so they must be estimated fromthe sample data.

    Unbiased estimator for is mix

    m

    xi

    i ,...,1,1

    ==

    Unbiased estimator for is , where

    and d2 is listed for various sample sizes in Appendix Table VI of

    Montgomerys SQC book (reference given in Control 2.ppt).

    2d

    R miRm

    Ri

    i ,...,1,1

    ==

    D M A I C

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    Constructing the chartX

    Centerline = X

    LCL =

    =

    ndRX2

    3nd

    RX2

    3+UCL =

    =RAX 2 RAX 2+

    Where A2 is found in Appendix Table VI.

    See Piston ring example from handout (Montgomery, pages 213-215).

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    C l

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    Constructing the and R charts in MinitabX

    Piston ring example:

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    Select

    Xbar-R

    chart

    D M A I C

    C t l

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    Control

    D M A I C

    C t l

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    252015105Subgroup 0

    74.015

    74.005

    73.995

    73.985

    SampleM

    ean

    X=74.00

    3.0SL=74.01

    -3.0SL=73.99

    0.05

    0.04

    0.03

    0.02

    0.01

    0.00SampleR

    ange

    R=0.02324

    3.0SL=0.04914

    -3.0SL=0.00E+

    Xbar/R Chart for x1-x5

    Minitab output:

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    P-chart example (with Minitab)

    See example 6-1 in Montgomery, pages 288-290 of handout.

    N=50 for each of the 30 samplesSampl e Di

    num1 122 153 8

    4 105 46 77 168 99 1410 1011 512 6

    13 1714 1215 22

    16 817 1018 5

    19 1320 1121 2022 1823 2424 1525 926 1227 7

    28 1329 930 6

    Sampl e Di

    num

    D M A I C

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    Minitab input:

    D M A I C

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    Since our n was constant for all samples,it can be entered as a constant here.

    D M A I C

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    3020100

    0.5

    0.4

    0.3

    0.2

    0.1

    0.0

    Sample Number

    Proportion

    P Chart for Di

    1

    1

    P=0.2313

    3.0SL=0.4102

    -3.0SL=0.05243

    Minitab output: