Improve and Control: Module Introduction

For the Green Belt, Improve and Control are combined into a single phase in which you will identify improvements, pilot and test solutions, evaluate the practicality of the solutions and implement a control plan. To better understand this concept, the ASQ Body of Knowledge provides the following topics: Design of experiments (DOE) Define and describe basic DOE terms such as independent and dependent variables, factors and levels, response, treatment, error, repetition, and replication. Interpret main effects and interaction plots.

Statistical process control (SPC) Describe the objectives and benefits of SPC, including controlling process performance, identifying special and common causes, etc. Define and describe how rational subgrouping is used. Identify, select, construct, and apply the following types of control charts: X-bar and R, X-bar and s, individuals and moving range (ImR / XMR), median (X~ and R), p, np, c and u. Interpret control charts and distinguish between common and special causes using rules for determining statistical control.

Implement and validate solutions Use various improvement methods such as brainstorming, main effects analysis, multi-vari studies, FMEA, measurement system capability re-analysis, and post-improvement capability analysis to identify, implement, and validate solutions through F-test, t-test, etc .

Control plan Assist in developing a control plan to document and hold the gains, and assist in implementing controls and monitoring systems.

Improve and Control: Module Overview

The tools and objectives of the Improve and Control phase are illustrated below.

Design of Experiments: Learning Objectives

At the end of this Improve and Control topic, all learners will be able to: define and describe basic DOE terms such as independent and dependent variables, factors and levels, response, treatment, error, repetition, and replication. interpret main effects and interaction plots.

Design and Analysis of Experiments

Design of experiments (DOE) are used to craft well-designed efforts to identify which process changes yield the best possible results for sustained improvement. Whereas most experiments address only one factor at a time, the design and analysis of experiments methodology focuses on multiple factors at one time. DOE provides the data that illustrates the significance to the output of input variables acting alone or interacting with one another. ASQ defines design of experiments (DOE) as a branch of applied statistics dealing with planning, conducting, analyzing and interpreting controlled tests to evaluate the factors that control the value of a parameter or group of parameters. Design and analysis of experiments provides these advantages over other,

more traditional methods: Evaluating multiple factors at the same time can reduce the time needed for experimentation. Some well-designed experiments do not require the use of sophisticated statistical methods to understand the results at a basic level. However, computer software can be used to yield very precise results as needed. The costs vary depending on the experiment, but the financial benefits realized from these experiments can be substantial.

DOE Components
The graphic below depicts an example of a relationship between the components that DOE examines. process input variables, normally referred to as x variables and as factors in design and analysis of experiments terminology process output variables, normally referred to as y variables and as responses in design and analysis of experiments terminology the relationship between input variables and output variables the interaction, or relationship, between input variables as it relates to the output variables

DOE Terminology
Certain terms used with Design of Experiments need to be defined clearly.

Term Independent Variable Dependent Variable

Definition A variable that can contribute to the explanation of the outcome of an experiment. Also known as a predictor variable. A variable representing the outcome of an experiment. The response is often referred to as the output variable" orresponse variable.

Factors

A predictor (or independent) variable that is varied with the intent of assessing its effect on a response (or dependent) variable. Most often referred to as an input variable. A factor may be quantitative (such as a temperature in degrees F or cycle time in pieces per minute) or qualitative (such as a different production machine or a different mold). A specific setting for a factor. In DOE, levels are frequently set as high and low for each factor. A potential setting, value, or assignment of a factor of the value of the predictor variable. If the experiment is to be performed at two different temperatures, then the factor temperature has two levels. For example, if the factor is time, then the low level may be 50 minutes, and the high level may be 70 minutes. A single level assigned to a single factor in an experiment. For example, cycle time at 300 pieces per minute is a treatment. A treatment combination is the set of levels for all factors in a specific experimental run. For example, a temperature of 150 degrees F, cycle time of 300 pieces per minute, and a blow pressure of 50 psi is a treatment combination. The specific setting of factor levels for an experimental unit. For example, a level of temperature at 65 degrees C and a level of time at 45 minutes describe a treatment as it relates to an output of yield. An error from an experiment reveals variation in the outcome of identical tests. An error is variation in the response variable beyond that accounted for by the factors, blocks, or other assignable sources while conducting an experiment. Many times referred to as experimental error. Performance of an experiment more than once for a given set of predictor variables. Each of the repetitions of the experiment is called a replicate. Replication differs from repeated measures in that replication is a repeat of the entire experiment for a given set of predictor variables, not just repeat of measurements of the same experiment. Note: Replication increases the precision of the estimates of the effects in an experiment. Replication is more effective when all elements contributing to the experimental error are included. In some cases, replication may be limited to repeated measures under essentially the same conditions. In other cases, replication may be deliberately different, though similar, in order to make the results more general. A repeated measure, or repetition, is the measurement of a response variable more than once under similar conditions. Repeated measures allow one to determine the inherent variability in the measurement system. Repetition occurs when each run is conducted n times in a row.

Levels

Response

Treatment

Error

Replication

Repeated Measures (Repetition)

Interactions and Main Effects

Interactions are a condition when the effect of one factor depends on the level of another input factor. The conditions combined effect is greater than the individual effect either factor would create on its own and the sum of the individual effects. For instance, the combined effect of medication X and alcohol causes more drowsiness than either the medication or alcohol does on its own. Think of this interaction as 2 + 2 = 5. When studying a process in a Six Sigma project, many factors interact. Using experiments containing all combinations of all levels of all factors (full factorial) is very time-consuming and not always cost-effective. With fractional factorial(selected) experiments, not all interactions occur. Since advantages and disadvantages exist, you must carefully plan to improve the process. You can view a main effects analysis of an interaction from the perspective of either variable. Keep in mind that one perspective may provide a better view than the other. The degree of nonparallel lines visually displays the interaction. You can determine a mathematical relationship by relating two points from each line and compute the relationship as follows:

A x B interaction effect = (A1B1 - A2B1) - (A1B2 - A2B2)

Statistical Process Control: Learning Objectives

At the end of this Improve and Control topic, all learners will be able to: describe the objectives and benefits of SPC, including controlling process performance, identifying special and common causes, etc. define and describe how rational subgrouping is used. identify, select, construct, and apply the following types of control charts:X-bar and R, X-bar and s, individuals and moving range (ImR / XMR), median (X~ and R), p, np, c and u. interpret control charts and distinguish between common and special causes using rules for determining statistical control.

SPC Background
"A phenomenon will be said to be controlled, when, through the use of past experience, we can predict, at least within limits, how the phenomenon may be expected to behave in the future." - Walter Shewhart Statistical process control (SPC) is not a particular technique or procedure, but a philosophy focusing on optimizing continuous improvement by using statistical tools for analyzing data, making inferences about process behavior, and then making a decision. Pioneered by Dr. Walter Shewhart in the 1920s and later enhanced by Dr. W. Edwards Deming, SPC is a collection of statistical techniques used to measure and analyze the variation in processes. A process is monitored by sampling data from the process stream. The data provide clues about the process operation from which consistency of process improvement can be measured. If the variability is large, the next step is to investigate root causes of the variability. The basic rule of SPC is to leave the variations from common causes to chance, and instead focus on identifying and eliminating special causes. Since all processes are subject to variation, SPC relies on the evidence rather than intuition.

SPC Objectives
Dr. Shewharts pioneering work in the area of process analysis enabled generations of quality engineers to adopt an effective approach to data analysis and process monitoring. For use by any organization measuring processes (not just manufacturing), SPC is a feedback system for identifying the need for process intervention.

Objectives of SPC Produce data to inform and guide process improvement Reduce variation Increase knowledge about the process Quickly detect occurrences of special causes shifting the process

Uses of SPC techniques Monitor processes for maintaining control Detect out-of-control conditions in processes Analyze process capability Serve as a decision-making tool Assures customers that product is produced consistently over time Enables proactive process improvement

Increase profits and improve customer service by the following: Assuring customers that product is produced consistently over time Increasing product consistency Improving product quality Reducing the need for inspection Decreasing scrap and rework Increasing production output Streamlining processes

SPC Tools
Basic Quality Tools The following are important SPC tools: Flow charts Run charts Pareto charts and analysis Fishbone diagrams Histograms Scatter diagrams

SPC Methods Control charts Pre-control charts Process capability analysis

Advanced Statistical Analysis Methods Regression and correlation Hypothesis testing

Design of experiments Analysis of variance

SPC Basic Statistical Concepts

These concepts are the basis for statistical process control. Variation A change in the process data, a characteristic, or a function that results from some cause. Stability The condition when observing only random variation around the process target; the absence of special causes of variation; the property of being in statistical control. Capability The performance of a process demonstrated to be in a state of statistical control. Overadjustment Making adjustments to a process based on limited data

Rational Subgrouping
Rational subgrouping is a subset defined by a specific factor. As a sample with variations caused by conditions producing random effects, the rational subgroup identifies and separates variations by special causes. Rational subgroups are our attempt to ask the right questions about the data. Selecting the appropriate control chart to use depends on the subgroups. The issue of rational subgroups is perhaps one of the least understood ideas in all of statistical process control. As Donald J. Wheeler points out in Advanced Topics in Statistical Process Control, rational subgroups are part of the conceptual foundation of Shewhart charts.

Key Concepts in Rational Subgrouping

Select a Measurement Identify a significant process variable or product characteristic to track. Focus on the vital few, not the trivial many. Select the appropriate data for the charts you may want to use. Practice similar subgroup elements. Number of Subgroups Establishing rational subgroups is important for dividing observations. Compute statistics for each subgroup separately before plotting on the control chart. Define a minimal chance of variation within a subgroup: o Five subgroups of five typically provide more useful information than one subgroup of 25, because the elapsed time between samples is minimized, providing more opportunities to detect process shift.

Defect or Defective Defect An undesirable result on a product; also known as a nonconformity. (Note: The biggest difference between the term defect and nonconformity is that defect has product liability associated with it.) Defective ) An entire unit failing to meet specifications; also known as a nonconformance. (Note: A defective part may have one or more defects.)

Sample Size Generally, a sample size consists of five to ten items produced under essentially the same conditions.

Rational Subgrouping Summary

Construct rational subgroups to allow for quick identification of the most important sources of variation. This is typically more important than the question of subgroup size, though more people seem to worry about subgroup size. Without an appropriately designed control chart (one that detects the signals effectively and helps identify the sources of variation), control

charts simply become data collection devices that do not support the process of continual improvement (and, in fact, probably hinder it).

Rational Subgrouping Activity

Rationalsubgroupsaresubgroupsofdatacollectedunderrelativelyhomogeneousconditions,and structuredinawaythatallowsforthemonitoringofthesourcesofvariationofinterest.Seebelowfor anexampleofrationalsubgroups.Samplesinarationalsubgroupshouldbefromthesamesetof causes.Forexample,samplesmanufacturedondifferentmachineprocesseswouldnotnormallybe includedinthesamesubgroupormonitoredonthesamecontrolchart.

ForExample
Aqualityengineer(QE)desirestomonitoraprocessthatmanufacturesPET(plastic)bottlesforthe beverageindustry.Thebottlesareinjectionmoldedonamulticavitycarousel.Theparticularcarousel containsfourcavities,andtheQEinitiallydecidestotakethreebottlesfromeachcavityeachhourand measureacriticalcharacteristic.Thedatamightlooklikethetablebelow(whereM1,M2,andM3are thethreemeasures). Option1:Everyhour,takethreesamples(subgroups)offourbottles(n=4)atrandom.Plottheprocess (ononechart). Positives Eachhourhasthreeaveragesandthreerangestoplot. Therangeindicatesoverallprocessvariation. Theoptionprovidesoverallassessmentofthequalityduringthetimeperiod. Optionprovidesdataforoverallassessmentofprocesscapability. Thisistheeasiestmethodofsampling.

Negatives Dataaresampledwithoutregardastowhichcavity. Donotprovidedatarelativetoindividualcavitiestoassistinlookingforcausesofvariation.

Option2:Everyhour,takethreesamples(subgroups)offourbottles(n=4)ofonebottlefromeach cavity.Plotchartforprocessononechart. Positives Datarecordsthecavitythebottleisfrom. Eachhourhasthreeaveragesandthreerangestoplot. Dataprovidesoverallassessmentofthequalityduringthetimeperiod. Dataprovidesabasisforoverallassessmentofprocesscapability. Therangereflectsthedifferencebetweenthecavities.

Negatives Procedurerequiresmoretimecollectingandrecordingdata. Datawouldbeavailabletoperformassessmentbycavity,butrequiresadditionalanalysis,not immediatefeedback. Thechartmayindicateinstabilityduetothemixtureofthethreecavities,evenwhenthethree cavitiesarestable.

Option3:Everyhour,takefoursamples(subgroups)andthreebottles(n=3)witheachsamplefroma differentcavity.Plotcharteachcavityonseparatecharts. Positives Maintainingfourseparatecharts(onepercavity). Eachcharthasonemeanandonerangetoploteachhour. Easyidentificationofwhere(whichcavity)changesintheprocessoccur. Areasofneedforimprovementcanbereadilytargeted. Subgroupsprovidedatarelativetocapabilitybycavity. Subgroupsprovidemostinformationrelativetotheprocess.

Negatives Requiresmoretimefordatacollectionandplotting. Requirescollectingmoredatatoestablishthecontrollimits.

Key Questions
Each option is appropriate depending on the circumstances. Key questions to consider are the following:

How capable is the process? Is monitoring overall quality more important than detecting shifts? How easy is it to identify a special cause when it occurs? How much does it cost to collect the data and perform the tests?

Summary

Rational subgroups are our attempts to be sure that we are asking the right questions about the data. Creating rational subgroups is not the same thing as obtaining a random sample. When obtaining a random sample, each member of the sampling frame has the same chance of being selected (not the goal of rational subgrouping). Construct rational subgroups to allow for quick identification of the most important sources of variation. Subgroup size is important, but not more important than identifying sources of variation. Without appropriate design, control charts simply become data collection devices that do not support the process of continual improvement. Effective detection of signals and identification of the sources of variation results from appropriately designed control charts.

Rational Subgrouping Exercise

The following example is taken from The Certified Six Sigma Black Belt Handbook by Donald W. Benbow and T.M. Kubiak. Suppose a candy-making process uses 40 pistons to deposit 40 chocolate pieces on a moving sheet of wax paper in a 5 x 8 array on a conveyor belt. Below are two options illustrating how a rational subgrouping of five are selected: Option 1: The first five chocolates in each row formed by five different pistons. Option 2: The upper left-hand chocolate formed in five consecutive arrays by the same piston.

Answer:(Option2isRightAnswer)

Control Charts
Originated by Walter Shewhart, control charts are a type of graph for studying how a process changes over time. Samples are entered onto a control chart in a time-order sequence. By comparing data points to a central line average, with an upper control limit (UCL) and lower control limit (LCL), users can note variation, track common causes, and seek special causes. Alternative names are statistical process control charts and Shewhart charts.

Control Chart Benefits

The addition of calculated control limits facilitates the ability to detect special or assignable causes of variation. The current process is displayed and compared to the improved process by identifying shifts in either average or variation. Since every process varies within predictable limits, identifying assignable causes and addressing them will save money.

Control Charts: Run Charts

Run charts display data measures over time without the central line average and the limits

Basic Control Charts

Use Basic Control Charts When
Controlling ongoing processes by finding and correcting problems as they occur. Predicting the expected range of outcomes from a process. Determining if a process is in statistical control. Differentiating variation from non-routine events or common causes. Determining whether the quality improvement should aim to prevent specific problems or make fundamental process changes. The process is in statistical control.

Procedure
1. Choose the appropriate control chart for your data (Information about specific type appears later). 2. Determine the appropriate time period for collecting and plotting data. 3. Collect data, and construct the chart with trial control limits, using rational subgrouping. 4. Analyze the chart to determine process stability, looking for out-ofcontrol signals. 5. Resolve any control issues, looking for assignable causes. 6. Recalculate the limits as necessary. 7. Prepare charts and instructions for production use. 8. Take samples and record data on the control chart. 9. Look for out-of-control conditions. 10. When out-of-control conditions occur, take appropriate action. Otherwise, leave the process alone.

Control Chart Tips

Time is always the horizontal (X) axis. Control charts must have: o Centerline (grand average) o An upper control limit (UCL) and lower control limit (LCL) o Data points o Title o Legend o Labeled axes When starting a new control chart, the process must be in control. The control limits calculated from the first 20 points are conditional limits. Recalculate the control limits after collecting at least 25 to 30 time-ordered points from a period when the process is operating in control, or whenever a significant and known change to the process has occurred. Developing a control chart with fewer than 25-30 points may not be statistically valid. If encountering an outlier when developing the control chart, investigate to see if there is an assignable cause; if so, eliminate the point from the analysis.

Control Chart Types

Different types of control charts exist depending on the measurement used. This topic reviews two basic categories of control: variable charts and attribute charts. Variable charts Constructed from variable data (data that consists of measurements like weight, length, etc.) Variable data contains more information than data that simply qualifies or counts something. Consequently, variable charts are some of the most powerful tools in quality improvement. Types: Average and range (X-bar and R), median and range (X~ and R), average and standard deviation (X-bar and s), and individual and moving range (X-MR, I-MR, or I-mR). Samples are taken in a constant subgroup size of between two and ten at predetermined intervals with the statistic (mean and range or standard deviation) calculated and recorded in a time-order sequence on the chart.

Attribute charts Use attribute data (data that counts items, such as the number of rejects or the number of errors). Control charts based on attribute data are generally less powerful. Sometimes more difficult to interpret than variable charts. Types: p-charts, np-charts, c-charts, u-charts. Samples are taken from lots of material where the number of defective units in the sample are counted (for p and np-charts) or the number of individual defects are counted for a defined unit (c and ucharts). Sample data are recorded in a time-order sequence on the chart. Attribute charts that count defectives (p charts and np charts) are based on the binomial distribution. Attribute charts that count defects (c charts and u charts) are based on the Poisson distribution.

The structure of both types of control charts is similar, but the statistical construction of the control limits is different due to the differences in the distributions.

Control Charts Roadmap

The roadmap below leads users to the appropriate control chart. To introduce a control chart type in upcoming sections, this map will reappear highlighting the path (characteristics) of the particular control chart. Study each to learn the characteristics of each control chart.

X-Bar and R
The average and range chart or X-bar and R chart is the first type of variable control chart we will explore.

Calculating X-Bar and R

X-bar and R charts are commonly used as X-bar evaluates the processs central tendency over time, while the range (R) evaluates the process spread over time. Calculating X-bar and R requires the steps presented on the following pages.

Collect Data by Subgroup

Calculate the Mean for Each Group

Calculate the Range within Each Group

Find the Appropriate A2 Value

Calculate the UCL and LCL for the Mean

Find D4 and D3 from Reference Table

Calculate the UCL and LCL for the Ranges

Finished

Completed X-bar and R Graph

The image below is an example of a completed X-bar and R graph.

Median (X-Tilde and R)

The median control chart or X~ and R chart is easier to use and requires fewer calculations than the average and range chart or X-bar and R chart. The median, rather than the average of the sample, is plotted. The advantage of using a median chart is the ease of using arithmetic. X~ and R charts are similar to X-bar and R charts, but plot the median of the sample rather than the average. The median chart is often used when outliers are expected.

X-bar and s
The average and standard deviation chart (X-bar and s) is quite similar to the average and range chart, except that the statistic used to measure subgroup dispersion is the subgroup standard deviation, instead of the subgroup range. Mean-and-standard deviation (X-bar and s) control charts are conceptually similar to X-bar and R control charts. Instead of using the subgroups range, the X-bar and s use standard deviation (a measure of dispersion). With subgroups greater than 10, X-bar and s are more efficient than X-bar and R, but more difficult to calculate and understand.

Moving Range
Various control charts may be applicable depending on the situation and available data. Given the unknowns of future projects and situations, the Certified Quality professional may prefer to use the individual and moving range (X-MR, I-MR) control chart. Quality professionals often use this chart with limited data, such as when production rates are slow, testing costs are very high, or there is a high level of uncertainty relative to future projects. The individual and moving range chart is also used where data are plentiful, such as in the case of automatic testing of every unit where no basis exists for establishing subgroups. On a typical moving range chart, calculate the range between two successive units (n = 2), but more successive units may be included in the range calculation. The factors for calculating upper and lower control limits on the MR-chart are the same as those used in the R-chart. On the X-chart, plot every observation, and calculate the upper and lower limits using the factor E2.

X-MR
The individual and moving range chart (X-MR, I-MR) is applicable when the sample size used for process monitoring is n = 1. Also called I-MR, it is named moving range because of the calculation of a constant changing range between two successive values. Good for: individual measurements or situations where there is not a basis for rational subgrouping infrequently repeating processes process operating differently at different times

p-Charts
The p-chart is one of the most-used types of attribute charts. It shows the proportion of defective items in successive samples of equal or varying size. The proportion is the number of defectives divided by the number in the sample. To develop the control limits for a p-chart, consider this example, in which we are inspecting a variable sample size and recording the number of nonconforming items in each sample.

p-chart Concepts
Variable Sample Sizes Sample size n does not affect the centerline on a p-chart. However, the calculation of the upper and lower control limits is dependent on the sample size. Where a sample size is variable, a common technique is to calculate the upper and lower control limits using the average sample size. When using a chart with control limits, evaluate any points occurring near the upper or lower control limits to determine if, when the actual limits of the sample size are used, an out-of-control condition exists. Alternative Methods Once establishing the process average p, alternative methods are available to handle variable sample sizes. If using a computer to monitor the process, it is common to calculate the limits based on every sample size. Some refer to this process as having moving limits. OR Put two sets of limits on the chart, calculated using the maximum and minimum anticipated sample sizes. Then evaluate the points falling in between these two limits to determine if, when actual limits for the sample size are used, they signal out-of-control conditions.

np-Charts
The np-chart, number of defective units, is related to the p-chart. The np-chart is a control chart of the counts of nonconforming items (defectives) in successive samples of constant size. The np-chart can be used in place of the p-chart to plot the counts of nonconforming items when there is a constant sample size. In effect, using np-charts involves converting from proportions to a plot of the actual counts.

Summary of p and np Charts

The p-chart is used for fraction nonconforming and is used most often. It provides an estimate of the ongoing quality level, and it is easy to use. A customer might request using a p-chart to ensure that a certain quality level is being obtained. Recall that p-charts have the advantage of being applicable when subgroup size varies. The np-chart, a p-chart cousin, is more difficult to use when the subgroup size varies. The centerlines in p-charts and np-charts may not be midway between the control limits because sometimes the lower control limit is zero. Binomial distribution serves as the statistical model for both p-charts and npcharts.Thus, quality professionals often misuse p and np-charts because they fail to realize that the data does not meet the conditions of a binomial model.

Is a Binomial Model Appropriate?

There are several conditions to meet before the binomial model is applicable and p and np-charts are appropriate:

Each item must either possess or not possess the characteristic in question to the quality standard (items judged as acceptable or not acceptable, good or bad, etc.). The probability that a given item possesses the characteristic of interest is independent of whether there are or not preceding items.

Quality professionals often use X-MR charts instead of p and np-charts, especially when there is doubt about meeting the binomial model conditions.

Introducing c and u-charts

C-charts and u-charts are based on the Poisson distribution. These attribute control charts are used to monitor the count of individual defects rather than the number of defective units. Quality professionals use c- and u-charts where there are opportunities for many defects per defined inspection unit. With c- and u-charts, it is very important to define the defects and the unit. The unit is the area of opportunity to count the defects. Inspection Unit 50 miles of pipeline 10 yards of cloth 50 circuit boards 100 forms Type of Defects Counted Weld defects Blemishes, snags Solder joint defects, damaged components Incorrect data entry, missing data

c-Chart formula
Thecchartformulaassumescountingthenumberofdefectsinthesameareaofopportunity. Thecintheformulaisthenumberofdefectsfoundinthedefinedinspectionunit,andthatis plottedonthechart.Forexample,iftheinspectionunitis100forms,countthedefectsona sampleof100formsandplotthatnumberonthecchart.

c-Charts
Use the c-chart (c standing for counts) when you are interested in the number of defects per inspection unit. The formulas for the control limits for the c-chart (and the u-chart, discussed later) are based upon the Poisson model.

u-Chart Formula
With a u-chart, the number of inspection units may vary. The u-chart requires an additional calculation with each sample to determine the average number of defects per inspection unit. The n in the formula is the number of inspection units in the sample.

u-Charts
The u-chart monitors the defects (nonconformities) per unit when the number of inspection units is allowed to vary.

ForExample
A firm generates 250 forms in a given day and inspection found 27 errors. Since a sample contains 100 forms, 2.5 inspected units were examined (250 forms / 100 forms/sample). To calculate u (defects per unit), divide the number of errors by the inspection unit (27 errors / 2.5 inspection units). Plot the u = 10.8 defects per unit on the control chart.

u and Variable Sample Size

Because the u-chart equations for the upper and lower control limits are dependent on the number of inspection units (n), use the same alternatives relative to handling the variable sample size as with the p-charts: Use the average sample size to develop the limits, and evaluate points close to the limits. Calculate the limits for each sample based on n.

Summary of c and u Charts

Use the c-chart to monitor the number of defects (nonconformities). The application of the cchart requires the inspection unit to be defined clearly and the areas of opportunity to be consistent. The u-chart monitors the defects (nonconformities) per unit, and does not require a constant sample size. This is the reason you had to calculate two sets of limits in the example. It essentially changes the counts into rates in cases where the area of opportunity varies from sample to sample. The Poisson model is the statistical model that is the foundation of c-charts and u-charts. Like the binomial model for p-charts and np-charts, the Poisson model has several conditions that must be met: The counts must be discrete events. The counts must be clearly defined with an unambiguous area of opportunity described. The events must be independent. The defects (nonconformities) must be few compared to the areas of opportunity.

Advantage Can be used where the nonconformities from many potential sources may be found in a single inspection.

Disadvantage Requires a constant sample size.

Summary of Attribute Charts

Quality professionals often use attribute charts to monitor the quality of a complex unit when the data are easy to obtain. Many companies are including attribute gauging in their measurement systems. Attribute charts are some of the first charts a quality professional may attempt to use. They will likely discover that a critical process characteristic needs to be monitored with a variable chart. p-Chart The most often used, the p-chart employs fraction nonconforming data. It provides an estimate of the ongoing quality level, and it is easy to use. A customer might request using a p-chart to ensure that a certain quality level is being obtained. Remember that p-charts have the advantage of being applicable when the subgroup size varies. np-Chart The np-chart records the number of defective units (nonconformances) and is more difficult to use when the subgroup size varies. c-Chart The c-chart monitors the number of nonconformities (defects) and requires the inspection unit to be defined clearly and the area of opportunity to be consistent. u-Chart The u-chart monitors the nonconformities (defects) per unit. It essentially changes the counts into rates in cases where the area of opportunity varies from sample to sample.

Analyzing Control Charts

Every process varies, and the purpose of control charts is to identify how the process is doing against the customers target and specifications. Six Sigma links control charts to process capability diagrams. Control limits are 3 on each side of the targe,t and in-control processes have 99.7% of the results within the limits. Control limits set the process boundaries for detecting variations. Since variable data control charts (X and R, X~ and R, X and s and X-MR) have two graphs, if either graph shows data outside the limits, the process is out of control. Control charts also serve as the processs historical record.

Identifying Causes
Interpreting control charts is an art grounded in continual analysis over time. Many common anomalies (such as spikes and points outside the limits) may be obvious; however, some special causes are subtle, and noticed only by the keen observer using the control chart. Control charts help detect special causes that must be found and eliminated. On the bottom image, notice the difference between first and second shift. Where are special causes noted? Common causes?

Common Signals
To see some of the common signs of an abnormality on a control chart, roll over each term below to see a chart example. When finished, see the next screen for Western Electric guidelines for interpreting control charts.

Common Signal Rules

Wheeler lists Western Electrics four out-of-control signal rules: Rule 1: A point outside a three-sigma limit is taken as a signal of exceptional variation that is attributable to a dominant assignable cause. Rule 2: Two out of three successive values on the same side of the centerline and more than two standard deviations away from the centerline are taken as a signal of a moderate but sustained shift in the process. Rule 3: Four out of five successive values on the same side of the centerline and more than one standard deviation away from the centerline are taken as a signal of a moderate but sustained shift in the process. Rule 4: Eight successive values on the same side of the centerline are taken as a signal of a small but sustained shift. Wheeler states that the presence of any one of these four conditions implies that enough evidence has been accumulated to make you reasonably confident that there has been a change in the process.

Implement and Validate Solutions: Learning Objectives

At the end of this Improve and Control topic, all learners will be able to use various improvement methods such as brainstorming, main effects analysis, multi-vari studies, FMEA, measurement system capability re-analysis, and post-improvement capability analysis to identify, implement, and validate solutions through F-test, t-test, etc .

Implement and Validate Solutions: Introduction

After the Analyze phase of the Six Sigma process, you have identified significant Xs through the statistical testing process. The next step of the Improve and Control phase of the Six Sigma process is to implement and validate solutions through a four-part process:

Implement and Validate Solutions: Identify Solutions

Step 1: Identify solutions to address critical Xs. Solutions are meant to improve the output (Y) through modification and control of the process and possible removal of one or more of the significant Xs. The following are tools and exercises to generate solution identification: The critical X summary chart is a popular tool used to state the critical Xs identified through the DMAIC process.

Identify solutions to address critical Xs (continued)

Step 1: Identify solutions to address critical Xs (continued) A brainstorming session is a tool for generating as many ideas or solutions as possible to a problem or issue. In this case, a data-driven brainstorming session is used instead of a gut feeling, I think, or I feel session. At the beginning of your project, a fishbone diagram was used to classify the sources of defects in the process. For the Improve and Control phase, potential solutions can be classified in the fishbone diagram using the same categories that you used earlier in the project to identify potential Xs. In the fishbone diagram under the cause-and-effect-category name, click Solution to see a solution example for each category.

Select and Screen Solutions

Step 2: Select and screen solutions. You will not implement all potential solutions discussed as a result of brainstorming. Selection of the best solutions will depend on other factors beyond the statistical significance of Xs. You need to consider factors such as cost, effort, return on investment, risk and timing. The solution selection matrix is a tool to assist in prioritizing potential improvements based on three criteria: Cost to implement Impact of improvements on critical Xs Potential risks of implementing an improvement

Solution selection matrices are templates, and may vary in format to best fit the industry or business of interest. Keep in mind that just because something has been proven to have a statistical impact does not mean it has a practical impact!

Pilot - Implements Solutions

Step 3: Pilot - implement solutions. After completing the FMEA exercise in Step 2, characterize and compare the improvements with high RPNs. The team should discuss how improvements might be implemented and the cost compared to the benefits provided. If possible, pilot the solution to demonstrate results and to verify that there are no unintended side effects. You can use a DOE to test potential solutions in pilot form. An example of a pilot would be: during a three-month time period (quarterly), the manual exception processing within the corporate account department was removed from 80% of the wholesale lockbox transactions. this data was tracked, collected, and analyzed to compare to the existing process to see if there was an improvement. Using a statistical software program such as Minitab and multi-vari studies, the results are shown on the next page.

Pilot - Implement Solutions (continued)

This test is used to determine if the process defect rate (proportion, p) of one sample differs by a certain amount D from that of another sample (i.e., before and after improvements are implemented).

Ho: p1 = p2 Ha: p1 p2 Sample 1 2 X 1417 421 N 2106 2106 Sample p 0.672840 0.199905

Estimate for p(1) - p(2): 0.472934 95% Confidence Interval for p(1) - p(2): (0.446604, 0.499264) Test for p(1) - p(2) = 0 (vs. not = 0): Z = 35.20 p-value = 0.000

The p-value <.05 (.0000), so the null hypothesis is rejected (Ha: p1 p2). They are statistically different. This test shows that implementing the suggested solutions will statistically improve the wholesale lockbox process within the corporate account department. The improved process should be maps are modified based on pilot data and analysis.

Validate Solutions
Step 4: Validate solutions. After implementing solutions, it is important to validate the solutions to see if the process has been statistically changed. To complete this step, use various tools such as measurement system capability re-analysis, post improvement capability analysis, and multi-vari studies: 1. The measurement system capability analysis (Gauge R&R) used during the Measure phase can be used here to see if there is an improvement with repeatability, reproducibility, and accuracy. Readminister the Gauge R&R study from the Measure phase and compare results. 2. To estimate process improvements gained through the projects life, compare the current process performance to the improved process performance. Complete a process capability study during the Measure phase to see how capable the process is currently performing and then again as a post-improvement capability analysis to see how capable the improved process is performing. 3. Determine improvement validation using multi-vari analysis comparing the before process to the improved process to see if a statistically significant gain will be realized from implementing the proposed solutions. The test statistic used for improvement validation is dependent on the type of data. Follow the hypothesis testing roadmap as seen in the Analyze lesson of this course to help you choose which statistical test is appropriate for your data.

Validate Solutions (continued)

Step 4: Validate solutions (continued) The following is an example of a multi-vari analysis test to discern if there is a statistical difference in the before process and the after process: Chi-square test XYZ Human Resources Department completed a Six Sigma project to improve the employee turnover rate. Shown below are the results of comparing data for the last three-month period before improvements were made to the most recent three-month period after changes were implemented using a Chi-square table and Minitab: Ho: pb = pa Ha: pb > pa Sample 1 Employees 852 858.38 0.047 2 852 845.62 0.048 Total 1704 Turnovers 23 16.62 2.446 10 16.38 2.483 33 1737 862 Total 875

Chi-square = 5.024, df = 1, p-value = 0.025 The p-value of 0.025 < 0.05, so the null hypothesis is rejected (Ha: pb > pa). The employee turnover rate from the before process compared to the after process is statistically different, reflecting a lower turnover rate during the latter time period.

Control Plan Module: Learning Objectives

At the end of this Improve and Control topic, all learners will be able to assist in developing a control plan to document and hold the gains, and assist in implementing controls and monitoring systems.

Control Plan Introduction

A control plan is a written summary that explains the systems used to describe, monitor, and control a process. Control plans are critical to holding the gains of Six Sigma and ensure that improvements are sustained over time. The plans also identify continual opportunities within the process. If the gains are not held, all the efforts to make improvements and the time and effort spent learning Six Sigma processes are wasted! Therefore, it is imperative that Green Belts assure that control plans are robust and followed, allowing for continuing longterm competitiveness of the organization.

Control Plan Basics

The control plan: provides a systematic memory of the improved status of a process. provides for timely process troubleshooting and repair. describes the needed process controls to ensure that the project objectives are maintained over time. fosters process knowledge transfer to new process team members over time. facilitates training and audit activities. displays the targets controls and reaction plans to sustain process improvement. concentrates on the Xs to ensure that the customer Ys are met. describes actions needed to ensure that process owners sustain the gains of process improvement. documents the control activities of a Six Sigma project prior to completion.

The control plan is a collaborative effort created by the project team. As a Green Belt, remember to include representatives of all functions involved in the process, especially the process owner. Depending on the industry and the organization, control plans will vary in format and content. For the purpose of this course, typical control plan elements will be discussed. An action/control plan summarizes the: improved process depicting the process flow. key process indicators (metrics). responsibility of the Six Sigma project team members.

Control Plan Procedure

The following are steps in constructing a control plan. See below to learn more.

1. Describe the process.

The mailroom for At Your Service Bank receives commingled mail from the post office. The mail is then sorted by the cost center with return mail separated, bundled, and logged. The return mail is then routed to the respective business unit where it is reviewed for address changes.

2. List the process output user.

The departments within At Your Service Bank are the process output users.

3. List the department/persons. 4. Provide the process map. 5. Determine the specifications.

The departments with incoming/outgoing mail from At Your Service Bank are the persons required to perform the process steps.

Customer requirements: return mail volume of multiple customer relationship items is < 5% of total outgoing mail.

6. Determine the quality indicators.

Quality indicators are used such as control charts, frequency, and sample size to verify that the requirement is met (such as once a day, when the error occurs, 100%, etc.). Use an X-bar and R chart to track the number of return mail items from customers with multiple relationships with correct address and other account(s). Check 10 weekly samples.

7. Identify the process control method.

Review the multiple customer relationship report.

Examples of process control methods are reports, templates, forms, etc.

8. Identify the reportable condition. 9. Determine course of action.

Return mail volume of multiple customer relationship items > 5% of total outgoing mail. Submit a universal system exception note to the IT department to review the multiple relationship maintenance feature.

Improve and Control: Lesson Summary

Design of experiments The final phase of the DMAIC process is designed to help the Green Belt identify improvements and test them through the design of experiments (DOE), main effects, and interaction plots. Statistical process control The control portion of the phase provides tools to continue measuring the process and evaluate the results through the use of various control charts. Implement and validate solutions Solutions must be developed, tried, and implemented with the support of data. To accomplish this, solutions should be developed using a planned, systematic approach aimed at eliminating or reducing the impact of the identified root cause. Control plan A successful project is one in which the solutions are implemented, documented, and monitored to prevent the process from reverting to the previous pre-improvement state. The goal of the control phase is to "sustain the gain."